chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: shoulder stiffness/stiff upto ear/Stiff left arm where she received her vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (shoulder stiffness/stiff upto ear/Stiff left arm where she received her vaccine) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-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 MUSCULOSKELETAL STIFFNESS (shoulder stiffness/stiff upto ear/Stiff left arm where she received her vaccine). At the time of the report, MUSCULOSKELETAL STIFFNESS (shoulder stiffness/stiff upto ear/Stiff left arm where she received her vaccine) had resolved.            No concomitant medications were reported.  On 6-AUG-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) in unknown route with batch no.007B21A  Patient received compresses and pain relievers as treatment medications but they did not help. Patient went to the ER and they gave her a muscle relaxer and she is fine now.   This case was linked to MOD-2021-274267 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Added event and treatment information. On 23-Sep-2021: Follow up document received contains event coding and outcome of event updated
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Dizziness; Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and VERTIGO (Vertigo) in a 63-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 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced DIZZINESS (Dizziness) and VERTIGO (Vertigo). The patient was treated with MECLIZINE [MECLOZINE] for Dizziness and Vertigo, at a dose of 12.5 mg. At the time of the report, DIZZINESS (Dizziness) and VERTIGO (Vertigo) outcome was unknown.            No concomitant medications were reported.  The patient reports the onset of the events occurring some weeks after vaccination.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Follow up received contains non-significant information, but initial events onset date captured as 2021 and vaccine facility information added hence processed as significant .; Sender's Comments: This case concerns a 63-year-old female patient with no relevant history reported, who experienced the unexpected non serious events of Dizziness and Vertigo. The events started a few weeks after the second dose of Moderna COVID-19 Vaccine. The stop date and outcome of the events are unknown. Rechallenge is not applicable as no additional dosing will be given. The delayed onset of the events remains as a confounder for the case. The benefit-risk relationship of covid-19 vaccine is not affected by this report.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: More than 36 days after first dose without receiving the second dose.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 36 days after first dose without receiving the second dose) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-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 PRODUCT DOSE OMISSION ISSUE (More than 36 days after first dose without receiving the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 36 days after first dose without receiving the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided.  No treatment information provided by the reporter.   Most recent FOLLOW-UP information incorporated above included on 24-Sep-2021 Follow up received contained Updated demographics, gender female.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Nausea, Presyncope, Product dose omission issue
Clinical narrative: Patient did not take the second dose of vaccine.; Nausea; Vomiting; Dizziness; Diaphoresis; Near syncope; Spinning room; BPPV; Mild tinnitus; This spontaneous case was reported by a physician and describes the occurrence of Dizziness, Diaphoresis, Near syncope, Vertigo, and BPPV 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 Hypertension (HTN), Foramen ovale patent (PFO), and Adrenal disorder (Overactive adrenal gland).    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced Dizziness, Diaphoresis, Near syncope, Viertigo, BPPV, Tinnitus, Nausea, and Vomiting. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient did not take the second dose of vaccine). The patient was treated with MECLIZINE at a dose of UNK dosage form, ZOFRAN, at a dose of UNK dosage form; Physical therapy (Vertigo exercises (Epley maneuver)) for Vertigo and Physical therapy (Vertigo exercises (Epley maneuver)) for Vertigo positional. In May 2021, Dizziness had not resolved, Diaphoresis, Near syncope, Vertigo, BPPV, Tinnitus, Nausea, and Vomiting had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient did not take the second dose of vaccine) had resolved. Not Provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was taken to Emergency Room and was discharged on the same day. Patient prescribed for vertigo exercises, Epley maneuver. Concomitant product use was not provided.   This case was linked to MOD-2021-276754 (Patient Link).   Most recent FOLLOW-UP information incorporated above included on 06-Aug-2021: Follow-up received on 06-Aug-2021 and included non-significant information.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Vertigo, Vertigo positional, Vomiting
Clinical narrative: Patient did not take the second dose of vaccine.; Nausea; Vomiting; Dizziness; Diaphoresis; Near syncope; Spinning room; BPPV; Mild tinnitus; This spontaneous case was reported by a physician and describes the occurrence of Dizziness, Diaphoresis, Near syncope, Vertigo, and BPPV 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 Hypertension (HTN), Foramen ovale patent (PFO), and Adrenal disorder (Overactive adrenal gland).    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced Dizziness, Diaphoresis, Near syncope, Viertigo, BPPV, Tinnitus, Nausea, and Vomiting. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient did not take the second dose of vaccine). The patient was treated with MECLIZINE at a dose of UNK dosage form, ZOFRAN, at a dose of UNK dosage form; Physical therapy (Vertigo exercises (Epley maneuver)) for Vertigo and Physical therapy (Vertigo exercises (Epley maneuver)) for Vertigo positional. In May 2021, Dizziness had not resolved, Diaphoresis, Near syncope, Vertigo, BPPV, Tinnitus, Nausea, and Vomiting had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient did not take the second dose of vaccine) had resolved. Not Provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was taken to Emergency Room and was discharged on the same day. Patient prescribed for vertigo exercises, Epley maneuver. Concomitant product use was not provided.   This case was linked to MOD-2021-276754 (Patient Link).   Most recent FOLLOW-UP information incorporated above included on 06-Aug-2021: Follow-up received on 06-Aug-2021 and included non-significant information.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.  On 08-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 08-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow-up received. patient contact details added. event onset date updated. vaccine start date updated. On 09-Aug-2021: Follow-up information include no new information
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Myalgia, Vaccination site warmth
Clinical narrative: after their first and second dose, their injection arm was warm; patient  also experienced a little discomfort; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (after their first and second dose, their injection arm was warm), DISCOMFORT (patient  also experienced a little discomfort) and MYALGIA (Body ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039K20A) for COVID-19 vaccination.     The patient's past medical history included Thyroidectomy. Concurrent medical conditions included Diabetes.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (after their first and second dose, their injection arm was warm), DISCOMFORT (patient  also experienced a little discomfort) and MYALGIA (Body ache). At the time of the report, VACCINATION SITE WARMTH (after their first and second dose, their injection arm was warm), DISCOMFORT (patient  also experienced a little discomfort) and MYALGIA (Body ache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported  No Treatment medications reported   This case was linked to MOD-2021-318331, MOD-2021-318415 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Off label use, Pain, Peripheral swelling
Clinical narrative: body ache; discomfort; swelling on their left arm; got the third dose  without being immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING, PAIN, DISCOMFORT, and OFF LABEL USE in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A, 039K20A and 029K20A) for COVID-19 vaccination.     The patient's past medical history included Thyroidectomy. Concurrent medical conditions included Diabetes.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Sep-2021, the patient experienced OFF LABEL USE. On 05-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PERIPHERAL SWELLING. On an unknown date, the patient experienced PAIN, and DISCOMFORT. On 04-Sep-2021, OFF LABEL USE (got the third dose  without being immunocompromised) had resolved. At the time of the report, PERIPHERAL SWELLING, PAIN, and DISCOMFORT outcome was unknown.            Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-318414, MOD-2021-318331 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Limb discomfort, Migraine, Pyrexia
Clinical narrative: arm felt heavy after the second dose; fever of 100.2°F after the second dose; Strong headache after the second dose; Chills; Migraine; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (arm felt heavy after the second dose), PYREXIA (fever of 100.2°F after the second dose), HEADACHE (Strong headache after the second dose), CHILLS (Chills) and MIGRAINE (Migraine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. UNKNOWN and UNKNOWN) for COVID-19 vaccination.     Concurrent medical conditions included Cancer in remission and Immunosuppression (Immune system is very low).   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Feb-2021, the patient experienced LIMB DISCOMFORT (arm felt heavy after the second dose), PYREXIA (fever of 100.2°F after the second dose), HEADACHE (Strong headache after the second dose), CHILLS (Chills) and MIGRAINE (Migraine). On 22-Feb-2021, PYREXIA (fever of 100.2°F after the second dose), HEADACHE (Strong headache after the second dose), CHILLS (Chills) and MIGRAINE (Migraine) had resolved. On 23-Feb-2021, LIMB DISCOMFORT (arm felt heavy after the second dose) had resolved.            No concomitant medications were provided. No treatment medications were provided.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature abnormal, Feeling abnormal, Illness, Mobility decreased, Pyrexia
Clinical narrative: he got sleepy; so drowsy; temperature of 99.9; sick for a month; heart felt like it was going to beat out of chest/he felt bad; could hardly hold head up/could not get out of bed; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE, DOWZY, BODY TEMPERATURE ABNORMAL (temperature of 99.9), ILLNESS, and FEELING ABNORMAL (heart felt like it was going to beat out of chest/he felt bad) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included PREDNISONE and METHOTREXATE for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE, DROWSY, BODY TEMPERATURE ABNORMAL (temperature of 99.9), ILLNESS, FEELING ABNORMAL (heart felt like it was going to beat out of chest/he felt bad), and MOBILITY DECREASED (could hardly hold head up/could not get out of bed). At the time of the report, SOMNOLENCE, DROWSY, BODY TEMPERATURE ABNORMAL (temperature of 99.9), ILLNESS (sick for a month), FEELING ABNORMAL (heart felt like it was going to beat out of chest/he felt bad), and MOBILITY DECREASED (could hardly hold head up/could not get out of bed) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on 19-Aug-2021, Body temperature 99.9 (High) body temperature elevated.         No treatment medications reported.  Patient has symptoms for a month after third dose, but now he's feeling fine.   Most recent FOLLOW-UP information incorporated above includes on 24-Sep-2021: Significant follow up received on 24 Sep 2021, first and second dosage information added in product tab, outcome of event updated to recovered.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: he got sleepy; so drowsy; temperature of 99.9; sick for a month; heart felt like it was going to beat out of chest/he felt bad; could hardly hold head up/could not get out of bed; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE, DOWZY, BODY TEMPERATURE ABNORMAL (temperature of 99.9), ILLNESS, and FEELING ABNORMAL (heart felt like it was going to beat out of chest/he felt bad) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included PREDNISONE and METHOTREXATE for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE, DROWSY, BODY TEMPERATURE ABNORMAL (temperature of 99.9), ILLNESS, FEELING ABNORMAL (heart felt like it was going to beat out of chest/he felt bad), and MOBILITY DECREASED (could hardly hold head up/could not get out of bed). At the time of the report, SOMNOLENCE, DROWSY, BODY TEMPERATURE ABNORMAL (temperature of 99.9), ILLNESS (sick for a month), FEELING ABNORMAL (heart felt like it was going to beat out of chest/he felt bad), and MOBILITY DECREASED (could hardly hold head up/could not get out of bed) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on 19-Aug-2021, Body temperature 99.9 (High) body temperature elevated.         No treatment medications reported.  Patient has symptoms for a month after third dose, but now he's feeling fine.   Most recent FOLLOW-UP information incorporated above includes on 24-Sep-2021: Significant follow up received on 24 Sep 2021, first and second dosage information added in product tab, outcome of event updated to recovered.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood test, Headache, Heart rate, Pain
Clinical narrative: Felt a rapid heart beat/ Heartbeat felt like he it was pounding through his chest/ he could not get his heartbeat to calm down/ heart palpitation; Aches; Low grade fever; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Felt a rapid heart beat/ Heartbeat felt like he it was pounding through his chest/ he could not get his heartbeat to calm down/ heart palpitation), PAIN (Aches), PYREXIA (Low grade fever) and HEADACHE (Slight headache) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017(B or 8)21A, 045B21A and 039A21A) for COVID-19 vaccination.     Concurrent medical conditions included Muscular dystrophy (MD).   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Sep-2021, the patient experienced PALPITATIONS (Felt a rapid heart beat/ Heartbeat felt like he it was pounding through his chest/ he could not get his heartbeat to calm down/ heart palpitation), PAIN (Aches), PYREXIA (Low grade fever) and HEADACHE (Slight headache). At the time of the report, PALPITATIONS (Felt a rapid heart beat/ Heartbeat felt like he it was pounding through his chest/ he could not get his heartbeat to calm down/ heart palpitation) had not resolved and PAIN (Aches), PYREXIA (Low grade fever) and HEADACHE (Slight headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Sep-2021, Blood test: normal (normal) normal. On an unknown date, Blood pressure measurement: 160/95 (High) Elevated. On an unknown date, Heart rate: 80 (High) 80 beats per minute, heartbeat felt like it was pounding through the chest. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         No concomitant medications were provided.  No treatment medications were reported.  On 15-Sep-2021, the heart beat felt like pounding through the chest and could not take the deep breath. The patient went to the urgent care. The patient had elevated heart beat and blood pressure with no chest pain.   Due to the increased heart beat, the patient called EMS and they gave oxygen which calmed and so patient declined to admit in ER.   The patient mentioned in the follow up document that patient had taken 3 doses in which there was no issues with 1st and 2nd doses only problem with 3rd dose and stated that patient had fever for 2nd dose.   This case was linked to MOD-2021-334108 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Follow up document received on 27-Sep-2021 contained significant information that Patient enquired regarding filling the form and had no issues with 1st and 2nd doses of moderna.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia, SARS-CoV-2 test
Clinical narrative: Felt a rapid heart beat/ Heartbeat felt like he it was pounding through his chest/ he could not get his heartbeat to calm down/ heart palpitation; Aches; Low grade fever; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Felt a rapid heart beat/ Heartbeat felt like he it was pounding through his chest/ he could not get his heartbeat to calm down/ heart palpitation), PAIN (Aches), PYREXIA (Low grade fever) and HEADACHE (Slight headache) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017(B or 8)21A, 045B21A and 039A21A) for COVID-19 vaccination.     Concurrent medical conditions included Muscular dystrophy (MD).   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Sep-2021, the patient experienced PALPITATIONS (Felt a rapid heart beat/ Heartbeat felt like he it was pounding through his chest/ he could not get his heartbeat to calm down/ heart palpitation), PAIN (Aches), PYREXIA (Low grade fever) and HEADACHE (Slight headache). At the time of the report, PALPITATIONS (Felt a rapid heart beat/ Heartbeat felt like he it was pounding through his chest/ he could not get his heartbeat to calm down/ heart palpitation) had not resolved and PAIN (Aches), PYREXIA (Low grade fever) and HEADACHE (Slight headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Sep-2021, Blood test: normal (normal) normal. On an unknown date, Blood pressure measurement: 160/95 (High) Elevated. On an unknown date, Heart rate: 80 (High) 80 beats per minute, heartbeat felt like it was pounding through the chest. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         No concomitant medications were provided.  No treatment medications were reported.  On 15-Sep-2021, the heart beat felt like pounding through the chest and could not take the deep breath. The patient went to the urgent care. The patient had elevated heart beat and blood pressure with no chest pain.   Due to the increased heart beat, the patient called EMS and they gave oxygen which calmed and so patient declined to admit in ER.   The patient mentioned in the follow up document that patient had taken 3 doses in which there was no issues with 1st and 2nd doses only problem with 3rd dose and stated that patient had fever for 2nd dose.   This case was linked to MOD-2021-334108 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Follow up document received on 27-Sep-2021 contained significant information that Patient enquired regarding filling the form and had no issues with 1st and 2nd doses of moderna.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: strong pressure in the chest/ but feels like some pressure there; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (strong pressure in the chest/ but feels like some pressure there) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Sep-2021, the patient experienced CHEST DISCOMFORT (strong pressure in the chest/ but feels like some pressure there). At the time of the report, CHEST DISCOMFORT (strong pressure in the chest/ but feels like some pressure there) outcome was unknown.            Concomitant medications was not provided by the reporter Treatment information was not provided   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Product administered at inappropriate site
Clinical narrative: Got the first dose of the vaccine "on the butt"; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Got the first dose of the vaccine "on the butt") in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Amputation (double amputee (no arms)).    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 PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Got the first dose of the vaccine "on the butt"). At the time of the report, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Got the first dose of the vaccine "on the butt") had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  The patient was a double amputee and had no arms. It was reported that patient got the first dose of the vaccine on the butt. Patient had administered a 3rd dose of the vaccine in the anterolateral thigh.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Follow up received contains significant information of third dose administration. which is  in the I-narrative
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Extra dose administered, Headache, Malaise
Clinical narrative: I was feeling unwell; Patient was scheduled for a FLU vaccine last September 15, 2021 Pharmacist mistakenly administered; Patient was scheduled for a FLU vaccine last September 15, 2021 Pharmacist mistakenly administered; Muscle aches; Joint pain; Chills; Low grade fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle aches), ARTHRALGIA (Joint pain), CHILLS (Chills), PYREXIA (Low grade fever) and HEADACHE (Headache) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088D21A, 025A21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included FLUVOXAMINE for Anxiety, MONTELUKAST SODIUM (SINGULAIR) and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Seasonal allergy, PROBIOTICS NOS for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Sep-2021, the patient experienced MYALGIA (Muscle aches), ARTHRALGIA (Joint pain), CHILLS (Chills), PYREXIA (Low grade fever), HEADACHE (Headache), EXTRA DOSE ADMINISTERED (Patient was scheduled for a FLU vaccine last September 15, 2021 CVS Pharmacist mistakenly administered) and PRODUCT ADMINISTRATION ERROR (Patient was scheduled for a FLU vaccine last September 15, 2021  Pharmacist mistakenly administered). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Headache, at an unspecified dose and frequency. On 15-Sep-2021, EXTRA DOSE ADMINISTERED (Patient was scheduled for a FLU vaccine last September 15, 2021  Pharmacist mistakenly administered) and PRODUCT ADMINISTRATION ERROR (Patient was scheduled for a FLU vaccine last September 15, 2021  Pharmacist mistakenly administered) had resolved. On 20-Sep-2021, MYALGIA (Muscle aches), ARTHRALGIA (Joint pain), CHILLS (Chills), PYREXIA (Low grade fever) and HEADACHE (Headache) had resolved.            Patient was scheduled for a FLU vaccine last September 15, 2021. Pharmacist mistakenly administered.Moderna COVID vaccine. Case is currently under the Regional Director. Shot act as a booster but official paper works are still unavailable.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Product administration error, Pyrexia
Clinical narrative: I was feeling unwell; Patient was scheduled for a FLU vaccine last September 15, 2021 Pharmacist mistakenly administered; Patient was scheduled for a FLU vaccine last September 15, 2021 Pharmacist mistakenly administered; Muscle aches; Joint pain; Chills; Low grade fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle aches), ARTHRALGIA (Joint pain), CHILLS (Chills), PYREXIA (Low grade fever) and HEADACHE (Headache) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088D21A, 025A21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included FLUVOXAMINE for Anxiety, MONTELUKAST SODIUM (SINGULAIR) and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Seasonal allergy, PROBIOTICS NOS for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Sep-2021, the patient experienced MYALGIA (Muscle aches), ARTHRALGIA (Joint pain), CHILLS (Chills), PYREXIA (Low grade fever), HEADACHE (Headache), EXTRA DOSE ADMINISTERED (Patient was scheduled for a FLU vaccine last September 15, 2021 CVS Pharmacist mistakenly administered) and PRODUCT ADMINISTRATION ERROR (Patient was scheduled for a FLU vaccine last September 15, 2021  Pharmacist mistakenly administered). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Headache, at an unspecified dose and frequency. On 15-Sep-2021, EXTRA DOSE ADMINISTERED (Patient was scheduled for a FLU vaccine last September 15, 2021  Pharmacist mistakenly administered) and PRODUCT ADMINISTRATION ERROR (Patient was scheduled for a FLU vaccine last September 15, 2021  Pharmacist mistakenly administered) had resolved. On 20-Sep-2021, MYALGIA (Muscle aches), ARTHRALGIA (Joint pain), CHILLS (Chills), PYREXIA (Low grade fever) and HEADACHE (Headache) had resolved.            Patient was scheduled for a FLU vaccine last September 15, 2021. Pharmacist mistakenly administered.Moderna COVID vaccine. Case is currently under the Regional Director. Shot act as a booster but official paper works are still unavailable.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dyskinesia, Dysstasia, Gait disturbance
Clinical narrative: Asthenia; Dysstasia; Dyskinesia; Chills; Headache; Gait Disturbance; Limb discomfort; Sore arm; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Sep-2021. The most recent information was received on 23-Sep-2021 and was forwarded to Moderna on 23-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Asthenia), DYSSTASIA (Dysstasia), GAIT DISTURBANCE (Gait Disturbance), LIMB DISCOMFORT (Limb discomfort) and DYSKINESIA (Dyskinesia) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL, ATENOLOL, ATORVASTATIN, FISH OIL and CALCIUM for an unknown indication.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced MYALGIA (Sore arm). On 14-May-2021, the patient experienced GAIT DISTURBANCE (Gait Disturbance), LIMB DISCOMFORT (Limb discomfort), CHILLS (Chills) and HEADACHE (Headache). On 15-May-2021, the patient experienced DYSKINESIA (Dyskinesia). On an unknown date, the patient experienced ASTHENIA (Asthenia) and DYSSTASIA (Dysstasia). On 15-May-2021, DYSKINESIA (Dyskinesia), CHILLS (Chills) and HEADACHE (Headache) had resolved. On 16-May-2021, GAIT DISTURBANCE (Gait Disturbance) and LIMB DISCOMFORT (Limb discomfort) had resolved. At the time of the report, ASTHENIA (Asthenia), DYSSTASIA (Dysstasia) and MYALGIA (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   treatment medications were not provided   This case was linked to MOD-2021-325844 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Significant follow up
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Limb discomfort, Myalgia
Clinical narrative: Asthenia; Dysstasia; Dyskinesia; Chills; Headache; Gait Disturbance; Limb discomfort; Sore arm; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Sep-2021. The most recent information was received on 23-Sep-2021 and was forwarded to Moderna on 23-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Asthenia), DYSSTASIA (Dysstasia), GAIT DISTURBANCE (Gait Disturbance), LIMB DISCOMFORT (Limb discomfort) and DYSKINESIA (Dyskinesia) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL, ATENOLOL, ATORVASTATIN, FISH OIL and CALCIUM for an unknown indication.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced MYALGIA (Sore arm). On 14-May-2021, the patient experienced GAIT DISTURBANCE (Gait Disturbance), LIMB DISCOMFORT (Limb discomfort), CHILLS (Chills) and HEADACHE (Headache). On 15-May-2021, the patient experienced DYSKINESIA (Dyskinesia). On an unknown date, the patient experienced ASTHENIA (Asthenia) and DYSSTASIA (Dysstasia). On 15-May-2021, DYSKINESIA (Dyskinesia), CHILLS (Chills) and HEADACHE (Headache) had resolved. On 16-May-2021, GAIT DISTURBANCE (Gait Disturbance) and LIMB DISCOMFORT (Limb discomfort) had resolved. At the time of the report, ASTHENIA (Asthenia), DYSSTASIA (Dysstasia) and MYALGIA (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   treatment medications were not provided   This case was linked to MOD-2021-325844 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Significant follow up
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received 2nd dose almost 4 months later; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose almost 4 months later) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose almost 4 months later). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose almost 4 months later) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   patient have not experienced any known symptoms and not received any treatments. no concomitant medications are provided, treatment to the events not reported.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On 20-May-2021, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was provided.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Feeling abnormal, Myalgia
Clinical narrative: Feeling weird; Tightness in her chest; Like when you smoke a pack of cigarettes and that kind of soreness.; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Feeling weird), CHEST DISCOMFORT (Tightness in her chest) and MYALGIA (Like when you smoke a pack of cigarettes and that kind of soreness.) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Sep-2021, the patient experienced FEELING ABNORMAL (Feeling weird), CHEST DISCOMFORT (Tightness in her chest) and MYALGIA (Like when you smoke a pack of cigarettes and that kind of soreness.). At the time of the report, FEELING ABNORMAL (Feeling weird), CHEST DISCOMFORT (Tightness in her chest) and MYALGIA (Like when you smoke a pack of cigarettes and that kind of soreness.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant use were reported No Treatment were reported
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Feeling jittery, Flushing, Heart rate
Clinical narrative: Numb Tongue/Tip of the tongue still numb; Jittery; Numb Face with tingling; Flushing; Chest pain; Heart was fast; Shortness of breath/Hard time breathing; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Numb Tongue/Tip of the tongue still numb), FEELING JITTERY (Jittery), HYPOAESTHESIA (Numb Face with tingling), FLUSHING (Flushing) and CHEST PAIN (Chest pain) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced HYPOAESTHESIA ORAL (Numb Tongue/Tip of the tongue still numb), FEELING JITTERY (Jittery), HYPOAESTHESIA (Numb Face with tingling), FLUSHING (Flushing), CHEST PAIN (Chest pain), HEART RATE INCREASED (Heart was fast) and DYSPNOEA (Shortness of breath/Hard time breathing). At the time of the report, HYPOAESTHESIA ORAL (Numb Tongue/Tip of the tongue still numb), FEELING JITTERY (Jittery), HYPOAESTHESIA (Numb Face with tingling), FLUSHING (Flushing), CHEST PAIN (Chest pain), HEART RATE INCREASED (Heart was fast) and DYSPNOEA (Shortness of breath/Hard time breathing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Aug-2021, Heart rate: fast fast.     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.   After the shot the patient waited more than 15 minutes and within 30 minutes felt a numb tongue, jittery, numb face with tingling, flushing, chest pain, her heart was fast, shortness of breath/hard time breathing for about 6 hours. But the tip of tongue was still numb since then. No Concomitant medications were provided. No treatment medications were provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Numb Tongue/Tip of the tongue still numb; Jittery; Numb Face with tingling; Flushing; Chest pain; Heart was fast; Shortness of breath/Hard time breathing; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Numb Tongue/Tip of the tongue still numb), FEELING JITTERY (Jittery), HYPOAESTHESIA (Numb Face with tingling), FLUSHING (Flushing) and CHEST PAIN (Chest pain) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced HYPOAESTHESIA ORAL (Numb Tongue/Tip of the tongue still numb), FEELING JITTERY (Jittery), HYPOAESTHESIA (Numb Face with tingling), FLUSHING (Flushing), CHEST PAIN (Chest pain), HEART RATE INCREASED (Heart was fast) and DYSPNOEA (Shortness of breath/Hard time breathing). At the time of the report, HYPOAESTHESIA ORAL (Numb Tongue/Tip of the tongue still numb), FEELING JITTERY (Jittery), HYPOAESTHESIA (Numb Face with tingling), FLUSHING (Flushing), CHEST PAIN (Chest pain), HEART RATE INCREASED (Heart was fast) and DYSPNOEA (Shortness of breath/Hard time breathing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Aug-2021, Heart rate: fast fast.     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.   After the shot the patient waited more than 15 minutes and within 30 minutes felt a numb tongue, jittery, numb face with tingling, flushing, chest pain, her heart was fast, shortness of breath/hard time breathing for about 6 hours. But the tip of tongue was still numb since then. No Concomitant medications were provided. No treatment medications were provided.