chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Patient got less than 0.1mL of the dose; most of it got on her jeans; The seal on the syringe was not good; This spontaneous case was reported by a health care professional and describes the occurrence of UNDERDOSE (Patient got less than 0.1mL of the dose; most of it got on her jeans) and DEVICE CONNECTION ISSUE (The seal on the syringe was not good) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) 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 UNDERDOSE (Patient got less than 0.1mL of the dose; most of it got on her jeans) and DEVICE CONNECTION ISSUE (The seal on the syringe was not good). At the time of the report, UNDERDOSE (Patient got less than 0.1mL of the dose; most of it got on her jeans) and DEVICE CONNECTION ISSUE (The seal on the syringe was not good) 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.   No concomitant medication details were provided. No treatment medication details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow-up received on 24-May-2021. The pharmacist stated that the patient was fine after receiving the under dose, that patient didn't experience any adverse events and has already received her 2nd dose.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Dysphoria, Dyspnoea, Pain, Wheezing
Clinical narrative: advanced difficulty in breathing; intense dysphoria when breathing; had a hard time standing; pain in the back; slight reduction in the wheezes in his left lung; This spontaneous case was reported by a physician and describes the occurrence of DYSPNOEA (advanced difficulty in breathing), DYSPHORIA (intense dysphoria when breathing), PAIN (had a hard time standing), BACK PAIN (pain in the back) and WHEEZING (slight reduction in the wheezes in his left lung) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included Lobivon                                                        Nebivolol, Triatec-plus                                                   Ramipril/Hydrochlorothiazide, Salospir                                                       Acetylsalicylic acid, Zocor                                                          Simvastatin, Omnic-tocas                                                    Tamsulosin, Zyloric                                                        Allopurinol, Lobivon                                                        Nebivolol, Triatec-plus                                                   Ramipril/Hydrochlorothiazide, Salospir                                                       Acetylsalicylic acid, Zocor                                                          Simvastatin, Omnic-tocas                                                    Tamsulosin and Zyloric                                                        Allopurinol for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced DYSPNOEA (advanced difficulty in breathing), DYSPHORIA (intense dysphoria when breathing), PAIN (had a hard time standing), BACK PAIN (pain in the back) and WHEEZING (slight reduction in the wheezes in his left lung). On 25-Mar-2021, DYSPNOEA (advanced difficulty in breathing), DYSPHORIA (intense dysphoria when breathing), PAIN (had a hard time standing), BACK PAIN (pain in the back) and WHEEZING (slight reduction in the wheezes in his left lung) 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.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included Sarcoidosis, Heart disease, unspecified and Shingles. Concurrent medical conditions included Thyroid nodule. Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALTREX) for Shingles.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown. Not Provided          Reporter did not allow further contact
Age: 62.0
Sex: M
Vaccine: COVID19, UNK, UNK
Symptoms: Cardiac operation
Clinical narrative: open heart surgery; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC OPERATION (open heart surgery) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 0H7A21A) for COVID-19 vaccination.    Co-suspect products included non-company products METFORMIN for an unknown indication and MULTIVITAMINS & MINERALS PLUS LUTEIN for an unknown indication.    Concomitant products included AMLODIPINE, METOPROLOL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), OMEPRAZOLE, ATORVASTATIN, FERROUS SULFATE, SIMETHICONE, METHIMAZOLE, ASCORBIC ACID and Tylenol PRN for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form, METFORMIN (unknown route) 500 mg once a day and MULTIVITAMINS & MINERALS PLUS LUTEIN (unknown route) dosage form. On 08-Mar-2021, the patient experienced CARDIAC OPERATION (open heart surgery). At the time of the report, CARDIAC OPERATION (open heart surgery) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medicines include Amlodipine, Metoprolol, Aspirin  ,Omeprazole, Atorvastatin, Ferrous Sulfate, Simethicone Methimazole  Metformin, Ascorbic Acid, Tylenol , Multivitamins  Treatment drugs were not provided  Action taken with mRNA-1273 in response to the event was not applicable   This case was linked to US-MODERNATX, INC.-MOD-2021-061260 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Non significant follow up received on 13-MAY-2021, AE contact information updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-061260:2nd dose
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Chills; fever; Shivering; injection site was quite swollen; Hurts; Very hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (injection site was quite swollen), VACCINATION SITE PAIN (Hurts), VACCINATION SITE WARMTH (Very hot), CHILLS (Chills) and PYREXIA (fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pneumonia, Kidney infection (from childhood) and Overweight.    On 26-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 VACCINATION SITE SWELLING (injection site was quite swollen), VACCINATION SITE PAIN (Hurts) and VACCINATION SITE WARMTH (Very hot). On an unknown date, the patient experienced CHILLS (Chills), PYREXIA (fever) and CHILLS (Shivering). At the time of the report, VACCINATION SITE SWELLING (injection site was quite swollen), VACCINATION SITE PAIN (Hurts), VACCINATION SITE WARMTH (Very hot), CHILLS (Chills), PYREXIA (fever) and CHILLS (Shivering) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, COVID-19: 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.   Concomitant medications provided by the reporter included medications for pre-existing medical conditions. Treatment for the events chills,fever and shivering included Tylenol.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Chills; fever; Shivering; injection site was quite swollen; Hurts; Very hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (injection site was quite swollen), VACCINATION SITE PAIN (Hurts), VACCINATION SITE WARMTH (Very hot), CHILLS (Chills) and PYREXIA (fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pneumonia, Kidney infection (from childhood) and Overweight.    On 26-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 VACCINATION SITE SWELLING (injection site was quite swollen), VACCINATION SITE PAIN (Hurts) and VACCINATION SITE WARMTH (Very hot). On an unknown date, the patient experienced CHILLS (Chills), PYREXIA (fever) and CHILLS (Shivering). At the time of the report, VACCINATION SITE SWELLING (injection site was quite swollen), VACCINATION SITE PAIN (Hurts), VACCINATION SITE WARMTH (Very hot), CHILLS (Chills), PYREXIA (fever) and CHILLS (Shivering) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, COVID-19: 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.   Concomitant medications provided by the reporter included medications for pre-existing medical conditions. Treatment for the events chills,fever and shivering included Tylenol.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Pyrexia, Vaccination complication, Vaccination site erythema
Clinical narrative: Fever 100.6 - 101.4; Both arms are sore; Doesn't feel like doing anything; Chills; Red spot the size of a grapefruit; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 100.6 - 101.4), PAIN IN EXTREMITY (Both arms are sore), VACCINATION COMPLICATION (Doesn't feel like doing anything), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Red spot the size of a grapefruit) in a 78-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 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red spot the size of a grapefruit). On 29-Mar-2021, the patient experienced PYREXIA (Fever 100.6 - 101.4), PAIN IN EXTREMITY (Both arms are sore), VACCINATION COMPLICATION (Doesn't feel like doing anything) and CHILLS (Chills). At the time of the report, PYREXIA (Fever 100.6 - 101.4), PAIN IN EXTREMITY (Both arms are sore), VACCINATION COMPLICATION (Doesn't feel like doing anything), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Red spot the size of a grapefruit) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment taken was not reported Second dose: 29Mar2021, Lot number: 007B21A.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Labyrinthitis
Clinical narrative: Inner ear infection; This spontaneous case was reported by a consumer and describes the occurrence of LABYRINTHITIS (Inner ear infection) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 29-Mar-2021, the patient experienced LABYRINTHITIS (Inner ear infection). The patient was treated with VALACYCLOVIR [VALACICLOVIR] at an unspecified dose and frequency and METHYLPREDNISOLONE at an unspecified dose and frequency. At the time of the report, LABYRINTHITIS (Inner ear infection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Erythema
Clinical narrative: REDNESS NOT REALLY LIKE LAST TIME, SLIGHTLY SMALLER; LITTLE BIT PAIN UNDER THE ARMPIT; REDNESS; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (REDNESS), ERYTHEMA (REDNESS NOT REALLY LIKE LAST TIME, SLIGHTLY SMALLER) and AXILLARY PAIN (LITTLE BIT PAIN UNDER THE ARMPIT) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3001177) for COVID-19 vaccination.     Concomitant products included CANDESARTAN for Hypertension, CEFUROXIME (FURIX [CEFUROXIME]) for Leg edema, OMEPRAZOL [OMEPRAZOLE] for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced ERYTHEMA (REDNESS). On 29-Mar-2021, the patient experienced AXILLARY PAIN (LITTLE BIT PAIN UNDER THE ARMPIT). On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ERYTHEMA (REDNESS NOT REALLY LIKE LAST TIME, SLIGHTLY SMALLER). The patient was treated with PARACETAMOL (ALVEDON) on 29-Mar-2021 at a dose of UNK, bid. On 29-Mar-2021, AXILLARY PAIN (LITTLE BIT PAIN UNDER THE ARMPIT) had resolved. At the time of the report, ERYTHEMA (REDNESS) had resolved and ERYTHEMA (REDNESS NOT REALLY LIKE LAST TIME, SLIGHTLY SMALLER) had not resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: body ache; fever; chills; sharp headache / dull headache; pain at injection site left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body ache), INJECTION SITE PAIN (pain at injection site left arm), PYREXIA (fever), CHILLS (chills) and HEADACHE (sharp headache / dull headache) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 032M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 14-Feb-2021, the patient experienced INJECTION SITE PAIN (pain at injection site left arm). On an unknown date, the patient experienced PAIN (body ache), PYREXIA (fever), CHILLS (chills) and HEADACHE (sharp headache / dull headache). On 15-Feb-2021, INJECTION SITE PAIN (pain at injection site left arm) had resolved. At the time of the report, PAIN (body ache), PYREXIA (fever), CHILLS (chills) and HEADACHE (sharp headache / dull headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information provided as, Tylenol 4-6 times daily, then changed to Advil 17-MARCH-2021 one dose 4-6 times daily. On 18-March-2021 Advil increased to 3 doses, every 4-6 hours daily IV fentanyl, gabapentin, naproxen, tramadol, Fioricet. On 23-MARCH-2021 caller consulted ER and treatment included CT scan, lab, IV fentanyl with a pain score 6 out of 10. A Zoom follow up appointment has taken place on 29-MARCH-2021 and medications were changed to Rx naproxen, fioricet,no tramadol and tapering off gabapentin.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: redness at the vaccination site; Temperature is high at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness at the vaccination site) and VACCINATION SITE WARMTH (Temperature is high at the injection site) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at the vaccination site) and VACCINATION SITE WARMTH (Temperature is high at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (redness at the vaccination site) and VACCINATION SITE WARMTH (Temperature is high at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Fear of eating, Headache
Clinical narrative: Vomiting; Diarrhea; Head ache; Dizziness; Chills; Scared to eat in fear of vomiting; Arm hurts a lot; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting), DIARRHOEA (Diarrhea), HEADACHE (Head ache), DIZZINESS (Dizziness) and CHILLS (Chills) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) 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 ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VOMITING (Vomiting), DIARRHOEA (Diarrhea), HEADACHE (Head ache), DIZZINESS (Dizziness), CHILLS (Chills), FEAR OF EATING (Scared to eat in fear of vomiting) and PAIN IN EXTREMITY (Arm hurts a lot). At the time of the report, VOMITING (Vomiting), DIARRHOEA (Diarrhea), HEADACHE (Head ache), DIZZINESS (Dizziness), CHILLS (Chills), FEAR OF EATING (Scared to eat in fear of vomiting) and PAIN IN EXTREMITY (Arm hurts a lot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vomiting
Clinical narrative: Vomiting; Diarrhea; Head ache; Dizziness; Chills; Scared to eat in fear of vomiting; Arm hurts a lot; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting), DIARRHOEA (Diarrhea), HEADACHE (Head ache), DIZZINESS (Dizziness) and CHILLS (Chills) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) 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 ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VOMITING (Vomiting), DIARRHOEA (Diarrhea), HEADACHE (Head ache), DIZZINESS (Dizziness), CHILLS (Chills), FEAR OF EATING (Scared to eat in fear of vomiting) and PAIN IN EXTREMITY (Arm hurts a lot). At the time of the report, VOMITING (Vomiting), DIARRHOEA (Diarrhea), HEADACHE (Head ache), DIZZINESS (Dizziness), CHILLS (Chills), FEAR OF EATING (Scared to eat in fear of vomiting) and PAIN IN EXTREMITY (Arm hurts a lot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site paraesthesia, Micturition urgency, Pain in extremity
Clinical narrative: tingling from the injection site towards the cervical spine; cannot raise left hand because of the pain; he needs to use the restroom more frequently; Chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PARAESTHESIA (tingling from the injection site towards the cervical spine), PAIN IN EXTREMITY (cannot raise left hand because of the pain), MICTURITION URGENCY (he needs to use the restroom more frequently), CHILLS (Chills) and HEADACHE (headache) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Lymphocytes (suffered from lowered number of t-lymphocytes). Concomitant products included DIOSMIN, HESPERIDIN (DETRALEX) for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced INJECTION SITE PARAESTHESIA (tingling from the injection site towards the cervical spine), PAIN IN EXTREMITY (cannot raise left hand because of the pain), MICTURITION URGENCY (he needs to use the restroom more frequently), CHILLS (Chills) and HEADACHE (headache). On 30-Mar-2021, CHILLS (Chills) had resolved. At the time of the report, INJECTION SITE PARAESTHESIA (tingling from the injection site towards the cervical spine), PAIN IN EXTREMITY (cannot raise left hand because of the pain), MICTURITION URGENCY (he needs to use the restroom more frequently) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Sensory disturbance, Vaccination site pruritus
Clinical narrative: sensation of "conflict in arm"; redness; upper arm itchiness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of SENSORY DISTURBANCE (sensation of "conflict in arm"), ERYTHEMA (redness) and VACCINATION SITE PRURITUS (upper arm itchiness around the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and HYDROCORTISONE for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced SENSORY DISTURBANCE (sensation of "conflict in arm") and VACCINATION SITE PRURITUS (upper arm itchiness around the injection site). 13-Mar-2021, the patient experienced ERYTHEMA (redness). On 13-Mar-2021, SENSORY DISTURBANCE (sensation of "conflict in arm") and VACCINATION SITE PRURITUS (upper arm itchiness around the injection site) had resolved. At the time of the report, ERYTHEMA (redness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Inhibiting antibodies positive: positive IgG Positive. In 2021, SARS-CoV-2 test: negative (Negative) Covid-19 tested Negative.         Patient treatment included Hydrocortisone cream and Benadryl.  Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD-2021-060017 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Added patient's demographic and medical history. Event (redness) was added.
Sex: U
Vaccine: COVID19
Symptoms: Bronchitis, Chest pain, Headache, Tinnitus
Clinical narrative: chest pain; Bronchitis; hissing in ear; headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), BRONCHITIS (Bronchitis), TINNITUS (hissing in ear) and HEADACHE (headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 17-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 CHEST PAIN (chest pain), BRONCHITIS (Bronchitis), TINNITUS (hissing in ear) and HEADACHE (headache). At the time of the report, CHEST PAIN (chest pain), BRONCHITIS (Bronchitis), TINNITUS (hissing in ear) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Caller was warm transferred from Moderna Customer Care, case number 00132442. Caller was very angry and refused to answer any of the agents questions. She stated "you don't sound like you know anything and you are not a medical professional. You need to answer my questions, I don't need to answer yours!" Customer care stated that caller developed bronchitis, hissing in ear, chest pain and headache. Caller did not provide consent for safety follow up.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Peripheral swelling, Pruritus, Vaccination complication, Vaccination site erythema
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Arm responded to it in angry way), VACCINATION COMPLICATION (Did not do well and have to go to bed), VACCINATION SITE WARMTH (Hot), PRURITUS (Itchy) and PERIPHERAL SWELLING (Swollen arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anxiety and Difficulty breathing. Concurrent medical conditions included Post-traumatic stress disorder and Blood pressure increased. Concomitant products included HYDROXYZINE, HYDROCHLOROTHIAZIDE, AMITRIPTYLINE, OMEPRAZOLE, SIMVASTATIN, GABAPENTIN, TRAZODONE and DULOXETINE for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE REACTION (Arm responded to it in angry way), VACCINATION COMPLICATION (Did not do well and have to go to bed), VACCINATION SITE WARMTH (Hot), PRURITUS (Itchy), PERIPHERAL SWELLING (Swollen arm), FATIGUE (Tired) and VACCINATION SITE ERYTHEMA (red). At the time of the report, VACCINATION SITE REACTION (Arm responded to it in angry way) and FATIGUE (Tired) 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.   Inhalers are used as concomitant drugs and had birdflu in 2011.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction, Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Arm responded to it in angry way), VACCINATION COMPLICATION (Did not do well and have to go to bed), VACCINATION SITE WARMTH (Hot), PRURITUS (Itchy) and PERIPHERAL SWELLING (Swollen arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anxiety and Difficulty breathing. Concurrent medical conditions included Post-traumatic stress disorder and Blood pressure increased. Concomitant products included HYDROXYZINE, HYDROCHLOROTHIAZIDE, AMITRIPTYLINE, OMEPRAZOLE, SIMVASTATIN, GABAPENTIN, TRAZODONE and DULOXETINE for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE REACTION (Arm responded to it in angry way), VACCINATION COMPLICATION (Did not do well and have to go to bed), VACCINATION SITE WARMTH (Hot), PRURITUS (Itchy), PERIPHERAL SWELLING (Swollen arm), FATIGUE (Tired) and VACCINATION SITE ERYTHEMA (red). At the time of the report, VACCINATION SITE REACTION (Arm responded to it in angry way) and FATIGUE (Tired) 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.   Inhalers are used as concomitant drugs and had birdflu in 2011.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm in the injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (sore arm in the injection site) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 ml. On 29-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore arm in the injection site). At the time of the report, VACCINATION SITE PAIN (sore arm in the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   concominant treaments were not provided , lab data and past history, allergises were not provided.  Benadryl was given as a treatment drug
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Incorrect route of product administration, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Itchy; red sore/pink; IM injection given SC; site soon became tender; pocket of fluid; warm; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (pocket of fluid), VACCINATION SITE WARMTH (warm), VACCINATION SITE PRURITUS (Itchy), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (IM injection given SC) and VACCINATION SITE PAIN (site soon became tender) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 011J20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, DENOSUMAB (PROLIA) for Osteoporosis, HYDROCHLOROTHIAZIDE for Renal disease.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced BLISTER (pocket of fluid), VACCINATION SITE WARMTH (warm), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (IM injection given SC) and VACCINATION SITE PAIN (site soon became tender). On 07-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (red sore/pink). On 06-Feb-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (IM injection given SC) had resolved. At the time of the report, BLISTER (pocket of fluid), VACCINATION SITE WARMTH (warm), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE PAIN (site soon became tender) and VACCINATION SITE ERYTHEMA (red sore/pink) had resolved.            Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Itchy; red sore/pink; IM injection given SC; site soon became tender; pocket of fluid; warm; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (pocket of fluid), VACCINATION SITE WARMTH (warm), VACCINATION SITE PRURITUS (Itchy), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (IM injection given SC) and VACCINATION SITE PAIN (site soon became tender) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 011J20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, DENOSUMAB (PROLIA) for Osteoporosis, HYDROCHLOROTHIAZIDE for Renal disease.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced BLISTER (pocket of fluid), VACCINATION SITE WARMTH (warm), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (IM injection given SC) and VACCINATION SITE PAIN (site soon became tender). On 07-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (red sore/pink). On 06-Feb-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (IM injection given SC) had resolved. At the time of the report, BLISTER (pocket of fluid), VACCINATION SITE WARMTH (warm), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE PAIN (site soon became tender) and VACCINATION SITE ERYTHEMA (red sore/pink) had resolved.            Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Feeling hot, Myalgia
Clinical narrative: swelling redness & warmness on her upper arm; swelling redness & warmness on her upper arm; swelling redness & warmness on her upper arm; tiredness low grade fever, chills and body aches; tiredness low grade fever, chills and body aches; tiredness low grade fever, chills and body aches; tiredness low grade fever, chills and body aches; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tiredness low grade fever, chills and body aches), PYREXIA (tiredness low grade fever, chills and body aches), CHILLS (tiredness low grade fever, chills and body aches), MYALGIA (tiredness low grade fever, chills and body aches) and PERIPHERAL SWELLING (swelling redness & warmness on her upper arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017b21a and 023m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tiredness, Fever, Chills, Pain (body aches), Swelling and Redness. Concomitant products included LEVOTHYROXINE for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced FATIGUE (tiredness low grade fever, chills and body aches), PYREXIA (tiredness low grade fever, chills and body aches), CHILLS (tiredness low grade fever, chills and body aches) and MYALGIA (tiredness low grade fever, chills and body aches). On 29-Mar-2021, the patient experienced PERIPHERAL SWELLING (swelling redness & warmness on her upper arm), ERYTHEMA (swelling redness & warmness on her upper arm) and FEELING HOT (swelling redness & warmness on her upper arm). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, FATIGUE (tiredness low grade fever, chills and body aches), PYREXIA (tiredness low grade fever, chills and body aches), CHILLS (tiredness low grade fever, chills and body aches) and MYALGIA (tiredness low grade fever, chills and body aches) had resolved and PERIPHERAL SWELLING (swelling redness & warmness on her upper arm), ERYTHEMA (swelling redness & warmness on her upper arm) and FEELING HOT (swelling redness & warmness on her upper arm) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: swelling redness & warmness on her upper arm; swelling redness & warmness on her upper arm; swelling redness & warmness on her upper arm; tiredness low grade fever, chills and body aches; tiredness low grade fever, chills and body aches; tiredness low grade fever, chills and body aches; tiredness low grade fever, chills and body aches; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tiredness low grade fever, chills and body aches), PYREXIA (tiredness low grade fever, chills and body aches), CHILLS (tiredness low grade fever, chills and body aches), MYALGIA (tiredness low grade fever, chills and body aches) and PERIPHERAL SWELLING (swelling redness & warmness on her upper arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017b21a and 023m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tiredness, Fever, Chills, Pain (body aches), Swelling and Redness. Concomitant products included LEVOTHYROXINE for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced FATIGUE (tiredness low grade fever, chills and body aches), PYREXIA (tiredness low grade fever, chills and body aches), CHILLS (tiredness low grade fever, chills and body aches) and MYALGIA (tiredness low grade fever, chills and body aches). On 29-Mar-2021, the patient experienced PERIPHERAL SWELLING (swelling redness & warmness on her upper arm), ERYTHEMA (swelling redness & warmness on her upper arm) and FEELING HOT (swelling redness & warmness on her upper arm). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, FATIGUE (tiredness low grade fever, chills and body aches), PYREXIA (tiredness low grade fever, chills and body aches), CHILLS (tiredness low grade fever, chills and body aches) and MYALGIA (tiredness low grade fever, chills and body aches) had resolved and PERIPHERAL SWELLING (swelling redness & warmness on her upper arm), ERYTHEMA (swelling redness & warmness on her upper arm) and FEELING HOT (swelling redness & warmness on her upper arm) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Condition aggravated, Erythema, Ligament sprain
Clinical narrative: Soreness in arm; Shoulder looks inflamed; Excruciating pain in shoulder that goes down the arm when patient reaches with it, pain radiates from shoulder to underarm; progressive pain; Feels like something is tweaked; Shoulder looks red; Underarm pain; Pain in shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in arm), SWELLING (Shoulder looks inflamed), PAIN (Excruciating pain in shoulder that goes down the arm when patient reaches with it, pain radiates from shoulder to underarm), CONDITION AGGRAVATED (progressive pain) and LIGAMENT SPRAIN (Feels like something is tweaked) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: FLU. Concurrent medical conditions included Seasonal allergy.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness in arm), SWELLING (Shoulder looks inflamed), PAIN (Excruciating pain in shoulder that goes down the arm when patient reaches with it, pain radiates from shoulder to underarm), CONDITION AGGRAVATED (progressive pain), LIGAMENT SPRAIN (Feels like something is tweaked), ERYTHEMA (Shoulder looks red), AXILLARY PAIN (Underarm pain) and ARTHRALGIA (Pain in shoulder). At the time of the report, PAIN IN EXTREMITY (Soreness in arm), SWELLING (Shoulder looks inflamed), PAIN (Excruciating pain in shoulder that goes down the arm when patient reaches with it, pain radiates from shoulder to underarm), CONDITION AGGRAVATED (progressive pain), LIGAMENT SPRAIN (Feels like something is tweaked), AXILLARY PAIN (Underarm pain) and ARTHRALGIA (Pain in shoulder) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was unknown Treatment information was unknown
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Swelling
Clinical narrative: Soreness in arm; Shoulder looks inflamed; Excruciating pain in shoulder that goes down the arm when patient reaches with it, pain radiates from shoulder to underarm; progressive pain; Feels like something is tweaked; Shoulder looks red; Underarm pain; Pain in shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in arm), SWELLING (Shoulder looks inflamed), PAIN (Excruciating pain in shoulder that goes down the arm when patient reaches with it, pain radiates from shoulder to underarm), CONDITION AGGRAVATED (progressive pain) and LIGAMENT SPRAIN (Feels like something is tweaked) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: FLU. Concurrent medical conditions included Seasonal allergy.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness in arm), SWELLING (Shoulder looks inflamed), PAIN (Excruciating pain in shoulder that goes down the arm when patient reaches with it, pain radiates from shoulder to underarm), CONDITION AGGRAVATED (progressive pain), LIGAMENT SPRAIN (Feels like something is tweaked), ERYTHEMA (Shoulder looks red), AXILLARY PAIN (Underarm pain) and ARTHRALGIA (Pain in shoulder). At the time of the report, PAIN IN EXTREMITY (Soreness in arm), SWELLING (Shoulder looks inflamed), PAIN (Excruciating pain in shoulder that goes down the arm when patient reaches with it, pain radiates from shoulder to underarm), CONDITION AGGRAVATED (progressive pain), LIGAMENT SPRAIN (Feels like something is tweaked), AXILLARY PAIN (Underarm pain) and ARTHRALGIA (Pain in shoulder) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was unknown Treatment information was unknown
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose after 36 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose after 36 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose after 36 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose after 36 days) had resolved.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site mass, Pain
Clinical narrative: redness; bump; soreness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), INJECTION SITE MASS (bump) and PAIN (soreness) 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 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced ERYTHEMA (redness), INJECTION SITE MASS (bump) and PAIN (soreness). At the time of the report, ERYTHEMA (redness), INJECTION SITE MASS (bump) and PAIN (soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.