chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: a really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (a really bad headache) 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 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 HEADACHE (a really bad headache). At the time of the report, HEADACHE (a really bad headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not provided Treatment medication include Tylenol
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the Polio vaccine less than 24 after the first Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the Polio vaccine less than 24 after the first Moderna vaccine) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the Polio vaccine less than 24 after the first Moderna vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the Polio vaccine less than 24 after the first Moderna vaccine) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications reported. No treatment reported.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test negative, Inappropriate schedule of product administration
Clinical narrative: Antibody test negative; Second Moderna vaccine on 3-12-2021; A Spontaneous case  was reported by a health care professional, concerning a female who received Moderna COVID-19 Vaccine (mRNA-1273) and describe the occurrence of second Moderna vaccine on 3-12-2021, antibody test negative.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 26-feb-2021, the patient started taking first dose of Moderna COVID-19 Vaccine (mRNA-1273) Intramuscularly for prophylaxis of COVID-19 Infection.   On 12-Mar-2021, the patient received second dose of mRNA-1273. On 23-mar-2021, the patient experienced Antibody test negative.  Treatment for the events were not specified.  Action taken with mRNA-1273 in response to the event was not provided.  The events, second Moderna vaccine on 3-12-2021, antibody test negative, was considered unknown.; Reporter's Comments: This report refers to a case of inappropriate schedule of product administration and antibody test negative, for mRNA-1273, lot # unknown,  with no associated AEs.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Fatigue, Hypersomnia, Nausea
Clinical narrative: Tightness in his chest; Difficulty breathing; Slept a lot; Body aches; Pain in arm; Low grade fever; Nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Tightness in his chest), DYSPNOEA (Difficulty breathing), HYPERSOMNIA (Slept a lot), PAIN (Body aches) and PAIN IN EXTREMITY (Pain in arm) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Anxiety.  No concomitant medication reported.   On 23-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 CHEST DISCOMFORT (Tightness in his chest), DYSPNOEA (Difficulty breathing), HYPERSOMNIA (Slept a lot), PAIN (Body aches), PAIN IN EXTREMITY (Pain in arm), PYREXIA (Low grade fever), NAUSEA (Nausea) and FATIGUE (Fatigue). The patient was treated with ALBUTEROL [SALBUTAMOL] ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, CHEST DISCOMFORT (Tightness in his chest), HYPERSOMNIA (Slept a lot), PAIN (Body aches), PAIN IN EXTREMITY (Pain in arm), PYREXIA (Low grade fever), NAUSEA (Nausea) and FATIGUE (Fatigue) was resolving and DYSPNOEA (Difficulty breathing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Tightness in his chest; Difficulty breathing; Slept a lot; Body aches; Pain in arm; Low grade fever; Nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Tightness in his chest), DYSPNOEA (Difficulty breathing), HYPERSOMNIA (Slept a lot), PAIN (Body aches) and PAIN IN EXTREMITY (Pain in arm) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Anxiety.  No concomitant medication reported.   On 23-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 CHEST DISCOMFORT (Tightness in his chest), DYSPNOEA (Difficulty breathing), HYPERSOMNIA (Slept a lot), PAIN (Body aches), PAIN IN EXTREMITY (Pain in arm), PYREXIA (Low grade fever), NAUSEA (Nausea) and FATIGUE (Fatigue). The patient was treated with ALBUTEROL [SALBUTAMOL] ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, CHEST DISCOMFORT (Tightness in his chest), HYPERSOMNIA (Slept a lot), PAIN (Body aches), PAIN IN EXTREMITY (Pain in arm), PYREXIA (Low grade fever), NAUSEA (Nausea) and FATIGUE (Fatigue) was resolving and DYSPNOEA (Difficulty breathing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Vomiting
Clinical narrative: Extreme pain in right abdomen; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Extreme pain in right abdomen) and VOMITING (Vomiting) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced ABDOMINAL PAIN (Extreme pain in right abdomen) and VOMITING (Vomiting). At the time of the report, ABDOMINAL PAIN (Extreme pain in right abdomen) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: When removed a Band aid, whole large amount of liquid came off; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (When removed a Band aid, whole large amount of liquid came off) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (When removed a Band aid, whole large amount of liquid came off). At the time of the report, PRODUCT ADMINISTRATION ERROR (When removed a Band aid, whole large amount of liquid came off) 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.   No concomitant product use was provided by the reporter.  No treatment medication was provided.  The pharmacist states it was not underdose as it was like a small drop and 0.001% liquid came out. The patient did not experience any side effects after that. And reported there was no need for further follow up. Did not provide any contact information.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Added new information for event.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Fatigue, Pain in extremity
Clinical narrative: Pain in the bones; Tiredness; Little pain in my arm; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Pain in the bones), PAIN IN EXTREMITY (Little pain in my arm) and FATIGUE (Tiredness) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     no medical history was reported by reporter.  Concomitant products included FAMOTIDINE (PEPCID [FAMOTIDINE]) for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (Little pain in my arm). On 26-Mar-2021, the patient experienced BONE PAIN (Pain in the bones) and FATIGUE (Tiredness). At the time of the report, BONE PAIN (Pain in the bones) and FATIGUE (Tiredness) outcome was unknown and PAIN IN EXTREMITY (Little pain in my arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medicines was not reported by reporter   treatment information was not provided   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 54.0
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Got the Pfizer vaccine for shot 2 on 27 Mar 2021; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Got the Pfizer vaccine for shot 2 on 27 Mar 2021) in a 54-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (Got the Pfizer vaccine for shot 2 on 27 Mar 2021). At the time of the report, INCORRECT DOSE ADMINISTERED (Got the Pfizer vaccine for shot 2 on 27 Mar 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant was not provided. patient treatment information was not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: Neck pain; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain) in a 67-year-old female patient 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 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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NECK PAIN (Neck pain). At the time of the report, NECK PAIN (Neck pain) outcome was unknown.            No concomitant and treatment medication information was reported.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: patient received 0.25ml dose; A spontaneous report was received from a consumer concerning a 29-Year-old female patient, of unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273) and reported vaccine underdose.  The patient's medical history was not provided. No relevant concomitant medications were reported. No information on allergies were provided. The reported stated that the patient was physically and mentally healthy before vaccination.  On 25 Mar 2021, prior to the onset of the events, the patient received her first of the two planned vaccine doses of mRNA-1273 (Lot number: 017B21A) via intramuscular route into her left arm for prophylaxis of COVID-19 infection .  On 25 mar 2021, the 2 nurses administered 0.25 ml doses to 5 patients and all were employees of prison. Nurses would like to know if another dose should be administered immediately.   Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event, underdose, was recovered.; Reporter's Comments: This report refers to a case of Underdose, for mRNA-1273, lot #: 017B21A, with no associated AEs.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Headache; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and PAIN IN EXTREMITY (Sore Arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concomitant products included TOPIRAMATE (TOPAMAX), ALPRAZOLAM (XANAX) and QUETIAPINE FUMARATE (SEROQUEL) for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced HEADACHE (Headache) and PAIN IN EXTREMITY (Sore Arm). The patient was treated with PARACETAMOL (TYLENOL) for Headache and Pain in arm, at an unspecified dose and frequency. On 17-Feb-2021, HEADACHE (Headache) and PAIN IN EXTREMITY (Sore Arm) 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.   Patient feels better now.   This case was linked to MOD21-063341 (E2B Linked Report).; Sender's Comments:  MOD21-063341:MOD-2021-059668 -2nd Dose of Vaccine
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced HEADACHE (headache) and PYREXIA (fever). At the time of the report, HEADACHE (headache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 2nd dose not given in recommended time; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (2nd dose not given in recommended time) 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 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose not given in recommended time). At the time of the report, PRODUCT DOSE OMISSION ISSUE (2nd dose not given in recommended time) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant Concomitant Medications were reported. No Treatment Information Provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pain in extremity, Pregnancy test
Clinical narrative: a sore arm; caller received first dose on left arm; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (caller received first dose on left arm) and PAIN IN EXTREMITY (a sore arm) in a 36-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 12-Feb-2021 and the estimated date of delivery was 19-Nov-2021. On 26-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (caller received first dose on left arm). On 26-Mar-2021, the patient experienced PAIN IN EXTREMITY (a sore arm). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  second week of the pregnancy.  On 26-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (caller received first dose on left arm) had resolved. At the time of the report, PAIN IN EXTREMITY (a sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported Full term child birth on 09Sep2019 in history. Treatment information does not provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: itching; Red Injection Site; Swollen Injection Site; Warm to the touch Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Red Injection Site), INJECTION SITE SWELLING (Swollen Injection Site), INJECTION SITE WARMTH (Warm to the touch Injection Site) and INJECTION SITE PRURITUS (itching) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (Red Injection Site), INJECTION SITE SWELLING (Swollen Injection Site) and INJECTION SITE WARMTH (Warm to the touch Injection Site). On 26-Mar-2021, the patient experienced INJECTION SITE PRURITUS (itching). On 22-Mar-2021, INJECTION SITE ERYTHEMA (Red Injection Site), INJECTION SITE SWELLING (Swollen Injection Site) and INJECTION SITE WARMTH (Warm to the touch Injection Site) had resolved. At the time of the report, INJECTION SITE PRURITUS (itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant drugs included hydrocortisone cream  used as treatment
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered by product
Clinical narrative: partial dose of vaccine received; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INCORRECT DOSE ADMINISTERED BY PRODUCT (partial dose of vaccine received) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and #010A21A / 017A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (Patient is medication for high blood pressure) and Asthma (Patient is under medication). Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for Asthma.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced INCORRECT DOSE ADMINISTERED BY PRODUCT (partial dose of vaccine received). On 09-Feb-2021, INCORRECT DOSE ADMINISTERED BY PRODUCT (partial dose of vaccine received) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications and treatment information were reported.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Skin exfoliation
Clinical narrative: Rash is a bit itchy; Shedding skin in big flakes; Bright pink rash shoulder to shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Rash is a bit itchy), SKIN EXFOLIATION (Shedding skin in big flakes) and RASH (Bright pink rash shoulder to shoulder) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Rash is a bit itchy), SKIN EXFOLIATION (Shedding skin in big flakes) and RASH (Bright pink rash shoulder to shoulder). At the time of the report, PRURITUS (Rash is a bit itchy), SKIN EXFOLIATION (Shedding skin in big flakes) and RASH (Bright pink rash shoulder to shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment details included Steroid cream.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Fatigue, Headache, Malaise, Pain in extremity
Clinical narrative: sore arm after first dose; has eye aches; he still feels drowsy; not feeling quite right/ not feeling like himself; felt tired on the first day so he slept it off for 12 hours; has headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm after first dose), EYE PAIN (has eye aches), SOMNOLENCE (he still feels drowsy), MALAISE (not feeling quite right/ not feeling like himself) and FATIGUE (felt tired on the first day so he slept it off for 12 hours) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 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 an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm after first dose), EYE PAIN (has eye aches), SOMNOLENCE (he still feels drowsy), MALAISE (not feeling quite right/ not feeling like himself), FATIGUE (felt tired on the first day so he slept it off for 12 hours) and HEADACHE (has headaches). At the time of the report, PAIN IN EXTREMITY (sore arm after first dose), EYE PAIN (has eye aches), SOMNOLENCE (he still feels drowsy), MALAISE (not feeling quite right/ not feeling like himself), FATIGUE (felt tired on the first day so he slept it off for 12 hours) and HEADACHE (has headaches) had not resolved.            No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-059660 (Patient Link).
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: sore arm after first dose; has eye aches; he still feels drowsy; not feeling quite right/ not feeling like himself; felt tired on the first day so he slept it off for 12 hours; has headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm after first dose), EYE PAIN (has eye aches), SOMNOLENCE (he still feels drowsy), MALAISE (not feeling quite right/ not feeling like himself) and FATIGUE (felt tired on the first day so he slept it off for 12 hours) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 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 an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm after first dose), EYE PAIN (has eye aches), SOMNOLENCE (he still feels drowsy), MALAISE (not feeling quite right/ not feeling like himself), FATIGUE (felt tired on the first day so he slept it off for 12 hours) and HEADACHE (has headaches). At the time of the report, PAIN IN EXTREMITY (sore arm after first dose), EYE PAIN (has eye aches), SOMNOLENCE (he still feels drowsy), MALAISE (not feeling quite right/ not feeling like himself), FATIGUE (felt tired on the first day so he slept it off for 12 hours) and HEADACHE (has headaches) had not resolved.            No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-059660 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Injection site swelling
Clinical narrative: Chills; Dizziness; fatigue; Headache; Swelling at injection site; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), DIZZINESS (Dizziness), FATIGUE (fatigue), HEADACHE (Headache) and INJECTION SITE SWELLING (Swelling at injection site) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced CHILLS (Chills), DIZZINESS (Dizziness), FATIGUE (fatigue), HEADACHE (Headache), INJECTION SITE SWELLING (Swelling at injection site), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, CHILLS (Chills), DIZZINESS (Dizziness), FATIGUE (fatigue), HEADACHE (Headache), INJECTION SITE SWELLING (Swelling at injection site), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Chills; Dizziness; fatigue; Headache; Swelling at injection site; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), DIZZINESS (Dizziness), FATIGUE (fatigue), HEADACHE (Headache) and INJECTION SITE SWELLING (Swelling at injection site) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced CHILLS (Chills), DIZZINESS (Dizziness), FATIGUE (fatigue), HEADACHE (Headache), INJECTION SITE SWELLING (Swelling at injection site), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, CHILLS (Chills), DIZZINESS (Dizziness), FATIGUE (fatigue), HEADACHE (Headache), INJECTION SITE SWELLING (Swelling at injection site), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion
Clinical narrative: cough; nasal congestion; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough) and NASAL CONGESTION (nasal congestion) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included BUSPIRONE and PRAVASTATIN for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced COUGH (cough) and NASAL CONGESTION (nasal congestion). At the time of the report, COUGH (cough) and NASAL CONGESTION (nasal congestion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment include: Vicks NyQuil.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Excruciating pain in arm of the injection; achiness and pain in her legs and feet; experienced some soreness in the injection arm (left); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (achiness and pain in her legs and feet), VACCINATION SITE PAIN (experienced some soreness in the injection arm (left)) and VACCINATION SITE PAIN (Excruciating pain in arm of the injection) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) 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 PAIN IN EXTREMITY (achiness and pain in her legs and feet) and VACCINATION SITE PAIN (experienced some soreness in the injection arm (left)). On 26-Mar-2021, the patient experienced VACCINATION SITE PAIN (Excruciating pain in arm of the injection). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (achiness and pain in her legs and feet), VACCINATION SITE PAIN (experienced some soreness in the injection arm (left)) and VACCINATION SITE PAIN (Excruciating pain in arm of the injection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Fatigue, Feeling abnormal, Headache, Pain in extremity
Clinical narrative: sore arm after second dose; feels drowsy; has eye aches; not feeling like himself; felt tired on first day after second dose; has headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm after second dose), SOMNOLENCE (feels drowsy), EYE PAIN (has eye aches), FEELING ABNORMAL (not feeling like himself) and FATIGUE (felt tired on first day after second dose) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 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 an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm after second dose), SOMNOLENCE (feels drowsy), EYE PAIN (has eye aches), FEELING ABNORMAL (not feeling like himself), FATIGUE (felt tired on first day after second dose) and HEADACHE (has headaches). At the time of the report, PAIN IN EXTREMITY (sore arm after second dose), SOMNOLENCE (feels drowsy), EYE PAIN (has eye aches), FEELING ABNORMAL (not feeling like himself), FATIGUE (felt tired on first day after second dose) and HEADACHE (has headaches) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2021-059655 (Patient Link).
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: sore arm after second dose; feels drowsy; has eye aches; not feeling like himself; felt tired on first day after second dose; has headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm after second dose), SOMNOLENCE (feels drowsy), EYE PAIN (has eye aches), FEELING ABNORMAL (not feeling like himself) and FATIGUE (felt tired on first day after second dose) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 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 an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm after second dose), SOMNOLENCE (feels drowsy), EYE PAIN (has eye aches), FEELING ABNORMAL (not feeling like himself), FATIGUE (felt tired on first day after second dose) and HEADACHE (has headaches). At the time of the report, PAIN IN EXTREMITY (sore arm after second dose), SOMNOLENCE (feels drowsy), EYE PAIN (has eye aches), FEELING ABNORMAL (not feeling like himself), FATIGUE (felt tired on first day after second dose) and HEADACHE (has headaches) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2021-059655 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Myalgia
Clinical narrative: muscle pain and couldn't even lift her arm; cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough) and MYALGIA (muscle pain and couldn't even lift her arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced COUGH (cough). On an unknown date, the patient experienced MYALGIA (muscle pain and couldn't even lift her arm). On 27-Mar-2021, COUGH (cough) had resolved. At the time of the report, MYALGIA (muscle pain and couldn't even lift her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Claustrophobia, Injection site haemorrhage, Injection site warmth, Peripheral swelling
Clinical narrative: Feels like struck in a circle; Bumpy; Very warm at the injection area; Swollen/ big knot; This spontaneous case was reported by a consumer and describes the occurrence of CLAUSTROPHOBIA (Feels like struck in a circle), INJECTION SITE HAEMORRHAGE (Bumpy), INJECTION SITE WARMTH (Very warm at the injection area) and PERIPHERAL SWELLING (Swollen/ big knot) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concomitant products included CITALOPRAM for Depression, OXYCODONE for Pain.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CLAUSTROPHOBIA (Feels like struck in a circle), INJECTION SITE HAEMORRHAGE (Bumpy), INJECTION SITE WARMTH (Very warm at the injection area) and PERIPHERAL SWELLING (Swollen/ big knot). At the time of the report, CLAUSTROPHOBIA (Feels like struck in a circle), INJECTION SITE HAEMORRHAGE (Bumpy), INJECTION SITE WARMTH (Very warm at the injection area) and PERIPHERAL SWELLING (Swollen/ big knot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication include anxiety medication.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: TCR added. Reporter declined for e-mail address and further FU.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Vaccination site erythema, Vertigo
Clinical narrative: 2 weeks later after both shots developed vertigo; left arm at shot site turned pinkish for about a 4-inch area with itching; Redness; Itchiness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), PRURITUS (Itchiness), VERTIGO (2 weeks later after both shots developed vertigo) and VACCINATION SITE ERYTHEMA (left arm at shot site turned pinkish for about a 4-inch area with itching) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical history information provided by the reporter.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], LISINOPRIL, FOLIC ACID, ROSUVASTATIN, ROSUVASTATIN CALCIUM (CRESTOR) and MULTIVITAMIN [VITAMINS NOS] 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 24-Mar-2021, the patient experienced ERYTHEMA (Redness) and PRURITUS (Itchiness). On an unknown date, the patient experienced VERTIGO (2 weeks later after both shots developed vertigo) and VACCINATION SITE ERYTHEMA (left arm at shot site turned pinkish for about a 4-inch area with itching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Redness) had resolved and PRURITUS (Itchiness), VERTIGO (2 weeks later after both shots developed vertigo) and VACCINATION SITE ERYTHEMA (left arm at shot site turned pinkish for about a 4-inch area with itching) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: New events were added.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Myalgia, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Right arm is red; Right arm is itchy; Right arm has a rash; Caller report mild pain, states the arm isn't any more worse then a sore muscle.; While sleeping right arm became sore again; While sleeping right arm swollen again; Right arm was sore; Right arm kind swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right arm was sore), PERIPHERAL SWELLING (Right arm kind swollen), PAIN IN EXTREMITY (While sleeping right arm became sore again), PERIPHERAL SWELLING (While sleeping right arm swollen again) and ERYTHEMA (Right arm is red) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information reported.  Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL AND HYDROCHLOROTHIAZIDE) for an unknown indication.    On 16-Mar-2021 at 6:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (Right arm was sore) and PERIPHERAL SWELLING (Right arm kind swollen). On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (While sleeping right arm became sore again) and PERIPHERAL SWELLING (While sleeping right arm swollen again). On 26-Mar-2021, the patient experienced ERYTHEMA (Right arm is red), PRURITUS (Right arm is itchy), VACCINATION SITE RASH (Right arm has a rash) and MYALGIA (Caller report mild pain, states the arm isn't any more worse then a sore muscle.). The patient was treated with OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) at an unspecified dose and frequency. On 18-Mar-2021, PAIN IN EXTREMITY (Right arm was sore) and PERIPHERAL SWELLING (Right arm kind swollen) had resolved. At the time of the report, PAIN IN EXTREMITY (While sleeping right arm became sore again), PERIPHERAL SWELLING (While sleeping right arm swollen again), ERYTHEMA (Right arm is red), PRURITUS (Right arm is itchy), VACCINATION SITE RASH (Right arm has a rash) and MYALGIA (Caller report mild pain, states the arm isn't any more worse then a sore muscle.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The reporter states states taking Claritin to help relieve side effects.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Right arm is red; Right arm is itchy; Right arm has a rash; Caller report mild pain, states the arm isn't any more worse then a sore muscle.; While sleeping right arm became sore again; While sleeping right arm swollen again; Right arm was sore; Right arm kind swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right arm was sore), PERIPHERAL SWELLING (Right arm kind swollen), PAIN IN EXTREMITY (While sleeping right arm became sore again), PERIPHERAL SWELLING (While sleeping right arm swollen again) and ERYTHEMA (Right arm is red) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information reported.  Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL AND HYDROCHLOROTHIAZIDE) for an unknown indication.    On 16-Mar-2021 at 6:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (Right arm was sore) and PERIPHERAL SWELLING (Right arm kind swollen). On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (While sleeping right arm became sore again) and PERIPHERAL SWELLING (While sleeping right arm swollen again). On 26-Mar-2021, the patient experienced ERYTHEMA (Right arm is red), PRURITUS (Right arm is itchy), VACCINATION SITE RASH (Right arm has a rash) and MYALGIA (Caller report mild pain, states the arm isn't any more worse then a sore muscle.). The patient was treated with OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) at an unspecified dose and frequency. On 18-Mar-2021, PAIN IN EXTREMITY (Right arm was sore) and PERIPHERAL SWELLING (Right arm kind swollen) had resolved. At the time of the report, PAIN IN EXTREMITY (While sleeping right arm became sore again), PERIPHERAL SWELLING (While sleeping right arm swollen again), ERYTHEMA (Right arm is red), PRURITUS (Right arm is itchy), VACCINATION SITE RASH (Right arm has a rash) and MYALGIA (Caller report mild pain, states the arm isn't any more worse then a sore muscle.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The reporter states states taking Claritin to help relieve side effects.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: hardness at injection site; Itching at injection site; Swelling at injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (hardness at injection site), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and HEADACHE (Headache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE INDURATION (hardness at injection site), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and HEADACHE (Headache). At the time of the report, VACCINATION SITE INDURATION (hardness at injection site), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was taking concomitant medication not specified.  Treatment details included Used ice pack on effected arm.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: No new information
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Headache, Hypoaesthesia, Hypoaesthesia oral, Throat irritation
Clinical narrative: Plugged ears; Numbness right side of face; Numbness right lip; Tingling in throat; Headache; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISCOMFORT (Plugged ears), HYPOAESTHESIA (Numbness right side of face), HYPOAESTHESIA ORAL (Numbness right lip), THROAT IRRITATION (Tingling in throat) and HEADACHE (Headache) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021 at 10:11 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced EAR DISCOMFORT (Plugged ears), HYPOAESTHESIA (Numbness right side of face), HYPOAESTHESIA ORAL (Numbness right lip), THROAT IRRITATION (Tingling in throat) and HEADACHE (Headache). At the time of the report, EAR DISCOMFORT (Plugged ears), HYPOAESTHESIA (Numbness right side of face), HYPOAESTHESIA ORAL (Numbness right lip), THROAT IRRITATION (Tingling in throat) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provider by the reporter.  Treatment information was not provided.