chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling hot, Pyrexia
Clinical narrative: woke up from nap and felt hot all over, her face was hot as could be; temperature of 101 degree Fahrenheit.; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (woke up from nap and felt hot all over, her face was hot as could be) and PYREXIA (temperature of 101 degree Fahrenheit.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 007M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced FEELING HOT (woke up from nap and felt hot all over, her face was hot as could be) and PYREXIA (temperature of 101 degree Fahrenheit.). The patient was treated with ACETAMINOPHEN on 18-Mar-2021 for Fever and Feeling hot, at a dose of 250 mg. On 18-Mar-2021, FEELING HOT (woke up from nap and felt hot all over, her face was hot as could be) and PYREXIA (temperature of 101 degree Fahrenheit.) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Body temperature: 101 degree fahrenheit (High) 101 degree Fahrenheit.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Nausea, Vomiting
Clinical narrative: Persisting stomach pain; Nausea and vomiting; Nausea and vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Persisting stomach pain), NAUSEA (Nausea and vomiting) and VOMITING (Nausea and vomiting) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Persisting stomach pain), NAUSEA (Nausea and vomiting) and VOMITING (Nausea and vomiting). The patient was treated with BISMUTH SUBSALICYLATE, CALCIUM CARBONATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE;CALCIUM CARBONATE]) at a dose of UNK dosage form. At the time of the report, ABDOMINAL PAIN UPPER (Persisting stomach pain), NAUSEA (Nausea and vomiting) and VOMITING (Nausea and vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Medications were not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Rash, Rash pruritic
Clinical narrative: lip was swollen; Itchy Rash; rash on her arms and shoulders; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (lip was swollen), RASH PRURITIC (Itchy Rash) and RASH (rash on her arms and shoulders) 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 03-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 LIP SWELLING (lip was swollen), RASH PRURITIC (Itchy Rash) and RASH (rash on her arms and shoulders). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, LIP SWELLING (lip was swollen), RASH PRURITIC (Itchy Rash) and RASH (rash on her arms and shoulders) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received the covid-19 vaccine on March 18 following a temperature excursion; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received the covid-19 vaccine on March 18 following a temperature excursion) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 EXPIRED PRODUCT ADMINISTERED (received the covid-19 vaccine on March 18 following a temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received the covid-19 vaccine on March 18 following a temperature excursion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No concomitant medications were reported. No treatment related information has been reported.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Haemoptysis
Clinical narrative: Coughing Up Blood; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of HAEMOPTYSIS (Coughing Up Blood) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), THYMINE, METOPROLOL TARTRATE (METOPROLOLTARTRAAT ACCORD), BUSPIRONE and PANTOPRAZOLE for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced HAEMOPTYSIS (Coughing Up Blood). At the time of the report, HAEMOPTYSIS (Coughing Up Blood) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid-19) 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.   In February 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. In March 2021, the patient experienced COVID-19 (covid-19). At the time of the report, COVID-19 (covid-19) outcome was unknown.            Concomitant medication was not provided. Treatment information was not provided.  Action taken with mRNA-1273 Moderna vaccine was Not applicable
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia
Clinical narrative: the lower half of her right eye is bloodshot; It is just sort of red; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (the lower half of her right eye is bloodshot) and OCULAR HYPERAEMIA (It is just sort of red) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 immunisation.     Concomitant products included ALLOPURINOL (ELAVIL [ALLOPURINOL]), LISINOPRIL, AMITRIPTYLINE, LORAZEPAM and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 17-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 18-Mar-2021, the patient experienced OCULAR HYPERAEMIA (the lower half of her right eye is bloodshot) and OCULAR HYPERAEMIA (It is just sort of red). At the time of the report, OCULAR HYPERAEMIA (the lower half of her right eye is bloodshot) and OCULAR HYPERAEMIA (It is just sort of red) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product includes blood pressure medication. No treatment was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Stress, Tachycardia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Heart was beating fast; Stressed after seeing her arm; Big red spot on her right arm; Is still sore; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Heart was beating fast), STRESS (Stressed after seeing her arm), VACCINATION SITE ERYTHEMA (Big red spot on her right arm) and VACCINATION SITE PAIN (Is still sore) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced TACHYCARDIA (Heart was beating fast), STRESS (Stressed after seeing her arm), VACCINATION SITE ERYTHEMA (Big red spot on her right arm) and VACCINATION SITE PAIN (Is still sore). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, TACHYCARDIA (Heart was beating fast), STRESS (Stressed after seeing her arm), VACCINATION SITE ERYTHEMA (Big red spot on her right arm) and VACCINATION SITE PAIN (Is still sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was not planning to get the second shot.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Nausea, Pyrexia
Clinical narrative: Lightheadedness / dizziness; High fever; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheadedness / dizziness), PYREXIA (High fever), CHILLS (Chills) and NAUSEA (Nausea) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced PYREXIA (High fever), CHILLS (Chills) and NAUSEA (Nausea). On 17-Mar-2021, the patient experienced DIZZINESS (Lightheadedness / dizziness). The patient was treated with ACETAMINOPHEN for Fever, at an unspecified dose and frequency and ZINGIBER OFFICINALE (GINGER [ZINGIBER OFFICINALE]) for Nausea, at a dose of Tea. On 17-Mar-2021, PYREXIA (High fever), CHILLS (Chills) and NAUSEA (Nausea) had resolved. At the time of the report, DIZZINESS (Lightheadedness / dizziness) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Body temperature: 101 (High) 101 F and 102 (High) 102 F.         Concomitant product use was not provided.  Action taken with mRNA-1273 in response to the events was  not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Vaccination site erythema, Vaccination site pain, Vaccination site rash
Clinical narrative: Reddish Rash on the Vaccine Site 3" Round; Reddish Rash on the Vaccine Site 3" Round/ 9 days after first dose I woke up with a baseball size rash around the injection site which lasted about 4-5 days; Diarrhea; Fatigue; Sore Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), FATIGUE (Fatigue), VACCINATION SITE PAIN (Sore Injection Site), VACCINATION SITE ERYTHEMA (Reddish Rash on the Vaccine Site 3" Round) and VACCINATION SITE RASH (Reddish Rash on the Vaccine Site 3" Round/ 9 days after first dose I woke up with a baseball size rash around the injection site which lasted about 4-5 days) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder. Concomitant products included LEVOTHYROXINE SODIUM (LEVOXYL) and VITAMINS NOS for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Sore Injection Site). On 18-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Reddish Rash on the Vaccine Site 3" Round) and VACCINATION SITE RASH (Reddish Rash on the Vaccine Site 3" Round/ 9 days after first dose I woke up with a baseball size rash around the injection site which lasted about 4-5 days). The patient was treated with ALLERGY MEDICATION (oral) for Vaccination site rash, at a dose of 2 allergy pills for 2 days. On 10-Mar-2021, DIARRHOEA (Diarrhea), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Sore Injection Site) had resolved. On 23-Mar-2021, VACCINATION SITE RASH (Reddish Rash on the Vaccine Site 3" Round/ 9 days after first dose I woke up with a baseball size rash around the injection site which lasted about 4-5 days) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Reddish Rash on the Vaccine Site 3" Round) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-066596 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Apr-2021: Added patient demographics (Date of Birth, Medical history), second dose of the drug, concomitant medications. Updated the outcome of the event (Vaccination site rash) from unknown to recovered. On 07-May-2021: Follow up received on 07-MAY-2021 and does not contain any new information for first dose.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Soreness; Fatigue; This spontaneous case was reported by a physician and describes the occurrence of PAIN (Soreness) and FATIGUE (Fatigue) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 immunisation.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 milliliter. On 18-Feb-2021, the patient experienced PAIN (Soreness) and FATIGUE (Fatigue). At the time of the report, PAIN (Soreness) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided. No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-049706 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-049706:Crosslinked with dose 2
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Hypertension, Palpitations, Pyrexia
Clinical narrative: Fast heart rate; Raised blood pressure; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Fast heart rate), HYPERTENSION (Raised blood pressure) and PYREXIA (Fever) in a 73-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 03-Mar-2021 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021 at 10:00 PM, the patient experienced PALPITATIONS (Fast heart rate), HYPERTENSION (Raised blood pressure) and PYREXIA (Fever). At the time of the report, PALPITATIONS (Fast heart rate), HYPERTENSION (Raised blood pressure) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Blood pressure increased: 213/97 mmHg (High) Raised blood pressure (BP 213/97 mmhg).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Herpes zoster, Pain in extremity, Rash, Rash papular
Clinical narrative: rash is still very sore; Rash on chest/Rash under breast(s)/Very sore rash; Shingles blisters from center of chest under her right breast and around the back; hurting on right side of her breast front to back; right arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (right arm was sore), BREAST PAIN (hurting on right side of her breast front to back), HERPES ZOSTER (Shingles blisters from center of chest under her right breast and around the back), RASH PAPULAR (rash is still very sore) and RASH (Rash on chest/Rash under breast(s)/Very sore rash) in an 82-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 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (right arm was sore). On 14-Mar-2021, the patient experienced BREAST PAIN (hurting on right side of her breast front to back). On 16-Mar-2021, the patient experienced HERPES ZOSTER (Shingles blisters from center of chest under her right breast and around the back). On an unknown date, the patient experienced RASH PAPULAR (rash is still very sore) and RASH (Rash on chest/Rash under breast(s)/Very sore rash). The patient was treated with GABAPENTIN at a dose of 1 dosage form; VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) at a dose of 1 dosage form and PARACETAMOL (TYLENOL EXTRA STRENGTH) at a dose of 2 dosage form as necessary. On 13-Mar-2021, PAIN IN EXTREMITY (right arm was sore) had resolved. At the time of the report, BREAST PAIN (hurting on right side of her breast front to back), HERPES ZOSTER (Shingles blisters from center of chest under her right breast and around the back), RASH PAPULAR (rash is still very sore) and RASH (Rash on chest/Rash under breast(s)/Very sore rash) had not resolved. Not Provided          No concomitant product was reported.   Symptoms: Patient reported that she has shingles and shingles are dried but not resolved yet, she still has rash which is very sore.  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up received: Added event outcome, treatment medication.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Limb discomfort, Skin reaction, Vaccination site erythema
Clinical narrative: delay in side effects; injection arm irritated; injection arm itchy; injection arm red; This spontaneous case was reported by a consumer and describes the occurrence of SKIN REACTION (delay in side effects), LIMB DISCOMFORT (injection arm irritated), INJECTION SITE PRURITUS (injection arm itchy) and VACCINATION SITE ERYTHEMA (injection arm red) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for an unknown indication.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced SKIN REACTION (delay in side effects), LIMB DISCOMFORT (injection arm irritated), INJECTION SITE PRURITUS (injection arm itchy) and VACCINATION SITE ERYTHEMA (injection arm red). At the time of the report, SKIN REACTION (delay in side effects), LIMB DISCOMFORT (injection arm irritated), INJECTION SITE PRURITUS (injection arm itchy) and VACCINATION SITE ERYTHEMA (injection arm red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were given by the reporter. Treatment included Benadryl was noted.
Age: 77.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Covid-19 vaccine on March 18 following a temperature excursion; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Covid-19 vaccine on March 18 following a temperature excursion) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Covid-19 vaccine on March 18 following a temperature excursion). On 18-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Received Covid-19 vaccine on March 18 following a temperature excursion) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact  No concomitant medications were reported. No treatment related information has been reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: patient was administered a 1 mL instead of the 0.5 mL of the second dose; A spontaneous report was received from a physician concerning  64 years old female patient,  who received moderna's COVID-19 vaccine (mRNA-1273) and patient was administered a 1 mL instead of the 0.5 mL of the second dose (Incorrect dose administered).  The patient's medical history, as provided by the reporter was unknown. Concomitant medications as provided by the reporter was unknown  On 18 Feb 2021  prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number:031L20A) in left arm for prophylaxis of COVID-19 infection. The patient experienced mild soreness and fatigue after the first dose.  On 18 Mar 2021, the patient was administered 1 ml instead of 0.5 ml  of the second dose of Moderna vaccine (lot number: 032M20A) intramuscularly in his right arm..     Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of event the patient was administered a 1 mL instead of the 0.5 mL of the second dose was considered resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273, lot # 032M20A with no associated AEs.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-049697:Crosslinked with dose 1
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Hypersensitivity
Clinical narrative: experiencing "allergies"; nose is stuffy; scratchy throat; sinus drainage; sinus infection; bad headaches; felt tired / stayed in bed off and on for two weeks / feels tired; felt like she had the flu; the injection made her sick; had weakness; had dizziness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like she had the flu), VACCINATION COMPLICATION (the injection made her sick), ASTHENIA (had weakness), DIZZINESS (had dizziness) and SINUSITIS (sinus infection) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy, Hypertension, Heart disease, unspecified (with heart palpitations) and Migraine headache.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like she had the flu), VACCINATION COMPLICATION (the injection made her sick), ASTHENIA (had weakness), DIZZINESS (had dizziness), HEADACHE (bad headaches) and FATIGUE (felt tired / stayed in bed off and on for two weeks / feels tired). On 11-Mar-2021, the patient experienced SINUSITIS (sinus infection). On 18-Mar-2021, the patient experienced HYPERSENSITIVITY (experiencing "allergies"), NASAL CONGESTION (nose is stuffy), THROAT IRRITATION (scratchy throat) and SINUSITIS (sinus drainage). At the time of the report, INFLUENZA LIKE ILLNESS (felt like she had the flu), VACCINATION COMPLICATION (the injection made her sick), ASTHENIA (had weakness), DIZZINESS (had dizziness), SINUSITIS (sinus infection), THROAT IRRITATION (scratchy throat), SINUSITIS (sinus drainage) and HEADACHE (bad headaches) outcome was unknown and HYPERSENSITIVITY (experiencing "allergies"), NASAL CONGESTION (nose is stuffy) and FATIGUE (felt tired / stayed in bed off and on for two weeks / feels tired) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported concomitant medications for her current medical conditions, not otherwise specified.  On 24-Feb-2021, the patient presented to her healthcare provider and allergy shots were administered. No additional treatment was reported for the events.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Nasal congestion, Sinusitis, Throat irritation, Vaccination complication
Clinical narrative: experiencing "allergies"; nose is stuffy; scratchy throat; sinus drainage; sinus infection; bad headaches; felt tired / stayed in bed off and on for two weeks / feels tired; felt like she had the flu; the injection made her sick; had weakness; had dizziness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like she had the flu), VACCINATION COMPLICATION (the injection made her sick), ASTHENIA (had weakness), DIZZINESS (had dizziness) and SINUSITIS (sinus infection) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy, Hypertension, Heart disease, unspecified (with heart palpitations) and Migraine headache.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like she had the flu), VACCINATION COMPLICATION (the injection made her sick), ASTHENIA (had weakness), DIZZINESS (had dizziness), HEADACHE (bad headaches) and FATIGUE (felt tired / stayed in bed off and on for two weeks / feels tired). On 11-Mar-2021, the patient experienced SINUSITIS (sinus infection). On 18-Mar-2021, the patient experienced HYPERSENSITIVITY (experiencing "allergies"), NASAL CONGESTION (nose is stuffy), THROAT IRRITATION (scratchy throat) and SINUSITIS (sinus drainage). At the time of the report, INFLUENZA LIKE ILLNESS (felt like she had the flu), VACCINATION COMPLICATION (the injection made her sick), ASTHENIA (had weakness), DIZZINESS (had dizziness), SINUSITIS (sinus infection), THROAT IRRITATION (scratchy throat), SINUSITIS (sinus drainage) and HEADACHE (bad headaches) outcome was unknown and HYPERSENSITIVITY (experiencing "allergies"), NASAL CONGESTION (nose is stuffy) and FATIGUE (felt tired / stayed in bed off and on for two weeks / feels tired) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported concomitant medications for her current medical conditions, not otherwise specified.  On 24-Feb-2021, the patient presented to her healthcare provider and allergy shots were administered. No additional treatment was reported for the events.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Chills, Headache, Muscle spasms
Clinical narrative: cramp in her left thigh; pain in her chest; Chills; headache; Fever; muscle pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (cramp in her left thigh), CHEST PAIN (pain in her chest), CHILLS (Chills), HEADACHE (headache) and PYREXIA (Fever) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced CHILLS (Chills), HEADACHE (headache), PYREXIA (Fever), MYALGIA (muscle pain) and ARTHRALGIA (Joint pain). On 10-Mar-2021, the patient experienced CHEST PAIN (pain in her chest). On 11-Mar-2021, the patient experienced MUSCLE SPASMS (cramp in her left thigh). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (cramp in her left thigh), CHEST PAIN (pain in her chest), CHILLS (Chills), HEADACHE (headache), PYREXIA (Fever), MYALGIA (muscle pain) and ARTHRALGIA (Joint pain) outcome was unknown.            Concomitant medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow-up information received on 23-JUN-2021 and contains non-significant information. Updated email and address of the reporter
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: cramp in her left thigh; pain in her chest; Chills; headache; Fever; muscle pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (cramp in her left thigh), CHEST PAIN (pain in her chest), CHILLS (Chills), HEADACHE (headache) and PYREXIA (Fever) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced CHILLS (Chills), HEADACHE (headache), PYREXIA (Fever), MYALGIA (muscle pain) and ARTHRALGIA (Joint pain). On 10-Mar-2021, the patient experienced CHEST PAIN (pain in her chest). On 11-Mar-2021, the patient experienced MUSCLE SPASMS (cramp in her left thigh). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (cramp in her left thigh), CHEST PAIN (pain in her chest), CHILLS (Chills), HEADACHE (headache), PYREXIA (Fever), MYALGIA (muscle pain) and ARTHRALGIA (Joint pain) outcome was unknown.            Concomitant medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow-up information received on 23-JUN-2021 and contains non-significant information. Updated email and address of the reporter
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, General symptom, Pain, Pain in extremity, SARS-CoV-2 test
Clinical narrative: body aches; Sore arm; Mild Symptoms; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), PAIN IN EXTREMITY (Sore arm), GENERAL SYMPTOM (Mild Symptoms) and FATIGUE (fatigue) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, ENALAPRIL and TRAVOPROST for an unknown indication.   On 13-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 13-Mar-2021, the patient experienced PAIN (body aches), PAIN IN EXTREMITY (Sore arm), GENERAL SYMPTOM (Mild Symptoms) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 13-Mar-2021, PAIN (body aches) and FATIGUE (fatigue) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) and GENERAL SYMPTOM (Mild Symptoms) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.         Action taken with mRNA-1273 in response to the events were Not Applicable
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID-19) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided.).    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) 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 treatment medications were reported.
Age: 36.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received Covid-19 vaccine on March 18 following temperature excursion; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received Covid-19 vaccine on March 18 following temperature excursion) in a 36-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     No Medical History information was reported.    On 18-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received Covid-19 vaccine on March 18 following temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received Covid-19 vaccine on March 18 following temperature excursion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    No concomitant medications were reported. No treatment related information has been reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Side effects; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ADVERSE EVENT (Side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Side effects). At the time of the report, ADVERSE EVENT (Side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-049532 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up was received on 07-may-2021 and contains no significant information
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Vaccination site pain
Clinical narrative: Vaccination site pain; Arm was itchy; Erythema; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Arm was itchy), ERYTHEMA (Erythema) and VACCINATION SITE PAIN (Vaccination site pain) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PRURITUS (Arm was itchy) and ERYTHEMA (Erythema). On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, PRURITUS (Arm was itchy), ERYTHEMA (Erythema) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided.  No treatment information was provided.
Age: 46.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received Covid-19 vaccine on March 18 following temperature excursion; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received Covid-19 vaccine on March 18 following temperature excursion) in a 46-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNKNOWN) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received Covid-19 vaccine on March 18 following temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received Covid-19 vaccine on March 18 following temperature excursion) 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 treatment related information has been reported.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Hot to Touch Sensation - Near Injection Site; Swelling - Near Injection Site; Hardness - Near Injection Site; Itchy - Near Injection Site; Rash - Near Injection Site; Arm Pain - Near Injection Site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), VACCINATION SITE SWELLING (Swelling - Near Injection Site), VACCINATION SITE INDURATION (Hardness - Near Injection Site), VACCINATION SITE PRURITUS (Itchy - Near Injection Site) and VACCINATION SITE RASH (Rash - Near Injection Site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concomitant products included CITALOPRAM for Antidepressant therapy, MELATONIN for Sleep disorder.    On 05-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 VACCINATION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), VACCINATION SITE SWELLING (Swelling - Near Injection Site), VACCINATION SITE INDURATION (Hardness - Near Injection Site), VACCINATION SITE PRURITUS (Itchy - Near Injection Site), VACCINATION SITE RASH (Rash - Near Injection Site) and VACCINATION SITE PAIN (Arm Pain - Near Injection Site). At the time of the report, VACCINATION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), VACCINATION SITE SWELLING (Swelling - Near Injection Site), VACCINATION SITE INDURATION (Hardness - Near Injection Site), VACCINATION SITE PRURITUS (Itchy - Near Injection Site), VACCINATION SITE RASH (Rash - Near Injection Site) and VACCINATION SITE PAIN (Arm Pain - Near Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant product included supplements for general health. Treatment included cold compress as advised by HCP to alleviate the symptoms.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Hot to Touch Sensation - Near Injection Site; Swelling - Near Injection Site; Hardness - Near Injection Site; Itchy - Near Injection Site; Rash - Near Injection Site; Arm Pain - Near Injection Site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), VACCINATION SITE SWELLING (Swelling - Near Injection Site), VACCINATION SITE INDURATION (Hardness - Near Injection Site), VACCINATION SITE PRURITUS (Itchy - Near Injection Site) and VACCINATION SITE RASH (Rash - Near Injection Site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concomitant products included CITALOPRAM for Antidepressant therapy, MELATONIN for Sleep disorder.    On 05-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 VACCINATION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), VACCINATION SITE SWELLING (Swelling - Near Injection Site), VACCINATION SITE INDURATION (Hardness - Near Injection Site), VACCINATION SITE PRURITUS (Itchy - Near Injection Site), VACCINATION SITE RASH (Rash - Near Injection Site) and VACCINATION SITE PAIN (Arm Pain - Near Injection Site). At the time of the report, VACCINATION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), VACCINATION SITE SWELLING (Swelling - Near Injection Site), VACCINATION SITE INDURATION (Hardness - Near Injection Site), VACCINATION SITE PRURITUS (Itchy - Near Injection Site), VACCINATION SITE RASH (Rash - Near Injection Site) and VACCINATION SITE PAIN (Arm Pain - Near Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant product included supplements for general health. Treatment included cold compress as advised by HCP to alleviate the symptoms.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pruritus, Pyrexia, Rash pruritic, Vaccination site erythema
Clinical narrative: itchy rash around neck/itchy rash around chin/itchy rash around face/itchy rash around back; itchy all the way down inner legs; right arm hot/right hand hot; body sore; fever; right arm swollen/right arm swollen; right arm red/right hand red; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash around neck/itchy rash around chin/itchy rash around face/itchy rash around back), PRURITUS (itchy all the way down inner legs), VACCINATION SITE WARMTH (right arm hot/right hand hot), MYALGIA (body sore) and PYREXIA (fever) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pacemaker insertion (cardiac). Concurrent medical conditions included Allergy to animals (Allergies to cats,shelfish), Latex allergy, Allergy to molds, Grass allergy, Allergy to nuts, Drug allergy (Allergic to lisinopril, speralactose, tramadol, cipro, sulfur.), Multiple allergies (Allergic to rye, barley, cherries, chocolate, dust mites, roach feces.) and Penicillin allergy. Concomitant products included EPINEPHRINE (EPIPEN), BUMETANIDE, BUPROPION, CYCLOBENZAPRINE, PANTOPRAZOLE, PRAZOSIN, CARVEDILOL, SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO), FLUTICASONE, RISPERIDONE, DICLOFENAC SODIUM, CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]), METFORMIN HYDROCHLORIDE (METFORMIN ER), MULTIVITAMINS [VITAMINS NOS], GABAPENTIN, LUBIPROSTONE (AMITIZA), CITALOPRAM, DICYCLOMINE [DICYCLOVERINE] and LEVOFLOXACIN HEMIHYDRATE (LEVOZINE [LEVOFLOXACIN HEMIHYDRATE]) for an unknown indication.    On 16-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 RASH PRURITIC (itchy rash around neck/itchy rash around chin/itchy rash around face/itchy rash around back), PRURITUS (itchy all the way down inner legs), VACCINATION SITE WARMTH (right arm hot/right hand hot), MYALGIA (body sore), PYREXIA (fever), VACCINATION SITE SWELLING (right arm swollen/right arm swollen) and VACCINATION SITE ERYTHEMA (right arm red/right hand red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL ALLERGY/COLD) at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (itchy rash around neck/itchy rash around chin/itchy rash around face/itchy rash around back), PRURITUS (itchy all the way down inner legs), VACCINATION SITE WARMTH (right arm hot/right hand hot), VACCINATION SITE SWELLING (right arm swollen/right arm swollen) and VACCINATION SITE ERYTHEMA (right arm red/right hand red) had not resolved and MYALGIA (body sore) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.