chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inadvertently gave the third booster dose at 3 months instead of the 6 months/patient got a booster dose before 6 months had past after their second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inadvertently gave the third booster dose at 3 months instead of the 6 months/patient got a booster dose before 6 months had past after their second dose) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006D21A and 041C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 01-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inadvertently gave the third booster dose at 3 months instead of the 6 months/patient got a booster dose before 6 months had past after their second dose). On 01-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inadvertently gave the third booster dose at 3 months instead of the 6 months/patient got a booster dose before 6 months had past after their second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was given.  No treatment medication was given.  Patient received third booster dose at 3 months instead of the 6 months that is indicated.   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Follow-up received: Added reporter city, state, postal code, phone number, patient gender, suspect dose (started month of 1st, 2nd and booster dose) details and indication. On 08-Nov-2021: Follow-up received: Added patient demographics (initials, age and date of birth), suspect dose start dates (1st, 2nd and booster dose), dose (booster) and batch numbers. On 10-Nov-2021: Follow-up received contains no new information (NNI).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue, SARS-CoV-2 test
Clinical narrative: Missed dose; COVID19 infection after 1st dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (COVID19 infection after 1st dose) and PRODUCT DOSE OMISSION ISSUE (Missed dose) 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 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced COVID-19 (COVID19 infection after 1st dose). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed dose). At the time of the report, COVID-19 (COVID19 infection after 1st dose) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment information was reported. This spontaneous case concerns a patient of unknown age and gender with no relevant medical history reported, who experienced non-serious unexpected event of special interest (AESI) COVID-19.. The event occurred approximatelly 2 months after the first dose of the Moderna COVID-19 Vaccine (mRNA-1273). Rechallenge was not applicable since due to nature of the event and considering that the patient did not receive the second dose in a recommended timeframe, no rechallenge was done and thus, recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no relevant medical history reported, who experienced non-serious unexpected event of special interest (AESI) COVID-19.. The event occurred approximatelly 2 months after the first dose of the Moderna COVID-19 Vaccine (mRNA-1273). Rechallenge was not applicable since due to nature of the event and considering that the patient did not receive the second dose in a recommended timeframe, no rechallenge was done and thus, recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Sinus congestion
Clinical narrative: chest congestion; sinus drainage; heavy feeling in my chest; I have coughing; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Nov-2021 and was forwarded to Moderna on 08-Nov-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (chest congestion) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 002A21A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunosuppressant drug therapy. Concomitant products included DICLOFENAC DIETHYLAMINE (VOLTAREN [DICLOFENAC DIETHYLAMINE]), ATORVASTATIN CALCIUM (LIPITOR), OMEPRAZOLE, LOSARTAN, HYDROXYCHLOROQUINE, METFORMIN HYDROCHLORIDE (METFORMIN ER), PREDNISONE, HYDROCHLOROTHIAZIDE and LINAGLIPTIN (TRADJENTA) for an unknown indication.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PULMONARY CONGESTION (chest congestion) (seriousness criterion medically significant), SINUS OPERATION (sinus drainage), CHEST DISCOMFORT (heavy feeling in my chest) and COUGH (I have coughing). At the time of the report, PULMONARY CONGESTION (chest congestion), SINUS OPERATION (sinus drainage), CHEST DISCOMFORT (heavy feeling in my chest) and COUGH (I have coughing) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   treatment to the events not reported.; Sender's Comments: Case is non serious
Sex: M
Vaccine: COVID19
Symptoms: Headache, Swelling, Vaccination site pain
Clinical narrative: swelling; headache; pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling), HEADACHE (headache) and VACCINATION SITE PAIN (pain in the arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Stroke.   On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, the patient experienced SWELLING (swelling), HEADACHE (headache) and VACCINATION SITE PAIN (pain in the arm). On 03-Nov-2021, SWELLING (swelling), HEADACHE (headache) and VACCINATION SITE PAIN (pain in the arm) had resolved.            No concomitants medications was reported. no treatment drugs are provided.   This case was linked to MOD-2021-378301, MOD-2021-378302 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: patients receive dose from vial which was more than 30 days in the fridge; Dose administered after 30-day Use By Date or after manufacturer date of expiry,patients that received Moderna vaccines that had been stored in the refrigerator > 30 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (patients receive dose from vial which was more than 30 days in the fridge) and EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry,patients that received Moderna vaccines that had been stored in the refrigerator > 30 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (patients receive dose from vial which was more than 30 days in the fridge) and EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry,patients that received Moderna vaccines that had been stored in the refrigerator > 30 days). At the time of the report, PRODUCT STORAGE ERROR (patients receive dose from vial which was more than 30 days in the fridge) and EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry,patients that received Moderna vaccines that had been stored in the refrigerator > 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that specifically, few patients that were vaccinated with a vaccine that was 40 days in the refrigerator, 45 days in the refrigerator, and 50 days in the refrigerator.  No concomitant medications reported.  No treatment details provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Significant Follow up On 09-Nov-2021: Follow up document received on 09-Nov-2021 includes vaccine administration related information. On 12-Nov-2021: Non Significant follow up updated contains no new information
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm was sore for a few hours; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm was sore for a few hours) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 08-Feb-2021, the patient experienced VACCINATION SITE PAIN (Arm was sore for a few hours). At the time of the report, VACCINATION SITE PAIN (Arm was sore for a few hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported No treatment medication were reported  The patient received the Moderna covid-19 vaccine in her right arm shoulder deltoid muscle.   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Significant Follow up-Document attached, Reporter occupation, Vaccine Anatomical location, Dose 2 added & Event verbatim corrected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-378298 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Follow up received contains no new information.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: PFIZER BIONTECH COVID-19 VACCINE (First dose was Pfizer on 05Apr2021) on 05-Apr-2021, PFIZER BIONTECH COVID-19 VACCINE (second dose was Pfizer and on 26Apr2021 at a mass vaccination facility.) on 26-Apr-2021.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant treatment was provided. No treatment medication was provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Ache; Headache; Fever; Exhaustion/wiped out a day; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Ache), HEADACHE (Headache), PYREXIA (Fever) and FATIGUE (Exhaustion/wiped out a day) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and D(0)13M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Ache), HEADACHE (Headache), PYREXIA (Fever) and FATIGUE (Exhaustion/wiped out a day). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 1 dosage form every six hours. At the time of the report, MYALGIA (Ache), HEADACHE (Headache), PYREXIA (Fever) and FATIGUE (Exhaustion/wiped out a day) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Had shot in morning took Tylenol in the evening. Resolved within a day, took an extra nap, slept for a couple hours.   This case was linked to MOD-2021-379495 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: hives/she "thought it was bug bite" but says 1-2 new hives appear daily; itching; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives/she "thought it was bug bite" but says 1-2 new hives appear daily) and PRURITUS (itching) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A, 028L20A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-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 URTICARIA (hives/she "thought it was bug bite" but says 1-2 new hives appear daily) and PRURITUS (itching). At the time of the report, URTICARIA (hives/she "thought it was bug bite" but says 1-2 new hives appear daily) had not resolved and PRURITUS (itching) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-380792 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Aches/Achy; Exhaustion; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches/Achy), FATIGUE (Exhaustion), HEADACHE (Headache) and PYREXIA (Fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006021A and 012A21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Aches/Achy), FATIGUE (Exhaustion), HEADACHE (Headache) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of every 6 hours. At the time of the report, PAIN (Aches/Achy), FATIGUE (Exhaustion), HEADACHE (Headache) and PYREXIA (Fever) had resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient got shot in the morning, took Tylenol, in the evening, took an extra nap, slept for a couple hours and it got resolved in a day.   This case was linked to MOD-2021-379489 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Instead of getting 0.5ml for the third dose received 0.25; 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 ACCIDENTAL UNDERDOSE (Instead of getting 0.5ml for the third dose received 0.25) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Instead of getting 0.5ml for the third dose received 0.25). At the time of the report, ACCIDENTAL UNDERDOSE (Instead of getting 0.5ml for the third dose received 0.25) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment drugs were provided.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: Woke up with loss of taste and smell today; Woke up with loss of taste and smell today; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Woke up with loss of taste and smell today) and ANOSMIA (Woke up with loss of taste and smell today) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, the patient experienced AGEUSIA (Woke up with loss of taste and smell today) and ANOSMIA (Woke up with loss of taste and smell today). At the time of the report, AGEUSIA (Woke up with loss of taste and smell today) and ANOSMIA (Woke up with loss of taste and smell today) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.  This case concerns a female patient of unknown age, with no relevant medical history provided, who experienced the non-serious unexpected AESI of ageusia and anosmia. The events occurred the day after receiving the booster dose of the Moderna COVID 19 vaccine. The rechallenge is not applicable as AEs occurred after booster dose. The benefit-risk relationship of the Moderna COVID 19 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a female patient of unknown age, with no relevant medical history provided, who experienced the non-serious unexpected AESI of ageusia and anosmia. The events occurred the day after receiving the booster dose of the Moderna COVID 19 vaccine. The rechallenge is not applicable as AEs occurred after booster dose. The benefit-risk relationship of the Moderna COVID 19 vaccine is not affected by this report.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Oral disorder, Oral mucosal discolouration, Swollen tongue
Clinical narrative: tongue swollen up; the discoloration in the mouth was black and blue; lesions in the side of the tongue; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE, ORAL MUCOSAL DISCOLOURATION, and ORAL DISORDER in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065FCIA, 031M20A, and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Urinary tract infection. Concomitant products included NITROFURANTOIN for Urinary tract infection, ELIQUIS, CORTISONE, LISINOPRIL, HYDROCHLOROTHIAZIDE, ZETIA, ZYRETIC, BYSTOLIC, LIPITOR, CYMBALTA, NEURONTIN, BESEROL, and ASPIRIN for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, the patient experienced SWOLLEN TONGUE, ORAL MUCOSAL DISCOLOURATION, and ORAL DISORDER. At the time of the report, SWOLLEN TONGUE, ORAL MUCOSAL DISCOLOURATION, and ORAL DISORDER had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient took two antihistaminic for treatment of the events.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Impaired driving ability, Nausea, Pyrexia
Clinical narrative: Stopped driving because of that.; She was in bed yesterday all day with chills; Fever; Dizziness; Had little nausea; Within 48 hours, she started with blurred vision/This is the 3rd time she had blurred vision/Especially when she reads and stopped driving because of that; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), IMPAIRED DRIVING ABILITY (Stopped driving because of that.), VISION BLURRED (Within 48 hours, she started with blurred vision/This is the 3rd time she had blurred vision/Especially when she reads and stopped driving because of that), NAUSEA (Had little nausea) and CHILLS (She was in bed yesterday all day with chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 013626A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported by the reporter.  Concomitant products included METFORMIN, LEVOTHYROXINE, LOSARTAN and HYDROCHLOROTHIAZIDE for an unknown indication.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, the patient experienced DIZZINESS (Dizziness) and NAUSEA (Had little nausea). On 08-Nov-2021, the patient experienced CHILLS (She was in bed yesterday all day with chills) and PYREXIA (Fever). In November 2021, the patient experienced VISION BLURRED (Within 48 hours, she started with blurred vision/This is the 3rd time she had blurred vision/Especially when she reads and stopped driving because of that). On an unknown date, the patient experienced IMPAIRED DRIVING ABILITY (Stopped driving because of that.). At the time of the report, DIZZINESS (Dizziness), NAUSEA (Had little nausea), CHILLS (She was in bed yesterday all day with chills) and PYREXIA (Fever) outcome was unknown, IMPAIRED DRIVING ABILITY (Stopped driving because of that.) had not resolved and VISION BLURRED (Within 48 hours, she started with blurred vision/This is the 3rd time she had blurred vision/Especially when she reads and stopped driving because of that) had resolved.            This was the 3rd time patient had blurred vision. Especially when reads, it was blurry.  No treatment medication details were reported.   This case was linked to MOD-2021-379644, MOD-2021-379645 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Additional information received and reporter details, suspect product dose information, concomitant medications and new events were added.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Stopped driving because of that.; She was in bed yesterday all day with chills; Fever; Dizziness; Had little nausea; Within 48 hours, she started with blurred vision/This is the 3rd time she had blurred vision/Especially when she reads and stopped driving because of that; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), IMPAIRED DRIVING ABILITY (Stopped driving because of that.), VISION BLURRED (Within 48 hours, she started with blurred vision/This is the 3rd time she had blurred vision/Especially when she reads and stopped driving because of that), NAUSEA (Had little nausea) and CHILLS (She was in bed yesterday all day with chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 013626A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported by the reporter.  Concomitant products included METFORMIN, LEVOTHYROXINE, LOSARTAN and HYDROCHLOROTHIAZIDE for an unknown indication.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, the patient experienced DIZZINESS (Dizziness) and NAUSEA (Had little nausea). On 08-Nov-2021, the patient experienced CHILLS (She was in bed yesterday all day with chills) and PYREXIA (Fever). In November 2021, the patient experienced VISION BLURRED (Within 48 hours, she started with blurred vision/This is the 3rd time she had blurred vision/Especially when she reads and stopped driving because of that). On an unknown date, the patient experienced IMPAIRED DRIVING ABILITY (Stopped driving because of that.). At the time of the report, DIZZINESS (Dizziness), NAUSEA (Had little nausea), CHILLS (She was in bed yesterday all day with chills) and PYREXIA (Fever) outcome was unknown, IMPAIRED DRIVING ABILITY (Stopped driving because of that.) had not resolved and VISION BLURRED (Within 48 hours, she started with blurred vision/This is the 3rd time she had blurred vision/Especially when she reads and stopped driving because of that) had resolved.            This was the 3rd time patient had blurred vision. Especially when reads, it was blurry.  No treatment medication details were reported.   This case was linked to MOD-2021-379644, MOD-2021-379645 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Additional information received and reporter details, suspect product dose information, concomitant medications and new events were added.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory rate decreased
Clinical narrative: breathing had dropped down and is on Oxygen; This spontaneous case was reported by an other health care professional and describes the occurrence of RESPIRATORY RATE DECREASED (breathing had dropped down and is on Oxygen) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A, 21038012 and 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. In October 2021, the patient experienced RESPIRATORY RATE DECREASED (breathing had dropped down and is on Oxygen) (seriousness criterion medically significant). The patient was treated with OXYGEN for Breathing slowed, at an unspecified dose and frequency. At the time of the report, RESPIRATORY RATE DECREASED (breathing had dropped down and is on Oxygen) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Pharmacy technician reported that patient had Moderna Covid-19 booster at their facility on 26-Oct-2021 came on 08-Nov-2021, yesterday and reported that ever since she received the booster her breathing had dropped down and was on Oxygen.  Company comment- This case concerns a 66-year old, female subject with no relevant medical history, who experienced the serious unexpected event of Respiratory rate decreased. The event occurred unknown number of days after the booster dose of mRNA-1273 vaccine. Patient is currently on oxygen therapy. Rechallenge is not applicable as no information about adverse event/s and its/their resolution following the first and second dose is available. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Also, there seems to be an error in the patient's date of birth (6-MAR-2021) provided in the SD.; Sender's Comments: This case concerns a 66-year old, female subject with no relevant medical history, who experienced the serious unexpected event of Respiratory rate decreased. The event occurred unknown number of days after the booster dose of mRNA-1273 vaccine. Patient is currently on oxygen therapy. Rechallenge is not applicable as no information about adverse event/s and its/their resolution following the first and second dose is available. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: "few muscle aches"; "I was tired, nothing dramatic"; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA ("few muscle aches") and FATIGUE ("I was tired, nothing dramatic") in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA ("few muscle aches") and FATIGUE ("I was tired, nothing dramatic"). At the time of the report, MYALGIA ("few muscle aches") and FATIGUE ("I was tired, nothing dramatic") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-379667 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: She has had a wart on her nose for 10 years that started to dissipate after receiving her second dose of the vaccine/it was kind of shriveling up. It went from a 10 to a 1; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (She has had a wart on her nose for 10 years that started to dissipate after receiving her second dose of the vaccine/it was kind of shriveling up. It went from a 10 to a 1) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 013L20A) for COVID-19 vaccination.     The patient's past medical history included Surgery (The patient had attempted using anti-wart medication and surgery to address the wart prior, however it had not helped). Concurrent medical conditions included Wart (The patient had a wart on her nose for 10 years.).   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (She has had a wart on her nose for 10 years that started to dissipate after receiving her second dose of the vaccine/it was kind of shriveling up. It went from a 10 to a 1). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (She has had a wart on her nose for 10 years that started to dissipate after receiving her second dose of the vaccine/it was kind of shriveling up. It went from a 10 to a 1) outcome was unknown.            It was reported that te patient had a positive side effect. She had a wart on her nose for 10 years that started to dissipate after receiving her second dose of the vaccine. The wart was a flat thing and she had attempted using anti-wart medication and surgery to address the wart prior, however it had not helped. Within a couple weeks after receiving the second dose of the vaccine it was kind of shriveling up. "It went from a 10 to a 1. The wart came back around August or September.  No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-380171 (Patient Link).
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: felt like arm hit with a baseball bat; soreness on injection site since January; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (felt like arm hit with a baseball bat) and VACCINATION SITE PAIN (soreness on injection site since January) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE PAIN (soreness on injection site since January). On an unknown date, the patient experienced PAIN IN EXTREMITY (felt like arm hit with a baseball bat). At the time of the report, PAIN IN EXTREMITY (felt like arm hit with a baseball bat) and VACCINATION SITE PAIN (soreness on injection site since January) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient does not have any medical conditions, but was recently prescribed with high blood  pressure medication in May after the vaccine.  No treatment medications were reported.   This case was linked to MOD-2021-379693 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patients that received Moderna vaccines that had been stored in the refrigerator > 30 days; 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 (patients that received Moderna vaccines that had been stored in the refrigerator > 30 days) 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 EXPIRED PRODUCT ADMINISTERED (patients that received Moderna vaccines that had been stored in the refrigerator > 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients that received Moderna vaccines that had been stored in the refrigerator > 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: 10-15 days after blurred vision went away but clarity never returned.; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (10-15 days after blurred vision went away but clarity never returned.) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013626A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN, LEVOTHYROXINE, LOSARTAN and HYDROCHLOROTHIAZIDE for an unknown indication.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VISION BLURRED (10-15 days after blurred vision went away but clarity never returned.). At the time of the report, VISION BLURRED (10-15 days after blurred vision went away but clarity never returned.) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment medications were reported.    This case was linked to MOD-2021-379516, MOD-2021-379645 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: we had a few patients that were vaccinated with a vaccinethat was 50 days in the refrigerator; 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 (we had a few patients that were vaccinated with a vaccinethat was 50 days in the refrigerator) 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 EXPIRED PRODUCT ADMINISTERED (we had a few patients that were vaccinated with a vaccinethat was 50 days in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (we had a few patients that were vaccinated with a vaccinethat was 50 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: few muscle aches; Patient was tired, nothing dramatic; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (few muscle aches) and FATIGUE (Patient was tired, nothing dramatic) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 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 MYALGIA (few muscle aches) and FATIGUE (Patient was tired, nothing dramatic). At the time of the report, MYALGIA (few muscle aches) and FATIGUE (Patient was tired, nothing dramatic) had resolved.            No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-379581 (Patient Link).   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: 0.25mL dose administered accidentally for a first dose; 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 ACCIDENTAL UNDERDOSE (0.25mL dose administered accidentally for a first dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (0.25mL dose administered accidentally for a first dose). At the time of the report, ACCIDENTAL UNDERDOSE (0.25mL dose administered accidentally for a first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information were reported.  The nurse thought the vaccine administered to the patient was a booster dose, but after administration, the patient reported this was the patient's first dose.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pain in extremity, Pyrexia
Clinical narrative: soreness comes and goes; soreness radiates up to shoulder; fever; bodyache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness comes and goes), PAIN (soreness radiates up to shoulder), PYREXIA (fever) and MYALGIA (bodyache) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness comes and goes), PAIN (soreness radiates up to shoulder), PYREXIA (fever) and MYALGIA (bodyache). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (soreness comes and goes) had not resolved and PAIN (soreness radiates up to shoulder), PYREXIA (fever) and MYALGIA (bodyache) outcome was unknown.            Concomitant drug details include High blood pressure medication. Patient was recently prescribed with high blood pressure medication in May after the vaccine.   This case was linked to MOD-2021-379624 (Patient Link).
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Flatulence, Mobility decreased, Pain in extremity, Pruritus
Clinical narrative: Pimples in my neck; itching; sometimes she needed to take left hand to life up right hand; gas pain/Gas/getting  up very early with the gas; pain that ran all the way down into my finger tips from the neck (back of ear, down to right side); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain that ran all the way down into my finger tips from the neck (back of ear, down to right side)), ACNE (Pimples in my neck), PRURITUS (itching), MOBILITY DECREASED (sometimes she needed to take left hand to life up right hand) and FLATULENCE (gas pain/Gas/getting  up very early with the gas) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SPIRONOLACTONE, PRAVASTATIN, LISINOPRIL, LORATADINE (LORATADIN), LATANOPROST and TIZANIDINE for an unknown indication.    On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced PAIN IN EXTREMITY (pain that ran all the way down into my finger tips from the neck (back of ear, down to right side)), MOBILITY DECREASED (sometimes she needed to take left hand to life up right hand) and FLATULENCE (gas pain/Gas/getting  up very early with the gas). On an unknown date, the patient experienced ACNE (Pimples in my neck) and PRURITUS (itching). The patient was treated with CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain that ran all the way down into my finger tips from the neck (back of ear, down to right side)), ACNE (Pimples in my neck) and PRURITUS (itching) outcome was unknown and MOBILITY DECREASED (sometimes she needed to take left hand to life up right hand) and FLATULENCE (gas pain/Gas/getting  up very early with the gas) was resolving.            Patient was rubbing alcohol for the pimples in her neck and itching.   This case was linked to MOD-2021-379760.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (fever) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included SPIRONOLACTONE, PRAVASTATIN, LISINOPRIL, LORATADINE (LORATADIN), LATANOPROST and TIZANIDINE for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced CHILLS (Chills) and PYREXIA (fever). In March 2021, CHILLS (Chills) and PYREXIA (fever) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information was unknown.   This case was linked to MOD-2021-379721 (Patient Link).