chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 no. 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 shot (Patient get tired after any vaccine). Past adverse reactions to the above products included Tiredness with Flu shot.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced BEDRIDDEN (in bed for 2 days) and FATIGUE (tired). On 06-Mar-2021, BEDRIDDEN (in bed for 2 days) had resolved. At the time of the report, FATIGUE (tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was provided. No treatment medication details was provided.  The patient got the second dose vaccination on 01APR2021.   This case was linked to MOD-2021-360282 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Headache, Nausea
Clinical narrative: felt weak; COVID rash on her arm; was very tired; had a terrible headache; was nauseated; joints hurt; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt weak), RASH (COVID rash on her arm), FATIGUE (was very tired), HEADACHE (had a terrible headache) and NAUSEA (was nauseated) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 0306Z0A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021, the patient experienced ASTHENIA (felt weak), RASH (COVID rash on her arm), FATIGUE (was very tired), HEADACHE (had a terrible headache), NAUSEA (was nauseated) and ARTHRALGIA (joints hurt). The patient was treated with PARACETAMOL (TYLENOL) in October 2021 for Headache, at an unspecified dose and frequency. On 20-Oct-2021, ASTHENIA (felt weak), RASH (COVID rash on her arm), FATIGUE (was very tired), HEADACHE (had a terrible headache), NAUSEA (was nauseated) and ARTHRALGIA (joints hurt) had resolved.            No concomitant medication information was provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: felt weak; COVID rash on her arm; was very tired; had a terrible headache; was nauseated; joints hurt; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt weak), RASH (COVID rash on her arm), FATIGUE (was very tired), HEADACHE (had a terrible headache) and NAUSEA (was nauseated) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 0306Z0A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021, the patient experienced ASTHENIA (felt weak), RASH (COVID rash on her arm), FATIGUE (was very tired), HEADACHE (had a terrible headache), NAUSEA (was nauseated) and ARTHRALGIA (joints hurt). The patient was treated with PARACETAMOL (TYLENOL) in October 2021 for Headache, at an unspecified dose and frequency. On 20-Oct-2021, ASTHENIA (felt weak), RASH (COVID rash on her arm), FATIGUE (was very tired), HEADACHE (had a terrible headache), NAUSEA (was nauseated) and ARTHRALGIA (joints hurt) had resolved.            No concomitant medication information was provided.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Arm was a little swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm was a little swollen) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 031A21A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PERIPHERAL SWELLING (Arm was a little swollen). At the time of the report, PERIPHERAL SWELLING (Arm was a little swollen) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Follow up received contains non significant information.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: I'm afraid I got an expired vaccine/ the card has an expiration date of August; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (I'm afraid I got an expired vaccine/ the card has an expiration date of August) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination. No Medical History information was reported. On 20-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (I'm afraid I got an expired vaccine/ the card has an expiration date of August). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (I'm afraid I got an expired vaccine/ the card has an expiration date of August) had resolved.  No Concomitant medications were provided by the reporter. No Treatment information was reported. Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Follow up received on 25-Oct-2021 : Patient demographic details, Vaccine information was Updated.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Feeling hot, Peripheral swelling, Pruritus
Clinical narrative: Arm  was swollen; Arm was red, red, red; Arm was hot like it had fever; Itchy; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm  was swollen), ERYTHEMA (Arm was red, red, red), FEELING HOT (Arm was hot like it had fever), PRURITUS (Itchy) and PYREXIA (Fever) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm  was swollen), ERYTHEMA (Arm was red, red, red), FEELING HOT (Arm was hot like it had fever), PRURITUS (Itchy), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Arm  was swollen), ERYTHEMA (Arm was red, red, red), FEELING HOT (Arm was hot like it had fever), PRURITUS (Itchy), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Arm  was swollen; Arm was red, red, red; Arm was hot like it had fever; Itchy; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm  was swollen), ERYTHEMA (Arm was red, red, red), FEELING HOT (Arm was hot like it had fever), PRURITUS (Itchy) and PYREXIA (Fever) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm  was swollen), ERYTHEMA (Arm was red, red, red), FEELING HOT (Arm was hot like it had fever), PRURITUS (Itchy), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Arm  was swollen), ERYTHEMA (Arm was red, red, red), FEELING HOT (Arm was hot like it had fever), PRURITUS (Itchy), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Dysgeusia, Dysphagia, Feeding disorder, Vaccination site erythema
Clinical narrative: Disoriented after the first shot; Metal taste in mouth ,bitter taste in mouth after first shot; Not been able to eat after first shot; Not been able to swallow after first shot; Throws up after eating and drinking after the first shot; Redness on the injection site after the first shot; Itching injection site after the first shot; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Oct-2021 and was forwarded to Moderna on 21-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (Disoriented after the first shot), DYSGEUSIA (Metal taste in mouth ,bitter taste in mouth after first shot), FEEDING DISORDER (Not been able to eat after first shot), DYSPHAGIA (Not been able to swallow after first shot) and VOMITING (Throws up after eating and drinking after the first shot) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: TETANUS VACCINE TOXOID (Reaction to Tetanus shot so they watched her for 1 hour after each vaccination.). Past adverse reactions to the above products included No adverse event with TETANUS VACCINE TOXOID.    On 21-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, the patient experienced DISORIENTATION (Disoriented after the first shot), DYSGEUSIA (Metal taste in mouth ,bitter taste in mouth after first shot), FEEDING DISORDER (Not been able to eat after first shot), DYSPHAGIA (Not been able to swallow after first shot), VOMITING (Throws up after eating and drinking after the first shot), VACCINATION SITE ERYTHEMA (Redness on the injection site after the first shot) and VACCINATION SITE PRURITUS (Itching injection site after the first shot). On 28-Sep-2021, VACCINATION SITE PRURITUS (Itching injection site after the first shot) had resolved. At the time of the report, DISORIENTATION (Disoriented after the first shot), DYSGEUSIA (Metal taste in mouth ,bitter taste in mouth after first shot), FEEDING DISORDER (Not been able to eat after first shot), DYSPHAGIA (Not been able to swallow after first shot) and VOMITING (Throws up after eating and drinking after the first shot) outcome was unknown and VACCINATION SITE ERYTHEMA (Redness on the injection site after the first shot) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was provided.  No concomitant medication was provided.   This case was linked to MOD-2021-360579 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vomiting
Clinical narrative: Disoriented after the first shot; Metal taste in mouth ,bitter taste in mouth after first shot; Not been able to eat after first shot; Not been able to swallow after first shot; Throws up after eating and drinking after the first shot; Redness on the injection site after the first shot; Itching injection site after the first shot; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Oct-2021 and was forwarded to Moderna on 21-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (Disoriented after the first shot), DYSGEUSIA (Metal taste in mouth ,bitter taste in mouth after first shot), FEEDING DISORDER (Not been able to eat after first shot), DYSPHAGIA (Not been able to swallow after first shot) and VOMITING (Throws up after eating and drinking after the first shot) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: TETANUS VACCINE TOXOID (Reaction to Tetanus shot so they watched her for 1 hour after each vaccination.). Past adverse reactions to the above products included No adverse event with TETANUS VACCINE TOXOID.    On 21-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, the patient experienced DISORIENTATION (Disoriented after the first shot), DYSGEUSIA (Metal taste in mouth ,bitter taste in mouth after first shot), FEEDING DISORDER (Not been able to eat after first shot), DYSPHAGIA (Not been able to swallow after first shot), VOMITING (Throws up after eating and drinking after the first shot), VACCINATION SITE ERYTHEMA (Redness on the injection site after the first shot) and VACCINATION SITE PRURITUS (Itching injection site after the first shot). On 28-Sep-2021, VACCINATION SITE PRURITUS (Itching injection site after the first shot) had resolved. At the time of the report, DISORIENTATION (Disoriented after the first shot), DYSGEUSIA (Metal taste in mouth ,bitter taste in mouth after first shot), FEEDING DISORDER (Not been able to eat after first shot), DYSPHAGIA (Not been able to swallow after first shot) and VOMITING (Throws up after eating and drinking after the first shot) outcome was unknown and VACCINATION SITE ERYTHEMA (Redness on the injection site after the first shot) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was provided.  No concomitant medication was provided.   This case was linked to MOD-2021-360579 (Patient Link).
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 15-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered  past the expiration date). On 15-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.   It was reported that the patient was administered with the vaccine from the vial expired on 13-Oct-2021. The vial was moved to the refrigerator on 14-Oct-2021.  No concomitant medication was reported. No treatment information was reported.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant at the time of first and second inoculation; This spontaneous retrospective pregnancy case was reported by a pharmacist and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant at the time of first and second inoculation) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A, 028L20A and 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 28-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant at the time of first and second inoculation). The delivery occurred  on 28-May-2021, which was reported as Normal Pregnancy Outcome. For neonate 1, The outcome was reported as Delivered NOS. On 28-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant at the time of first and second inoculation) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication is provided by reporter. No treatment was provided COMPANY COMMENT: This case concerns a 34 year old female, with no medical information reported, who experienced non-serious unexpected event of Maternal exposure during pregnancy. The age of gestation of the pregnancy  at the time of exposure of the 1st to 2nd dose is unknown since we do not have details of the LMP of the patient . The  re-challenge for this case is not applicable. The benefit-risk relationship of mRNA-1273 (Moderna ) is not affected by this report.   This case was linked to MOD-2021-360694 (Patient Link).; Sender's Comments: This case concerns a 34 year old female, with no medical information reported, who experienced non-serious unexpected event of Maternal exposure during pregnancy. The age of gestation of the pregnancy  at the time of exposure of the 1st to 2nd dose is unknown since we do not have details of the LMP of the patient . The  re-challenge for this case is not applicable. The benefit-risk relationship of mRNA-1273 (Moderna ) is not affected by this report.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Nightmare
Clinical narrative: got sick the same day; got crazy nightmares.; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got sick the same day) and NIGHTMARE (got crazy nightmares.) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, the patient experienced ILLNESS (got sick the same day) and NIGHTMARE (got crazy nightmares.). On 15-Jul-2021, ILLNESS (got sick the same day) and NIGHTMARE (got crazy nightmares.) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The concomitant and treatment medication were not reported.  The patient got sick the same day and got crazy nightmares.   This case was linked to MOD-2021-360843 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Pain in extremity
Clinical narrative: Pain in the Left calf and left leg  at nights after 2nd shot; Limping off and on after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the Left calf and left leg  at nights after 2nd shot) and GAIT DISTURBANCE (Limping off and on after 2nd shot) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 003A21A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer (Radiation) since August 2020 and Blood pressure high. Concomitant products included VERAPAMIL, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE & HCTZ) and ANASTROZOLE for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in the Left calf and left leg  at nights after 2nd shot) and GAIT DISTURBANCE (Limping off and on after 2nd shot). The patient was treated with IBUPROFEN at an unspecified dose and frequency; MENTHOL, METHYL SALICYLATE (BENGAY [MENTHOL;METHYL SALICYLATE]) at an unspecified dose and frequency and CAMPHOR, MENTHOL (VICKS [CAMPHOR;MENTHOL]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in the Left calf and left leg  at nights after 2nd shot) and GAIT DISTURBANCE (Limping off and on after 2nd shot) outcome was unknown.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Dyspnoea
Clinical narrative: Getting asthma every day; Have labor breathing/They struggle  breathing; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (Getting asthma every day) and DYSPNOEA (Have labor breathing/They struggle  breathing) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033c21a and 024c21a) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included EPHEDRINE HYDROCHLORIDE, GUAIFENESIN (PRIMATENE [EPHEDRINE HYDROCHLORIDE;GUAIFENESIN]) for Asthma.   On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced ASTHMA (Getting asthma every day) and DYSPNOEA (Have labor breathing/They struggle  breathing). At the time of the report, ASTHMA (Getting asthma every day) and DYSPNOEA (Have labor breathing/They struggle  breathing) had not resolved.            Other concomitant medications included inhaler for asthma.  It was reported that patient used Primatene tablet and asthma inhaler for his adverse reactions but the pills were not working anymore.   This case was linked to MOD-2021-360771 (Patient Link).
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Vaccination site erythema
Clinical narrative: weakness; fatigue; trapezoidal pink area about 3 by 4 inches from; developed into a red spot, like a patch; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (trapezoidal pink area about 3 by 4 inches from) and VACCINATION SITE ERYTHEMA (developed into a red spot, like a patch) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakness), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (trapezoidal pink area about 3 by 4 inches from) and VACCINATION SITE ERYTHEMA (developed into a red spot, like a patch). At the time of the report, ASTHENIA (weakness), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (trapezoidal pink area about 3 by 4 inches from) and VACCINATION SITE ERYTHEMA (developed into a red spot, like a patch) 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.   Concomitant drugs were not reported.  The first shot gave him a trapezoidal pink area about 3 by 4 inches from where the needle was injected and developed into a red spot. It was like a patch. He did not have ill effects to speak of other than fatigue and weakness.  Treatment medications were not provided.   This case was linked to MOD-2021-361014 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of adverse event (wants to report adverse event) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On Oct 21, 2021, patient experienced an adverse event (wants to report adverse event). At the time of the report, adverse event (wants to report adverse event) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chest pain
Clinical narrative: Chest pain ,hurting on the inside; Pain in the back; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain ,hurting on the inside) and BACK PAIN (Pain in the back) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Around 7 Months ago).    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 CHEST PAIN (Chest pain ,hurting on the inside) and BACK PAIN (Pain in the back). At the time of the report, CHEST PAIN (Chest pain ,hurting on the inside) and BACK PAIN (Pain in the back) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported   No treatment information was provided   This case was linked to MOD-2021-361232 (Patient Link).
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Chills, Tremor
Clinical narrative: anxiety; tremors/ shaking; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (anxiety), TREMOR (tremors/ shaking) and CHILLS (Chills) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. D1DF21A, 008B21A and 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Muscle disorder NOS and Immunocompromised.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-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 ANXIETY (anxiety), TREMOR (tremors/ shaking) and CHILLS (Chills). At the time of the report, ANXIETY (anxiety), TREMOR (tremors/ shaking) and CHILLS (Chills) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2021-361351, MOD-2021-361352 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: AFIB; 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 ATRIAL FIBRILLATION (AFIB) 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 ATRIAL FIBRILLATION (AFIB) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (AFIB) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was  not reported. Relevant concomitant medications were not provided by the reporter. It was reported that "two people that work for reporter had the vaxx had to quite shortly after they got the vax because they developed AFIB. Their lives have changed".  Company Comment: This case concerns an unknown age and unknown gender patient with no relevant medical history, who experienced the unexpected event of atrial fibrillation. 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.   This case was linked to US-MODERNATX, INC.-MOD-2021-361454 (E2B Linked 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 atrial fibrillation. 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. US-MODERNATX, INC.-MOD-2021-361454:Crosslinked case (same reporter)
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine). On 21-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was reported.   This case was linked to MOD-2021-362834 (Patient Link).
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Impaired driving ability, Suspected COVID-19
Clinical narrative: Couldn't even drive home; As soon as I took the shot I was sick; 15 minutes after the first shot got COVID; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED DRIVING ABILITY (Couldn't even drive home), ILLNESS (As soon as I took the shot I was sick) and COVID-19 (15 minutes after the first shot got COVID) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011620A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced IMPAIRED DRIVING ABILITY (Couldn't even drive home) and ILLNESS (As soon as I took the shot I was sick). 05-Jan-2021, the patient experienced COVID-19 (15 minutes after the first shot got COVID). At the time of the report, IMPAIRED DRIVING ABILITY (Couldn't even drive home), ILLNESS (As soon as I took the shot I was sick) and COVID-19 (15 minutes after the first shot got COVID) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were reported.  The patient was on a high risk category. Patient had pre existences. The patient will have a total knee replacement.  This case concerns a 59-year-old male patient with no details on previous relevant medical history, who experienced the unexpected non serious event/AESI of Suspected COVID after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The event occurred immediately after the first dose of Spikevax. The patient reported that 15 minutes after the first dose he felt ill and on the following day was diagnosed with COVID-19. Confirmation test was not reported. The rechallenge for the event COVID-19 is not applicable. The benefit-risk relationship of Spikevax vaccine is not affected by this report.   This case was linked to MOD-2021-361662 (Patient Link).; Sender's Comments: This case concerns a 59-year-old male patient with no details on previous relevant medical history, who experienced the unexpected non serious event/AESI of Suspected COVID after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The event occurred immediately after the first dose of Spikevax. The patient reported that 15 minutes after the first dose he felt ill and on the following day was diagnosed with COVID-19. Confirmation test was not reported. The rechallenge for the event COVID-19 is not applicable. The benefit-risk relationship of Spikevax vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal pain
Clinical narrative: Left shoulder blade/shoulder has been hurting; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Left shoulder blade/shoulder has been hurting) 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 ARTHRALGIA (Left shoulder blade/shoulder has been hurting). At the time of the report, ARTHRALGIA (Left shoulder blade/shoulder has been hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant and Treatment medication were reported.  It was reported that patient left shoulder blade and shoulder has been hurting ever since patient got a dose of Moderna covid-19 vaccine
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Fourteen patients were administered expired doses of the Moderna COVID-19 vaccine; 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 (Fourteen patients were administered expired doses of the Moderna COVID-19 vaccine) 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 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Fourteen patients were administered expired doses of the Moderna COVID-19 vaccine). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Fourteen patients were administered expired doses of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported.  It was reported that the vials were initially stored in the refrigerator on 16-OCT-2021 and 14 patients were administered with booster doses.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Injection site was very tender/ injection site hurt/had pain at the injection site; Had swelling at the injection site; Injection site had a bump/bump, it was itchy and hard, and this morning it is a little bigger/feel a bump in the skin/itches but not so much, and they feel a bump in the skin.; Injection site was hard/injection site was bump and  hard; Injection site was a little red/m injection site had redness; Injection site was itchy; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site was itchy), VACCINATION SITE PAIN (Injection site was very tender/ injection site hurt/had pain at the injection site), VACCINATION SITE INDURATION (Injection site was hard/injection site was bump and  hard), VACCINATION SITE ERYTHEMA (Injection site was a little red/m injection site had redness) and VACCINATION SITE SWELLING (Had swelling at the injection site) 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.     The patient's past medical history included Hysterectomy. Concurrent medical conditions included Drug allergy (Allergic to several antibiotics).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site was itchy), VACCINATION SITE INDURATION (Injection site was hard/injection site was bump and  hard) and VACCINATION SITE ERYTHEMA (Injection site was a little red/m injection site had redness). On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection site was very tender/ injection site hurt/had pain at the injection site), VACCINATION SITE SWELLING (Had swelling at the injection site) and VACCINATION SITE RASH (Injection site had a bump/bump, it was itchy and hard, and this morning it is a little bigger/feel a bump in the skin/itches but not so much, and they feel a bump in the skin.). At the time of the report, VACCINATION SITE PRURITUS (Injection site was itchy), VACCINATION SITE PAIN (Injection site was very tender/ injection site hurt/had pain at the injection site), VACCINATION SITE INDURATION (Injection site was hard/injection site was bump and  hard), VACCINATION SITE ERYTHEMA (Injection site was a little red/m injection site had redness), VACCINATION SITE SWELLING (Had swelling at the injection site) and VACCINATION SITE RASH (Injection site had a bump/bump, it was itchy and hard, and this morning it is a little bigger/feel a bump in the skin/itches but not so much, and they feel a bump in the skin.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Injection site was very tender/ injection site hurt/had pain at the injection site; Had swelling at the injection site; Injection site had a bump/bump, it was itchy and hard, and this morning it is a little bigger/feel a bump in the skin/itches but not so much, and they feel a bump in the skin.; Injection site was hard/injection site was bump and  hard; Injection site was a little red/m injection site had redness; Injection site was itchy; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site was itchy), VACCINATION SITE PAIN (Injection site was very tender/ injection site hurt/had pain at the injection site), VACCINATION SITE INDURATION (Injection site was hard/injection site was bump and  hard), VACCINATION SITE ERYTHEMA (Injection site was a little red/m injection site had redness) and VACCINATION SITE SWELLING (Had swelling at the injection site) 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.     The patient's past medical history included Hysterectomy. Concurrent medical conditions included Drug allergy (Allergic to several antibiotics).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site was itchy), VACCINATION SITE INDURATION (Injection site was hard/injection site was bump and  hard) and VACCINATION SITE ERYTHEMA (Injection site was a little red/m injection site had redness). On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection site was very tender/ injection site hurt/had pain at the injection site), VACCINATION SITE SWELLING (Had swelling at the injection site) and VACCINATION SITE RASH (Injection site had a bump/bump, it was itchy and hard, and this morning it is a little bigger/feel a bump in the skin/itches but not so much, and they feel a bump in the skin.). At the time of the report, VACCINATION SITE PRURITUS (Injection site was itchy), VACCINATION SITE PAIN (Injection site was very tender/ injection site hurt/had pain at the injection site), VACCINATION SITE INDURATION (Injection site was hard/injection site was bump and  hard), VACCINATION SITE ERYTHEMA (Injection site was a little red/m injection site had redness), VACCINATION SITE SWELLING (Had swelling at the injection site) and VACCINATION SITE RASH (Injection site had a bump/bump, it was itchy and hard, and this morning it is a little bigger/feel a bump in the skin/itches but not so much, and they feel a bump in the skin.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Oropharyngeal pain, Pyrexia
Clinical narrative: Recurring sore throat that comes and goes; after second dose and still ongoing; Chills; Spike of fever/may be a slight fever; Aching around the joints; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Recurring sore throat that comes and goes; after second dose and still ongoing), CHILLS (Chills), PYREXIA (Spike of fever/may be a slight fever), ARTHRALGIA (Aching around the joints) and FATIGUE (Fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced CHILLS (Chills), PYREXIA (Spike of fever/may be a slight fever), ARTHRALGIA (Aching around the joints) and FATIGUE (Fatigue). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Recurring sore throat that comes and goes; after second dose and still ongoing). On 22-Feb-2021, CHILLS (Chills), PYREXIA (Spike of fever/may be a slight fever), ARTHRALGIA (Aching around the joints) and FATIGUE (Fatigue) had resolved. At the time of the report, OROPHARYNGEAL PAIN (Recurring sore throat that comes and goes; after second dose and still ongoing) had not resolved.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-017860 (Patient Link).
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got sick for about 5 hours/as soon as I took the shot I was sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got sick for about 5 hours/as soon as I took the shot I was sick) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 011620A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-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 ILLNESS (got sick for about 5 hours/as soon as I took the shot I was sick). In February 2021, ILLNESS (got sick for about 5 hours/as soon as I took the shot I was sick) had resolved.            no concomitant and treatment medications are provided by the reporter.  The patient was on a high risk category. Patient had pre existences. The patient would have a total knee replacement.  3 patients that had the Pfizer's shoot and died from COVID.   This case was linked to MOD-2021-361518 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pt received a dose of moderna past 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 (Pt received a dose of moderna past 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 21-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pt received a dose of moderna past expiration date). On 21-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Pt received a dose of moderna past expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported. The reporter stated that the patient took either second or third shot but not the first shot. No Treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2021: FU contains no new information. On 21-Oct-2021: Follow up received on 21-OCT-2021. Dosing details were added, phone number is provided. On 21-Oct-2021: FU contains no new information. On 21-Oct-2021: FU contains no new information.