chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise
Clinical narrative: Didn't feel well; Felt like been run over by a truck, just wiped out; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Didn't feel well) and FATIGUE (Felt like been run over by a truck, just wiped out) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Didn't feel well) and FATIGUE (Felt like been run over by a truck, just wiped out). At the time of the report, MALAISE (Didn't feel well) and FATIGUE (Felt like been run over by a truck, just wiped out) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       This case was linked to MOD-2021-072998, MOD-2021-072998.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Injection site warmth, Pyrexia
Clinical narrative: little bit of swelling; redness; warmth at the injection site; fever; chills; extreme fatigue; rash; This spontaneous case was reported by a physician and describes the occurrence of SWELLING (little bit of swelling), INJECTION SITE WARMTH (warmth at the injection site), ERYTHEMA (redness), RASH (rash) and PYREXIA (fever) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 29A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Tramadol allergy) and Drug allergy (Does not respond well to any type of pain reliever). Concomitant products included METFORMIN, SITAGLIPTIN (JANUVIA [SITAGLIPTIN]) and LIRAGLUTIDE (VICTOZA) for Diabetes.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced RASH (rash). On 09-Apr-2021, the patient experienced INJECTION SITE WARMTH (warmth at the injection site), PYREXIA (fever), CHILLS (chills) and FATIGUE (extreme fatigue). On 11-Apr-2021, the patient experienced SWELLING (little bit of swelling) and ERYTHEMA (redness). At the time of the report, SWELLING (little bit of swelling), INJECTION SITE WARMTH (warmth at the injection site), ERYTHEMA (redness), RASH (rash), PYREXIA (fever), CHILLS (chills) and FATIGUE (extreme fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reported that she again developed a rash again but this time it was spread across her arm  and also underneath.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling
Clinical narrative: little bit of swelling; redness; warmth at the injection site; fever; chills; extreme fatigue; rash; This spontaneous case was reported by a physician and describes the occurrence of SWELLING (little bit of swelling), INJECTION SITE WARMTH (warmth at the injection site), ERYTHEMA (redness), RASH (rash) and PYREXIA (fever) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 29A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Tramadol allergy) and Drug allergy (Does not respond well to any type of pain reliever). Concomitant products included METFORMIN, SITAGLIPTIN (JANUVIA [SITAGLIPTIN]) and LIRAGLUTIDE (VICTOZA) for Diabetes.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced RASH (rash). On 09-Apr-2021, the patient experienced INJECTION SITE WARMTH (warmth at the injection site), PYREXIA (fever), CHILLS (chills) and FATIGUE (extreme fatigue). On 11-Apr-2021, the patient experienced SWELLING (little bit of swelling) and ERYTHEMA (redness). At the time of the report, SWELLING (little bit of swelling), INJECTION SITE WARMTH (warmth at the injection site), ERYTHEMA (redness), RASH (rash), PYREXIA (fever), CHILLS (chills) and FATIGUE (extreme fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reported that she again developed a rash again but this time it was spread across her arm  and also underneath.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling jittery, Flushing, Palpitations, Vaccination site erythema, Vaccination site inflammation
Clinical narrative: Inflamation and redness at the site of the injection; Itchiness at the site of the injection; Inflamation and redness at the site of the injection; Face flush; Experiencing jitters and palpitations of the heart; Heart palpitations; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Face flush), FEELING JITTERY (Experiencing jitters and palpitations of the heart), PALPITATIONS (Heart palpitations), VACCINATION SITE INFLAMMATION (Inflamation and redness at the site of the injection) and VACCINATION SITE PRURITUS (Itchiness at the site of the injection) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced FLUSHING (Face flush), FEELING JITTERY (Experiencing jitters and palpitations of the heart) and PALPITATIONS (Heart palpitations). On 02-Apr-2021, the patient experienced VACCINATION SITE INFLAMMATION (Inflamation and redness at the site of the injection), VACCINATION SITE PRURITUS (Itchiness at the site of the injection) and VACCINATION SITE ERYTHEMA (Inflamation and redness at the site of the injection). On 02-Apr-2021, FLUSHING (Face flush), FEELING JITTERY (Experiencing jitters and palpitations of the heart) and PALPITATIONS (Heart palpitations) had resolved. On 11-Apr-2021, VACCINATION SITE INFLAMMATION (Inflamation and redness at the site of the injection), VACCINATION SITE PRURITUS (Itchiness at the site of the injection) and VACCINATION SITE ERYTHEMA (Inflamation and redness at the site of the injection) had resolved. Not Provided          No relevant concomitant medications were reported. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, the action taken with the drug in response to the events was not applicable.     This case was linked to MOD21-073269 (E2B Linked Report).; Sender's Comments:  MOD21-073269:cross link
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Inflamation and redness at the site of the injection; Itchiness at the site of the injection; Inflamation and redness at the site of the injection; Face flush; Experiencing jitters and palpitations of the heart; Heart palpitations; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Face flush), FEELING JITTERY (Experiencing jitters and palpitations of the heart), PALPITATIONS (Heart palpitations), VACCINATION SITE INFLAMMATION (Inflamation and redness at the site of the injection) and VACCINATION SITE PRURITUS (Itchiness at the site of the injection) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced FLUSHING (Face flush), FEELING JITTERY (Experiencing jitters and palpitations of the heart) and PALPITATIONS (Heart palpitations). On 02-Apr-2021, the patient experienced VACCINATION SITE INFLAMMATION (Inflamation and redness at the site of the injection), VACCINATION SITE PRURITUS (Itchiness at the site of the injection) and VACCINATION SITE ERYTHEMA (Inflamation and redness at the site of the injection). On 02-Apr-2021, FLUSHING (Face flush), FEELING JITTERY (Experiencing jitters and palpitations of the heart) and PALPITATIONS (Heart palpitations) had resolved. On 11-Apr-2021, VACCINATION SITE INFLAMMATION (Inflamation and redness at the site of the injection), VACCINATION SITE PRURITUS (Itchiness at the site of the injection) and VACCINATION SITE ERYTHEMA (Inflamation and redness at the site of the injection) had resolved. Not Provided          No relevant concomitant medications were reported. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, the action taken with the drug in response to the events was not applicable.     This case was linked to MOD21-073269 (E2B Linked Report).; Sender's Comments:  MOD21-073269:cross link
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysstasia
Clinical narrative: Dizziness; Unable to stand up; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and DYSSTASIA (Unable to stand up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced DIZZINESS (Dizziness) and DYSSTASIA (Unable to stand up). At the time of the report, DIZZINESS (Dizziness) and DYSSTASIA (Unable to stand up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Non-significant follow-up received.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: insignificant leakage of vaccine during second dose administration; insignificant leakage of vaccine during second dose administration; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (insignificant leakage of vaccine during second dose administration) and DEVICE CONNECTION ISSUE (insignificant leakage of vaccine during second dose administration) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to UNK dosage form. On 09-Apr-2021, the patient experienced UNDERDOSE (insignificant leakage of vaccine during second dose administration) and DEVICE CONNECTION ISSUE (insignificant leakage of vaccine during second dose administration). On 09-Apr-2021, UNDERDOSE (insignificant leakage of vaccine during second dose administration) and DEVICE CONNECTION ISSUE (insignificant leakage of vaccine during second dose administration) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter stated that During the second dose administration the insignificant leakage of vaccine occurred.No concomitant medications were reported.No treatment information was provided.Action taken with mRNA-1273 in response to the events was not applicable.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Injection site erythema, Injection site pain, Pain in extremity
Clinical narrative: a huge lump; terrible headaches; arm is very sore and red; tingling; numb to her fingers; arm is very sore; arm which was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (arm which was a little sore), VACCINATION SITE MASS (a huge lump), HEADACHE (terrible headaches), INJECTION SITE ERYTHEMA (arm is very sore and red) and PARAESTHESIA (tingling) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced INJECTION SITE PAIN (arm which was a little sore). On 10-Apr-2021, the patient experienced VACCINATION SITE MASS (a huge lump), HEADACHE (terrible headaches), INJECTION SITE ERYTHEMA (arm is very sore and red), PARAESTHESIA (tingling), HYPOAESTHESIA (numb to her fingers) and PAIN IN EXTREMITY (arm is very sore). At the time of the report, INJECTION SITE PAIN (arm which was a little sore), VACCINATION SITE MASS (a huge lump), HEADACHE (terrible headaches), INJECTION SITE ERYTHEMA (arm is very sore and red), PARAESTHESIA (tingling), HYPOAESTHESIA (numb to her fingers) and PAIN IN EXTREMITY (arm is very sore) 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.   The patient took Tylenol on 11Apr2021 for treatment.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Vaccination site mass
Clinical narrative: a huge lump; terrible headaches; arm is very sore and red; tingling; numb to her fingers; arm is very sore; arm which was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (arm which was a little sore), VACCINATION SITE MASS (a huge lump), HEADACHE (terrible headaches), INJECTION SITE ERYTHEMA (arm is very sore and red) and PARAESTHESIA (tingling) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced INJECTION SITE PAIN (arm which was a little sore). On 10-Apr-2021, the patient experienced VACCINATION SITE MASS (a huge lump), HEADACHE (terrible headaches), INJECTION SITE ERYTHEMA (arm is very sore and red), PARAESTHESIA (tingling), HYPOAESTHESIA (numb to her fingers) and PAIN IN EXTREMITY (arm is very sore). At the time of the report, INJECTION SITE PAIN (arm which was a little sore), VACCINATION SITE MASS (a huge lump), HEADACHE (terrible headaches), INJECTION SITE ERYTHEMA (arm is very sore and red), PARAESTHESIA (tingling), HYPOAESTHESIA (numb to her fingers) and PAIN IN EXTREMITY (arm is very sore) 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.   The patient took Tylenol on 11Apr2021 for treatment.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives all over body 8 days after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives all over body 8 days after 1st dose) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 19-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 URTICARIA (Hives all over body 8 days after 1st dose). The patient was treated with PREDNISONE for Hives, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives all over body 8 days after 1st dose) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient went to his doctor who said it was probably a delayed reaction to the vaccine.No concomitant medication were provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pruritus, Rash, Rash macular
Clinical narrative: 2 big blotches; very itchy; blotches on her left shoulder; breakout on stomach above waist; "Covid arm"; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (2 big blotches), PRURITUS (very itchy), RASH MACULAR (blotches on her left shoulder), HYPERSENSITIVITY ("Covid arm") and RASH (breakout on stomach above waist) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 036A21A) for COVID-19 vaccination.     The patient's past medical history included High cholesterol.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced HYPERSENSITIVITY ("Covid arm"). On 10-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH MACULAR (2 big blotches), PRURITUS (very itchy), RASH MACULAR (blotches on her left shoulder) and RASH (breakout on stomach above waist). The patient was treated with CORTISONE at an unspecified dose and frequency and Manual therapy (Ice) for Rash macular. At the time of the report, RASH MACULAR (2 big blotches), PRURITUS (very itchy), RASH MACULAR (blotches on her left shoulder), HYPERSENSITIVITY ("Covid arm") and RASH (breakout on stomach above waist) outcome was unknown.            Concomitant product use was not provided by the reporter.    Treatment for the event included topical cortisone cream and ice.  Action taken with mRNA-1273 in response to the event was not applicable
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Hypercoagulation
Clinical narrative: Blood has thickened, blood was viscous/ Not able to get a single full drop of blood; This spontaneous case was reported by a consumer and describes the occurrence of HYPERCOAGULATION (Blood has thickened, blood was viscous/ Not able to get a single full drop of blood) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.   No relevant Medical history Reported.  Concomitant products included LEVOTHYROXINE from 01-Apr-2021 to an unknown date for Hypothyroidism.  On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021 at 6:00 PM, the patient experienced HYPERCOAGULATION (Blood has thickened, blood was viscous/ Not able to get a single full drop of blood). At the time of the report, HYPERCOAGULATION (Blood has thickened, blood was viscous/ Not able to get a single full drop of blood) had not resolved.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood test: (normal) Normal.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Treatment medications were unknown.  The patient received three sporadic home blood tests as part of the study. She had always gotten several drops of blood right after accidentally pricking herself. Coincidentally, She had done one of the home tests, which require 5 full drops of blood, a couple of weeks before my first Moderna vaccine. She used the first of the two lancets provided and easily got the five full drops of blood without any effort. On 06-Apr-2021 and for the next three days, she tried getting blood from different fingers and using tips (warm water, rubbing hands, etc.) and was not able to get a single full drop of blood. A tiny bit would come out and immediately after, nothing else, even pressing or squeezing. She had to go to a lab and they draw blood to be able to complete the test. She hesitated taking the second dose and requested my doctor to order a thickness test before deciding. The test came back normal and although not entirely convinced.   This case was linked to MOD-2021-162995 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow-up information was received on 24-May-2021 contains information regarding reporter address, the patient demographics, site of vaccine administration, details of concomitant medication (start date and indication), event start date, and the outcome of the event blood thickened.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Chronic kidney disease stage 4, Congestive heart failure and Drug allergy (allergy to pain killers).    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.No treatment information was provided.    This case was linked to MOD-2021-073000 (Patient Link).
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Surgery
Clinical narrative: he was having a procedure done; Tested positive for COVID19; This spontaneous case was reported by a consumer and describes the occurrence of SURGERY (he was having a procedure done) and SARS-COV-2 TEST POSITIVE (Tested positive for COVID19) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included Atrial fibrillation (Atrial fibrillation for 20 years and treated by cardiologist.).    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID19). On an unknown date, the patient experienced SURGERY (he was having a procedure done). The patient was treated with REMDESIVIR (iv drip) from 13-Apr-2021 to 17-Apr-2021 at a dose of 1 dosage form. At the time of the report, SURGERY (he was having a procedure done) and SARS-COV-2 TEST POSITIVE (Tested positive for COVID19) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Follow up attached - NNI On 26-May-2021: Follow up information received. treatment information were updated, past history details were updated.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Vaccine leaked out during injection; Vaccine leaked out during injection; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of UNDERDOSE (Vaccine leaked out during injection) and DEVICE CONNECTION ISSUE (Vaccine leaked out during injection) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced UNDERDOSE (Vaccine leaked out during injection) and DEVICE CONNECTION ISSUE (Vaccine leaked out during injection). On 10-Apr-2021, UNDERDOSE (Vaccine leaked out during injection) and DEVICE CONNECTION ISSUE (Vaccine leaked out during injection) 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 information was not provided.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Fatigue, Pain in extremity, Paraesthesia
Clinical narrative: arm soreness; fatigue; temperature of 99.0F; tingling sensation in her tongue; extreme lightheadedness; extreme dizziness; tingling sensation in her legs; tingling sensation in her mouth; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (extreme lightheadedness), DIZZINESS (extreme dizziness), PARAESTHESIA (tingling sensation in her legs), PARAESTHESIA ORAL (tingling sensation in her mouth) and PAIN IN EXTREMITY (arm soreness) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 DIZZINESS (extreme lightheadedness), DIZZINESS (extreme dizziness), PARAESTHESIA (tingling sensation in her legs), PARAESTHESIA ORAL (tingling sensation in her mouth) and PARAESTHESIA ORAL (tingling sensation in her tongue). On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm soreness), FATIGUE (fatigue) and PYREXIA (temperature of 99.0F). On 24-Mar-2021, DIZZINESS (extreme lightheadedness) and DIZZINESS (extreme dizziness) had resolved. On 26-Mar-2021, PARAESTHESIA (tingling sensation in her legs), PARAESTHESIA ORAL (tingling sensation in her mouth), PAIN IN EXTREMITY (arm soreness), PARAESTHESIA ORAL (tingling sensation in her tongue), FATIGUE (fatigue) and PYREXIA (temperature of 99.0F) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.0 f 99.0 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  The patient was also taking Skyla for birth control.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Pyrexia
Clinical narrative: arm soreness; fatigue; temperature of 99.0F; tingling sensation in her tongue; extreme lightheadedness; extreme dizziness; tingling sensation in her legs; tingling sensation in her mouth; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (extreme lightheadedness), DIZZINESS (extreme dizziness), PARAESTHESIA (tingling sensation in her legs), PARAESTHESIA ORAL (tingling sensation in her mouth) and PAIN IN EXTREMITY (arm soreness) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 DIZZINESS (extreme lightheadedness), DIZZINESS (extreme dizziness), PARAESTHESIA (tingling sensation in her legs), PARAESTHESIA ORAL (tingling sensation in her mouth) and PARAESTHESIA ORAL (tingling sensation in her tongue). On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm soreness), FATIGUE (fatigue) and PYREXIA (temperature of 99.0F). On 24-Mar-2021, DIZZINESS (extreme lightheadedness) and DIZZINESS (extreme dizziness) had resolved. On 26-Mar-2021, PARAESTHESIA (tingling sensation in her legs), PARAESTHESIA ORAL (tingling sensation in her mouth), PAIN IN EXTREMITY (arm soreness), PARAESTHESIA ORAL (tingling sensation in her tongue), FATIGUE (fatigue) and PYREXIA (temperature of 99.0F) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.0 f 99.0 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  The patient was also taking Skyla for birth control.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Bedridden, Fatigue, Haemorrhage, Loss of personal independence in daily activities
Clinical narrative: lumps on leg; weird pimple; pains like an athlete preparing for the Olympics; I was basically bedridden for two months; unable to complete tasks and work which is a relatively small amount; I have a scar; had bleeding; extreme fatigue; debilitating muscle aches; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Apr-2021. The most recent information was received on 23-Jul-2021 and was forwarded to Moderna on 23-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MASS (lumps on leg), ACNE (weird pimple), PAIN (pains like an athlete preparing for the Olympics), BEDRIDDEN (I was basically bedridden for two months) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (unable to complete tasks and work which is a relatively small amount) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes, Speech disorder (speech problem) and Cancer. Concomitant products included INSULIN.    On 06-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MASS (lumps on leg), ACNE (weird pimple), PAIN (pains like an athlete preparing for the Olympics), BEDRIDDEN (I was basically bedridden for two months), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (unable to complete tasks and work which is a relatively small amount), SCAR (I have a scar), HAEMORRHAGE (had bleeding), FATIGUE (extreme fatigue) and MYALGIA (debilitating muscle aches). At the time of the report, MASS (lumps on leg), ACNE (weird pimple), PAIN (pains like an athlete preparing for the Olympics), BEDRIDDEN (I was basically bedridden for two months), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (unable to complete tasks and work which is a relatively small amount), SCAR (I have a scar), HAEMORRHAGE (had bleeding), FATIGUE (extreme fatigue) and MYALGIA (debilitating muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Follow up information provided updates on patient. On an unknown date, post vaccination, the patient reported that she experienced symptoms of fatigue, lump on leg, pain, hemorrhage, scarring, myalgia and loss of independence.  No treatment information was provided.   This case was linked to MOD21-071383 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Significant follow up received. New events added. On 23-Jul-2021: NNI follow up received.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Myalgia, Pain, Scar
Clinical narrative: lumps on leg; weird pimple; pains like an athlete preparing for the Olympics; I was basically bedridden for two months; unable to complete tasks and work which is a relatively small amount; I have a scar; had bleeding; extreme fatigue; debilitating muscle aches; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Apr-2021. The most recent information was received on 23-Jul-2021 and was forwarded to Moderna on 23-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MASS (lumps on leg), ACNE (weird pimple), PAIN (pains like an athlete preparing for the Olympics), BEDRIDDEN (I was basically bedridden for two months) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (unable to complete tasks and work which is a relatively small amount) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes, Speech disorder (speech problem) and Cancer. Concomitant products included INSULIN.    On 06-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MASS (lumps on leg), ACNE (weird pimple), PAIN (pains like an athlete preparing for the Olympics), BEDRIDDEN (I was basically bedridden for two months), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (unable to complete tasks and work which is a relatively small amount), SCAR (I have a scar), HAEMORRHAGE (had bleeding), FATIGUE (extreme fatigue) and MYALGIA (debilitating muscle aches). At the time of the report, MASS (lumps on leg), ACNE (weird pimple), PAIN (pains like an athlete preparing for the Olympics), BEDRIDDEN (I was basically bedridden for two months), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (unable to complete tasks and work which is a relatively small amount), SCAR (I have a scar), HAEMORRHAGE (had bleeding), FATIGUE (extreme fatigue) and MYALGIA (debilitating muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Follow up information provided updates on patient. On an unknown date, post vaccination, the patient reported that she experienced symptoms of fatigue, lump on leg, pain, hemorrhage, scarring, myalgia and loss of independence.  No treatment information was provided.   This case was linked to MOD21-071383 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Significant follow up received. New events added. On 23-Jul-2021: NNI follow up received.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ringing ears; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of TINNITUS (ringing ears) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 008B212A) for COVID-19 vaccination.     The patient's past medical history included Diabetes (Insulin). Concomitant products included INSULIN BOVINE (INSULIN 2) for Diabetes.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Mar-2021, 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 28-Feb-2021, the patient experienced TINNITUS (ringing ears). At the time of the report, TINNITUS (ringing ears) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 23-May-2021: Patients demographics updated, AE outcome, batch number of the doses updated
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Feeling hot, Hyperhidrosis, Pruritus, Urticaria
Clinical narrative: Hives on the armpits and the cheeks of the buttocks; Sweating; Hotness; Itches; Very high blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on the armpits and the cheeks of the buttocks), HYPERHIDROSIS (Sweating), FEELING HOT (Hotness), PRURITUS (Itches) and BLOOD PRESSURE INCREASED (Very high blood pressure) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced URTICARIA (Hives on the armpits and the cheeks of the buttocks), HYPERHIDROSIS (Sweating), FEELING HOT (Hotness), PRURITUS (Itches) and BLOOD PRESSURE INCREASED (Very high blood pressure). At the time of the report, URTICARIA (Hives on the armpits and the cheeks of the buttocks), HYPERHIDROSIS (Sweating), FEELING HOT (Hotness), PRURITUS (Itches) and BLOOD PRESSURE INCREASED (Very high blood pressure) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received the first dose and started experiencing hives on the arm pit and the cheeks of the buttocks, sweating, hotness, itches and a very high blood pressure. Patient inquires if will be the second dose worse or is safe to take it anyway, and is afraid of getting an anaphylaxis
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Burning sensation, Paraesthesia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Severe lower back pain), BURNING SENSATION (Burning sensation on neck, radiates to back and arms) and PARAESTHESIA (Tingling on neck, radiates to back and arms) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027E21A and 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included Birth control pills for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced BACK PAIN (Severe lower back pain), BURNING SENSATION (Burning sensation on neck, radiates to back and arms) and PARAESTHESIA (Tingling on neck, radiates to back and arms). At the time of the report, BACK PAIN (Severe lower back pain), BURNING SENSATION (Burning sensation on neck, radiates to back and arms) and PARAESTHESIA (Tingling on neck, radiates to back and arms) 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.   Patient had received first dose of the vaccine, no side effects following that first dose.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Thirst, Vaccination site pain
Clinical narrative: Thirst; Injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of THIRST (Thirst) and VACCINATION SITE PAIN (Injection site soreness) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Heart rate high (patient stated that sometimes her heart goes a little faster). Concomitant products included ATORVASTATIN, METOPROLOL SUCCINATE, LEVOCETIRIZINE and ACETYLSALICYLIC ACID (BAYER ASPIRIN) for an unknown indication.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced THIRST (Thirst) and VACCINATION SITE PAIN (Injection site soreness). On 11-Apr-2021, THIRST (Thirst) and VACCINATION SITE PAIN (Injection site soreness) 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.    Treatment information was not provided.   This case was linked to MOD-2021-124783, MOD-2021-125294 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Initial additional 1 received, no newinformation(NNI) On 16-Jun-2021: Initial additional 2 received, Updated reporter details. Added patient height, weight, race, ethnicity, other relevant history. Updated anatomical location of vaccine, Action taken, dechallenge & rechallenge, vaccine facility information. Added concomitant medications. Updated outcome of events to resolved and product - event details tab.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: seeing downhill and uphill around the house; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (seeing downhill and uphill around the house) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Enlargement of lymph nodes (A week before getting Moderna vaccine, the patient noticed enlarge lymph node in her arm and elbow, the patient is scheduled for a biopsy) and Cataract. Concomitant products included ALPRAZOLAM for Anxiety, SIMVASTATIN for Cholesterol, DULOXETINE HYDROCHLORIDE (CYMBALTA) for Depression, ATENOLOL for Heart disorder, CLONIDINE (CATAPRES [CLONIDINE]) for Hypertension, GABAPENTIN for Neuropathy, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced FEELING ABNORMAL (seeing downhill and uphill around the house). At the time of the report, FEELING ABNORMAL (seeing downhill and uphill around the house) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-073074 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Had a Headache but went away after taking Tylenol; Dizziness but now can describe as slight; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Had a Headache but went away after taking Tylenol) and DIZZINESS (Dizziness but now can describe as slight) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced HEADACHE (Had a Headache but went away after taking Tylenol) and DIZZINESS (Dizziness but now can describe as slight). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (Had a Headache but went away after taking Tylenol) had resolved and DIZZINESS (Dizziness but now can describe as slight) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment for the event included dizziness patch.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dehydration, Myalgia
Clinical narrative: body aches; felt dehydrated; joint aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), DEHYDRATION (felt dehydrated) and ARTHRALGIA (joint aches) 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 (No medical history reported).    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced MYALGIA (body aches), DEHYDRATION (felt dehydrated) and ARTHRALGIA (joint aches). At the time of the report, MYALGIA (body aches), DEHYDRATION (felt dehydrated) and ARTHRALGIA (joint aches) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-084414 (Patient Link).
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Skin discolouration, Skin haemorrhage, Vaccination site erythema, Vaccination site mass
Clinical narrative: arm appears a half inch long tiny blood vessel that may be burst; feels hard; above the injection site is red; above the injection site is hot; inch and a half in size; dark discoloration in the center; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (above the injection site is hot), VACCINATION SITE MASS (inch and a half in size), SKIN DISCOLOURATION (dark discoloration in the center), SKIN HAEMORRHAGE (arm appears a half inch long tiny blood vessel that may be burst) and INJECTION SITE INDURATION (feels hard) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Enlargement of lymph nodes (Patient noticed a week before getting Moderna vaccine, the patient is scheduled for a biopsy) and Cataract. Concomitant products included ALPRAZOLAM for Anxiety, SIMVASTATIN for Cholesterol, DULOXETINE HYDROCHLORIDE (CYMBALTA) for Depression, ATENOLOL for Heart disorder, CLONIDINE (CATAPRESS) for Hypertension, GABAPENTIN for Neuropathy, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced VACCINATION SITE WARMTH (above the injection site is hot), VACCINATION SITE MASS (inch and a half in size), SKIN DISCOLOURATION (dark discoloration in the center) and VACCINATION SITE ERYTHEMA (above the injection site is red). On 11-Apr-2021, the patient experienced SKIN HAEMORRHAGE (arm appears a half inch long tiny blood vessel that may be burst) and INJECTION SITE INDURATION (feels hard). On 11-Apr-2021, VACCINATION SITE WARMTH (above the injection site is hot), VACCINATION SITE MASS (inch and a half in size), SKIN DISCOLOURATION (dark discoloration in the center) and VACCINATION SITE ERYTHEMA (above the injection site is red) had resolved. At the time of the report, SKIN HAEMORRHAGE (arm appears a half inch long tiny blood vessel that may be burst) and INJECTION SITE INDURATION (feels hard) outcome was unknown.            This case was linked to MOD-2021-073063, MOD-2021-073063 (Patient Link).