chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Pain
Clinical narrative: Light Headed; Pain; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light Headed), PAIN (Pain), FATIGUE (Fatigue) and CHILLS (Chills) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced DIZZINESS (Light Headed), PAIN (Pain), FATIGUE (Fatigue) and CHILLS (Chills). On 16-Mar-2021, DIZZINESS (Light Headed) outcome was unknown. On 21-Mar-2021, PAIN (Pain) and FATIGUE (Fatigue) outcome was unknown and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medicine was reported.  No treatment was reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Warm to the touch at the site of injection; Itchiness at the site of injection; Redness at the site of injection; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch at the site of injection), VACCINATION SITE PRURITUS (Itchiness at the site of injection), VACCINATION SITE ERYTHEMA (Redness at the site of injection) and PYREXIA (Fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) 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) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm to the touch at the site of injection), VACCINATION SITE PRURITUS (Itchiness at the site of injection), VACCINATION SITE ERYTHEMA (Redness at the site of injection) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and CORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Warm to the touch at the site of injection), VACCINATION SITE PRURITUS (Itchiness at the site of injection), VACCINATION SITE ERYTHEMA (Redness at the site of injection) and PYREXIA (Fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: follow up received: contains no new information
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Long lasting headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Long lasting headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 024M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (Long lasting headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, HEADACHE (Long lasting headache) had not resolved.            Patient experienced event for the first vaccine dose which lasted for one day two weeks after administration.  Patient informed she also experienced headaches on a daily basis.   Action taken with mRNA-1273 in response to the event was not Applicable   This case was linked to MOD-2021-053416 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow-up information received on 14 MAY 2021 and does not contain any new information.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure measurement, Incorrect route of product administration, Pain, Shoulder injury related to vaccine administration
Clinical narrative: Specialist indicated SIRVA; inflamed (the area); pain went from shoulder to wrist; shoulder pain; shot went straight into my shoulder; stuck needle in twice; This spontaneous case was reported by a consumer and describes the occurrence of SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (Specialist indicated SIRVA), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (shot went straight into my shoulder), WRONG TECHNIQUE IN DEVICE USAGE PROCESS (stuck needle in twice), VACCINATION SITE INFLAMMATION (inflamed (the area)) and PAIN (pain went from shoulder to wrist) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (shot went straight into my shoulder) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (stuck needle in twice). On an unknown date, the patient experienced SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (Specialist indicated SIRVA), VACCINATION SITE INFLAMMATION (inflamed (the area)), PAIN (pain went from shoulder to wrist) and ARTHRALGIA (shoulder pain). On 04-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (shot went straight into my shoulder) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (stuck needle in twice) had resolved. At the time of the report, SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (Specialist indicated SIRVA), VACCINATION SITE INFLAMMATION (inflamed (the area)) and PAIN (pain went from shoulder to wrist) outcome was unknown and ARTHRALGIA (shoulder pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood pressure measurement: 179/101 (High) A VERY SCARY 179 / 101.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   The vaccination was delivered into the rotator cuff and the patient said that the shot was given in the acromioclavicular area.   The treatment information included anti-inflammatories (for pain), and physical therapy.     Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Demographics updated On 08-Apr-2021: Follow up received on 8 April 2021 and  updated batch number for the first dose, lab data.; Reporter's Comments: This report refers to a case of Product administration error for mRNA-1273, lot # unknown with associated AEs of Shoulder injury related to vaccine administration, arthralgia, vaccination site inflammation and radiating pain  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site inflammation, Wrong technique in device usage process
Clinical narrative: Specialist indicated SIRVA; inflamed (the area); pain went from shoulder to wrist; shoulder pain; shot went straight into my shoulder; stuck needle in twice; This spontaneous case was reported by a consumer and describes the occurrence of SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (Specialist indicated SIRVA), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (shot went straight into my shoulder), WRONG TECHNIQUE IN DEVICE USAGE PROCESS (stuck needle in twice), VACCINATION SITE INFLAMMATION (inflamed (the area)) and PAIN (pain went from shoulder to wrist) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (shot went straight into my shoulder) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (stuck needle in twice). On an unknown date, the patient experienced SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (Specialist indicated SIRVA), VACCINATION SITE INFLAMMATION (inflamed (the area)), PAIN (pain went from shoulder to wrist) and ARTHRALGIA (shoulder pain). On 04-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (shot went straight into my shoulder) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (stuck needle in twice) had resolved. At the time of the report, SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (Specialist indicated SIRVA), VACCINATION SITE INFLAMMATION (inflamed (the area)) and PAIN (pain went from shoulder to wrist) outcome was unknown and ARTHRALGIA (shoulder pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood pressure measurement: 179/101 (High) A VERY SCARY 179 / 101.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   The vaccination was delivered into the rotator cuff and the patient said that the shot was given in the acromioclavicular area.   The treatment information included anti-inflammatories (for pain), and physical therapy.     Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Demographics updated On 08-Apr-2021: Follow up received on 8 April 2021 and  updated batch number for the first dose, lab data.; Reporter's Comments: This report refers to a case of Product administration error for mRNA-1273, lot # unknown with associated AEs of Shoulder injury related to vaccine administration, arthralgia, vaccination site inflammation and radiating pain  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient subsequently had a miscarriage and therefore got the second dose of the vaccine today, 17Mar2021 (61 days after first dose); This spontaneous retrospective pregnancy case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient subsequently had a miscarriage and therefore got the second dose of the vaccine today, 17Mar2021 (61 days after first dose)) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 17-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient subsequently had a miscarriage and therefore got the second dose of the vaccine today, 17Mar2021 (61 days after first dose)). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. On 17-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Patient subsequently had a miscarriage and therefore got the second dose of the vaccine today, 17Mar2021 (61 days after first dose)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to events was not applicable.   This case was linked to MOD-2021-048004 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow up received contains:- No new information received.
Age: 98.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Rash, Swelling
Clinical narrative: redness; swelling; rash; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), SWELLING (swelling) and RASH (rash) in a 98-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 044A2.) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced ERYTHEMA (redness), SWELLING (swelling) and RASH (rash). At the time of the report, ERYTHEMA (redness), SWELLING (swelling) and RASH (rash) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter  Treatment medication included IV antibiotics   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: TCR was received Contains no new information
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Join discomfort; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Join discomfort) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced ARTHRALGIA (Join discomfort). At the time of the report, ARTHRALGIA (Join discomfort) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable. Treatment information was not provided.   This case was linked to MOD-2021-059443 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Malaise, Pain in extremity, Pyrexia
Clinical narrative: a little pain in the arm; trembling; chills; had fever (that was never more than 101.5); malaise in the body; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (malaise in the body), PAIN IN EXTREMITY (a little pain in the arm), TREMOR (trembling), CHILLS (chills) and PYREXIA (had fever (that was never more than 101.5)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 19-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 MALAISE (malaise in the body), TREMOR (trembling), CHILLS (chills) and PYREXIA (had fever (that was never more than 101.5)). On an unknown date, the patient experienced PAIN IN EXTREMITY (a little pain in the arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK, q4h. On 21-Mar-2021, TREMOR (trembling), CHILLS (chills) and PYREXIA (had fever (that was never more than 101.5)) had resolved. At the time of the report, MALAISE (malaise in the body) and PAIN IN EXTREMITY (a little pain in the arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.5 (High) fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Patient stated that it felt like COVID-19 symptoms which occurred previously.
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: a little pain in the arm; trembling; chills; had fever (that was never more than 101.5); malaise in the body; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (malaise in the body), PAIN IN EXTREMITY (a little pain in the arm), TREMOR (trembling), CHILLS (chills) and PYREXIA (had fever (that was never more than 101.5)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 19-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 MALAISE (malaise in the body), TREMOR (trembling), CHILLS (chills) and PYREXIA (had fever (that was never more than 101.5)). On an unknown date, the patient experienced PAIN IN EXTREMITY (a little pain in the arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK, q4h. On 21-Mar-2021, TREMOR (trembling), CHILLS (chills) and PYREXIA (had fever (that was never more than 101.5)) had resolved. At the time of the report, MALAISE (malaise in the body) and PAIN IN EXTREMITY (a little pain in the arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.5 (High) fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Patient stated that it felt like COVID-19 symptoms which occurred previously.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of EXPOSURE VIA BREAST MILK (breastfeeding) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-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 EXPOSURE VIA BREAST MILK (breastfeeding). At the time of the report, EXPOSURE VIA BREAST MILK (breastfeeding) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment was provided for the event that was reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Live follow up received.No new information was updated.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Administration site bruise, Illness, Skin texture abnormal, Vaccination site erythema
Clinical narrative: little bit red at the injection site; like bruises (in the arm of the injection); little spot, like chicken skin; really sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (really sick), ADMINISTRATION SITE BRUISE (like bruises (in the arm of the injection)), SKIN TEXTURE ABNORMAL (little spot, like chicken skin) and VACCINATION SITE ERYTHEMA (little bit red at the injection site) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) 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) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced ILLNESS (really sick). On 21-Mar-2021, the patient experienced ADMINISTRATION SITE BRUISE (like bruises (in the arm of the injection)) and SKIN TEXTURE ABNORMAL (little spot, like chicken skin). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (little bit red at the injection site). At the time of the report, ILLNESS (really sick), ADMINISTRATION SITE BRUISE (like bruises (in the arm of the injection)), SKIN TEXTURE ABNORMAL (little spot, like chicken skin) and VACCINATION SITE ERYTHEMA (little bit red at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included blood pressure medication.  No treatment medication was reported.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, SARS-CoV-2 antibody test
Clinical narrative: pure liquid diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (pure liquid diarrhea) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced DIARRHOEA (pure liquid diarrhea). At the time of the report, DIARRHOEA (pure liquid diarrhea) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Mar-2021, SARS-CoV-2 antibody test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included fewamount supplements and prescribed medications.  No concomitant medication was reported.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dyspnoea, Headache, Hypersomnia, Illness
Clinical narrative: initial arm pain; Felt thirsty; felt like she was out of breathe; Slept for three days; Upper back back like she stood to long; Felt sick; Felt nausea; Had Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (initial arm pain), THIRST (Felt thirsty), DYSPNOEA (felt like she was out of breathe), HYPERSOMNIA (Slept for three days) and BACK PAIN (Upper back back like she stood to long) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (initial arm pain), THIRST (Felt thirsty), DYSPNOEA (felt like she was out of breathe), HYPERSOMNIA (Slept for three days), BACK PAIN (Upper back back like she stood to long), ILLNESS (Felt sick), NAUSEA (Felt nausea) and HEADACHE (Had Headache). At the time of the report, PAIN IN EXTREMITY (initial arm pain), THIRST (Felt thirsty), DYSPNOEA (felt like she was out of breathe), HYPERSOMNIA (Slept for three days), BACK PAIN (Upper back back like she stood to long), ILLNESS (Felt sick), NAUSEA (Felt nausea) and HEADACHE (Had Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment drug used was Bayer Aspirin
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Thirst
Clinical narrative: initial arm pain; Felt thirsty; felt like she was out of breathe; Slept for three days; Upper back back like she stood to long; Felt sick; Felt nausea; Had Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (initial arm pain), THIRST (Felt thirsty), DYSPNOEA (felt like she was out of breathe), HYPERSOMNIA (Slept for three days) and BACK PAIN (Upper back back like she stood to long) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (initial arm pain), THIRST (Felt thirsty), DYSPNOEA (felt like she was out of breathe), HYPERSOMNIA (Slept for three days), BACK PAIN (Upper back back like she stood to long), ILLNESS (Felt sick), NAUSEA (Felt nausea) and HEADACHE (Had Headache). At the time of the report, PAIN IN EXTREMITY (initial arm pain), THIRST (Felt thirsty), DYSPNOEA (felt like she was out of breathe), HYPERSOMNIA (Slept for three days), BACK PAIN (Upper back back like she stood to long), ILLNESS (Felt sick), NAUSEA (Felt nausea) and HEADACHE (Had Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment drug used was Bayer Aspirin
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Malaise, Vaccination site paraesthesia
Clinical narrative: Left arm tingling; Physically "out of it"; Mentally "out of it", felt like it could kill patient; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PARAESTHESIA (Left arm tingling), MALAISE (Physically "out of it") and FEELING ABNORMAL (Mentally "out of it", felt like it could kill patient) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS and Blood pressure high.   On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced MALAISE (Physically "out of it") and FEELING ABNORMAL (Mentally "out of it", felt like it could kill patient). On 13-Mar-2021, the patient experienced VACCINATION SITE PARAESTHESIA (Left arm tingling). At the time of the report, VACCINATION SITE PARAESTHESIA (Left arm tingling) had not resolved and MALAISE (Physically "out of it") and FEELING ABNORMAL (Mentally "out of it", felt like it could kill patient) was resolving. Not Provided          Concomitant medication use included thyroid medication and high blood pressure medication. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: No specific follow-up information recorded.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: contracted COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (contracted COVID-19) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced COVID-19 (contracted COVID-19). At the time of the report, COVID-19 (contracted COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication was reported.
Age: 98.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Nausea
Clinical narrative: Weakness; Dizzy; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), DIZZINESS (Dizzy), NAUSEA (Nausea) and HEADACHE (Headache) in a 98-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 044A2) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced ASTHENIA (Weakness), DIZZINESS (Dizzy), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, ASTHENIA (Weakness), DIZZINESS (Dizzy), NAUSEA (Nausea) and HEADACHE (Headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient stated doing very good right now and had no problems.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.   This case was linked to MOD-2021-053413 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up received , adverse events outcome and case narrative were updated.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Feeling hot
Clinical narrative: face got warm; he felt tired; face got a little reddish; This spontaneous case was reported by a patient and describes the occurrence of FEELING HOT (face got warm), ERYTHEMA (face got a little reddish) and FATIGUE (he felt tired) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis and Eye disorder. Concomitant products included PARACETAMOL (TYLENOL) for Arthritis, SELENOMETHIONINE (75 SE), XANTOFYL (LUTEIN-VISION) for Eye disorder.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced ERYTHEMA (face got a little reddish). On an unknown date, the patient experienced FEELING HOT (face got warm) and FATIGUE (he felt tired). At the time of the report, FEELING HOT (face got warm), ERYTHEMA (face got a little reddish) and FATIGUE (he felt tired) was resolving.            On an unspecified date, the patient felt tired and face got warm and after taking paracetamol he felt better. On 21-MAR-2021 night, his face got warm again and l little reddish and after taking paracetamol he felt better. Action taken with mRNA-1273 in response to events was not applicable.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Headache
Clinical narrative: Pregnancy; headache; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of HEADACHE (headache) and EXPOSURE DURING PREGNANCY (Pregnancy) in a 42-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 007M20A) for COVID-19 vaccination.     There was no medical history reported by the reporter.  Concurrent medical conditions included Type 1 diabetes mellitus and Hashimoto's disease. Concomitant products included INSULIN ASPART (NOVOLOG) for Diabetes, LEVOTHYROXINE for Hashimoto's disease, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 01-Jul-2020 and the estimated date of delivery was 07-Apr-2021. On 07-Mar-2021, the patient experienced HEADACHE (headache). On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fifth week of the pregnancy. The delivery occurred  on 15-Mar-2021.  The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 11-Mar-2021, HEADACHE (headache) had resolved. At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.            The reporter reported that there had not been any complications or acute illnesses during this pregnancy to date  The patient did not had a family history of congenital anomalies/genetic disease.  The reporter reported that the patient did not use alcohol, nicotine, marijuana or any other illicit substance in past or present.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Panic attack, Pyrexia
Clinical narrative: Load of panic attacks; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PANIC ATTACK (Load of panic attacks) and PYREXIA (Fever) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02AL20A and 013L20A) for COVID-19 vaccination.     The patient's past medical history included Anxiety. Concomitant products included BUPROPION for COVID-19 vaccination, LORAZEPAM for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced PYREXIA (Fever). On 14-Mar-2021, the patient experienced PANIC ATTACK (Load of panic attacks). At the time of the report, PANIC ATTACK (Load of panic attacks) and PYREXIA (Fever) outcome was unknown. Not Provided          No treatment medications were reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Pyrexia
Clinical narrative: feels so weak; fever; Severe throbbing headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (feels so weak), PYREXIA (fever) and HEADACHE (Severe throbbing headache) in a 58-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 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced ASTHENIA (feels so weak), PYREXIA (fever) and HEADACHE (Severe throbbing headache). At the time of the report, ASTHENIA (feels so weak), PYREXIA (fever) and HEADACHE (Severe throbbing headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   Treatment detail included that the patient took Tylenol.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Drug interaction, Pain
Clinical narrative: pains; She stated that before the had the vaccine she took 1 Advil. Wanted to know if this will affect the antibody development; achy joints; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pains), DRUG INTERACTION (She stated that before the had the vaccine she took 1 Advil. Wanted to know if this will affect the antibody development) and ARTHRALGIA (achy joints) 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 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (pains), DRUG INTERACTION (She stated that before the had the vaccine she took 1 Advil. Wanted to know if this will affect the antibody development) and ARTHRALGIA (achy joints). At the time of the report, PAIN (pains), DRUG INTERACTION (She stated that before the had the vaccine she took 1 Advil. Wanted to know if this will affect the antibody development) and ARTHRALGIA (achy joints) outcome was unknown.            No concomitant medication was not reported. No treatment medication was not reported Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Vaccine Information, second dose added.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Moderna vaccine to a 17 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine to a 17 year old) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 045B21A) 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) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine to a 17 year old). On 19-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine to a 17 year old) 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 medication was reported No treatment medication was reported   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up information received on 11-May-2021, Added Patient Demographics, Suspect drug information.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site discolouration, Vaccination site pain, Vaccination site pruritus
Clinical narrative: sore arm; itching at site; pinkish in color (size of a nickel); soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), VACCINATION SITE PRURITUS (itching at site), VACCINATION SITE DISCOLOURATION (pinkish in color (size of a nickel)) and VACCINATION SITE PAIN (soreness at injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M120A) for COVID-19 vaccination.     No medical history for the patient was reported.  Concomitant products included LEVOTHYROXINE.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE PAIN (soreness at injection site). On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), VACCINATION SITE PRURITUS (itching at site) and VACCINATION SITE DISCOLOURATION (pinkish in color (size of a nickel)). On 22-Feb-2021, PAIN IN EXTREMITY (sore arm), VACCINATION SITE PRURITUS (itching at site) and VACCINATION SITE DISCOLOURATION (pinkish in color (size of a nickel)) outcome was unknown. At the time of the report, VACCINATION SITE PAIN (soreness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Myalgia
Clinical narrative: he is having aches; discomfort; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (he is having aches), DISCOMFORT (discomfort) and FATIGUE (fatigue) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On an unknown date, the patient experienced MYALGIA (he is having aches), DISCOMFORT (discomfort) and FATIGUE (fatigue). At the time of the report, MYALGIA (he is having aches), DISCOMFORT (discomfort) and FATIGUE (fatigue) outcome was unknown.            Concomitant medications includes Metoprolol, Atorvastatin, Quinapril, Lansoprazole, Solifenacin succinate, Sertraline, Baby Aspirin.  Treatment medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: Nausea; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and FATIGUE (fatigue) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TUCATINIB (TUKYSA) for Malignant neoplasm of female breast, unspecified.    Concurrent medical conditions included Breast cancer female (Unspecified site of unspecified female breast).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and TUCATINIB (TUKYSA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced NAUSEA (Nausea) and FATIGUE (fatigue). At the time of the report, NAUSEA (Nausea) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: she got really sick; fever of 103 (°F); Dose 2, 28 days later in February; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 2, 28 days later in February), ILLNESS (she got really sick) and PYREXIA (fever of 103 (°F)) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history reported.).   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 2, 28 days later in February). On an unknown date, the patient experienced ILLNESS (she got really sick) and PYREXIA (fever of 103 (°F)). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 2, 28 days later in February), ILLNESS (she got really sick) and PYREXIA (fever of 103 (°F)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided No treatment medications were provided Action taken with mRNA-1273 is not applicable.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: Sore arm; Rash that started on ankles and wrists and the moved to arms and legs in clusters; This spontaneous case was reported by an other health care professional and describes the occurrence of RASH (Rash that started on ankles and wrists and the moved to arms and legs in clusters) and PAIN IN EXTREMITY (Sore arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included CELECOXIB (CELEXA [CELECOXIB]), LEVOTHYROXINE SODIUM (SYNTHROID) and LEVETIRACETAM (KEPPRA) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced RASH (Rash that started on ankles and wrists and the moved to arms and legs in clusters). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, RASH (Rash that started on ankles and wrists and the moved to arms and legs in clusters) and PAIN IN EXTREMITY (Sore arm) 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.   Treatment medications like Benadryl (Diphenhydramine) was included.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash got dark; red rash on her legs and arms; This spontaneous case was reported by a consumer and describes the occurrence of RASH (red rash on her legs and arms) and RASH (rash got dark) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced RASH (red rash on her legs and arms). On an unknown date, the patient experienced RASH (rash got dark). At the time of the report, RASH (red rash on her legs and arms) and RASH (rash got dark) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included hydrocortizone cream and Benadryl   Reporter did not allow further contact
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Headache, Insomnia, Pain, Pain in extremity
Clinical narrative: toothache; body ache; didnt sleep; loss of equilibrium; headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of TOOTHACHE (toothache), PAIN (body ache), PAIN IN EXTREMITY (sore arm), INSOMNIA (didnt sleep) and BALANCE DISORDER (loss of equilibrium) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 18-Mar-2021, the patient experienced TOOTHACHE (toothache), PAIN (body ache), INSOMNIA (didnt sleep), BALANCE DISORDER (loss of equilibrium) and HEADACHE (headache). At the time of the report, TOOTHACHE (toothache), PAIN (body ache), PAIN IN EXTREMITY (sore arm), INSOMNIA (didnt sleep), BALANCE DISORDER (loss of equilibrium) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       NO concomitant medication provided Treatment included Tylenol   This case was linked to MOD-2021-116598 (Patient Link).