chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Vaccination site pain
Clinical narrative: Allergic to Polysorbate; Little pain where the shot was; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (Allergic to Polysorbate) and VACCINATION SITE PAIN (Little pain where the shot was) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 032M20A) for COVID-19 vaccination.     The patient's past medical history included Percutaneous endoscopic gastrostomy. Concurrent medical conditions included Allergy to chemicals (Allergic to polysorbate.) and Allergic reaction to drug (Allergic to Cartia XT (diltiazem).).   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic to Polysorbate) and VACCINATION SITE PAIN (Little pain where the shot was). At the time of the report, HYPERSENSITIVITY (Allergic to Polysorbate) and VACCINATION SITE PAIN (Little pain where the shot was) outcome was unknown.        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 medication was not provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain, Vaccination site pain
Clinical narrative: arm was sore at the injection site; my right leg, from my hip down to foot, went completely numb; felt pins & needles in my right leg; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (my right leg, from my hip down to foot, went completely numb), PAIN (felt pins & needles in my right leg) and VACCINATION SITE PAIN (arm was sore at the injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0U7A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced HYPOAESTHESIA (my right leg, from my hip down to foot, went completely numb) and PAIN (felt pins & needles in my right leg). On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm was sore at the injection site). On 18-Mar-2021, HYPOAESTHESIA (my right leg, from my hip down to foot, went completely numb) had resolved. At the time of the report, PAIN (felt pins & needles in my right leg) and VACCINATION SITE PAIN (arm was sore at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Mobility decreased, Musculoskeletal stiffness, Vaccination site pain
Clinical narrative: injection shoulder stiffness; could not lift injection arm; injection shoulder tenderness; injection shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (injection shoulder stiffness), MOBILITY DECREASED (could not lift injection arm), VACCINATION SITE PAIN (injection shoulder tenderness) and ARTHRALGIA (injection shoulder pain) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 209L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (injection shoulder stiffness), MOBILITY DECREASED (could not lift injection arm), VACCINATION SITE PAIN (injection shoulder tenderness) and ARTHRALGIA (injection shoulder pain). At the time of the report, MUSCULOSKELETAL STIFFNESS (injection shoulder stiffness), MOBILITY DECREASED (could not lift injection arm), VACCINATION SITE PAIN (injection shoulder tenderness) and ARTHRALGIA (injection shoulder pain) outcome was unknown.            No concomitant medication was reported. The treatment information was unknown.  Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-056518 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-056518:Cross-Linked with patient case
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Peripheral swelling, Pruritus
Clinical narrative: swollen arm; itching; warm/fever arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm), PRURITUS (itching) and INJECTION SITE WARMTH (warm/fever arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) 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 an unknown date, the patient experienced PERIPHERAL SWELLING (swollen arm), PRURITUS (itching) and INJECTION SITE WARMTH (warm/fever arm). The patient was treated with TRIAMCINOLONE at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (swollen arm), PRURITUS (itching) and INJECTION SITE WARMTH (warm/fever arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant product usage were not reported by the reporter.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Pain, Pruritus, Swelling
Clinical narrative: Swollen; Red; Itchy; looks like "Ring Worm"; Pain; Swelling; Hardness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), SWELLING (Swelling), INDURATION (Hardness), ERYTHEMA (Red) and PRURITUS (Itchy) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN (Pain), SWELLING (Swelling) and INDURATION (Hardness). On 19-Mar-2021, the patient experienced ERYTHEMA (Red), PRURITUS (Itchy) and PRURITUS (looks like "Ring Worm"). On an unknown date, the patient experienced SWELLING (Swollen). At the time of the report, PAIN (Pain), SWELLING (Swelling), INDURATION (Hardness), ERYTHEMA (Red), PRURITUS (Itchy), PRURITUS (looks like "Ring Worm") and SWELLING (Swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication history not provided. Treatment received for events include Tylenol, Motrin.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     Concurrent medical conditions included Parkinson's disease.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizzy). At the time of the report, DIZZINESS (dizzy) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-056448 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Reporters email address added. Outcome of event dizzy was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-056448:Crosslinked case
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Very hot to touch; Flu like symptoms; Injection site was very red; Rash; Itchy; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Very hot to touch), INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE ERYTHEMA (Injection site was very red), VACCINATION SITE RASH (Rash) and VACCINATION SITE PRURITUS (Itchy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included AMLODIPINE, METOPROLOL TARTRATE, INSULIN GLARGINE, OMEPRAZOLE, PIOGLITAZONE, HYDROCHLOROTHIAZIDE, GLIPIZIDE and TRAZODONE for an unknown indication. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Very hot to touch), INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE ERYTHEMA (Injection site was very red), VACCINATION SITE RASH (Rash), VACCINATION SITE PRURITUS (Itchy) and HEADACHE (Headache). At the time of the report, VACCINATION SITE WARMTH (Very hot to touch), INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE ERYTHEMA (Injection site was very red), VACCINATION SITE RASH (Rash), VACCINATION SITE PRURITUS (Itchy) and HEADACHE (Headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information were reported   This case was linked to MOD-2021-029591, MOD-2021-056454 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Very hot to touch; Flu like symptoms; Injection site was very red; Rash; Itchy; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Very hot to touch), INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE ERYTHEMA (Injection site was very red), VACCINATION SITE RASH (Rash) and VACCINATION SITE PRURITUS (Itchy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included AMLODIPINE, METOPROLOL TARTRATE, INSULIN GLARGINE, OMEPRAZOLE, PIOGLITAZONE, HYDROCHLOROTHIAZIDE, GLIPIZIDE and TRAZODONE for an unknown indication. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Very hot to touch), INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE ERYTHEMA (Injection site was very red), VACCINATION SITE RASH (Rash), VACCINATION SITE PRURITUS (Itchy) and HEADACHE (Headache). At the time of the report, VACCINATION SITE WARMTH (Very hot to touch), INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE ERYTHEMA (Injection site was very red), VACCINATION SITE RASH (Rash), VACCINATION SITE PRURITUS (Itchy) and HEADACHE (Headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information were reported   This case was linked to MOD-2021-029591, MOD-2021-056454 (Patient Link).
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient second dose outside of 42 days; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient second dose outside of 42 days) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient second dose outside of 42 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient second dose outside of 42 days) 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.   No Concomitant medications were provided No Treatment information provided    This case was linked to MOD21-061829, MOD-2021-056417 (Patient Link).   Reporter did not allow further contact
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of an invalid dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an invalid dose) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of an invalid dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of an invalid dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No Concomitant medications were provided No Treatment information provided    This case was linked to MOD-2021-056335 (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: May have COVID-19; chills; Clamminess; Body aches; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (May have COVID-19), COLD SWEAT (Clamminess), PAIN (Body aches), PYREXIA (Low grade fever) and CHILLS (chills) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced COLD SWEAT (Clamminess), PAIN (Body aches) and PYREXIA (Low grade fever). On an unknown date, the patient experienced SUSPECTED COVID-19 (May have COVID-19) and CHILLS (chills). At the time of the report, SUSPECTED COVID-19 (May have COVID-19) outcome was unknown, COLD SWEAT (Clamminess), PYREXIA (Low grade fever) and CHILLS (chills) had resolved and PAIN (Body aches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Mar-2021, SARS-CoV-2 test: (Negative) Fairly certain the test result was wrong..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Products known to have been used by the patient, within two weeks prior to the event , included atorvastatin, metformin and vitamins nos. The treatment information was not provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: May have COVID-19; chills; Clamminess; Body aches; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (May have COVID-19), COLD SWEAT (Clamminess), PAIN (Body aches), PYREXIA (Low grade fever) and CHILLS (chills) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced COLD SWEAT (Clamminess), PAIN (Body aches) and PYREXIA (Low grade fever). On an unknown date, the patient experienced SUSPECTED COVID-19 (May have COVID-19) and CHILLS (chills). At the time of the report, SUSPECTED COVID-19 (May have COVID-19) outcome was unknown, COLD SWEAT (Clamminess), PYREXIA (Low grade fever) and CHILLS (chills) had resolved and PAIN (Body aches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Mar-2021, SARS-CoV-2 test: (Negative) Fairly certain the test result was wrong..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Products known to have been used by the patient, within two weeks prior to the event , included atorvastatin, metformin and vitamins nos. The treatment information was not provided.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood test, Computerised tomogram, Headache, Magnetic resonance imaging
Clinical narrative: Debilitating pain, pain worsened; Stomach pain; Headache; Slept all day; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SOMNOLENCE (Slept all day), PAIN (Debilitating pain, pain worsened), ABDOMINAL PAIN UPPER (Stomach pain) and HEADACHE (Headache) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event history). Concomitant products included WARFARIN, GLIPIZIDE and METFORMIN for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced SOMNOLENCE (Slept all day). On 03-Mar-2021, the patient experienced PAIN (Debilitating pain, pain worsened), ABDOMINAL PAIN UPPER (Stomach pain) and HEADACHE (Headache). On 01-Mar-2021, SOMNOLENCE (Slept all day) had resolved. On 18-Mar-2021, PAIN (Debilitating pain, pain worsened), ABDOMINAL PAIN UPPER (Stomach pain) and HEADACHE (Headache) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, Blood test: inconclusive (Inconclusive) Five blood tests. On 06-Mar-2021, Computerised tomogram: inconclusive (Inconclusive) Inconclusive. On 06-Mar-2021, Magnetic resonance imaging: inconclusive (Inconclusive) For contrast Imaging.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.  On 06 Mar 2021, pain worsened and the patient went to emergency room. The health care provider in the emergency room checked for the evidence of stroke. They mentioned these symptoms attributing to the side effect of the vaccine.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Somnolence
Clinical narrative: Debilitating pain, pain worsened; Stomach pain; Headache; Slept all day; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SOMNOLENCE (Slept all day), PAIN (Debilitating pain, pain worsened), ABDOMINAL PAIN UPPER (Stomach pain) and HEADACHE (Headache) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event history). Concomitant products included WARFARIN, GLIPIZIDE and METFORMIN for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced SOMNOLENCE (Slept all day). On 03-Mar-2021, the patient experienced PAIN (Debilitating pain, pain worsened), ABDOMINAL PAIN UPPER (Stomach pain) and HEADACHE (Headache). On 01-Mar-2021, SOMNOLENCE (Slept all day) had resolved. On 18-Mar-2021, PAIN (Debilitating pain, pain worsened), ABDOMINAL PAIN UPPER (Stomach pain) and HEADACHE (Headache) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, Blood test: inconclusive (Inconclusive) Five blood tests. On 06-Mar-2021, Computerised tomogram: inconclusive (Inconclusive) Inconclusive. On 06-Mar-2021, Magnetic resonance imaging: inconclusive (Inconclusive) For contrast Imaging.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.  On 06 Mar 2021, pain worsened and the patient went to emergency room. The health care provider in the emergency room checked for the evidence of stroke. They mentioned these symptoms attributing to the side effect of the vaccine.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Heart rate increased, Hyperhidrosis, Myalgia
Clinical narrative: slightly elevated heart rate, 101 BPM.; Facial swelling, skin on face feels tight; Throat feels slightly swollen; lightheaded; Woke up in a sweat this morning; slight muscle aches in neck & shoulders; chills last night; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (slightly elevated heart rate, 101 BPM.), SWELLING FACE (Facial swelling, skin on face feels tight), PHARYNGEAL SWELLING (Throat feels slightly swollen), DIZZINESS (lightheaded) and HYPERHIDROSIS (Woke up in a sweat this morning) in a 40-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.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced HEART RATE INCREASED (slightly elevated heart rate, 101 BPM.), SWELLING FACE (Facial swelling, skin on face feels tight), PHARYNGEAL SWELLING (Throat feels slightly swollen), DIZZINESS (lightheaded), HYPERHIDROSIS (Woke up in a sweat this morning), MYALGIA (slight muscle aches in neck & shoulders) and CHILLS (chills last night). At the time of the report, HEART RATE INCREASED (slightly elevated heart rate, 101 BPM.), SWELLING FACE (Facial swelling, skin on face feels tight), PHARYNGEAL SWELLING (Throat feels slightly swollen), DIZZINESS (lightheaded), HYPERHIDROSIS (Woke up in a sweat this morning), MYALGIA (slight muscle aches in neck & shoulders) and CHILLS (chills last night) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided    Reporter did not allow further contact
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Swelling face
Clinical narrative: slightly elevated heart rate, 101 BPM.; Facial swelling, skin on face feels tight; Throat feels slightly swollen; lightheaded; Woke up in a sweat this morning; slight muscle aches in neck & shoulders; chills last night; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (slightly elevated heart rate, 101 BPM.), SWELLING FACE (Facial swelling, skin on face feels tight), PHARYNGEAL SWELLING (Throat feels slightly swollen), DIZZINESS (lightheaded) and HYPERHIDROSIS (Woke up in a sweat this morning) in a 40-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.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced HEART RATE INCREASED (slightly elevated heart rate, 101 BPM.), SWELLING FACE (Facial swelling, skin on face feels tight), PHARYNGEAL SWELLING (Throat feels slightly swollen), DIZZINESS (lightheaded), HYPERHIDROSIS (Woke up in a sweat this morning), MYALGIA (slight muscle aches in neck & shoulders) and CHILLS (chills last night). At the time of the report, HEART RATE INCREASED (slightly elevated heart rate, 101 BPM.), SWELLING FACE (Facial swelling, skin on face feels tight), PHARYNGEAL SWELLING (Throat feels slightly swollen), DIZZINESS (lightheaded), HYPERHIDROSIS (Woke up in a sweat this morning), MYALGIA (slight muscle aches in neck & shoulders) and CHILLS (chills last night) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided    Reporter did not allow further contact
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: left wrist red; could not move fingers; felt like left wrist was broken (extremely painful)/sore; left wrist swelled up/swelling went halfway up his forearm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (could not move fingers), VACCINATION SITE PAIN (felt like left wrist was broken (extremely painful)/sore), VACCINATION SITE SWELLING (left wrist swelled up/swelling went halfway up his forearm) and VACCINATION SITE ERYTHEMA (left wrist red) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (could not move fingers), VACCINATION SITE PAIN (felt like left wrist was broken (extremely painful)/sore) and VACCINATION SITE SWELLING (left wrist swelled up/swelling went halfway up his forearm). On 23-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (left wrist red). On 23-Mar-2021, PAIN IN EXTREMITY (could not move fingers) had resolved. On 24-Mar-2021, VACCINATION SITE SWELLING (left wrist swelled up/swelling went halfway up his forearm) had resolved. At the time of the report, VACCINATION SITE PAIN (felt like left wrist was broken (extremely painful)/sore) and VACCINATION SITE ERYTHEMA (left wrist red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided No Treatment information provided
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Injection site redness; Injection site swelling; Sneezing; Injection site itching; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SNEEZING (Sneezing), VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (Injection site swelling) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced SNEEZING (Sneezing), VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE SWELLING (Injection site swelling). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Injection site redness). The patient was treated with PREDNISOLONE at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SNEEZING (Sneezing), VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (Injection site swelling) 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.    The patient called her HCP who prescribe prednisolone and asked her not to receive the 2nd dose of the Moderna Covid-19 vaccine.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 27-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No medical history provided by Reporter.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 22-Aug-2020 and the estimated date of delivery was 28-May-2021. On 24-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirtieth week of the pregnancy.  On 24-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   concomitant drugs were not provided
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 010A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced MYALGIA. The patient was treated with TYLENOL at a dose of 1 dosage form and IBUPROFEN at a dose of 1 dosage form. At the time of the report, MYALGIA had resolved.            Concomitant product use was not provided.  Treatment included Tylenol and Motrin.   This case was linked to US-MODERNATX, INC.-MOD-2021-056534. Sender's Comments:  US-MODERNATX, INC MOD-2021-056534: Second dose of vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Dizzy; Head ache; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Dizzy) and HEADACHE (Head ache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizzy) and HEADACHE (Head ache). At the time of the report, DIZZINESS (Dizzy) and HEADACHE (Head ache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Redness around injection site; Warmness around injection site; Itchiness around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness around injection site), VACCINATION SITE WARMTH (Warmness around injection site) and VACCINATION SITE PRURITUS (Itchiness around injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 23-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness around injection site), VACCINATION SITE WARMTH (Warmness around injection site) and VACCINATION SITE PRURITUS (Itchiness around injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness around injection site), VACCINATION SITE WARMTH (Warmness around injection site) and VACCINATION SITE PRURITUS (Itchiness around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication taken was Calendula Cream.  Patient second dose was scheduled on 11-APR-2021.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pain, Parosmia
Clinical narrative: Just smelling things that are not there/smelling unusual odors; Chills; Aches all over the body; Pains all over the body; This spontaneous case was reported by a physician and describes the occurrence of PAIN (Pains all over the body), PAROSMIA (Just smelling things that are not there/smelling unusual odors), CHILLS (Chills) and MYALGIA (Aches all over the body) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced PAIN (Pains all over the body), CHILLS (Chills) and MYALGIA (Aches all over the body). In March 2021, the patient experienced PAROSMIA (Just smelling things that are not there/smelling unusual odors). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Pain and Chills, at a dose of 1 dosage form. At the time of the report, PAIN (Pains all over the body), CHILLS (Chills) and MYALGIA (Aches all over the body) outcome was unknown and PAROSMIA (Just smelling things that are not there/smelling unusual odors) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.   This case was linked to MOD-2021-079425 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Updated Patient Demographics, Suspect product details, and Event outcome as Not recovered / Ongoing.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: weakness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness) and FATIGUE (Fatigue) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036AZ1A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol and Pain.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced ASTHENIA (weakness) and FATIGUE (Fatigue). At the time of the report, ASTHENIA (weakness) and FATIGUE (Fatigue) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were reported include blood thinners (unspecified), cholesterol medication (unspecified), pain medication (unspecified). Treatment details not provided  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Pain in extremity, Product dose omission issue
Clinical narrative: soreness in arm; It's over 45 days from first dose of vaccine; fatigue; Tested positive with COVID-19; A Spontaneous report  was received by a consumer concerning a male patient of 90 years of age, who received Moderna's COVID-19 vaccine on 29 Jan 2021 and experienced Soreness in the arm, Fatigue, Covid-19 positive result and Product dose omission issue on various known and unknown dates.  The patient's medical history was unknown. Concomitant product use was not provided by the reporter.  On 29 Jan 2021, prior to the onset of events, the patient received a dose of mRNA-1273 (lot number - 032L20A) via intramuscular route for COVID-19 infection prophylaxis.  On an unknown date, after dose of vaccine, the patient experienced Soreness in the arm, Fatigue, Product dose omission issue.  On 19 Feb 2021 , after the dose of vaccine the patient experienced Covid-19 positive result.   Treatment medication was not reported by the reporter .  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event, Soreness in the arm, Fatigue, Covid-19 positive result and Product dose omission issue was considered to be unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, Pain in extremity, Fatigue and Covid-19, a causal relationship cannot be excluded.  This report also refers to a case of Product dose omission issue, for mRNA-1273, lot #: 032L20A.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Vaccination site pain, Vaccination site rash, Vaccination site warmth
Clinical narrative: pain at the injection site; redness; hot to touch; rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site), ERYTHEMA (redness), VACCINATION SITE WARMTH (hot to touch) and VACCINATION SITE RASH (rash at injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 024M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 11-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. In February 2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site), ERYTHEMA (redness), VACCINATION SITE WARMTH (hot to touch) and VACCINATION SITE RASH (rash at injection site). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at a dose of 50 milligram and METHYLPREDNISOLONE ACETATE (DEPO-MEDROL) (intramuscular) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PAIN (pain at the injection site), ERYTHEMA (redness), VACCINATION SITE WARMTH (hot to touch) and VACCINATION SITE RASH (rash at injection site) outcome was unknown. Not Provided          Treatment medication also included tagament
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: had to travel overseas for about 3 months.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (had to travel overseas for about 3 months.) 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 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (had to travel overseas for about 3 months.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (had to travel overseas for about 3 months.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered 15-20 minutes after the 6 hour vial puncture expiration; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered 15-20 minutes after the 6 hour vial puncture expiration) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20a) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered 15-20 minutes after the 6 hour vial puncture expiration). On 23-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered 15-20 minutes after the 6 hour vial puncture expiration) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication use was provided by the reporter.  No treatment of events was reported.   This case was linked to MOD21-061626, MOD21-061629, MOD21-061632, MOD21-063388 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Contact Information for reporter was updated; Reporter's Comments: This report refers to a case of Expired product administration, for mRNA-1273, lot #: 041L20A,  with no associated AEs.; Sender's Comments:  MOD21-061626: MOD21-061629: MOD21-061632: MOD21-063388:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inflammation, Pain in extremity, Pruritus, Pyrexia
Clinical narrative: Inflammation; Itching; Tired; fever; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), INFLAMMATION (Inflammation), PRURITUS (Itching), FATIGUE (Tired) and PYREXIA (fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 14-Mar-2021, the patient experienced INFLAMMATION (Inflammation), PRURITUS (Itching), FATIGUE (Tired) and PYREXIA (fever). On 13-Mar-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, INFLAMMATION (Inflammation), PRURITUS (Itching), FATIGUE (Tired) and PYREXIA (fever) 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. Treatment information was not provided.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: Arm soreness; Fever; Chills; Headache; Fatigue; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 030L20A) for COVID-19 vaccination.     The patient's medical history was not reported.  Concomitant products included METFORMIN for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN for Adverse event, at a dose of UNK dosage form and PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (Arm soreness), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: 8 syringes found with 0.1-0.25 cc of Moderna vaccine left; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of WRONG TECHNIQUE IN DEVICE USAGE PROCESS (8 syringes found with small amounts of vaccine left in them) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) UNK dosage form. On an unknown date, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (8 syringes found with small amounts of vaccine left in them). At the time of the report, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (8 syringes found with small amounts of vaccine left in them) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Movement disorder, Nasopharyngitis, Pain in extremity, Pyrexia
Clinical narrative: pain in his Right; hardness at the injection site; i had fever; i felt like something was moving in my back; feel a bit of hot; cold; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (i had fever), MOVEMENT DISORDER (i felt like something was moving in my back), FEELING HOT (feel a bit of hot), NASOPHARYNGITIS (cold) and PAIN IN EXTREMITY (pain in his Right) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036AZIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced PYREXIA (i had fever), MOVEMENT DISORDER (i felt like something was moving in my back), FEELING HOT (feel a bit of hot) and NASOPHARYNGITIS (cold). On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain in his Right) and VACCINATION SITE INDURATION (hardness at the injection site). At the time of the report, PYREXIA (i had fever), MOVEMENT DISORDER (i felt like something was moving in my back), FEELING HOT (feel a bit of hot), NASOPHARYNGITIS (cold), PAIN IN EXTREMITY (pain in his Right) and VACCINATION SITE INDURATION (hardness at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided Treatment for the events were not provided