chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Multiple allergies, Oxygen saturation, Oxygen saturation decreased
Clinical narrative: Condition aggravated; Allergies; Eyes  was burning; Checked  her oxygen and was little low; She slept more; Mild cough; More fatigue/ tiredness; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Condition aggravated), MULTIPLE ALLERGIES (Allergies), EYE IRRITATION (Eyes  was burning), OXYGEN SATURATION DECREASED (Checked  her oxygen and was little low) and HYPERSOMNIA (She slept more) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD and Seasonal allergy (Patient has nose running constantly, little cough, eyes burning  due to spring.).   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CONDITION AGGRAVATED (Condition aggravated), MULTIPLE ALLERGIES (Allergies), EYE IRRITATION (Eyes  was burning), OXYGEN SATURATION DECREASED (Checked  her oxygen and was little low), HYPERSOMNIA (She slept more), COUGH (Mild cough) and FATIGUE (More fatigue/ tiredness). At the time of the report, CONDITION AGGRAVATED (Condition aggravated), MULTIPLE ALLERGIES (Allergies), EYE IRRITATION (Eyes  was burning), OXYGEN SATURATION DECREASED (Checked  her oxygen and was little low), HYPERSOMNIA (She slept more), COUGH (Mild cough) and FATIGUE (More fatigue/ tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Oxygen saturation: normal (normal) Patient checked her oxygen  level was fine. On 08-Apr-2021, Oxygen saturation: low (Low) After second dose patient oxygen was low.          No treatment information was provided. No relevant concomitant medications were reported.   This case was linked to MOD-2021-080402 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Blister, Cholelithiasis, Pain in extremity
Clinical narrative: gallbladder stones; broke out with blisters; pain in arm / sore arm; This spontaneous case was reported by an other and describes the occurrence of CHOLELITHIASIS (gallbladder stones), BLISTER (broke out with blisters) and PAIN IN EXTREMITY (pain in arm / sore arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Alcohol use (two to three glasses of wine or champagne. No tobacco.) and Drug allergy (Allergy with Codeine manifested by break out with rash on the palm and hand.). Concomitant products included SIMVASTATIN for High cholesterol, LISINOPRIL for Hypertension, UPADACITINIB (RINVOQ) for Rheumatoid arthritis, KRILL OIL (MEGARED OMEGA 3 KRILL OIL) for Vitamin supplementation, HYDROCODONE BITARTRATE;PARACETAMOL for an unknown indication.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (pain in arm / sore arm). On 29-Mar-2021, the patient experienced BLISTER (broke out with blisters). On an unknown date, the patient experienced CHOLELITHIASIS (gallbladder stones). In March 2021, PAIN IN EXTREMITY (pain in arm / sore arm) had resolved. At the time of the report, CHOLELITHIASIS (gallbladder stones) and BLISTER (broke out with blisters) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PAIN IN EXTREMITY (pain in arm / sore arm) to be possibly related. No further causality assessments were provided for CHOLELITHIASIS (gallbladder stones) and BLISTER (broke out with blisters).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Chest pain, Dyspnoea, Headache, Pain in extremity
Clinical narrative: shortness of breath; chest pain; low humming in the left ear; abdominal fullness; headache; pain in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the left arm), DYSPNOEA (shortness of breath), CHEST PAIN (chest pain), TINNITUS (low humming in the left ear) and ABDOMINAL DISTENSION (abdominal fullness) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in the left arm). On an unknown date, the patient experienced DYSPNOEA (shortness of breath), CHEST PAIN (chest pain), TINNITUS (low humming in the left ear), ABDOMINAL DISTENSION (abdominal fullness) and HEADACHE (headache). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (pain in the left arm) had resolved and DYSPNOEA (shortness of breath), CHEST PAIN (chest pain), TINNITUS (low humming in the left ear), ABDOMINAL DISTENSION (abdominal fullness) and HEADACHE (headache) outcome was unknown. Not Provided          This case was linked to US-MODERNATX, INC.-MOD-2021-080393, US-MODERNATX, INC.-MOD-2021-080027 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080393:case for first dose US-MODERNATX, INC.-MOD-2021-080027:wife case
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: shortness of breath; chest pain; low humming in the left ear; abdominal fullness; headache; pain in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the left arm), DYSPNOEA (shortness of breath), CHEST PAIN (chest pain), TINNITUS (low humming in the left ear) and ABDOMINAL DISTENSION (abdominal fullness) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in the left arm). On an unknown date, the patient experienced DYSPNOEA (shortness of breath), CHEST PAIN (chest pain), TINNITUS (low humming in the left ear), ABDOMINAL DISTENSION (abdominal fullness) and HEADACHE (headache). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (pain in the left arm) had resolved and DYSPNOEA (shortness of breath), CHEST PAIN (chest pain), TINNITUS (low humming in the left ear), ABDOMINAL DISTENSION (abdominal fullness) and HEADACHE (headache) outcome was unknown. Not Provided          This case was linked to US-MODERNATX, INC.-MOD-2021-080393, US-MODERNATX, INC.-MOD-2021-080027 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080393:case for first dose US-MODERNATX, INC.-MOD-2021-080027:wife case
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Anxiety, Crying, Daydreaming, Dyspnoea
Clinical narrative: Vision issue; Difficulty in breathing due to anxiety; Thyroid was swollen however, today it is back to normal; Taste bud are decreased where food does not taste the same; Brain fog; PSTD; Visional dreams where she relives them during the day; Anxiety issues/High levels of anxiety; Emotional issues were she has uncontrollable crying; Lack of sleep; Acne break out that is painful; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VISUAL IMPAIRMENT (Vision issue), DYSPNOEA (Difficulty in breathing due to anxiety), GOITRE (Thyroid was swollen however, today it is back to normal), TASTE DISORDER (Taste bud are decreased where food does not taste the same) and FEELING ABNORMAL (Brain fog) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045ABLA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Oral surgery in February 2021. Concurrent medical conditions included Post-traumatic stress disorder and Anxiety.    On 02-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 VISUAL IMPAIRMENT (Vision issue), DYSPNOEA (Difficulty in breathing due to anxiety), GOITRE (Thyroid was swollen however, today it is back to normal), TASTE DISORDER (Taste bud are decreased where food does not taste the same), FEELING ABNORMAL (Brain fog), POST-TRAUMATIC STRESS DISORDER (PSTD), DAYDREAMING (Visional dreams where she relives them during the day), ANXIETY (Anxiety issues/High levels of anxiety), CRYING (Emotional issues were she has uncontrollable crying), INSOMNIA (Lack of sleep) and ACNE (Acne break out that is painful). On 19-Apr-2021, GOITRE (Thyroid was swollen however, today it is back to normal) had resolved. At the time of the report, VISUAL IMPAIRMENT (Vision issue), DYSPNOEA (Difficulty in breathing due to anxiety), TASTE DISORDER (Taste bud are decreased where food does not taste the same), FEELING ABNORMAL (Brain fog), POST-TRAUMATIC STRESS DISORDER (PSTD), DAYDREAMING (Visional dreams where she relives them during the day), ANXIETY (Anxiety issues/High levels of anxiety), CRYING (Emotional issues were she has uncontrollable crying), INSOMNIA (Lack of sleep) and ACNE (Acne break out that is painful) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Goitre, Insomnia, Post-traumatic stress disorder, Taste disorder
Clinical narrative: Vision issue; Difficulty in breathing due to anxiety; Thyroid was swollen however, today it is back to normal; Taste bud are decreased where food does not taste the same; Brain fog; PSTD; Visional dreams where she relives them during the day; Anxiety issues/High levels of anxiety; Emotional issues were she has uncontrollable crying; Lack of sleep; Acne break out that is painful; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VISUAL IMPAIRMENT (Vision issue), DYSPNOEA (Difficulty in breathing due to anxiety), GOITRE (Thyroid was swollen however, today it is back to normal), TASTE DISORDER (Taste bud are decreased where food does not taste the same) and FEELING ABNORMAL (Brain fog) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045ABLA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Oral surgery in February 2021. Concurrent medical conditions included Post-traumatic stress disorder and Anxiety.    On 02-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 VISUAL IMPAIRMENT (Vision issue), DYSPNOEA (Difficulty in breathing due to anxiety), GOITRE (Thyroid was swollen however, today it is back to normal), TASTE DISORDER (Taste bud are decreased where food does not taste the same), FEELING ABNORMAL (Brain fog), POST-TRAUMATIC STRESS DISORDER (PSTD), DAYDREAMING (Visional dreams where she relives them during the day), ANXIETY (Anxiety issues/High levels of anxiety), CRYING (Emotional issues were she has uncontrollable crying), INSOMNIA (Lack of sleep) and ACNE (Acne break out that is painful). On 19-Apr-2021, GOITRE (Thyroid was swollen however, today it is back to normal) had resolved. At the time of the report, VISUAL IMPAIRMENT (Vision issue), DYSPNOEA (Difficulty in breathing due to anxiety), TASTE DISORDER (Taste bud are decreased where food does not taste the same), FEELING ABNORMAL (Brain fog), POST-TRAUMATIC STRESS DISORDER (PSTD), DAYDREAMING (Visional dreams where she relives them during the day), ANXIETY (Anxiety issues/High levels of anxiety), CRYING (Emotional issues were she has uncontrollable crying), INSOMNIA (Lack of sleep) and ACNE (Acne break out that is painful) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Vision issue; Difficulty in breathing due to anxiety; Thyroid was swollen however, today it is back to normal; Taste bud are decreased where food does not taste the same; Brain fog; PSTD; Visional dreams where she relives them during the day; Anxiety issues/High levels of anxiety; Emotional issues were she has uncontrollable crying; Lack of sleep; Acne break out that is painful; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VISUAL IMPAIRMENT (Vision issue), DYSPNOEA (Difficulty in breathing due to anxiety), GOITRE (Thyroid was swollen however, today it is back to normal), TASTE DISORDER (Taste bud are decreased where food does not taste the same) and FEELING ABNORMAL (Brain fog) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045ABLA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Oral surgery in February 2021. Concurrent medical conditions included Post-traumatic stress disorder and Anxiety.    On 02-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 VISUAL IMPAIRMENT (Vision issue), DYSPNOEA (Difficulty in breathing due to anxiety), GOITRE (Thyroid was swollen however, today it is back to normal), TASTE DISORDER (Taste bud are decreased where food does not taste the same), FEELING ABNORMAL (Brain fog), POST-TRAUMATIC STRESS DISORDER (PSTD), DAYDREAMING (Visional dreams where she relives them during the day), ANXIETY (Anxiety issues/High levels of anxiety), CRYING (Emotional issues were she has uncontrollable crying), INSOMNIA (Lack of sleep) and ACNE (Acne break out that is painful). On 19-Apr-2021, GOITRE (Thyroid was swollen however, today it is back to normal) had resolved. At the time of the report, VISUAL IMPAIRMENT (Vision issue), DYSPNOEA (Difficulty in breathing due to anxiety), TASTE DISORDER (Taste bud are decreased where food does not taste the same), FEELING ABNORMAL (Brain fog), POST-TRAUMATIC STRESS DISORDER (PSTD), DAYDREAMING (Visional dreams where she relives them during the day), ANXIETY (Anxiety issues/High levels of anxiety), CRYING (Emotional issues were she has uncontrollable crying), INSOMNIA (Lack of sleep) and ACNE (Acne break out that is painful) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Fatigue, Headache
Clinical narrative: Pain behind her eyes; Headache on top of her head; Little tired; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (Pain behind her eyes), HEADACHE (Headache on top of her head) and FATIGUE (Little tired) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01832A) for COVID-19 vaccination.     No medical history provided.  Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), ASCORBIC ACID, BIOFLAVONOIDS NOS (VITAMIN C [ASCORBIC ACID;BIOFLAVONOIDS NOS]) and MANUKA HONEY for an unknown indication.   On 25-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 25-Mar-2021, the patient experienced EYE PAIN (Pain behind her eyes), HEADACHE (Headache on top of her head) and FATIGUE (Little tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, EYE PAIN (Pain behind her eyes), HEADACHE (Headache on top of her head) and FATIGUE (Little tired) outcome was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Eating disorder symptom, Headache, Hypotension, Injection site erythema
Clinical narrative: lost 2 pounds; injection site is red; headache; very lethargic; did not want to eat; craving for salt; blood pressure dropping 116/60mmHg to 86/64mmHg within first 24 hours of receiving; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (very lethargic), EATING DISORDER SYMPTOM (did not want to eat), SALT CRAVING (craving for salt), WEIGHT DECREASED (lost 2 pounds) and HYPOTENSION (blood pressure dropping 116/60mmHg to 86/64mmHg within first 24 hours of receiving) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026a21a and 031m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Blood pressure low. Concomitant products included XYLOMETAZOLINE HYDROCHLORIDE (NASAL SPRAY II) for Allergy, VITAMIN B6 and ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) for an unknown indication.   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) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced HYPOTENSION (blood pressure dropping 116/60mmHg to 86/64mmHg within first 24 hours of receiving). On 06-Apr-2021, the patient experienced LETHARGY (very lethargic), EATING DISORDER SYMPTOM (did not want to eat), SALT CRAVING (craving for salt) and HEADACHE (headache). On 07-Apr-2021, the patient experienced WEIGHT DECREASED (lost 2 pounds) and INJECTION SITE ERYTHEMA (injection site is red). On 06-Apr-2021, HYPOTENSION (blood pressure dropping 116/60mmHg to 86/64mmHg within first 24 hours of receiving) had resolved. On 07-Apr-2021, LETHARGY (very lethargic) and EATING DISORDER SYMPTOM (did not want to eat) had resolved. On 16-Apr-2021, HEADACHE (headache) had resolved. At the time of the report, SALT CRAVING (craving for salt), WEIGHT DECREASED (lost 2 pounds) and INJECTION SITE ERYTHEMA (injection site is red) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Blood pressure measurement: 86/64 mmHg (abnormal) low. On 07-Apr-2021, Blood pressure measurement: 97/62 mmHg (abnormal) low and 113/64 mmHg (abnormal) low.         Concomitant product used was nasal spray for allergies, vitamin b6 and vitamin c No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-069816 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: adding MOD21-077549 per MI reconevents and events outcome was updated.concomitant drugs were updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-069816:friends case
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Salt craving, Weight decreased
Clinical narrative: lost 2 pounds; injection site is red; headache; very lethargic; did not want to eat; craving for salt; blood pressure dropping 116/60mmHg to 86/64mmHg within first 24 hours of receiving; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (very lethargic), EATING DISORDER SYMPTOM (did not want to eat), SALT CRAVING (craving for salt), WEIGHT DECREASED (lost 2 pounds) and HYPOTENSION (blood pressure dropping 116/60mmHg to 86/64mmHg within first 24 hours of receiving) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026a21a and 031m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Blood pressure low. Concomitant products included XYLOMETAZOLINE HYDROCHLORIDE (NASAL SPRAY II) for Allergy, VITAMIN B6 and ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) for an unknown indication.   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) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced HYPOTENSION (blood pressure dropping 116/60mmHg to 86/64mmHg within first 24 hours of receiving). On 06-Apr-2021, the patient experienced LETHARGY (very lethargic), EATING DISORDER SYMPTOM (did not want to eat), SALT CRAVING (craving for salt) and HEADACHE (headache). On 07-Apr-2021, the patient experienced WEIGHT DECREASED (lost 2 pounds) and INJECTION SITE ERYTHEMA (injection site is red). On 06-Apr-2021, HYPOTENSION (blood pressure dropping 116/60mmHg to 86/64mmHg within first 24 hours of receiving) had resolved. On 07-Apr-2021, LETHARGY (very lethargic) and EATING DISORDER SYMPTOM (did not want to eat) had resolved. On 16-Apr-2021, HEADACHE (headache) had resolved. At the time of the report, SALT CRAVING (craving for salt), WEIGHT DECREASED (lost 2 pounds) and INJECTION SITE ERYTHEMA (injection site is red) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Blood pressure measurement: 86/64 mmHg (abnormal) low. On 07-Apr-2021, Blood pressure measurement: 97/62 mmHg (abnormal) low and 113/64 mmHg (abnormal) low.         Concomitant product used was nasal spray for allergies, vitamin b6 and vitamin c No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-069816 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: adding MOD21-077549 per MI reconevents and events outcome was updated.concomitant drugs were updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-069816:friends case
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on both arms and the back of both of her legs; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on both arms and the back of both of her legs) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced RASH (rash on both arms and the back of both of her legs). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) at an unspecified dose and frequency. At the time of the report, RASH (rash on both arms and the back of both of her legs) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication Benadryl
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis, Injection site pain, Myalgia, Skin irritation, Vaccination site haemorrhage
Clinical narrative: skin irritated; skin inflamed; bleeding; bit of sore arm; Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of SKIN IRRITATION (skin irritated), DERMATITIS (skin inflamed), VACCINATION SITE HAEMORRHAGE (bleeding), MYALGIA (bit of sore arm) and INJECTION SITE PAIN (Injection site pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 SKIN IRRITATION (skin irritated), DERMATITIS (skin inflamed), VACCINATION SITE HAEMORRHAGE (bleeding), MYALGIA (bit of sore arm) and INJECTION SITE PAIN (Injection site pain). At the time of the report, SKIN IRRITATION (skin irritated), DERMATITIS (skin inflamed), VACCINATION SITE HAEMORRHAGE (bleeding) and MYALGIA (bit of sore arm) outcome was unknown and INJECTION SITE PAIN (Injection site pain) had resolved.            This case was linked to US-MODERNATX, INC.-MOD-2021-080392 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2021: New event and its outcome is added; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080392:dose 1
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling abnormal, Head discomfort, Mass, Tinnitus
Clinical narrative: Felt a ball or mass that moved through his head; ringing in ears; felt like something hit him on back of head; changed position of head and felt something move inside his head, felt like it floated through his head, pushed head forward; shortness of breath, somewhat having difficulty of breathing; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Apr-2021 and was forwarded to Moderna on 19-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in ears), FEELING ABNORMAL (felt like something hit him on back of head), HEAD DISCOMFORT (changed position of head and felt something move inside his head, felt like it floated through his head, pushed head forward), DYSPNOEA (shortness of breath, somewhat having difficulty of breathing) and MASS (Felt a ball or mass that moved through his head) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included Fall on 05-Mar-2021. Concomitant products included IBUPROFEN from an unknown date to 16-Apr-2021 for Pain and Fall.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced DYSPNOEA (shortness of breath, somewhat having difficulty of breathing). On 16-Apr-2021, the patient experienced TINNITUS (ringing in ears), FEELING ABNORMAL (felt like something hit him on back of head) and HEAD DISCOMFORT (changed position of head and felt something move inside his head, felt like it floated through his head, pushed head forward). On 19-Apr-2021, the patient experienced MASS (Felt a ball or mass that moved through his head). At the time of the report, TINNITUS (ringing in ears), FEELING ABNORMAL (felt like something hit him on back of head), HEAD DISCOMFORT (changed position of head and felt something move inside his head, felt like it floated through his head, pushed head forward), DYSPNOEA (shortness of breath, somewhat having difficulty of breathing) and MASS (Felt a ball or mass that moved through his head) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: events was updated , contact information was updated.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Nausea
Clinical narrative: Tremor; constantlyThirsty; Nausea; Joint pain; Pain in arm; Chills; Headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of THIRST (constantlyThirsty), PAIN IN EXTREMITY (Pain in arm), TREMOR (Tremor), CHILLS (Chills) and HEADACHE (Headache) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B(UA)) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LISINOPRIL, SIMVASTATIN and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 16-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (fatigue). On 17-Apr-2021, the patient experienced THIRST (constantlyThirsty), TREMOR (Tremor), NAUSEA (Nausea) and ARTHRALGIA (Joint pain). On 17-Apr-2021, PAIN IN EXTREMITY (Pain in arm), HEADACHE (Headache) and FATIGUE (fatigue) had resolved. On 18-Apr-2021, THIRST (constantlyThirsty), TREMOR (Tremor), CHILLS (Chills), NAUSEA (Nausea) and ARTHRALGIA (Joint pain) had resolved.            Treatment drug: PARACETAMOL taken by the patient .   This case was linked to US-MODERNATX, INC.-MOD-2021-080414 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080414:FIRST DOSE
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Thirst, Tremor
Clinical narrative: Tremor; constantlyThirsty; Nausea; Joint pain; Pain in arm; Chills; Headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of THIRST (constantlyThirsty), PAIN IN EXTREMITY (Pain in arm), TREMOR (Tremor), CHILLS (Chills) and HEADACHE (Headache) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B(UA)) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LISINOPRIL, SIMVASTATIN and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 16-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (fatigue). On 17-Apr-2021, the patient experienced THIRST (constantlyThirsty), TREMOR (Tremor), NAUSEA (Nausea) and ARTHRALGIA (Joint pain). On 17-Apr-2021, PAIN IN EXTREMITY (Pain in arm), HEADACHE (Headache) and FATIGUE (fatigue) had resolved. On 18-Apr-2021, THIRST (constantlyThirsty), TREMOR (Tremor), CHILLS (Chills), NAUSEA (Nausea) and ARTHRALGIA (Joint pain) had resolved.            Treatment drug: PARACETAMOL taken by the patient .   This case was linked to US-MODERNATX, INC.-MOD-2021-080414 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080414:FIRST DOSE
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: 6 hours of not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (6 hours of not feeling well) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MALAISE (6 hours of not feeling well). On 05-Feb-2021, MALAISE (6 hours of not feeling well) had resolved.   Action taken with mRNA-1273 in response to the events was not applicable     No concomitant medications were reported.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: follow-up was received on 20-MAY-2021 which had no new information.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Malaise, Muscular weakness
Clinical narrative: Dizziness; does not feel well; tired; nausea; muscle pain; drain; muscle weakness; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (drain), MUSCULAR WEAKNESS (muscle weakness), DIZZINESS (Dizziness), MALAISE (does not feel well) and PYREXIA (Fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included High cholesterol. Concomitant products included EVOLOCUMAB (REPATHA) for an unknown indication.   On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced PYREXIA (Fever). On 16-Apr-2021, the patient experienced ASTHENIA (drain), MUSCULAR WEAKNESS (muscle weakness), MYALGIA (muscle pain) and NAUSEA (nausea). On an unknown date, the patient experienced DIZZINESS (Dizziness), MALAISE (does not feel well) and FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL) on 08-Apr-2021 for Fever, at an unspecified dose and frequency. At the time of the report, ASTHENIA (drain), MUSCULAR WEAKNESS (muscle weakness), DIZZINESS (Dizziness), MALAISE (does not feel well), PYREXIA (Fever), MYALGIA (muscle pain), FATIGUE (tired) and NAUSEA (nausea) had resolved.            No concomitant medications were reported.  No treatment information was reported.    Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow up received contain outcome of the events such as Asthenia, Muscular weakness, Dizziness, Malaise, Pyrexia, Myalgia, Fatigue, Nausea to recovered/ resolved.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Dizziness; does not feel well; tired; nausea; muscle pain; drain; muscle weakness; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (drain), MUSCULAR WEAKNESS (muscle weakness), DIZZINESS (Dizziness), MALAISE (does not feel well) and PYREXIA (Fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included High cholesterol. Concomitant products included EVOLOCUMAB (REPATHA) for an unknown indication.   On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced PYREXIA (Fever). On 16-Apr-2021, the patient experienced ASTHENIA (drain), MUSCULAR WEAKNESS (muscle weakness), MYALGIA (muscle pain) and NAUSEA (nausea). On an unknown date, the patient experienced DIZZINESS (Dizziness), MALAISE (does not feel well) and FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL) on 08-Apr-2021 for Fever, at an unspecified dose and frequency. At the time of the report, ASTHENIA (drain), MUSCULAR WEAKNESS (muscle weakness), DIZZINESS (Dizziness), MALAISE (does not feel well), PYREXIA (Fever), MYALGIA (muscle pain), FATIGUE (tired) and NAUSEA (nausea) had resolved.            No concomitant medications were reported.  No treatment information was reported.    Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow up received contain outcome of the events such as Asthenia, Muscular weakness, Dizziness, Malaise, Pyrexia, Myalgia, Fatigue, Nausea to recovered/ resolved.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives on hands, ears, back of neck, body, legs and foot; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Apr-2021 and was forwarded to Moderna on 19-Apr-2021.    This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (hives on hands, ears, back of neck, body, legs and foot) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced URTICARIA (hives on hands, ears, back of neck, body, legs and foot). On 08-Apr-2021, URTICARIA (hives on hands, ears, back of neck, body, legs and foot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took Zyrtec as treatment drug . o concomitant drug is provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Stomatitis, Tongue discomfort
Clinical narrative: feeling like "a bad rash in mouth"; loss of taste because of chapped mouth; rash on back; rash on top of both arms; dry mouth; end (tip) of tongue burning; lips "molting like snakeskin"; inability to eat; "whole inside of mouth burning"; raw mouth; tongue "feeling sunburnt"; lips felt "sun burnt."; feeling of "rush/surge"; Chapped lips; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DRY MOUTH (dry mouth), ORAL MUCOSAL ERUPTION (feeling like "a bad rash in mouth"), TONGUE DISCOMFORT (end (tip) of tongue burning), LIP EXFOLIATION (lips "molting like snakeskin") and CHAPPED LIPS (Chapped lips) in a 60-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.     Concurrent medical conditions included Food allergy, Allergy to chemicals (Allergic to dyes and preservatives.) and Allergy to vaccine (lip swelling).    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced CHAPPED LIPS (Chapped lips), PARAESTHESIA ORAL (tongue "feeling sunburnt"), ORAL DISCOMFORT (lips felt "sun burnt.") and FEELING ABNORMAL (feeling of "rush/surge"). On 27-Mar-2021, the patient experienced EATING DISORDER (inability to eat), ORAL DISCOMFORT ("whole inside of mouth burning") and STOMATITIS (raw mouth). On 19-Apr-2021, the patient experienced DRY MOUTH (dry mouth), TONGUE DISCOMFORT (end (tip) of tongue burning) and LIP EXFOLIATION (lips "molting like snakeskin"). On 27-Apr-2021, the patient experienced ORAL MUCOSAL ERUPTION (feeling like "a bad rash in mouth"), AGEUSIA (loss of taste because of chapped mouth), RASH (rash on back) and RASH (rash on top of both arms). At the time of the report, DRY MOUTH (dry mouth), ORAL MUCOSAL ERUPTION (feeling like "a bad rash in mouth"), TONGUE DISCOMFORT (end (tip) of tongue burning), LIP EXFOLIATION (lips "molting like snakeskin") and CHAPPED LIPS (Chapped lips) had not resolved, AGEUSIA (loss of taste because of chapped mouth), EATING DISORDER (inability to eat), ORAL DISCOMFORT ("whole inside of mouth burning"), RASH (rash on back) and RASH (rash on top of both arms) outcome was unknown, STOMATITIS (raw mouth), PARAESTHESIA ORAL (tongue "feeling sunburnt") and ORAL DISCOMFORT (lips felt "sun burnt.") was resolving and FEELING ABNORMAL (feeling of "rush/surge") had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment on visit to physician on 30-MAR-2021 includes Magic mouthwash to be used before meals, Vaseline (topical to lips), Chapstick (topical to lips), Beeswax (topical to lips).   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: updated events( rash and ageusia ), the vaccine was withdrawn after the 1st dose.
Sex: F
Vaccine: COVID19
Symptoms: Muscle discomfort, Pain in extremity
Clinical narrative: Muscles in the back of my legs and thighs have been giving her issues; Pain from when trying to move her legs and walk; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE DISCOMFORT (Muscles in the back of my legs and thighs have been giving her issues) and PAIN IN EXTREMITY (Pain from when trying to move her legs and walk) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A22A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced MUSCLE DISCOMFORT (Muscles in the back of my legs and thighs have been giving her issues) and PAIN IN EXTREMITY (Pain from when trying to move her legs and walk). At the time of the report, MUSCLE DISCOMFORT (Muscles in the back of my legs and thighs have been giving her issues) and PAIN IN EXTREMITY (Pain from when trying to move her legs and walk) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     No concomitant medication information was provided The patients treatment products information included Tylenol.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ear problems of tinnitus after getting the vaccine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (ear problems of tinnitus after getting the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TINNITUS (ear problems of tinnitus after getting the vaccine). At the time of the report, TINNITUS (ear problems of tinnitus after getting the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant product was reported.  no treatment product was reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Phantom limb syndrome
Clinical narrative: little more phantom pain than normal; This spontaneous case was reported by a consumer and describes the occurrence of PHANTOM LIMB SYNDROME (little more phantom pain than normal) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     The patient's past medical history included Amputation in 2010.    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced PHANTOM LIMB SYNDROME (little more phantom pain than normal). At the time of the report, PHANTOM LIMB SYNDROME (little more phantom pain than normal) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: joint pain - felt like an increase in the arthritis pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain - felt like an increase in the arthritis pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis.   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) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ARTHRALGIA (joint pain - felt like an increase in the arthritis pain). The patient was treated with PARACETAMOL (TYLENOL) for Joint pain, at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (joint pain - felt like an increase in the arthritis pain) outcome was unknown.            No concomitant medications were reported.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-080095 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080095:Wife case
Age: 61.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: Fatigue; injection site pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection site pain), HEADACHE (headache) and FATIGUE (Fatigue) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) injection for Crohn's disease and Rheumatoid arthritis and METHOTREXATE for Psoriasis.    The patient's past medical history included Cyst ovary from April 2020 to September 2020, Appendicitis in January 2015, Hepatic steatosis, General physical condition abnormal in 2012, Weight increased in 2012 and Elevated liver enzymes in 2017. Previously administered products included for an unreported indication: HUMIRA (40 mg/0.4 ml - for MODERATE TO SEVERE ADULT CROHN'S DISEASE and MODERATE TO SEVERE RHEUMATOID ARTHRITIS) in 2010 and LIDOCAINE from September 2020 to October 2020. Concurrent medical conditions included Drug allergy (Sulfa drug allergy associated with manifestations of itching and burning skin.), Diabetes mellitus since 2016, Psoriasis since 2016, Shingles in November 2020, Rheumatoid arthritis (Moderate to severe) and Crohn's disease (Moderate to severe). Concomitant products included DOXYCYCLINE and LIDOCAINE for an unknown indication.   In July 2020, the patient started ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started METHOTREXATE (unknown route) at an unspecified dose. On 30-Dec-2020, the patient experienced VACCINATION SITE PAIN (injection site pain) and HEADACHE (headache). On an unknown date, the patient experienced FATIGUE (Fatigue). On 03-Jan-2021, VACCINATION SITE PAIN (injection site pain) and HEADACHE (headache) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.      This case was linked to MOD-2021-080937 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow up received on 28-MAY-2021 has no significant updates