chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Lymphadenopathy, Palpitations, Vomiting
Clinical narrative: So dizzy that felt like passing out; Sick to her stomach; Diarrhea; Fast rapid heart beat; Couldn't move; Could breathe but not right; Lymph nodes on both sides of her neck swollen; Vomiting; Massive headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (So dizzy that felt like passing out), ABDOMINAL DISCOMFORT (Sick to her stomach), DIARRHOEA (Diarrhea), PALPITATIONS (Fast rapid heart beat) and HYPOKINESIA (Couldn't move) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer (Patient is on remission from cancer for the third time.) and Heart attack (Patient reported having several heart attacks in the past.). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), LEVOTHYROXINE SODIUM (LEVOXYL), CARVEDILOL and LOVASTATIN for an unknown indication.    On 13-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 DIZZINESS (So dizzy that felt like passing out), ABDOMINAL DISCOMFORT (Sick to her stomach), DIARRHOEA (Diarrhea), PALPITATIONS (Fast rapid heart beat), HYPOKINESIA (Couldn't move), DYSPNOEA (Could breathe but not right), LYMPHADENOPATHY (Lymph nodes on both sides of her neck swollen), VOMITING (Vomiting) and HEADACHE (Massive headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 13-Apr-2021, DIZZINESS (So dizzy that felt like passing out) and HYPOKINESIA (Couldn't move) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (Sick to her stomach), LYMPHADENOPATHY (Lymph nodes on both sides of her neck swollen), VOMITING (Vomiting) and HEADACHE (Massive headache) outcome was unknown, DIARRHOEA (Diarrhea) and PALPITATIONS (Fast rapid heart beat) had not resolved and DYSPNOEA (Could breathe but not right) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Nausea
Clinical narrative: Fatigue; Nauseous; Red rash again on my arm, itched; Red rash again on my arm; red rash again on my arm it swelled up; Chills; Sore arm; Fever; Headache; Flu-like side symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like side symptoms), VACCINATION SITE PRURITUS (Red rash again on my arm, itched), VACCINATION SITE RASH (Red rash again on my arm), VACCINATION SITE PAIN (Sore arm) and VACCINATION SITE SWELLING (red rash again on my arm it swelled up) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008821A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Food allergy (HONEY,NUTTIN), Pollen allergy and Fibromyalgia. Concomitant products included ATENOLOL for Blood pressure management, CHLORPHENIRAMINE MALEATE from an unknown date to 10-Mar-2021 for Pollen allergy, LEVETIRACETAM for Spasticity and Fibromyalgia.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like side symptoms), VACCINATION SITE PAIN (Sore arm), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever). On 10-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Red rash again on my arm, itched), VACCINATION SITE RASH (Red rash again on my arm) and VACCINATION SITE SWELLING (red rash again on my arm it swelled up). On 14-Apr-2021, the patient experienced NAUSEA (Nauseous). On an unknown date, the patient experienced FATIGUE (Fatigue). On 10-Apr-2021, PYREXIA (Fever) had resolved. On 17-Apr-2021, INFLUENZA LIKE ILLNESS (Flu-like side symptoms), VACCINATION SITE PRURITUS (Red rash again on my arm, itched), VACCINATION SITE RASH (Red rash again on my arm), VACCINATION SITE PAIN (Sore arm), CHILLS (Chills) and HEADACHE (Headache) had resolved. At the time of the report, VACCINATION SITE SWELLING (red rash again on my arm it swelled up) had not resolved and FATIGUE (Fatigue) and NAUSEA (Nauseous) outcome was unknown.            No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-050374 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2021: Updated some of the event details. On 16-May-2021: Current condition and ADR form updated. On 29-Jul-2021: Follow-up added information for first dose of vaccine, updated batch number for second dose of vaccine, concomitant medications, outcome updated for events of sore arm, rash, headache, chills itch and flu symptoms to recovered.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-050374:First dose case
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Fatigue; Nauseous; Red rash again on my arm, itched; Red rash again on my arm; red rash again on my arm it swelled up; Chills; Sore arm; Fever; Headache; Flu-like side symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like side symptoms), VACCINATION SITE PRURITUS (Red rash again on my arm, itched), VACCINATION SITE RASH (Red rash again on my arm), VACCINATION SITE PAIN (Sore arm) and VACCINATION SITE SWELLING (red rash again on my arm it swelled up) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008821A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Food allergy (HONEY,NUTTIN), Pollen allergy and Fibromyalgia. Concomitant products included ATENOLOL for Blood pressure management, CHLORPHENIRAMINE MALEATE from an unknown date to 10-Mar-2021 for Pollen allergy, LEVETIRACETAM for Spasticity and Fibromyalgia.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like side symptoms), VACCINATION SITE PAIN (Sore arm), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever). On 10-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Red rash again on my arm, itched), VACCINATION SITE RASH (Red rash again on my arm) and VACCINATION SITE SWELLING (red rash again on my arm it swelled up). On 14-Apr-2021, the patient experienced NAUSEA (Nauseous). On an unknown date, the patient experienced FATIGUE (Fatigue). On 10-Apr-2021, PYREXIA (Fever) had resolved. On 17-Apr-2021, INFLUENZA LIKE ILLNESS (Flu-like side symptoms), VACCINATION SITE PRURITUS (Red rash again on my arm, itched), VACCINATION SITE RASH (Red rash again on my arm), VACCINATION SITE PAIN (Sore arm), CHILLS (Chills) and HEADACHE (Headache) had resolved. At the time of the report, VACCINATION SITE SWELLING (red rash again on my arm it swelled up) had not resolved and FATIGUE (Fatigue) and NAUSEA (Nauseous) outcome was unknown.            No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-050374 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2021: Updated some of the event details. On 16-May-2021: Current condition and ADR form updated. On 29-Jul-2021: Follow-up added information for first dose of vaccine, updated batch number for second dose of vaccine, concomitant medications, outcome updated for events of sore arm, rash, headache, chills itch and flu symptoms to recovered.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-050374:First dose case
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and MYALGIA (Body aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 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 PYREXIA (Fever) and MYALGIA (Body aches). At the time of the report, PYREXIA (Fever) and MYALGIA (Body aches) outcome was unknown. Not Provided          Concomitant drug details not provided. Treatment details not provided.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: infected with covid within 10 days of 1st Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (infected with covid within 10 days of 1st Moderna vaccine) in a 78-year-old male patient 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 COVID-19 (infected with covid within 10 days of 1st Moderna vaccine). At the time of the report, COVID-19 (infected with covid within 10 days of 1st Moderna vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) COVID-19 Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient has received 3 hour antibodies infusion and doctor suggested not to take second dose of Moderna until 90 days but when the patient scheduled for the second dose they are told that patient can receive second dose within a time frame of 41 days of their first dose.  No concomitant medications were reported.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Pyrexia
Clinical narrative: Pain in his left shoulder from second shot; Chills; Fever 103F; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in his left shoulder from second shot), CHILLS (Chills) and PYREXIA (Fever 103F) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 011L20A) for COVID-19 vaccination.     Concomitant products included PANTOPRAZOLE, LISINOPRIL and TAMSULOSIN for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced ARTHRALGIA (Pain in his left shoulder from second shot), CHILLS (Chills) and PYREXIA (Fever 103F). At the time of the report, ARTHRALGIA (Pain in his left shoulder from second shot), CHILLS (Chills) and PYREXIA (Fever 103F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Body temperature: 103 (High) 103 Degree Fahrenheit.         No treatment information was provided. Action taken with mRNA-1273 in response to the drug was not applicable   This case was linked to MOD21-09710 (E2B Linked Report).; Sender's Comments:  MOD21-09710:Crosslink case
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Pharyngeal swelling, Swelling, Swelling face, Swollen tongue
Clinical narrative: swelling in her sinuses; feel swelling in upper throat; Swelling of face; Cheek swelling; felt lips swell up; tongue swell up; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling in her sinuses), PHARYNGEAL SWELLING (feel swelling in upper throat), SWELLING FACE (Swelling of face), SWELLING FACE (Cheek swelling) and LIP SWELLING (felt lips swell up) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced SWELLING (swelling in her sinuses), PHARYNGEAL SWELLING (feel swelling in upper throat), SWELLING FACE (Swelling of face), SWELLING FACE (Cheek swelling), LIP SWELLING (felt lips swell up) and SWOLLEN TONGUE (tongue swell up). At the time of the report, SWELLING (swelling in her sinuses), PHARYNGEAL SWELLING (feel swelling in upper throat), SWELLING FACE (Swelling of face), SWELLING FACE (Cheek swelling), LIP SWELLING (felt lips swell up) and SWOLLEN TONGUE (tongue swell up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant drugs provided no treatment drugs provided
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-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 VACCINATION SITE PAIN (soreness at injection site). At the time of the report, VACCINATION SITE PAIN (soreness at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information were not provided by the reporter. Treatment information were not reported.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Dysgeusia, Myalgia, Pyrexia
Clinical narrative: Dysgeusia; Loss of taste; Fever; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Dysgeusia), AGEUSIA (Loss of taste), PYREXIA (Fever) and MYALGIA (Body ache) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (Dysgeusia), AGEUSIA (Loss of taste), PYREXIA (Fever) and MYALGIA (Body ache). At the time of the report, DYSGEUSIA (Dysgeusia), AGEUSIA (Loss of taste), PYREXIA (Fever) and MYALGIA (Body ache) outcome was unknown. Not Provided          No concomitant medications were reported. No treatment medication were provided. Action taken for Moderna COVID-19 vaccine was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-076576 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076576:First Dose Case
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product dose omission issue
Clinical narrative: It has been greater than 42 days since she has had the first dose; It has been greater than 42 days since she has had the first dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (It has been greater than 42 days since she has had the first dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It has been greater than 42 days since she has had the first dose) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (It has been greater than 42 days since she has had the first dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It has been greater than 42 days since she has had the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (It has been greater than 42 days since she has had the first dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It has been greater than 42 days since she has had the first dose) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No  concomitant medical  provided by the reporter. No treatment medication provided by the reporter.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Hyperhidrosis
Clinical narrative: chest pain on his left side; hot sweats; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain on his left side) and HYPERHIDROSIS (hot sweats) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02B21A and A07A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced CHEST PAIN (chest pain on his left side) and HYPERHIDROSIS (hot sweats). At the time of the report, CHEST PAIN (chest pain on his left side) and HYPERHIDROSIS (hot sweats) had not resolved. Not Provided          Patient weight is 220 (units not reported) No concomitant medication reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-076580 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076580:For first dose
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Myalgia, Neck pain, Pain in extremity
Clinical narrative: very tired; hurting so bad in my neck; hurting so bad in my back; hurting so bad in my arm; real sore arm - right arm; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (hurting so bad in my neck), BACK PAIN (hurting so bad in my back), PAIN IN EXTREMITY (hurting so bad in my arm), MYALGIA (real sore arm - right arm) and FATIGUE (very tired) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced MYALGIA (real sore arm - right arm). On 10-Apr-2021, the patient experienced NECK PAIN (hurting so bad in my neck), BACK PAIN (hurting so bad in my back) and PAIN IN EXTREMITY (hurting so bad in my arm). On 13-Apr-2021, the patient experienced FATIGUE (very tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NECK PAIN (hurting so bad in my neck), BACK PAIN (hurting so bad in my back), PAIN IN EXTREMITY (hurting so bad in my arm), MYALGIA (real sore arm - right arm) and FATIGUE (very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medication reported.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Oropharyngeal pain, Pain in extremity, Pruritus
Clinical narrative: Warm left leg; Red left leg; Itching left leg; Puked water; Sore arm; sore throat; warm head; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VOMITING (Puked water), FEELING HOT (Warm left leg), ERYTHEMA (Red left leg) and PRURITUS (Itching left leg) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat) and FEELING HOT (warm head). On 12-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 13-Apr-2021, the patient experienced VOMITING (Puked water). On 14-Apr-2021, the patient experienced FEELING HOT (Warm left leg), ERYTHEMA (Red left leg) and PRURITUS (Itching left leg). At the time of the report, PAIN IN EXTREMITY (Sore arm), VOMITING (Puked water), FEELING HOT (Warm left leg), ERYTHEMA (Red left leg), PRURITUS (Itching left leg), OROPHARYNGEAL PAIN (sore throat) and FEELING HOT (warm head) outcome was unknown. Not provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MODERNATX, INC.-MOD-2021-076582 (E2B Linked Report); Sender's Comments:  MODERNATX, INC.-MOD-2021-076582:CROSSLINKED WITH DOSE 1
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Warm left leg; Red left leg; Itching left leg; Puked water; Sore arm; sore throat; warm head; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VOMITING (Puked water), FEELING HOT (Warm left leg), ERYTHEMA (Red left leg) and PRURITUS (Itching left leg) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat) and FEELING HOT (warm head). On 12-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 13-Apr-2021, the patient experienced VOMITING (Puked water). On 14-Apr-2021, the patient experienced FEELING HOT (Warm left leg), ERYTHEMA (Red left leg) and PRURITUS (Itching left leg). At the time of the report, PAIN IN EXTREMITY (Sore arm), VOMITING (Puked water), FEELING HOT (Warm left leg), ERYTHEMA (Red left leg), PRURITUS (Itching left leg), OROPHARYNGEAL PAIN (sore throat) and FEELING HOT (warm head) outcome was unknown. Not provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MODERNATX, INC.-MOD-2021-076582 (E2B Linked Report); Sender's Comments:  MODERNATX, INC.-MOD-2021-076582:CROSSLINKED WITH DOSE 1
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vaccination site erythema, Vaccination site inflammation, Vaccination site pain, Vaccination site pruritus
Clinical narrative: warm to the touch; inflammed; itches really bad just like a mosquito bite; swollen again in the area of the shot; bright red; swollen; pain in the shot area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE INFLAMMATION (inflammed), SWELLING (swollen), VACCINATION SITE PRURITUS (itches really bad just like a mosquito bite) and VACCINATION SITE PAIN (pain in the shot area) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0211321A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack in 2017. Concurrent medical conditions included Hypertension and High cholesterol. Concomitant products included METOPROLOL, ATORVASTATIN, CLOPIDOGREL and RANOLAZINE for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE PAIN (pain in the shot area). On 07-Apr-2021, the patient experienced SWELLING (swollen). On 13-Apr-2021, the patient experienced VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE INFLAMMATION (inflammed), VACCINATION SITE PRURITUS (itches really bad just like a mosquito bite), VACCINATION SITE SWELLING (swollen again in the area of the shot) and VACCINATION SITE ERYTHEMA (bright red). At the time of the report, VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE INFLAMMATION (inflammed), VACCINATION SITE PRURITUS (itches really bad just like a mosquito bite), VACCINATION SITE PAIN (pain in the shot area), VACCINATION SITE SWELLING (swollen again in the area of the shot) and VACCINATION SITE ERYTHEMA (bright red) outcome was unknown and SWELLING (swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: warm to the touch; inflammed; itches really bad just like a mosquito bite; swollen again in the area of the shot; bright red; swollen; pain in the shot area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE INFLAMMATION (inflammed), SWELLING (swollen), VACCINATION SITE PRURITUS (itches really bad just like a mosquito bite) and VACCINATION SITE PAIN (pain in the shot area) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0211321A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack in 2017. Concurrent medical conditions included Hypertension and High cholesterol. Concomitant products included METOPROLOL, ATORVASTATIN, CLOPIDOGREL and RANOLAZINE for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE PAIN (pain in the shot area). On 07-Apr-2021, the patient experienced SWELLING (swollen). On 13-Apr-2021, the patient experienced VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE INFLAMMATION (inflammed), VACCINATION SITE PRURITUS (itches really bad just like a mosquito bite), VACCINATION SITE SWELLING (swollen again in the area of the shot) and VACCINATION SITE ERYTHEMA (bright red). At the time of the report, VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE INFLAMMATION (inflammed), VACCINATION SITE PRURITUS (itches really bad just like a mosquito bite), VACCINATION SITE PAIN (pain in the shot area), VACCINATION SITE SWELLING (swollen again in the area of the shot) and VACCINATION SITE ERYTHEMA (bright red) outcome was unknown and SWELLING (swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Myalgia, Nausea, Pyrexia
Clinical narrative: weakness; nausea; muscle pain; fever, pretty hot; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), NAUSEA (nausea), MYALGIA (muscle pain) and PYREXIA (fever, pretty hot) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 038B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included OMEPRAZOLE for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced ASTHENIA (weakness), NAUSEA (nausea), MYALGIA (muscle pain) and PYREXIA (fever, pretty hot). At the time of the report, ASTHENIA (weakness), NAUSEA (nausea), MYALGIA (muscle pain) and PYREXIA (fever, pretty hot) outcome was unknown.            This case was linked to US-MODERNATX, INC.-MOD-2021-076479, US-MODERNATX, INC.-MOD-2021-076514, US-MODERNATX, INC.-MOD-2021-076575 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076479:1st dose vaccine - husband US-MODERNATX, INC.-MOD-2021-076514:2nd dose vaccine - husband US-MODERNATX, INC.-MOD-2021-076575:1st dose vaccine - Wife
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Pyrexia
Clinical narrative: chills; high fever; fatigue; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (high fever), FATIGUE (fatigue) and ARTHRALGIA (joint pain) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (chills), PYREXIA (high fever), FATIGUE (fatigue) and ARTHRALGIA (joint pain). At the time of the report, CHILLS (chills), PYREXIA (high fever), FATIGUE (fatigue) and ARTHRALGIA (joint pain) outcome was unknown. Not Provided          Concomitant medication was not provided Treatment information was not provided    This case was linked to US-MODERNATX, INC.-MOD-2021-011440 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-011440:First dose
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032b21) for COVID-19 vaccination.     Concurrent medical conditions included Depression. Concomitant products included LAMOTRIGINE and TRAZODONE for Depression, LEVONORGESTREL for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced DIZZINESS (dizziness). At the time of the report, DIZZINESS (dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Injection site pain, Lymph node pain
Clinical narrative: flu like symptoms; achy glands under her neck; pain at the injection site; headache; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), LYMPH NODE PAIN (achy glands under her neck), INJECTION SITE PAIN (pain at the injection site) and HEADACHE (headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Acid reflux (esophageal). Concomitant products included OMEPRAZOLE for Acid reflux (esophageal).   On 14-Apr-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), LYMPH NODE PAIN (achy glands under her neck), INJECTION SITE PAIN (pain at the injection site) and HEADACHE (headache). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), LYMPH NODE PAIN (achy glands under her neck), INJECTION SITE PAIN (pain at the injection site) and HEADACHE (headache) outcome was unknown. Not Provided          No treatment information was provided.    This case was linked to MOD-2021-076578 (E2B Linked Report).; Sender's Comments:  MOD-2021-076578:First dose case
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration
Clinical narrative: injection site it began to have discoloration/discoloration is now about 6 inches big; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (injection site it began to have discoloration/discoloration is now about 6 inches big) in a 91-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 26-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 VACCINATION SITE DISCOLOURATION (injection site it began to have discoloration/discoloration is now about 6 inches big). At the time of the report, VACCINATION SITE DISCOLOURATION (injection site it began to have discoloration/discoloration is now about 6 inches big) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Pain in extremity
Clinical narrative: sore arm; Expired Product Administered; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (sore arm) and EXPIRED PRODUCT ADMINISTERED (Expired Product Administered) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 12-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and EXPIRED PRODUCT ADMINISTERED (Expired Product Administered). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown and EXPIRED PRODUCT ADMINISTERED (Expired Product Administered) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant or treatment information provided.  Patient is going to seek an antibody test to ensure that she is covered.   This case was linked to MOD21-075500, MOD21-074055, MOD21-075351, MOD21-075527, MOD21-075532, MOD21-075540, MOD21-075544, MOD21-075549 (E2B Linked Report). This case was linked to MOD-2021-076892 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow-up information received on 27-MAY-2021 contains significant information- Patient demographics, event added; Sender's Comments:  MOD21-075500:Cross linked case MOD21-074055:Cross linked case MOD21-075351:Cross linked case MOD21-075527:Cross linked case MOD21-075532:Cross linked case MOD21-075540:Cross linked case MOD21-075544:Cross linked case MOD21-075549:Cross linked case
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: bad headache; body aches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (bad headache) and MYALGIA (body aches) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included CICLESONIDE (ALVESCO).    On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 1. On 13-Apr-2021, the patient experienced HEADACHE (bad headache) and MYALGIA (body aches). At the time of the report, HEADACHE (bad headache) and MYALGIA (body aches) 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.   Treatment information not provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin swelling
Clinical narrative: Within 3 days it was full blown; Rashes on her feet, legs, arms, back, buttock, head, hands, shoulders; This spontaneous case was reported by a consumer and describes the occurrence of SKIN SWELLING (Within 3 days it was full blown) and RASH (Rashes on her feet, legs, arms, back, buttock, head, hands, shoulders) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     Concomitant products included SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]), METFORMIN HYDROCHLORIDE (GLUCOPHAGE), CARVEDILOL and AMLODIPINE for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 30-Mar-2021, the patient experienced RASH (Rashes on her feet, legs, arms, back, buttock, head, hands, shoulders). On 01-Apr-2021, the patient experienced SKIN SWELLING (Within 3 days it was full blown). At the time of the report, SKIN SWELLING (Within 3 days it was full blown) and RASH (Rashes on her feet, legs, arms, back, buttock, head, hands, shoulders) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, Infusion
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of COVID-19 (designated positive for COVID-19), inappropriate schedule of product administration (scheduling the second dose of the vaccine more than 36 days after the first dose) and infusion (received the antibody infusion) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Jan 7, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jan 11, 2021, patient experienced COVID-19 (designated positive for COVID-19). On an unknown date, patient experienced  inappropriate schedule of product administration (scheduling the second dose of the vaccine more than 36 days after the first dose) and infusion (received the antibody infusion). At the time of the report, COVID-19 (designated positive for COVID-19) and infusion (received the antibody infusion) outcome: unknown and  inappropriate schedule of product administration (scheduling the second dose of the vaccine more than 36 days after the first dose) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication, treatment information or causality assessments reported.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose scheduled 42 days after the first; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose scheduled 42 days after the first) in a male 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose scheduled 42 days after the first). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose scheduled 42 days after the first) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided   Reporter did not allow further contact
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Erythema, Pruritus, Swelling, Vaccination site reaction
Clinical narrative: slightly itchy; slightly red; ball of swelling; COVID arm; Nose bleeds; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Nose bleeds), PRURITUS (slightly itchy), ERYTHEMA (slightly red), SWELLING (ball of swelling) and VACCINATION SITE REACTION (COVID arm) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-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 EPISTAXIS (Nose bleeds). On 13-Apr-2021, the patient experienced PRURITUS (slightly itchy), ERYTHEMA (slightly red), SWELLING (ball of swelling) and VACCINATION SITE REACTION (COVID arm). At the time of the report, EPISTAXIS (Nose bleeds) had resolved, PRURITUS (slightly itchy), ERYTHEMA (slightly red) and SWELLING (ball of swelling) outcome was unknown and VACCINATION SITE REACTION (COVID arm) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medication was provided. No treatment  was provided.  The nosebleeds have stopped, but the "COVID arm" is still ongoing.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: warm to touch; itchy; Swelling of injection site; hurts pretty bad; red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE SWELLING (Swelling of injection site), VACCINATION SITE PAIN (hurts pretty bad) and VACCINATION SITE ERYTHEMA (red) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included VALSARTAN for Blood pressure.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE SWELLING (Swelling of injection site), VACCINATION SITE PAIN (hurts pretty bad) and VACCINATION SITE ERYTHEMA (red). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency and ALCOHOL at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE SWELLING (Swelling of injection site), VACCINATION SITE PAIN (hurts pretty bad) and VACCINATION SITE ERYTHEMA (red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information also included cold compression and rubbing alcohol.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Gait inability, Myalgia, Vaccination site pain
Clinical narrative: couldn't walk at times; shooting paint in both legs, just above the knee, more around inner area,Intense pain,sore arm; injection arm sore; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (couldn't walk at times), FATIGUE (Fatigue), MYALGIA (shooting paint in both legs, just above the knee, more around inner area,Intense pain,sore arm) and VACCINATION SITE PAIN (injection arm sore) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced FATIGUE (Fatigue) and VACCINATION SITE PAIN (injection arm sore). On 11-Apr-2021, the patient experienced GAIT INABILITY (couldn't walk at times) and MYALGIA (shooting paint in both legs, just above the knee, more around inner area,Intense pain,sore arm). On 11-Apr-2021, FATIGUE (Fatigue) and VACCINATION SITE PAIN (injection arm sore) had resolved. At the time of the report, GAIT INABILITY (couldn't walk at times) and MYALGIA (shooting paint in both legs, just above the knee, more around inner area,Intense pain,sore arm) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenopia, Erythema, Feeling hot, Headache, Peripheral swelling
Clinical narrative: Headache; Swollen arm; Itchy arm; Red hands; Arm was Hot to touch; strained, tired eyes and fely heavy; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (Headache), PERIPHERAL SWELLING (Swollen arm), PRURITUS (Itchy arm), ERYTHEMA (Red hands) and FEELING HOT (Arm was Hot to touch) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced HEADACHE (Headache), PERIPHERAL SWELLING (Swollen arm), PRURITUS (Itchy arm), ERYTHEMA (Red hands), FEELING HOT (Arm was Hot to touch) and ASTHENOPIA (strained, tired eyes and fely heavy). On 10-Apr-2021, HEADACHE (Headache), PERIPHERAL SWELLING (Swollen arm), PRURITUS (Itchy arm), ERYTHEMA (Red hands), FEELING HOT (Arm was Hot to touch) and ASTHENOPIA (strained, tired eyes and fely heavy) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported.  Treatment information not provided.