chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: More than 36 days after the first dose without receiving the second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving the second dose) 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.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications were unknown.; Sender's Comments: This report refers to a case of Product dose omission issue for mRNA-1273, lot # unknown with no associated AEs.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Lethargy, Pain in extremity, Pyrexia
Clinical narrative: soreness in arm; lethargic; burning pain in armpit; large red spot on her arm 2 inches below the shot; hard little lump; slight low grade fever; soreness in arm after first dose; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (soreness in arm), LETHARGY (lethargic), BURNING SENSATION (burning pain in armpit), ERYTHEMA (large red spot on her arm 2 inches below the shot) and VACCINATION SITE ERYTHEMA (soreness in arm after first dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included SUMATRIPTAN SUCCINATE (IMITREX DF), OMEPRAZOLE and ZOLPIDEM TARTRATE (AMBIEN) for an unknown indication.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (soreness in arm after first dose). On 29-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in arm), LETHARGY (lethargic), BURNING SENSATION (burning pain in armpit), ERYTHEMA (large red spot on her arm 2 inches below the shot), VACCINATION SITE SWELLING (hard little lump) and PYREXIA (slight low grade fever). At the time of the report, PAIN IN EXTREMITY (soreness in arm), LETHARGY (lethargic), BURNING SENSATION (burning pain in armpit), ERYTHEMA (large red spot on her arm 2 inches below the shot), VACCINATION SITE ERYTHEMA (soreness in arm after first dose) and PYREXIA (slight low grade fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-065400 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-065400:2nd dose
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: soreness in arm; lethargic; burning pain in armpit; large red spot on her arm 2 inches below the shot; hard little lump; slight low grade fever; soreness in arm after first dose; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (soreness in arm), LETHARGY (lethargic), BURNING SENSATION (burning pain in armpit), ERYTHEMA (large red spot on her arm 2 inches below the shot) and VACCINATION SITE ERYTHEMA (soreness in arm after first dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included SUMATRIPTAN SUCCINATE (IMITREX DF), OMEPRAZOLE and ZOLPIDEM TARTRATE (AMBIEN) for an unknown indication.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (soreness in arm after first dose). On 29-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in arm), LETHARGY (lethargic), BURNING SENSATION (burning pain in armpit), ERYTHEMA (large red spot on her arm 2 inches below the shot), VACCINATION SITE SWELLING (hard little lump) and PYREXIA (slight low grade fever). At the time of the report, PAIN IN EXTREMITY (soreness in arm), LETHARGY (lethargic), BURNING SENSATION (burning pain in armpit), ERYTHEMA (large red spot on her arm 2 inches below the shot), VACCINATION SITE ERYTHEMA (soreness in arm after first dose) and PYREXIA (slight low grade fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-065400 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-065400:2nd dose
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Headache, Myalgia, Pyrexia
Clinical narrative: COVID-19; Fever; Body Aches; Headache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), PYREXIA (Fever), MYALGIA (Body Aches) and HEADACHE (Headache) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) 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) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PYREXIA (Fever), MYALGIA (Body Aches) and HEADACHE (Headache). On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19), PYREXIA (Fever), MYALGIA (Body Aches) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Body temperature: 101 (High) Fever 101 F. On an unknown date, SARS-CoV-2 test: positive (Positive) PCR test tested Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Additional information received New event COVID-19 was added
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: COVID-19; Fever; Body Aches; Headache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), PYREXIA (Fever), MYALGIA (Body Aches) and HEADACHE (Headache) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) 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) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PYREXIA (Fever), MYALGIA (Body Aches) and HEADACHE (Headache). On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19), PYREXIA (Fever), MYALGIA (Body Aches) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Body temperature: 101 (High) Fever 101 F. On an unknown date, SARS-CoV-2 test: positive (Positive) PCR test tested Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Additional information received New event COVID-19 was added
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Heart rate increased, Pyrexia
Clinical narrative: rapid heart rate; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (rapid heart rate), PYREXIA (fever) and CHILLS (chills) in a 64-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 (no relevant medical history reported).    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced HEART RATE INCREASED (rapid heart rate), PYREXIA (fever) and CHILLS (chills). On 30-Mar-2021, HEART RATE INCREASED (rapid heart rate), PYREXIA (fever) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       NO concomitant medication provided treatment included pain reliver
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Pruritus, Rash
Clinical narrative: Itching in their hands; Widespread rash; Chills; Arm pain; This spontaneous case was reported by a physician and describes the occurrence of PRURITUS (Itching in their hands), PAIN IN EXTREMITY (Arm pain), RASH (Widespread rash) and CHILLS (Chills) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B2124 and 0021A) for COVID-19 vaccination.     No medical history provided.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm pain) and CHILLS (Chills). On 27-Mar-2021, the patient experienced PRURITUS (Itching in their hands) and RASH (Widespread rash). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching in their hands), PAIN IN EXTREMITY (Arm pain), RASH (Widespread rash) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) 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 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intra-abdominal) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intra-abdominal) was unknown.       No concomitant and treatment information was not provided.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm in the arm of administration that subsided; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm in the arm of administration that subsided) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included Kidney disorder, Aortic aneurysm and Heart disease, unspecified. Concurrent medical conditions included COPD. Concomitant products included LEVOTHYROXINE, LEVOTHYROXINE SODIUM (SYNTHROID) and ATORVASTATIN for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore arm in the arm of administration that subsided). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (sore arm in the arm of administration that subsided) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was only sore a little bit; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was only sore a little bit) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 037A21B) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was only sore a little bit). At the time of the report, PAIN IN EXTREMITY (arm was only sore a little bit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2021-065445 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN (All over my body hurts), CHILLS (Chills), HEADACHE (Headache), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) 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 (No reported medical history). On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN (All over my body hurts), CHILLS (Chills), HEADACHE (Headache), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain). At the time of the report, PAIN (All over my body hurts), CHILLS (Chills), HEADACHE (Headache), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) had not resolved.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. Treatment details included paracetamol and melatonin.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, Wrong technique in device usage process
Clinical narrative: needle separated from syringe during attempted injection; half of the dose administered to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG TECHNIQUE IN DEVICE USAGE PROCESS (needle separated from syringe during attempted injection) and ACCIDENTAL UNDERDOSE (half of the dose administered to patient) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021 at 1:01 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021 at 1:03 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced ACCIDENTAL UNDERDOSE (half of the dose administered to patient). On 31-Mar-2021 at 1:01 PM, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (needle separated from syringe during attempted injection). On 31-Mar-2021, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (needle separated from syringe during attempted injection) and ACCIDENTAL UNDERDOSE (half of the dose administered to patient) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered WRONG TECHNIQUE IN DEVICE USAGE PROCESS (needle separated from syringe during attempted injection) and ACCIDENTAL UNDERDOSE (half of the dose administered to patient) to be not related.    It was reported that appoximately half way through the injection the needle separated from the syringe at the hub resulting in 1/2 dose being administered. The staff was instructed to administer a second inject of 1/2 dose. This resulted in 2 injections but a full dose was administered.  The reporter stated that the patient stayed for observation (15 minutes) without any adverse effects. Also noted that a follow up call was made several days later and the patient reported no adverse effects. No concomitant medications were reported. No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Patient demographics, product information and event details updated
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Pain, Pyrexia
Clinical narrative: pain in knee; achy; tired; temperature 99.0F; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy), FATIGUE (tired), PYREXIA (temperature 99.0F) and ARTHRALGIA (pain in knee) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Knee pain.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced PAIN (achy), FATIGUE (tired) and PYREXIA (temperature 99.0F). On an unknown date, the patient experienced ARTHRALGIA (pain in knee). At the time of the report, PAIN (achy), FATIGUE (tired), PYREXIA (temperature 99.0F) and ARTHRALGIA (pain in knee) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter states Lot# 023m20a, but the patient is unsure if this is the lot number for 1st 0r 2nd dose.  Concomitant medications include antidepressants and BP for unknown indication
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Eye pain, Gait disturbance, Headache
Clinical narrative: sore eye balls; chills so bad "she couldn't walk"; Sore Arm at the injection site; Chills; Headache; shakiness; Sore Throat; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), GAIT DISTURBANCE (chills so bad "she couldn't walk"), HEADACHE (Headache), EYE PAIN (sore eye balls) and TREMOR (shakiness) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE, LEVOTHYROXINE SODIUM (SYNTHROID) and ATORVASTATIN for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced CHILLS (Chills), HEADACHE (Headache), TREMOR (shakiness), OROPHARYNGEAL PAIN (Sore Throat) and DIZZINESS (Dizziness). On an unknown date, the patient experienced GAIT DISTURBANCE (chills so bad "she couldn't walk"), EYE PAIN (sore eye balls) and VACCINATION SITE PAIN (Sore Arm at the injection site). At the time of the report, CHILLS (Chills), GAIT DISTURBANCE (chills so bad "she couldn't walk"), HEADACHE (Headache), EYE PAIN (sore eye balls), TREMOR (shakiness), OROPHARYNGEAL PAIN (Sore Throat), DIZZINESS (Dizziness) and VACCINATION SITE PAIN (Sore Arm at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-065430 (Patient Link).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Tremor, Vaccination site pain
Clinical narrative: sore eye balls; chills so bad "she couldn't walk"; Sore Arm at the injection site; Chills; Headache; shakiness; Sore Throat; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), GAIT DISTURBANCE (chills so bad "she couldn't walk"), HEADACHE (Headache), EYE PAIN (sore eye balls) and TREMOR (shakiness) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE, LEVOTHYROXINE SODIUM (SYNTHROID) and ATORVASTATIN for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced CHILLS (Chills), HEADACHE (Headache), TREMOR (shakiness), OROPHARYNGEAL PAIN (Sore Throat) and DIZZINESS (Dizziness). On an unknown date, the patient experienced GAIT DISTURBANCE (chills so bad "she couldn't walk"), EYE PAIN (sore eye balls) and VACCINATION SITE PAIN (Sore Arm at the injection site). At the time of the report, CHILLS (Chills), GAIT DISTURBANCE (chills so bad "she couldn't walk"), HEADACHE (Headache), EYE PAIN (sore eye balls), TREMOR (shakiness), OROPHARYNGEAL PAIN (Sore Throat), DIZZINESS (Dizziness) and VACCINATION SITE PAIN (Sore Arm at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-065430 (Patient Link).
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dehydration, Heart rate, Nausea, Palpitations
Clinical narrative: dehydration; Racing heart beat; fever; nausea; vomiting; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEHYDRATION (dehydration), PALPITATIONS (Racing heart beat), PYREXIA (fever), NAUSEA (nausea) and VOMITING (vomiting) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced DEHYDRATION (dehydration), PALPITATIONS (Racing heart beat), PYREXIA (fever), NAUSEA (nausea), VOMITING (vomiting) and CHILLS (chills). On 25-Feb-2021, DEHYDRATION (dehydration), PALPITATIONS (Racing heart beat), PYREXIA (fever), NAUSEA (nausea), VOMITING (vomiting) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Feb-2021, Heart rate: 150 breaths per minute High.         No relevant concomitant medications were reported. No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: dehydration; Racing heart beat; fever; nausea; vomiting; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEHYDRATION (dehydration), PALPITATIONS (Racing heart beat), PYREXIA (fever), NAUSEA (nausea) and VOMITING (vomiting) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced DEHYDRATION (dehydration), PALPITATIONS (Racing heart beat), PYREXIA (fever), NAUSEA (nausea), VOMITING (vomiting) and CHILLS (chills). On 25-Feb-2021, DEHYDRATION (dehydration), PALPITATIONS (Racing heart beat), PYREXIA (fever), NAUSEA (nausea), VOMITING (vomiting) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Feb-2021, Heart rate: 150 breaths per minute High.         No relevant concomitant medications were reported. No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Hyperhidrosis
Clinical narrative: Not feeling very well; Sweated a lot; Pain on left arm; Swollen left arm; Chills; Feeling very tired; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Not feeling very well), HYPERHIDROSIS (Sweated a lot), PAIN IN EXTREMITY (Pain on left arm), SWELLING (Swollen left arm) and CHILLS (Chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in June 2020.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced FEELING ABNORMAL (Not feeling very well), HYPERHIDROSIS (Sweated a lot), PAIN IN EXTREMITY (Pain on left arm), SWELLING (Swollen left arm), CHILLS (Chills), FATIGUE (Feeling very tired), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, FEELING ABNORMAL (Not feeling very well), HYPERHIDROSIS (Sweated a lot), PAIN IN EXTREMITY (Pain on left arm), SWELLING (Swollen left arm), CHILLS (Chills), FATIGUE (Feeling very tired), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Swelling
Clinical narrative: Not feeling very well; Sweated a lot; Pain on left arm; Swollen left arm; Chills; Feeling very tired; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Not feeling very well), HYPERHIDROSIS (Sweated a lot), PAIN IN EXTREMITY (Pain on left arm), SWELLING (Swollen left arm) and CHILLS (Chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in June 2020.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced FEELING ABNORMAL (Not feeling very well), HYPERHIDROSIS (Sweated a lot), PAIN IN EXTREMITY (Pain on left arm), SWELLING (Swollen left arm), CHILLS (Chills), FATIGUE (Feeling very tired), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, FEELING ABNORMAL (Not feeling very well), HYPERHIDROSIS (Sweated a lot), PAIN IN EXTREMITY (Pain on left arm), SWELLING (Swollen left arm), CHILLS (Chills), FATIGUE (Feeling very tired), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Feeling hot, Nervousness
Clinical narrative: Fatigue; Felt something going through his system; Felt dizzy; Shaky; Felt warmth all over body; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt something going through his system), DIZZINESS (Felt dizzy), NERVOUSNESS (Shaky), FEELING HOT (Felt warmth all over body) and FATIGUE (Fatigue) in a male 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 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced FEELING ABNORMAL (Felt something going through his system). 17-Mar-2021, the patient experienced DIZZINESS (Felt dizzy), NERVOUSNESS (Shaky) and FEELING HOT (Felt warmth all over body). On 19-Mar-2021, the patient experienced FATIGUE (Fatigue). On 17-Mar-2021, FEELING ABNORMAL (Felt something going through his system), DIZZINESS (Felt dizzy), NERVOUSNESS (Shaky) and FEELING HOT (Felt warmth all over body) had resolved. At the time of the report, FATIGUE (Fatigue) had resolved.            The patient's medical history was not provided.  No relevant concomitant medications were reported. No treatment information was provided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test positive, Dyspnoea, Hypoaesthesia
Clinical narrative: Antibody test positive; numbness on her face; Shortness of breath, ¨it was pretty bad, and lasted 2 weeks and a half¨; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath, ¨it was pretty bad, and lasted 2 weeks and a half¨), HYPOAESTHESIA (numbness on her face) and ANTIBODY TEST POSITIVE (Antibody test positive) in a 40-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 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced DYSPNOEA (Shortness of breath, ¨it was pretty bad, and lasted 2 weeks and a half¨). On 20-Feb-2021, the patient experienced HYPOAESTHESIA (numbness on her face). On 24-Mar-2021, the patient experienced ANTIBODY TEST POSITIVE (Antibody test positive). On 21-Feb-2021, HYPOAESTHESIA (numbness on her face) had resolved. At the time of the report, DYSPNOEA (Shortness of breath, ¨it was pretty bad, and lasted 2 weeks and a half¨) and ANTIBODY TEST POSITIVE (Antibody test positive) 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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Looks like a little blue vein in the mark; "covid arm", warm, red, itchy, swollen; "covid arm", warm, red, itchy, swollen; "covid arm", warm, red, itchy, swollen; "covid arm", warm, red, itchy, swollen; hardness.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE DISCOLOURATION (Looks like a little blue vein in the mark), VACCINATION SITE WARMTH ("covid arm", warm, red, itchy, swollen), VACCINATION SITE ERYTHEMA ("covid arm", warm, red, itchy, swollen), VACCINATION SITE PRURITUS ("covid arm", warm, red, itchy, swollen) and VACCINATION SITE SWELLING ("covid arm", warm, red, itchy, swollen) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included HYDROCHLOROTHIAZIDE and POTASSIUM for an unknown indication.    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 VACCINATION SITE DISCOLOURATION (Looks like a little blue vein in the mark), VACCINATION SITE WARMTH ("covid arm", warm, red, itchy, swollen), VACCINATION SITE ERYTHEMA ("covid arm", warm, red, itchy, swollen), VACCINATION SITE PRURITUS ("covid arm", warm, red, itchy, swollen), VACCINATION SITE SWELLING ("covid arm", warm, red, itchy, swollen) and VACCINATION SITE INDURATION (hardness.). At the time of the report, VACCINATION SITE DISCOLOURATION (Looks like a little blue vein in the mark), VACCINATION SITE WARMTH ("covid arm", warm, red, itchy, swollen), VACCINATION SITE ERYTHEMA ("covid arm", warm, red, itchy, swollen), VACCINATION SITE PRURITUS ("covid arm", warm, red, itchy, swollen), VACCINATION SITE SWELLING ("covid arm", warm, red, itchy, swollen) and VACCINATION SITE INDURATION (hardness.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       treatment med: hydrocortisone ointment, claritine, cold compress   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Looks like a little blue vein in the mark; "covid arm", warm, red, itchy, swollen; "covid arm", warm, red, itchy, swollen; "covid arm", warm, red, itchy, swollen; "covid arm", warm, red, itchy, swollen; hardness.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE DISCOLOURATION (Looks like a little blue vein in the mark), VACCINATION SITE WARMTH ("covid arm", warm, red, itchy, swollen), VACCINATION SITE ERYTHEMA ("covid arm", warm, red, itchy, swollen), VACCINATION SITE PRURITUS ("covid arm", warm, red, itchy, swollen) and VACCINATION SITE SWELLING ("covid arm", warm, red, itchy, swollen) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included HYDROCHLOROTHIAZIDE and POTASSIUM for an unknown indication.    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 VACCINATION SITE DISCOLOURATION (Looks like a little blue vein in the mark), VACCINATION SITE WARMTH ("covid arm", warm, red, itchy, swollen), VACCINATION SITE ERYTHEMA ("covid arm", warm, red, itchy, swollen), VACCINATION SITE PRURITUS ("covid arm", warm, red, itchy, swollen), VACCINATION SITE SWELLING ("covid arm", warm, red, itchy, swollen) and VACCINATION SITE INDURATION (hardness.). At the time of the report, VACCINATION SITE DISCOLOURATION (Looks like a little blue vein in the mark), VACCINATION SITE WARMTH ("covid arm", warm, red, itchy, swollen), VACCINATION SITE ERYTHEMA ("covid arm", warm, red, itchy, swollen), VACCINATION SITE PRURITUS ("covid arm", warm, red, itchy, swollen), VACCINATION SITE SWELLING ("covid arm", warm, red, itchy, swollen) and VACCINATION SITE INDURATION (hardness.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       treatment med: hydrocortisone ointment, claritine, cold compress   Reporter did not allow further contact
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Hypoaesthesia, Paraesthesia, Vaccination site haemorrhage
Clinical narrative: when she received her second dose, it bled; fingers numb on her left side, little finger and ring finger on her left hand are still numb; fingertips to elbow cold inside; fingers tingly on her left side where she received vaccine, little finger and ring finger on her left hand are still tingly up to her elbow; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE HAEMORRHAGE (when she received her second dose, it bled), HYPOAESTHESIA (fingers numb on her left side, little finger and ring finger on her left hand are still numb), FEELING COLD (fingertips to elbow cold inside) and PARAESTHESIA (fingers tingly on her left side where she received vaccine, little finger and ring finger on her left hand are still tingly up to her elbow) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 022M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021 at 9:45 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced HYPOAESTHESIA (fingers numb on her left side, little finger and ring finger on her left hand are still numb), FEELING COLD (fingertips to elbow cold inside) and PARAESTHESIA (fingers tingly on her left side where she received vaccine, little finger and ring finger on her left hand are still tingly up to her elbow). On 01-Apr-2021 at 9:45 AM, the patient experienced VACCINATION SITE HAEMORRHAGE (when she received her second dose, it bled). At the time of the report, VACCINATION SITE HAEMORRHAGE (when she received her second dose, it bled) outcome was unknown and HYPOAESTHESIA (fingers numb on her left side, little finger and ring finger on her left hand are still numb), FEELING COLD (fingertips to elbow cold inside) and PARAESTHESIA (fingers tingly on her left side where she received vaccine, little finger and ring finger on her left hand are still tingly up to her elbow) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information were not reported. Action taken with mRNA-1273 in response to the events was not Applicable.  Company comment:Based on the current information and the temporal association between the events and the use of the product a causal relationship cannot be excluded.   This case was linked to MOD-2021-065431 (Patient Link).; Sender's Comments: Based on the current information and the temporal association between the events and the use of the product a causal relationship cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Incorrect route of product administration, Pain, Pain in extremity, Product dose omission issue
Clinical narrative: late for second dose; believes injection was administered too high on arm; severe pain in waist; svere pain in left shoulder; Severe Pain in left arms/arm pain for 5 weeks; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Severe Pain in left arms/arm pain for 5 weeks), PRODUCT DOSE OMISSION ISSUE (late for second dose), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (believes injection was administered too high on arm), PAIN (severe pain in waist) and ARTHRALGIA (svere pain in left shoulder) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder and Cholesterol.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (Severe Pain in left arms/arm pain for 5 weeks), PAIN (severe pain in waist) and ARTHRALGIA (svere pain in left shoulder). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (late for second dose) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (believes injection was administered too high on arm). At the time of the report, PAIN IN EXTREMITY (Severe Pain in left arms/arm pain for 5 weeks), PRODUCT DOSE OMISSION ISSUE (late for second dose), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (believes injection was administered too high on arm), PAIN (severe pain in waist) and ARTHRALGIA (svere pain in left shoulder) outcome was unknown.            Concomitant product Unspecific thyroid medication and Unspecific cholesterol medication.  Treatment was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Follow up received; AE information was updated.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Facial spasm, Fatigue, Gait inability, Hypotension
Clinical narrative: sore throat.; felt tired; fever was 101.9 °F; couldn't walk; chills; blood pressure going down; L side of the face started to spasm; tired; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL SPASM (L side of the face started to spasm), GAIT INABILITY (couldn't walk), OROPHARYNGEAL PAIN (sore throat.), FATIGUE (felt tired) and PYREXIA (fever was 101.9 °F) in a 56-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.     The patient's past medical history included COVID-19.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced FACIAL SPASM (L side of the face started to spasm), FATIGUE (tired) and HYPOTENSION (blood pressure going down). On 14-Mar-2021, the patient experienced GAIT INABILITY (couldn't walk), PYREXIA (fever was 101.9 °F) and CHILLS (chills). On 01-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat.) and FATIGUE (felt tired). At the time of the report, FACIAL SPASM (L side of the face started to spasm), GAIT INABILITY (couldn't walk), OROPHARYNGEAL PAIN (sore throat.), FATIGUE (felt tired), PYREXIA (fever was 101.9 °F), FATIGUE (tired), CHILLS (chills) and HYPOTENSION (blood pressure going down) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       relevant concomitant products usage were not reported by the reporter.treatment details not included.   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2021: Initial Additional-1
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: sore throat.; felt tired; fever was 101.9 °F; couldn't walk; chills; blood pressure going down; L side of the face started to spasm; tired; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL SPASM (L side of the face started to spasm), GAIT INABILITY (couldn't walk), OROPHARYNGEAL PAIN (sore throat.), FATIGUE (felt tired) and PYREXIA (fever was 101.9 °F) in a 56-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.     The patient's past medical history included COVID-19.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced FACIAL SPASM (L side of the face started to spasm), FATIGUE (tired) and HYPOTENSION (blood pressure going down). On 14-Mar-2021, the patient experienced GAIT INABILITY (couldn't walk), PYREXIA (fever was 101.9 °F) and CHILLS (chills). On 01-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat.) and FATIGUE (felt tired). At the time of the report, FACIAL SPASM (L side of the face started to spasm), GAIT INABILITY (couldn't walk), OROPHARYNGEAL PAIN (sore throat.), FATIGUE (felt tired), PYREXIA (fever was 101.9 °F), FATIGUE (tired), CHILLS (chills) and HYPOTENSION (blood pressure going down) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       relevant concomitant products usage were not reported by the reporter.treatment details not included.   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2021: Initial Additional-1
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Headache, Pyrexia
Clinical narrative: fever; chills; joint pain; headache; diarrhoea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhoea), PYREXIA (fever), CHILLS (chills), ARTHRALGIA (joint pain) and HEADACHE (headache) in a 69-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. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), GABAPENTIN, HYDROXYCHLOROQUINE, cetroline and sleeping medicine taken rarely for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced DIARRHOEA (diarrhoea). On an unknown date, the patient experienced PYREXIA (fever), CHILLS (chills), ARTHRALGIA (joint pain) and HEADACHE (headache). On 04-Mar-2021, DIARRHOEA (diarrhoea) had resolved. At the time of the report, PYREXIA (fever), CHILLS (chills), ARTHRALGIA (joint pain) and HEADACHE (headache) 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.   Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), GABAPENTIN, HYDROXYCHLOROQUINE, cetroline and sleeping medicine taken rarely for an unknown indication