chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Sleep disorder, Urinary incontinence
Clinical narrative: "urinated in PJs"; did not have strength to get back up; slept very sound; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Mar-2021 and was forwarded to Moderna on 31-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (slept very sound), URINARY INCONTINENCE ("urinated in PJs") and ASTHENIA (did not have strength to get back up) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 002A21A) for COVID-19 vaccination.     The patient's past medical history included Hypertension (Controlled) since an unknown date, Sciatica, Arthritis and Cholesterol (Controlled). Concomitant products included GABAPENTIN, ATORVASTATIN, lanosterol, MELOXICAM, eye vitamin, AMLODIPINE and LOSARTAN for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 05-Mar-2021, the patient experienced SLEEP DISORDER (slept very sound). On 06-Mar-2021, the patient experienced ASTHENIA (did not have strength to get back up). On an unknown date, the patient experienced URINARY INCONTINENCE ("urinated in PJs"). At the time of the report, SLEEP DISORDER (slept very sound), URINARY INCONTINENCE ("urinated in PJs") and ASTHENIA (did not have strength to get back up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dysgeusia, Nausea, Vomiting
Clinical narrative: Sour taste in my mouth; Nausea; Vomit a few times; Sick to my stomach; 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 ABDOMINAL DISCOMFORT (Sick to my stomach), DYSGEUSIA (Sour taste in my mouth), NAUSEA (Nausea) and VOMITING (Vomit a few times) in a not specif 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 (no medication report were provided).    On 23-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 28-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (Sick to my stomach). On 29-Mar-2021, the patient experienced NAUSEA (Nausea) and VOMITING (Vomit a few times). On 30-Mar-2021, the patient experienced DYSGEUSIA (Sour taste in my mouth). At the time of the report, ABDOMINAL DISCOMFORT (Sick to my stomach), DYSGEUSIA (Sour taste in my mouth), NAUSEA (Nausea) and VOMITING (Vomit a few times) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Magnetic resonance imaging, Pyrexia
Clinical narrative: headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and PYREXIA (Fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Amoxcillin), Blood cholesterol increased and Paroxysmal atrial tachycardia. Concomitant products included LOVASTATIN and DILTIAZEM for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced HEADACHE (headache) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. On 04-May-2021, HEADACHE (headache) had resolved. At the time of the report, PYREXIA (Fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, Magnetic resonance imaging: normal (normal) normal.         Treatment mediations included Tylenol, Advil, and Aleve.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Patient demographics updated, medical history, lab data and outcome of the event updated.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site urticaria, Pruritus, Urticaria
Clinical narrative: hive behind her ear; itchy behind the left ear; big welt the size of an egg at the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Mar-2021 and was forwarded to Moderna on 31-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hive behind her ear), PRURITUS (itchy behind the left ear) and INJECTION SITE URTICARIA (big welt the size of an egg at the injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included unspecified cholesterol medication and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced INJECTION SITE URTICARIA (big welt the size of an egg at the injection site). On 07-Mar-2021, the patient experienced URTICARIA (hive behind her ear) and PRURITUS (itchy behind the left ear). On 31-Mar-2021, URTICARIA (hive behind her ear) and PRURITUS (itchy behind the left ear) had resolved. At the time of the report, INJECTION SITE URTICARIA (big welt the size of an egg at the injection site) 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.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cyst, Eye pain, Hordeolum
Clinical narrative: a cyst; stye on eyelid; pain in eyeballs; swollen on left side of neck; joint pain; swollen lymph nodes on right side of face; body aches; chills; fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Mar-2021 and was forwarded to the company on 31-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CYST (a cyst), HORDEOLUM (stye on eyelid), EYE PAIN (pain in eyeballs), SWELLING (swollen on left side of neck) and ARTHRALGIA (joint pain) in a 63-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.     Concomitant products included CEFALEXIN (CEPHALEXIN AMEL), SALICYLIC ACID, SULFUR (OINTMENT NO.1) and CORTICOSTEROIDS.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-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 CYST (a cyst), HORDEOLUM (stye on eyelid), EYE PAIN (pain in eyeballs), SWELLING (swollen on left side of neck), ARTHRALGIA (joint pain), LYMPHADENOPATHY (swollen lymph nodes on right side of face), MYALGIA (body aches), CHILLS (chills) and PYREXIA (fever). At the time of the report, CYST (a cyst), HORDEOLUM (stye on eyelid), EYE PAIN (pain in eyeballs), SWELLING (swollen on left side of neck), ARTHRALGIA (joint pain), LYMPHADENOPATHY (swollen lymph nodes on right side of face), MYALGIA (body aches), CHILLS (chills) and PYREXIA (fever) had not resolved.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Myalgia, Pyrexia, Swelling
Clinical narrative: a cyst; stye on eyelid; pain in eyeballs; swollen on left side of neck; joint pain; swollen lymph nodes on right side of face; body aches; chills; fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Mar-2021 and was forwarded to the company on 31-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CYST (a cyst), HORDEOLUM (stye on eyelid), EYE PAIN (pain in eyeballs), SWELLING (swollen on left side of neck) and ARTHRALGIA (joint pain) in a 63-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.     Concomitant products included CEFALEXIN (CEPHALEXIN AMEL), SALICYLIC ACID, SULFUR (OINTMENT NO.1) and CORTICOSTEROIDS.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-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 CYST (a cyst), HORDEOLUM (stye on eyelid), EYE PAIN (pain in eyeballs), SWELLING (swollen on left side of neck), ARTHRALGIA (joint pain), LYMPHADENOPATHY (swollen lymph nodes on right side of face), MYALGIA (body aches), CHILLS (chills) and PYREXIA (fever). At the time of the report, CYST (a cyst), HORDEOLUM (stye on eyelid), EYE PAIN (pain in eyeballs), SWELLING (swollen on left side of neck), ARTHRALGIA (joint pain), LYMPHADENOPATHY (swollen lymph nodes on right side of face), MYALGIA (body aches), CHILLS (chills) and PYREXIA (fever) had not resolved.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: I am pregnant and I received a Moderna Vaccine yesterday.; This spontaneous prospective pregnancy case was reported by an other (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (I am pregnant and I received a Moderna Vaccine yesterday.) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 15-Dec-2020 and the estimated date of delivery was 23-Sep-2021. On 30-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (I am pregnant and I received a Moderna Vaccine yesterday.). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifteenth week of the pregnancy.  On 30-Mar-2021, EXPOSURE DURING PREGNANCY (I am pregnant and I received a Moderna Vaccine yesterday.) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient would like to be a part of Moderna Pregnancy Registry concomitant product is not provided. treatment is not provided
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: Urinary tract infection; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Mar-2021 and was forwarded to Moderna on 31-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Urinary tract infection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 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 URINARY TRACT INFECTION (Urinary tract infection). At the time of the report, URINARY TRACT INFECTION (Urinary tract infection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment for the event included Nitrofurantoin twice a day for 7 days
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Body aches; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches), PYREXIA (Fever) and CHILLS (Chills) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 025A21A) for COVID-19 vaccination.     Medical history was not provided.  Concomitant products included CITALOPRAM for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced MYALGIA (Body aches) and PYREXIA (Fever). 30-Mar-2021, the patient experienced CHILLS (Chills). At the time of the report, MYALGIA (Body aches) had not resolved and PYREXIA (Fever) and CHILLS (Chills) had resolved.            Concomitant medications included unspecified contraceptive. Treatment details were not reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Groin pain
Clinical narrative: felt a pulling pain near her groin and had some trouble urinating; This spontaneous case was reported by a consumer and describes the occurrence of GROIN PAIN (felt a pulling pain near her groin and had some trouble urinating) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GROIN PAIN (felt a pulling pain near her groin and had some trouble urinating). At the time of the report, GROIN PAIN (felt a pulling pain near her groin and had some trouble urinating) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-062230 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Fatigue, Hyperhidrosis, Pain
Clinical narrative: Tired and sore; Tired and sore; shakes; sweating; diarrhea; TIired and slept most of Tuesday; aches and pains were more intense; Tired and slept most of tuesday; Fever of 101F, fever rose to 102 F; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Mar-2021 and was forwarded to Moderna on 31-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shakes), HYPERHIDROSIS (sweating), DIARRHOEA (diarrhea), PAIN (Tired and sore) and SOMNOLENCE (TIired and slept most of Tuesday) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sciatica and Arthroscopy (Orthoscopic surgery on knee). Concomitant products included NAPROXEN for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced TREMOR (shakes), HYPERHIDROSIS (sweating), DIARRHOEA (diarrhea), SOMNOLENCE (TIired and slept most of Tuesday), PAIN IN EXTREMITY (aches and pains were more intense), FATIGUE (Tired and slept most of tuesday) and PYREXIA (Fever of 101F, fever rose to 102 F). On 31-Mar-2021, the patient experienced PAIN (Tired and sore) and FATIGUE (Tired and sore). On 30-Mar-2021, TREMOR (shakes), HYPERHIDROSIS (sweating), DIARRHOEA (diarrhea), SOMNOLENCE (TIired and slept most of Tuesday), PAIN IN EXTREMITY (aches and pains were more intense), FATIGUE (Tired and slept most of tuesday) and PYREXIA (Fever of 101F, fever rose to 102 F) had resolved. At the time of the report, PAIN (Tired and sore) and FATIGUE (Tired and sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, Body temperature: 101 f High and 102 f High.         Treatment using acetaminophen and naproxen was reported
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Somnolence, Tremor
Clinical narrative: Tired and sore; Tired and sore; shakes; sweating; diarrhea; TIired and slept most of Tuesday; aches and pains were more intense; Tired and slept most of tuesday; Fever of 101F, fever rose to 102 F; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Mar-2021 and was forwarded to Moderna on 31-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shakes), HYPERHIDROSIS (sweating), DIARRHOEA (diarrhea), PAIN (Tired and sore) and SOMNOLENCE (TIired and slept most of Tuesday) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sciatica and Arthroscopy (Orthoscopic surgery on knee). Concomitant products included NAPROXEN for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced TREMOR (shakes), HYPERHIDROSIS (sweating), DIARRHOEA (diarrhea), SOMNOLENCE (TIired and slept most of Tuesday), PAIN IN EXTREMITY (aches and pains were more intense), FATIGUE (Tired and slept most of tuesday) and PYREXIA (Fever of 101F, fever rose to 102 F). On 31-Mar-2021, the patient experienced PAIN (Tired and sore) and FATIGUE (Tired and sore). On 30-Mar-2021, TREMOR (shakes), HYPERHIDROSIS (sweating), DIARRHOEA (diarrhea), SOMNOLENCE (TIired and slept most of Tuesday), PAIN IN EXTREMITY (aches and pains were more intense), FATIGUE (Tired and slept most of tuesday) and PYREXIA (Fever of 101F, fever rose to 102 F) had resolved. At the time of the report, PAIN (Tired and sore) and FATIGUE (Tired and sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, Body temperature: 101 f High and 102 f High.         Treatment using acetaminophen and naproxen was reported
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Skin exfoliation
Clinical narrative: started to experience reactions; Skin peeling both on hands and legs; This spontaneous case was reported by a consumer and describes the occurrence of SKIN EXFOLIATION (Skin peeling both on hands and legs) and ADVERSE REACTION (started to experience reactions) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included DULAGLUTIDE (TRULICITY), LOSARTAN, Aspirin prescribed every morning, PANTOPRAZOLE, Acorvastatin, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), MULTIVITAMIN & MINERAL and EZETIMIBE for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced SKIN EXFOLIATION (Skin peeling both on hands and legs). On an unknown date, the patient experienced ADVERSE REACTION (started to experience reactions). At the time of the report, SKIN EXFOLIATION (Skin peeling both on hands and legs) and ADVERSE REACTION (started to experience reactions) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       she applied lotion at the site of skin peeling . Treatment information was unknown. She was concerned with that peeling of skin and she wanted to know whether any of other patients who received moderna vaccine had the same symptoms.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Extensive rash over body, it is an urticarial rash and it is getting worse/; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Mar-2021 and was forwarded to Moderna on 31-Mar-2021.    This spontaneous case was reported by a health care professional and describes the occurrence of URTICARIA (Extensive rash over body, it is an urticarial rash and it is getting worse/) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced URTICARIA (Extensive rash over body, it is an urticarial rash and it is getting worse/). At the time of the report, URTICARIA (Extensive rash over body, it is an urticarial rash and it is getting worse/) 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.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Myalgia, Sensory loss, Skin sensitisation
Clinical narrative: second dose was given 8 weeks after first one; changes in nerves in the skin of arms and legs; skin is more sensitive as usual; muscle aches; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Mar-2021 and was forwarded to Moderna on 31-Mar-2021.    This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was given 8 weeks after first one), SENSORY LOSS (changes in nerves in the skin of arms and legs), SKIN SENSITISATION (skin is more sensitive as usual) and MYALGIA (muscle aches) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 24M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medication history reported).   On 02-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 an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was given 8 weeks after first one), SENSORY LOSS (changes in nerves in the skin of arms and legs), SKIN SENSITISATION (skin is more sensitive as usual) and MYALGIA (muscle aches). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was given 8 weeks after first one), SENSORY LOSS (changes in nerves in the skin of arms and legs), SKIN SENSITISATION (skin is more sensitive as usual) and MYALGIA (muscle aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by the reporter  Treatment included Tylenol
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Fatigue, Headache
Clinical narrative: cold sweats (drenched in sweat); fatigue; headaches; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (cold sweats (drenched in sweat)), FATIGUE (fatigue) and HEADACHE (headaches) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced COLD SWEAT (cold sweats (drenched in sweat)), FATIGUE (fatigue) and HEADACHE (headaches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COLD SWEAT (cold sweats (drenched in sweat)), FATIGUE (fatigue) and HEADACHE (headaches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: initial additional document. Outcome of event updated.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Nausea, Product dose omission issue
Clinical narrative: patient has not received the 2nd Dose > 35 days after the 1st Dose; Patient started experiencing fatigue; worsening nausea; worsening headache; worsening joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patient has not received the 2nd Dose > 35 days after the 1st Dose), FATIGUE (Patient started experiencing fatigue), NAUSEA (worsening nausea), HEADACHE (worsening headache) and ARTHRALGIA (worsening joint pain) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in September 2020. Concurrent medical conditions included Autoimmune disorder and Blood pressure high (high blood pressure).    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced FATIGUE (Patient started experiencing fatigue), NAUSEA (worsening nausea), HEADACHE (worsening headache) and ARTHRALGIA (worsening joint pain). On 24-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient has not received the 2nd Dose > 35 days after the 1st Dose). On 24-Mar-2021, PRODUCT DOSE OMISSION ISSUE (patient has not received the 2nd Dose > 35 days after the 1st Dose) had resolved. At the time of the report, FATIGUE (Patient started experiencing fatigue), NAUSEA (worsening nausea), HEADACHE (worsening headache) and ARTHRALGIA (worsening joint pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the current available information and temporal association between the use of the product and the start dates of the events of nausea, arthralgia, fatigue and headache, a causal relationship cannot be excluded. This report also refers to an event of dose omission.  There were no AEs specifically associated with this medication error  Concomitant medications included thyroid medications, high blood pressure medications.  Treatment medication was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Additional information received on 03-May-2021 received as email address was updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events of nausea, arthralgia, fatigue and headache, a causal relationship cannot be excluded. This report also refers to an event of dose omission.  There were no AEs specifically associated with this medication error
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-064106 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow up received on 12 May 2021 included no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-064106:Mother case
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Vaccination site pain
Clinical narrative: Left upper arm and chest developed a rash; Arm sore; Fever middle of the night; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Mar-2021 and was forwarded to Moderna on 31-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH (Left upper arm and chest developed a rash), VACCINATION SITE PAIN (Arm sore) and PYREXIA (Fever middle of the night) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Historical condition not reported.).    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION SITE PAIN (Arm sore) and PYREXIA (Fever middle of the night). On 26-Mar-2021, the patient experienced RASH (Left upper arm and chest developed a rash). On 16-Mar-2021, VACCINATION SITE PAIN (Arm sore) and PYREXIA (Fever middle of the night) outcome was unknown. At the time of the report, RASH (Left upper arm and chest developed a rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment Caller states taking Saturday Zyrtec to help relieve side effects.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test negative
Clinical narrative: Anti-body blood screen was non-reactive; This spontaneous case was reported by a nurse and describes the occurrence of ANTIBODY TEST NEGATIVE (Anti-body blood screen was non-reactive) 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 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANTIBODY TEST NEGATIVE (Anti-body blood screen was non-reactive). At the time of the report, ANTIBODY TEST NEGATIVE (Anti-body blood screen was non-reactive) outcome was unknown. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided. No relevant concomitant medications reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Dec-2020, the patient experienced NAUSEA (Nausea). On 31-Dec-2020, NAUSEA (Nausea) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash on lower back/ Chin/ Ankle after 1st dose; Hives after 1st dose; Hot and itchy rash after 1st dose; This spontaneous case was reported by a health care professional and describes the occurrence of RASH (Rash on lower back/ Chin/ Ankle after 1st dose), URTICARIA (Hives after 1st dose) and PRURITUS (Hot and itchy rash after 1st dose) 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 RASH (Rash on lower back/ Chin/ Ankle after 1st dose), URTICARIA (Hives after 1st dose) and PRURITUS (Hot and itchy rash after 1st dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) at an unspecified dose and frequency and HYDROCORTISONE (topical) at an unspecified dose and frequency. At the time of the report, RASH (Rash on lower back/ Chin/ Ankle after 1st dose), URTICARIA (Hives after 1st dose) and PRURITUS (Hot and itchy rash after 1st dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction) 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 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic reaction). At the time of the report, HYPERSENSITIVITY (Allergic reaction) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided. No relevant concomitant medications reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Soreness on injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Soreness on injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 043L20A) for COVID-19 vaccination.     Concurrent medical conditions included Pre-existing disease (pre-existing medical conditions). Concomitant products included DIAZEPAM (VALIUM) 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 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced INJECTION SITE PAIN (Soreness on injection site). At the time of the report, INJECTION SITE PAIN (Soreness on injection site) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.   The patient's concomitant medications included gout medications and muscle relaxants. The patient did not received treatment medications and did not suffer any other ill effects from the vaccine.   This case was linked to MOD-2021-062264 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Initial Additional-1-Possible NNI
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Vaccination site was red; Vaccination site was raised; Vaccination site was bruised; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Vaccination site was red), VACCINATION SITE SWELLING (Vaccination site was raised) and VACCINATION SITE BRUISING (Vaccination site was bruised) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Vaccination site was red), VACCINATION SITE SWELLING (Vaccination site was raised) and VACCINATION SITE BRUISING (Vaccination site was bruised). At the time of the report, VACCINATION SITE ERYTHEMA (Vaccination site was red), VACCINATION SITE SWELLING (Vaccination site was raised) and VACCINATION SITE BRUISING (Vaccination site was bruised) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No treatment information was provided. No relevant concomitant medications reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Myalgia
Clinical narrative: arm is red/pink; arm is sore/stiff; arm feels warm to touch/Under the weather and logey; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm is red/pink), MYALGIA (arm is sore/stiff) and FEELING HOT (arm feels warm to touch/Under the weather and logey) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced MYALGIA (arm is sore/stiff) and FEELING HOT (arm feels warm to touch/Under the weather and logey). On 31-Mar-2021, the patient experienced ERYTHEMA (arm is red/pink). At the time of the report, ERYTHEMA (arm is red/pink), MYALGIA (arm is sore/stiff) and FEELING HOT (arm feels warm to touch/Under the weather and logey) outcome was unknown. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided. No relevant concomitant medications reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Hot/spreading rash on left arm; Broke out in hives; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Hot/spreading rash on left arm) and URTICARIA (Broke out in hives) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included Hives. Concurrent medical conditions included Allergy to antibiotic (Antibiotics).    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced RASH (Hot/spreading rash on left arm) and URTICARIA (Broke out in hives). At the time of the report, RASH (Hot/spreading rash on left arm) and URTICARIA (Broke out in hives) outcome was unknown.        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: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Pruritus, Rash
Clinical narrative: rash; itching; red; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash), PAIN IN EXTREMITY (sore arm), PRURITUS (itching) and ERYTHEMA (red) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergy to sulfur). Concomitant products included METOPROLOL TARTRATE for Hypertension, LEVOTHYROXINE SODIUM for Hypothyroidism, GABAPENTIN (NEURONTIN), MECLIZINE HCL and ALPRAZOLAM for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 31-Mar-2021, the patient experienced RASH (rash), PRURITUS (itching) and ERYTHEMA (red). At the time of the report, RASH (rash), PAIN IN EXTREMITY (sore arm), PRURITUS (itching) and ERYTHEMA (red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details include antihistamine.   This case was linked to MOD21-066716 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: extreme itching; inch diamond shape round which is hard and warm to touch; Lower arm is swollen; Flushing feverish; nausea; fatigue; severe pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (severe pain in arm), PRURITUS (extreme itching), SWELLING (inch diamond shape round which is hard and warm to touch), PERIPHERAL SWELLING (Lower arm is swollen) and PYREXIA (Flushing feverish) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 01B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced PAIN IN EXTREMITY (severe pain in arm), PYREXIA (Flushing feverish), NAUSEA (nausea) and FATIGUE (fatigue). On 31-Mar-2021, the patient experienced PRURITUS (extreme itching), SWELLING (inch diamond shape round which is hard and warm to touch) and PERIPHERAL SWELLING (Lower arm is swollen). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 29-Mar-2021, PAIN IN EXTREMITY (severe pain in arm), PYREXIA (Flushing feverish), NAUSEA (nausea) and FATIGUE (fatigue) had resolved. At the time of the report, PRURITUS (extreme itching), SWELLING (inch diamond shape round which is hard and warm to touch) and PERIPHERAL SWELLING (Lower arm is swollen) outcome was unknown.            Treatment  drugs used Benadryl cream, cold moistened washcloth Action taken for  mRNA-1273 vaccine t was not applicable. no concomitant medication was given by the reporter   This case was linked to US-MODERNATX, INC.-MOD-2021-065017 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow up included no new information; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-065017:1st dose case
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling
Clinical narrative: extreme itching; inch diamond shape round which is hard and warm to touch; Lower arm is swollen; Flushing feverish; nausea; fatigue; severe pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (severe pain in arm), PRURITUS (extreme itching), SWELLING (inch diamond shape round which is hard and warm to touch), PERIPHERAL SWELLING (Lower arm is swollen) and PYREXIA (Flushing feverish) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 01B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced PAIN IN EXTREMITY (severe pain in arm), PYREXIA (Flushing feverish), NAUSEA (nausea) and FATIGUE (fatigue). On 31-Mar-2021, the patient experienced PRURITUS (extreme itching), SWELLING (inch diamond shape round which is hard and warm to touch) and PERIPHERAL SWELLING (Lower arm is swollen). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 29-Mar-2021, PAIN IN EXTREMITY (severe pain in arm), PYREXIA (Flushing feverish), NAUSEA (nausea) and FATIGUE (fatigue) had resolved. At the time of the report, PRURITUS (extreme itching), SWELLING (inch diamond shape round which is hard and warm to touch) and PERIPHERAL SWELLING (Lower arm is swollen) outcome was unknown.            Treatment  drugs used Benadryl cream, cold moistened washcloth Action taken for  mRNA-1273 vaccine t was not applicable. no concomitant medication was given by the reporter   This case was linked to US-MODERNATX, INC.-MOD-2021-065017 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow up included no new information; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-065017:1st dose case
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on cheeks, around eyes, on abdomen, legs, under breast; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on cheeks, around eyes, on abdomen, legs, under breast) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No medical history provided by the reporter.  Concomitant products included ESOMEPRAZOLE for an unknown indication.   On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced RASH (Rash on cheeks, around eyes, on abdomen, legs, under breast). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash generalised, at an unspecified dose and frequency. At the time of the report, RASH (Rash on cheeks, around eyes, on abdomen, legs, under breast) had not resolved.            Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: TCR document received on 26-jun-2021 has no new information