chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Syringe issue, Vaccination site haemorrhage
Clinical narrative: About 80% of dose drained down the arm of patient when Rph injected due to unsecured leur lock; bleeding at the injection site; syringe issue; A spontaneous report was received from a consumer concerning about a 73 years old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced medication error of syringe connection issue (Incorrect dose administered and syringe issue) and event of vaccination site bleeding (vaccination site hemorrhage).  The patient's medical history was not reported. Concomitant medications were not reported.  On 26 Mar 2021, prior to the onset of the events the patient received their second planned doses of mRNA-1273 (Batch number: 028A21A) via intramuscular for the prophylaxis of COVID-19 infection.  On 26 Mar 2021, the reporter reported that during vaccination the leur-lock was not secured to the syringe and when it administered to the patient, he pushed the plunger in, and he felt that liquid running out down the arm. When he went to secure the needle, needle stayed in patient's arm. So about 80% of dose ran down the arm. The patient also experienced bleeding at the site of the injection.  Laboratory details was not mentioned. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event are unknown.  The outcome of the event device connection issue remain resolved.  On 26 Mar 2021, the outcome of the event medication error of syringe connection issue was considered resolved. The outcome of the event bleeding at the site of injection was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, vaccination site hemorrhage, a causal relationship cannot be excluded. This report also refers to a case of  Incorrect dose administered and syringe issue, for mRNA-1273, lot #: 028A21A.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: fast heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (fast heartbeat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced HEART RATE INCREASED (fast heartbeat). At the time of the report, HEART RATE INCREASED (fast heartbeat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Cough, Facial pain, Fatigue
Clinical narrative: sinus symptoms; facial pain; tiredness; loss of sense of taste; loss of sense of smell; positive COVID-19 rapid test; low grade fever; throat itch; deep cough; A spontaneous report  was received from a healthcare professional concerning a 40-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events low grade fever, throat itch, deep cough, sinus symptoms, positive covid-19 rapid test, loss of sense of taste, loss of sense of smell, facial pain, tiredness.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 038A21A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 17 Mar 2021, the patient experienced the event(s) low grade fever, throat itch, deep cough, sinus symptoms. On 20 Mar 2021, the patient experienced the event(s) positive covid-19 rapid test. On 21 Mar 2021, the patient experienced the event(s) loss of sense of taste, loss of sense of smell. On 26 Mar 2021, the patient experienced the event(s) facial pain, tiredness.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), low grade fever, throat itch, deep cough, sinus symptoms, positive covid-19 rapid test, loss of sense of taste, loss of sense of smell, facial pain, tiredness was unknown.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive, Sinus disorder, Throat irritation
Clinical narrative: sinus symptoms; facial pain; tiredness; loss of sense of taste; loss of sense of smell; positive COVID-19 rapid test; low grade fever; throat itch; deep cough; A spontaneous report  was received from a healthcare professional concerning a 40-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events low grade fever, throat itch, deep cough, sinus symptoms, positive covid-19 rapid test, loss of sense of taste, loss of sense of smell, facial pain, tiredness.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 038A21A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 17 Mar 2021, the patient experienced the event(s) low grade fever, throat itch, deep cough, sinus symptoms. On 20 Mar 2021, the patient experienced the event(s) positive covid-19 rapid test. On 21 Mar 2021, the patient experienced the event(s) loss of sense of taste, loss of sense of smell. On 26 Mar 2021, the patient experienced the event(s) facial pain, tiredness.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), low grade fever, throat itch, deep cough, sinus symptoms, positive covid-19 rapid test, loss of sense of taste, loss of sense of smell, facial pain, tiredness was unknown.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: injection hurts; muscle pain; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (injection hurts) and MYALGIA (muscle pain) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (injection hurts) and MYALGIA (muscle pain). At the time of the report, VACCINATION SITE PAIN (injection hurts) and MYALGIA (muscle pain) 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.   No concomitant and treatment medication were provided
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Extra dose administered
Clinical narrative: While receiving vaccine some came out of shoulder; Vaccinator re administered the amount they thought came out; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (While receiving vaccine some came out of shoulder) and EXTRA DOSE ADMINISTERED (Vaccinator re administered the amount they thought came out) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037a21b) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced ACCIDENTAL UNDERDOSE (While receiving vaccine some came out of shoulder) and EXTRA DOSE ADMINISTERED (Vaccinator re administered the amount they thought came out). On 24-Mar-2021, ACCIDENTAL UNDERDOSE (While receiving vaccine some came out of shoulder) and EXTRA DOSE ADMINISTERED (Vaccinator re administered the amount they thought came out) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness on both of her leg and arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness on both of her leg and arm) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2021, the patient experienced HYPOAESTHESIA (Numbness on both of her leg and arm). At the time of the report, HYPOAESTHESIA (Numbness on both of her leg and arm) outcome was unknown.            No Concomitant medication were reported. Treatment medication was not provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Headache, Myalgia
Clinical narrative: Chills; Fatigue; Difficulty in breathing; Heart racing; Muscle Pain; Headache; A spontaneous report was received from a consumer concerning a 73-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events chills, fatigue, difficulty in breathing, heart racing, muscle pain, headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 24 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 003B21A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 24 Mar 2021, the patient experienced the event(s) chills, fatigue, difficulty in breathing, heart racing, muscle pain, headache.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), chills, fatigue, difficulty in breathing, heart racing, muscle pain, headache was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Chills; Fatigue; Difficulty in breathing; Heart racing; Muscle Pain; Headache; A spontaneous report was received from a consumer concerning a 73-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events chills, fatigue, difficulty in breathing, heart racing, muscle pain, headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 24 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 003B21A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 24 Mar 2021, the patient experienced the event(s) chills, fatigue, difficulty in breathing, heart racing, muscle pain, headache.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), chills, fatigue, difficulty in breathing, heart racing, muscle pain, headache was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Headache, Influenza, Pain, Pain in extremity
Clinical narrative: really sore arm; low grade fever; feeling flu-ish; body aches; headaches; eyes hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (really sore arm), PYREXIA (low grade fever), INFLUENZA (feeling flu-ish), PAIN (body aches) and HEADACHE (headaches) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included TIZANIDINE, HYDROCODONE BITARTRATE, PARACETAMOL (NORCO), DULOXETINE HYDROCHLORIDE (CYMBALTA), METFORMIN, FLUOXETINE, FENTANYL, LOSARTAN, HYDROCHLOROTHIAZIDE, METOPROLOL, ATORVASTATIN, Terasozin and OTC supplements for an unknown indication.   On 25-Mar-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 26-Mar-2021, the patient experienced PAIN IN EXTREMITY (really sore arm), PYREXIA (low grade fever), INFLUENZA (feeling flu-ish), PAIN (body aches), HEADACHE (headaches) and EYE PAIN (eyes hurt). At the time of the report, PAIN IN EXTREMITY (really sore arm), PYREXIA (low grade fever), INFLUENZA (feeling flu-ish), PAIN (body aches), HEADACHE (headaches) and EYE PAIN (eyes hurt) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: really sore arm; low grade fever; feeling flu-ish; body aches; headaches; eyes hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (really sore arm), PYREXIA (low grade fever), INFLUENZA (feeling flu-ish), PAIN (body aches) and HEADACHE (headaches) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included TIZANIDINE, HYDROCODONE BITARTRATE, PARACETAMOL (NORCO), DULOXETINE HYDROCHLORIDE (CYMBALTA), METFORMIN, FLUOXETINE, FENTANYL, LOSARTAN, HYDROCHLOROTHIAZIDE, METOPROLOL, ATORVASTATIN, Terasozin and OTC supplements for an unknown indication.   On 25-Mar-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 26-Mar-2021, the patient experienced PAIN IN EXTREMITY (really sore arm), PYREXIA (low grade fever), INFLUENZA (feeling flu-ish), PAIN (body aches), HEADACHE (headaches) and EYE PAIN (eyes hurt). At the time of the report, PAIN IN EXTREMITY (really sore arm), PYREXIA (low grade fever), INFLUENZA (feeling flu-ish), PAIN (body aches), HEADACHE (headaches) and EYE PAIN (eyes hurt) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for COVID) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) 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) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Mar-2021, SARS-CoV-2 test: positive (Positive) Tested positive for COVID.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. The patient did not take any treatment medication.   This case was linked to MOD-2021-059459 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: red marks under skin on right leg; red marks under skin on left knee; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red marks under skin on right leg) and ERYTHEMA (red marks under skin on left knee) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046a21a) 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) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced ERYTHEMA (red marks under skin on right leg) and ERYTHEMA (red marks under skin on left knee). At the time of the report, ERYTHEMA (red marks under skin on right leg) and ERYTHEMA (red marks under skin on left knee) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided.  No treatment information was provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site erythema
Clinical narrative: Redness at the injection site; Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at the injection site) and MYALGIA (Soreness at the injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at the injection site) and MYALGIA (Soreness at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at the injection site) and MYALGIA (Soreness at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Ventricular extrasystoles
Clinical narrative: Premature ventricular contractions; This spontaneous case was reported by a health care professional and describes the occurrence of VENTRICULAR EXTRASYSTOLES (Premature ventricular contractions) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (NO REPORTED MEDICAL HISTORY).   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 12-Mar-2021, the patient experienced VENTRICULAR EXTRASYSTOLES (Premature ventricular contractions). At the time of the report, VENTRICULAR EXTRASYSTOLES (Premature ventricular contractions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications are included. no treatment was provided.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pyrexia
Clinical narrative: arm pain; Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), PYREXIA (Fever) and FATIGUE (Fatigue) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (arm pain), PYREXIA (Fever) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (arm pain), PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Got COVID four day after getting the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got COVID four day after getting the vaccine) 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 COVID-19 (Got COVID four day after getting the vaccine). At the time of the report, COVID-19 (Got COVID four day after getting the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: covid-19 positive (Positive) COVID-19 Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter  As per client, MI error in DOB.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up received on 26MAY2021, no new information
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site reaction, Vaccination site swelling
Clinical narrative: covid arm; red rash; bumps; itchy; A spontaneous report was received from a consumer concerning a 62-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events covid arm, red rash, bumps, itchy.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 17 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 045A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 25 Mar 2021, the patient experienced the event(s) covid arm, red rash, bumps, itchy.  Treatment details included none.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), covid arm, red rash, bumps, itchy was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Vaccine administered had a leakage between the syringe and needle; Pharmacist believed the patient did not receive any dose of Moderna vaccine; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of DEVICE CONNECTION ISSUE (Vaccine administered had a leakage between the syringe and needle) and UNDERDOSE (Pharmacist believed the patient did not receive any dose of Moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided).    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 DEVICE CONNECTION ISSUE (Vaccine administered had a leakage between the syringe and needle) and UNDERDOSE (Pharmacist believed the patient did not receive any dose of Moderna vaccine). At the time of the report, DEVICE CONNECTION ISSUE (Vaccine administered had a leakage between the syringe and needle) and UNDERDOSE (Pharmacist believed the patient did not receive any dose of Moderna vaccine) 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 medications were provided by the pharmacist.  Treatment of these events were not provided.  This report refers to a case of Vaccine underdose AND Syringe Connection Issue for mRNA-1273, lot # unknwon  with no associated AEs.   Reporter did not allow further contact; Sender's Comments: This report refers to a case of Vaccine underdose AND Syringe Connection Issue for mRNA-1273, lot # unknwon  with no associated AEs.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: very fatigued; fever; joint and body pain; Slight headache; Freezing; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Freezing), FATIGUE (very fatigued), PYREXIA (fever), ARTHRALGIA (joint and body pain) and HEADACHE (Slight headache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced CHILLS (Freezing). On 25-Mar-2021, the patient experienced FATIGUE (very fatigued), PYREXIA (fever), ARTHRALGIA (joint and body pain) and HEADACHE (Slight headache). The patient was treated with IBUPROFEN at a dose of 200 mg. At the time of the report, CHILLS (Freezing), FATIGUE (very fatigued), PYREXIA (fever), ARTHRALGIA (joint and body pain) and HEADACHE (Slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided No Treatment information Provided   This case was linked to MOD-2021-278874 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow up received contain significant information about second dose information
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Tachycardia, Vaccination site pain, Vaccination site swelling
Clinical narrative: dizziness; weakness; rapid heart beat; arm soreness; arm swelling; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), ASTHENIA (weakness), TACHYCARDIA (rapid heart beat), VACCINATION SITE PAIN (arm soreness) and VACCINATION SITE SWELLING (arm swelling) in a 62-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 25-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 DIZZINESS (dizziness), ASTHENIA (weakness), TACHYCARDIA (rapid heart beat), VACCINATION SITE PAIN (arm soreness) and VACCINATION SITE SWELLING (arm swelling). At the time of the report, DIZZINESS (dizziness), ASTHENIA (weakness), TACHYCARDIA (rapid heart beat), VACCINATION SITE PAIN (arm soreness) and VACCINATION SITE SWELLING (arm swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: got diagnosed with COVID19; hasn't had her second dose of the vaccine and has missed it.; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (got diagnosed with COVID19) and PRODUCT DOSE OMISSION ISSUE (hasn't had her second dose of the vaccine and has missed it.) 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) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (hasn't had her second dose of the vaccine and has missed it.). On an unknown date, the patient experienced COVID-19 (got diagnosed with COVID19). At the time of the report, COVID-19 (got diagnosed with COVID19) and PRODUCT DOSE OMISSION ISSUE (hasn't had her second dose of the vaccine and has missed it.) 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 concomitant details were provided no treatment details were provided   Reporter did not allow further contact
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Felt like tendinitis; Skin burning on legs for a couple hours; Still has slight pain in arm where he had surgery; Fatigue; Severe joint and bone ache; Severe joint and bone ache; Slight headache; Minor nausea; This spontaneous case was reported by a consumer and describes the occurrence of TENDONITIS (Felt like tendinitis), SKIN BURNING SENSATION (Skin burning on legs for a couple hours), PAIN IN EXTREMITY (Still has slight pain in arm where he had surgery), FATIGUE (Fatigue) and MYALGIA (Severe joint and bone ache) in a 56-year-old male 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 were reported.  Concomitant products included EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (DESCOVY) for an unknown indication.    On 07-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 TENDONITIS (Felt like tendinitis), SKIN BURNING SENSATION (Skin burning on legs for a couple hours), PAIN IN EXTREMITY (Still has slight pain in arm where he had surgery), FATIGUE (Fatigue), MYALGIA (Severe joint and bone ache), ARTHRALGIA (Severe joint and bone ache), HEADACHE (Slight headache) and NAUSEA (Minor nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, TENDONITIS (Felt like tendinitis), SKIN BURNING SENSATION (Skin burning on legs for a couple hours), PAIN IN EXTREMITY (Still has slight pain in arm where he had surgery), FATIGUE (Fatigue), MYALGIA (Severe joint and bone ache), ARTHRALGIA (Severe joint and bone ache), HEADACHE (Slight headache) and NAUSEA (Minor nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included cholesterol medicine, over the counter sinus medicine and EMTRICITABINE, for an unknown indication.   This case was linked to MOD-2021-059685 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up received on 11-MAY-2021. Reported email ID has been updated.; Sender's Comments:  MOD-2021-059685:First Dose Case
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Skin burning sensation, Tendonitis
Clinical narrative: Felt like tendinitis; Skin burning on legs for a couple hours; Still has slight pain in arm where he had surgery; Fatigue; Severe joint and bone ache; Severe joint and bone ache; Slight headache; Minor nausea; This spontaneous case was reported by a consumer and describes the occurrence of TENDONITIS (Felt like tendinitis), SKIN BURNING SENSATION (Skin burning on legs for a couple hours), PAIN IN EXTREMITY (Still has slight pain in arm where he had surgery), FATIGUE (Fatigue) and MYALGIA (Severe joint and bone ache) in a 56-year-old male 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 were reported.  Concomitant products included EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (DESCOVY) for an unknown indication.    On 07-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 TENDONITIS (Felt like tendinitis), SKIN BURNING SENSATION (Skin burning on legs for a couple hours), PAIN IN EXTREMITY (Still has slight pain in arm where he had surgery), FATIGUE (Fatigue), MYALGIA (Severe joint and bone ache), ARTHRALGIA (Severe joint and bone ache), HEADACHE (Slight headache) and NAUSEA (Minor nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, TENDONITIS (Felt like tendinitis), SKIN BURNING SENSATION (Skin burning on legs for a couple hours), PAIN IN EXTREMITY (Still has slight pain in arm where he had surgery), FATIGUE (Fatigue), MYALGIA (Severe joint and bone ache), ARTHRALGIA (Severe joint and bone ache), HEADACHE (Slight headache) and NAUSEA (Minor nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included cholesterol medicine, over the counter sinus medicine and EMTRICITABINE, for an unknown indication.   This case was linked to MOD-2021-059685 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up received on 11-MAY-2021. Reported email ID has been updated.; Sender's Comments:  MOD-2021-059685:First Dose Case
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Delayed rash, on chest; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Delayed rash, on chest) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced RASH (Delayed rash, on chest). At the time of the report, RASH (Delayed rash, on chest) outcome was unknown. Not Provided          No Concomitant medication were reported. Treatment medication was not provided.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17-years-old received the 1st dose of  Moderna COVID 19 vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-years-old received the 1st dose of  Moderna COVID 19 vaccine) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-years-old received the 1st dose of  Moderna COVID 19 vaccine). On 26-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-years-old received the 1st dose of  Moderna COVID 19 vaccine) 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 medications were reported. Treatment drugs were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Follow-up received on 09-APR-2021 and does not contain any new information.; Sender's Comments: This report refers to a case of inappropriate age at vaccine administration for mRNA-1273, lot # unknown  with no associated AEs.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Muscle twitching
Clinical narrative: tiredness; slight headache; twitch in her eyelid.; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (twitch in her eyelid.), FATIGUE (tiredness) and HEADACHE (slight headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MUSCLE TWITCHING (twitch in her eyelid.). On an unknown date, the patient experienced FATIGUE (tiredness) and HEADACHE (slight headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, MUSCLE TWITCHING (twitch in her eyelid.) had not resolved and FATIGUE (tiredness) and HEADACHE (slight headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (Inconclusive) fever of 100.         Concomitant medication was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: nausea; diarrhea; fatigued; sharp pain in small area of upper left back; headaches; A spontaneous report was received from a healthcare professional concerning a 55-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headaches, nausea, diarrhea, fatigued, sharp pain in small area of upper left back.  The patient's medical history was not provided. Concomitant medications reported were Vitamin B for drug use for unknown indication.  On 5 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 027A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 5 Mar 2021, the patient experienced the event(s) headaches. On 6 Mar 2021, the patient experienced the event(s) nausea, diarrhea, fatigued, sharp pain in small area of upper left back.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), headaches, nausea, diarrhea, fatigued, sharp pain in small area of upper left back was unknown.
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain, Tinnitus
Clinical narrative: Tinnitus; Sore arm; A spontaneous report was received from a consumer concerning a 58-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tinnitus, sore arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 4 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 4 Mar 2021, the patient experienced the event(s) tinnitus. On 27 Feb 2021, the patient experienced the event(s) sore arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), tinnitus, sore arm was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 26-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain in arm). At the time of the report, PAIN IN EXTREMITY (pain in arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. no treatment details reported.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rashes; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rashes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (rashes). At the time of the report, RASH (rashes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication were reported. Treatment medication was not provided.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity
Clinical narrative: Red left arm; Sore left arm; Left arm got sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm got sore), ERYTHEMA (Red left arm) and PAIN IN EXTREMITY (Sore left arm) in a 29-year-old male 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 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (Left arm got sore). On 25-Mar-2021, the patient experienced ERYTHEMA (Red left arm) and PAIN IN EXTREMITY (Sore left arm). On 18-Mar-2021, PAIN IN EXTREMITY (Left arm got sore) had resolved. At the time of the report, ERYTHEMA (Red left arm) and PAIN IN EXTREMITY (Sore left arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The Concomitant medications were not provided. The treatment information was not provided.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Rash
Clinical narrative: Sore arm; Rash; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), RASH (Rash) and HEADACHE (Headache) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No relevant Medical history Reported.  Concomitant products included PREGABALIN for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache). 01-Mar-2021, the patient experienced RASH (Rash). At the time of the report, PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) had resolved and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment medication was provided.   This case was linked to MOD-2021-121565 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Additional  information was received on 11-May-2021 does not contain any information.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, SARS-CoV-2 test
Clinical narrative: shortness of breath; COVID-19 positive diagnosis; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (shortness of breath) and COVID-19 (COVID-19 positive diagnosis) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COPD.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced DYSPNOEA (shortness of breath) and COVID-19 (COVID-19 positive diagnosis). On 26-Mar-2021, DYSPNOEA (shortness of breath) had resolved. At the time of the report, COVID-19 (COVID-19 positive diagnosis) outcome was unknown. Unknown    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that he was still under quarantine, but felt well. Patient reported that he was originally scheduled to receive his second Moderna dose on 25Mar2021, but it had been rescheduled for 5Apr2021 due to his isolation.   No concomitant medication reported.  Patient went to emergency room visit for treatment.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: sore arm; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PYREXIA (fever) and HEADACHE (headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PYREXIA (fever) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), PYREXIA (fever) and HEADACHE (headache) outcome was unknown. Not Provided          No Concomitant medication were reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Erythema, Headache, Nervousness, Peripheral swelling
Clinical narrative: At the site of injection is a white mark with 2 red dots; Headache; She was nervous; A metallic taste; Fingers were swollen and red; Fingers were swollen and red; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (She was nervous), DYSGEUSIA (A metallic taste), PERIPHERAL SWELLING (Fingers were swollen and red), ERYTHEMA (Fingers were swollen and red) and VACCINATION SITE ERYTHEMA (At the site of injection is a white mark with 2 red dots) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced NERVOUSNESS (She was nervous), DYSGEUSIA (A metallic taste), PERIPHERAL SWELLING (Fingers were swollen and red) and HEADACHE (Headache). 25-Mar-2021, the patient experienced ERYTHEMA (Fingers were swollen and red). On 26-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (At the site of injection is a white mark with 2 red dots). On 25-Mar-2021, NERVOUSNESS (She was nervous) and DYSGEUSIA (A metallic taste) had resolved. On 26-Mar-2021, PERIPHERAL SWELLING (Fingers were swollen and red), ERYTHEMA (Fingers were swollen and red) and HEADACHE (Headache) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (At the site of injection is a white mark with 2 red dots) outcome was unknown.            No relevant concomitant medications provided. No relevant treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Followup was received with NNI