chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Off label use
Clinical narrative: I can't tell you if 100 or 50 mcg is administered; Received third dose being not eligible; This spontaneous case was reported by a physician and describes the occurrence of INCORRECT DOSE ADMINISTERED (I can't tell you if 100 or 50 mcg is administered) and OFF LABEL USE (Received third dose being not eligible) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A, 012M20A and 021B21A) for COVID-19 vaccination.     Concomitant products included LOSARTAN for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Sep-2021, the patient experienced INCORRECT DOSE ADMINISTERED (I can't tell you if 100 or 50 mcg is administered) and OFF LABEL USE (Received third dose being not eligible). On 22-Sep-2021, INCORRECT DOSE ADMINISTERED (I can't tell you if 100 or 50 mcg is administered) and OFF LABEL USE (Received third dose being not eligible) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient take low dose steroids.  Patient did antibody test PCR test and it showed antibody did not register very high. Agent upon asking clarifying question about immunocompromised status , patient  stated that he is not.   This case was linked to MOD-2021-329820 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal discomfort, X-ray
Clinical narrative: joint discomfort on right and left side of calf and behind knee/ discomfort at joints when he "goes to get out of a chair" or "if I have to squat low"; elbow, forearm flare ups of joint discomfort and pain / "Feels like arthritis that comes and goes"; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (joint discomfort on right and left side of calf and behind knee/ discomfort at joints when he "goes to get out of a chair" or "if I have to squat low") and ARTHRALGIA (elbow, forearm flare ups of joint discomfort and pain / "Feels like arthritis that comes and goes") in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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. In 2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (joint discomfort on right and left side of calf and behind knee/ discomfort at joints when he "goes to get out of a chair" or "if I have to squat low") and ARTHRALGIA (elbow, forearm flare ups of joint discomfort and pain / "Feels like arthritis that comes and goes"). At the time of the report, MUSCULOSKELETAL DISCOMFORT (joint discomfort on right and left side of calf and behind knee/ discomfort at joints when he "goes to get out of a chair" or "if I have to squat low") and ARTHRALGIA (elbow, forearm flare ups of joint discomfort and pain / "Feels like arthritis that comes and goes") outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, X-ray: normal (normal) normal.         Patient stated that  he had this type of discomfort in his life and that he was always healthy and wondered if this was due to the Moderna vaccine. Patient also was scheduled for MRI.  No concomitant medications were reported  Treatment medication included  anti-inflammatories
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included MTHFR gene mutation (MThfr compound heterozygous (sometimes she methylates, or absorb medications very quickly, and there are other times where she absorbs medications very slowly)), Fibromyalgia, Hypothyroidism (Low thyroid), Anxiety and Arthritis. Concomitant products included DIAZEPAM (VALIUM) for Anxiety, DULOXETINE HYDROCHLORIDE (CYMBALTA) for Fibromyalgia, VITAMIN C [ASCORBIC ACID], VITAMIN D [VITAMIN D NOS], CALCIUM and ZINC for an unknown indication.    On 30-Jan-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 PAIN IN EXTREMITY (Arm soreness). At the time of the report, PAIN IN EXTREMITY (Arm soreness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication of the patient also included thyroid medication.  The patient received vaccine in her left arm, which was non dominant arm.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-329866 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dyspnoea, Fatigue, Influenza like illness, Pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like she had flu), DYSPNOEA (shortness of breath,could not take full breath in), PAIN (pain), RASH PRURITIC (itching from her rash, mostly on back) and RASH (2 days later rash came all over body) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia, Thyroid disorder and Anxiety. Concomitant products included DIAZEPAM (VALIUM) for Anxiety, DULOXETINE HYDROCHLORIDE (CYMBALTA) for Fibromyalgia, VITAMIN C [ASCORBIC ACID], VITAMIN D NOS, CALCIUM and ZINC for an unknown indication.    On 07-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (felt like she had flu), DYSPNOEA (shortness of breath,could not take full breath in), PAIN (pain), RASH PRURITIC (itching from her rash, mostly on back), RASH (2 days later rash came all over body), PYREXIA (100 F temperature) and FATIGUE (Fatigue which was pretty overwhelming,fatigue for a full day). The patient was treated with PARACETAMOL (TYLENOL) for Rash, at a dose of 1 dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (felt like she had flu), DYSPNOEA (shortness of breath,could not take full breath in), PAIN (pain), RASH PRURITIC (itching from her rash, mostly on back), RASH (2 days later rash came all over body), PYREXIA (100 F temperature) and FATIGUE (Fatigue which was pretty overwhelming,fatigue for a full day) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 100 (High) reports temperature of 100 degrees F (her normal temperature is 97 to 97.7 F).         Patient reports that she has a genetic defect called MThfr compound heterozygous. It means sometimes she methylates, or absorb medications very quickly, and there were other times where she absorbs medications very slowly.   Patient mentioned that she asked her doctor about receiving the flu vaccine, and her doctor told her to wait a bit to receive it. She mentioned she will wait until December to receive it because of her condition and the vaccines.   This case was linked to MOD-2021-329852, MOD-2021-329866 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Rash pruritic
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like she had flu), DYSPNOEA (shortness of breath,could not take full breath in), PAIN (pain), RASH PRURITIC (itching from her rash, mostly on back) and RASH (2 days later rash came all over body) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia, Thyroid disorder and Anxiety. Concomitant products included DIAZEPAM (VALIUM) for Anxiety, DULOXETINE HYDROCHLORIDE (CYMBALTA) for Fibromyalgia, VITAMIN C [ASCORBIC ACID], VITAMIN D NOS, CALCIUM and ZINC for an unknown indication.    On 07-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (felt like she had flu), DYSPNOEA (shortness of breath,could not take full breath in), PAIN (pain), RASH PRURITIC (itching from her rash, mostly on back), RASH (2 days later rash came all over body), PYREXIA (100 F temperature) and FATIGUE (Fatigue which was pretty overwhelming,fatigue for a full day). The patient was treated with PARACETAMOL (TYLENOL) for Rash, at a dose of 1 dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (felt like she had flu), DYSPNOEA (shortness of breath,could not take full breath in), PAIN (pain), RASH PRURITIC (itching from her rash, mostly on back), RASH (2 days later rash came all over body), PYREXIA (100 F temperature) and FATIGUE (Fatigue which was pretty overwhelming,fatigue for a full day) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 100 (High) reports temperature of 100 degrees F (her normal temperature is 97 to 97.7 F).         Patient reports that she has a genetic defect called MThfr compound heterozygous. It means sometimes she methylates, or absorb medications very quickly, and there were other times where she absorbs medications very slowly.   Patient mentioned that she asked her doctor about receiving the flu vaccine, and her doctor told her to wait a bit to receive it. She mentioned she will wait until December to receive it because of her condition and the vaccines.   This case was linked to MOD-2021-329852, MOD-2021-329866 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccine breakthrough infection
Clinical narrative: Getting breakthrough cases; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Sep-2021 and was forwarded to Moderna on 23-Sep-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINE BREAKTHROUGH INFECTION (Getting breakthrough cases) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINE BREAKTHROUGH INFECTION (Getting breakthrough cases) (seriousness criterion medically significant). At the time of the report, VACCINE BREAKTHROUGH INFECTION (Getting breakthrough cases) outcome was unknown.            Concomitant product use was not provided by the reporter.  Reporter stated some people who have completed the Moderna COVID-19 vaccination series (dose 1 and dose 2) are now getting breakthrough cases.  No treatment information was provided.  This case concerns and unknown person with no history who called to report that several people, presumably who they knew, had received both doses of a COVID-19 vaccine, manufacturer unknown, and had a breakthrough infection. No dates dosing information or other relevant information is reported. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.; Sender's Comments: This case concerns and unknown person with no history who called to report that several people, persmably who they knew, had received both doses of a COVID-19 vaccine, manufacturer unknown, and had a breakthrough infection. No dates dosing information or other relevant information is reported. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Injection site erythema, Pain in extremity
Clinical narrative: achy in my arms and my core; injection site is a little red, but not bad; a little dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (a little dizzy), PAIN IN EXTREMITY (achy in my arms and my core) and INJECTION SITE ERYTHEMA (injection site is a little red, but not bad) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Sep-2021, the patient experienced DIZZINESS (a little dizzy). On 23-Sep-2021, the patient experienced PAIN IN EXTREMITY (achy in my arms and my core) and INJECTION SITE ERYTHEMA (injection site is a little red, but not bad). At the time of the report, DIZZINESS (a little dizzy), PAIN IN EXTREMITY (achy in my arms and my core) and INJECTION SITE ERYTHEMA (injection site is a little red, but not bad) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Patients who got Moderna had the same symptoms as me; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Patients who got Moderna had the same symptoms as me) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Patients who got Moderna had the same symptoms as me). At the time of the report, VACCINATION COMPLICATION (Patients who got Moderna had the same symptoms as me) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product was provided by the reporter.  No treatment medication was provided.  Reporter stated that her Chiropractor had some patients who had received the Moderna vaccine and experienced the same symptoms as the reporter.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of unexpected therapeutic response (right away, his infection started clearing up; he dramatically cut back on inhalers) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 0035C21A, 007B21A and 022M20A) for COVID-19 immunization. Concurrent medical conditions included lung infection. On Feb 26, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 26, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Sep 1, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Sep 1, 2021, patient experienced unexpected therapeutic response (right away, his infection started clearing up; he dramatically cut back on inhalers). At the time of the report, unexpected therapeutic response (right away, his infection started clearing up; he dramatically cut back on inhalers) outcome: unknown. The reporter did not provide any causality assessments. The doctor gave 3 inhalers to patient but that did not help for his infection. This case linked to MOD-2021-329780, MOD-2021-329750 (patient link).
Sex: U
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Dose administered out a vial that was not completely thawed out.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Dose administered out a vial that was not completely thawed out.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 ADMINISTRATION ERROR (Dose administered out a vial that was not completely thawed out.). At the time of the report, PRODUCT ADMINISTRATION ERROR (Dose administered out a vial that was not completely thawed out.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant and Treatment medications were reported.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Bradyphrenia, Dizziness, Fatigue, Pain, Pyrexia
Clinical narrative: Dizzy; Thinking slowly; More tired than ever; Vertigo; Fever/febrile; aches; This spontaneous case was reported by an other health care professional and describes the occurrence of VERTIGO (Vertigo), DIZZINESS (Dizzy), BRADYPHRENIA (Thinking slowly), PAIN (aches) and FATIGUE (More tired than ever) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sinus disorder (have not had vertigo with sinus/ear issues in the past) and Ear disorder NOS (have not had vertigo with sinus/ear issues in the past). Concurrent medical conditions included Knee pain (Taking medicatiion). Concomitant products included IBUPROFEN for Knee pain, BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.   On 05-Aug-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021 at 5:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Sep-2021 at 4:00 AM, the patient experienced VERTIGO (Vertigo). On an unknown date, the patient experienced DIZZINESS (Dizzy), BRADYPHRENIA (Thinking slowly), PAIN (aches), FATIGUE (More tired than ever) and PYREXIA (Fever/febrile). The patient was treated with PARACETAMOL (TYLENOL) for Fever and Ache, at an unspecified dose and frequency and PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED SINUS) for Vertigo, at an unspecified dose and frequency. At the time of the report, VERTIGO (Vertigo) and FATIGUE (More tired than ever) had not resolved, DIZZINESS (Dizzy) and BRADYPHRENIA (Thinking slowly) outcome was unknown and PAIN (aches) and PYREXIA (Fever/febrile) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 antibody test: negative (Negative) testing was negative but was diagnosed by the physician.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VERTIGO (Vertigo) to be not related. No further causality assessments were provided for DIZZINESS (Dizzy), BRADYPHRENIA (Thinking slowly), PAIN (aches), FATIGUE (More tired than ever) and PYREXIA (Fever/febrile).    The pharmacist reported that the vertigo was not related to the vaccine but was somewhat related to the sinus issues and was somewhat relived by Sudafed. The vertigo had lessened slightly but still bothered the patient.   This case was linked to MOD-2021-293323 (Patient Link).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Vertigo
Clinical narrative: Dizzy; Thinking slowly; More tired than ever; Vertigo; Fever/febrile; aches; This spontaneous case was reported by an other health care professional and describes the occurrence of VERTIGO (Vertigo), DIZZINESS (Dizzy), BRADYPHRENIA (Thinking slowly), PAIN (aches) and FATIGUE (More tired than ever) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sinus disorder (have not had vertigo with sinus/ear issues in the past) and Ear disorder NOS (have not had vertigo with sinus/ear issues in the past). Concurrent medical conditions included Knee pain (Taking medicatiion). Concomitant products included IBUPROFEN for Knee pain, BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.   On 05-Aug-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021 at 5:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Sep-2021 at 4:00 AM, the patient experienced VERTIGO (Vertigo). On an unknown date, the patient experienced DIZZINESS (Dizzy), BRADYPHRENIA (Thinking slowly), PAIN (aches), FATIGUE (More tired than ever) and PYREXIA (Fever/febrile). The patient was treated with PARACETAMOL (TYLENOL) for Fever and Ache, at an unspecified dose and frequency and PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED SINUS) for Vertigo, at an unspecified dose and frequency. At the time of the report, VERTIGO (Vertigo) and FATIGUE (More tired than ever) had not resolved, DIZZINESS (Dizzy) and BRADYPHRENIA (Thinking slowly) outcome was unknown and PAIN (aches) and PYREXIA (Fever/febrile) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 antibody test: negative (Negative) testing was negative but was diagnosed by the physician.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VERTIGO (Vertigo) to be not related. No further causality assessments were provided for DIZZINESS (Dizzy), BRADYPHRENIA (Thinking slowly), PAIN (aches), FATIGUE (More tired than ever) and PYREXIA (Fever/febrile).    The pharmacist reported that the vertigo was not related to the vaccine but was somewhat related to the sinus issues and was somewhat relived by Sudafed. The vertigo had lessened slightly but still bothered the patient.   This case was linked to MOD-2021-293323 (Patient Link).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Head discomfort, Rhinorrhoea, Sleep disorder
Clinical narrative: felt crummy; sniffles; chills; head felt dull; sleep like log/didn't sleep well; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (head felt dull), SLEEP DISORDER (sleep like log/didn't sleep well), FEELING ABNORMAL (felt crummy), RHINORRHOEA (sniffles) and CHILLS (chills) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Post-traumatic stress disorder.    On 10-Mar-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced FEELING ABNORMAL (felt crummy). In March 2021, the patient experienced HEAD DISCOMFORT (head felt dull), SLEEP DISORDER (sleep like log/didn't sleep well), RHINORRHOEA (sniffles) and CHILLS (chills). At the time of the report, HEAD DISCOMFORT (head felt dull), SLEEP DISORDER (sleep like log/didn't sleep well), FEELING ABNORMAL (felt crummy), RHINORRHOEA (sniffles) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had not slept well because of PTSD on Thursday night, 11-March-2021.  Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Headache
Clinical narrative: felt cold and hot; headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (felt cold and hot) and HEADACHE (headache) 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 February 2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (felt cold and hot) and HEADACHE (headache). At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (felt cold and hot) and HEADACHE (headache) outcome was unknown.            The patient had her second dose. She went to bed early the previous night of reporting and stated that she felt cold and hot. The next morning she had a headache.  No concomitant medications were reported.  No treatment information was reported.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: received first dose of Moderna COVID-19 vaccine under 18 years of age; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received first dose of Moderna COVID-19 vaccine under 18 years of age) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received first dose of Moderna COVID-19 vaccine under 18 years of age). On 23-Sep-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received first dose of Moderna COVID-19 vaccine under 18 years of age) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported and no adverse reactions following vaccination as per the nurse. The nurse stated the patient waited 15 minutes after vaccination and they were fine.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-329314.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: but that he developed a red spot "smaller than a baseball but larger than a golf ball" at the site of injec; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (but that he developed a red spot "smaller than a baseball but larger than a golf ball" at the site of injec) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 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 VACCINATION SITE ERYTHEMA (but that he developed a red spot "smaller than a baseball but larger than a golf ball" at the site of injec). At the time of the report, VACCINATION SITE ERYTHEMA (but that he developed a red spot "smaller than a baseball but larger than a golf ball" at the site of injec) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was reported. No concomitant medication was reported.   This case was linked to MOD-2021-330240.
Sex: U
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: My throat closed; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (My throat closed) 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 THROAT TIGHTNESS (My throat closed). At the time of the report, THROAT TIGHTNESS (My throat closed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer
Clinical narrative: She got the breast cancer diagnosis after getting the vaccine (about May/June); This spontaneous case was reported by a consumer and describes the occurrence of BREAST CANCER (She got the breast cancer diagnosis after getting the vaccine (about May/June)) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Depression and Blood pressure. Concomitant products included ATORVASTATIN for an unknown indication.   On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced BREAST CANCER (She got the breast cancer diagnosis after getting the vaccine (about May/June)) (seriousness criterion medically significant). The patient was treated with PALBOCICLIB (IBRANCE) ongoing since an unknown date for Breast cancer, at an unspecified dose and frequency. At the time of the report, BREAST CANCER (She got the breast cancer diagnosis after getting the vaccine (about May/June)) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications of the patient also included, blood pressure pill and antidepressant pill Patient was taking cancer treatment for breast cancer and a pill from Pfizer. Patient was diagnosed with breast cancer after getting the vaccine (about May/June). Patient took first dose on  0 14 2021 (unclear in the vaccination card).  Company Comment: This case concerns a  80-year-old, female patient with no relevant medical history, who experienced the unexpected event of Breast cancer. The event occurred at unknown interval after the second dose of mRNA-1273 (Moderna Covid-19 Vaccine). The rechallenge was unknown since no complete information about the first dose was disclosed. Limited information provided preclude a complete medical and causal assessment of this case. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.; Sender's Comments: This case concerns a  80-year-old, female patient with no relevant medical history, who experienced the unexpected event of Breast cancer. The event occurred at unknown interval after the second dose of mRNA-1273 (Moderna Covid-19 Vaccine). The rechallenge was unknown since no complete information about the first dose was disclosed. Limited information provided preclude a complete medical and causal assessment of this case. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Off label use, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: thermo skin reaction; mark that hurts; mark that itches; Colour was pink first and red after 70 hours; Patient received 3rd dose without being immunocompromised and said it was an off-label dose; This spontaneous case was reported by a nurse and describes the occurrence of FEELING HOT (thermo skin reaction), VACCINATION SITE PAIN (mark that hurts), VACCINATION SITE PRURITUS (mark that itches), VACCINATION SITE ERYTHEMA (Colour was pink first and red after 70 hours) and OFF LABEL USE (Patient received 3rd dose without being immunocompromised and said it was an off-label dose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045C21A, 032L20A and 032L21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concurrent medical conditions included Allergic bronchitis (Has been experiencing this condition for 3 years.). Concomitant products included DEXAMETHASONE ACETATE (DECADRON [DEXAMETHASONE ACETATE]) and TRIAMCINOLONE ACETONIDE (KENALOG [TRIAMCINOLONE ACETONIDE]) for Allergic bronchitis.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, the patient experienced FEELING HOT (thermo skin reaction), VACCINATION SITE PAIN (mark that hurts), VACCINATION SITE PRURITUS (mark that itches), VACCINATION SITE ERYTHEMA (Colour was pink first and red after 70 hours) and OFF LABEL USE (Patient received 3rd dose without being immunocompromised and said it was an off-label dose). On 24-Sep-2021, OFF LABEL USE (Patient received 3rd dose without being immunocompromised and said it was an off-label dose) had resolved. At the time of the report, FEELING HOT (thermo skin reaction), VACCINATION SITE PAIN (mark that hurts), VACCINATION SITE PRURITUS (mark that itches) and VACCINATION SITE ERYTHEMA (Colour was pink first and red after 70 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were not provided   Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Follow-up received on 24-SEP-2021 : start date for dose updated and start date of event changed to 24-SEP-2021
Sex: F
Vaccine: COVID19
Symptoms: Inflammatory pain, Therapeutic response unexpected
Clinical narrative: beneficial side effect; pain due to inflammation disappeared; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (beneficial side effect) and INFLAMMATORY PAIN (pain due to inflammation disappeared) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (beneficial side effect) and INFLAMMATORY PAIN (pain due to inflammation disappeared). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (beneficial side effect) outcome was unknown and INFLAMMATORY PAIN (pain due to inflammation disappeared) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medication was provided. No treatment  was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination complication (her friend experienced negative effects following vaccination) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Sep 23, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Sep 23, 2021, patient experienced vaccination complication (her friend experienced negative effects following vaccination). At the time of the report, vaccination complication (her friend experienced negative effects following vaccination) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered dose more than 12 hours after vial  was punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered dose more than 12 hours after vial  was punctured) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered dose more than 12 hours after vial  was punctured). On 20-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Administered dose more than 12 hours after vial  was punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient is taking unknown concomitant medications. Treatment information was not provided. It was reported that the patient received vaccine 67 hours after the 12 hours expiry that is total of 79 hours after the vials was punctured.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Chest discomfort, Fatigue
Clinical narrative: after both vaccine they notices that they were very tired and low blood pressure; After both vaccine they notices that they were very tired and low blood pressure; felt tightness of the chest, at moment of the vaccine  but didn't linger.; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (felt tightness of the chest, at moment of the vaccine  but didn't linger.), BLOOD PRESSURE DECREASED (after both vaccine they notices that they were very tired and low blood pressure) and FATIGUE (After both vaccine they notices that they were very tired and low blood pressure) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010a21a and 029l20a) for COVID-19 vaccination.     Concurrent medical conditions included Overweight, Blood pressure high and Coronary disease. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), AMINOPHYLLINE, LOSARTAN, METOPROLOL, MULTIVITAMIN [VITAMINS NOS] and AMLODIPINE for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHEST DISCOMFORT (felt tightness of the chest, at moment of the vaccine  but didn't linger.). On an unknown date, the patient experienced BLOOD PRESSURE DECREASED (after both vaccine they notices that they were very tired and low blood pressure) and FATIGUE (After both vaccine they notices that they were very tired and low blood pressure). On 12-Mar-2021, CHEST DISCOMFORT (felt tightness of the chest, at moment of the vaccine  but didn't linger.) had resolved. At the time of the report, BLOOD PRESSURE DECREASED (after both vaccine they notices that they were very tired and low blood pressure) and FATIGUE (After both vaccine they notices that they were very tired and low blood pressure) outcome was unknown.            No treatment medication was provided   This case was linked to MOD-2021-330698, MOD-2021-330881 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Follow-up received. concomitant product amlodipine added. concomitant product frequency added.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Possible 7 doses administered from unknown # of vials which the lot had 2 different temperature excursions; Possible 7 doses administered from unknown # of vials which the lot had 2 different temperature excursions; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Possible 7 doses administered from unknown # of vials which the lot had 2 different temperature excursions) and PRODUCT STORAGE ERROR (Possible 7 doses administered from unknown # of vials which the lot had 2 different temperature excursions) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Possible 7 doses administered from unknown # of vials which the lot had 2 different temperature excursions) and PRODUCT STORAGE ERROR (Possible 7 doses administered from unknown # of vials which the lot had 2 different temperature excursions). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Possible 7 doses administered from unknown # of vials which the lot had 2 different temperature excursions) and PRODUCT STORAGE ERROR (Possible 7 doses administered from unknown # of vials which the lot had 2 different temperature excursions) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination.     Concomitant products included TELMISARTAN, ROSUVASTATIN CALCIUM, DUTASTERIDE, ALFUZOSIN HYDROCHLORIDE, VITAMIN D NOS, ZINC and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Sep-2021, SARS-CoV-2 test: positive (Positive) positive.         It was reported that currently patient was experiencing minor cold like symptoms.  Treatment medication was not reported.  .   This case was linked to MOD-2021-330449, MOD-2021-330550 (Patient Link).
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Hypotension
Clinical narrative: short of breath; hypotension; This spontaneous case was reported by a physician and describes the occurrence of DYSPNOEA (short of breath) and HYPOTENSION (hypotension) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Sep-2021, 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (short of breath) and HYPOTENSION (hypotension). At the time of the report, DYSPNOEA (short of breath) and HYPOTENSION (hypotension) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drug was not reported. Treatment medication included fluids.  It was reported that the reaction was severe and got better with fluids. It was reported after 24 hours of vaccination patient experienced hypotension and shortness of breath.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Vaccination site pain
Clinical narrative: feels ache when she movies her arm up down and in any way; started feeling pain while being injected with shot and progressively gotten worse; feels like pain in muscle area; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (feels ache when she movies her arm up down and in any way), MYALGIA (feels like pain in muscle area) and VACCINATION SITE PAIN (started feeling pain while being injected with shot and progressively gotten worse) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B201A and 024M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Allergy (Patient has allergic to an ingredient of Aleve.). Concomitant products included AMLODIPINE, METOPROLOL SUCCINATE (METOPROLOL SUCC CT), COLECALCIFEROL (VIT D3), VITAMIN D2, FENOFIBRATE, MAGNESIUM OXIDE (MAG OXIDE), ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE (PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]) and FLUTICASONE PROPIONATE (FLOVENT) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced MYALGIA (feels like pain in muscle area). On an unknown date, the patient experienced PAIN IN EXTREMITY (feels ache when she movies her arm up down and in any way) and VACCINATION SITE PAIN (started feeling pain while being injected with shot and progressively gotten worse). At the time of the report, PAIN IN EXTREMITY (feels ache when she movies her arm up down and in any way), MYALGIA (feels like pain in muscle area) and VACCINATION SITE PAIN (started feeling pain while being injected with shot and progressively gotten worse) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient has not taken anything yet. Patient had not issues after first dose.