chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Diplopia, Eating disorder symptom, Fall, Feeling abnormal, Hypoacusis
Clinical narrative: Double vision; Headache turned migraine, whole head; Shaking like Parkinsons Disease; when I get up, I feel like I've been drinking, but I don't drink; Fell; Can't talk right, sentences don't come out right; Can't eat; Can't hear the phone ring; All my muscles hurt; This spontaneous case was reported by a consumer and describes the occurrence of DIPLOPIA (Double vision), MIGRAINE (Headache turned migraine, whole head), TREMOR (Shaking like Parkinsons Disease), FEELING ABNORMAL (when I get up, I feel like I've been drinking, but I don't drink) and FALL (Fell) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included GABAPENTIN, BUPROPION HYDROCHLORIDE (WELLBUTRIN), DIAZEPAM, CEFIXIME (FLEXERIL [CEFIXIME]), OXYCODONE and HYDROCODONE for an unknown indication.   On 24-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) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced DIPLOPIA (Double vision), MIGRAINE (Headache turned migraine, whole head), TREMOR (Shaking like Parkinsons Disease), FEELING ABNORMAL (when I get up, I feel like I've been drinking, but I don't drink), FALL (Fell), SPEECH DISORDER (Can't talk right, sentences don't come out right), EATING DISORDER SYMPTOM (Can't eat), HYPOACUSIS (Can't hear the phone ring) and MYALGIA (All my muscles hurt). At the time of the report, DIPLOPIA (Double vision), MIGRAINE (Headache turned migraine, whole head), TREMOR (Shaking like Parkinsons Disease), FEELING ABNORMAL (when I get up, I feel like I've been drinking, but I don't drink), FALL (Fell), SPEECH DISORDER (Can't talk right, sentences don't come out right), EATING DISORDER SYMPTOM (Can't eat), HYPOACUSIS (Can't hear the phone ring) and MYALGIA (All my muscles hurt) outcome was unknown.            No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-089539 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Myalgia, Speech disorder, Tremor
Clinical narrative: Double vision; Headache turned migraine, whole head; Shaking like Parkinsons Disease; when I get up, I feel like I've been drinking, but I don't drink; Fell; Can't talk right, sentences don't come out right; Can't eat; Can't hear the phone ring; All my muscles hurt; This spontaneous case was reported by a consumer and describes the occurrence of DIPLOPIA (Double vision), MIGRAINE (Headache turned migraine, whole head), TREMOR (Shaking like Parkinsons Disease), FEELING ABNORMAL (when I get up, I feel like I've been drinking, but I don't drink) and FALL (Fell) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included GABAPENTIN, BUPROPION HYDROCHLORIDE (WELLBUTRIN), DIAZEPAM, CEFIXIME (FLEXERIL [CEFIXIME]), OXYCODONE and HYDROCODONE for an unknown indication.   On 24-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) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced DIPLOPIA (Double vision), MIGRAINE (Headache turned migraine, whole head), TREMOR (Shaking like Parkinsons Disease), FEELING ABNORMAL (when I get up, I feel like I've been drinking, but I don't drink), FALL (Fell), SPEECH DISORDER (Can't talk right, sentences don't come out right), EATING DISORDER SYMPTOM (Can't eat), HYPOACUSIS (Can't hear the phone ring) and MYALGIA (All my muscles hurt). At the time of the report, DIPLOPIA (Double vision), MIGRAINE (Headache turned migraine, whole head), TREMOR (Shaking like Parkinsons Disease), FEELING ABNORMAL (when I get up, I feel like I've been drinking, but I don't drink), FALL (Fell), SPEECH DISORDER (Can't talk right, sentences don't come out right), EATING DISORDER SYMPTOM (Can't eat), HYPOACUSIS (Can't hear the phone ring) and MYALGIA (All my muscles hurt) outcome was unknown.            No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-089539 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Myalgia
Clinical narrative: couldn't eat or drink; really bad headache; fever; chills; whole body aches; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (couldn't eat or drink), HEADACHE (really bad headache), PYREXIA (fever), CHILLS (chills) and MYALGIA (whole body aches) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy. Concomitant products included METFORMIN, POTASSIUM, LEVOTHYROXINE, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), MULTIVITAMIN [VITAMINS NOS], COLECALCIFEROL (VITAMIN D 3), DOCUSATE SODIUM (STOOL SOFTENER), CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]), OMEGA-3 NOS, LINAGLIPTIN (TRAJENTA), DENOSUMAB (PROLIA), ATORVASTATIN CALCIUM (LIPITOR), LOSARTAN POTASSIUM (LOSARTIN), ANASTROZOLE and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced DECREASED APPETITE (couldn't eat or drink), HEADACHE (really bad headache), PYREXIA (fever), CHILLS (chills), MYALGIA (whole body aches) and FATIGUE (fatigue). On 10-Feb-2021, DECREASED APPETITE (couldn't eat or drink), HEADACHE (really bad headache), PYREXIA (fever), CHILLS (chills) and MYALGIA (whole body aches) had resolved. On 11-Feb-2021, FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications cranberry pill and andapamin. No treatment medication details was reported.   This case was linked to MOD-2021-089517 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: couldn't eat or drink; really bad headache; fever; chills; whole body aches; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (couldn't eat or drink), HEADACHE (really bad headache), PYREXIA (fever), CHILLS (chills) and MYALGIA (whole body aches) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy. Concomitant products included METFORMIN, POTASSIUM, LEVOTHYROXINE, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), MULTIVITAMIN [VITAMINS NOS], COLECALCIFEROL (VITAMIN D 3), DOCUSATE SODIUM (STOOL SOFTENER), CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]), OMEGA-3 NOS, LINAGLIPTIN (TRAJENTA), DENOSUMAB (PROLIA), ATORVASTATIN CALCIUM (LIPITOR), LOSARTAN POTASSIUM (LOSARTIN), ANASTROZOLE and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced DECREASED APPETITE (couldn't eat or drink), HEADACHE (really bad headache), PYREXIA (fever), CHILLS (chills), MYALGIA (whole body aches) and FATIGUE (fatigue). On 10-Feb-2021, DECREASED APPETITE (couldn't eat or drink), HEADACHE (really bad headache), PYREXIA (fever), CHILLS (chills) and MYALGIA (whole body aches) had resolved. On 11-Feb-2021, FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications cranberry pill and andapamin. No treatment medication details was reported.   This case was linked to MOD-2021-089517 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID-19 after receiving first vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Tested positive for COVID-19 after receiving first vaccine) in a 61-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 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced COVID-19 (Tested positive for COVID-19 after receiving first vaccine). At the time of the report, COVID-19 (Tested positive for COVID-19 after receiving first vaccine) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2021, SARS-CoV-2 test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications and treatment information were reported.   This case was linked to MOD-2021-089851 (E2B Linked Report).; Sender's Comments:  MOD-2021-089851:Husband's case
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: blurred vision in right eye; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (blurred vision in right eye) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002821A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included blood pressure medication for an unknown indication.    On 16-Mar-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 VISION BLURRED (blurred vision in right eye). At the time of the report, VISION BLURRED (blurred vision in right eye) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and CHILLS (chills) 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, the patient experienced PYREXIA (fever) and CHILLS (chills). At the time of the report, PYREXIA (fever) and CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-089378 (E2B Linked Report).; Sender's Comments:  MOD-2021-089378:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: Sleeping non stop; she has had constant fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleeping non stop) and FATIGUE (she has had constant fatigue) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037b21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) and HYDROCORTISONE, OXYTETRACYCLINE (HYDROCYCLIN) for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced SOMNOLENCE (Sleeping non stop) and FATIGUE (she has had constant fatigue). At the time of the report, SOMNOLENCE (Sleeping non stop) and FATIGUE (she has had constant fatigue) outcome was unknown.            Concomitant medications also included antidepressant medications and Ids medications. No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Myalgia
Clinical narrative: Soreness on arm; Redness on arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Apr-2021 and was forwarded to Moderna on 25-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Soreness on arm) and ERYTHEMA (Redness on arm) 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-Apr-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 23-Apr-2021, the patient experienced MYALGIA (Soreness on arm) and ERYTHEMA (Redness on arm). At the time of the report, MYALGIA (Soreness on arm) and ERYTHEMA (Redness on arm) outcome was unknown.            No concomitant medications were provided. No treatment drugs were reported.   Reporter did not allow further contact
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria, Vaccination complication, Vaccination site reaction
Clinical narrative: Lesions are isolated to his hands now. More on his fingers and one palm; almost looked like COVID hands; broke out into hives all over the body: elbow, chest, legs, buttocks, claves, traps (tops of back neck area) and hands; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (broke out into hives all over the body: elbow, chest, legs, buttocks, claves, traps (tops of back neck area) and hands), VACCINATION COMPLICATION (Lesions are isolated to his hands now. More on his fingers and one palm) and VACCINATION SITE REACTION (almost looked like COVID hands) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 030M20A) for COVID-19 vaccination.     No medical history was not provided by reporter.  Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), OMALIZUMAB (XOLAIR) and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced URTICARIA (broke out into hives all over the body: elbow, chest, legs, buttocks, claves, traps (tops of back neck area) and hands) and VACCINATION SITE REACTION (almost looked like COVID hands). On an unknown date, the patient experienced VACCINATION COMPLICATION (Lesions are isolated to his hands now. More on his fingers and one palm). The patient was treated with LEVOCETIRIZINE at an unspecified dose and frequency; TRIAMCINOLONE at an unspecified dose and frequency; DEXAMETHASONE at a dose of 4 mg and DOXYCYCLINE at an unspecified dose and frequency. At the time of the report, URTICARIA (broke out into hives all over the body: elbow, chest, legs, buttocks, claves, traps (tops of back neck area) and hands), VACCINATION COMPLICATION (Lesions are isolated to his hands now. More on his fingers and one palm) and VACCINATION SITE REACTION (almost looked like COVID hands) outcome was unknown. Not Provided          Treatment medication include levocitrazine, triamcinolone, dexamethasone, doxycycline, Zyrtec  .  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-089538 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Facial pain, Headache, Hypertension, Pain in jaw
Clinical narrative: Blood pressure spike to 190/90 4 days after vaccination; severe headaches; Severe pain in the Jaw; Severe pain in the face; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN JAW (Severe pain in the Jaw), FACIAL PAIN (Severe pain in the face), HYPERTENSION (Blood pressure spike to 190/90 4 days after vaccination) and HEADACHE (severe headaches) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 044B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus. Concomitant products included METFORMIN for Diabetes mellitus.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced PAIN IN JAW (Severe pain in the Jaw), FACIAL PAIN (Severe pain in the face) and HEADACHE (severe headaches). On 17-Apr-2021, the patient experienced HYPERTENSION (Blood pressure spike to 190/90 4 days after vaccination). At the time of the report, PAIN IN JAW (Severe pain in the Jaw), FACIAL PAIN (Severe pain in the face), HYPERTENSION (Blood pressure spike to 190/90 4 days after vaccination) and HEADACHE (severe headaches) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Apr-2021, Blood pressure measurement: 190/80 mmHg.         The patient visited the emergency room for PAIN IN JAW (Severe pain in the Jaw), FACIAL PAIN (Severe pain in the face) and HEADACHE (severe headaches).The emergency room visit lasted for  8 hours.  The patient received Tylenol and Gabapentin as treatment medication
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Vision blurred
Clinical narrative: Blurred vision in right eye; muscle aches; chills; headaches; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurred vision in right eye), MYALGIA (muscle aches), CHILLS (chills) and HEADACHE (headaches) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040821A and 002821A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 12-Apr-2021, the patient experienced MYALGIA (muscle aches), CHILLS (chills) and HEADACHE (headaches). On an unknown date, the patient experienced VISION BLURRED (Blurred vision in right eye). At the time of the report, VISION BLURRED (Blurred vision in right eye), MYALGIA (muscle aches), CHILLS (chills) and HEADACHE (headaches) outcome was unknown.            Concomitant medicines include Blood pressure medication Treatment medicine include Tylenol
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site lymphadenopathy, Vaccination site pain
Clinical narrative: Lymph node Inflammation under injection arm; Rash; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (Lymph node Inflammation under injection arm), RASH (Rash) and VACCINATION SITE PAIN (Pain at the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Lymph node Inflammation under injection arm), RASH (Rash) and VACCINATION SITE PAIN (Pain at the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. On 27-Mar-2021, VACCINATION SITE LYMPHADENOPATHY (Lymph node Inflammation under injection arm), RASH (Rash) and VACCINATION SITE PAIN (Pain at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No  Concomitant medications were provided   This case was linked to MOD-2021-089699 (Patient Link).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Covid arm rash 10 days after receiving the 1st shot; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Covid arm rash 10 days after receiving the 1st shot) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Antidepressant discontinuation syndrome, CLONAZEPAM for Anxiety, LEVOTHYROXINE SODIUM (THYROXIN) for Hashimoto's thyroiditis.    On 25-Mar-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 RASH (Covid arm rash 10 days after receiving the 1st shot). At the time of the report, RASH (Covid arm rash 10 days after receiving the 1st shot) 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.   treatment include Applied Calamine lotion for the rash developed after the 1st dose.   This case was linked to US-MODERNATX, INC.-MOD-2021-089488 (E2B Linked Report). This case was linked to MOD-2021-089565 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089488:
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Asthenia, Pyrexia
Clinical narrative: similar side effects as caller; laying down after 2nd dose; he had more symptoms; had fever; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (similar side effects as caller), ASTHENIA (laying down after 2nd dose), ADVERSE EVENT (he had more symptoms) and PYREXIA (had fever) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-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 ADVERSE EVENT (similar side effects as caller), ASTHENIA (laying down after 2nd dose), ADVERSE EVENT (he had more symptoms) and PYREXIA (had fever). At the time of the report, ADVERSE EVENT (similar side effects as caller), ASTHENIA (laying down after 2nd dose), ADVERSE EVENT (he had more symptoms) and PYREXIA (had fever) had resolved.            No concomitant medications were reported.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Mental fatigue, Pyrexia
Clinical narrative: mentally exhausted; felt tired and worn out; sore arm where the shot was injected; low grade fever 100.3; headachy; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL FATIGUE (mentally exhausted), FATIGUE (felt tired and worn out), INJECTION SITE PAIN (sore arm where the shot was injected), PYREXIA (low grade fever 100.3) and HEADACHE (headachy) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Phobia. Concomitant products included NAPROXEN and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced MENTAL FATIGUE (mentally exhausted), FATIGUE (felt tired and worn out), INJECTION SITE PAIN (sore arm where the shot was injected), PYREXIA (low grade fever 100.3) and HEADACHE (headachy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MENTAL FATIGUE (mentally exhausted) had not resolved, FATIGUE (felt tired and worn out), INJECTION SITE PAIN (sore arm where the shot was injected) and HEADACHE (headachy) outcome was unknown and PYREXIA (low grade fever 100.3) had resolved. Not Provided          Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow up received contain :-AR Onset Date.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Haemoptysis, Pain in extremity, Pruritus, Vaccination site pain
Clinical narrative: Coughing blood; Sore arm; Itchiness; Pain at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HAEMOPTYSIS (Coughing blood), PAIN IN EXTREMITY (Sore arm), PRURITUS (Itchiness) and VACCINATION SITE PAIN (Pain at injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M2DA) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PRURITUS (Itchiness) and VACCINATION SITE PAIN (Pain at injection site). On 18-Apr-2021, the patient experienced HAEMOPTYSIS (Coughing blood). At the time of the report, HAEMOPTYSIS (Coughing blood), PAIN IN EXTREMITY (Sore arm), PRURITUS (Itchiness) and VACCINATION SITE PAIN (Pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was provided by the reporter. No concomitant medication was provided by the reporter. No lab data was provided by the reporter.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Cough, Illness, Myalgia
Clinical narrative: sinus congestion; cough symptom; joint pain; muscle pain; fever; felt really sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (felt really sick), SINUS CONGESTION (sinus congestion), COUGH (cough symptom), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CLONAZEPAM for Anxiety, LEVOTHYROXINE SODIUM (THYROXIN) for Hashimoto's thyroiditis, ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced ILLNESS (felt really sick), ARTHRALGIA (joint pain), MYALGIA (muscle pain) and PYREXIA (fever ). On 23-Apr-2021, the patient experienced SINUS CONGESTION (sinus congestion) and COUGH (cough symptom). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, ILLNESS (felt really sick), SINUS CONGESTION (sinus congestion), COUGH (cough symptom), ARTHRALGIA (joint pain), MYALGIA (muscle pain) and PYREXIA (fever ) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Body temperature: 102f (High) Fever 102F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-089488 (E2B Linked Report). This case was linked to MOD-2021-089560 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089488:Crossed linked
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sinus congestion
Clinical narrative: sinus congestion; cough symptom; joint pain; muscle pain; fever; felt really sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (felt really sick), SINUS CONGESTION (sinus congestion), COUGH (cough symptom), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CLONAZEPAM for Anxiety, LEVOTHYROXINE SODIUM (THYROXIN) for Hashimoto's thyroiditis, ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced ILLNESS (felt really sick), ARTHRALGIA (joint pain), MYALGIA (muscle pain) and PYREXIA (fever ). On 23-Apr-2021, the patient experienced SINUS CONGESTION (sinus congestion) and COUGH (cough symptom). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, ILLNESS (felt really sick), SINUS CONGESTION (sinus congestion), COUGH (cough symptom), ARTHRALGIA (joint pain), MYALGIA (muscle pain) and PYREXIA (fever ) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Body temperature: 102f (High) Fever 102F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-089488 (E2B Linked Report). This case was linked to MOD-2021-089560 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089488:Crossed linked
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: headachey; both times arm felt sore where the shot was injected; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (both times arm felt sore where the shot was injected) and HEADACHE (headachey) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced VACCINATION SITE PAIN (both times arm felt sore where the shot was injected). On 25-Apr-2021, the patient experienced HEADACHE (headachey). At the time of the report, VACCINATION SITE PAIN (both times arm felt sore where the shot was injected) and HEADACHE (headachey) 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: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Interchange of vaccine products
Clinical narrative: interchange of vaccine products; expired vaccine used; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication were not reported .  Treatment medication were not reported .
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle strain
Clinical narrative: Pulled a muscle; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE STRAIN (Pulled a muscle) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced MUSCLE STRAIN (Pulled a muscle). At the time of the report, MUSCLE STRAIN (Pulled a muscle) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter. No laboratory provided by reporter Treatment medications prescribed by HCP included pain pills and muscle relaxers. The reporter wanted to know if the patient can take them .
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: mild flu like symptoms; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (mild flu like symptoms) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Rheumatoid arthritis and Osteoarthritis (walks with cane.). Concomitant products included HYDROCODONE, GABAPENTIN, CLONAZEPAM (KLONOPIN), IBUPROFEN, VITAMIN D3 and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (mild flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (mild flu like symptoms) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: fatigue; arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) and MYALGIA (arm soreness) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included Lupus syndrome, Fibromyalgia and Gastrointestinal symptom NOS.   On 21-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 21-Apr-2021, the patient experienced FATIGUE (fatigue) and MYALGIA (arm soreness). On 21-Apr-2021, FATIGUE (fatigue) had resolved. At the time of the report, MYALGIA (arm soreness) outcome was unknown.            The concomitant medications information was not reported. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD21-060565 (E2B Linked Report). This case was linked to MOD-2021-054664 (Patient Link).; Sender's Comments:  MOD21-060565:
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product complaint
Clinical narrative: Another dose was administered on opposite arm from first shot in both patients as indicated in; Needle came apart and two patients didn't received the full dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT COMPLAINT (Needle came apart and two patients didn't received the full dose.) and INCORRECT DOSE ADMINISTERED (Another dose was administered on opposite arm from first shot in both patients as indicated in) 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 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced PRODUCT COMPLAINT (Needle came apart and two patients didn't received the full dose.). On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (Another dose was administered on opposite arm from first shot in both patients as indicated in). At the time of the report, PRODUCT COMPLAINT (Needle came apart and two patients didn't received the full dose.) and INCORRECT DOSE ADMINISTERED (Another dose was administered on opposite arm from first shot in both patients as indicated in) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported No treatment medications were provided   This case was linked to US-MODERNATX, INC.-MOD-2021-089585 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089585:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Migraine, Pain, Swelling
Clinical narrative: soreness in arm wasn't as bad; Hair loss; terrible migraine; had a small lump after second dose; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (soreness in arm wasn't as bad), SWELLING (had a small lump after second dose), MIGRAINE (terrible migraine) and ALOPECIA (Hair loss) 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 Surgery (Has only left kidney, as right was removed d/t possible cancer.). Concurrent medical conditions included Drug allergy (Codeine). Concomitant products included TURMERIC [CURCUMA LONGA RHIZOME] for Arthritis, ATORVASTATIN for Hypercholesterolaemia, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HYDROCHLOROTHIAZID) for Hypertension, ASCORBIC ACID, TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC (AREDS) for Vitamin supplementation, BIFIDOBACTERIUM LONGUM, LACTOBACILLUS ACIDOPHILUS, LACTOBACILLUS RHAMNOSUS (PROBIOTICS [BIFIDOBACTERIUM LONGUM;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS RHAMNOSUS]), CALCIUM and NICOTINAMIDE (VIT B3).    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced SWELLING (had a small lump after second dose). On 04-Mar-2021, the patient experienced MIGRAINE (terrible migraine). On an unknown date, the patient experienced PAIN (soreness in arm wasn't as bad) and ALOPECIA (Hair loss). On 05-Feb-2021, PAIN (soreness in arm wasn't as bad) outcome was unknown. On 11-Feb-2021, SWELLING (had a small lump after second dose) outcome was unknown. On 05-Mar-2021, MIGRAINE (terrible migraine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication includes Nutrasol supplement.  Patient had a "terrible migraine" for 24 hours, but her only history of previous migraines was during menopause 15-18 yrs ago.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Anal pruritus, Cheilitis, Discomfort, Lip swelling, Mouth swelling
Clinical narrative: inside of her mouth swelled up; advised not to receive second dose of vaccine; pressure behind the face; irritation of lips/rash over lips; lip began to swell; scratchy throat; anal pain; anal itching; anal swelling; rash around and inside her mouth; This spontaneous case was reported by a consumer and describes the occurrence of ORAL MUCOSAL ERUPTION (rash around and inside her mouth), MOUTH SWELLING, LIP SWELLING, OROPHARYNGEAL PAIN (scratchy throat), and PROCTALGIA (anal pain) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Irritable bowel syndrome and Clostridium difficile colitis. Concurrent medical conditions included Drug allergy (rash), Drug allergy (rash), Anaphylaxis (throat closes), Dust allergy, Pollen allergy, Adhesive tape allergy, Allergy to animals (dogs Sneezing, Hives, Asthma), and Asthma. Concomitant products included BENADRYL, IBUPROFEN, and ALBUTEROL for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced ORAL MUCOSAL ERUPTION (rash around and inside her mouth). On 27-Mar-2021, the patient experienced LIP SWELLING, OROPHARYNGEAL PAIN (scratchy throat), PROCTALGIA (anal pain), ANAL PRURITUS (anal itching) and SWELLING (anal swelling). On an unknown date, the patient experienced MOUTH SWELLING (inside of her mouth swelled up), PRODUCT DOSE OMISSION ISSUE (advised not to receive second dose of vaccine), DISCOMFORT (pressure behind the face) and CHEILITIS (irritation of lips/rash over lips). The patient was treated with ZYRTEC at a dose of 10 mg; CLOBETASOL PROPIONATE (topical) at a dose of 0.5% cream; PREDNISONE (topical) at an unspecified dose and frequency, and HYDROCORTISONE (topical) at a dose of 1%. At the time of the report, ORAL MUCOSAL ERUPTION (rash around and inside her mouth), MOUTH SWELLING, LIP SWELLING, OROPHARYNGEAL PAIN (scratchy throat), PROCTALGIA (anal pain), ANAL PRURITUS (anal itching), SWELLING (anal swelling) and DISCOMFORT (pressure behind the face) had not resolved and PRODUCT DOSE OMISSION ISSUE (advised not to receive second dose of vaccine) and CHEILITIS (rash over lips) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       concomitant medicine includes multivitamin and probiotic.    Most recent FOLLOW-UP information incorporated above included, on 13-Jun-2021 follow up received on 13-jun-21 includes patient demographics and medical history allergic conditions was updated vaccine facility information was updated.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Oral mucosal eruption, Oropharyngeal pain, Proctalgia, Product dose omission issue, Swelling
Clinical narrative: inside of her mouth swelled up; advised not to receive second dose of vaccine; pressure behind the face; irritation of lips/rash over lips; lip began to swell; scratchy throat; anal pain; anal itching; anal swelling; rash around and inside her mouth; This spontaneous case was reported by a consumer and describes the occurrence of ORAL MUCOSAL ERUPTION (rash around and inside her mouth), MOUTH SWELLING, LIP SWELLING, OROPHARYNGEAL PAIN (scratchy throat), and PROCTALGIA (anal pain) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Irritable bowel syndrome and Clostridium difficile colitis. Concurrent medical conditions included Drug allergy (rash), Drug allergy (rash), Anaphylaxis (throat closes), Dust allergy, Pollen allergy, Adhesive tape allergy, Allergy to animals (dogs Sneezing, Hives, Asthma), and Asthma. Concomitant products included BENADRYL, IBUPROFEN, and ALBUTEROL for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced ORAL MUCOSAL ERUPTION (rash around and inside her mouth). On 27-Mar-2021, the patient experienced LIP SWELLING, OROPHARYNGEAL PAIN (scratchy throat), PROCTALGIA (anal pain), ANAL PRURITUS (anal itching) and SWELLING (anal swelling). On an unknown date, the patient experienced MOUTH SWELLING (inside of her mouth swelled up), PRODUCT DOSE OMISSION ISSUE (advised not to receive second dose of vaccine), DISCOMFORT (pressure behind the face) and CHEILITIS (irritation of lips/rash over lips). The patient was treated with ZYRTEC at a dose of 10 mg; CLOBETASOL PROPIONATE (topical) at a dose of 0.5% cream; PREDNISONE (topical) at an unspecified dose and frequency, and HYDROCORTISONE (topical) at a dose of 1%. At the time of the report, ORAL MUCOSAL ERUPTION (rash around and inside her mouth), MOUTH SWELLING, LIP SWELLING, OROPHARYNGEAL PAIN (scratchy throat), PROCTALGIA (anal pain), ANAL PRURITUS (anal itching), SWELLING (anal swelling) and DISCOMFORT (pressure behind the face) had not resolved and PRODUCT DOSE OMISSION ISSUE (advised not to receive second dose of vaccine) and CHEILITIS (rash over lips) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       concomitant medicine includes multivitamin and probiotic.    Most recent FOLLOW-UP information incorporated above included, on 13-Jun-2021 follow up received on 13-jun-21 includes patient demographics and medical history allergic conditions was updated vaccine facility information was updated.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Dizziness, Swelling of eyelid
Clinical narrative: Disorientation; Dizziness; left upper eyelid swelling; This spontaneous case was reported by a physician and describes the occurrence of DISORIENTATION (Disorientation), DIZZINESS (Dizziness) and SWELLING OF EYELID (left upper eyelid swelling) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 DISORIENTATION (Disorientation), DIZZINESS (Dizziness) and SWELLING OF EYELID (left upper eyelid swelling). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. On 29-Mar-2021, DISORIENTATION (Disorientation), DIZZINESS (Dizziness) and SWELLING OF EYELID (left upper eyelid swelling) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided