chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Impaired work ability, Lethargy, Malaise, SARS-CoV-2 antibody test
Clinical narrative: lost taste; lost smell; no appetite; lost so much weight; had no energy; lethargic; had to push himself every day to go to work; felt like he had COVID 19; wasn't feeling well; woke up at night in cold sweat; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (wasn't feeling well), COLD SWEAT (woke up at night in cold sweat), AGEUSIA (lost taste), ANOSMIA (lost smell) and DECREASED APPETITE (no appetite) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced MALAISE (wasn't feeling well) and COLD SWEAT (woke up at night in cold sweat). On 18-Aug-2021, the patient experienced AGEUSIA (lost taste), ANOSMIA (lost smell), DECREASED APPETITE (no appetite), WEIGHT DECREASED (lost so much weight), ASTHENIA (had no energy), LETHARGY (lethargic), IMPAIRED WORK ABILITY (had to push himself every day to go to work) and FEELING ABNORMAL (felt like he had COVID 19). On 17-Aug-2021, MALAISE (wasn't feeling well) had resolved. On 18-Aug-2021, COLD SWEAT (woke up at night in cold sweat) had resolved. On 25-Aug-2021, AGEUSIA (lost taste), ANOSMIA (lost smell), DECREASED APPETITE (no appetite), WEIGHT DECREASED (lost so much weight), ASTHENIA (had no energy), LETHARGY (lethargic), IMPAIRED WORK ABILITY (had to push himself every day to go to work) and FEELING ABNORMAL (felt like he had COVID 19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Aug-2021, SARS-CoV-2 antibody test: negative (Negative) test showed no Antibodies.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided  No treatment medications were provided.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: lost taste; lost smell; no appetite; lost so much weight; had no energy; lethargic; had to push himself every day to go to work; felt like he had COVID 19; wasn't feeling well; woke up at night in cold sweat; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (wasn't feeling well), COLD SWEAT (woke up at night in cold sweat), AGEUSIA (lost taste), ANOSMIA (lost smell) and DECREASED APPETITE (no appetite) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced MALAISE (wasn't feeling well) and COLD SWEAT (woke up at night in cold sweat). On 18-Aug-2021, the patient experienced AGEUSIA (lost taste), ANOSMIA (lost smell), DECREASED APPETITE (no appetite), WEIGHT DECREASED (lost so much weight), ASTHENIA (had no energy), LETHARGY (lethargic), IMPAIRED WORK ABILITY (had to push himself every day to go to work) and FEELING ABNORMAL (felt like he had COVID 19). On 17-Aug-2021, MALAISE (wasn't feeling well) had resolved. On 18-Aug-2021, COLD SWEAT (woke up at night in cold sweat) had resolved. On 25-Aug-2021, AGEUSIA (lost taste), ANOSMIA (lost smell), DECREASED APPETITE (no appetite), WEIGHT DECREASED (lost so much weight), ASTHENIA (had no energy), LETHARGY (lethargic), IMPAIRED WORK ABILITY (had to push himself every day to go to work) and FEELING ABNORMAL (felt like he had COVID 19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Aug-2021, SARS-CoV-2 antibody test: negative (Negative) test showed no Antibodies.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided  No treatment medications were provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot
Clinical narrative: Legs were feeling warm/Warm sensations; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Legs were feeling warm/Warm sensations) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M0A) for COVID-19 vaccination.     The patient's past medical history included Mumps. Concurrent medical conditions included Blood sugar increased and Blood pressure high. Concomitant products included DILTIAZEM for Blood pressure high, METFORMIN for Sugar blood increased.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced FEELING HOT (Legs were feeling warm/Warm sensations). At the time of the report, FEELING HOT (Legs were feeling warm/Warm sensations) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was reported.   This case was linked to MOD-2021-319681 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered after improper storage and handling; Dose administered after improper storage and handling/ pre-drawn syringe that was; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Dose administered after improper storage and handling) and EXPIRED PRODUCT ADMINISTERED (Dose administered after improper storage and handling/ pre-drawn syringe that was) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) 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 PRODUCT STORAGE ERROR (Dose administered after improper storage and handling) and EXPIRED PRODUCT ADMINISTERED (Dose administered after improper storage and handling/ pre-drawn syringe that was). At the time of the report, PRODUCT STORAGE ERROR (Dose administered after improper storage and handling) and EXPIRED PRODUCT ADMINISTERED (Dose administered after improper storage and handling/ pre-drawn syringe that was) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.  Reporter informed that one dose of the moderna vaccine was administered to an employee from a pre-drawn syringe that was left out for 24-36 hours. Dose administered after improper storage and handling.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Incorrect dose administered
Clinical narrative: received an unknown amount due to lure lock syringe becoming detached during injection; needles were not screwed tightly enough . Some of the vaccine leaked on onto the patient during administration.; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (received an unknown amount due to lure lock syringe becoming detached during injection) and INCORRECT DOSE ADMINISTERED (needles were not screwed tightly enough . Some of the vaccine leaked on onto the patient during administration.) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     Concomitant products included AZITHROMYCIN from 26-Jun-2021 to an unknown date, SALBUTAMOL (VENTOLINE [SALBUTAMOL]) from 26-Jun-2021 to an unknown date and IBUPROFEN from 10-Mar-2021 to an unknown date for an unknown indication.    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, the patient experienced DEVICE CONNECTION ISSUE (received an unknown amount due to lure lock syringe becoming detached during injection) and INCORRECT DOSE ADMINISTERED (needles were not screwed tightly enough . Some of the vaccine leaked on onto the patient during administration.). On 10-Sep-2021, DEVICE CONNECTION ISSUE (received an unknown amount due to lure lock syringe becoming detached during injection) and INCORRECT DOSE ADMINISTERED (needles were not screwed tightly enough . Some of the vaccine leaked on onto the patient during administration.) 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 considered DEVICE CONNECTION ISSUE (received an unknown amount due to lure lock syringe becoming detached during injection) and INCORRECT DOSE ADMINISTERED (needles were not screwed tightly enough . Some of the vaccine leaked on onto the patient during administration.) to be not related.    No concomitant medications were reported, No treatment medications were reported.  Apparently a bag of syringes with needles was received and the needles were not screwed tightly enough . Some of the vaccine leaked on onto the patient during administration. Patient was unharmed. An email has received to administer on opposite arm.   Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Significant follow up Appended - New reporter (Physician) added and concomitant drugs added, vaccine facility information added and Incomplete dose administered added.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Vomiting
Clinical narrative: Sweating; Chills; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), CHILLS (Chills) and VOMITING (Vomiting) 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 HYPERHIDROSIS (Sweating), CHILLS (Chills) and VOMITING (Vomiting). At the time of the report, HYPERHIDROSIS (Sweating), CHILLS (Chills) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Pyrexia, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: my arm had hard knot below injection site skin was red and itchy and hot; Felt faint; my arm had hard knot below injection site skin was red and itchy and hot; my arm had hard knot below injection site skin was red and itchy and hot; Low grade fever; my arm had hard knot below injection site skin was red and itchy and hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (my arm had hard knot below injection site skin was red and itchy and hot), DIZZINESS (Felt faint), VACCINATION SITE INDURATION (my arm had hard knot below injection site skin was red and itchy and hot), VACCINATION SITE PRURITUS (my arm had hard knot below injection site skin was red and itchy and hot) and PYREXIA (Low grade fever) in a  patient of an unknown age and gender 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.    In September 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced VACCINATION SITE WARMTH (my arm had hard knot below injection site skin was red and itchy and hot), DIZZINESS (Felt faint), VACCINATION SITE INDURATION (my arm had hard knot below injection site skin was red and itchy and hot), VACCINATION SITE PRURITUS (my arm had hard knot below injection site skin was red and itchy and hot), PYREXIA (Low grade fever) and VACCINATION SITE ERYTHEMA (my arm had hard knot below injection site skin was red and itchy and hot). At the time of the report, VACCINATION SITE WARMTH (my arm had hard knot below injection site skin was red and itchy and hot), DIZZINESS (Felt faint), VACCINATION SITE INDURATION (my arm had hard knot below injection site skin was red and itchy and hot), VACCINATION SITE PRURITUS (my arm had hard knot below injection site skin was red and itchy and hot), PYREXIA (Low grade fever) and VACCINATION SITE ERYTHEMA (my arm had hard knot below injection site skin was red and itchy and hot) outcome was unknown.            No concomitant medication was reported. No treatment information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: my arm had hard knot below injection site skin was red and itchy and hot; Felt faint; my arm had hard knot below injection site skin was red and itchy and hot; my arm had hard knot below injection site skin was red and itchy and hot; Low grade fever; my arm had hard knot below injection site skin was red and itchy and hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (my arm had hard knot below injection site skin was red and itchy and hot), DIZZINESS (Felt faint), VACCINATION SITE INDURATION (my arm had hard knot below injection site skin was red and itchy and hot), VACCINATION SITE PRURITUS (my arm had hard knot below injection site skin was red and itchy and hot) and PYREXIA (Low grade fever) in a  patient of an unknown age and gender 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.    In September 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced VACCINATION SITE WARMTH (my arm had hard knot below injection site skin was red and itchy and hot), DIZZINESS (Felt faint), VACCINATION SITE INDURATION (my arm had hard knot below injection site skin was red and itchy and hot), VACCINATION SITE PRURITUS (my arm had hard knot below injection site skin was red and itchy and hot), PYREXIA (Low grade fever) and VACCINATION SITE ERYTHEMA (my arm had hard knot below injection site skin was red and itchy and hot). At the time of the report, VACCINATION SITE WARMTH (my arm had hard knot below injection site skin was red and itchy and hot), DIZZINESS (Felt faint), VACCINATION SITE INDURATION (my arm had hard knot below injection site skin was red and itchy and hot), VACCINATION SITE PRURITUS (my arm had hard knot below injection site skin was red and itchy and hot), PYREXIA (Low grade fever) and VACCINATION SITE ERYTHEMA (my arm had hard knot below injection site skin was red and itchy and hot) outcome was unknown.            No concomitant medication was reported. No treatment information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: The vials were kept in frozen state. The freezer got warmer for about 8 minutes (6:08 to 6:16 PM on 16Aug2021)reaching max temperature of (+) 6.3 degrees Fahrenheit.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (The vials were kept in frozen state. The freezer got warmer for about 8 minutes (6:08 to 6:16 PM on 16Aug2021)reaching max temperature of (+) 6.3 degrees Fahrenheit.) 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 PRODUCT STORAGE ERROR (The vials were kept in frozen state. The freezer got warmer for about 8 minutes (6:08 to 6:16 PM on 16Aug2021)reaching max temperature of (+) 6.3 degrees Fahrenheit.). At the time of the report, PRODUCT STORAGE ERROR (The vials were kept in frozen state. The freezer got warmer for about 8 minutes (6:08 to 6:16 PM on 16Aug2021)reaching max temperature of (+) 6.3 degrees Fahrenheit.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No Treatment medications were reported.  The excursion occurred on 16Aug2021. The vials did not previously experienced excursions. Out of those 250 doses affected, 70 doses have been administered. Lot # are 005C21A and 048C21A.   Reporter did not allow further contact
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Periarthritis
Clinical narrative: frozen shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PERIARTHRITIS (frozen shoulder) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 039K20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: shingles (in her right arm) in February 2021. Past adverse reactions to the above products included Frozen shoulder with shingles. Concurrent medical conditions included Frozen shoulder since February 2021.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIARTHRITIS (frozen shoulder). At the time of the report, PERIARTHRITIS (frozen shoulder) was resolving.            Concomitant medication of the patient was not reported.  The patient still neither reach front or back nor reach up or behind. At the time of reporting the patient had two bad arms. The patient was recommended by her doctor to get the booster or third dose vaccine in her glute muscle, not on the same arm.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-319769 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Inappropriate schedule of product administration, Nausea, Vomiting, Weight
Clinical narrative: feels "bad"; vomiting; nausea; Less than 21 days between vaccine administrations; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 21 days between vaccine administrations), FEELING ABNORMAL (feels "bad"), VOMITING (vomiting) and NAUSEA (nausea) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 21 days between vaccine administrations). On an unknown date, the patient experienced FEELING ABNORMAL (feels "bad"), VOMITING (vomiting) and NAUSEA (nausea). On 23-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 21 days between vaccine administrations) had resolved. At the time of the report, FEELING ABNORMAL (feels "bad"), VOMITING (vomiting) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: decreased (abnormal) Lost 5 pounds..     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.  Patient had experienced-Delayed reaction after taking the COVID-19 vaccine.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Hyperhidrosis, Nasopharyngitis, Nervousness, Pyrexia
Clinical narrative: still sweaty; was cold; shaky; felt the tightness on the chest again; "internal fever", meaning that she felt hot on the inside but had no temperature; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (still sweaty), NASOPHARYNGITIS (was cold), NERVOUSNESS (shaky), CHEST DISCOMFORT (felt the tightness on the chest again) and PYREXIA ("internal fever", meaning that she felt hot on the inside but had no temperature) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059E21A and 052CVIA) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in February 2021. Concurrent medical conditions included Endometriosis and Sjogren's disease. Concomitant products included HYDROXYCHLOROQUINE for an unknown indication.   On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jul-2021, the patient experienced HYPERHIDROSIS (still sweaty), NASOPHARYNGITIS (was cold), NERVOUSNESS (shaky), CHEST DISCOMFORT (felt the tightness on the chest again) and PYREXIA ("internal fever", meaning that she felt hot on the inside but had no temperature). The patient was treated with KETOROLAC at a dose of 30 mg/ml 1 ml injection and IBUPROFEN for Chest tightness, at a dose of 800 microgram. At the time of the report, HYPERHIDROSIS (still sweaty) had not resolved and NASOPHARYNGITIS (was cold), NERVOUSNESS (shaky), CHEST DISCOMFORT (felt the tightness on the chest again) and PYREXIA ("internal fever", meaning that she felt hot on the inside but had no temperature) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, SARS-CoV-2 test: covid (Positive) diagnosed with COVID.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient felt the tightness on the chest again and she immediately started taking Ibuprofen. She tried massaging the area and moving it. The injections were given in the upper arm, left arm both times  her non dominant arm. In the ER she got tested and a blood clot was ruled out. She got a chest X-ray, an ECG, a blood differential test, a CBC with differential, a comprehensive metabolic panel, a troponin I test, a Ddimer quantitative test, POC lactic acid panel with a laboratory lactic acid/lactate, oxygen therapy and an urine analysis. The final report stated: Chest pain. She got discharged with a diagnose of chest wall pain and costochondritis.   This case was linked to MOD-2021-319766 (Patient Link).
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: still sweaty; was cold; shaky; felt the tightness on the chest again; "internal fever", meaning that she felt hot on the inside but had no temperature; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (still sweaty), NASOPHARYNGITIS (was cold), NERVOUSNESS (shaky), CHEST DISCOMFORT (felt the tightness on the chest again) and PYREXIA ("internal fever", meaning that she felt hot on the inside but had no temperature) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059E21A and 052CVIA) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in February 2021. Concurrent medical conditions included Endometriosis and Sjogren's disease. Concomitant products included HYDROXYCHLOROQUINE for an unknown indication.   On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jul-2021, the patient experienced HYPERHIDROSIS (still sweaty), NASOPHARYNGITIS (was cold), NERVOUSNESS (shaky), CHEST DISCOMFORT (felt the tightness on the chest again) and PYREXIA ("internal fever", meaning that she felt hot on the inside but had no temperature). The patient was treated with KETOROLAC at a dose of 30 mg/ml 1 ml injection and IBUPROFEN for Chest tightness, at a dose of 800 microgram. At the time of the report, HYPERHIDROSIS (still sweaty) had not resolved and NASOPHARYNGITIS (was cold), NERVOUSNESS (shaky), CHEST DISCOMFORT (felt the tightness on the chest again) and PYREXIA ("internal fever", meaning that she felt hot on the inside but had no temperature) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, SARS-CoV-2 test: covid (Positive) diagnosed with COVID.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient felt the tightness on the chest again and she immediately started taking Ibuprofen. She tried massaging the area and moving it. The injections were given in the upper arm, left arm both times  her non dominant arm. In the ER she got tested and a blood clot was ruled out. She got a chest X-ray, an ECG, a blood differential test, a CBC with differential, a comprehensive metabolic panel, a troponin I test, a Ddimer quantitative test, POC lactic acid panel with a laboratory lactic acid/lactate, oxygen therapy and an urine analysis. The final report stated: Chest pain. She got discharged with a diagnose of chest wall pain and costochondritis.   This case was linked to MOD-2021-319766 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick). At the time of the report, ILLNESS (sick) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported Treatment information was not provided.   This case was linked to MOD-2021-297570 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Fatigue, Pyrexia
Clinical narrative: Bit more tired than usual; Running a temp of 100.7; Sick to my stomach; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Sick to my stomach), FATIGUE (Bit more tired than usual) and PYREXIA (Running a temp of 100.7) 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 Immunocompromised.   On 14-Sep-2021, the patient 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 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 15-Sep-2021, the patient experienced ABDOMINAL DISCOMFORT (Sick to my stomach) and PYREXIA (Running a temp of 100.7 F). On an unknown date, the patient experienced FATIGUE (Bit more tired than usual). At the time of the report, ABDOMINAL DISCOMFORT (Sick to my stomach) and PYREXIA (Running a temp of 100.7F ) had resolved and FATIGUE (Bit more tired than usual) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.7 F (High) High.         No concomitant products were reported. No treatment information was reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: The outcome of event (sick to my stomach and running a temp of 100.7 F) updated to recovered/resolved and newevent (bit more tired than usual) added.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Somnolence
Clinical narrative: was out for the day; slept the day,once it was out the system, he was fine; This spontaneous case was reported by a health care professional and describes the occurrence of FEELING ABNORMAL (was out for the day) and SOMNOLENCE (slept the day,once it was out the system, he was fine) in a male 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (was out for the day) and SOMNOLENCE (slept the day,once it was out the system, he was fine). At the time of the report, FEELING ABNORMAL (was out for the day) and SOMNOLENCE (slept the day,once it was out the system, he was fine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  No treatment medications were provided.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Chills, Pyrexia
Clinical narrative: Mild, short term memory loss, can't remeber what he said; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (Mild, short term memory loss, can't remeber what he said), PYREXIA (Fever) and CHILLS (Chills) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Smoker.    On 02-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AMNESIA (Mild, short term memory loss, can't remeber what he said), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, AMNESIA (Mild, short term memory loss, can't remeber what he said), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.   This case was linked to MOD-2021-143933 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Fatigue, Inappropriate schedule of product administration, Myalgia, Poor quality sleep
Clinical narrative: Mild, short term memory loss; Not sleeping well; Received the second dose "on the line" (timeline for 2nd dose); Fatigue; Full body muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (Mild, short term memory loss), POOR QUALITY SLEEP (Not sleeping well), FATIGUE (Fatigue), MYALGIA (Full body muscle aches) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the second dose "on the line" (timeline for 2nd dose)) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia. Concomitant products included PREGABALIN (LYRICA) for Pain.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 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 AMNESIA (Mild, short term memory loss), POOR QUALITY SLEEP (Not sleeping well), FATIGUE (Fatigue), MYALGIA (Full body muscle aches) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the second dose "on the line" (timeline for 2nd dose)). At the time of the report, AMNESIA (Mild, short term memory loss), POOR QUALITY SLEEP (Not sleeping well), FATIGUE (Fatigue), MYALGIA (Full body muscle aches) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the second dose "on the line" (timeline for 2nd dose)) outcome was unknown.            Treatment medications were not reported.   This case was linked to MOD-2021-320098 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Anaemia, Blood albumin, C-reactive protein, Globulin, Inflammation
Clinical narrative: Anemia; severe inflammation indicated in the blood work; "felt the symptoms you would commonly get after receiving the vaccine but they are ongoing"; 2 weeks after 2nd dose was administered the pneumovax vaccine and felt achy for a week; This spontaneous case was reported by a consumer and describes the occurrence of ANAEMIA (Anemia), INFLAMMATION (severe inflammation indicated in the blood work), VACCINATION COMPLICATION ("felt the symptoms you would commonly get after receiving the vaccine but they are ongoing") and MYALGIA (2 weeks after 2nd dose was administered the pneumovax vaccine and felt achy for a week) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 010A21A) for COVID-19 vaccination.     Previously administered products included for Ache NOS: pneumovax in 2021.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced MYALGIA (2 weeks after 2nd dose was administered the pneumovax vaccine and felt achy for a week). On an unknown date, the patient experienced ANAEMIA (Anemia), INFLAMMATION (severe inflammation indicated in the blood work) and VACCINATION COMPLICATION ("felt the symptoms you would commonly get after receiving the vaccine but they are ongoing"). The patient was treated with IBUPROFEN for Adverse event, at a dose of 1 dosage form and CELECOXIB (CELEBREX) for Adverse event, at a dose of 1 dosage form. At the time of the report, ANAEMIA (Anemia), INFLAMMATION (severe inflammation indicated in the blood work), VACCINATION COMPLICATION ("felt the symptoms you would commonly get after receiving the vaccine but they are ongoing") and MYALGIA (2 weeks after 2nd dose was administered the pneumovax vaccine and felt achy for a week) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood albumin: low (Low) Low. In 2021, C-reactive protein: 77 (High) High. In 2021, Globulin: high (High) High. In 2021, Red blood cell sedimentation rate: 88 (High) 88.         Patient reported that he was taking supplements.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Red blood cell sedimentation rate, Vaccination complication
Clinical narrative: Anemia; severe inflammation indicated in the blood work; "felt the symptoms you would commonly get after receiving the vaccine but they are ongoing"; 2 weeks after 2nd dose was administered the pneumovax vaccine and felt achy for a week; This spontaneous case was reported by a consumer and describes the occurrence of ANAEMIA (Anemia), INFLAMMATION (severe inflammation indicated in the blood work), VACCINATION COMPLICATION ("felt the symptoms you would commonly get after receiving the vaccine but they are ongoing") and MYALGIA (2 weeks after 2nd dose was administered the pneumovax vaccine and felt achy for a week) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 010A21A) for COVID-19 vaccination.     Previously administered products included for Ache NOS: pneumovax in 2021.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced MYALGIA (2 weeks after 2nd dose was administered the pneumovax vaccine and felt achy for a week). On an unknown date, the patient experienced ANAEMIA (Anemia), INFLAMMATION (severe inflammation indicated in the blood work) and VACCINATION COMPLICATION ("felt the symptoms you would commonly get after receiving the vaccine but they are ongoing"). The patient was treated with IBUPROFEN for Adverse event, at a dose of 1 dosage form and CELECOXIB (CELEBREX) for Adverse event, at a dose of 1 dosage form. At the time of the report, ANAEMIA (Anemia), INFLAMMATION (severe inflammation indicated in the blood work), VACCINATION COMPLICATION ("felt the symptoms you would commonly get after receiving the vaccine but they are ongoing") and MYALGIA (2 weeks after 2nd dose was administered the pneumovax vaccine and felt achy for a week) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood albumin: low (Low) Low. In 2021, C-reactive protein: 77 (High) High. In 2021, Globulin: high (High) High. In 2021, Red blood cell sedimentation rate: 88 (High) 88.         Patient reported that he was taking supplements.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 15-year old patient received Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15-year old patient received Moderna vaccine) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15-year old patient received Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15-year old patient received Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication information was reported. No Treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Patient demographics-ethnicity updated, race information updated , pregnancy information updated
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Influenza like illness
Clinical narrative: Feels like he has flu; Diarrhea; Extremely sore right shoulder/ it's worse this time; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Feels like he has flu), DIARRHOEA (Diarrhea) and ARTHRALGIA (Extremely sore right shoulder/ it's worse this time) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A and 026D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-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 INFLUENZA LIKE ILLNESS (Feels like he has flu), DIARRHOEA (Diarrhea) and ARTHRALGIA (Extremely sore right shoulder/ it's worse this time). At the time of the report, INFLUENZA LIKE ILLNESS (Feels like he has flu), DIARRHOEA (Diarrhea) and ARTHRALGIA (Extremely sore right shoulder/ it's worse this time) outcome was unknown.            No concomitant medications provided.  No treatment medications provided.   This case was linked to MOD-2021-320078.   Reporter did not allow further contact
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: arm was a little sore after receiving the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (arm was a little sore after receiving the 1st dose) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 937902) for COVID-19 vaccination.     Concomitant products included ATENOLOL for Blood pressure, ARTEMETHER (ARTANE [ARTEMETHER]), GABAPENTIN, CLONIDINE, METHOCARBAMOL (ROBAXIN), HYDROXYZINE EMBONATE (VISTARIL [HYDROXYZINE EMBONATE]), CELECOXIB (CELEXA [CELECOXIB]), VITAMIN C [ASCORBIC ACID] and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 07-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Aug-2021, the patient experienced MYALGIA (arm was a little sore after receiving the 1st dose). At the time of the report, MYALGIA (arm was a little sore after receiving the 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-320090 (Patient Link).
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Erythema, Headache, Malaise
Clinical narrative: malaise; covid arm; low grade fever/low grade temperature/normal temperature is 97.8, on sunday he recorded 100.2; body aches; (arm) swollen; (arm) it had redness; headache; chills; joint pain; pain that night/still sore to the touch; itch; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (malaise), VACCINATION SITE REACTION (covid arm), PAIN (pain that night/still sore to the touch), PRURITUS (itch) and PERIPHERAL SWELLING ((arm) swollen) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A, 003AZ1A and 030L(Z)0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METOPROLOL, TIMOLOL and CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]) for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Sep-2021, the patient experienced PAIN (pain that night/still sore to the touch) and PRURITUS (itch). On 12-Sep-2021, the patient experienced PERIPHERAL SWELLING ((arm) swollen), ERYTHEMA ((arm) it had redness), HEADACHE (headache), CHILLS (chills) and ARTHRALGIA (joint pain). On an unknown date, the patient experienced MALAISE (malaise), VACCINATION SITE REACTION (covid arm), PYREXIA (low grade fever/low grade temperature/normal temperature is 97.8, on sunday he recorded 100.2) and MYALGIA (body aches). At the time of the report, MALAISE (malaise), VACCINATION SITE REACTION (covid arm), PAIN (pain that night/still sore to the touch), PRURITUS (itch), PERIPHERAL SWELLING ((arm) swollen), ERYTHEMA ((arm) it had redness), PYREXIA (low grade fever/low grade temperature/normal temperature is 97.8, on sunday he recorded 100.2), HEADACHE (headache), CHILLS (chills), ARTHRALGIA (joint pain) and MYALGIA (body aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided.  Patient was taking vitamins and supplements.   Patient received the 3rd dose. It was not clarified if the caller was immunocompromised or not.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: malaise; covid arm; low grade fever/low grade temperature/normal temperature is 97.8, on sunday he recorded 100.2; body aches; (arm) swollen; (arm) it had redness; headache; chills; joint pain; pain that night/still sore to the touch; itch; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (malaise), VACCINATION SITE REACTION (covid arm), PAIN (pain that night/still sore to the touch), PRURITUS (itch) and PERIPHERAL SWELLING ((arm) swollen) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A, 003AZ1A and 030L(Z)0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METOPROLOL, TIMOLOL and CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]) for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Sep-2021, the patient experienced PAIN (pain that night/still sore to the touch) and PRURITUS (itch). On 12-Sep-2021, the patient experienced PERIPHERAL SWELLING ((arm) swollen), ERYTHEMA ((arm) it had redness), HEADACHE (headache), CHILLS (chills) and ARTHRALGIA (joint pain). On an unknown date, the patient experienced MALAISE (malaise), VACCINATION SITE REACTION (covid arm), PYREXIA (low grade fever/low grade temperature/normal temperature is 97.8, on sunday he recorded 100.2) and MYALGIA (body aches). At the time of the report, MALAISE (malaise), VACCINATION SITE REACTION (covid arm), PAIN (pain that night/still sore to the touch), PRURITUS (itch), PERIPHERAL SWELLING ((arm) swollen), ERYTHEMA ((arm) it had redness), PYREXIA (low grade fever/low grade temperature/normal temperature is 97.8, on sunday he recorded 100.2), HEADACHE (headache), CHILLS (chills), ARTHRALGIA (joint pain) and MYALGIA (body aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided.  Patient was taking vitamins and supplements.   Patient received the 3rd dose. It was not clarified if the caller was immunocompromised or not.