chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Gait disturbance, Headache, Injection site pain, Insomnia
Clinical narrative: Wanted to jump out a window; In "agony"; Couldn't sleep for 36 hours; Intense chest pain (felt like an Myocardial infarction); Had to crawl back to bed on hands and knees; Chest pain resolved in 10 minutes; Dizzy; Bilateral redness on cheeks; Pain "unbearable"; Head started pounding; Chills (not too bad); Felt like knives were going into her head through both eyes; Sore injected arm; Felt as if she could unzip her head, and let the pressure out she would feel better; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Wanted to jump out a window), EMOTIONAL DISTRESS (In "agony"), INSOMNIA (Couldn't sleep for 36 hours), CHEST PAIN (Intense chest pain (felt like an Myocardial infarction)) and GAIT DISTURBANCE (Had to crawl back to bed on hands and knees) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 05-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 FEELING ABNORMAL (Wanted to jump out a window), EMOTIONAL DISTRESS (In "agony"), INSOMNIA (Couldn't sleep for 36 hours), CHEST PAIN (Intense chest pain (felt like an Myocardial infarction)), GAIT DISTURBANCE (Had to crawl back to bed on hands and knees), CHEST PAIN (Chest pain resolved in 10 minutes), DIZZINESS (Dizzy), ERYTHEMA (Bilateral redness on cheeks), PAIN (Pain "unbearable"), HEADACHE (Head started pounding), CHILLS (Chills (not too bad)), HEADACHE (Felt like knives were going into her head through both eyes), INJECTION SITE PAIN (Sore injected arm) and HEADACHE (Felt as if she could unzip her head, and let the pressure out she would feel better). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, FEELING ABNORMAL (Wanted to jump out a window), EMOTIONAL DISTRESS (In "agony"), INSOMNIA (Couldn't sleep for 36 hours), CHEST PAIN (Intense chest pain (felt like an Myocardial infarction)), GAIT DISTURBANCE (Had to crawl back to bed on hands and knees), CHEST PAIN (Chest pain resolved in 10 minutes), DIZZINESS (Dizzy), ERYTHEMA (Bilateral redness on cheeks), PAIN (Pain "unbearable"), HEADACHE (Head started pounding), CHILLS (Chills (not too bad)), HEADACHE (Felt like knives were going into her head through both eyes), INJECTION SITE PAIN (Sore injected arm) and HEADACHE (Felt as if she could unzip her head, and let the pressure out she would feel better) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medication included multivitamin, Emer-GN-cee   This case was linked to US-MODERNATX, INC.-MOD-2021-078099 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-078099:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Wanted to jump out a window; In "agony"; Couldn't sleep for 36 hours; Intense chest pain (felt like an Myocardial infarction); Had to crawl back to bed on hands and knees; Chest pain resolved in 10 minutes; Dizzy; Bilateral redness on cheeks; Pain "unbearable"; Head started pounding; Chills (not too bad); Felt like knives were going into her head through both eyes; Sore injected arm; Felt as if she could unzip her head, and let the pressure out she would feel better; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Wanted to jump out a window), EMOTIONAL DISTRESS (In "agony"), INSOMNIA (Couldn't sleep for 36 hours), CHEST PAIN (Intense chest pain (felt like an Myocardial infarction)) and GAIT DISTURBANCE (Had to crawl back to bed on hands and knees) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 05-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 FEELING ABNORMAL (Wanted to jump out a window), EMOTIONAL DISTRESS (In "agony"), INSOMNIA (Couldn't sleep for 36 hours), CHEST PAIN (Intense chest pain (felt like an Myocardial infarction)), GAIT DISTURBANCE (Had to crawl back to bed on hands and knees), CHEST PAIN (Chest pain resolved in 10 minutes), DIZZINESS (Dizzy), ERYTHEMA (Bilateral redness on cheeks), PAIN (Pain "unbearable"), HEADACHE (Head started pounding), CHILLS (Chills (not too bad)), HEADACHE (Felt like knives were going into her head through both eyes), INJECTION SITE PAIN (Sore injected arm) and HEADACHE (Felt as if she could unzip her head, and let the pressure out she would feel better). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, FEELING ABNORMAL (Wanted to jump out a window), EMOTIONAL DISTRESS (In "agony"), INSOMNIA (Couldn't sleep for 36 hours), CHEST PAIN (Intense chest pain (felt like an Myocardial infarction)), GAIT DISTURBANCE (Had to crawl back to bed on hands and knees), CHEST PAIN (Chest pain resolved in 10 minutes), DIZZINESS (Dizzy), ERYTHEMA (Bilateral redness on cheeks), PAIN (Pain "unbearable"), HEADACHE (Head started pounding), CHILLS (Chills (not too bad)), HEADACHE (Felt like knives were going into her head through both eyes), INJECTION SITE PAIN (Sore injected arm) and HEADACHE (Felt as if she could unzip her head, and let the pressure out she would feel better) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medication included multivitamin, Emer-GN-cee   This case was linked to US-MODERNATX, INC.-MOD-2021-078099 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-078099:
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: swelling of the left armpit; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling of the left armpit) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 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 1 dosage form. On 15-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SWELLING (swelling of the left armpit). At the time of the report, SWELLING (swelling of the left armpit) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not Applicable. No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: increased tooth pain; This spontaneous case was reported by a consumer and describes the occurrence of TOOTHACHE (increased tooth pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TOOTHACHE (increased tooth pain). At the time of the report, TOOTHACHE (increased tooth pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information provided. The event was reported to be subsiding
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest discomfort, Diarrhoea, Dizziness, Electrocardiogram
Clinical narrative: Dizziness now & then; Vertigo; Rash at the opposite arm; Heart palpitation; Chest tighness/occasional left chest tightness; Pressure in her head; Diarrhea; This spontaneous case was reported by a health care professional and describes the occurrence of PALPITATIONS (Heart palpitation), CHEST DISCOMFORT (Chest tighness/occasional left chest tightness), HEAD DISCOMFORT (Pressure in her head), DIARRHOEA (Diarrhea) and DIZZINESS (Dizziness now & then) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included RA and Iron decreased. Concomitant products included IRON for Iron deficiency, MINOCYCLINE for Rheumatoid arthritis.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PALPITATIONS (Heart palpitation), CHEST DISCOMFORT (Chest tighness/occasional left chest tightness), HEAD DISCOMFORT (Pressure in her head), DIARRHOEA (Diarrhea) and RASH (Rash at the opposite arm). On an unknown date, the patient experienced DIZZINESS (Dizziness now & then) and VERTIGO (Vertigo). On 12-Apr-2021, PALPITATIONS (Heart palpitation) and RASH (Rash at the opposite arm) had resolved. At the time of the report, CHEST DISCOMFORT (Chest tighness/occasional left chest tightness), HEAD DISCOMFORT (Pressure in her head), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness now & then) and VERTIGO (Vertigo) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Blood test: high (High) ESR high. On 12-Apr-2021, Electrocardiogram: normal (normal) Normal.     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.   Pills loaded with vitamins are the other concomitant medication reported by reporter  for an unknown indication. No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up received on 26-May-2021, contains non significant information. On 21-Jul-2021: Follow up received on 21-Jul-2021 contains non significant information.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Palpitations, Rash, Vertigo
Clinical narrative: Dizziness now & then; Vertigo; Rash at the opposite arm; Heart palpitation; Chest tighness/occasional left chest tightness; Pressure in her head; Diarrhea; This spontaneous case was reported by a health care professional and describes the occurrence of PALPITATIONS (Heart palpitation), CHEST DISCOMFORT (Chest tighness/occasional left chest tightness), HEAD DISCOMFORT (Pressure in her head), DIARRHOEA (Diarrhea) and DIZZINESS (Dizziness now & then) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included RA and Iron decreased. Concomitant products included IRON for Iron deficiency, MINOCYCLINE for Rheumatoid arthritis.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PALPITATIONS (Heart palpitation), CHEST DISCOMFORT (Chest tighness/occasional left chest tightness), HEAD DISCOMFORT (Pressure in her head), DIARRHOEA (Diarrhea) and RASH (Rash at the opposite arm). On an unknown date, the patient experienced DIZZINESS (Dizziness now & then) and VERTIGO (Vertigo). On 12-Apr-2021, PALPITATIONS (Heart palpitation) and RASH (Rash at the opposite arm) had resolved. At the time of the report, CHEST DISCOMFORT (Chest tighness/occasional left chest tightness), HEAD DISCOMFORT (Pressure in her head), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness now & then) and VERTIGO (Vertigo) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Blood test: high (High) ESR high. On 12-Apr-2021, Electrocardiogram: normal (normal) Normal.     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.   Pills loaded with vitamins are the other concomitant medication reported by reporter  for an unknown indication. No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up received on 26-May-2021, contains non significant information. On 21-Jul-2021: Follow up received on 21-Jul-2021 contains non significant information.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Mobility decreased, Pain in extremity
Clinical narrative: so severe she could not get out of bed; pain in her legs; sore arm; She had a headache ever since; pain in hip area; chills; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (so severe she could not get out of bed), PAIN IN EXTREMITY (pain in her legs), PAIN IN EXTREMITY (sore arm), HEADACHE (She had a headache ever since) and ARTHRALGIA (pain in hip area) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-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 13-Apr-2021, the patient experienced MOBILITY DECREASED (so severe she could not get out of bed), PAIN IN EXTREMITY (pain in her legs), PAIN IN EXTREMITY (sore arm), HEADACHE (She had a headache ever since), ARTHRALGIA (pain in hip area) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. On 14-Apr-2021, PAIN IN EXTREMITY (sore arm) and CHILLS (chills) had resolved. At the time of the report, MOBILITY DECREASED (so severe she could not get out of bed), PAIN IN EXTREMITY (pain in her legs), HEADACHE (She had a headache ever since) and ARTHRALGIA (pain in hip area) outcome was unknown.            No concomitant medications were reported. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: First dose of Moderna and mistakenly Pfizer was given as second dose; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (First dose of Moderna and mistakenly Pfizer was given as second dose) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025a21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN GLARGINE (Lantus), METFORMIN, GLIMEPIRIDE, LISINOPRIL and SIMVASTATIN for Diabetes.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (First dose of Moderna and mistakenly Pfizer was given as second dose). On 26-Mar-2021, INTERCHANGE OF VACCINE PRODUCTS (First dose of Moderna and mistakenly Pfizer was given as second dose) 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.   The patient was feeling fine.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) and MULTIVITAMIN & MINERAL for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medications also included Emer-GN-cee.   This case was linked to INC.-MOD-2021-078089 (E2B Linked Report).; Sender's Comments: INC.-MOD-2021-078089:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: slight fever after second dose; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (slight fever after second dose) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (slight fever after second dose). At the time of the report, PYREXIA (slight fever after second dose) outcome was unknown. Not Provided          No concomitant and treatment  medications were reported.  For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable.    This case was linked to US-MODERNATX, INC.-MOD-2021-078079 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-078079:1st dose event
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Product administered to patient of inappropriate age
Clinical narrative: 17 year old patient received the first dose of Moderna COVID-19 vaccine; Slight arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient received the first dose of Moderna COVID-19 vaccine) and MYALGIA (Slight arm soreness) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient received the first dose of Moderna COVID-19 vaccine) and MYALGIA (Slight arm soreness). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient received the first dose of Moderna COVID-19 vaccine) and MYALGIA (Slight arm soreness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia, Skin mass
Clinical narrative: There are two lumps on left shoulder that is on her left collar bone and one new lumps on back of her neck; Whole body ache; Fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (There are two lumps on left shoulder that is on her left collar bone and one new lumps on back of her neck), PAIN (Whole body ache), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-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 14-Apr-2021, the patient experienced SKIN MASS (There are two lumps on left shoulder that is on her left collar bone and one new lumps on back of her neck), PAIN (Whole body ache), PYREXIA (Fever) and CHILLS (Chills). 14-Apr-2021, the patient experienced HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SKIN MASS (There are two lumps on left shoulder that is on her left collar bone and one new lumps on back of her neck), PAIN (Whole body ache), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown. Not Provided          Concomitants were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-056408 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-056408:Dose 1
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concomitant products included RIVAROXABAN (XARELTO) for Anticoagulant therapy, VALSARTAN and AMLODIPINE for Blood pressure high, PRAVASTATIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (Soreness). On 19-Mar-2021, PAIN (Soreness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history weren't reported and relevant concomitant medication include "Complete multivitamin"   Treatment information was not provided.   This case was linked to MOD-2021-078088, MOD-2021-078059, MOD-2021-078068, MOD-2021-078029, MOD-2021-078048 (E2B Linked Report).; Sender's Comments:  MOD-2021-078088:Husband First dose case MOD-2021-078059:Wife First Dose Case MOD-2021-078068:Wife Second dose case MOD-2021-078029:Sons first dose case MOD-2021-078048:Son second dose case
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Pain
Clinical narrative: Soreness around surgery area; Agitation around surgery area; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness around surgery area) and AGITATION (Agitation around surgery area) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Surgery (shoulder surgery).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Soreness around surgery area) and AGITATION (Agitation around surgery area). At the time of the report, PAIN (Soreness around surgery area) and AGITATION (Agitation around surgery area) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.      This case was linked to MOD21-076332. (E2B Linked Report).; Sender's Comments:  MOD21-076332.:
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia, Head discomfort, Injection site erythema, Injection site mass, Movement disorder
Clinical narrative: uncontrollable head movement; head vobling; head node is uncontrollable; arm got sore; big lump at the injection site; at the injection site white center and red dot around; then pink dot; red dote inch away from injection site; This spontaneous case was reported by a consumer and describes the occurrence of DYSKINESIA (uncontrollable head movement), HEAD DISCOMFORT (head vobling), MOVEMENT DISORDER (head node is uncontrollable), PAIN IN EXTREMITY (arm got sore) and INJECTION SITE MASS (big lump at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included BUSPIRONE and OXCARBAZEPINE.    On 14-Apr-2021 at 11:26 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced DYSKINESIA (uncontrollable head movement), HEAD DISCOMFORT (head vobling), MOVEMENT DISORDER (head node is uncontrollable), PAIN IN EXTREMITY (arm got sore), INJECTION SITE MASS (big lump at the injection site), SKIN DISCOLOURATION (at the injection site white center and red dot around), SKIN DISCOLOURATION (then pink dot) and INJECTION SITE ERYTHEMA (red dote inch away from injection site). At the time of the report, DYSKINESIA (uncontrollable head movement), PAIN IN EXTREMITY (arm got sore), INJECTION SITE MASS (big lump at the injection site), SKIN DISCOLOURATION (at the injection site white center and red dot around), SKIN DISCOLOURATION (then pink dot) and INJECTION SITE ERYTHEMA (red dote inch away from injection site) outcome was unknown and HEAD DISCOMFORT (head vobling) and MOVEMENT DISORDER (head node is uncontrollable) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication not provided
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Skin discolouration
Clinical narrative: uncontrollable head movement; head vobling; head node is uncontrollable; arm got sore; big lump at the injection site; at the injection site white center and red dot around; then pink dot; red dote inch away from injection site; This spontaneous case was reported by a consumer and describes the occurrence of DYSKINESIA (uncontrollable head movement), HEAD DISCOMFORT (head vobling), MOVEMENT DISORDER (head node is uncontrollable), PAIN IN EXTREMITY (arm got sore) and INJECTION SITE MASS (big lump at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included BUSPIRONE and OXCARBAZEPINE.    On 14-Apr-2021 at 11:26 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced DYSKINESIA (uncontrollable head movement), HEAD DISCOMFORT (head vobling), MOVEMENT DISORDER (head node is uncontrollable), PAIN IN EXTREMITY (arm got sore), INJECTION SITE MASS (big lump at the injection site), SKIN DISCOLOURATION (at the injection site white center and red dot around), SKIN DISCOLOURATION (then pink dot) and INJECTION SITE ERYTHEMA (red dote inch away from injection site). At the time of the report, DYSKINESIA (uncontrollable head movement), PAIN IN EXTREMITY (arm got sore), INJECTION SITE MASS (big lump at the injection site), SKIN DISCOLOURATION (at the injection site white center and red dot around), SKIN DISCOLOURATION (then pink dot) and INJECTION SITE ERYTHEMA (red dote inch away from injection site) outcome was unknown and HEAD DISCOMFORT (head vobling) and MOVEMENT DISORDER (head node is uncontrollable) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication not provided
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling
Clinical narrative: swelling around right eye; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (swelling around right eye) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced EYE SWELLING (swelling around right eye). At the time of the report, EYE SWELLING (swelling around right eye) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was not reported.   Treatment information was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: 0.6 ML dose given; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (0.6 ML dose given) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (0.6 ML dose given). At the time of the report, ACCIDENTAL OVERDOSE (0.6 ML dose given) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient's medical history  and relevant concomitant medications weren't reported Treatment information was not provided
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Fatigue, Hypertension, Migraine
Clinical narrative: High Blood Pressure, never back to normal; Muscle Pain; Tiredness; Chills; Nausea; Vomiting; Migraines; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraines), HYPERTENSION (High Blood Pressure, never back to normal), MYALGIA (Muscle Pain), FATIGUE (Tiredness) and CHILLS (Chills) in a 63-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.     Concurrent medical conditions included Hypertension and Lung disorder NOS. Concomitant products included LISINOPRIL and ATORVASTATIN for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced MIGRAINE (Migraines), MYALGIA (Muscle Pain), FATIGUE (Tiredness), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting). On 25-Mar-2021, the patient experienced HYPERTENSION (High Blood Pressure, never back to normal). On 29-Mar-2021, MIGRAINE (Migraines), MYALGIA (Muscle Pain), FATIGUE (Tiredness), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) had resolved. At the time of the report, HYPERTENSION (High Blood Pressure, never back to normal) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 152/67 mmHg. On an unknown date, SARS-CoV-2 test: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, SARS-CoV-2 test, Vomiting
Clinical narrative: High Blood Pressure, never back to normal; Muscle Pain; Tiredness; Chills; Nausea; Vomiting; Migraines; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraines), HYPERTENSION (High Blood Pressure, never back to normal), MYALGIA (Muscle Pain), FATIGUE (Tiredness) and CHILLS (Chills) in a 63-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.     Concurrent medical conditions included Hypertension and Lung disorder NOS. Concomitant products included LISINOPRIL and ATORVASTATIN for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced MIGRAINE (Migraines), MYALGIA (Muscle Pain), FATIGUE (Tiredness), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting). On 25-Mar-2021, the patient experienced HYPERTENSION (High Blood Pressure, never back to normal). On 29-Mar-2021, MIGRAINE (Migraines), MYALGIA (Muscle Pain), FATIGUE (Tiredness), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) had resolved. At the time of the report, HYPERTENSION (High Blood Pressure, never back to normal) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 152/67 mmHg. On an unknown date, SARS-CoV-2 test: Negative.     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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Weird non stop ringing in his ears; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (Weird non stop ringing in his ears) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TINNITUS (Weird non stop ringing in his ears). The patient was treated with AMOXICILLIN TRIHYDRATE, CLAVULANATE POTASSIUM (AMOXCLA) on 06-Apr-2021 at an unspecified dose and frequency. At the time of the report, TINNITUS (Weird non stop ringing in his ears) outcome was unknown. Not Provided          No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administering vaccine Improperly stored and handled; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of PRODUCT STORAGE ERROR (Administering vaccine Improperly stored and handled) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administering vaccine Improperly stored and handled). At the time of the report, PRODUCT STORAGE ERROR (Administering vaccine Improperly stored and handled) had resolved. 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.   Administered the vaccine used a punctured vial for 24hours and some even more than 24hours.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Muscle spasms, Palpitations
Clinical narrative: piercing sudden pain in her ankle; right leg is feeling funny like a cramping in her lower leg; heart Palpitations; This spontaneous case was reported by a physician and describes the occurrence of PALPITATIONS (heart Palpitations), MUSCLE SPASMS (right leg is feeling funny like a cramping in her lower leg) and ARTHRALGIA (piercing sudden pain in her ankle) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Menopausal (patient is pre-menopausal). Concomitant products included CETIRIZINE for Allergy NOS, ESCITALOPRAM for Anxiety, LOSARTAN for Blood pressure high.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PALPITATIONS (heart Palpitations). On 10-Apr-2021, the patient experienced MUSCLE SPASMS (right leg is feeling funny like a cramping in her lower leg). On an unknown date, the patient experienced ARTHRALGIA (piercing sudden pain in her ankle). The patient was treated with ACETYLSALICYLIC ACID (ASPIRINE 325 MG) for Pain, at a dose of 325 mg. On 30-Mar-2021, PALPITATIONS (heart Palpitations) had resolved. At the time of the report, MUSCLE SPASMS (right leg is feeling funny like a cramping in her lower leg) had not resolved and ARTHRALGIA (piercing sudden pain in her ankle) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Influenza, Pain in extremity
Clinical narrative: Terrible flu after firs vaccine dose; Sore arm after first vaccine dose; Weakness after first vaccine dose; Chills after first vaccine dose; Headache after first vaccine dose; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Terrible flu after firs vaccine dose), PAIN IN EXTREMITY (Sore arm after first vaccine dose), ASTHENIA (Weakness after first vaccine dose), CHILLS (Chills after first vaccine dose) and HEADACHE (Headache after first vaccine dose) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M30A) for COVID-19 vaccination.     Concurrent medical conditions included Mitral valve prolapse since 2017, Cholesterol, Blood pressure and Heart rate. Concomitant products included AMLODIPINE for Blood pressure management, ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol, METOPROLOL for Pulse rate.    On 30-Jan-2021 at 4:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced INFLUENZA (Terrible flu after firs vaccine dose), PAIN IN EXTREMITY (Sore arm after first vaccine dose), ASTHENIA (Weakness after first vaccine dose), CHILLS (Chills after first vaccine dose) and HEADACHE (Headache after first vaccine dose). At the time of the report, INFLUENZA (Terrible flu after firs vaccine dose) had resolved and PAIN IN EXTREMITY (Sore arm after first vaccine dose), ASTHENIA (Weakness after first vaccine dose), CHILLS (Chills after first vaccine dose) and HEADACHE (Headache after first vaccine dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-078143 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Patient demographic details were updated, relevant medical history was updated, concomitant medications were added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-078143:Case for dose 2
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: severe vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (severe vomiting) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced VOMITING (severe vomiting). At the time of the report, VOMITING (severe vomiting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Tooth infection, Tooth loss, Toothache
Clinical narrative: She had a toothache; tooth infection; tooth loss; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TOOTHACHE (She had a toothache), TOOTH INFECTION (tooth infection) and TOOTH LOSS (tooth loss) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced TOOTHACHE (She had a toothache) and TOOTH INFECTION (tooth infection). In April 2021, the patient experienced TOOTH LOSS (tooth loss). The patient was treated with AMOXICILLIN for Tooth infection, at a dose of 500 mg three times a day. At the time of the report, TOOTHACHE (She had a toothache), TOOTH INFECTION (tooth infection) and TOOTH LOSS (tooth loss) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: stomach pain; This spontaneous case was reported by a physician and describes the occurrence of ABDOMINAL PAIN UPPER (stomach pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for an unknown indication.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach pain). At the time of the report, ABDOMINAL PAIN UPPER (stomach pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information includes Took a couple of Tums to alleviate reflux but did not do any good.
Sex: U
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: vaccine given after 24 hrs of opening of the vial; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Apr-2021 and was forwarded to Moderna on 15-Apr-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (vaccine given after 24 hrs of opening of the vial) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (vaccine given after 24 hrs of opening of the vial). At the time of the report, PRODUCT ADMINISTRATION ERROR (vaccine given after 24 hrs of opening of the vial) 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.   Concomitant medication was not provided Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: TCR doc attached and contains No new information. Reporter confirmed he'd like to close the case
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Sensation of foreign body, Tenderness
Clinical narrative: noticed two bumps over the left side side of the neck near the injection arm; tender to touch; This spontaneous case was reported by a consumer and describes the occurrence of SENSATION OF FOREIGN BODY (noticed two bumps over the left side side of the neck near the injection arm) and TENDERNESS (tender to touch) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 044A21A) for COVID-19 vaccination.     The patient's past medical history included Blood pressure. Concomitant products included LISINOPRIL and AMLODIPINE for Hypertension, ASPIRIN [ACETYLSALICYLIC ACID] and COLECALCIFEROL (VIT D [COLECALCIFEROL]) for an unknown indication.   On 16-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 SENSATION OF FOREIGN BODY (noticed two bumps over the left side side of the neck near the injection arm) and TENDERNESS (tender to touch). At the time of the report, SENSATION OF FOREIGN BODY (noticed two bumps over the left side side of the neck near the injection arm) and TENDERNESS (tender to touch) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drugs are Iron pills, Calcium supplement.   This case was linked to MOD-2021-078184 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Sinusitis
Clinical narrative: Headache; Fatigue; sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), FATIGUE (Fatigue) and SINUSITIS (sinus infection) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Sinus infection. Concomitant products included AMOXICILLIN and PARACETAMOL (TYLENOL) for Sinus infection.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced HEADACHE (Headache), FATIGUE (Fatigue) and SINUSITIS (sinus infection). At the time of the report, HEADACHE (Headache), FATIGUE (Fatigue) and SINUSITIS (sinus infection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.