chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose given past expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose given past expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose given past expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose given past expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Refrigerator expiration date reported as 05-Feb-2022 as it was removed from freezer on 06-Jan-2022. No temperature excursion was reported during storage.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Feb-2022: Non significant follow up received.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Palpitations, Vaccination site mass, Vaccination site pain
Clinical narrative: Fatigue; Heart Palpitation; Severe headache; 2nd Vaccine arm developed hard ball size of a basball, tender to the touch and felt hot; 2nd Vaccine arm developed hard ball size of a basball, tender to the touch; 2nd Vaccine arm developed hard ball size of a basball, tender to the touch and felt hot; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart Palpitation), VACCINATION SITE WARMTH (2nd Vaccine arm developed hard ball size of a basball, tender to the touch and felt hot), FATIGUE (Fatigue), HEADACHE (Severe headache) and VACCINATION SITE MASS (2nd Vaccine arm developed hard ball size of a basball, tender to the touch and felt hot) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high.   On 03-Jan-2022, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2022, the patient experienced HEADACHE (Severe headache). On an unknown date, the patient experienced PALPITATIONS (Heart Palpitation), VACCINATION SITE WARMTH (2nd Vaccine arm developed hard ball size of a basball, tender to the touch and felt hot), FATIGUE (Fatigue), VACCINATION SITE MASS (2nd Vaccine arm developed hard ball size of a basball, tender to the touch and felt hot) and VACCINATION SITE PAIN (2nd Vaccine arm developed hard ball size of a basball, tender to the touch). At the time of the report, PALPITATIONS (Heart Palpitation), FATIGUE (Fatigue) and HEADACHE (Severe headache) had not resolved and VACCINATION SITE WARMTH (2nd Vaccine arm developed hard ball size of a basball, tender to the touch and felt hot), VACCINATION SITE MASS (2nd Vaccine arm developed hard ball size of a basball, tender to the touch and felt hot) and VACCINATION SITE PAIN (2nd Vaccine arm developed hard ball size of a basball, tender to the touch) had resolved.            Concomitant medications included unspecified high blood pressure medications.  It was reported that vaccine made the patient so severely sick and did not feel the same. Patient did not receive any treatments.   This case was linked to MOD-2022-477408 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Fatigue; Heart Palpitation; Severe headache; 2nd Vaccine arm developed hard ball size of a basball, tender to the touch and felt hot; 2nd Vaccine arm developed hard ball size of a basball, tender to the touch; 2nd Vaccine arm developed hard ball size of a basball, tender to the touch and felt hot; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart Palpitation), VACCINATION SITE WARMTH (2nd Vaccine arm developed hard ball size of a basball, tender to the touch and felt hot), FATIGUE (Fatigue), HEADACHE (Severe headache) and VACCINATION SITE MASS (2nd Vaccine arm developed hard ball size of a basball, tender to the touch and felt hot) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high.   On 03-Jan-2022, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2022, the patient experienced HEADACHE (Severe headache). On an unknown date, the patient experienced PALPITATIONS (Heart Palpitation), VACCINATION SITE WARMTH (2nd Vaccine arm developed hard ball size of a basball, tender to the touch and felt hot), FATIGUE (Fatigue), VACCINATION SITE MASS (2nd Vaccine arm developed hard ball size of a basball, tender to the touch and felt hot) and VACCINATION SITE PAIN (2nd Vaccine arm developed hard ball size of a basball, tender to the touch). At the time of the report, PALPITATIONS (Heart Palpitation), FATIGUE (Fatigue) and HEADACHE (Severe headache) had not resolved and VACCINATION SITE WARMTH (2nd Vaccine arm developed hard ball size of a basball, tender to the touch and felt hot), VACCINATION SITE MASS (2nd Vaccine arm developed hard ball size of a basball, tender to the touch and felt hot) and VACCINATION SITE PAIN (2nd Vaccine arm developed hard ball size of a basball, tender to the touch) had resolved.            Concomitant medications included unspecified high blood pressure medications.  It was reported that vaccine made the patient so severely sick and did not feel the same. Patient did not receive any treatments.   This case was linked to MOD-2022-477408 (Patient Link).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Rash erythematous, Swelling face
Clinical narrative: Started to swell; Face was red like a rash; Arm was swollen; Face was reddish; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm was swollen), ERYTHEMA (Face was reddish), SWELLING FACE (Started to swell) and RASH ERYTHEMATOUS (Face was red like a rash) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (apricot), Food allergy (dumplings), Food allergy (a type of tea) and Allergy to plants (aloe vera).    On 10-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2022, the patient experienced PERIPHERAL SWELLING (Arm was swollen) and ERYTHEMA (Face was reddish). On an unknown date, the patient experienced SWELLING FACE (Started to swell) and RASH ERYTHEMATOUS (Face was red like a rash). At the time of the report, PERIPHERAL SWELLING (Arm was swollen), ERYTHEMA (Face was reddish), SWELLING FACE (Started to swell) and RASH ERYTHEMATOUS (Face was red like a rash) 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 medications were reported.  No treatment medications were reported.  Patient had no allergies to medicines or vaccines.  Reporter stated that patient had not had a previous diagnosis of covid-19. She was currently at a clinic awaiting treatment at the time of this call. No tests or medications have been administered at this time.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient inadvertently received their Moderna booster after 24 hour exposure to room  temperature; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient inadvertently received their Moderna booster after 24 hour exposure to room  temperature) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient inadvertently received their Moderna booster after 24 hour exposure to room  temperature). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient inadvertently received their Moderna booster after 24 hour exposure to room  temperature) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  The vial was initially stored in the refrigerator on 03-FEB-2022.  The vial was opened on 09-FEB-2022 at 10:00 am. the vial was not discarded and sat out in room temperature for a little over 24 hours.  Treatment medications was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired vaccine) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015f21a) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided.  The two patients involved were in their thirties.One partial date of births reported as 21 September.   No treatment information was provided.   This case was linked to MOD-2022-480710 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Feb-2022: Added reporter details (phone number, mail ID and address). Added patient initial and age group.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore Left Arm after first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Left Arm after first vaccine) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included Vertigo (Used to get vertigo) in 2018. Concurrent medical conditions included Blood pressure (under control with medications). Concomitant products included BENAZEPRIL, AMLODIPINE and SPIRONOLACTONE for Blood pressure abnormal.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore Left Arm after first vaccine). On 14-Mar-2021, PAIN IN EXTREMITY (Sore Left Arm after first vaccine) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment medication details was provided.   This case was linked to MOD-2022-480672, MOD-2022-480677 (Patient Link).
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Illness
Clinical narrative: Sick after booster; Light headed when lie down and when getting up after booster; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick after booster) and DIZZINESS (Light headed when lie down and when getting up after booster) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033H21A, 037A21B and 011A21A) for COVID-19 vaccination.     The patient's past medical history included Vertigo (Used to get vertigo and the last time felt vertigo was in 2018.) in 2018. Concurrent medical conditions included Hypertension (Blood pressure under control with medications.). Concomitant products included BENAZEPRIL, AMLODIPINE and SPIRONOLACTONE for Hypertension.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 30-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2021, the patient experienced ILLNESS (Sick after booster) and DIZZINESS (Light headed when lie down and when getting up after booster). On 02-Jan-2022, ILLNESS (Sick after booster) had resolved. At the time of the report, DIZZINESS (Light headed when lie down and when getting up after booster) outcome was unknown.            No treatment medications were reported.   This case was linked to MOD-2022-480662, MOD-2022-480672 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dispensed two doses of Moderna vaccine past 24 hours after vials removed from refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dispensed two doses of Moderna vaccine past 24 hours after vials removed from refrigerator) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dispensed two doses of Moderna vaccine past 24 hours after vials removed from refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dispensed two doses of Moderna vaccine past 24 hours after vials removed from refrigerator) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not reported.  Reported Total amount of time the vial was exposed to room temperature range (8 degree  to 25 degree C= 46 degree to 77 degree F) and 24-48 hours. Reported Date the vial was initially stored in the refrigerator was 08FEB2022 Removed from the fridge on 09FEB2022  Treatment medications was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Feb-2022: Follow up received includes non significant information
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 3-decade-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015f21a) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was in her thirties, one partial date of births 21 September.  No concomitant medication was reported.   The treatment information was unknown.   This case was linked to MOD-2022-480631 (Patient Link).
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dispensed two doses of Moderna vaccine past 24 hours after vials removed from refrigerator; Dispensed two doses of a Moderna covid vaccine past it's storage and handling requirements; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dispensed two doses of Moderna vaccine past 24 hours after vials removed from refrigerator) and PRODUCT STORAGE ERROR (Dispensed two doses of a Moderna covid vaccine past it's storage and handling requirements) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dispensed two doses of Moderna vaccine past 24 hours after vials removed from refrigerator) and PRODUCT STORAGE ERROR (Dispensed two doses of a Moderna covid vaccine past it's storage and handling requirements). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dispensed two doses of Moderna vaccine past 24 hours after vials removed from refrigerator) and PRODUCT STORAGE ERROR (Dispensed two doses of a Moderna covid vaccine past it's storage and handling requirements) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The reporter stated that they found out that they dispensed two doses of a Moderna Covid vaccine past its storage and handling requirements. The reporter informed that it has been greater than 24 hours after the vials had been removed from the refrigerator.  Reportedly, the date the vial was initially stored in the refrigerator was 08-Feb-2022 and was removed from the fridge on 09-Feb-2022. The vaccine was administered on 10-Feb-2022. It was also reported that the vial didn't undergo any temperature excursions. The total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was 24-48 hours.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-Feb-2022: Follow-up received contains no new information.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient inadvertently received their Moderna booster after 24 hour exposure to room temperature; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient inadvertently received their Moderna booster after 24 hour exposure to room temperature) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.   No Medical History information was reported.    On 10-Feb-2022 at 10:20 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient inadvertently received their Moderna booster after 24 hour exposure to room temperature). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient inadvertently received their Moderna booster after 24 hour exposure to room temperature) outcome was unknown.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. The vial was opened on 09 Feb 2022 at 10:00 am. She further reported that the vial was not discarded and sat out in room temperature for a little over 24 hours.  No treatment information was provided by reporter.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Body temperature, Chills, Pyrexia, Tremor
Clinical narrative: hair has been falling out; COVID arm [after second and booster doses]; shaking; hot; itching; bumps; red; she got fever between 100-101; chills; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (hair has been falling out), VACCINATION SITE REACTION (COVID arm [after second and booster doses]), TREMOR (shaking), VACCINATION SITE WARMTH (hot) and VACCINATION SITE PRURITUS (itching) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058F21A, 038A21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Drug allergy, Sulfonamide allergy, Drug allergy, Hypertension (started 20 years ago) and Osteoarthritis (15 years ago; age-related).   On 19-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-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced ALOPECIA (hair has been falling out), VACCINATION SITE REACTION (COVID arm [after second and booster doses]), TREMOR (shaking), VACCINATION SITE WARMTH (hot), VACCINATION SITE PRURITUS (itching), VACCINATION SITE SWELLING (bumps), VACCINATION SITE ERYTHEMA (red), PYREXIA (she got fever between 100-101) and CHILLS (chills). In November 2021, VACCINATION SITE REACTION (COVID arm [after second and booster doses]), TREMOR (shaking), VACCINATION SITE WARMTH (hot), VACCINATION SITE PRURITUS (itching), VACCINATION SITE SWELLING (bumps), VACCINATION SITE ERYTHEMA (red), PYREXIA (she got fever between 100-101) and CHILLS (chills) had resolved. At the time of the report, ALOPECIA (hair has been falling out) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Body temperature: 100-101 got fever between 100-101.  Concomitant medication was not provided. Patient received flu shot in September 2021 was given within 1 month prior to Moderna COVID-19. It was reported that, patient was standing ankle deep in her shower cleaning hair out of her drain. She would call it shedding lots and lots of shedding. The patient also added that after taking booster dose, had the COVID arm - red, hot, itching, bumps, not blisters. That lasted between 5-6 days. Within 24 hours, she got fever between 100-101. That lasted about 24 hours. Treatment information was not provided.   This case was linked to MOD-2022-481363 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site reaction, Vaccination site swelling, Vaccination site warmth
Clinical narrative: hair has been falling out; COVID arm [after second and booster doses]; shaking; hot; itching; bumps; red; she got fever between 100-101; chills; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (hair has been falling out), VACCINATION SITE REACTION (COVID arm [after second and booster doses]), TREMOR (shaking), VACCINATION SITE WARMTH (hot) and VACCINATION SITE PRURITUS (itching) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058F21A, 038A21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Drug allergy, Sulfonamide allergy, Drug allergy, Hypertension (started 20 years ago) and Osteoarthritis (15 years ago; age-related).   On 19-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-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced ALOPECIA (hair has been falling out), VACCINATION SITE REACTION (COVID arm [after second and booster doses]), TREMOR (shaking), VACCINATION SITE WARMTH (hot), VACCINATION SITE PRURITUS (itching), VACCINATION SITE SWELLING (bumps), VACCINATION SITE ERYTHEMA (red), PYREXIA (she got fever between 100-101) and CHILLS (chills). In November 2021, VACCINATION SITE REACTION (COVID arm [after second and booster doses]), TREMOR (shaking), VACCINATION SITE WARMTH (hot), VACCINATION SITE PRURITUS (itching), VACCINATION SITE SWELLING (bumps), VACCINATION SITE ERYTHEMA (red), PYREXIA (she got fever between 100-101) and CHILLS (chills) had resolved. At the time of the report, ALOPECIA (hair has been falling out) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Body temperature: 100-101 got fever between 100-101.  Concomitant medication was not provided. Patient received flu shot in September 2021 was given within 1 month prior to Moderna COVID-19. It was reported that, patient was standing ankle deep in her shower cleaning hair out of her drain. She would call it shedding lots and lots of shedding. The patient also added that after taking booster dose, had the COVID arm - red, hot, itching, bumps, not blisters. That lasted between 5-6 days. Within 24 hours, she got fever between 100-101. That lasted about 24 hours. Treatment information was not provided.   This case was linked to MOD-2022-481363 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Illness, Influenza, Movement disorder, Speech disorder
Clinical narrative: Could not control her bladder / lost bladder control; Extremely Sick; bad Flu; She could not walk; She couldn't walk couldn't move / was on the floor and just layed there; She couldn't talk; This spontaneous case was reported by a consumer and describes the occurrence of URINARY INCONTINENCE (Could not control her bladder / lost bladder control), ILLNESS (Extremely Sick), INFLUENZA (bad Flu), GAIT INABILITY (She could not walk) and MOVEMENT DISORDER (She couldn't walk couldn't move / was on the floor and just layed there) 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.     The patient's past medical history included Migraine headache. Concurrent medical conditions included Claustrophobia, Muscle spasms and Multiple sclerosis. Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.    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 URINARY INCONTINENCE (Could not control her bladder / lost bladder control), ILLNESS (Extremely Sick), INFLUENZA (bad Flu), GAIT INABILITY (She could not walk), MOVEMENT DISORDER (She couldn't walk couldn't move / was on the floor and just layed there) and SPEECH DISORDER (She couldn't talk). At the time of the report, URINARY INCONTINENCE (Could not control her bladder / lost bladder control) had not resolved and ILLNESS (Extremely Sick), INFLUENZA (bad Flu), GAIT INABILITY (She could not walk), MOVEMENT DISORDER (She couldn't walk couldn't move / was on the floor and just layed there) and SPEECH DISORDER (She couldn't talk) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were provided.  Patient was just layed on floor and lost bladder control.
Sex: F
Vaccine: COVID19
Symptoms: Urinary incontinence
Clinical narrative: Could not control her bladder / lost bladder control; Extremely Sick; bad Flu; She could not walk; She couldn't walk couldn't move / was on the floor and just layed there; She couldn't talk; This spontaneous case was reported by a consumer and describes the occurrence of URINARY INCONTINENCE (Could not control her bladder / lost bladder control), ILLNESS (Extremely Sick), INFLUENZA (bad Flu), GAIT INABILITY (She could not walk) and MOVEMENT DISORDER (She couldn't walk couldn't move / was on the floor and just layed there) 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.     The patient's past medical history included Migraine headache. Concurrent medical conditions included Claustrophobia, Muscle spasms and Multiple sclerosis. Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.    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 URINARY INCONTINENCE (Could not control her bladder / lost bladder control), ILLNESS (Extremely Sick), INFLUENZA (bad Flu), GAIT INABILITY (She could not walk), MOVEMENT DISORDER (She couldn't walk couldn't move / was on the floor and just layed there) and SPEECH DISORDER (She couldn't talk). At the time of the report, URINARY INCONTINENCE (Could not control her bladder / lost bladder control) had not resolved and ILLNESS (Extremely Sick), INFLUENZA (bad Flu), GAIT INABILITY (She could not walk), MOVEMENT DISORDER (She couldn't walk couldn't move / was on the floor and just layed there) and SPEECH DISORDER (She couldn't talk) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were provided.  Patient was just layed on floor and lost bladder control.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia, Tremor, Vaccination site reaction
Clinical narrative: after taking the second dose and booster dose, she had the COVID arm - red, hot, itching, bumps, not blisters; shaking [after second and booster doses]; Within 24 hours, she got fever between 100-101 [after second and booster doses]; chills [after second and booster doses]; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (after taking the second dose and booster dose, she had the COVID arm - red, hot, itching, bumps, not blisters), TREMOR (shaking [after second and booster doses]), PYREXIA (Within 24 hours, she got fever between 100-101 [after second and booster doses]) and CHILLS (chills [after second and booster doses]) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Drug allergy (had codeine allergy), Drug allergy (had sulfa allergy), Drug allergy (had Ultram allergy), Hypertension (from 20 years ago) and Osteoarthritis (from 15 years).   On 19-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. In March 2021, the patient experienced VACCINATION SITE REACTION (after taking the second dose and booster dose, she had the COVID arm - red, hot, itching, bumps, not blisters), TREMOR (shaking [after second and booster doses]), PYREXIA (Within 24 hours, she got fever between 100-101 [after second and booster doses]) and CHILLS (chills [after second and booster doses]). In March 2021, VACCINATION SITE REACTION (after taking the second dose and booster dose, she had the COVID arm - red, hot, itching, bumps, not blisters), TREMOR (shaking [after second and booster doses]), PYREXIA (Within 24 hours, she got fever between 100-101 [after second and booster doses]) and CHILLS (chills [after second and booster doses]) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body temperature: 100-101 100-101.         No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-481278 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia, Vomiting
Clinical narrative: fever of 99.8°F; been throwing up all night; he has a bad headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 99.8°F), VOMITING (been throwing up all night) and HEADACHE (he has a bad headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Kidney dysfunction.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever of 99.8°F), VOMITING (been throwing up all night) and HEADACHE (he has a bad headache). At the time of the report, PYREXIA (fever of 99.8°F), VOMITING (been throwing up all night) and HEADACHE (he has a bad headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.8°f (High) high 99.8°F.         Patient stated that was the first time  experienced adverse event after Moderna shot. Patient reported after three hours after received the Moderna shot experienced events. Concomitant medications was not reported. Treatment medications was not reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nasopharyngitis
Clinical narrative: got a cold; tired for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (got a cold) and FATIGUE (tired for 24 hours) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced NASOPHARYNGITIS (got a cold) and FATIGUE (tired for 24 hours). On 24-Apr-2021, NASOPHARYNGITIS (got a cold) and FATIGUE (tired for 24 hours) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient height reported as 5  8. No concomitant and treatment products were reported.    This case was linked to MOD-2022-481416, MOD-2022-481420 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Nasopharyngitis
Clinical narrative: Patient felt like she got a cold; Left arm felt a bit warm; Patient felt tired; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Patient felt like she got a cold), FEELING HOT (Left arm felt a bit warm) and FATIGUE (Patient felt tired) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A, 002C21A and 056H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2021, the patient experienced NASOPHARYNGITIS (Patient felt like she got a cold), FEELING HOT (Left arm felt a bit warm) and FATIGUE (Patient felt tired). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) at an unspecified dose and frequency and CORTISONE (topical) at an unspecified dose and frequency. On 22-May-2021, NASOPHARYNGITIS (Patient felt like she got a cold), FEELING HOT (Left arm felt a bit warm) and FATIGUE (Patient felt tired) had resolved.            No Concomitant medications were reported.   This case was linked to MOD-2022-481401, MOD-2022-481420 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: When patient scratch it, it becomes red; intermittent itchy hives in different parts of her body: sometimes neck, or collar bone area, stomach, legs.; started getting intermittent itchy hives in different parts of her body: sometimes neck, or collar bone area, stomach, legs. When patient scratch it, it becomes red.; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (intermittent itchy hives in different parts of her body: sometimes neck, or collar bone area, stomach, legs.), PRURITUS (started getting intermittent itchy hives in different parts of her body: sometimes neck, or collar bone area, stomach, legs. When patient scratch it, it becomes red.) and ERYTHEMA (When patient scratch it, it becomes red) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056H21A, 002C21A and 041C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2022, the patient experienced URTICARIA (intermittent itchy hives in different parts of her body: sometimes neck, or collar bone area, stomach, legs.) and PRURITUS (started getting intermittent itchy hives in different parts of her body: sometimes neck, or collar bone area, stomach, legs. When patient scratch it, it becomes red.). On an unknown date, the patient experienced ERYTHEMA (When patient scratch it, it becomes red). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) at an unspecified dose and frequency and CORTISONE (topical) at an unspecified dose and frequency. At the time of the report, URTICARIA (intermittent itchy hives in different parts of her body: sometimes neck, or collar bone area, stomach, legs.), PRURITUS (started getting intermittent itchy hives in different parts of her body: sometimes neck, or collar bone area, stomach, legs. When patient scratch it, it becomes red.) and ERYTHEMA (When patient scratch it, it becomes red) had not resolved.            Patient was not under any concomitant or regular medications. Patient had no allergies. Patient does not have a history relating to the adverse events occurred.   This case was linked to MOD-2022-481401, MOD-2022-481416 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity, Pruritus, Rash
Clinical narrative: allergic reaction (rash, itchiness, redness); allergic reaction (rash, itchiness, redness).; allergic reaction (rash, itchiness, redness).; allergic reaction (rash, itchiness, redness); This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (allergic reaction (rash, itchiness, redness)), ERYTHEMA (allergic reaction (rash, itchiness, redness).), HYPERSENSITIVITY (allergic reaction (rash, itchiness, redness).) and RASH (allergic reaction (rash, itchiness, redness)) 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.    In January 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2022, the patient experienced PRURITUS (allergic reaction (rash, itchiness, redness)), ERYTHEMA (allergic reaction (rash, itchiness, redness).), HYPERSENSITIVITY (allergic reaction (rash, itchiness, redness).) and RASH (allergic reaction (rash, itchiness, redness)). At the time of the report, PRURITUS (allergic reaction (rash, itchiness, redness)), ERYTHEMA (allergic reaction (rash, itchiness, redness).), HYPERSENSITIVITY (allergic reaction (rash, itchiness, redness).) and RASH (allergic reaction (rash, itchiness, redness)) had not resolved.            No concomitant medications were provided.  Patient reported that it had been a week and still experiencing these symptoms and patient was not sure if these symptoms were possible side effect of booster.  No treatment medications were provided.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of diarrhea (bad diarrhea after the first shot) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 041J21A) for COVID-19 immunization. No medical history reported. On Jan 26, 2022, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jan 27, 2022, patient experienced diarrhea (bad diarrhea after the first shot). On Feb 6, 2022, diarrhea (bad diarrhea after the first shot): resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication reported. The next day, after the first shot, patient had bad diarrhea. It continued for 10 days. He did not take any medicine and did not inform his doctor. The diarrhea stopped by itself.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of inappropriate schedule of product administration (2nd dose administered beyond 35 days) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 029K20A and 039K20K) for COVID-19 immunization. No medical history reported. On Dec 19, 2020, at 8:00 am, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jan 26, 2021, at 8:00 am, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jan 26, 2021, patient given inappropriate schedule of product (2nd dose administered beyond 35 days). At the time of the report, inappropriate schedule of product administration (2nd dose administered beyond 35 days) outcome: unknown. No concomitant medication or treatment information reported. This case linked to MOD-2022-452964 (patient link).
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Vaccination site discomfort, Vaccination site pain
Clinical narrative: Local pain and discomfort to her L arm; Local pain and discomfort to her L arm; 16 year female patient Given Dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (Local pain and discomfort to her L arm), VACCINATION SITE PAIN (Local pain and discomfort to her L arm) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year female patient Given Dose) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced VACCINATION SITE DISCOMFORT (Local pain and discomfort to her L arm), VACCINATION SITE PAIN (Local pain and discomfort to her L arm) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year female patient Given Dose). On 06-May-2021, VACCINATION SITE DISCOMFORT (Local pain and discomfort to her L arm) and VACCINATION SITE PAIN (Local pain and discomfort to her L arm) had resolved. At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year female patient Given Dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications was reported. Treatment medications was not provided.   This case was linked to MOD-2022-458050 (Patient Link).
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Discomfort, Dysmenorrhoea, Polymenorrhoea
Clinical narrative: A lot of weakness; Menstrual cycle cramping; Discomfort; Back ache; Two menstrual cycles in less than one month, second menstrual cycle; This spontaneous case was reported by a consumer and describes the occurrence of POLYMENORRHOEA (Two menstrual cycles in less than one month, second menstrual cycle), ASTHENIA (A lot of weakness), DYSMENORRHOEA (Menstrual cycle cramping), DISCOMFORT (Discomfort) and BACK PAIN (Back ache) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POLYMENORRHOEA (Two menstrual cycles in less than one month, second menstrual cycle). On an unknown date, the patient experienced ASTHENIA (A lot of weakness), DYSMENORRHOEA (Menstrual cycle cramping), DISCOMFORT (Discomfort) and BACK PAIN (Back ache). The patient was treated with ACETAMINOPHEN at a dose of 500 milligram. At the time of the report, POLYMENORRHOEA (Two menstrual cycles in less than one month, second menstrual cycle), ASTHENIA (A lot of weakness), DYSMENORRHOEA (Menstrual cycle cramping), DISCOMFORT (Discomfort) and BACK PAIN (Back ache) outcome was unknown.            Patient had her booster shot on 14-Jan-2022, unknown if were intramuscular. No Concomitant information was reported. Patient had second period on 04-Feb-2022 and undergone symptoms of menstrual cycle from on 04-Feb-2022 and Patient had an appointment with HCP.