chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Vaccination site pain
Clinical narrative: 1 day of flu type symptoms; soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (1 day of flu type symptoms) and VACCINATION SITE PAIN (soreness at injection site) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     The patient's past medical history included Prostate cancer (Had a radical Prostatectomy (04-OCT-2004)) on 14-Aug-2004. Concurrent medical conditions included Bee sting hypersensitivity and Drug allergy (Carry an EpiPen).    On 18-Jun-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (soreness at injection site). On 19-Jun-2021, the patient experienced INFLUENZA LIKE ILLNESS (1 day of flu type symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (1 day of flu type symptoms) and VACCINATION SITE PAIN (soreness at injection site) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       It was reported that the patient has been using Salonpas on shoulders to reduce soreness.  Concomitant medication information was not reported  Treatment information was not reported   This case was linked to MOD-2021-355775, MOD-2021-355775 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Bedridden, Body temperature, Chills, Discomfort
Clinical narrative: Stayed in bed all day; Transpiring quite a lot; Had a fever of 101F; Discomfort; Could not sleep at all that night was twisting and turning all night; Chills; Extreme fatigue/booster knocked them out for a few days; Dizziness; Having no energy at all; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Discomfort), INSOMNIA (Could not sleep at all that night was twisting and turning all night), BEDRIDDEN (Stayed in bed all day), HYPERHIDROSIS (Transpiring quite a lot) and DIZZINESS (Dizziness) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A, 031B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included CETIRIZINE HYDROCHLORIDE and MONTELUKAST SODIUM (SINGULAIR) for Allergy, LEVOTHYROXINE, BUPROPION HYDROCHLORIDE (WELLBUTRIN), FINASTERIDE (PROSCAR), ROSUVASTATIN CALCIUM (CRESTOR), EZETIMIBE (ZETIA), ACETYLSALICYLIC ACID (BABY ASPIRIN), UBIDECARENONE (COQ10 [UBIDECARENONE]), DUPILUMAB (DUPIXENT) and ALFUZOSIN for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced DIZZINESS (Dizziness) and ASTHENIA (Having no energy at all). On 19-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DISCOMFORT (Discomfort), INSOMNIA (Could not sleep at all that night was twisting and turning all night), CHILLS (Chills) and FATIGUE (Extreme fatigue/booster knocked them out for a few days). On 20-Oct-2021, the patient experienced BEDRIDDEN (Stayed in bed all day), HYPERHIDROSIS (Transpiring quite a lot) and PYREXIA (Had a fever of 101F). At the time of the report, DISCOMFORT (Discomfort), INSOMNIA (Could not sleep at all that night was twisting and turning all night), BEDRIDDEN (Stayed in bed all day), HYPERHIDROSIS (Transpiring quite a lot), DIZZINESS (Dizziness), ASTHENIA (Having no energy at all), CHILLS (Chills), FATIGUE (Extreme fatigue/booster knocked them out for a few days) and PYREXIA (Had a fever of 101F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Oct-2021, Body temperature: 101 (High) 101 degree fahreheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2021: Follow up received and contains No New Information
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Hyperhidrosis, Insomnia, Pyrexia
Clinical narrative: Stayed in bed all day; Transpiring quite a lot; Had a fever of 101F; Discomfort; Could not sleep at all that night was twisting and turning all night; Chills; Extreme fatigue/booster knocked them out for a few days; Dizziness; Having no energy at all; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Discomfort), INSOMNIA (Could not sleep at all that night was twisting and turning all night), BEDRIDDEN (Stayed in bed all day), HYPERHIDROSIS (Transpiring quite a lot) and DIZZINESS (Dizziness) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A, 031B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included CETIRIZINE HYDROCHLORIDE and MONTELUKAST SODIUM (SINGULAIR) for Allergy, LEVOTHYROXINE, BUPROPION HYDROCHLORIDE (WELLBUTRIN), FINASTERIDE (PROSCAR), ROSUVASTATIN CALCIUM (CRESTOR), EZETIMIBE (ZETIA), ACETYLSALICYLIC ACID (BABY ASPIRIN), UBIDECARENONE (COQ10 [UBIDECARENONE]), DUPILUMAB (DUPIXENT) and ALFUZOSIN for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced DIZZINESS (Dizziness) and ASTHENIA (Having no energy at all). On 19-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DISCOMFORT (Discomfort), INSOMNIA (Could not sleep at all that night was twisting and turning all night), CHILLS (Chills) and FATIGUE (Extreme fatigue/booster knocked them out for a few days). On 20-Oct-2021, the patient experienced BEDRIDDEN (Stayed in bed all day), HYPERHIDROSIS (Transpiring quite a lot) and PYREXIA (Had a fever of 101F). At the time of the report, DISCOMFORT (Discomfort), INSOMNIA (Could not sleep at all that night was twisting and turning all night), BEDRIDDEN (Stayed in bed all day), HYPERHIDROSIS (Transpiring quite a lot), DIZZINESS (Dizziness), ASTHENIA (Having no energy at all), CHILLS (Chills), FATIGUE (Extreme fatigue/booster knocked them out for a few days) and PYREXIA (Had a fever of 101F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Oct-2021, Body temperature: 101 (High) 101 degree fahreheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2021: Follow up received and contains No New Information
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Peripheral swelling, Pruritus, Pyrexia, Rash
Clinical narrative: hands were swollen, but didn't look swollen; they're itchy; mosquito bite like rash over his forearms, but they were internal instead of external like; a welt on my belt line/another one on my hip; bones started to ache; fever; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (bones started to ache), URTICARIA (a welt on my belt line/another one on my hip), PERIPHERAL SWELLING (hands were swollen, but didn't look swollen), PRURITUS (they're itchy) and RASH (mosquito bite like rash over his forearms, but they were internal instead of external like) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Oct-2021, the patient experienced BONE PAIN (bones started to ache) and PYREXIA (fever). On 20-Oct-2021, the patient experienced URTICARIA (a welt on my belt line/another one on my hip). On 21-Oct-2021, the patient experienced PERIPHERAL SWELLING (hands were swollen, but didn't look swollen), PRURITUS (they're itchy) and RASH (mosquito bite like rash over his forearms, but they were internal instead of external like). At the time of the report, BONE PAIN (bones started to ache), URTICARIA (a welt on my belt line/another one on my hip), PERIPHERAL SWELLING (hands were swollen, but didn't look swollen), PRURITUS (they're itchy), RASH (mosquito bite like rash over his forearms, but they were internal instead of external like) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided. No treatment information were provided.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hands were swollen, but didn't look swollen; they're itchy; mosquito bite like rash over his forearms, but they were internal instead of external like; a welt on my belt line/another one on my hip; bones started to ache; fever; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (bones started to ache), URTICARIA (a welt on my belt line/another one on my hip), PERIPHERAL SWELLING (hands were swollen, but didn't look swollen), PRURITUS (they're itchy) and RASH (mosquito bite like rash over his forearms, but they were internal instead of external like) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Oct-2021, the patient experienced BONE PAIN (bones started to ache) and PYREXIA (fever). On 20-Oct-2021, the patient experienced URTICARIA (a welt on my belt line/another one on my hip). On 21-Oct-2021, the patient experienced PERIPHERAL SWELLING (hands were swollen, but didn't look swollen), PRURITUS (they're itchy) and RASH (mosquito bite like rash over his forearms, but they were internal instead of external like). At the time of the report, BONE PAIN (bones started to ache), URTICARIA (a welt on my belt line/another one on my hip), PERIPHERAL SWELLING (hands were swollen, but didn't look swollen), PRURITUS (they're itchy), RASH (mosquito bite like rash over his forearms, but they were internal instead of external like) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided. No treatment information were provided.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: a lot of people had loss of taste and smell; a lot of people had loss of taste and smell; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (a lot of people had loss of taste and smell) and ANOSMIA (a lot of people had loss of taste and smell) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced AGEUSIA (a lot of people had loss of taste and smell) and ANOSMIA (a lot of people had loss of taste and smell). At the time of the report, AGEUSIA (a lot of people had loss of taste and smell) and ANOSMIA (a lot of people had loss of taste and smell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.  This case concerns a patient of an unknown age and gender, with no reported relevant medical history, who experienced the non-serious unexpected events of AGEUSIA and ANOSMIA. The events occurred on an unknown date, after the administration of a dose of Moderna COVID-19 Vaccine. The re-challenge was not applicable. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a patient of an unknown age and gender, with no reported relevant medical history, who experienced the non-serious unexpected events of AGEUSIA and ANOSMIA. The events occurred on an unknown date, after the administration of a dose of Moderna COVID-19 Vaccine. The re-challenge was not applicable. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: not experienced any known symptoms or treatments; Dose expired on 13OCT2021 and was administered on 15OCT2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose expired on 13OCT2021 and was administered on 15OCT2021) and NO ADVERSE EVENT (not experienced any known symptoms or treatments) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A and 009D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose expired on 13OCT2021 and was administered on 15OCT2021). On an unknown date, the patient experienced NO ADVERSE EVENT (not experienced any known symptoms or treatments). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose expired on 13OCT2021 and was administered on 15OCT2021) had resolved. At the time of the report, NO ADVERSE EVENT (not experienced any known symptoms or treatments) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The caller wondered if the expiration date on the moderna vial, lot number 050E21A has been extended. A dose was administered on 15OCT2021, after the published expiration date of 13OCT2021.  Concomitant medications was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2021: Non-significant followup information received email id updated
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Pain in extremity
Clinical narrative: lump under her left arm/ lump is nowgetting bigger/ It's now about the size of a golf ball; still has the lump and now it has been painful; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (lump under her left arm/ lump is nowgetting bigger/ It's now about the size of a golf ball) and PAIN IN EXTREMITY (still has the lump and now it has been painful) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 020B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced AXILLARY MASS (lump under her left arm/ lump is nowgetting bigger/ It's now about the size of a golf ball) and PAIN IN EXTREMITY (still has the lump and now it has been painful). At the time of the report, AXILLARY MASS (lump under her left arm/ lump is nowgetting bigger/ It's now about the size of a golf ball) and PAIN IN EXTREMITY (still has the lump and now it has been painful) had not resolved.            No concomitant medication were reported.  No treatment information was provided by the reporter.  Patient started experiencing the symptoms 3 or 4 days after receiving the second dose of vaccine. The lump was getting bigger from the last week and was about the size of a golf ball. Patient hasn't seen a doctor yet but planned to.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered  past the expiration date; 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 EXPIRED PRODUCT ADMINISTERED (administered  past the expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered  past the expiration date). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered  past the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Treatment information was not provided.  The vial expired on 13 October 2021 and was administered to the patient on 20 October 2021.   This case was linked to MOD-2021-359945, MOD-2021-360524, MOD-2021-359936 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Goitre, Heart rate, Hyperhidrosis, Insomnia
Clinical narrative: Some enlargement of thyroid; 3 weeks ago she started to have difficulty sleeping; 5 weeks ago She started to develop  diaphoretic episodes that her clothes were soaked with sweat; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (5 weeks ago She started to develop  diaphoretic episodes that her clothes were soaked with sweat), INSOMNIA (3 weeks ago she started to have difficulty sleeping) and GOITRE (Some enlargement of thyroid) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 040A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included Metoprolol; Lisinopril; Coumadin; Rosuvastatin; Tylenol; Fish Oil; Melatonin for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPERHIDROSIS (5 weeks ago She started to develop  diaphoretic episodes that her clothes were soaked with sweat). On 04-Oct-2021, the patient experienced INSOMNIA (3 weeks ago she started to have difficulty sleeping). On an unknown date, the patient experienced GOITRE (Some enlargement of thyroid). At the time of the report, HYPERHIDROSIS (5 weeks ago She started to develop  diaphoretic episodes that her clothes were soaked with sweat), INSOMNIA (3 weeks ago she started to have difficulty sleeping) and GOITRE (Some enlargement of thyroid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Sep-2021, Heart rate: rapid pulse (abnormal) Rapid pulse. On an unknown date, Blood thyroid stimulating hormone: normal (normal) Normal. On an unknown date, Thyroxine: normal (normal) Normal.   Treatment information was not provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Thyroxine
Clinical narrative: Some enlargement of thyroid; 3 weeks ago she started to have difficulty sleeping; 5 weeks ago She started to develop  diaphoretic episodes that her clothes were soaked with sweat; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (5 weeks ago She started to develop  diaphoretic episodes that her clothes were soaked with sweat), INSOMNIA (3 weeks ago she started to have difficulty sleeping) and GOITRE (Some enlargement of thyroid) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 040A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included Metoprolol; Lisinopril; Coumadin; Rosuvastatin; Tylenol; Fish Oil; Melatonin for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPERHIDROSIS (5 weeks ago She started to develop  diaphoretic episodes that her clothes were soaked with sweat). On 04-Oct-2021, the patient experienced INSOMNIA (3 weeks ago she started to have difficulty sleeping). On an unknown date, the patient experienced GOITRE (Some enlargement of thyroid). At the time of the report, HYPERHIDROSIS (5 weeks ago She started to develop  diaphoretic episodes that her clothes were soaked with sweat), INSOMNIA (3 weeks ago she started to have difficulty sleeping) and GOITRE (Some enlargement of thyroid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Sep-2021, Heart rate: rapid pulse (abnormal) Rapid pulse. On an unknown date, Blood thyroid stimulating hormone: normal (normal) Normal. On an unknown date, Thyroxine: normal (normal) Normal.   Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: I got the Moderna vaccine in January/February and just tested positive for Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I got the Moderna vaccine in January/February and just tested positive for Covid) 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 COVID-19 (I got the Moderna vaccine in January/February and just tested positive for Covid). At the time of the report, COVID-19 (I got the Moderna vaccine in January/February and just tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient received Moderna vaccine in January or February. No concomitant product reported by reporter. No treatment medication reported by reporter. This case concerns a patient of unknown gender and age with no details on previous relevant medical history, who experienced the non serious unexpected event/AESI of COVID-19 after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The event occurred approximately 8 months after the dose of Spikevax, dose number unknown. The rechallenge is not applicable, since the only event reported was COVID-19. The benefit-risk relationship of Spikevax vaccine is not affected by this report. Drug ineffective was not captured since information regarding the schedule of vaccination is lacking.; Sender's Comments: This case concerns a patient of unknown gender and age with no details on previous relevant medical history, who experienced the non serious unexpected event/AESI of COVID-19 after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The event occurred approximately 8 months after the dose of Spikevax, dose number unknown. The rechallenge is not applicable, since the only event reported was COVID-19. The benefit-risk relationship of Spikevax vaccine is not affected by this report. Drug ineffective was not captured since information regarding the schedule of vaccination is lacking.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received dose from vial punctured for more than 12 hours; 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 EXPIRED PRODUCT ADMINISTERED (Received dose from vial punctured for more than 12 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939904) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from vial punctured for more than 12 hours). On 21-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from vial punctured for more than 12 hours) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F)24 hours. It was at room temperature since the moment it was punctured and the vaccine was administered 24 hours after that.  Concomitant medications was not provided by the reporter. Treatment information was not provided.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: injection site is swollen; Only hurts if the patient touches the injection site; 2x2 red square the injection site is swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (injection site is swollen), VACCINATION SITE PAIN (Only hurts if the patient touches the injection site) and VACCINATION SITE ERYTHEMA (2x2 red square the injection site is swollen) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A, 025L20A and 03T20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 20-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 100 mcg. In October 2021, the patient experienced VACCINATION SITE SWELLING (injection site is swollen), VACCINATION SITE PAIN (Only hurts if the patient touches the injection site) and VACCINATION SITE ERYTHEMA (2x2 red square the injection site is swollen). At the time of the report, VACCINATION SITE SWELLING (injection site is swollen), VACCINATION SITE PAIN (Only hurts if the patient touches the injection site) and VACCINATION SITE ERYTHEMA (2x2 red square the injection site is swollen) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.  The patient could feel the swelling in the injection site when touched.   This case was linked to MOD-2021-359860 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cyanosis, Dyspnoea, Feeling abnormal, Illness
Clinical narrative: Fibro neuropathy; Sick for 2 days; Couldn't sleep that night; Very breathy; My hands were turning blue for the circulation or like that; Not feeling healthier; 101°F Fever; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Fibro neuropathy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Fibro neuropathy) (seriousness criterion medically significant), ILLNESS (Sick for 2 days), INSOMNIA (Couldn't sleep that night), DYSPNOEA (Very breathy), CYANOSIS (My hands were turning blue for the circulation or like that), FEELING ABNORMAL (Not feeling healthier), PYREXIA (101°F Fever) and NAUSEA (Nausea). At the time of the report, NEUROPATHY PERIPHERAL (Fibro neuropathy), INSOMNIA (Couldn't sleep that night), DYSPNOEA (Very breathy), CYANOSIS (My hands were turning blue for the circulation or like that), FEELING ABNORMAL (Not feeling healthier), PYREXIA (101°F Fever) and NAUSEA (Nausea) outcome was unknown and ILLNESS (Sick for 2 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) 101°F Fever.         No relevant concomitant medications were reported.  No treatment information was provided.  Company comment: This case concerns a female patient of unknown age with previous relevant medical history reported who experienced the unexpected event of neuropathy peripheral. The events occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.   This case was linked to MOD-2021-360198 (Patient Link).; Sender's Comments: This case concerns a female patient of unknown age with previous relevant medical history reported who experienced the unexpected event of neuropathy peripheral. The events occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Nausea, Neuropathy peripheral, Pyrexia
Clinical narrative: Fibro neuropathy; Sick for 2 days; Couldn't sleep that night; Very breathy; My hands were turning blue for the circulation or like that; Not feeling healthier; 101°F Fever; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Fibro neuropathy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Fibro neuropathy) (seriousness criterion medically significant), ILLNESS (Sick for 2 days), INSOMNIA (Couldn't sleep that night), DYSPNOEA (Very breathy), CYANOSIS (My hands were turning blue for the circulation or like that), FEELING ABNORMAL (Not feeling healthier), PYREXIA (101°F Fever) and NAUSEA (Nausea). At the time of the report, NEUROPATHY PERIPHERAL (Fibro neuropathy), INSOMNIA (Couldn't sleep that night), DYSPNOEA (Very breathy), CYANOSIS (My hands were turning blue for the circulation or like that), FEELING ABNORMAL (Not feeling healthier), PYREXIA (101°F Fever) and NAUSEA (Nausea) outcome was unknown and ILLNESS (Sick for 2 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) 101°F Fever.         No relevant concomitant medications were reported.  No treatment information was provided.  Company comment: This case concerns a female patient of unknown age with previous relevant medical history reported who experienced the unexpected event of neuropathy peripheral. The events occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.   This case was linked to MOD-2021-360198 (Patient Link).; Sender's Comments: This case concerns a female patient of unknown age with previous relevant medical history reported who experienced the unexpected event of neuropathy peripheral. The events occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Pain in extremity
Clinical narrative: Pain in the calf and leg at nights/pain in leg when lay down at night; limping off and on; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the calf and leg at nights/pain in leg when lay down at night) and GAIT DISTURBANCE (limping off and on) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in the calf and leg at nights/pain in leg when lay down at night) and GAIT DISTURBANCE (limping off and on). At the time of the report, PAIN IN EXTREMITY (Pain in the calf and leg at nights/pain in leg when lay down at night) and GAIT DISTURBANCE (limping off and on) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information were provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Fatigue
Clinical narrative: in bed for 2 days; Tired; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (in bed for 2 days) and FATIGUE (Tired) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 002A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient was on a respirator) in 2020. Previously administered products included for Product used for unknown indication: Flu vaccine. Past adverse reactions to the above products included Tiredness with Flu vaccine.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced BEDRIDDEN (in bed for 2 days) and FATIGUE (Tired). At the time of the report, BEDRIDDEN (in bed for 2 days) and FATIGUE (Tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient get tired after any vaccine. No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Infection, Vaccination site cyst, Vaccination site erythema, Vaccination site mass, Vaccination site swelling
Clinical narrative: infection; big lump in the injection site; feels like it is on fire to the touch; Feels like cyst/ It is silky, moveable, squishy and does not feel like it is connected; Very red; Swollen; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (infection), VACCINATION SITE MASS (big lump in the injection site), VACCINATION SITE WARMTH (feels like it is on fire to the touch), VACCINATION SITE CYST (Feels like cyst/ It is silky, moveable, squishy and does not feel like it is connected) and VACCINATION SITE ERYTHEMA (Very red) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFECTION (infection), VACCINATION SITE MASS (big lump in the injection site), VACCINATION SITE WARMTH (feels like it is on fire to the touch), VACCINATION SITE CYST (Feels like cyst/ It is silky, moveable, squishy and does not feel like it is connected), VACCINATION SITE ERYTHEMA (Very red) and VACCINATION SITE SWELLING (Swollen). At the time of the report, INFECTION (infection), VACCINATION SITE MASS (big lump in the injection site), VACCINATION SITE WARMTH (feels like it is on fire to the touch), VACCINATION SITE CYST (Feels like cyst/ It is silky, moveable, squishy and does not feel like it is connected), VACCINATION SITE ERYTHEMA (Very red) and VACCINATION SITE SWELLING (Swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient does not take any concomitant medications in her daily life. Patient did not take medications to treat her symptoms.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: infection; big lump in the injection site; feels like it is on fire to the touch; Feels like cyst/ It is silky, moveable, squishy and does not feel like it is connected; Very red; Swollen; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (infection), VACCINATION SITE MASS (big lump in the injection site), VACCINATION SITE WARMTH (feels like it is on fire to the touch), VACCINATION SITE CYST (Feels like cyst/ It is silky, moveable, squishy and does not feel like it is connected) and VACCINATION SITE ERYTHEMA (Very red) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFECTION (infection), VACCINATION SITE MASS (big lump in the injection site), VACCINATION SITE WARMTH (feels like it is on fire to the touch), VACCINATION SITE CYST (Feels like cyst/ It is silky, moveable, squishy and does not feel like it is connected), VACCINATION SITE ERYTHEMA (Very red) and VACCINATION SITE SWELLING (Swollen). At the time of the report, INFECTION (infection), VACCINATION SITE MASS (big lump in the injection site), VACCINATION SITE WARMTH (feels like it is on fire to the touch), VACCINATION SITE CYST (Feels like cyst/ It is silky, moveable, squishy and does not feel like it is connected), VACCINATION SITE ERYTHEMA (Very red) and VACCINATION SITE SWELLING (Swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient does not take any concomitant medications in her daily life. Patient did not take medications to treat her symptoms.
Sex: U
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: bad flared up of rheumatoid arthritis; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (bad flared up of rheumatoid arthritis) 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 RHEUMATOID ARTHRITIS (bad flared up of rheumatoid arthritis) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (bad flared up of rheumatoid arthritis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient wasn't sure if it was the Moderna vaccine or not  No concomitant medications were reported   No treatment information was provided  Company Comment: This case concerns an unknown age and unknown gender patient with no relevant medical history, who experienced the unexpected event of rheumatoid arthritis. The event occurred unknown number of days after a dose of mRNA-1273 vaccine.  It is not clear from the source document whether this was a first or second dose. The rechallenge was unknown since there's not enough information to assess this in the source document. The benefit-risk relationship of the vaccine not affected by this report.; Sender's Comments: This case concerns an unknown age and unknown gender patient with no relevant medical history, who experienced the unexpected event of rheumatoid arthritis. The event occurred unknown number of days after a dose of mRNA-1273 vaccine.  It is not clear from the source document whether this was a first or second dose. The rechallenge was unknown since there's not enough information to assess this in the source document. The benefit-risk relationship of the vaccine not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine had been out of the fridge since 10:15 am of 20-Oct-2021 and was administered at 12:26 pm of 21-Oct-2021; 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 EXPIRED PRODUCT ADMINISTERED (Vaccine had been out of the fridge since 10:15 am of 20-Oct-2021 and was administered at 12:26 pm of 21-Oct-2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine had been out of the fridge since 10:15 am of 20-Oct-2021 and was administered at 12:26 pm of 21-Oct-2021). On 21-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine had been out of the fridge since 10:15 am of 20-Oct-2021 and was administered at 12:26 pm of 21-Oct-2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The vaccine had been out of the fridge since 10:15 am on 20-Oct-2021, exceeding the 12 hour window outside of fridge.   Dose administered after exposure to room temperature was >24 hours.  Total amount of time the vial was exposed to room temperature range 8 degrees to 25 degree C equal to  46 degree to 77 degree was given as unknown.  No treatment information was provided by the reporter.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered >12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0352CIA) for COVID-19 vaccination.   No Medical History information was reported.  On 21-Oct-2021 at 10:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture). On 21-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) had resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  No relevant concomitant medications were reported.  Treatment information was unknown.  Patient height is given as 66 inches.  On 20-Oct-2021 at 07:40 AM, the vial was first punctured and on 21-Oct-2021, patient was administered with the vaccine from the vial. The total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was 31 hours.  Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Follow up received contains significant information, patient details and suspect drug details updated