chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Heavy arm; Sore arm; Dull headache; Extreme fatigue and weakness; Violent Headache for almost 2 months/ Splitting Headache 10/10; Shivering; This spontaneous case was reported by a health care professional and describes the occurrence of LIMB DISCOMFORT (Heavy arm), MYALGIA (Sore arm), HEADACHE (Violent Headache for almost 2 months/ Splitting Headache 10/10), CHILLS (Shivering) and HEADACHE (Dull headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 026L21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hives on 06-Jun-1997. Concomitant products included ALPRAZOLAM (ATARAX [ALPRAZOLAM]) for Hives.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jan-2021 at 8:00 PM, the patient experienced HEADACHE (Violent Headache for almost 2 months/ Splitting Headache 10/10) and CHILLS (Shivering). On 26-Jan-2021, the patient experienced FATIGUE (Extreme fatigue and weakness). On 23-Mar-2021, the patient experienced HEADACHE (Dull headache). On an unknown date, the patient experienced LIMB DISCOMFORT (Heavy arm) and MYALGIA (Sore arm). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Headache, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 23-Mar-2021, HEADACHE (Violent Headache for almost 2 months/ Splitting Headache 10/10) had resolved with sequelae. At the time of the report, LIMB DISCOMFORT (Heavy arm), MYALGIA (Sore arm), CHILLS (Shivering) and FATIGUE (Extreme fatigue and weakness) outcome was unknown and HEADACHE (Dull headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered HEADACHE (Violent Headache for almost 2 months/ Splitting Headache 10/10), CHILLS (Shivering) and HEADACHE (Dull headache) to be related. No further causality assessments were provided for LIMB DISCOMFORT (Heavy arm), MYALGIA (Sore arm) and FATIGUE (Extreme fatigue and weakness).    Action taken with mRNA-1273 in response to the events was not applicable.       Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Patient demographics updated, added relevant history, updated dose 1 and 2 details,added concomitant and treatment drugs, updated event outcomes and added new event Fatigue,dull headache.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Fatigue, Lethargy, SARS-CoV-2 test positive
Clinical narrative: Positive for Covid; loss of smell; lethargic; Feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive for Covid), ANOSMIA (loss of smell), LETHARGY (lethargic) and FATIGUE (Feeling tired) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B214) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive for Covid), ANOSMIA (loss of smell), LETHARGY (lethargic) and FATIGUE (Feeling tired). On 27-Apr-2021, LETHARGY (lethargic) and FATIGUE (Feeling tired) had resolved. At the time of the report, SARS-COV-2 TEST POSITIVE (Positive for Covid) and ANOSMIA (loss of smell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment information was reported
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission in error
Clinical narrative: Missed 2nd shot and asking for 2nd shot which will be passed 42 days; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION IN ERROR (Missed 2nd shot and asking for 2nd shot which will be passed 42 days) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.   On 11-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 PRODUCT DOSE OMISSION IN ERROR (Missed 2nd shot and asking for 2nd shot which will be passed 42 days). At the time of the report, PRODUCT DOSE OMISSION IN ERROR (Missed 2nd shot and asking for 2nd shot which will be passed 42 days) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dental discomfort, Migraine, Myalgia, Rhinorrhoea, Vaccination site erythema
Clinical narrative: Area around the injection site is hot to the touch; The color of the skin is really red - like when you have infection, Staph or MRSA; It is kind of itchy - area around the injection site; Area around the injection site is swollen; Affecting her teeth; Migraine; Runny nose; Hurt; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine), RHINORRHOEA (Runny nose), DENTAL DISCOMFORT (Affecting her teeth), VACCINATION SITE WARMTH (Area around the injection site is hot to the touch) and VACCINATION SITE ERYTHEMA (The color of the skin is really red - like when you have infection, Staph or MRSA) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced MIGRAINE (Migraine), RHINORRHOEA (Runny nose) and MYALGIA (Hurt). On 20-Apr-2021, the patient experienced DENTAL DISCOMFORT (Affecting her teeth). On 28-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Area around the injection site is hot to the touch), VACCINATION SITE ERYTHEMA (The color of the skin is really red - like when you have infection, Staph or MRSA), VACCINATION SITE PRURITUS (It is kind of itchy - area around the injection site) and VACCINATION SITE SWELLING (Area around the injection site is swollen). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 21-Apr-2021, MIGRAINE (Migraine), RHINORRHOEA (Runny nose), DENTAL DISCOMFORT (Affecting her teeth) and MYALGIA (Hurt) had resolved. At the time of the report, VACCINATION SITE WARMTH (Area around the injection site is hot to the touch), VACCINATION SITE ERYTHEMA (The color of the skin is really red - like when you have infection, Staph or MRSA), VACCINATION SITE PRURITUS (It is kind of itchy - area around the injection site) and VACCINATION SITE SWELLING (Area around the injection site is swollen) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Area around the injection site is hot to the touch; The color of the skin is really red - like when you have infection, Staph or MRSA; It is kind of itchy - area around the injection site; Area around the injection site is swollen; Affecting her teeth; Migraine; Runny nose; Hurt; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine), RHINORRHOEA (Runny nose), DENTAL DISCOMFORT (Affecting her teeth), VACCINATION SITE WARMTH (Area around the injection site is hot to the touch) and VACCINATION SITE ERYTHEMA (The color of the skin is really red - like when you have infection, Staph or MRSA) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced MIGRAINE (Migraine), RHINORRHOEA (Runny nose) and MYALGIA (Hurt). On 20-Apr-2021, the patient experienced DENTAL DISCOMFORT (Affecting her teeth). On 28-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Area around the injection site is hot to the touch), VACCINATION SITE ERYTHEMA (The color of the skin is really red - like when you have infection, Staph or MRSA), VACCINATION SITE PRURITUS (It is kind of itchy - area around the injection site) and VACCINATION SITE SWELLING (Area around the injection site is swollen). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 21-Apr-2021, MIGRAINE (Migraine), RHINORRHOEA (Runny nose), DENTAL DISCOMFORT (Affecting her teeth) and MYALGIA (Hurt) had resolved. At the time of the report, VACCINATION SITE WARMTH (Area around the injection site is hot to the touch), VACCINATION SITE ERYTHEMA (The color of the skin is really red - like when you have infection, Staph or MRSA), VACCINATION SITE PRURITUS (It is kind of itchy - area around the injection site) and VACCINATION SITE SWELLING (Area around the injection site is swollen) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: missed 2nd dose appointment due to surgery/ over 42 days since dose 1; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed 2nd dose appointment due to surgery/ over 42 days since dose 1) 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 Surgery.    On 05-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 (missed 2nd dose appointment due to surgery/ over 42 days since dose 1). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed 2nd dose appointment due to surgery/ over 42 days since dose 1) 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 medication was reported.  Treatment information was not provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dental caries, Headache, Herpes zoster, Myalgia, Pyrexia
Clinical narrative: fever; soreness in right arm; headache; shingles outbreak on her back and tooth; tooth (described as 'like having a cavity"); This spontaneous case was reported by a patient and describes the occurrence of HERPES ZOSTER (shingles outbreak on her back and tooth), DENTAL CARIES (tooth (described as 'like having a cavity")), PYREXIA (fever), MYALGIA (soreness in right arm) and HEADACHE (headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 01-Apr-2021, the patient experienced PYREXIA (fever), MYALGIA (soreness in right arm) and HEADACHE (headache). In April 2021, the patient experienced HERPES ZOSTER (shingles outbreak on her back and tooth) and DENTAL CARIES (tooth (described as 'like having a cavity")). On 03-Apr-2021, PYREXIA (fever) and MYALGIA (soreness in right arm) had resolved. On 05-Apr-2021, HEADACHE (headache) had resolved. At the time of the report, HERPES ZOSTER (shingles outbreak on her back and tooth) and DENTAL CARIES (tooth (described as 'like having a cavity")) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient  took one Tylenol on 27Apr2021 at 14:00 and 28Apr2021 at 03:00.
Age: 60.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Grip strength decreased, Headache, Pain, Somnolence, Vaccination site pain
Clinical narrative: began dropping things, cannot hold onto things; sleeping alot; headache very severe from brain stem to forehead; left upper arm was a little sore for 24 hours; left upper arm was a little sore for 12hours; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (left upper arm was a little sore for 24 hours), PAIN (left upper arm was a little sore for 12hours), GRIP STRENGTH DECREASED (began dropping things, cannot hold onto things), SOMNOLENCE (sleeping alot) and HEADACHE (headache very severe from brain stem to forehead) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045821A and 018821A) for COVID-19 vaccination.    Co-suspect product included non-company product BUTALBITAL, CAFFEINE, PARACETAMOL (BUTALB/ACET/CAFFEINE) for Headache.    Concomitant products included CLONAZEPAM (CLONOPIN) for Depression, IBUPROFEN (MOTRIN [IBUPROFEN]) for Headache, FLEXAVIL for Tendonitis, CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient started BUTALBITAL, CAFFEINE, PARACETAMOL (BUTALB/ACET/CAFFEINE) (unknown route) at an unspecified dose. On 22-Mar-2021, the patient experienced PAIN (left upper arm was a little sore for 12hours). On 25-Mar-2021, the patient experienced VACCINATION SITE PAIN (left upper arm was a little sore for 24 hours). On 28-Apr-2021, the patient experienced HEADACHE (headache very severe from brain stem to forehead). On an unknown date, the patient experienced GRIP STRENGTH DECREASED (began dropping things, cannot hold onto things) and SOMNOLENCE (sleeping alot). On 23-Mar-2021, PAIN (left upper arm was a little sore for 12hours) outcome was unknown. On 25-Mar-2021, VACCINATION SITE PAIN (left upper arm was a little sore for 24 hours) had resolved. At the time of the report, GRIP STRENGTH DECREASED (began dropping things, cannot hold onto things), SOMNOLENCE (sleeping alot) and HEADACHE (headache very severe from brain stem to forehead) outcome was unknown. Not Related      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   other concomintant medication were Cholesterol pill,Whole Aspirin pill,triglycerides pill treatment products were Motrin andBenadryl - headache pain Flexaril,Clonopin   This case was linked to MOD-2021-095477 (Patient Link).
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: injection arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (injection arm soreness) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (injection arm soreness). On 27-Jan-2021, PAIN IN EXTREMITY (injection arm soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication history not provided by reporter.  Treatment information was unknown.   This case was linked to MOD-2021-095499 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Accident, Blood test, Disturbance in attention, Sleep study, Somnolence
Clinical narrative: Driving home and hit several trees; Van was totaled; Patient mentioned that patient could not stay awake after the dose/could not stay awake/3-4 hours nap; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Patient mentioned that patient could not stay awake after the dose/could not stay awake/3-4 hours nap), DISTURBANCE IN ATTENTION (Driving home and hit several trees) and ACCIDENT (Van was totaled) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 200GC21A) for COVID-19 vaccination.     The patient's past medical history included Loss of consciousness. Concurrent medical conditions included Seizure. Concomitant products included LEVETIRACETAM for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced SOMNOLENCE (Patient mentioned that patient could not stay awake after the dose/could not stay awake/3-4 hours nap). On 24-Apr-2021, the patient experienced DISTURBANCE IN ATTENTION (Driving home and hit several trees) and ACCIDENT (Van was totaled). At the time of the report, SOMNOLENCE (Patient mentioned that patient could not stay awake after the dose/could not stay awake/3-4 hours nap), DISTURBANCE IN ATTENTION (Driving home and hit several trees) and ACCIDENT (Van was totaled) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, Blood test: normal normal (normal) normal. On 21-Apr-2021, Sleep study: normal normal (normal) normal.         This case was linked to MOD-2021-095406 (Patient Link).
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: the Moderna vaccine was administered to a patient who is not 18 years old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (the Moderna vaccine was administered to a patient who is not 18 years old) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (the Moderna vaccine was administered to a patient who is not 18 years old). On 28-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (the Moderna vaccine was administered to a patient who is not 18 years old) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dysphagia, Dyspnoea, Insomnia
Clinical narrative: Difficulty in swallowing; Breathing issue; Dizziness; Weakness; Sleepless nights; Excruciating pain; Night sweat; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (Difficulty in swallowing), DYSPNOEA (Breathing issue), DIZZINESS (Dizziness), ASTHENIA (Weakness) and INSOMNIA (Sleepless nights) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPHAGIA (Difficulty in swallowing), DYSPNOEA (Breathing issue), DIZZINESS (Dizziness), ASTHENIA (Weakness), INSOMNIA (Sleepless nights), PAIN (Excruciating pain), NIGHT SWEATS (Night sweat) and NAUSEA (nausea). At the time of the report, DYSPHAGIA (Difficulty in swallowing), DYSPNOEA (Breathing issue), DIZZINESS (Dizziness), ASTHENIA (Weakness), INSOMNIA (Sleepless nights), PAIN (Excruciating pain), NIGHT SWEATS (Night sweat) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Night sweats, Pain
Clinical narrative: Difficulty in swallowing; Breathing issue; Dizziness; Weakness; Sleepless nights; Excruciating pain; Night sweat; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (Difficulty in swallowing), DYSPNOEA (Breathing issue), DIZZINESS (Dizziness), ASTHENIA (Weakness) and INSOMNIA (Sleepless nights) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPHAGIA (Difficulty in swallowing), DYSPNOEA (Breathing issue), DIZZINESS (Dizziness), ASTHENIA (Weakness), INSOMNIA (Sleepless nights), PAIN (Excruciating pain), NIGHT SWEATS (Night sweat) and NAUSEA (nausea). At the time of the report, DYSPHAGIA (Difficulty in swallowing), DYSPNOEA (Breathing issue), DIZZINESS (Dizziness), ASTHENIA (Weakness), INSOMNIA (Sleepless nights), PAIN (Excruciating pain), NIGHT SWEATS (Night sweat) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Erythema, Fatigue, Fibromyalgia
Clinical narrative: redness; Fibromyalgia worsened; vaccination site pain; 1 day; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), FIBROMYALGIA (Fibromyalgia worsened), FATIGUE (fatigue), PYREXIA (1 day) and VACCINATION SITE PAIN (vaccination site pain) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042A21A and 025A21X) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Anxiety and Fibromyalgia. Concomitant products included LORAZEPAM for Anxiety and Sleep disorder, TRAMADOL for Fibromyalgia.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (fatigue). On 14-Apr-2021, the patient experienced PYREXIA (1 day). On 23-Apr-2021, the patient experienced ERYTHEMA (redness), FIBROMYALGIA (Fibromyalgia worsened) and VACCINATION SITE PAIN (vaccination site pain). The patient was treated with LOSARTAN at a dose of 1 dosage form; PROPRANOLOL at a dose of 1 dosage form and FUROSEMIDE at an unspecified dose and frequency. At the time of the report, ERYTHEMA (redness), FIBROMYALGIA (Fibromyalgia worsened), FATIGUE (fatigue), PYREXIA (1 day) and VACCINATION SITE PAIN (vaccination site pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Blood pressure measurement: 145/115 (High) 145/115 mmHg. On 13-Apr-2021, Body temperature: 100 (High) 100F. On 28-Apr-2021, Blood pressure measurement: 118/93 (Inconclusive) 118/93. On an unknown date, Blood pressure measurement: 115-125/90-95 (Inconclusive) 115-125/90-95 and 160/115 (High) 160/115. On an unknown date, Heart rate: 110 (High) 110 and 135 (High) 135.         Action taken for Moderna COVID-19 Vaccine was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-095389 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Lab data updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-095389:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Pyrexia, Vaccination site pain
Clinical narrative: redness; Fibromyalgia worsened; vaccination site pain; 1 day; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), FIBROMYALGIA (Fibromyalgia worsened), FATIGUE (fatigue), PYREXIA (1 day) and VACCINATION SITE PAIN (vaccination site pain) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042A21A and 025A21X) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Anxiety and Fibromyalgia. Concomitant products included LORAZEPAM for Anxiety and Sleep disorder, TRAMADOL for Fibromyalgia.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (fatigue). On 14-Apr-2021, the patient experienced PYREXIA (1 day). On 23-Apr-2021, the patient experienced ERYTHEMA (redness), FIBROMYALGIA (Fibromyalgia worsened) and VACCINATION SITE PAIN (vaccination site pain). The patient was treated with LOSARTAN at a dose of 1 dosage form; PROPRANOLOL at a dose of 1 dosage form and FUROSEMIDE at an unspecified dose and frequency. At the time of the report, ERYTHEMA (redness), FIBROMYALGIA (Fibromyalgia worsened), FATIGUE (fatigue), PYREXIA (1 day) and VACCINATION SITE PAIN (vaccination site pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Blood pressure measurement: 145/115 (High) 145/115 mmHg. On 13-Apr-2021, Body temperature: 100 (High) 100F. On 28-Apr-2021, Blood pressure measurement: 118/93 (Inconclusive) 118/93. On an unknown date, Blood pressure measurement: 115-125/90-95 (Inconclusive) 115-125/90-95 and 160/115 (High) 160/115. On an unknown date, Heart rate: 110 (High) 110 and 135 (High) 135.         Action taken for Moderna COVID-19 Vaccine was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-095389 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Lab data updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-095389:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed 2nd shot and asking for 2nd shot passed 42 days of 1st shot; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed 2nd shot and asking for 2nd shot passed 42 days of 1st shot) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed 2nd shot and asking for 2nd shot passed 42 days of 1st shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed 2nd shot and asking for 2nd shot passed 42 days of 1st shot) 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.   Concomitant medication was not provided. Treatment information was not provided.   This case was linked to MOD21-083293 (E2B Linked Report).; Sender's Comments:  MOD21-083293:
Sex: U
Vaccine: COVID19
Symptoms: Product administered at inappropriate site
Clinical narrative: This spontaneous case reported by a physician, describes the occurrence of product administered at inappropriate site (site of the injection more towards the triceps than the deltoid muscle) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Apr 28, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 28, 2021, patient experienced product administered at inappropriate site (site of the injection more towards the triceps than the deltoid muscle). At the time of the report, product administered at inappropriate site (site of the injection more towards the triceps than the deltoid muscle) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. Reported information included injection taken towards the triceps than the deltoid muscle.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Somnolence, Vaccination site induration, Vaccination site swelling
Clinical narrative: felt drowsy; the injection site have swollen there is no discoloration but it's stiff; the injection site have swollen as a size of large mosquito bite; small headache; foggy in head; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (foggy in head), SOMNOLENCE (felt drowsy), VACCINATION SITE INDURATION (the injection site have swollen there is no discoloration but it's stiff), VACCINATION SITE SWELLING (the injection site have swollen as a size of large mosquito bite) and HEADACHE (small headache) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced FEELING ABNORMAL (foggy in head) and HEADACHE (small headache). On 28-Apr-2021, the patient experienced SOMNOLENCE (felt drowsy), VACCINATION SITE INDURATION (the injection site have swollen there is no discoloration but it's stiff) and VACCINATION SITE SWELLING (the injection site have swollen as a size of large mosquito bite). At the time of the report, FEELING ABNORMAL (foggy in head), SOMNOLENCE (felt drowsy), VACCINATION SITE INDURATION (the injection site have swollen there is no discoloration but it's stiff), VACCINATION SITE SWELLING (the injection site have swollen as a size of large mosquito bite) and HEADACHE (small headache) outcome was unknown.            No concomitant medications were provided.  No treatment details were provided.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Amniocentesis, Blood glucose, Cytogenetic analysis, Exposure during pregnancy, Pain in extremity
Clinical narrative: Sore arm; vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) and PAIN IN EXTREMITY (Sore arm) in a 31-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     The patient's past medical history included Alcoholic from 31-Mar-2011 to 12-Feb-2021 and Pregnant on 08-Sep-2020. Concurrent medical conditions included Anemia and Thalassemia. Concomitant products included IRON from 17-Feb-2021 to an unknown date for Anemia, CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]) for Nausea, PRENATAL S from 17-Feb-2021 to an unknown date for Pregnancy.    On 28-Apr-2021 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 02-Jan-2021 and the estimated date of delivery was 23-Oct-2021. On 28-Apr-2021, the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). On 29-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  sixteenth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Full-term. For neonate 1, The outcome was reported as Delivered NOS. On 28-Apr-2021, EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, Pregnancy test: positive (Positive) Positive. On 28-Apr-2021, Prenatal screening test: normal (normal) normal. On 24-May-2021, Cytogenetic analysis: normal (normal) Normal. On 26-May-2021, Amniocentesis: normal (normal) Normal. On 08-Jun-2021, Ultrasound scan normal: normal (normal) normal. On 21-Jul-2021, Blood glucose: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       .   This case was linked to MOD-2021-227709 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Initial Additional-1 : VAERS, AE details, Dose 2 Details, Patient medical history were reported. On 30-Jul-2021: Follow-up information received contains Significant information:Pregnancy Information updated, Patient details updated, Lab test and Concomitant product updated
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pregnancy test, Prenatal screening test, Ultrasound scan normal
Clinical narrative: Sore arm; vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) and PAIN IN EXTREMITY (Sore arm) in a 31-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     The patient's past medical history included Alcoholic from 31-Mar-2011 to 12-Feb-2021 and Pregnant on 08-Sep-2020. Concurrent medical conditions included Anemia and Thalassemia. Concomitant products included IRON from 17-Feb-2021 to an unknown date for Anemia, CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]) for Nausea, PRENATAL S from 17-Feb-2021 to an unknown date for Pregnancy.    On 28-Apr-2021 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 02-Jan-2021 and the estimated date of delivery was 23-Oct-2021. On 28-Apr-2021, the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). On 29-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  sixteenth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Full-term. For neonate 1, The outcome was reported as Delivered NOS. On 28-Apr-2021, EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, Pregnancy test: positive (Positive) Positive. On 28-Apr-2021, Prenatal screening test: normal (normal) normal. On 24-May-2021, Cytogenetic analysis: normal (normal) Normal. On 26-May-2021, Amniocentesis: normal (normal) Normal. On 08-Jun-2021, Ultrasound scan normal: normal (normal) normal. On 21-Jul-2021, Blood glucose: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       .   This case was linked to MOD-2021-227709 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Initial Additional-1 : VAERS, AE details, Dose 2 Details, Patient medical history were reported. On 30-Jul-2021: Follow-up information received contains Significant information:Pregnancy Information updated, Patient details updated, Lab test and Concomitant product updated
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Influenza like illness
Clinical narrative: feels like she has the flu; Chills; Diarrhea; slightly Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), INFLUENZA LIKE ILLNESS (feels like she has the flu), HEADACHE (slightly Headache) and CHILLS (Chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced DIARRHOEA (Diarrhea) and HEADACHE (slightly Headache). On 28-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (feels like she has the flu) and CHILLS (Chills). At the time of the report, DIARRHOEA (Diarrhea), INFLUENZA LIKE ILLNESS (feels like she has the flu), HEADACHE (slightly Headache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment information was provided.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain, Swelling, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: swollen; sore; site of the injection is itchy; more red and swollen and bigger and itchy/one arm looks a lot bigger than other arm; red around injection; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swollen), PAIN (sore), VACCINATION SITE PRURITUS (site of the injection is itchy), LIMB DISCOMFORT (more red and swollen and bigger and itchy/one arm looks a lot bigger than other arm) and VACCINATION SITE ERYTHEMA (red around injection) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING (swollen), PAIN (sore), VACCINATION SITE PRURITUS (site of the injection is itchy), LIMB DISCOMFORT (more red and swollen and bigger and itchy/one arm looks a lot bigger than other arm) and VACCINATION SITE ERYTHEMA (red around injection). At the time of the report, SWELLING (swollen), PAIN (sore), VACCINATION SITE PRURITUS (site of the injection is itchy), LIMB DISCOMFORT (more red and swollen and bigger and itchy/one arm looks a lot bigger than other arm) and VACCINATION SITE ERYTHEMA (red around injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. Treatment included use of ice.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site pain
Clinical narrative: Body ache; Sore arm at injection site; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body ache), VACCINATION SITE PAIN (Sore arm at injection site) and PYREXIA (Fever) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 01M20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced PAIN (Body ache), VACCINATION SITE PAIN (Sore arm at injection site) and PYREXIA (Fever). On 17-Feb-2021, PAIN (Body ache) and PYREXIA (Fever) had resolved. On 23-Feb-2021, VACCINATION SITE PAIN (Sore arm at injection site) had resolved.            No concomitant medications were provided. No treatment drugs were reported.  Action taken with respect to mRNA-1273 was not applicable.  Patient reported having symptoms within 12-24 hours from vaccine. Soreness at injection site persisted for a week.   This case was linked to MOD-2021-095439 (Patient Link).
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient missed her second Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient missed her second Moderna vaccine) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient missed her second Moderna vaccine). On 28-Apr-2021, PRODUCT DOSE OMISSION ISSUE (Patient missed her second Moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications were not reported.  Treatment information was not provided.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Diarrhea; Fever 100.4 F; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and PYREXIA (Fever 100.4 F) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced DIARRHOEA (Diarrhea) and PYREXIA (Fever 100.4 F). At the time of the report, DIARRHOEA (Diarrhea) and PYREXIA (Fever 100.4 F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications was not reported. the treatment history was not provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Insomnia
Clinical narrative: Shivering; weakness; Out of work - extreme fatigue; Uncontrollable shaking; Violent Headache for almost 2 months/ severe headache; Uncontrollable aches; Sleepless due to unconfortable shaking; This spontaneous case was reported by a nurse and describes the occurrence of ASTHENIA (weakness), TREMOR (Uncontrollable shaking), INSOMNIA (Sleepless due to unconfortable shaking), CHILLS (Shivering) and HEADACHE (Violent Headache for almost 2 months/ severe headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 02bL20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hives since 06-Jun-1997. Concomitant products included HYDROXYZINE HYDROCHLORIDE (ATARAX [HYDROXYZINE HYDROCHLORIDE]) for Itching.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INSOMNIA (Sleepless due to unconfortable shaking). On 25-Jan-2021 at 8:00 PM, the patient experienced TREMOR (Uncontrollable shaking), HEADACHE (Violent Headache for almost 2 months/ severe headache) and MYALGIA (Uncontrollable aches). On 26-Jan-2021, the patient experienced ASTHENIA (weakness) and FATIGUE (Out of work - extreme fatigue). On an unknown date, the patient experienced CHILLS (Shivering). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) for Adverse event, at an unspecified dose and frequency. At the time of the report, ASTHENIA (weakness), TREMOR (Uncontrollable shaking), INSOMNIA (Sleepless due to unconfortable shaking), CHILLS (Shivering), MYALGIA (Uncontrollable aches) and FATIGUE (Out of work - extreme fatigue) outcome was unknown and HEADACHE (Violent Headache for almost 2 months/ severe headache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Did Moderna COVID-19 vaccine cause clotting or bleeding issue and patient like to get a feedback on the animal studies and past 15 year how their brains looked in autopsy.   This case was linked to MOD-2021-095404 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Medical history added, concomitant medication added, treatment medication added, event added and patient demographics added.