chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Thirst, Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: COVID arm; big red itchy rash on arm 2" in diameter at the injection site; itchy; injection site swelling; injection site redness; thirsty; This spontaneous case was reported by a consumer and describes the occurrence of THIRST (thirsty), INJECTION SITE PAIN (COVID arm), VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE RASH (big red itchy rash on arm 2" in diameter at the injection site) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A12A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced THIRST (thirsty), VACCINATION SITE SWELLING (injection site swelling) and VACCINATION SITE ERYTHEMA (injection site redness). On 13-Mar-2021, the patient experienced VACCINATION SITE RASH (big red itchy rash on arm 2" in diameter at the injection site) and VACCINATION SITE PRURITUS (itchy). On an unknown date, the patient experienced INJECTION SITE PAIN (COVID arm). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, THIRST (thirsty), INJECTION SITE PAIN (COVID arm), VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE ERYTHEMA (injection site redness), VACCINATION SITE RASH (big red itchy rash on arm 2" in diameter at the injection site) and VACCINATION SITE PRURITUS (itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: COVID arm; big red itchy rash on arm 2" in diameter at the injection site; itchy; injection site swelling; injection site redness; thirsty; This spontaneous case was reported by a consumer and describes the occurrence of THIRST (thirsty), INJECTION SITE PAIN (COVID arm), VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE RASH (big red itchy rash on arm 2" in diameter at the injection site) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A12A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced THIRST (thirsty), VACCINATION SITE SWELLING (injection site swelling) and VACCINATION SITE ERYTHEMA (injection site redness). On 13-Mar-2021, the patient experienced VACCINATION SITE RASH (big red itchy rash on arm 2" in diameter at the injection site) and VACCINATION SITE PRURITUS (itchy). On an unknown date, the patient experienced INJECTION SITE PAIN (COVID arm). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, THIRST (thirsty), INJECTION SITE PAIN (COVID arm), VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE ERYTHEMA (injection site redness), VACCINATION SITE RASH (big red itchy rash on arm 2" in diameter at the injection site) and VACCINATION SITE PRURITUS (itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hyperhidrosis, Pyrexia
Clinical narrative: body wet/drenched in the middle of the night; drained and can't function; fever 8 hrs after vaccine (102.5); This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (body wet/drenched in the middle of the night), PYREXIA (fever 8 hrs after vaccine (102.5)) and FATIGUE (drained and can't function) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 032M20A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol and Breast cancer (lumpectomy-left breast). Concomitant products included EXEMESTANE for Breast cancer, PITAVASTATIN CALCIUM (LIVALO) for Cholesterol, APIXABAN (ELIQUIS) and METOPROLOL for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced PYREXIA (fever 8 hrs after vaccine (102.5)). On 14-Mar-2021, the patient experienced HYPERHIDROSIS (body wet/drenched in the middle of the night) and FATIGUE (drained and can't function). On 14-Mar-2021, HYPERHIDROSIS (body wet/drenched in the middle of the night) had resolved. On 15-Mar-2021, PYREXIA (fever 8 hrs after vaccine (102.5)) had resolved. At the time of the report, FATIGUE (drained and can't function) had not resolved.            Treatment of events was not reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site mass, Vaccination site pruritus
Clinical narrative: knot in injection site; injection site again red; itching in injection site; sore arm; redness in injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (knot in injection site), PAIN IN EXTREMITY (sore arm), VACCINATION SITE ERYTHEMA (redness in injection site), VACCINATION SITE ERYTHEMA (injection site again red) and VACCINATION SITE PRURITUS (itching in injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and VACCINATION SITE ERYTHEMA (redness in injection site). On 14-Mar-2021, the patient experienced VACCINATION SITE MASS (knot in injection site), VACCINATION SITE ERYTHEMA (injection site again red) and VACCINATION SITE PRURITUS (itching in injection site). On 06-Mar-2021, PAIN IN EXTREMITY (sore arm) and VACCINATION SITE ERYTHEMA (redness in injection site) had resolved. At the time of the report, VACCINATION SITE MASS (knot in injection site), VACCINATION SITE ERYTHEMA (injection site again red) and VACCINATION SITE PRURITUS (itching in injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that she is not on any concomitant medications. She did not took any treatment for symptoms.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Herpes zoster, Nausea, Rash
Clinical narrative: Shingles; Developed rash around mastectomy site; blisters around mastectomy site; Nausea; This spontaneous case was reported by a patient and describes the occurrence of BLISTER (blisters around mastectomy site), HERPES ZOSTER (Shingles), RASH (Developed rash around mastectomy site) and NAUSEA (Nausea) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included Mastectomy.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced NAUSEA (Nausea). On 23-Feb-2021, the patient experienced BLISTER (blisters around mastectomy site) and RASH (Developed rash around mastectomy site). On an unknown date, the patient experienced HERPES ZOSTER (Shingles). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) at a dose of UNK dosage form and IBUPROFEN (ADVIL 12 HOUR) ongoing since an unknown date for Pain, at a dose of 1 dosage form. At the time of the report, BLISTER (blisters around mastectomy site), RASH (Developed rash around mastectomy site) and NAUSEA (Nausea) had resolved and HERPES ZOSTER (Shingles) 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.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Event  was added (herpes zoster) and Event outcome was added as recovered
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Injection site pain, Nasal congestion, Urticaria
Clinical narrative: breathing problems; hives; knots at the injection site that went away; extremely bad nasal congestion; A spontaneous report was received from a consumer concerning a 64-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events breathing problems, hives, knots at the injection site that went away, extremely bad nasal congestion.  The patient's medical history was not provided. Concomitant medications reported were Excedrin for drug use for unknown indication.  On 26 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 025A21A) Intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) breathing problems, hives, knots at the injection site that went away, extremely bad nasal congestion.  Treatment details included She has been taking Benadryl and Mucinex for congestion but hasn't been helping.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), breathing problems, hives, knots at the injection site that went away, extremely bad nasal congestion was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Musculoskeletal stiffness, Myalgia
Clinical narrative: stiffness; little bodyache; joint aches; headaches; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiffness), MYALGIA (little bodyache), ARTHRALGIA (joint aches), HEADACHE (headaches) and FATIGUE (fatigue) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 08-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 MUSCULOSKELETAL STIFFNESS (stiffness), MYALGIA (little bodyache), ARTHRALGIA (joint aches), HEADACHE (headaches) and FATIGUE (fatigue). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (stiffness), MYALGIA (little bodyache), ARTHRALGIA (joint aches), HEADACHE (headaches) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included blood pressure medications.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Hot around injection site; tennis ball size hard area around injection site; Swollen around injection site; Red around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot around injection site), VACCINATION SITE INDURATION (tennis ball size hard area around injection site), VACCINATION SITE SWELLING (Swollen around injection site) and VACCINATION SITE ERYTHEMA (Red around injection site) 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 04-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Hot around injection site), VACCINATION SITE INDURATION (tennis ball size hard area around injection site), VACCINATION SITE SWELLING (Swollen around injection site) and VACCINATION SITE ERYTHEMA (Red around injection site). At the time of the report, VACCINATION SITE WARMTH (Hot around injection site), VACCINATION SITE INDURATION (tennis ball size hard area around injection site), VACCINATION SITE SWELLING (Swollen around injection site) and VACCINATION SITE ERYTHEMA (Red around injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter.  Treatment of events was reported as none.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Pain in extremity
Clinical narrative: her hair started falling out; Sore Arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) and ALOPECIA (her hair started falling out) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 022M20A) for COVID-19 vaccination.     The patient's past medical history included Knee replacement (It took a while for the pain from the knee replacement to go away.) in July 2019 and Hernia repair (Hernia surgery 9 days before getting her vaccine).   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). On an unknown date, the patient experienced ALOPECIA (her hair started falling out). At the time of the report, PAIN IN EXTREMITY (Sore Arm) outcome was unknown and ALOPECIA (her hair started falling out) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-044695 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow-up received, added new event Alopecia, historical condition and event outcome.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Heart rate, Tachycardia
Clinical narrative: Tachycardia, 114 beats per minute; Joint pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TACHYCARDIA (Tachycardia, 114 beats per minute) and ARTHRALGIA (Joint pain) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concomitant products included DILTIAZEM for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced TACHYCARDIA (Tachycardia, 114 beats per minute) and ARTHRALGIA (Joint pain). On 09-Mar-2021, TACHYCARDIA (Tachycardia, 114 beats per minute) had resolved. At the time of the report, ARTHRALGIA (Joint pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 114 (High) 114.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medicine is reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Updated event outcome from unknown to recovered/resolved
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Vaccination site erythema, Vaccination site pain
Clinical narrative: arm is still quite sore, left arm; arm red, left arm; arm swollen, left arm; felt like she was hit by a truck; headache; had to go back to bed / still tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (felt like she was hit by a truck), HEADACHE (headache), FATIGUE (had to go back to bed / still tired), VACCINATION SITE PAIN (arm is still quite sore, left arm) and VACCINATION SITE ERYTHEMA (arm red, left arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METOPROLOL and ATORVASTATIN for an unknown indication.    On 11-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 PAIN (felt like she was hit by a truck) and HEADACHE (headache). 12-Mar-2021, the patient experienced FATIGUE (had to go back to bed / still tired). On 15-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm is still quite sore, left arm), VACCINATION SITE ERYTHEMA (arm red, left arm) and VACCINATION SITE SWELLING (arm swollen, left arm). At the time of the report, PAIN (felt like she was hit by a truck) and HEADACHE (headache) outcome was unknown and FATIGUE (had to go back to bed / still tired), VACCINATION SITE PAIN (arm is still quite sore, left arm), VACCINATION SITE ERYTHEMA (arm red, left arm) and VACCINATION SITE SWELLING (arm swollen, left arm) had not resolved.            Additional concomitant product reported was HEMOPRADIN for an unknown indication.  The patient did not report treatment of events aside from drinking a lot of water.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: arm is still quite sore, left arm; arm red, left arm; arm swollen, left arm; felt like she was hit by a truck; headache; had to go back to bed / still tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (felt like she was hit by a truck), HEADACHE (headache), FATIGUE (had to go back to bed / still tired), VACCINATION SITE PAIN (arm is still quite sore, left arm) and VACCINATION SITE ERYTHEMA (arm red, left arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METOPROLOL and ATORVASTATIN for an unknown indication.    On 11-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 PAIN (felt like she was hit by a truck) and HEADACHE (headache). 12-Mar-2021, the patient experienced FATIGUE (had to go back to bed / still tired). On 15-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm is still quite sore, left arm), VACCINATION SITE ERYTHEMA (arm red, left arm) and VACCINATION SITE SWELLING (arm swollen, left arm). At the time of the report, PAIN (felt like she was hit by a truck) and HEADACHE (headache) outcome was unknown and FATIGUE (had to go back to bed / still tired), VACCINATION SITE PAIN (arm is still quite sore, left arm), VACCINATION SITE ERYTHEMA (arm red, left arm) and VACCINATION SITE SWELLING (arm swollen, left arm) had not resolved.            Additional concomitant product reported was HEMOPRADIN for an unknown indication.  The patient did not report treatment of events aside from drinking a lot of water.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Pain in extremity, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: swollen in the center, exactly where the shot went in; noticed a red area that towards the night was a 3-inch oval mark at the site of injection; It was red and itchy; arm soreness, a lot of uncomfort, closer to the elbow; arm soreness, a lot of uncomfort, closer to the elbow; arm soreness, a lot of uncomfort, closer to the elbow; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness, a lot of uncomfort, closer to the elbow), DISCOMFORT (arm soreness, a lot of uncomfort, closer to the elbow), VACCINATION SITE PRURITUS (It was red and itchy), ARTHRALGIA (arm soreness, a lot of uncomfort, closer to the elbow) and VACCINATION SITE ERYTHEMA (noticed a red area that towards the night was a 3-inch oval mark at the site of injection) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high and Cholesterol. Concomitant products included VITAMIN D NOS for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm soreness, a lot of uncomfort, closer to the elbow), DISCOMFORT (arm soreness, a lot of uncomfort, closer to the elbow) and ARTHRALGIA (arm soreness, a lot of uncomfort, closer to the elbow). On 14-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (It was red and itchy) and VACCINATION SITE ERYTHEMA (noticed a red area that towards the night was a 3-inch oval mark at the site of injection). On 15-Mar-2021, the patient experienced VACCINATION SITE SWELLING (swollen in the center, exactly where the shot went in). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) 03-Mar-2021 for Pain in arm, at a dose of 1 dosage form and HYDROCORTISONE (ABIX [HYDROCORTISONE]) from 14-Mar-2021 to 15-Mar-2021 for Vaccination site pruritus, at an unspecified dose and frequency. On 05-Mar-2021, PAIN IN EXTREMITY (arm soreness, a lot of uncomfort, closer to the elbow), DISCOMFORT (arm soreness, a lot of uncomfort, closer to the elbow) and ARTHRALGIA (arm soreness, a lot of uncomfort, closer to the elbow) had resolved. On 15-Mar-2021, VACCINATION SITE PRURITUS (It was red and itchy) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (noticed a red area that towards the night was a 3-inch oval mark at the site of injection) and VACCINATION SITE SWELLING (swollen in the center, exactly where the shot went in) had not 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 products included cholesterol medication and  high blood pressure medication.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: swollen in the center, exactly where the shot went in; noticed a red area that towards the night was a 3-inch oval mark at the site of injection; It was red and itchy; arm soreness, a lot of uncomfort, closer to the elbow; arm soreness, a lot of uncomfort, closer to the elbow; arm soreness, a lot of uncomfort, closer to the elbow; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness, a lot of uncomfort, closer to the elbow), DISCOMFORT (arm soreness, a lot of uncomfort, closer to the elbow), VACCINATION SITE PRURITUS (It was red and itchy), ARTHRALGIA (arm soreness, a lot of uncomfort, closer to the elbow) and VACCINATION SITE ERYTHEMA (noticed a red area that towards the night was a 3-inch oval mark at the site of injection) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high and Cholesterol. Concomitant products included VITAMIN D NOS for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm soreness, a lot of uncomfort, closer to the elbow), DISCOMFORT (arm soreness, a lot of uncomfort, closer to the elbow) and ARTHRALGIA (arm soreness, a lot of uncomfort, closer to the elbow). On 14-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (It was red and itchy) and VACCINATION SITE ERYTHEMA (noticed a red area that towards the night was a 3-inch oval mark at the site of injection). On 15-Mar-2021, the patient experienced VACCINATION SITE SWELLING (swollen in the center, exactly where the shot went in). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) 03-Mar-2021 for Pain in arm, at a dose of 1 dosage form and HYDROCORTISONE (ABIX [HYDROCORTISONE]) from 14-Mar-2021 to 15-Mar-2021 for Vaccination site pruritus, at an unspecified dose and frequency. On 05-Mar-2021, PAIN IN EXTREMITY (arm soreness, a lot of uncomfort, closer to the elbow), DISCOMFORT (arm soreness, a lot of uncomfort, closer to the elbow) and ARTHRALGIA (arm soreness, a lot of uncomfort, closer to the elbow) had resolved. On 15-Mar-2021, VACCINATION SITE PRURITUS (It was red and itchy) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (noticed a red area that towards the night was a 3-inch oval mark at the site of injection) and VACCINATION SITE SWELLING (swollen in the center, exactly where the shot went in) had not 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 products included cholesterol medication and  high blood pressure medication.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal pain, Incomplete course of vaccination, Urinary tract infection, Vaccination site pain
Clinical narrative: Day 33 and has not received the second dose; Intestinal Pain; Urinary Tract Infection (UTI); Little sore left arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INCOMPLETE COURSE OF VACCINATION (Day 33 and has not received the second dose), URINARY TRACT INFECTION (Urinary Tract Infection (UTI)), GASTROINTESTINAL PAIN (Intestinal Pain) and VACCINATION SITE PAIN (Little sore left arm) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE PAIN (Little sore left arm). On 09-Mar-2021, the patient experienced URINARY TRACT INFECTION (Urinary Tract Infection (UTI)). On 14-Mar-2021, the patient experienced GASTROINTESTINAL PAIN (Intestinal Pain). On 15-Mar-2021, the patient experienced INCOMPLETE COURSE OF VACCINATION (Day 33 and has not received the second dose). On 13-Feb-2021, VACCINATION SITE PAIN (Little sore left arm) had resolved. At the time of the report, INCOMPLETE COURSE OF VACCINATION (Day 33 and has not received the second dose), URINARY TRACT INFECTION (Urinary Tract Infection (UTI)) and GASTROINTESTINAL PAIN (Intestinal Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication included nitrofurantoin for urinary tract infection and stopped the antibiotics later due to intestinal pain. Company Comment:This report refers to a case of incomplete course of vaccination for mRNA-1273, lot # 007M20A  with associated AEs vaccination site pain, urinarty tract infection and gastrointestinal pain NOS.; Sender's Comments: This report refers to a case of incomplete course of vaccination for mRNA-1273, lot # 007M20A  with associated AEs vaccination site pain, urinarty tract infection and gastrointestinal pain NOS.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Movement disorder, Pain, Peripheral swelling
Clinical narrative: Face swollen; Difficulty breathing; Fatigue; Hand swollen; Pain; Couldn't move arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Hand swollen), PAIN (Pain), MOVEMENT DISORDER (Couldn't move arm), SWELLING FACE (Face swollen) and DYSPNOEA (Difficulty breathing) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045076) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PERIPHERAL SWELLING (Hand swollen), PAIN (Pain), MOVEMENT DISORDER (Couldn't move arm) and FATIGUE (Fatigue). On 13-Mar-2021, the patient experienced SWELLING FACE (Face swollen) and DYSPNOEA (Difficulty breathing). The patient was treated with Ibuprofen at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Hand swollen), PAIN (Pain), MOVEMENT DISORDER (Couldn't move arm), SWELLING FACE (Face swollen), DYSPNOEA (Difficulty breathing) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Face swollen; Difficulty breathing; Fatigue; Hand swollen; Pain; Couldn't move arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Hand swollen), PAIN (Pain), MOVEMENT DISORDER (Couldn't move arm), SWELLING FACE (Face swollen) and DYSPNOEA (Difficulty breathing) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045076) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PERIPHERAL SWELLING (Hand swollen), PAIN (Pain), MOVEMENT DISORDER (Couldn't move arm) and FATIGUE (Fatigue). On 13-Mar-2021, the patient experienced SWELLING FACE (Face swollen) and DYSPNOEA (Difficulty breathing). The patient was treated with Ibuprofen at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Hand swollen), PAIN (Pain), MOVEMENT DISORDER (Couldn't move arm), SWELLING FACE (Face swollen), DYSPNOEA (Difficulty breathing) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: redness...on their left shoulder down their bicep; left shoulder down their bicep...itches; firmness on their left shoulder down their bicep; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE ERYTHEMA (redness...on their left shoulder down their bicep), VACCINATION SITE PRURITUS (left shoulder down their bicep...itches) and VACCINATION SITE INDURATION (firmness on their left shoulder down their bicep) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ACETYLSALICYLIC ACID, CARISOPRODOL (SOMA CMPD), ZINC, VITAMIN D NOS and CALCIUM for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness...on their left shoulder down their bicep), VACCINATION SITE PRURITUS (left shoulder down their bicep...itches) and VACCINATION SITE INDURATION (firmness on their left shoulder down their bicep). At the time of the report, VACCINATION SITE ERYTHEMA (redness..on their left shoulder down their bicep), VACCINATION SITE PRURITUS (left shoulder down their bicep..itches) and VACCINATION SITE INDURATION (firmness on their left shoulder down their bicep) had not 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.   The patient reported additional concomitant product of female hormone replacement therapy,   Treatment of events was reported as none.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Joint swelling, Limb discomfort, Myalgia
Clinical narrative: area is throbbing - left arm; around the joint of the arm and shoulder coming together, it is swollen; pain sometimes goes down to elbow - left arm; where the bone for the shoulder and arm bone connect is painful - Even sitting down is pretty; can't straighten arm - left arm; vaccination area is very hot - left arm; injection site painful to the touch; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (can't straighten arm - left arm), PAIN (area is throbbing - left arm), JOINT SWELLING (around the joint of the arm and shoulder coming together, it is swollen), VACCINATION SITE WARMTH (vaccination area is very hot - left arm) and MYALGIA (pain sometimes goes down to elbow - left arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced INJECTION SITE PAIN (injection site painful to the touch). On 12-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LIMB DISCOMFORT (can't straighten arm - left arm) and VACCINATION SITE WARMTH (vaccination area is very hot - left arm). On an unknown date, the patient experienced PAIN (area is throbbing - left arm), JOINT SWELLING (around the joint of the arm and shoulder coming together, it is swollen), MYALGIA (pain sometimes goes down to elbow - left arm) and ARTHRALGIA (where the bone for the shoulder and arm bone connect is painful - Even sitting down is pretty). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Pain, at a dose of UNK dosage form. At the time of the report, LIMB DISCOMFORT (can't straighten arm - left arm), PAIN (area is throbbing - left arm), JOINT SWELLING (around the joint of the arm and shoulder coming together, it is swollen), VACCINATION SITE WARMTH (vaccination area is very hot - left arm), MYALGIA (pain sometimes goes down to elbow - left arm), INJECTION SITE PAIN (injection site painful to the touch) and ARTHRALGIA (where the bone for the shoulder and arm bone connect is painful - Even sitting down is pretty) outcome was unknown.            Patient reported that after three weeks her arm was better and she was able to use it with little or no problem.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: follow up received on 24-may-2021. Patient arm was better.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site warmth
Clinical narrative: area is throbbing - left arm; around the joint of the arm and shoulder coming together, it is swollen; pain sometimes goes down to elbow - left arm; where the bone for the shoulder and arm bone connect is painful - Even sitting down is pretty; can't straighten arm - left arm; vaccination area is very hot - left arm; injection site painful to the touch; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (can't straighten arm - left arm), PAIN (area is throbbing - left arm), JOINT SWELLING (around the joint of the arm and shoulder coming together, it is swollen), VACCINATION SITE WARMTH (vaccination area is very hot - left arm) and MYALGIA (pain sometimes goes down to elbow - left arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced INJECTION SITE PAIN (injection site painful to the touch). On 12-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LIMB DISCOMFORT (can't straighten arm - left arm) and VACCINATION SITE WARMTH (vaccination area is very hot - left arm). On an unknown date, the patient experienced PAIN (area is throbbing - left arm), JOINT SWELLING (around the joint of the arm and shoulder coming together, it is swollen), MYALGIA (pain sometimes goes down to elbow - left arm) and ARTHRALGIA (where the bone for the shoulder and arm bone connect is painful - Even sitting down is pretty). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Pain, at a dose of UNK dosage form. At the time of the report, LIMB DISCOMFORT (can't straighten arm - left arm), PAIN (area is throbbing - left arm), JOINT SWELLING (around the joint of the arm and shoulder coming together, it is swollen), VACCINATION SITE WARMTH (vaccination area is very hot - left arm), MYALGIA (pain sometimes goes down to elbow - left arm), INJECTION SITE PAIN (injection site painful to the touch) and ARTHRALGIA (where the bone for the shoulder and arm bone connect is painful - Even sitting down is pretty) outcome was unknown.            Patient reported that after three weeks her arm was better and she was able to use it with little or no problem.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: follow up received on 24-may-2021. Patient arm was better.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Hypoaesthesia, Pain in extremity
Clinical narrative: back is hurting a lot; Numbness in hands; pain in hands; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in hands), PAIN IN EXTREMITY (pain in hands) and BACK PAIN (back is hurting a lot) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No medical history was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced HYPOAESTHESIA (Numbness in hands) and PAIN IN EXTREMITY (pain in hands). On 10-Mar-2021, the patient experienced BACK PAIN (back is hurting a lot). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (Numbness in hands) and PAIN IN EXTREMITY (pain in hands) outcome was unknown and BACK PAIN (back is hurting a lot) had not resolved.            No concomitant medication use was provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Feeling jittery, Influenza like illness, Nausea
Clinical narrative: Diarrhea; fatigue; nausea; flu like symptoms; jittery; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING JITTERY (jittery), DIARRHOEA (Diarrhea), FATIGUE (fatigue) and NAUSEA (nausea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029a21a and 041L20a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included IRBESARTAN for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING JITTERY (jittery), FATIGUE (fatigue) and NAUSEA (nausea). On 14-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) on 08-Mar-2021 for Flu like symptoms, at a dose of UNK dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING JITTERY (jittery), DIARRHOEA (Diarrhea), FATIGUE (fatigue) and NAUSEA (nausea) had not resolved.            After internal review it was decided to keep the patient's date of birth unknown until follow-up information was available.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Cough, Oropharyngeal pain, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: COUGH; THROAT PAIN; cough...sore throat...diagnosed with bronchitis; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of BRONCHITIS (cough...sore throat...diagnosed with bronchitis), COUGH (COUGH) and OROPHARYNGEAL PAIN (THROAT PAIN) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to Aspartame). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced BRONCHITIS (cough...sore throat...diagnosed with bronchitis). On an unknown date, the patient experienced COUGH (COUGH) and OROPHARYNGEAL PAIN (THROAT PAIN). At the time of the report, BRONCHITIS (cough..sore throat..diagnosed with bronchitis) had not resolved and COUGH (COUGH) and OROPHARYNGEAL PAIN (THROAT PAIN) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, SARS-CoV-2 antibody test: negative (Negative) Negative. On 11-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative.     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 treatment information was provided for cough.   This case was linked to MOD-2021-058662 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2021: Follow-up received and addition of two new event COUGH (COUGH) and OROPHARYNGEAL PAIN (THROAT PAIN)
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling
Clinical narrative: legs red; legs swollen; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (legs red) and PERIPHERAL SWELLING (legs swollen) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.    On 14-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 ERYTHEMA (legs red) and PERIPHERAL SWELLING (legs swollen). At the time of the report, ERYTHEMA (legs red) and PERIPHERAL SWELLING (legs swollen) 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.   Patent's wife reported husband was taking several medicines but could not remember the names.   Treatment of events was not reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dysgeusia, Hypertension, Tachycardia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste at time of vaccine administration), TACHYCARDIA (Tachycardia evening of 1st dose) and HYPERTENSION (High blood pressure evening of 1st dose) in a 75-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (Metallic taste at time of vaccine administration), TACHYCARDIA (Tachycardia evening of 1st dose) and HYPERTENSION (High blood pressure evening of 1st dose). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) for Adverse event, at a dose of 1 dosage form. At the time of the report, DYSGEUSIA (Metallic taste at time of vaccine administration), TACHYCARDIA (Tachycardia evening of 1st dose) and HYPERTENSION (High blood pressure evening of 1st dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: (High) elevated. On an unknown date, Tachycardia: 55 to 180 (abnormal) 55 to 180.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: Off label use: Vial given more than 6 hours after initially punctured; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Off label use: Vial given more than 6 hours after initially punctured) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced OFF LABEL USE (Off label use: Vial given more than 6 hours after initially punctured). On 14-Mar-2021, OFF LABEL USE (Off label use: Vial given more than 6 hours after initially punctured) 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.   Pharmacist made error in writing the correct date. The vaccine that was administered to the patient was not expired and had not been punctured.  No concomitant medication use was provided by the reporter. Treatment of events was not reported.