chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Vaccination site pain, Vaccination site swelling
Clinical narrative: "if I lift my arm, I have pain in that area/has radiating pain from injection site, up and down; sore arm ever since then; little bit swollen; she thought it was a muscle thing; This spontaneous case was reported by a consumer and describes the occurrence of PAIN ("if I lift my arm, I have pain in that area/has radiating pain from injection site, up and down), VACCINATION SITE PAIN (sore arm ever since then), VACCINATION SITE SWELLING (little bit swollen) and MYALGIA (she thought it was a muscle thing) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy. Concomitant products included OMEPRAZOLE, IRON and BUPROPION for an unknown indication.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced PAIN ("if I lift my arm, I have pain in that area/has radiating pain from injection site, up and down), VACCINATION SITE PAIN (sore arm ever since then), VACCINATION SITE SWELLING (little bit swollen) and MYALGIA (she thought it was a muscle thing). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PAIN ("if I lift my arm, I have pain in that area/has radiating pain from injection site, up and down), VACCINATION SITE PAIN (sore arm ever since then), VACCINATION SITE SWELLING (little bit swollen) and MYALGIA (she thought it was a muscle thing) outcome was unknown.            This case was linked to MOD-2021-065224 (Patient Link).
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Pyrexia, Vaccination site pain
Clinical narrative: Really weak after the 1st dose; Fever of upto 101 F after the 1st dose; Chills after the 1st dose; Arm pain at injection site after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Really weak after the 1st dose), PYREXIA (Fever of upto 101 F after the 1st dose), CHILLS (Chills after the 1st dose) and VACCINATION SITE PAIN (Arm pain at injection site after the 1st dose) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037a21b) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Really weak after the 1st dose), PYREXIA (Fever of upto 101 F after the 1st dose), CHILLS (Chills after the 1st dose) and VACCINATION SITE PAIN (Arm pain at injection site after the 1st dose). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, ASTHENIA (Really weak after the 1st dose), PYREXIA (Fever of upto 101 F after the 1st dose), CHILLS (Chills after the 1st dose) and VACCINATION SITE PAIN (Arm pain at injection site after the 1st dose) 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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). On 04-Mar-2021, PAIN IN EXTREMITY (arm was sore) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant and treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-065237 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-065237:Linked with second dose
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Feeling hot, Influenza like illness, Pruritus
Clinical narrative: Arm itching "like crazy"; "Huge red circle" on arm / "Softball size circle" on arm; Hot arm; Red arm; Fever; Chills; Flu-like Symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like Symptoms), PRURITUS (Arm itching "like crazy"), RASH ERYTHEMATOUS ("Huge red circle" on arm / "Softball size circle" on arm), FEELING HOT (Hot arm) and ERYTHEMA (Red arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like Symptoms), PYREXIA (Fever) and CHILLS (Chills). On 16-Mar-2021, the patient experienced PRURITUS (Arm itching "like crazy"), RASH ERYTHEMATOUS ("Huge red circle" on arm / "Softball size circle" on arm), FEELING HOT (Hot arm) and ERYTHEMA (Red arm). On 12-Mar-2021, INFLUENZA LIKE ILLNESS (Flu-like Symptoms), PYREXIA (Fever) and CHILLS (Chills) had resolved. On 17-Mar-2021, PRURITUS (Arm itching "like crazy"), RASH ERYTHEMATOUS ("Huge red circle" on arm / "Softball size circle" on arm), FEELING HOT (Hot arm) and ERYTHEMA (Red arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Treatment medication was not provided by the reporter.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: Arm itching "like crazy"; "Huge red circle" on arm / "Softball size circle" on arm; Hot arm; Red arm; Fever; Chills; Flu-like Symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like Symptoms), PRURITUS (Arm itching "like crazy"), RASH ERYTHEMATOUS ("Huge red circle" on arm / "Softball size circle" on arm), FEELING HOT (Hot arm) and ERYTHEMA (Red arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like Symptoms), PYREXIA (Fever) and CHILLS (Chills). On 16-Mar-2021, the patient experienced PRURITUS (Arm itching "like crazy"), RASH ERYTHEMATOUS ("Huge red circle" on arm / "Softball size circle" on arm), FEELING HOT (Hot arm) and ERYTHEMA (Red arm). On 12-Mar-2021, INFLUENZA LIKE ILLNESS (Flu-like Symptoms), PYREXIA (Fever) and CHILLS (Chills) had resolved. On 17-Mar-2021, PRURITUS (Arm itching "like crazy"), RASH ERYTHEMATOUS ("Huge red circle" on arm / "Softball size circle" on arm), FEELING HOT (Hot arm) and ERYTHEMA (Red arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Treatment medication was not provided by the reporter.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on her arm and chest, which looks like large spider bites; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on her arm and chest, which looks like large spider bites) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced RASH (Rash on her arm and chest, which looks like large spider bites). The patient was treated with TRIAMCINOLONE for Rash, at an unspecified dose and frequency. At the time of the report, RASH (Rash on her arm and chest, which looks like large spider bites) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Myalgia, Neck pain, Oropharyngeal pain
Clinical narrative: diarrhea; Neck hurts; Pains/ache; headache; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), DIARRHOEA (diarrhea), NECK PAIN (Neck hurts), MYALGIA (Pains/ache) and HEADACHE (headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 21B51A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), MYALGIA (Pains/ache) and HEADACHE (headache). On 31-Mar-2021, the patient experienced DIARRHOEA (diarrhea) and NECK PAIN (Neck hurts). At the time of the report, OROPHARYNGEAL PAIN (sore throat), DIARRHOEA (diarrhea) and NECK PAIN (Neck hurts) outcome was unknown, MYALGIA (Pains/ache) had resolved and HEADACHE (headache) had not resolved. Not Provided          No concomitant and treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-065232 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-065232:Cross-linked with first dose
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Headache, Illness, Myalgia
Clinical narrative: Sore arm; Red arm and hot to touch; So sick; Dry heaves; Sinus congestion; Dizziness; Ran fever; Headache; Body ache all over; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Red arm and hot to touch), ILLNESS (So sick), RETCHING (Dry heaves) and SINUS CONGESTION (Sinus congestion) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Red arm and hot to touch), ILLNESS (So sick), RETCHING (Dry heaves), SINUS CONGESTION (Sinus congestion), DIZZINESS (Dizziness), PYREXIA (Ran fever), HEADACHE (Headache) and MYALGIA (Body ache all over). At the time of the report, PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Red arm and hot to touch), ILLNESS (So sick), RETCHING (Dry heaves), SINUS CONGESTION (Sinus congestion), DIZZINESS (Dizziness), PYREXIA (Ran fever), HEADACHE (Headache) and MYALGIA (Body ache all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment medication was not provided by the reporter.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Retching, Sinus congestion
Clinical narrative: Sore arm; Red arm and hot to touch; So sick; Dry heaves; Sinus congestion; Dizziness; Ran fever; Headache; Body ache all over; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Red arm and hot to touch), ILLNESS (So sick), RETCHING (Dry heaves) and SINUS CONGESTION (Sinus congestion) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Red arm and hot to touch), ILLNESS (So sick), RETCHING (Dry heaves), SINUS CONGESTION (Sinus congestion), DIZZINESS (Dizziness), PYREXIA (Ran fever), HEADACHE (Headache) and MYALGIA (Body ache all over). At the time of the report, PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Red arm and hot to touch), ILLNESS (So sick), RETCHING (Dry heaves), SINUS CONGESTION (Sinus congestion), DIZZINESS (Dizziness), PYREXIA (Ran fever), HEADACHE (Headache) and MYALGIA (Body ache all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment medication was not provided by the reporter.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Ear pain, Neck pain, Pain in extremity, Pain in jaw
Clinical narrative: Jaw pain in both sides; Neck pain; Earache in both sides; Sore arm in left side; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm in left side), PAIN IN JAW (Jaw pain in both sides), NECK PAIN (Neck pain) and EAR PAIN (Earache in both sides) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included OMEPRAZOLE and CETIRIZINE HYDROCHLORIDE for an unknown indication.    On 29-Mar-2021 at 5:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm in left side). On 31-Mar-2021 at 9:00 PM, the patient experienced PAIN IN JAW (Jaw pain in both sides), NECK PAIN (Neck pain) and EAR PAIN (Earache in both sides). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 2 Tablets of Tylenol Extra Strength. At the time of the report, PAIN IN EXTREMITY (Sore arm in left side), PAIN IN JAW (Jaw pain in both sides), NECK PAIN (Neck pain) and EAR PAIN (Earache in both sides) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included Blood pressure medications.
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Cough, Fatigue, Haemoptysis, Headache
Clinical narrative: cold; runny nose; constant coughing; clots of blood coming out; a lot of tiredness; sick; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NASOPHARYNGITIS (cold), RHINORRHOEA (runny nose), COUGH (constant coughing), HAEMOPTYSIS (clots of blood coming out) and FATIGUE (a lot of tiredness) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Multiple myeloma.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced NASOPHARYNGITIS (cold), RHINORRHOEA (runny nose), COUGH (constant coughing), HAEMOPTYSIS (clots of blood coming out), FATIGUE (a lot of tiredness), ILLNESS (sick) and HEADACHE (Headache). On 02-Apr-2021, NASOPHARYNGITIS (cold), RHINORRHOEA (runny nose), COUGH (constant coughing), HAEMOPTYSIS (clots of blood coming out), FATIGUE (a lot of tiredness), ILLNESS (sick) and HEADACHE (Headache) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal Normal. On an unknown date, Ultrasound scan: normal Normal.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Patient had a past history of cancer(multiple myeloma) and was cancer free for 6 years. Treatment included antibiotics.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Events added
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nasopharyngitis, Rhinorrhoea, Ultrasound scan
Clinical narrative: cold; runny nose; constant coughing; clots of blood coming out; a lot of tiredness; sick; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NASOPHARYNGITIS (cold), RHINORRHOEA (runny nose), COUGH (constant coughing), HAEMOPTYSIS (clots of blood coming out) and FATIGUE (a lot of tiredness) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Multiple myeloma.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced NASOPHARYNGITIS (cold), RHINORRHOEA (runny nose), COUGH (constant coughing), HAEMOPTYSIS (clots of blood coming out), FATIGUE (a lot of tiredness), ILLNESS (sick) and HEADACHE (Headache). On 02-Apr-2021, NASOPHARYNGITIS (cold), RHINORRHOEA (runny nose), COUGH (constant coughing), HAEMOPTYSIS (clots of blood coming out), FATIGUE (a lot of tiredness), ILLNESS (sick) and HEADACHE (Headache) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal Normal. On an unknown date, Ultrasound scan: normal Normal.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Patient had a past history of cancer(multiple myeloma) and was cancer free for 6 years. Treatment included antibiotics.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Events added
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous case was reported by a pharmacist and describes the occurrence of HERPES ZOSTER (shingles) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for 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 HERPES ZOSTER (shingles). At the time of the report, HERPES ZOSTER (shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Chills, Cough, Decreased appetite, Diarrhoea
Clinical narrative: lot of mucus/the production of mucus in her body is absurd/The amount of mucus is just unbelievable; Little diarrhea; Lot of cough; Horrible side effects; extremely sick/violently sick; Lack of appetite; Heart was pumping out of her chest; Vomiting; chills; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of SECRETION DISCHARGE (lot of mucus/the production of mucus in her body is absurd/The amount of mucus is just unbelievable), DIARRHOEA (Little diarrhea), COUGH (Lot of cough), ADVERSE REACTION (Horrible side effects) and ILLNESS (extremely sick/violently sick) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced SECRETION DISCHARGE (lot of mucus/the production of mucus in her body is absurd/The amount of mucus is just unbelievable), DIARRHOEA (Little diarrhea), ADVERSE REACTION (Horrible side effects), ILLNESS (extremely sick/violently sick), DECREASED APPETITE (Lack of appetite), PALPITATIONS (Heart was pumping out of her chest), VOMITING (Vomiting), CHILLS (chills) and FATIGUE (Tiredness). 14-Mar-2021, the patient experienced COUGH (Lot of cough). On 03-May-2021, DIARRHOEA (Little diarrhea), ADVERSE REACTION (Horrible side effects), ILLNESS (extremely sick/violently sick), DECREASED APPETITE (Lack of appetite), PALPITATIONS (Heart was pumping out of her chest), VOMITING (Vomiting), CHILLS (chills) and FATIGUE (Tiredness) had resolved. At the time of the report, SECRETION DISCHARGE (lot of mucus/the production of mucus in her body is absurd/The amount of mucus is just unbelievable) had not resolved and COUGH (Lot of cough) outcome was unknown.            No concomitant product use was reported  No treatment information was provided  Action taken with mRNA-1273 Moderna COVID-19 Vaccine was not applicable   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Updated contact information, added new events, outcome provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness, Palpitations, Secretion discharge, Vomiting
Clinical narrative: lot of mucus/the production of mucus in her body is absurd/The amount of mucus is just unbelievable; Little diarrhea; Lot of cough; Horrible side effects; extremely sick/violently sick; Lack of appetite; Heart was pumping out of her chest; Vomiting; chills; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of SECRETION DISCHARGE (lot of mucus/the production of mucus in her body is absurd/The amount of mucus is just unbelievable), DIARRHOEA (Little diarrhea), COUGH (Lot of cough), ADVERSE REACTION (Horrible side effects) and ILLNESS (extremely sick/violently sick) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced SECRETION DISCHARGE (lot of mucus/the production of mucus in her body is absurd/The amount of mucus is just unbelievable), DIARRHOEA (Little diarrhea), ADVERSE REACTION (Horrible side effects), ILLNESS (extremely sick/violently sick), DECREASED APPETITE (Lack of appetite), PALPITATIONS (Heart was pumping out of her chest), VOMITING (Vomiting), CHILLS (chills) and FATIGUE (Tiredness). 14-Mar-2021, the patient experienced COUGH (Lot of cough). On 03-May-2021, DIARRHOEA (Little diarrhea), ADVERSE REACTION (Horrible side effects), ILLNESS (extremely sick/violently sick), DECREASED APPETITE (Lack of appetite), PALPITATIONS (Heart was pumping out of her chest), VOMITING (Vomiting), CHILLS (chills) and FATIGUE (Tiredness) had resolved. At the time of the report, SECRETION DISCHARGE (lot of mucus/the production of mucus in her body is absurd/The amount of mucus is just unbelievable) had not resolved and COUGH (Lot of cough) outcome was unknown.            No concomitant product use was reported  No treatment information was provided  Action taken with mRNA-1273 Moderna COVID-19 Vaccine was not applicable   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Updated contact information, added new events, outcome provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Lip blister, Oedema, Pyrexia, Swelling
Clinical narrative: lips are full of fever blisters; fever; swelling; redness; swelling above the left breast; shoulder bone has a knot of fluid; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling), ERYTHEMA (redness), SWELLING (swelling above the left breast), OEDEMA (shoulder bone has a knot of fluid) and LIP BLISTER (lips are full of fever blisters) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (In December 2020). Concomitant products included DIGOXIN, CARVEDILOL, DABIGATRAN and LOSARTAN for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced SWELLING (swelling), ERYTHEMA (redness), SWELLING (swelling above the left breast), OEDEMA (shoulder bone has a knot of fluid) and PYREXIA (fever). On 01-Apr-2021, the patient experienced LIP BLISTER (lips are full of fever blisters). At the time of the report, SWELLING (swelling), ERYTHEMA (redness), SWELLING (swelling above the left breast), OEDEMA (shoulder bone has a knot of fluid) and LIP BLISTER (lips are full of fever blisters) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    No treatment information was provided.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Myalgia
Clinical narrative: Muscle ache; doesn't feel all that great; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle ache) and FEELING ABNORMAL (doesn't feel all that great) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 021B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 07-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 at an unspecified dose. On 01-Apr-2021, the patient experienced MYALGIA (Muscle ache). 01-Apr-2021, the patient experienced FEELING ABNORMAL (doesn't feel all that great). At the time of the report, MYALGIA (Muscle ache) and FEELING ABNORMAL (doesn't feel all that great) had not resolved. Not Provided          This case was linked to MOD-2021-065209, US-MODERNATX, INC.-MOD-2021-065209 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD-2021-065209: US-MODERNATX, INC.-MOD-2021-065209:Husband case
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Headache; chills; Fever; Body aches; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), CHILLS (chills), PYREXIA (Fever), PAIN (Body aches) and FATIGUE (Fatigue) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-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), CHILLS (chills), PYREXIA (Fever), PAIN (Body aches) and FATIGUE (Fatigue). At the time of the report, HEADACHE (Headache), CHILLS (chills), PYREXIA (Fever), PAIN (Body aches) and FATIGUE (Fatigue) outcome was unknown. Not Provided  No treatment information was provided.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Headache, Insomnia, Peripheral swelling
Clinical narrative: horrible headache; Hotness; strong chills; sore and swollen arm; could not sleep; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (horrible headache), FEELING HOT (Hotness), CHILLS (strong chills), PERIPHERAL SWELLING (sore and swollen arm) and INSOMNIA (could not sleep) 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. Concomitant products included METOPROLOL, ISOSORBIDE and LOSARTAN for an unknown indication.    On 31-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 HEADACHE (horrible headache), FEELING HOT (Hotness), CHILLS (strong chills), PERIPHERAL SWELLING (sore and swollen arm) and INSOMNIA (could not sleep). At the time of the report, HEADACHE (horrible headache), FEELING HOT (Hotness), CHILLS (strong chills), PERIPHERAL SWELLING (sore and swollen arm) and INSOMNIA (could not sleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Polymerase chain reaction, SARS-CoV-2 test
Clinical narrative: COVID-19 Disease with Positive PCR Test Post First Vaccination; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 Disease with Positive PCR Test Post First Vaccination) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced COVID-19 (COVID-19 Disease with Positive PCR Test Post First Vaccination). In March 2021, COVID-19 (COVID-19 Disease with Positive PCR Test Post First Vaccination) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Polymerase chain reaction: positive (Positive) positive. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Fatigue, Nausea, Pain in extremity, Urticaria
Clinical narrative: eyes went "buggery", felt like drunken eyes; feels tired; her eyes made her feel like she was going to throw up; arm is a little sore; 2 hives in each corner of mouth; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (eyes went "buggery", felt like drunken eyes), FATIGUE (feels tired), NAUSEA (her eyes made her feel like she was going to throw up), PAIN IN EXTREMITY (arm is a little sore) and URTICARIA (2 hives in each corner of mouth) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019d21a) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Allergic to latex, penicillin, Novocain, codeine, and Neurontin.). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), CARBAMAZEPINE (TEGRETOL) and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication, ACETYLSALICYLIC ACID, CARISOPRODOL (SOMA CMPD).    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced EYE SWELLING (eyes went "buggery", felt like drunken eyes), FATIGUE (feels tired), NAUSEA (her eyes made her feel like she was going to throw up), PAIN IN EXTREMITY (arm is a little sore) and URTICARIA (2 hives in each corner of mouth). On 01-Apr-2021, EYE SWELLING (eyes went "buggery", felt like drunken eyes) and NAUSEA (her eyes made her feel like she was going to throw up) had resolved. At the time of the report, FATIGUE (feels tired), PAIN IN EXTREMITY (arm is a little sore) and URTICARIA (2 hives in each corner of mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Tired; Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired) and PAIN IN EXTREMITY (Sore left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tired) and PAIN IN EXTREMITY (Sore left arm). At the time of the report, FATIGUE (Tired) and PAIN IN EXTREMITY (Sore left arm) outcome was unknown. Not Provided   No treatment information was provided.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Injection site redness; Injection site swelling (circle); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (Injection site swelling (circle)) in a 55-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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (Injection site swelling (circle)). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (Injection site swelling (circle)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Site of injection had red rash twice a size of an egg; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Site of injection had red rash twice a size of an egg) in a 69-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 16-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 VACCINATION SITE RASH (Site of injection had red rash twice a size of an egg). On 01-Apr-2021, VACCINATION SITE RASH (Site of injection had red rash twice a size of an egg) had resolved. Not Provided    No treatment information was reported.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant caller received the 1st dose of the moderna vaccine; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant caller received the 1st dose of the moderna vaccine) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported. ).    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 08-Oct-2021. On 17-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant caller received the 1st dose of the moderna vaccine). On 17-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnant caller received the 1st dose of the moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.  This is a case of product exposure during pregnancy with no associated AEs for this 33-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 33-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st shot of Moderna vaccine 42 or more than 42 days ago; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st shot of Moderna vaccine 42 or more than 42 days ago) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st shot of Moderna vaccine 42 or more than 42 days ago). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st shot of Moderna vaccine 42 or more than 42 days ago) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.  This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot # unknown, with no associated AEs.; Sender's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot # unknown, with no associated AEs.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Oral surgery
Clinical narrative: minor oral surgery (oral care, "minor thing in the mouth"); This spontaneous case was reported by a consumer and describes the occurrence of ORAL SURGERY (minor oral surgery (oral care, "minor thing in the mouth")) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.  The patient's past medical history included No adverse event. Concomitant products included SIMVASTATIN, Travaprost and CLINDAMYCIN for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced ORAL SURGERY (minor oral surgery (oral care, "minor thing in the mouth")). At the time of the report, ORAL SURGERY (minor oral surgery (oral care, "minor thing in the mouth")) 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 considered ORAL SURGERY (minor oral surgery (oral care, "minor thing in the mouth")) to be possibly related.  No treatment information was provided.   The patient is scheduled to receive his 2nd dose on 02Apr2021.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dyspnoea, Fatigue, Influenza like illness, Nausea
Clinical narrative: Flu like symptoms; throat is really sore; breathing is kind of jammed up; stomach making a lot of noises; where she had the shot is still swollen; Nausea; Exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), OROPHARYNGEAL PAIN (throat is really sore), DYSPNOEA (breathing is kind of jammed up), ABDOMINAL DISCOMFORT (stomach making a lot of noises) and VACCINATION SITE SWELLING (where she had the shot is still swollen) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), OROPHARYNGEAL PAIN (throat is really sore), DYSPNOEA (breathing is kind of jammed up), ABDOMINAL DISCOMFORT (stomach making a lot of noises), VACCINATION SITE SWELLING (where she had the shot is still swollen), NAUSEA (Nausea) and FATIGUE (Exhaustion). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), OROPHARYNGEAL PAIN (throat is really sore), DYSPNOEA (breathing is kind of jammed up), ABDOMINAL DISCOMFORT (stomach making a lot of noises), VACCINATION SITE SWELLING (where she had the shot is still swollen), NAUSEA (Nausea) and FATIGUE (Exhaustion) outcome was unknown.            Concomitant medications includes heart medications and diabetic medications   This case was linked to INC.-MOD-2021-065267 (E2B Linked Report).; Sender's Comments:   INC.-MOD-2021-065267:first dose
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Vaccination site swelling
Clinical narrative: Flu like symptoms; throat is really sore; breathing is kind of jammed up; stomach making a lot of noises; where she had the shot is still swollen; Nausea; Exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), OROPHARYNGEAL PAIN (throat is really sore), DYSPNOEA (breathing is kind of jammed up), ABDOMINAL DISCOMFORT (stomach making a lot of noises) and VACCINATION SITE SWELLING (where she had the shot is still swollen) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), OROPHARYNGEAL PAIN (throat is really sore), DYSPNOEA (breathing is kind of jammed up), ABDOMINAL DISCOMFORT (stomach making a lot of noises), VACCINATION SITE SWELLING (where she had the shot is still swollen), NAUSEA (Nausea) and FATIGUE (Exhaustion). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), OROPHARYNGEAL PAIN (throat is really sore), DYSPNOEA (breathing is kind of jammed up), ABDOMINAL DISCOMFORT (stomach making a lot of noises), VACCINATION SITE SWELLING (where she had the shot is still swollen), NAUSEA (Nausea) and FATIGUE (Exhaustion) outcome was unknown.            Concomitant medications includes heart medications and diabetic medications   This case was linked to INC.-MOD-2021-065267 (E2B Linked Report).; Sender's Comments:   INC.-MOD-2021-065267:first dose
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Coronavirus test positive
Clinical narrative: I no longer have symptoms; I had positive reading; This spontaneous case was reported by a consumer and describes the occurrence of CORONAVIRUS TEST POSITIVE (I had positive reading) and ASYMPTOMATIC COVID-19 (I no longer have symptoms) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0274214) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced CORONAVIRUS TEST POSITIVE (I had positive reading). On 01-Apr-2021, the patient experienced ASYMPTOMATIC COVID-19 (I no longer have symptoms). At the time of the report, CORONAVIRUS TEST POSITIVE (I had positive reading) and ASYMPTOMATIC COVID-19 (I no longer have symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       doctor recommended to restart vaccination after 3 months No treatment details were provided.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: vaccinated 17 year old; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccinated 17 year old) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccinated 17 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccinated 17 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.    Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Patient was administered the 2nd dose with no adverse event reported.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old male) for mRNA-1273 (lot number 036A21A) with no associated AEs reported.