chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID19; This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (Tested positive for COVID19) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: BAMLANIVIMAB (Reporter stated patient recently received an antibody infusion called bamlanivimab).    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced COVID-19 (Tested positive for COVID19). At the time of the report, COVID-19 (Tested positive for COVID19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, SARS-CoV-2 test: other (Positive) Tested positive for COVID-19..     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 medications were not reported.  No treatment information was specified.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Dizziness, Heart rate, Pain
Clinical narrative: Weakness; Dizziness; Body aches; Fever; Sharp pains in her left knee and ankle; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), DIZZINESS (Dizziness), PAIN (Body aches), PYREXIA (Fever) and ARTHRALGIA (Sharp pains in her left knee and ankle) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced ASTHENIA (Weakness), DIZZINESS (Dizziness), PAIN (Body aches), PYREXIA (Fever) and ARTHRALGIA (Sharp pains in her left knee and ankle). At the time of the report, ASTHENIA (Weakness), DIZZINESS (Dizziness), PAIN (Body aches), PYREXIA (Fever) and ARTHRALGIA (Sharp pains in her left knee and ankle) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Feb-2021, Heart rate: 90-100 (High) Racing heart rate was 90s-100 while patient was just sitting.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that patient had super sharp pains in her left knee and ankle, it felt like it was coming from the flesh near the patella.  No Concomitant medications were reported.  No Treatments were reported.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Weakness; Dizziness; Body aches; Fever; Sharp pains in her left knee and ankle; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), DIZZINESS (Dizziness), PAIN (Body aches), PYREXIA (Fever) and ARTHRALGIA (Sharp pains in her left knee and ankle) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced ASTHENIA (Weakness), DIZZINESS (Dizziness), PAIN (Body aches), PYREXIA (Fever) and ARTHRALGIA (Sharp pains in her left knee and ankle). At the time of the report, ASTHENIA (Weakness), DIZZINESS (Dizziness), PAIN (Body aches), PYREXIA (Fever) and ARTHRALGIA (Sharp pains in her left knee and ankle) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Feb-2021, Heart rate: 90-100 (High) Racing heart rate was 90s-100 while patient was just sitting.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that patient had super sharp pains in her left knee and ankle, it felt like it was coming from the flesh near the patella.  No Concomitant medications were reported.  No Treatments were reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles after first shot; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles after first shot) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced HERPES ZOSTER (Shingles after first shot). The patient was treated with VALGANCICLOVIR for Shingles, at a dose of 10 day treatment. At the time of the report, HERPES ZOSTER (Shingles after first shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Personality change
Clinical narrative: memory kind of brain fog type of thing; "so out of character"; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (memory kind of brain fog type of thing) and PERSONALITY CHANGE ("so out of character") in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (memory kind of brain fog type of thing) and PERSONALITY CHANGE ("so out of character"). At the time of the report, FEELING ABNORMAL (memory kind of brain fog type of thing) had not resolved and PERSONALITY CHANGE ("so out of character") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatments were reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Paraesthesia, Pruritus
Clinical narrative: felt slight swelling in upper lip; prickly tingly feeling in my face that caused some itching; periodically, really bad itching on hand or foot like two mosquito bites/ Tingling caused face itching; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (felt slight swelling in upper lip), PARAESTHESIA (prickly tingly feeling in my face that caused some itching) and PRURITUS (periodically, really bad itching on hand or foot like two mosquito bites/ Tingling caused face itching) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced LIP SWELLING (felt slight swelling in upper lip), PARAESTHESIA (prickly tingly feeling in my face that caused some itching) and PRURITUS (periodically, really bad itching on hand or foot like two mosquito bites/ Tingling caused face itching). On 12-Mar-2021, LIP SWELLING (felt slight swelling in upper lip), PARAESTHESIA (prickly tingly feeling in my face that caused some itching) and PRURITUS (periodically, really bad itching on hand or foot like two mosquito bites/ Tingling caused face itching) 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. No Treatments were reported.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Left lower arm hurting; Hurting into her shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left lower arm hurting) and ARTHRALGIA (Hurting into her shoulder) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included PARACETAMOL (TYLENOL) for Arthritis.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (Left lower arm hurting) and ARTHRALGIA (Hurting into her shoulder). At the time of the report, PAIN IN EXTREMITY (Left lower arm hurting) and ARTHRALGIA (Hurting into her shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient used rubbing alcohol and heating pad to treat the events.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Has rash on the same arm of injection; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of RASH (Has rash on the same arm of injection) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Has rash on the same arm of injection). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, RASH (Has rash on the same arm of injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Contains non significant information.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder, Pain in extremity
Clinical narrative: Cant move right arm; Arm is still sore; This spontaneous case was reported by a consumer and describes the occurrence of MOVEMENT DISORDER (Cant move right arm) and PAIN IN EXTREMITY (Arm is still sore) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Polio. Concurrent medical conditions included Atrophy (atrophy in limbs), Heart disorder, Weakness of arms (left arm is extremely weak.) and Diabetes mellitus.    On 08-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 MOVEMENT DISORDER (Cant move right arm) and PAIN IN EXTREMITY (Arm is still sore). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MOVEMENT DISORDER (Cant move right arm) and PAIN IN EXTREMITY (Arm is still sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Numb lip) 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 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA ORAL (Numb lip). At the time of the report, HYPOAESTHESIA ORAL (Numb lip) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reporter did not allow further contact.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced TINNITUS (Tinnitus). At the time of the report, TINNITUS (Tinnitus) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow-up received: Event outcome updated.
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Felt throat is closing; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Felt throat is closing) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COPD.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced THROAT TIGHTNESS (Felt throat is closing). At the time of the report, THROAT TIGHTNESS (Felt throat is closing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  No treatment information was specified.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (loss of taste) and ANOSMIA (loss of smell) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced AGEUSIA (loss of taste) and ANOSMIA (loss of smell). At the time of the report, AGEUSIA (loss of taste) and ANOSMIA (loss of smell) had not resolved. Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Illness, Vomiting
Clinical narrative: Felt dizzy; Got really sick; Throwing up/ Keep running to the bathroom; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt dizzy), ILLNESS (Got really sick) and VOMITING (Throwing up/ Keep running to the bathroom) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced DIZZINESS (Felt dizzy), ILLNESS (Got really sick) and VOMITING (Throwing up/ Keep running to the bathroom). At the time of the report, DIZZINESS (Felt dizzy), ILLNESS (Got really sick) and VOMITING (Throwing up/ Keep running to the bathroom) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication including medicine for diabetes was reported.  No treatment information was specified.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Red raised circle around; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red raised circle around) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red raised circle around). At the time of the report, VACCINATION SITE ERYTHEMA (Red raised circle around) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Patient reported that she had not taken any medicines to alleviate her symptoms.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Ageusia, Arthralgia, Fatigue, Myalgia
Clinical narrative: Loss of taste; Stomach pains; Eexperienced body pain; Joint pains; Nausea; Fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Mar-2021 and was forwarded to Moderna on 16-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste), ABDOMINAL PAIN UPPER (Stomach pains), MYALGIA (Eexperienced body pain), ARTHRALGIA (Joint pains) and NAUSEA (Nausea) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced AGEUSIA (Loss of taste), NAUSEA (Nausea) and FATIGUE (Fatigue). 16-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pains), MYALGIA (Eexperienced body pain) and ARTHRALGIA (Joint pains). At the time of the report, AGEUSIA (Loss of taste), ABDOMINAL PAIN UPPER (Stomach pains), MYALGIA (Eexperienced body pain), ARTHRALGIA (Joint pains), NAUSEA (Nausea) and FATIGUE (Fatigue) outcome was unknown.            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 MOD21-055337, MOD21-055429, MOD21-055432, US-MODERNATX, INC.-MOD-2021-046257 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD21-055337: MOD21-055429: MOD21-055432: US-MODERNATX, INC.-MOD-2021-046257:patient case (male)
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Loss of taste; Stomach pains; Eexperienced body pain; Joint pains; Nausea; Fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Mar-2021 and was forwarded to Moderna on 16-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste), ABDOMINAL PAIN UPPER (Stomach pains), MYALGIA (Eexperienced body pain), ARTHRALGIA (Joint pains) and NAUSEA (Nausea) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced AGEUSIA (Loss of taste), NAUSEA (Nausea) and FATIGUE (Fatigue). 16-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pains), MYALGIA (Eexperienced body pain) and ARTHRALGIA (Joint pains). At the time of the report, AGEUSIA (Loss of taste), ABDOMINAL PAIN UPPER (Stomach pains), MYALGIA (Eexperienced body pain), ARTHRALGIA (Joint pains), NAUSEA (Nausea) and FATIGUE (Fatigue) outcome was unknown.            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 MOD21-055337, MOD21-055429, MOD21-055432, US-MODERNATX, INC.-MOD-2021-046257 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD21-055337: MOD21-055429: MOD21-055432: US-MODERNATX, INC.-MOD-2021-046257:patient case (male)
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth, Insomnia
Clinical narrative: injection site warm; could not sleep; swelling on her left arm which was half a peach size (around 3inches in diameter); eye twitch; slightly itchy at the injection site; pain at the injection site; red at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (injection site warm), INSOMNIA (could not sleep), PERIPHERAL SWELLING (swelling on her left arm which was half a peach size (around 3inches in diameter)), MUSCLE TWITCHING (eye twitch) and INJECTION SITE PRURITUS (slightly itchy at the injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Mar-2021, the patient received 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 11-Mar-2021, the patient experienced INJECTION SITE WARMTH (injection site warm). 11-Mar-2021, the patient experienced INSOMNIA (could not sleep), PERIPHERAL SWELLING (swelling on her left arm which was half a peach size (around 3inches in diameter)), MUSCLE TWITCHING (eye twitch), INJECTION SITE PRURITUS (slightly itchy at the injection site), INJECTION SITE PAIN (pain at the injection site) and INJECTION SITE ERYTHEMA (red at the injection site). On 12-Mar-2021, INSOMNIA (could not sleep) and MUSCLE TWITCHING (eye twitch) had resolved. On 14-Mar-2021, INJECTION SITE PRURITUS (slightly itchy at the injection site) had resolved. On 15-Mar-2021, INJECTION SITE PAIN (pain at the injection site) had resolved. At the time of the report, INJECTION SITE WARMTH (injection site warm), PERIPHERAL SWELLING (swelling on her left arm which was half a peach size (around 3inches in diameter)) and INJECTION SITE ERYTHEMA (red at the injection site) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant and treatment medications were reported.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Peripheral swelling
Clinical narrative: injection site warm; could not sleep; swelling on her left arm which was half a peach size (around 3inches in diameter); eye twitch; slightly itchy at the injection site; pain at the injection site; red at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (injection site warm), INSOMNIA (could not sleep), PERIPHERAL SWELLING (swelling on her left arm which was half a peach size (around 3inches in diameter)), MUSCLE TWITCHING (eye twitch) and INJECTION SITE PRURITUS (slightly itchy at the injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Mar-2021, the patient received 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 11-Mar-2021, the patient experienced INJECTION SITE WARMTH (injection site warm). 11-Mar-2021, the patient experienced INSOMNIA (could not sleep), PERIPHERAL SWELLING (swelling on her left arm which was half a peach size (around 3inches in diameter)), MUSCLE TWITCHING (eye twitch), INJECTION SITE PRURITUS (slightly itchy at the injection site), INJECTION SITE PAIN (pain at the injection site) and INJECTION SITE ERYTHEMA (red at the injection site). On 12-Mar-2021, INSOMNIA (could not sleep) and MUSCLE TWITCHING (eye twitch) had resolved. On 14-Mar-2021, INJECTION SITE PRURITUS (slightly itchy at the injection site) had resolved. On 15-Mar-2021, INJECTION SITE PAIN (pain at the injection site) had resolved. At the time of the report, INJECTION SITE WARMTH (injection site warm), PERIPHERAL SWELLING (swelling on her left arm which was half a peach size (around 3inches in diameter)) and INJECTION SITE ERYTHEMA (red at the injection site) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant and treatment medications were reported.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness in the arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness in the arm at the injection site) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010821A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE PAIN (Soreness in the arm at the injection site). On 11-Mar-2021, VACCINATION SITE PAIN (Soreness in the arm at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (headache, fever, exhaustion, and her arm was sore), FATIGUE (extremely exhausted and never been so tired in her life.), HEADACHE (headache, fever, exhaustion, and her arm was sore) and PYREXIA (headache, fever, exhaustion, and her arm was sore) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2002, the patient experienced PYREXIA (headache, fever, exhaustion, and her arm was sore). On 11-Mar-2021, the patient experienced FATIGUE (extremely exhausted and never been so tired in her life.). On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (headache, fever, exhaustion, and her arm was sore) and HEADACHE (headache, fever, exhaustion, and her arm was sore). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (headache, fever, exhaustion, and her arm was sore), FATIGUE (extremely exhausted and never been so tired in her life.), HEADACHE (headache, fever, exhaustion, and her arm was sore) and PYREXIA (headache, fever, exhaustion, and her arm was sore) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dyspnoea
Clinical narrative: sometimes get a little light headed; sometimes a little short of breath; feeling kind of weak; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (sometimes get a little light headed), DYSPNOEA (sometimes a little short of breath) and ASTHENIA (feeling kind of weak) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included Irritable bowel syndrome. Concomitant products included VENLAFAXINE for an unknown indication.   On 25-Feb-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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (sometimes get a little light headed), DYSPNOEA (sometimes a little short of breath) and ASTHENIA (feeling kind of weak). At the time of the report, DIZZINESS (sometimes get a little light headed), DYSPNOEA (sometimes a little short of breath) and ASTHENIA (feeling kind of weak) outcome was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue after second dose; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue after second dose) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 FATIGUE (Fatigue after second dose). At the time of the report, FATIGUE (Fatigue after second dose) outcome was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Fatigue, Headache, Rash
Clinical narrative: Eye pain; Purplish bad rash all over the body; Exhausted; Headache; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (Eye pain), RASH (Purplish bad rash all over the body), HEADACHE (Headache) and FATIGUE (Exhausted) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced HEADACHE (Headache). On 07-Mar-2021, the patient experienced EYE PAIN (Eye pain), RASH (Purplish bad rash all over the body) and FATIGUE (Exhausted). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, EYE PAIN (Eye pain), RASH (Purplish bad rash all over the body), HEADACHE (Headache) and FATIGUE (Exhausted) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: joint pain; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain) and MYALGIA (muscle pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced ARTHRALGIA (joint pain) and MYALGIA (muscle pain). At the time of the report, ARTHRALGIA (joint pain) and MYALGIA (muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Incorrect dose administered, Underdose
Clinical narrative: Dose leaked on the arm while administering; Dose leaked on the arm while administering; feels that the right quantity of the dose is not administered; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (Dose leaked on the arm while administering), DEVICE CONNECTION ISSUE (Dose leaked on the arm while administering) and INCORRECT DOSE ADMINISTERED (feels that the right quantity of the dose is not administered) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN, HYDROCHLOROTHIAZIDE, AMLODIPINE and CALCIUM for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced UNDERDOSE (Dose leaked on the arm while administering), DEVICE CONNECTION ISSUE (Dose leaked on the arm while administering) and INCORRECT DOSE ADMINISTERED (feels that the right quantity of the dose is not administered). On 11-Mar-2021, UNDERDOSE (Dose leaked on the arm while administering), DEVICE CONNECTION ISSUE (Dose leaked on the arm while administering) and INCORRECT DOSE ADMINISTERED (feels that the right quantity of the dose is not administered) had resolved. Not Provided          No treatment information was 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.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Insomnia, Myalgia, Suspected COVID-19
Clinical narrative: had body aches for one day; Now, is extremely weak and the strength is not coming back.; he can not sleep at night; felling extreme fatigue,; after the shot he started felling like he is going through Covid again and he was already recovered and fine before the shot.; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (after the shot he started felling like he is going through Covid again and he was already recovered and fine before the shot.), ASTHENIA (Now, is extremely weak and the strength is not coming back.), INSOMNIA (he can not sleep at night), FATIGUE (felling extreme fatigue,) and MYALGIA (had body aches for one day) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure, Cholesterol and Heart disorder. Concomitant products included INSULIN for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced SUSPECTED COVID-19 (after the shot he started felling like he is going through Covid again and he was already recovered and fine before the shot.), INSOMNIA (he can not sleep at night) and FATIGUE (felling extreme fatigue,). On 16-Mar-2021, the patient experienced ASTHENIA (Now, is extremely weak and the strength is not coming back.). On an unknown date, the patient experienced MYALGIA (had body aches for one day). At the time of the report, SUSPECTED COVID-19 (after the shot he started felling like he is going through Covid again and he was already recovered and fine before the shot.), ASTHENIA (Now, is extremely weak and the strength is not coming back.), INSOMNIA (he can not sleep at night), FATIGUE (felling extreme fatigue,) and MYALGIA (had body aches for one day) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature excursion) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature excursion). At the time of the report, PRODUCT STORAGE ERROR (Received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature excursion) 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.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: uncontrollable watery diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (uncontrollable watery diarrhea) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced DIARRHOEA (uncontrollable watery diarrhea). At the time of the report, DIARRHOEA (uncontrollable watery diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: itchy at injection site; red at injection site; developed a rash around the injection site approximately 3inches by 2.5 inches; sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchy at injection site), VACCINATION SITE PAIN (sore arm at the injection site), VACCINATION SITE RASH (developed a rash around the injection site approximately 3inches by 2.5 inches) and VACCINATION SITE ERYTHEMA (red at injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ALPRAZOLAM and AMLODIPINE for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore arm at the injection site). On 15-Mar-2021, the patient experienced VACCINATION SITE RASH (developed a rash around the injection site approximately 3inches by 2.5 inches). On 16-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itchy at injection site) and VACCINATION SITE ERYTHEMA (red at injection site). The patient was treated with PARACETAMOL (TYLENOL) on 10-Mar-2021 for Vaccination site pain, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (itchy at injection site), VACCINATION SITE RASH (developed a rash around the injection site approximately 3inches by 2.5 inches) and VACCINATION SITE ERYTHEMA (red at injection site) had not resolved and VACCINATION SITE PAIN (sore arm at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Muscle spasms
Clinical narrative: Little pain in stomach muscle; cramping; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Little pain in stomach muscle) and MUSCLE SPASMS (cramping) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced ABDOMINAL PAIN UPPER (Little pain in stomach muscle) and MUSCLE SPASMS (cramping). At the time of the report, ABDOMINAL PAIN UPPER (Little pain in stomach muscle) and MUSCLE SPASMS (cramping) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The reported was not sure if the adverse events were acid reflux related. Concomitant medication and treatment information were not reported.    Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Swelling
Clinical narrative: redness; Swelling; Injection site itching; a circle of redness in diameter of an orange and later a red streak coming from it that itched a lot; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), SWELLING (Swelling), INJECTION SITE PRURITUS (Injection site itching) and INJECTION SITE ERYTHEMA (a circle of redness in diameter of an orange and later a red streak coming from it that itched a lot) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced ERYTHEMA (redness), SWELLING (Swelling), INJECTION SITE PRURITUS (Injection site itching) and INJECTION SITE ERYTHEMA (a circle of redness in diameter of an orange and later a red streak coming from it that itched a lot). At the time of the report, ERYTHEMA (redness), SWELLING (Swelling), INJECTION SITE PRURITUS (Injection site itching) and INJECTION SITE ERYTHEMA (a circle of redness in diameter of an orange and later a red streak coming from it that itched a lot) had resolved.            Action taken with mRNA-1273 in response to the events was considered as not applicable.  Treatment medication include triple antibiotics and antihistamine.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: FU received on 27 April 2021. New events ( redness , erythema and injection site erythema ) were added , reaction onset date was added and outcome of event injection site pruritis was changed from unknown to recovered.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Pyrexia
Clinical narrative: fever; tired; some appetite loss; chills; This spontaneous case was reported by an other caregiver and describes the occurrence of CHILLS (chills), PYREXIA (fever), FATIGUE (tired) and DECREASED APPETITE (some appetite loss) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event on 09-Mar-2021.    On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (chills). On 16-Mar-2021, the patient experienced PYREXIA (fever), FATIGUE (tired) and DECREASED APPETITE (some appetite loss). At the time of the report, CHILLS (chills) had resolved and PYREXIA (fever), FATIGUE (tired) and DECREASED APPETITE (some appetite loss) had not resolved.            No concomitant medications were provided.  No treatments were provided. Reporter waiting on call back from HCP.   Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph node left behind right ear; This spontaneous case was reported by a patient and describes the occurrence of LYMPHADENOPATHY (swollen lymph node left behind right ear) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No medical history was reported.     On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced LYMPHADENOPATHY (swollen lymph node left behind right ear). At the time of the report, LYMPHADENOPATHY (swollen lymph node left behind right ear) had not resolved. Not Provided          Concomitant medication and treatment information were not reported.  Action taken with mRNA-1273 in response to the event was Not Applicable
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Pruritus, Swelling, Vaccination site erythema
Clinical narrative: redness; swelling; itching really bad; arm was sore to touch; red at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore to touch), PRURITUS (itching really bad), ERYTHEMA (redness), SWELLING (swelling) and VACCINATION SITE ERYTHEMA (red at the injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was sore to touch) and VACCINATION SITE ERYTHEMA (red at the injection site). On 15-Mar-2021, the patient experienced PRURITUS (itching really bad). On 16-Mar-2021, the patient experienced ERYTHEMA (redness) and SWELLING (swelling). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (arm was sore to touch) and PRURITUS (itching really bad) had resolved, ERYTHEMA (redness) and SWELLING (swelling) had not resolved and VACCINATION SITE ERYTHEMA (red at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was reported. Patient was prescribed Benadryl cream, The report is not clear about the specific indication or start/stop date.   This case was linked to MOD-2021-253021 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Non-significant follow up