chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site warmth
Clinical narrative: Vaccination site rash; Vaccination site redness; Vaccination site  itching; Flu-like Symptoms; joint pain; fatigue; nausea; injection site pain; headache; Shortness of breath; swelling; warmth; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), SWELLING (swelling), VACCINATION SITE WARMTH (warmth), INFLUENZA LIKE ILLNESS (Flu-like Symptoms) and INJECTION SITE PAIN (injection site pain) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Ceclor , codeine), Multiple myeloma since 19-Oct-2020, Sick sinus syndrome since 01-Jan-2017, Asthma since 02-Jan-1976, Sleep apnoea since 01-Jun-2000 and Hypotension since 31-Oct-2000. Concomitant products included METOPROLOL SUCCINATE (TOPROL XL) from 01-Jan-2016 to an unknown date for Angina pectoris, RIVAROXABAN (XARELTO) from 01-Aug-2019 to an unknown date for Anticoagulant therapy, LEVOSALBUTAMOL HYDROCHLORIDE (XOPENEX) from 01-Oct-2018 to an unknown date for Bronchospasm, IVABRADINE HYDROCHLORIDE (CORLANOR) from 01-May-2018 to an unknown date for Congestive heart failure, GABAPENTIN (NEURONTIN) from 01-Jan-2019 to an unknown date for Neuropathy.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced DYSPNOEA (Shortness of breath), SWELLING (swelling), VACCINATION SITE WARMTH (warmth), INJECTION SITE PAIN (injection site pain) and HEADACHE (headache). On 04-Feb-2021, the patient experienced NAUSEA (nausea). On 05-Feb-2021, the patient experienced FATIGUE (fatigue). On 09-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like Symptoms) and ARTHRALGIA (joint pain). On 12-Feb-2021, the patient experienced VACCINATION SITE RASH (Vaccination site rash), VACCINATION SITE ERYTHEMA (Vaccination site redness) and VACCINATION SITE PRURITUS (Vaccination site  itching). The patient was treated with EPINEPHRINE (EPIPEN) for Shortness of breath, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) (oral) for Headache, at a dose of 1 dosage form. On 11-Feb-2021, INFLUENZA LIKE ILLNESS (Flu-like Symptoms) had resolved. On 17-Feb-2021, VACCINATION SITE RASH (Vaccination site rash) and VACCINATION SITE ERYTHEMA (Vaccination site redness) had resolved, VACCINATION SITE PRURITUS (Vaccination site  itching) outcome was unknown. At the time of the report, DYSPNOEA (Shortness of breath) had resolved and SWELLING (swelling), VACCINATION SITE WARMTH (warmth), INJECTION SITE PAIN (injection site pain), HEADACHE (headache), NAUSEA (nausea), FATIGUE (fatigue) and ARTHRALGIA (joint pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Unspecific side effect; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Unspecific side effect) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Unspecific side effect). At the time of the report, ADVERSE EVENT (Unspecific side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that patient had a side effect but no information was provided.  No concomitant medication was reported  No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: 1st vaccination a week ago and started breaking or in hives about 3 days ago; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (1st vaccination a week ago and started breaking or in hives about 3 days ago) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 an unknown date, the patient experienced URTICARIA (1st vaccination a week ago and started breaking or in hives about 3 days ago). At the time of the report, URTICARIA (1st vaccination a week ago and started breaking or in hives about 3 days ago) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick from the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick from the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick from the vaccine). At the time of the report, ILLNESS (sick from the vaccine) outcome was unknown.            no concomitant medications and treatment details reported.   Consent for follow up - unknown
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: breastfeeding for baby; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (breastfeeding for baby) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced EXPOSURE VIA BREAST MILK (breastfeeding for baby). At the time of the report, EXPOSURE VIA BREAST MILK (breastfeeding for baby) had resolved.            Reporter did not allow further contact
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Slight arm soreness; Headache; This spontaneous case was reported by a patient and describes the occurrence of   in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 008B21-2A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Opioids), Type 1 diabetes mellitus since 30-May-1999 and Blood pressure high since 31-Jan-2015. Concomitant products included LISINOPRIL for BP raised, INSULIN GLARGINE (LANTUS), INSULIN LISPRO (HUMALOG) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for Diabetes, TOPIRAMATE (TOPAMAX) for Migraine.   On 03-Mar-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency.            Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-084083 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Why am I so sick; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Why am I so sick) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Why am I so sick). At the time of the report, ILLNESS (Why am I so sick) outcome was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site swelling
Clinical narrative: Rash in my arm where I received the shot; Muscle still swollen.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash in my arm where I received the shot) and VACCINATION SITE SWELLING (Muscle still swollen.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Rash in my arm where I received the shot) and VACCINATION SITE SWELLING (Muscle still swollen.). At the time of the report, VACCINATION SITE RASH (Rash in my arm where I received the shot) and VACCINATION SITE SWELLING (Muscle still swollen.) outcome was unknown.            No concomitant or treatment reported
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: head to toe rash 21 days post vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH (head to toe rash 21 days post vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (head to toe rash 21 days post vaccine). At the time of the report, RASH (head to toe rash 21 days post vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medications and treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Non significant follow up is added Contains NNI
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Food poisoning, Hyperhidrosis, Pyrexia
Clinical narrative: nothing solid, they runs; "funny belch that felt like food poisoning"; sweaty; an hour later started throwing up; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (nothing solid, they runs), FOOD POISONING ("funny belch that felt like food poisoning"), HYPERHIDROSIS (sweaty), VOMITING (an hour later started throwing up) and PYREXIA (fever) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, the patient experienced DIARRHOEA (nothing solid, they runs), FOOD POISONING ("funny belch that felt like food poisoning"), HYPERHIDROSIS (sweaty), VOMITING (an hour later started throwing up), PYREXIA (fever) and CHILLS (chills). At the time of the report, DIARRHOEA (nothing solid, they runs), FOOD POISONING ("funny belch that felt like food poisoning"), HYPERHIDROSIS (sweaty), VOMITING (an hour later started throwing up), PYREXIA (fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were provided. Patient provided that he is not currently taking any medication, but is borderline of being diabetic(prior to vaccine). Consumer stated he received his first Moderna COVID-19 Vaccine on 20May2021 (Lot: Unknown, Exp: Unknown, left upper arm). Starting yesterday, 24May2021, the consumer stated "nothing solid, they runs" (referring to bowel movements). He also started to experience a "funny belch that felt like food poisoning". He then stated, "an hour later started throwing up". Also reported fever, chills, and felt sweaty. Consumer stated the "runs" and "belching" have not resolved, but everything else has. Consumer provided he is not currently taking any medication, but is borderline of being diabetic (prior to vaccine). Consumer also stated prior to vaccine (about two weeks ago) he was throwing up and having the runs.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: non-significant follow up
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: nothing solid, they runs; "funny belch that felt like food poisoning"; sweaty; an hour later started throwing up; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (nothing solid, they runs), FOOD POISONING ("funny belch that felt like food poisoning"), HYPERHIDROSIS (sweaty), VOMITING (an hour later started throwing up) and PYREXIA (fever) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, the patient experienced DIARRHOEA (nothing solid, they runs), FOOD POISONING ("funny belch that felt like food poisoning"), HYPERHIDROSIS (sweaty), VOMITING (an hour later started throwing up), PYREXIA (fever) and CHILLS (chills). At the time of the report, DIARRHOEA (nothing solid, they runs), FOOD POISONING ("funny belch that felt like food poisoning"), HYPERHIDROSIS (sweaty), VOMITING (an hour later started throwing up), PYREXIA (fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were provided. Patient provided that he is not currently taking any medication, but is borderline of being diabetic(prior to vaccine). Consumer stated he received his first Moderna COVID-19 Vaccine on 20May2021 (Lot: Unknown, Exp: Unknown, left upper arm). Starting yesterday, 24May2021, the consumer stated "nothing solid, they runs" (referring to bowel movements). He also started to experience a "funny belch that felt like food poisoning". He then stated, "an hour later started throwing up". Also reported fever, chills, and felt sweaty. Consumer stated the "runs" and "belching" have not resolved, but everything else has. Consumer provided he is not currently taking any medication, but is borderline of being diabetic (prior to vaccine). Consumer also stated prior to vaccine (about two weeks ago) he was throwing up and having the runs.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: non-significant follow up
Sex: U
Vaccine: COVID19
Symptoms: Gingival pain, Infection, Oral pain, Swelling
Clinical narrative: gum pain; mouth pain; swelling; infection; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL PAIN (gum pain), ORAL PAIN (mouth pain), SWELLING (swelling) and INFECTION (infection) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GINGIVAL PAIN (gum pain), ORAL PAIN (mouth pain), SWELLING (swelling) and INFECTION (infection). At the time of the report, GINGIVAL PAIN (gum pain), ORAL PAIN (mouth pain), SWELLING (swelling) and INFECTION (infection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications and treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Initiative FU
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypersensitivity, Rhinorrhoea, Sinus disorder, Sneezing
Clinical narrative: allergies; she had sneezing; her nose was running; sinus problems on her right side; headache/ bad headache on her right side by her right eye the headache was about a 10 on the pain scale; arm discomfort; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergies), SNEEZING (she had sneezing), RHINORRHOEA (her nose was running), SINUS DISORDER (sinus problems on her right side) and VACCINATION SITE PAIN (arm discomfort) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Primary biliary cholangitis. Concomitant products included SIMVASTATIN (ZOCOR), DILTIAZEM, LEVOTHYROXINE, URSODIOL, ISOSORBIDE and OBETICHOLIC ACID (OCALIVA) for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced VACCINATION SITE PAIN (arm discomfort). On an unknown date, the patient experienced HYPERSENSITIVITY (allergies), SNEEZING (she had sneezing), RHINORRHOEA (her nose was running), SINUS DISORDER (sinus problems on her right side) and HEADACHE (headache/ bad headache on her right side by her right eye the headache was about a 10 on the pain scale). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) (oral) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (allergies), SNEEZING (she had sneezing), RHINORRHOEA (her nose was running), SINUS DISORDER (sinus problems on her right side), VACCINATION SITE PAIN (arm discomfort) and HEADACHE (headache/ bad headache on her right side by her right eye the headache was about a 10 on the pain scale) outcome was unknown.        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.   Fist vaccine was given on 28APR2021, the same day she had arm discomfort. A few days later patient reports she has headaches and sinus problems on her right side. Is this normal? Last Friday, 21MAY2021, the patient got a bad headache on her right side by her right eye, the headache was about a 10 on the pain scale. She took a baby aspirin and the pain went away. Yesterday, the patient went to her family doctor, for her allergies, she said she had sneezing, and her nose was running.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: NNI followUp
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: allergies; she had sneezing; her nose was running; sinus problems on her right side; headache/ bad headache on her right side by her right eye the headache was about a 10 on the pain scale; arm discomfort; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergies), SNEEZING (she had sneezing), RHINORRHOEA (her nose was running), SINUS DISORDER (sinus problems on her right side) and VACCINATION SITE PAIN (arm discomfort) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Primary biliary cholangitis. Concomitant products included SIMVASTATIN (ZOCOR), DILTIAZEM, LEVOTHYROXINE, URSODIOL, ISOSORBIDE and OBETICHOLIC ACID (OCALIVA) for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced VACCINATION SITE PAIN (arm discomfort). On an unknown date, the patient experienced HYPERSENSITIVITY (allergies), SNEEZING (she had sneezing), RHINORRHOEA (her nose was running), SINUS DISORDER (sinus problems on her right side) and HEADACHE (headache/ bad headache on her right side by her right eye the headache was about a 10 on the pain scale). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) (oral) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (allergies), SNEEZING (she had sneezing), RHINORRHOEA (her nose was running), SINUS DISORDER (sinus problems on her right side), VACCINATION SITE PAIN (arm discomfort) and HEADACHE (headache/ bad headache on her right side by her right eye the headache was about a 10 on the pain scale) outcome was unknown.        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.   Fist vaccine was given on 28APR2021, the same day she had arm discomfort. A few days later patient reports she has headaches and sinus problems on her right side. Is this normal? Last Friday, 21MAY2021, the patient got a bad headache on her right side by her right eye, the headache was about a 10 on the pain scale. She took a baby aspirin and the pain went away. Yesterday, the patient went to her family doctor, for her allergies, she said she had sneezing, and her nose was running.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: NNI followUp
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Chills, Decreased appetite, Disorientation, Fatigue
Clinical narrative: Disorientation; racing heart; lack of Appetite; loss of taste; Body felt like humming and didn't know what to do with the shot; Slept for 5 days; Strange reaction after first dose; brain fog; chills; too tired; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (Disorientation), HEART RATE INCREASED (racing heart), DECREASED APPETITE (lack of Appetite), AGEUSIA (loss of taste) and FEELING ABNORMAL (Body felt like humming and didn't know what to do with the shot) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No concomitant medications were reported.  Concurrent medical conditions included Shellfish allergy (developed anaphylactic reaction).    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 DISORIENTATION (Disorientation), HEART RATE INCREASED (racing heart), DECREASED APPETITE (lack of Appetite), AGEUSIA (loss of taste), FEELING ABNORMAL (Body felt like humming and didn't know what to do with the shot), SOMNOLENCE (Slept for 5 days), VACCINATION COMPLICATION (Strange reaction after first dose), FEELING ABNORMAL (brain fog), CHILLS (chills) and FATIGUE (too tired). At the time of the report, DISORIENTATION (Disorientation), HEART RATE INCREASED (racing heart), DECREASED APPETITE (lack of Appetite), AGEUSIA (loss of taste), FEELING ABNORMAL (Body felt like humming and didn't know what to do with the shot), SOMNOLENCE (Slept for 5 days), VACCINATION COMPLICATION (Strange reaction after first dose), FEELING ABNORMAL (brain fog), CHILLS (chills) and FATIGUE (too tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) tested negative for COVID-19 last week..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications provided. Patient mentioned that she tested negative for COVID-19 last week. Patient mentioned that she is not taking any concomitant medications   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: NNI follow up
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Heart rate increased, SARS-CoV-2 test, Somnolence, Vaccination complication
Clinical narrative: Disorientation; racing heart; lack of Appetite; loss of taste; Body felt like humming and didn't know what to do with the shot; Slept for 5 days; Strange reaction after first dose; brain fog; chills; too tired; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (Disorientation), HEART RATE INCREASED (racing heart), DECREASED APPETITE (lack of Appetite), AGEUSIA (loss of taste) and FEELING ABNORMAL (Body felt like humming and didn't know what to do with the shot) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No concomitant medications were reported.  Concurrent medical conditions included Shellfish allergy (developed anaphylactic reaction).    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 DISORIENTATION (Disorientation), HEART RATE INCREASED (racing heart), DECREASED APPETITE (lack of Appetite), AGEUSIA (loss of taste), FEELING ABNORMAL (Body felt like humming and didn't know what to do with the shot), SOMNOLENCE (Slept for 5 days), VACCINATION COMPLICATION (Strange reaction after first dose), FEELING ABNORMAL (brain fog), CHILLS (chills) and FATIGUE (too tired). At the time of the report, DISORIENTATION (Disorientation), HEART RATE INCREASED (racing heart), DECREASED APPETITE (lack of Appetite), AGEUSIA (loss of taste), FEELING ABNORMAL (Body felt like humming and didn't know what to do with the shot), SOMNOLENCE (Slept for 5 days), VACCINATION COMPLICATION (Strange reaction after first dose), FEELING ABNORMAL (brain fog), CHILLS (chills) and FATIGUE (too tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) tested negative for COVID-19 last week..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications provided. Patient mentioned that she tested negative for COVID-19 last week. Patient mentioned that she is not taking any concomitant medications   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: NNI follow up
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-Significant follow up
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site sireness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site sireness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection site sireness). At the time of the report, VACCINATION SITE PAIN (Injection site sireness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       NO CONCOMITANT AND TREATMENT MEDICATION WERE USED   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 25-MAY-2021. Nonsignificant Follow-up; Reporter's Comments: NA; Sender's Comments: NA
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: when I received 2nd dose I have I slept for 10 hours,its very unusual; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (when I received 2nd dose I have I slept for 10 hours,its very unusual) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (when I received 2nd dose I have I slept for 10 hours,its very unusual). At the time of the report, SOMNOLENCE (when I received 2nd dose I have I slept for 10 hours,its very unusual) outcome was unknown. Not Provided          No concomitant medications were mentioned. No treatment drugs were reported   This case was linked to MOD-2021-018827, MOD-2021-018827 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: NNI
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: extremely tired that had to lift the eyelid to see the hour; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (extremely tired that had to lift the eyelid to see the hour) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007821A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (extremely tired that had to lift the eyelid to see the hour). At the time of the report, FATIGUE (extremely tired that had to lift the eyelid to see the hour) outcome was unknown.        This case was linked to MOD-2021-043382 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-significant follow up accepted on 27-May-2021
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: first dose of COVID vaccine in 8 weeks ago & not possible to get second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first dose of COVID vaccine in 8 weeks ago & not possible to get second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included No Adverse Events.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose of COVID vaccine in 8 weeks ago & not possible to get second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (first dose of COVID vaccine in 8 weeks ago & not possible to get second dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       there is no concomitant medications given in the treatment .   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: non significant followup
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  The patient had dizziness more than four days and was concerned about the same.  Treatment information was not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Still tired; Felt some muscle ache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Still tired) and MYALGIA (Felt some muscle ache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Still tired) and MYALGIA (Felt some muscle ache). At the time of the report, FATIGUE (Still tired) and MYALGIA (Felt some muscle ache) outcome was unknown.            No concomitant medications were reported.  Treatment information was not provided.   Reporter did not allow further contact
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose given 46 days after first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given 46 days after first dose) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included Hip surgery. Concurrent medical conditions included Blood pressure management and Hypercholesterolaemia.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given 46 days after first dose). On 27-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given 46 days after first dose) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable.  Concomitant drug included blood pressure and cholesterol medications. Treatment medication was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present
Clinical narrative: blood in urine; This spontaneous case was reported by a patient and describes the occurrence of BLOOD URINE PRESENT (blood in urine) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLOOD URINE PRESENT (blood in urine). At the time of the report, BLOOD URINE PRESENT (blood in urine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       NO CONCOMITANT AND TREATMENT DRUGS WERE USED
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Delayed injection site reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Delayed injection site reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Delayed injection site reaction). At the time of the report, VACCINATION SITE REACTION (Delayed injection site reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had a delayed injection site reaction Treatment information was not provided. Concomitant product information was not provided
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: My daughter is experiencing words reaction after 1 month of her second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (My daughter is experiencing words reaction after 1 month of her second vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, 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 HYPERSENSITIVITY (My daughter is experiencing words reaction after 1 month of her second vaccine). At the time of the report, HYPERSENSITIVITY (My daughter is experiencing words reaction after 1 month of her second vaccine) outcome was unknown.            NO concomitant and treatment drugs were used
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: I have a big pink hot area where I got my shot; I have a big pink hot area where I got my shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (I have a big pink hot area where I got my shot) and VACCINATION SITE ERYTHEMA (I have a big pink hot area where I got my shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (I have a big pink hot area where I got my shot) and VACCINATION SITE ERYTHEMA (I have a big pink hot area where I got my shot). At the time of the report, VACCINATION SITE WARMTH (I have a big pink hot area where I got my shot) and VACCINATION SITE ERYTHEMA (I have a big pink hot area where I got my shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment medications were not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling, Swelling face
Clinical narrative: Increasing swelling in feet/ankles / increasing swelling in hands; increasing swelling in feet/ankles; Increasing swelling in face; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Increasing swelling in feet/ankles / increasing swelling in hands), JOINT SWELLING (increasing swelling in feet/ankles) and SWELLING FACE (Increasing swelling in face) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Increasing swelling in feet/ankles / increasing swelling in hands), JOINT SWELLING (increasing swelling in feet/ankles) and SWELLING FACE (Increasing swelling in face). At the time of the report, PERIPHERAL SWELLING (Increasing swelling in feet/ankles / increasing swelling in hands), JOINT SWELLING (increasing swelling in feet/ankles) and SWELLING FACE (Increasing swelling in face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment medications were not provided by the reporter
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: tingling in my arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in my arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, the patient experienced PARAESTHESIA (tingling in my arm). At the time of the report, PARAESTHESIA (tingling in my arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information was not reported. Treatment information was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm soreness/My arm hurt really bad; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm soreness/My arm hurt really bad) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm soreness/My arm hurt really bad). At the time of the report, VACCINATION SITE PAIN (Arm soreness/My arm hurt really bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided  No treatment medications provided
Sex: U
Vaccine: COVID19
Symptoms: Mobility decreased, Pyrexia, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: The spot where the injection went is hot; Unable to function; Running a fever; The spot where the injection went is swollen; The spot where the injection went is very painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (The spot where the injection went is hot), MOBILITY DECREASED (Unable to function), PYREXIA (Running a fever), VACCINATION SITE SWELLING (The spot where the injection went is swollen) and VACCINATION SITE PAIN (The spot where the injection went is very painful) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced VACCINATION SITE WARMTH (The spot where the injection went is hot), MOBILITY DECREASED (Unable to function), PYREXIA (Running a fever), VACCINATION SITE SWELLING (The spot where the injection went is swollen) and VACCINATION SITE PAIN (The spot where the injection went is very painful). At the time of the report, VACCINATION SITE WARMTH (The spot where the injection went is hot), MOBILITY DECREASED (Unable to function), PYREXIA (Running a fever), VACCINATION SITE SWELLING (The spot where the injection went is swollen) and VACCINATION SITE PAIN (The spot where the injection went is very painful) outcome was unknown.            Concomitant information was not reported. Treatment information was not reported. The action taken with mRNA-1273 with the event was considered as not applicable.
Age: 48.0
Sex: U
Vaccine: COVID19
Symptoms: Varicella
Clinical narrative: Got chicken pox; This spontaneous case was reported by a consumer and describes the occurrence of VARICELLA (Got chicken pox) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VARICELLA (Got chicken pox). At the time of the report, VARICELLA (Got chicken pox) outcome was unknown.            Concomitant medication list was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: second Moderna vaccine on 5May2021 started her menstrual cycle on 16 May 2021; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (second Moderna vaccine on 5May2021 started her menstrual cycle on 16 May 2021) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-May-2021, the patient experienced MENSTRUAL DISORDER (second Moderna vaccine on 5May2021 started her menstrual cycle on 16 May 2021). At the time of the report, MENSTRUAL DISORDER (second Moderna vaccine on 5May2021 started her menstrual cycle on 16 May 2021) outcome was unknown. Not Provided          No concomitant information was provided by the reporter.  No treatment information was provided.   This case was linked to MOD-2021-068636 (Patient Link).