chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: right arm was itching; right arm was swelling; right arm was warm/and hot to the touch; lump at the injection site; knot at the injection site; right arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (right arm was itching), SWELLING (right arm was swelling), FEELING HOT (right arm was warm/and hot to the touch), VACCINATION SITE MASS (lump at the injection site) and VACCINATION SITE INDURATION (knot at the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (right arm was sore). On 30-Mar-2021, the patient experienced PRURITUS (right arm was itching), SWELLING (right arm was swelling), FEELING HOT (right arm was warm/and hot to the touch), VACCINATION SITE MASS (lump at the injection site) and VACCINATION SITE INDURATION (knot at the injection site). At the time of the report, PRURITUS (right arm was itching), SWELLING (right arm was swelling), FEELING HOT (right arm was warm/and hot to the touch), VACCINATION SITE MASS (lump at the injection site), VACCINATION SITE INDURATION (knot at the injection site) and PAIN IN EXTREMITY (right arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow-up received on 07-Aug-2021 and included Non-significant information
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Body temperature, COVID-19, Cough, Dyspnoea
Clinical narrative: the side effects were worse than when I had COVID; I felt like I was going to die; achy all over; difficulty breathing; coughing; tired; really bad headache; temperature of 102.4F; nausea; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (the side effects were worse than when I had COVID), ADVERSE EVENT (I felt like I was going to die), PAIN (achy all over), DYSPNOEA (difficulty breathing) and COUGH (coughing) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) 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 BISOPROLOL, HYDROCHLOROTHIAZIDE, LOSARTAN, ROSUVASTATIN CALCIUM (CRESTOR), CITALOPRAM and ALLOPURINOL for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced COVID-19 (the side effects were worse than when I had COVID), ADVERSE EVENT (I felt like I was going to die), PAIN (achy all over), DYSPNOEA (difficulty breathing), COUGH (coughing), FATIGUE (tired), HEADACHE (really bad headache), PYREXIA (temperature of 102.4F) and NAUSEA (nausea). The patient was treated with IBUPROFEN at a dose of 1 dosage form and ACETYLSALICYLIC ACID, CAFFEINE, CITRIC ACID, SODIUM BICARBONATE (ALKA SELTZER [ACETYLSALICYLIC ACID;CAFFEINE;CITRIC ACID;SODIUM BICARBONATE]) at a dose of 1 dosage form. On 02-Apr-2021, COVID-19 (the side effects were worse than when I had COVID), ADVERSE EVENT (I felt like I was going to die), PAIN (achy all over), DYSPNOEA (difficulty breathing), COUGH (coughing), FATIGUE (tired), HEADACHE (really bad headache), PYREXIA (temperature of 102.4F) and NAUSEA (nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Body temperature: 102 (High) High.     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.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain, Pyrexia
Clinical narrative: the side effects were worse than when I had COVID; I felt like I was going to die; achy all over; difficulty breathing; coughing; tired; really bad headache; temperature of 102.4F; nausea; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (the side effects were worse than when I had COVID), ADVERSE EVENT (I felt like I was going to die), PAIN (achy all over), DYSPNOEA (difficulty breathing) and COUGH (coughing) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) 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 BISOPROLOL, HYDROCHLOROTHIAZIDE, LOSARTAN, ROSUVASTATIN CALCIUM (CRESTOR), CITALOPRAM and ALLOPURINOL for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced COVID-19 (the side effects were worse than when I had COVID), ADVERSE EVENT (I felt like I was going to die), PAIN (achy all over), DYSPNOEA (difficulty breathing), COUGH (coughing), FATIGUE (tired), HEADACHE (really bad headache), PYREXIA (temperature of 102.4F) and NAUSEA (nausea). The patient was treated with IBUPROFEN at a dose of 1 dosage form and ACETYLSALICYLIC ACID, CAFFEINE, CITRIC ACID, SODIUM BICARBONATE (ALKA SELTZER [ACETYLSALICYLIC ACID;CAFFEINE;CITRIC ACID;SODIUM BICARBONATE]) at a dose of 1 dosage form. On 02-Apr-2021, COVID-19 (the side effects were worse than when I had COVID), ADVERSE EVENT (I felt like I was going to die), PAIN (achy all over), DYSPNOEA (difficulty breathing), COUGH (coughing), FATIGUE (tired), HEADACHE (really bad headache), PYREXIA (temperature of 102.4F) and NAUSEA (nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Body temperature: 102 (High) High.     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.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site mass, Lymphadenopathy, Nausea
Clinical narrative: Hard lump about 4 inches round at the injection site; Body aches; lymph nodes on left side of my neck swelled; lymph nodes in my left arm pit swelled; Fever; Nausea; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (Hard lump about 4 inches round at the injection site), PAIN (Body aches), LYMPHADENOPATHY (lymph nodes on left side of my neck swelled), LYMPHADENOPATHY (lymph nodes in my left arm pit swelled) and PYREXIA (Fever) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 25-Mar-2021, the patient experienced INJECTION SITE MASS (Hard lump about 4 inches round at the injection site), PAIN (Body aches), LYMPHADENOPATHY (lymph nodes on left side of my neck swelled), LYMPHADENOPATHY (lymph nodes in my left arm pit swelled), PYREXIA (Fever), NAUSEA (Nausea), CHILLS (Chills) and HEADACHE (Headache). On 27-Mar-2021, PYREXIA (Fever) and NAUSEA (Nausea) had resolved. On 31-Mar-2021, INJECTION SITE MASS (Hard lump about 4 inches round at the injection site), PAIN (Body aches), LYMPHADENOPATHY (lymph nodes on left side of my neck swelled), LYMPHADENOPATHY (lymph nodes in my left arm pit swelled), CHILLS (Chills) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were provided. No treatment medication details were provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Hard lump about 4 inches round at the injection site; Body aches; lymph nodes on left side of my neck swelled; lymph nodes in my left arm pit swelled; Fever; Nausea; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (Hard lump about 4 inches round at the injection site), PAIN (Body aches), LYMPHADENOPATHY (lymph nodes on left side of my neck swelled), LYMPHADENOPATHY (lymph nodes in my left arm pit swelled) and PYREXIA (Fever) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 25-Mar-2021, the patient experienced INJECTION SITE MASS (Hard lump about 4 inches round at the injection site), PAIN (Body aches), LYMPHADENOPATHY (lymph nodes on left side of my neck swelled), LYMPHADENOPATHY (lymph nodes in my left arm pit swelled), PYREXIA (Fever), NAUSEA (Nausea), CHILLS (Chills) and HEADACHE (Headache). On 27-Mar-2021, PYREXIA (Fever) and NAUSEA (Nausea) had resolved. On 31-Mar-2021, INJECTION SITE MASS (Hard lump about 4 inches round at the injection site), PAIN (Body aches), LYMPHADENOPATHY (lymph nodes on left side of my neck swelled), LYMPHADENOPATHY (lymph nodes in my left arm pit swelled), CHILLS (Chills) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were provided. No treatment medication details were provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: ended up with a rash on my upper chest up into my neck; This spontaneous case was reported by a consumer and describes the occurrence of RASH (ended up with a rash on my upper chest up into my neck) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced RASH (ended up with a rash on my upper chest up into my neck). On 30-Mar-2021, RASH (ended up with a rash on my upper chest up into my neck) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Itchiness in the injection site; Rash in the injection site; Redness in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness in the injection site), VACCINATION SITE RASH (Rash in the injection site) and VACCINATION SITE ERYTHEMA (Redness in the injection site) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness in the injection site), VACCINATION SITE RASH (Rash in the injection site) and VACCINATION SITE ERYTHEMA (Redness in the injection site). At the time of the report, VACCINATION SITE PRURITUS (Itchiness in the injection site), VACCINATION SITE RASH (Rash in the injection site) and VACCINATION SITE ERYTHEMA (Redness in the injection site) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided  by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: NNI, reporter states he did not report anything and denied to FU
Sex: U
Vaccine: COVID19
Symptoms: Type IV hypersensitivity reaction
Clinical narrative: a friend had the same reaction but it only lasted 3 or 4 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION (a friend had the same reaction but it only lasted 3 or 4 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 TYPE IV HYPERSENSITIVITY REACTION (a friend had the same reaction but it only lasted 3 or 4 days). At the time of the report, TYPE IV HYPERSENSITIVITY REACTION (a friend had the same reaction but it only lasted 3 or 4 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Pain
Clinical narrative: Body aches; Back pain; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), BACK PAIN (Back pain) and ASTHENIA (Weakness) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN (Body aches), BACK PAIN (Back pain) and ASTHENIA (Weakness). At the time of the report, PAIN (Body aches), BACK PAIN (Back pain) and ASTHENIA (Weakness) 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 information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: soreness of arm; This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE PAIN (soreness of arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced INJECTION SITE PAIN (soreness of arm). At the time of the report, INJECTION SITE PAIN (soreness of arm) 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.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Product administration error, Product temperature excursion issue
Clinical narrative: Vaccine administered after temperature excursion; Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Vaccine administered after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Vaccine administered after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion). On 02-Apr-2021, PRODUCT ADMINISTRATION ERROR (Vaccine administered after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) had resolved.        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.   It was reported that there was a power outage on 02-Apr-2021 and vials were in freezer and refrigerator where Temperature dropped to -13.79 C for 47 minutes and 12 C for 59 minutes respectively.  No concomitant products were reported.  No treatment information was provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm is sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm is sore) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007D21A) for COVID-19 vaccination.     The patient's past medical history included Spasm of muscle.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (Arm is sore). At the time of the report, VACCINATION SITE PAIN (Arm is sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       relevant concomitant products usage were not reported by the reporter.treatment details not included.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) had resolved.        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.   On 02Apr2021 and vials were in Freezer and Refrigerator where Temperature dropped to Frozen Vaccine 47Minutes -13.79 C Refrigerator 59 Minutes 12 C and effected vials are: Lot no 003B21A, 100 doses ,Lot no 027B21A 100 doses , Lot no 030B21A 100 doses Lot No 02B21A 140 doses . HCP said that 63 doses were administered to 63 Patients. Crosslink of 45 bulk cases   This case was linked to MOD21-068620, MOD21-068805, MOD21-068804, MOD21-068645, MOD21-068696, MOD21-068803 (E2B Linked Report).; Sender's Comments:  MOD21-068620:crosslinked MOD21-068805:crosslinked MOD21-068804:crosslinked MOD21-068645:crosslinked MOD21-068696:crosslinked MOD21-068803:crosslinked
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Pruritus, Rash
Clinical narrative: red/The redness is prominent, and it is at the top of her arm. It began on day 16; mildly sore; Both itchiness and soreness are mild; she's had a rash; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red/The redness is prominent, and it is at the top of her arm. It began on day 16), PAIN (mildly sore), PRURITUS (Both itchiness and soreness are mild) and RASH (she's had a rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     Concomitant products included CALCIUM for Supplementation therapy, ESCITALOPRAM OXALATE (LEXAPRO) and TRAZODONE 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 01-Apr-2021, the patient experienced ERYTHEMA (red/The redness is prominent, and it is at the top of her arm. It began on day 16), PAIN (mildly sore), PRURITUS (Both itchiness and soreness are mild) and RASH (she's had a rash). At the time of the report, ERYTHEMA (red/The redness is prominent, and it is at the top of her arm. It began on day 16), PAIN (mildly sore), PRURITUS (Both itchiness and soreness are mild) and RASH (she's had a rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.    Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Non-significant FUP- Reporter contact info updated
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Vaccination site pain, Vaccination site rash
Clinical narrative: rash spread to spread to different parts all over the body; rash in injection site; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at injection site), VACCINATION SITE RASH (rash in injection site) and RASH (rash spread to spread to different parts all over the body) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B219) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site). On 26-Mar-2021, the patient experienced VACCINATION SITE RASH (rash in injection site). On 03-Apr-2021, the patient experienced RASH (rash spread to spread to different parts all over the body). At the time of the report, VACCINATION SITE PAIN (pain at injection site), VACCINATION SITE RASH (rash in injection site) and RASH (rash spread to spread to different parts all over the body) 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. No treatment information was provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Feeling hot, Head discomfort
Clinical narrative: Big knot at needle shot sight; Stiffness; Could not sleep; Heavy head; Restless; flu like symptoms; No Appetite; bodyaches; muscle achiness; Low grade 99.9 fever; chills; warm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Big knot at needle shot sight), MUSCULOSKELETAL STIFFNESS (Stiffness), INSOMNIA (Could not sleep), HEAD DISCOMFORT (Heavy head) and RESTLESSNESS (Restless) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Patient allergic to Demoral). Concomitant products included ESTRADIOL from 08-Mar-2020 to an unknown date and ALENDRONATE SODIUM from 03-Jan-2018 to an unknown date for an unknown indication.   On 02-Mar-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE MASS (Big knot at needle shot sight), MUSCULOSKELETAL STIFFNESS (Stiffness), INSOMNIA (Could not sleep), HEAD DISCOMFORT (Heavy head), RESTLESSNESS (Restless), PAIN (bodyaches) and PYREXIA (Low grade 99.9 fever). 02-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), DECREASED APPETITE (No Appetite), MYALGIA (muscle achiness), CHILLS (chills) and FEELING HOT (warm). At the time of the report, VACCINATION SITE MASS (Big knot at needle shot sight), MUSCULOSKELETAL STIFFNESS (Stiffness), INSOMNIA (Could not sleep), HEAD DISCOMFORT (Heavy head), RESTLESSNESS (Restless), INFLUENZA LIKE ILLNESS (flu like symptoms), DECREASED APPETITE (No Appetite), PAIN (bodyaches), PYREXIA (Low grade 99.9 fever), CHILLS (chills) and FEELING HOT (warm) had resolved and MYALGIA (muscle achiness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Body temperature: 99.9 (Inconclusive) N/A.         Treatment medication was not provided. Patient states that symptoms went away on the next day. Patient height provided as 5 with no units.   This case was linked to MOD-2021-268006 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Updated patient demographers, allergic condition, concomitant medications,  events include-chills, low grade fever, flue like symptoms, body aches, no appetite.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Insomnia, Musculoskeletal stiffness, Myalgia, Pain
Clinical narrative: Big knot at needle shot sight; Stiffness; Could not sleep; Heavy head; Restless; flu like symptoms; No Appetite; bodyaches; muscle achiness; Low grade 99.9 fever; chills; warm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Big knot at needle shot sight), MUSCULOSKELETAL STIFFNESS (Stiffness), INSOMNIA (Could not sleep), HEAD DISCOMFORT (Heavy head) and RESTLESSNESS (Restless) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Patient allergic to Demoral). Concomitant products included ESTRADIOL from 08-Mar-2020 to an unknown date and ALENDRONATE SODIUM from 03-Jan-2018 to an unknown date for an unknown indication.   On 02-Mar-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE MASS (Big knot at needle shot sight), MUSCULOSKELETAL STIFFNESS (Stiffness), INSOMNIA (Could not sleep), HEAD DISCOMFORT (Heavy head), RESTLESSNESS (Restless), PAIN (bodyaches) and PYREXIA (Low grade 99.9 fever). 02-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), DECREASED APPETITE (No Appetite), MYALGIA (muscle achiness), CHILLS (chills) and FEELING HOT (warm). At the time of the report, VACCINATION SITE MASS (Big knot at needle shot sight), MUSCULOSKELETAL STIFFNESS (Stiffness), INSOMNIA (Could not sleep), HEAD DISCOMFORT (Heavy head), RESTLESSNESS (Restless), INFLUENZA LIKE ILLNESS (flu like symptoms), DECREASED APPETITE (No Appetite), PAIN (bodyaches), PYREXIA (Low grade 99.9 fever), CHILLS (chills) and FEELING HOT (warm) had resolved and MYALGIA (muscle achiness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Body temperature: 99.9 (Inconclusive) N/A.         Treatment medication was not provided. Patient states that symptoms went away on the next day. Patient height provided as 5 with no units.   This case was linked to MOD-2021-268006 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Updated patient demographers, allergic condition, concomitant medications,  events include-chills, low grade fever, flue like symptoms, body aches, no appetite.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Restlessness, Vaccination site mass
Clinical narrative: Big knot at needle shot sight; Stiffness; Could not sleep; Heavy head; Restless; flu like symptoms; No Appetite; bodyaches; muscle achiness; Low grade 99.9 fever; chills; warm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Big knot at needle shot sight), MUSCULOSKELETAL STIFFNESS (Stiffness), INSOMNIA (Could not sleep), HEAD DISCOMFORT (Heavy head) and RESTLESSNESS (Restless) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Patient allergic to Demoral). Concomitant products included ESTRADIOL from 08-Mar-2020 to an unknown date and ALENDRONATE SODIUM from 03-Jan-2018 to an unknown date for an unknown indication.   On 02-Mar-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE MASS (Big knot at needle shot sight), MUSCULOSKELETAL STIFFNESS (Stiffness), INSOMNIA (Could not sleep), HEAD DISCOMFORT (Heavy head), RESTLESSNESS (Restless), PAIN (bodyaches) and PYREXIA (Low grade 99.9 fever). 02-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), DECREASED APPETITE (No Appetite), MYALGIA (muscle achiness), CHILLS (chills) and FEELING HOT (warm). At the time of the report, VACCINATION SITE MASS (Big knot at needle shot sight), MUSCULOSKELETAL STIFFNESS (Stiffness), INSOMNIA (Could not sleep), HEAD DISCOMFORT (Heavy head), RESTLESSNESS (Restless), INFLUENZA LIKE ILLNESS (flu like symptoms), DECREASED APPETITE (No Appetite), PAIN (bodyaches), PYREXIA (Low grade 99.9 fever), CHILLS (chills) and FEELING HOT (warm) had resolved and MYALGIA (muscle achiness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Body temperature: 99.9 (Inconclusive) N/A.         Treatment medication was not provided. Patient states that symptoms went away on the next day. Patient height provided as 5 with no units.   This case was linked to MOD-2021-268006 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Updated patient demographers, allergic condition, concomitant medications,  events include-chills, low grade fever, flue like symptoms, body aches, no appetite.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: soreness; redness; itching; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness), ERYTHEMA (redness) and PRURITUS (itching) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN (soreness), ERYTHEMA (redness) and PRURITUS (itching). The patient was treated with CORTISONE at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. At the time of the report, PAIN (soreness), ERYTHEMA (redness) and PRURITUS (itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Cold sweat, Feeling abnormal, Headache, Hypersensitivity, Paraesthesia
Clinical narrative: Allergic reaction; Broke out in hives; Swelling to my right arm; Tingling sensation threw out my body; Cold sweats; Feel funny off n on; Bad headaches; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction), URTICARIA (Broke out in hives), PERIPHERAL SWELLING (Swelling to my right arm), PARAESTHESIA (Tingling sensation threw out my body) and COLD SWEAT (Cold sweats) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced HYPERSENSITIVITY (Allergic reaction), URTICARIA (Broke out in hives), PERIPHERAL SWELLING (Swelling to my right arm), PARAESTHESIA (Tingling sensation threw out my body), COLD SWEAT (Cold sweats), FEELING ABNORMAL (Feel funny off n on) and HEADACHE (Bad headaches). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency and PREDNISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (Allergic reaction), URTICARIA (Broke out in hives), PERIPHERAL SWELLING (Swelling to my right arm), PARAESTHESIA (Tingling sensation threw out my body), COLD SWEAT (Cold sweats), FEELING ABNORMAL (Feel funny off n on) and HEADACHE (Bad headaches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.    Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow-up received on 18-JUN-2021 and event details updated.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling, Urticaria
Clinical narrative: Allergic reaction; Broke out in hives; Swelling to my right arm; Tingling sensation threw out my body; Cold sweats; Feel funny off n on; Bad headaches; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction), URTICARIA (Broke out in hives), PERIPHERAL SWELLING (Swelling to my right arm), PARAESTHESIA (Tingling sensation threw out my body) and COLD SWEAT (Cold sweats) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced HYPERSENSITIVITY (Allergic reaction), URTICARIA (Broke out in hives), PERIPHERAL SWELLING (Swelling to my right arm), PARAESTHESIA (Tingling sensation threw out my body), COLD SWEAT (Cold sweats), FEELING ABNORMAL (Feel funny off n on) and HEADACHE (Bad headaches). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency and PREDNISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (Allergic reaction), URTICARIA (Broke out in hives), PERIPHERAL SWELLING (Swelling to my right arm), PARAESTHESIA (Tingling sensation threw out my body), COLD SWEAT (Cold sweats), FEELING ABNORMAL (Feel funny off n on) and HEADACHE (Bad headaches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.    Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow-up received on 18-JUN-2021 and event details updated.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Vaccination site bruising, Vaccination site erythema
Clinical narrative: allergic reaction around my nipple area on both side; Redness In band area; Bruising at shot area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruising at shot area), HYPERSENSITIVITY (allergic reaction around my nipple area on both side) and VACCINATION SITE ERYTHEMA (Redness In band area) 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 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced VACCINATION SITE BRUISING (Bruising at shot area). On 28-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness In band area). On an unknown date, the patient experienced HYPERSENSITIVITY (allergic reaction around my nipple area on both side). At the time of the report, VACCINATION SITE BRUISING (Bruising at shot area) and VACCINATION SITE ERYTHEMA (Redness In band area) had resolved and HYPERSENSITIVITY (allergic reaction around my nipple area on both side) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter.  The patient slept with the band-aid and experienced redness next day. The bruising started 3 to 4 days after the dose. The patient had seen a specialist for the allergic reaction who conveyed that it might be something else that making it flare up  The patient was using an unspecified cream to help it to subside the allergic reaction.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up report received on 29-jun-2021 contains additional event of Allergic reaction NOS and the outcome for Vaccination site erythema was updated. On 19-Jul-2021: Significant FU received on 20-jul-2021 contains Outcome of the event updated.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: REDNESS; itchiness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (REDNESS) and PRURITUS (itchiness) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Cholesterol.    On 08-Mar-2021 at 8:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced ERYTHEMA (REDNESS) and PRURITUS (itchiness). On 13-Mar-2021, PRURITUS (itchiness) had resolved. At the time of the report, ERYTHEMA (REDNESS) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product included blood pressure and cholesterol medication. Treatment information included hydrocortisone cream.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion). At the time of the report, PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No Concomitant Medication was provided. No Treatment medication was provided.   This case was linked to MOD21-068620 (E2B Linked Report).; Sender's Comments:  MOD21-068620:crosslinked
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Visual field defect
Clinical narrative: felt like having aurora borealis in his peripheral side of both eyes; headache; chills; extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL FIELD DEFECT (felt like having aurora borealis in his peripheral side of both eyes), HEADACHE (headache), CHILLS (chills) and FATIGUE (extremely tired) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced VISUAL FIELD DEFECT (felt like having aurora borealis in his peripheral side of both eyes), HEADACHE (headache), CHILLS (chills) and FATIGUE (extremely tired). At the time of the report, VISUAL FIELD DEFECT (felt like having aurora borealis in his peripheral side of both eyes), HEADACHE (headache), CHILLS (chills) and FATIGUE (extremely tired) outcome was unknown.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache
Clinical narrative: weakness; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA, CHILLS, and HEADACHE in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced ASTHENIA, CHILLS, and HEADACHE. At the time of the report, ASTHENIA, CHILLS, and HEADACHE had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: pain in her legs; Her hands are numb; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in her legs) and HYPOAESTHESIA (Her hands are numb) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal and Arthritis.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain in her legs). 01-Apr-2021, the patient experienced HYPOAESTHESIA (Her hands are numb). At the time of the report, PAIN IN EXTREMITY (pain in her legs) and HYPOAESTHESIA (Her hands are numb) outcome was unknown. Not Provided          The patient was concomitantly taking unspecified medications for blood pressure and arthritis.  Treatment information was not provided for the events.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema
Clinical narrative: Rash under her arms/eczema; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Rash under her arms/eczema) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Eczema.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ECZEMA (Rash under her arms/eczema). At the time of the report, ECZEMA (Rash under her arms/eczema) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product  was not provided by the reporter. Treatment information was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: event was updated as eczema ( previously reported as rash under skin).Patient reported that the event rash under the arms was due to eczema not the vaccine.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Needle leaked (while administering SECOND dose); Not sure if the patient received even half the dose; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (Needle leaked (while administering SECOND dose)) and UNDERDOSE (Not sure if the patient received even half the dose) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced DEVICE CONNECTION ISSUE (Needle leaked (while administering SECOND dose)) and UNDERDOSE (Not sure if the patient received even half the dose). On 01-Apr-2021, DEVICE CONNECTION ISSUE (Needle leaked (while administering SECOND dose)) and UNDERDOSE (Not sure if the patient received even half the dose) had resolved. Not applicable      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment medications were reported Pharmacist reported that there was no adverse event that occurred after the vaccine was administered. Also reported that patient was administered full dose in the other arm.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Event update.