chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Discomfort, Limb discomfort, Myalgia, Pain in extremity
Clinical narrative: severe pain in extremities; could not get out of bed due to pain in her bones; overall feeling of heaviness; discomfort; severe pain in all her muscles; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (severe pain in extremities), BONE PAIN (could not get out of bed due to pain in her bones), LIMB DISCOMFORT (overall feeling of heaviness), DISCOMFORT (discomfort) and MYALGIA (severe pain in all her muscles) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-May-2021, the patient experienced PAIN IN EXTREMITY (severe pain in extremities), BONE PAIN (could not get out of bed due to pain in her bones), LIMB DISCOMFORT (overall feeling of heaviness), DISCOMFORT (discomfort) and MYALGIA (severe pain in all her muscles). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of 1 dosage form and BARIUM SULFATE (FLUID) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (severe pain in extremities), BONE PAIN (could not get out of bed due to pain in her bones), LIMB DISCOMFORT (overall feeling of heaviness), DISCOMFORT (discomfort) and MYALGIA (severe pain in all her muscles) outcome was unknown.            The patient had severe pain in all muscles and extremities over the last 48 hours. Patient had lots of fluids and ibuprofen because she could not get out of bed due to the pain in bones and muscles. She has an overall feeling of heaviness and discomfort.   Action taken with mRNA-1273 in response to the event was Not Applicable . No concomitant medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow-up received contains Reporter e-mail.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm hurt for 4-5 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt for 4-5 days) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No historical medical condition nor concomitant medication was reported.).    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (arm hurt for 4-5 days). On 15-Mar-2021, PAIN IN EXTREMITY (arm hurt for 4-5 days) had resolved. more details was not provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Pain in jaw, Toothache
Clinical narrative: Ear sensations; Pain in the lower right jaw implants; Roaming pain in her teeth; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EAR DISCOMFORT (Ear sensations), PAIN IN JAW (Pain in the lower right jaw implants) and TOOTHACHE (Roaming pain in her teeth) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced EAR DISCOMFORT (Ear sensations), PAIN IN JAW (Pain in the lower right jaw implants) and TOOTHACHE (Roaming pain in her teeth). At the time of the report, EAR DISCOMFORT (Ear sensations), PAIN IN JAW (Pain in the lower right jaw implants) and TOOTHACHE (Roaming pain in her teeth) had not resolved. Not Provided          Treatment included muscle relaxants, as advised by their HCP to try to alleviate the symptoms.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-101893 (E2B Linked Report). This case was linked to MOD-2021-101871 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-101893:case for wife(dose2)
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: Improper preparation of thawed vial; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Improper preparation of thawed vial) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical history was provided by the reporter.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Improper preparation of thawed vial). On 21-Apr-2021, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Improper preparation of thawed vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Thawed vial was stand in a room temperature, however they put the vial in front of a sitting fan for 30 minutes then administered to patient. Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Finger deformity, Muscle rigidity, Peripheral swelling
Clinical narrative: left hand got like rigor mortis in the morning; swollen like he has gout in his left hand; his index finger is hooked; Achy in joints; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE RIGIDITY (left hand got like rigor mortis in the morning), PERIPHERAL SWELLING (swollen like he has gout in his left hand), FINGER DEFORMITY (his index finger is hooked), ARTHRALGIA (Achy in joints) and CHILLS (chills) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced ARTHRALGIA (Achy in joints), CHILLS (chills) and PYREXIA (fever). On 08-Apr-2021, the patient experienced MUSCLE RIGIDITY (left hand got like rigor mortis in the morning), PERIPHERAL SWELLING (swollen like he has gout in his left hand) and FINGER DEFORMITY (his index finger is hooked). On 08-Apr-2021, ARTHRALGIA (Achy in joints), CHILLS (chills) and PYREXIA (fever) had resolved. At the time of the report, MUSCLE RIGIDITY (left hand got like rigor mortis in the morning), PERIPHERAL SWELLING (swollen like he has gout in his left hand) and FINGER DEFORMITY (his index finger is hooked) had resolved.            Patient had chills, achy in the joints, and fever for two days. A day or two after the second dose, his left hand got like rigor mortis in the morning, like arthritis, swollen like he has gout in his left hand and his index finger is hooked. This occurs only in the morning and resolves itself after 10-15 minutes.  Action taken with mRNA-1273 in response to the events was not applicable.  Concomitant and treatment information were not provided.   This case was linked to MOD-2021-101879 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow up information reported PT term of events muscle rigidity (left hand got like rigor mortis in the morning), peripheral swelling (swollen like he has gout in his left hand), finger deformity (his index finger is hooked)..
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: left hand got like rigor mortis in the morning; swollen like he has gout in his left hand; his index finger is hooked; Achy in joints; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE RIGIDITY (left hand got like rigor mortis in the morning), PERIPHERAL SWELLING (swollen like he has gout in his left hand), FINGER DEFORMITY (his index finger is hooked), ARTHRALGIA (Achy in joints) and CHILLS (chills) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced ARTHRALGIA (Achy in joints), CHILLS (chills) and PYREXIA (fever). On 08-Apr-2021, the patient experienced MUSCLE RIGIDITY (left hand got like rigor mortis in the morning), PERIPHERAL SWELLING (swollen like he has gout in his left hand) and FINGER DEFORMITY (his index finger is hooked). On 08-Apr-2021, ARTHRALGIA (Achy in joints), CHILLS (chills) and PYREXIA (fever) had resolved. At the time of the report, MUSCLE RIGIDITY (left hand got like rigor mortis in the morning), PERIPHERAL SWELLING (swollen like he has gout in his left hand) and FINGER DEFORMITY (his index finger is hooked) had resolved.            Patient had chills, achy in the joints, and fever for two days. A day or two after the second dose, his left hand got like rigor mortis in the morning, like arthritis, swollen like he has gout in his left hand and his index finger is hooked. This occurs only in the morning and resolves itself after 10-15 minutes.  Action taken with mRNA-1273 in response to the events was not applicable.  Concomitant and treatment information were not provided.   This case was linked to MOD-2021-101879 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow up information reported PT term of events muscle rigidity (left hand got like rigor mortis in the morning), peripheral swelling (swollen like he has gout in his left hand), finger deformity (his index finger is hooked)..
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pain in extremity, Peripheral swelling
Clinical narrative: arm is still swollen lumpy; Arm bothers when she exercises; Arm giving off heat; very red arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm is still swollen lumpy), PAIN IN EXTREMITY (Arm bothers when she exercises), FEELING HOT (Arm giving off heat) and ERYTHEMA (very red arm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No historical medical condition nor concomitant medication was reported.).    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced PERIPHERAL SWELLING (arm is still swollen lumpy), PAIN IN EXTREMITY (Arm bothers when she exercises), FEELING HOT (Arm giving off heat) and ERYTHEMA (very red arm). At the time of the report, PERIPHERAL SWELLING (arm is still swollen lumpy), PAIN IN EXTREMITY (Arm bothers when she exercises), FEELING HOT (Arm giving off heat) and ERYTHEMA (very red arm) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed the second of the vaccine / past 42 days from the first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed the second of the vaccine / past 42 days from the first vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-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 PRODUCT DOSE OMISSION ISSUE (Missed the second of the vaccine / past 42 days from the first vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed the second of the vaccine / past 42 days from the first vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: Bleeding a lot after the second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Bleeding a lot after the second vaccine) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (Bleeding a lot after the second vaccine). On 03-May-2021, VACCINATION SITE HAEMORRHAGE (Bleeding a lot after the second vaccine) outcome was unknown.            Concomitant and Treatment information not provided.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Intentional product use issue, Migraine, Pain in extremity, Stress
Clinical narrative: sore arm; Stress will bring on her migraine headaches, and that she could not tell the difference between the effects of the vaccine or one of her migraines; Stress will bring on her migraine headaches; Headache, lasting longer than a week; Missed second shot due to an overpowering migraine headache / then rescheduled; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), MIGRAINE (Stress will bring on her migraine headaches, and that she could not tell the difference between the effects of the vaccine or one of her migraines), STRESS (Stress will bring on her migraine headaches), HEADACHE (Headache, lasting longer than a week) and INTENTIONAL PRODUCT USE ISSUE (Missed second shot due to an overpowering migraine headache / then rescheduled) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004CC1A and 006B21A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine. Concomitant products included TRAMADOL and AMITRIPTYLINE for Migraine, ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm), MIGRAINE (Stress will bring on her migraine headaches, and that she could not tell the difference between the effects of the vaccine or one of her migraines), STRESS (Stress will bring on her migraine headaches), HEADACHE (Headache, lasting longer than a week) and INTENTIONAL PRODUCT USE ISSUE (Missed second shot due to an overpowering migraine headache / then rescheduled). On 30-Apr-2021, INTENTIONAL PRODUCT USE ISSUE (Missed second shot due to an overpowering migraine headache / then rescheduled) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) and HEADACHE (Headache, lasting longer than a week) had not resolved and MIGRAINE (Stress will bring on her migraine headaches, and that she could not tell the difference between the effects of the vaccine or one of her migraines) and STRESS (Stress will bring on her migraine headaches) outcome was unknown.            Patient was using aspirin for anti platelet medication.  The patient took tramadol and amitriptyline for migraine headaches.   This case was linked to MOD-2021-090200 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Chills, Feeling cold, Illness, Pain
Clinical narrative: excruciating pain from 2nd dose; Still sick; Anxiety; freezing, teeth chattering; panic attacks; chills; This spontaneous case was reported by a patient and describes the occurrence of PAIN (excruciating pain from 2nd dose), ILLNESS (Still sick), ANXIETY (Anxiety), FEELING COLD (freezing, teeth chattering) and PANIC ATTACK (panic attacks) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Rash: dexamethasone (Dexamethasone 4mg for 6 days). Concurrent medical conditions included Polymyalgia rheumatica. Concomitant products included METHOTREXATE and PREDNISONE for Inflammation.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (excruciating pain from 2nd dose), ILLNESS (Still sick), ANXIETY (Anxiety), FEELING COLD (freezing, teeth chattering), PANIC ATTACK (panic attacks) and CHILLS (chills). At the time of the report, PAIN (excruciating pain from 2nd dose), ILLNESS (Still sick), ANXIETY (Anxiety), FEELING COLD (freezing, teeth chattering), PANIC ATTACK (panic attacks) and CHILLS (chills) outcome was unknown. Not Provided          Concomitant products included METHOTREXATE and PREDNISONE for Inflammation.  Treatment medication includes STEROIDS.  Patient stated after 2nd dose of vaccine that he had typical symptoms from the vaccine chills (patient did not check his temperature) freezing, teeth chattering, felt a little off the next day symptoms lasted a couple of days, he had severe anxiety and panic attacks.  Action taken with mRNA-1273 in response to the event was Not Applicable   This case was linked to MOD-2021-081819 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Significant follow up received on 03-jun-2021, patient past medication and concomitant medications were updated
Sex: M
Vaccine: COVID19
Symptoms: Panic attack
Clinical narrative: excruciating pain from 2nd dose; Still sick; Anxiety; freezing, teeth chattering; panic attacks; chills; This spontaneous case was reported by a patient and describes the occurrence of PAIN (excruciating pain from 2nd dose), ILLNESS (Still sick), ANXIETY (Anxiety), FEELING COLD (freezing, teeth chattering) and PANIC ATTACK (panic attacks) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Rash: dexamethasone (Dexamethasone 4mg for 6 days). Concurrent medical conditions included Polymyalgia rheumatica. Concomitant products included METHOTREXATE and PREDNISONE for Inflammation.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (excruciating pain from 2nd dose), ILLNESS (Still sick), ANXIETY (Anxiety), FEELING COLD (freezing, teeth chattering), PANIC ATTACK (panic attacks) and CHILLS (chills). At the time of the report, PAIN (excruciating pain from 2nd dose), ILLNESS (Still sick), ANXIETY (Anxiety), FEELING COLD (freezing, teeth chattering), PANIC ATTACK (panic attacks) and CHILLS (chills) outcome was unknown. Not Provided          Concomitant products included METHOTREXATE and PREDNISONE for Inflammation.  Treatment medication includes STEROIDS.  Patient stated after 2nd dose of vaccine that he had typical symptoms from the vaccine chills (patient did not check his temperature) freezing, teeth chattering, felt a little off the next day symptoms lasted a couple of days, he had severe anxiety and panic attacks.  Action taken with mRNA-1273 in response to the event was Not Applicable   This case was linked to MOD-2021-081819 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Significant follow up received on 03-jun-2021, patient past medication and concomitant medications were updated
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Minor rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Minor rash) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE RASH (Minor rash). At the time of the report, VACCINATION SITE RASH (Minor rash) had resolved. Not Provided          The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-101871, US-MODERNATX, INC.-MOD-2021-101881 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-101871:case for wife(dose1) US-MODERNATX, INC.-MOD-2021-101881:case for wife(dose2)
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: Weakness; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness) and FATIGUE (tiredness) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037a21b) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included OMEPRAZOLE for an unknown indication.    On 25-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 ASTHENIA (Weakness) and FATIGUE (tiredness). On 30-Mar-2021, ASTHENIA (Weakness) and FATIGUE (tiredness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-101907 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Rash, Rash pustular, Scratch
Clinical narrative: Swelling her feet; Severe Itching; Excessive scratching; Oozing of pus out from the area that was scratched; Rash on body and legs; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling her feet), PRURITUS (Severe Itching), SCRATCH (Excessive scratching), RASH PUSTULAR (Oozing of pus out from the area that was scratched) and RASH (Rash on body and legs) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced PERIPHERAL SWELLING (Swelling her feet), PRURITUS (Severe Itching), SCRATCH (Excessive scratching), RASH PUSTULAR (Oozing of pus out from the area that was scratched) and RASH (Rash on body and legs). At the time of the report, PERIPHERAL SWELLING (Swelling her feet), PRURITUS (Severe Itching), SCRATCH (Excessive scratching), RASH PUSTULAR (Oozing of pus out from the area that was scratched) and RASH (Rash on body and legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow-up received on 04-MAY-2021. Adverse events updated.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Pain in extremity
Clinical narrative: She had broken out with shingles on her foot; Her leg started to get really achy; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (She had broken out with shingles on her foot) and PAIN IN EXTREMITY (Her leg started to get really achy) 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 reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (She had broken out with shingles on her foot) and PAIN IN EXTREMITY (Her leg started to get really achy). At the time of the report, HERPES ZOSTER (She had broken out with shingles on her foot) and PAIN IN EXTREMITY (Her leg started to get really achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Feeling abnormal, Hypertension, Limb discomfort, Peripheral swelling
Clinical narrative: still itchy; arm was swollen for a couple of days; she started feeling extremely heavy and strange; Her blood pressure was a little high; she feels weird; This spontaneous case was reported by a nurse and describes the occurrence of PRURITUS (still itchy), LIMB DISCOMFORT (she started feeling extremely heavy and strange), HYPERTENSION (Her blood pressure was a little high), FEELING ABNORMAL (she feels weird) and PERIPHERAL SWELLING (arm was swollen for a couple of days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic. Concomitant products included ESTRADIOL (ESTROGEN) for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced LIMB DISCOMFORT (she started feeling extremely heavy and strange), HYPERTENSION (Her blood pressure was a little high) and FEELING ABNORMAL (she feels weird). On an unknown date, the patient experienced PRURITUS (still itchy) and PERIPHERAL SWELLING (arm was swollen for a couple of days). At the time of the report, PRURITUS (still itchy), LIMB DISCOMFORT (she started feeling extremely heavy and strange), HYPERTENSION (Her blood pressure was a little high), FEELING ABNORMAL (she feels weird) and PERIPHERAL SWELLING (arm was swollen for a couple of days) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Blood pressure measurement: 155/102 (High) 155/102, 171/110 (High) 171/110 and 180/115 (High) 180/115.     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 called her cardiologist who suggested she takes her blood pressure medication right away and then at regular time. She even called the poison control and they told her to double up her dose of blood pressure medication before going in for her second dose.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: still itchy; arm was swollen for a couple of days; she started feeling extremely heavy and strange; Her blood pressure was a little high; she feels weird; This spontaneous case was reported by a nurse and describes the occurrence of PRURITUS (still itchy), LIMB DISCOMFORT (she started feeling extremely heavy and strange), HYPERTENSION (Her blood pressure was a little high), FEELING ABNORMAL (she feels weird) and PERIPHERAL SWELLING (arm was swollen for a couple of days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic. Concomitant products included ESTRADIOL (ESTROGEN) for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced LIMB DISCOMFORT (she started feeling extremely heavy and strange), HYPERTENSION (Her blood pressure was a little high) and FEELING ABNORMAL (she feels weird). On an unknown date, the patient experienced PRURITUS (still itchy) and PERIPHERAL SWELLING (arm was swollen for a couple of days). At the time of the report, PRURITUS (still itchy), LIMB DISCOMFORT (she started feeling extremely heavy and strange), HYPERTENSION (Her blood pressure was a little high), FEELING ABNORMAL (she feels weird) and PERIPHERAL SWELLING (arm was swollen for a couple of days) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Blood pressure measurement: 155/102 (High) 155/102, 171/110 (High) 171/110 and 180/115 (High) 180/115.     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 called her cardiologist who suggested she takes her blood pressure medication right away and then at regular time. She even called the poison control and they told her to double up her dose of blood pressure medication before going in for her second dose.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Myalgia, Pyrexia, Vaccination site induration, Vaccination site warmth
Clinical narrative: huge bright red welt below injection site on side of bicep; Area below injection site is warm; lump below injection site; Area below injection site is sore; low-grade fever; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (huge bright red welt below injection site on side of bicep), VACCINATION SITE WARMTH (Area below injection site is warm), VACCINATION SITE INDURATION (lump below injection site), PYREXIA (low-grade fever) and MYALGIA (Area below injection site is sore) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 003C21A) for COVID-19 vaccination.     No medical history for the patient was reported.  Concomitant products included TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) for Bronchial disorder.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-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 PYREXIA (low-grade fever). On 30-Apr-2021, the patient experienced ERYTHEMA (huge bright red welt below injection site on side of bicep), VACCINATION SITE WARMTH (Area below injection site is warm), VACCINATION SITE INDURATION (lump below injection site) and MYALGIA (Area below injection site is sore). On 02-Apr-2021, PYREXIA (low-grade fever) had resolved. At the time of the report, ERYTHEMA (huge bright red welt below injection site on side of bicep), VACCINATION SITE WARMTH (Area below injection site is warm), VACCINATION SITE INDURATION (lump below injection site) and MYALGIA (Area below injection site is sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment include Tylenol on 30Apr2021, ice to area on 30Apr2021, warm compress to area on 01May2021 - 02May2021.  Concomitant medication include vitamin supplement.   This case was linked to MOD-2021-102021 (Patient Link).
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hot flush, Pain, Vaccination site rash
Clinical narrative: Hot flashes have gotten worse; Sore and red rash; red; rash an inch below the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Hot flashes have gotten worse), PAIN (Sore and red rash), ERYTHEMA (red) and VACCINATION SITE RASH (rash an inch below the injection site) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced HOT FLUSH (Hot flashes have gotten worse), PAIN (Sore and red rash), ERYTHEMA (red) and VACCINATION SITE RASH (rash an inch below the injection site). At the time of the report, HOT FLUSH (Hot flashes have gotten worse), PAIN (Sore and red rash), ERYTHEMA (red) and VACCINATION SITE RASH (rash an inch below the injection site) outcome was unknown. Not Provided          No relevant concomitant medications were reported. No treatment information was reported.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: 1st dose of covid vaccine with Pfizer. 2nd covid vaccine dose with Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (1st dose of covid vaccine with Pfizer. 2nd covid vaccine dose with Moderna vaccine) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 26-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 26-Apr-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (1st dose of covid vaccine with Pfizer. 2nd covid vaccine dose with Moderna vaccine). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (1st dose of covid vaccine with Pfizer. 2nd covid vaccine dose with Moderna vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Mobility decreased, Myalgia
Clinical narrative: loss of mobility; felt like someone punched me in the arm; Searing joint pain, feels like pain in joint, shoulder pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-May-2021 and was forwarded to Moderna on 04-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Searing joint pain, feels like pain in joint, shoulder pain), MOBILITY DECREASED (loss of mobility) and MYALGIA (felt like someone punched me in the arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced ARTHRALGIA (Searing joint pain, feels like pain in joint, shoulder pain). On an unknown date, the patient experienced MOBILITY DECREASED (loss of mobility) and MYALGIA (felt like someone punched me in the arm). At the time of the report, ARTHRALGIA (Searing joint pain, feels like pain in joint, shoulder pain), MOBILITY DECREASED (loss of mobility) and MYALGIA (felt like someone punched me in the arm) had not resolved.            Concomitant product use was not provided by the reporter. Treatment information was not provided. The action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-101918 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow-up received on 07-jun-2021 and no new information were provided On 20-Jun-2021: Follow-up received on 20-jun-2021 and No new information is provided.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Rash
Clinical narrative: weakness; a rash on his neck; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), RASH (a rash on his neck) and FATIGUE (tiredness) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039b21a and 037a21b) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included OMEPRAZOLE for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced ASTHENIA (weakness), RASH (a rash on his neck) and FATIGUE (tiredness). On 27-Apr-2021, ASTHENIA (weakness) and FATIGUE (tiredness) had resolved. At the time of the report, RASH (a rash on his neck) had not resolved. Not Provided          Treatment information was not provided. Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to MOD-2021-101894 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Throat tightness
Clinical narrative: drowning in her throat; Headache; exhausted; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (drowning in her throat), HEADACHE (Headache) and FATIGUE (exhausted) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     Concomitant products included DESOGESTREL (CELEA), ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETICONE (PEPSID), CLONAZEPAM (KLONOPIN), BUPROPION HYDROCHLORIDE (WELLBUTRIN) and VITAMIN D NOS for an unknown indication.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced THROAT TIGHTNESS (drowning in her throat), HEADACHE (Headache) and FATIGUE (exhausted). The patient was treated with GUAIFENESIN (MUCINEX) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 03-May-2021, THROAT TIGHTNESS (drowning in her throat), HEADACHE (Headache) and FATIGUE (exhausted) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17years and 8 months got the first dose of Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17years and 8 months got the first dose of Moderna vaccine) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17years and 8 months got the first dose of Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17years and 8 months got the first dose of Moderna vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow-up information received on 08-JUN-2021 contains non-significant information. Reporter declined giving her personal email but said she is happy to speak over the phone to the safety department.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Itchy rash; had the rash a week after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash) and RASH (had the rash a week after the vaccine) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Cholesterol.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 20-Feb-2021, the patient experienced RASH (had the rash a week after the vaccine). On an unknown date, the patient experienced RASH PRURITIC (Itchy rash). At the time of the report, RASH PRURITIC (Itchy rash) and RASH (had the rash a week after the vaccine) outcome was unknown.            Treatment was reported as Zantac Pepcid Allegra.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Decreased appetite, Fatigue, Headache, Nausea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (had no appetite), PAIN (her body ached very bad, like she got ran over), FATIGUE (feeling fatigue), HEADACHE (very bad headache) and NAUSEA (she felt nauseous) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced FATIGUE (feeling fatigue) and HEADACHE (very bad headache). On 28-Apr-2021, the patient experienced PAIN (her body ached very bad, like she got ran over). On 29-Apr-2021, the patient experienced DECREASED APPETITE (had no appetite) and NAUSEA (she felt nauseous). At the time of the report, DECREASED APPETITE (had no appetite), PAIN (her body ached very bad, like she got ran over), FATIGUE (feeling fatigue), HEADACHE (very bad headache) and NAUSEA (she felt nauseous) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, COVID-19: other (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Treatment information not provided. No concomitant medications were reported
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (had no appetite), PAIN (her body ached very bad, like she got ran over), FATIGUE (feeling fatigue), HEADACHE (very bad headache) and NAUSEA (she felt nauseous) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced FATIGUE (feeling fatigue) and HEADACHE (very bad headache). On 28-Apr-2021, the patient experienced PAIN (her body ached very bad, like she got ran over). On 29-Apr-2021, the patient experienced DECREASED APPETITE (had no appetite) and NAUSEA (she felt nauseous). At the time of the report, DECREASED APPETITE (had no appetite), PAIN (her body ached very bad, like she got ran over), FATIGUE (feeling fatigue), HEADACHE (very bad headache) and NAUSEA (she felt nauseous) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, COVID-19: other (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Treatment information not provided. No concomitant medications were reported
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Urticaria
Clinical narrative: Hives; Nausea; Chills; This spontaneous case was reported by a nurse and describes the occurrence of URTICARIA (Hives), NAUSEA (Nausea) and CHILLS (Chills) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012420A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-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 experienced URTICARIA (Hives), NAUSEA (Nausea) and CHILLS (Chills). At the time of the report, URTICARIA (Hives), NAUSEA (Nausea) and CHILLS (Chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-023426 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: rash on injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash on injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE RASH (rash on injection site). On 03-Mar-2021, VACCINATION SITE RASH (rash on injection site) had resolved.            This case was linked to MOD-2021-027529 (Patient Link).