chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Headache, Illness, Myalgia
Clinical narrative: Head Ache; Stomach Pain; Loss of memory; Loss of appetite; fatigue; Weakness; Sore muscules; I am still sick; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Head Ache), ABDOMINAL PAIN UPPER (Stomach Pain), AMNESIA (Loss of memory), DECREASED APPETITE (Loss of appetite) and FATIGUE (fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 HEADACHE (Head Ache), ABDOMINAL PAIN UPPER (Stomach Pain), AMNESIA (Loss of memory), DECREASED APPETITE (Loss of appetite), FATIGUE (fatigue), ASTHENIA (Weakness), MYALGIA (Sore muscules) and ILLNESS (I am still sick). At the time of the report, HEADACHE (Head Ache), ABDOMINAL PAIN UPPER (Stomach Pain), AMNESIA (Loss of memory), DECREASED APPETITE (Loss of appetite), FATIGUE (fatigue), ASTHENIA (Weakness), MYALGIA (Sore muscules) and ILLNESS (I am still sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment medications was not given.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: random on and off nose bleeds since receiving thevaccine; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (random on and off nose bleeds since receiving thevaccine) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included Cancer. Concomitant products included FLECAINIDE, ATORVASTATIN, MONTELUKAST SODIUM (SINGULAIR), METFORMIN, RABEPRAZOLE SODIUM (ACIPHEX), TELMISARTAN, SEMAGLUTIDE (OZEMPIC), RIVAROXABAN (XARELTO) and LIRAGLUTIDE (SAXENDA) for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-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 EPISTAXIS (random on and off nose bleeds since receiving thevaccine). At the time of the report, EPISTAXIS (random on and off nose bleeds since receiving thevaccine) outcome was unknown.            No treatment medication reported by the reporter. Patient was on blood thinner since last 4 years. Patient stated that she never had nose bleeds in her life. patient spoke with her doctor once back in April-march 2021 and the doctor said it might be a result of dry weather. Patient was going to see the MD in 2 weeks. Vaccination facility was fire department. Patient also reported that most nose bleeds lasts 2-3 minutes. On 30-JUN-2021, it lasted about 4-5 minutes and then stopped. Then it started again, and she stopped it right away within minutes. The occurrence was every couple of weeks initially, then it started happening twice every few weeks, then 3 days in a row and not every 2-3 days. Consent provided for Safety to follow up preferably via email (not working right now) and/or Phone (Leave detailed message because she does not answer calls from random numbers).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: random on and off nose bleeds since receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (random on and off nose bleeds since receiving the vaccine) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 022M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Cancer (cancer survivor.). Concomitant products included FLECAINIDE, ATORVASTATIN, MONTELUKAST SODIUM (SINGULAIR), METFORMIN, RABEPRAZOLE SODIUM (ACIFIX [RABEPRAZOLE SODIUM]), TELMISARTAN, SEMAGLUTIDE (OZEMPIC), RIVAROXABAN (XARELTO) and LIRAGLUTIDE (SAXENDA) for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-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 EPISTAXIS (random on and off nose bleeds since receiving the vaccine). At the time of the report, EPISTAXIS (random on and off nose bleeds since receiving the vaccine) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine)  was Not applicable.       No treatment medication was reported. Patient inquired about side effects which she experienced after receiving both doses of Moderna COVID-19 vaccine. The patient mentioned that she never had nose bleeds in her life. The patient spoke with her doctor once back in April-march2021 and the doctor said it might be a result of dry weather. The patient would be seeing the MD in 2 weeks.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Vaccination site pain
Clinical narrative: Weakness; Pain at injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain at injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included No adverse event (no medical history reported ). Concomitant products included ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ) and HYDROCHLOROTHIAZIDE (DIURETIC [HYDROCHLOROTHIAZIDE]) for an unknown indication.    On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced ASTHENIA (Weakness) and VACCINATION SITE PAIN (Pain at injection site). At the time of the report, ASTHENIA (Weakness), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: doses 50 days apart.; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (doses 50 days apart.) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. UNK and 025C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jun-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (doses 50 days apart.). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (doses 50 days apart.) outcome was unknown.            No relevant concomitant medication was reported. Treatment medication was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: soar throat; stuffy/runny nose; sick; This spontaneous case was reported by a  and describes the occurrence of OROPHARYNGEAL PAIN (soar throat), RHINORRHOEA (stuffy/runny nose) and ILLNESS (sick) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 OROPHARYNGEAL PAIN (soar throat), RHINORRHOEA (stuffy/runny nose) and ILLNESS (sick). At the time of the report, OROPHARYNGEAL PAIN (soar throat), RHINORRHOEA (stuffy/runny nose) and ILLNESS (sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not provided. The Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: I had first shot of moderna on may 5. Then had to have a tetanus shot the first of June. I have delayed my second shot.; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (I had first shot of moderna on may 5. Then had to have a tetanus shot the first of June. I have delayed my second shot.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included TETANUS VACCINE from 01-Jun-2021 to 01-Jun-2021 for Tetanus immunization.    On 05-May-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 OFF LABEL USE (I had first shot of moderna on may 5. Then had to have a tetanus shot the first of June. I have delayed my second shot.). At the time of the report, OFF LABEL USE (I had first shot of moderna on may 5. Then had to have a tetanus shot the first of June. I have delayed my second shot.) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing was delayed on an unknown date.       Concomitant product information was not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: missed appointment for second shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed appointment for second shot) 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 05-Jun-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 PRODUCT DOSE OMISSION ISSUE (missed appointment for second shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed appointment for second shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant was provided no treatment medication was provided
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: stiff fingers; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiff fingers) 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 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-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 MUSCULOSKELETAL STIFFNESS (stiff fingers). At the time of the report, MUSCULOSKELETAL STIFFNESS (stiff fingers) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19
Clinical narrative: was diagnosed with Covid with no symptoms; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Jun-2021 and was forwarded to Moderna on 30-Jun-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of ASYMPTOMATIC COVID-19 (was diagnosed with Covid with no symptoms) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jun-2021, the patient experienced ASYMPTOMATIC COVID-19 (was diagnosed with Covid with no symptoms). At the time of the report, ASYMPTOMATIC COVID-19 (was diagnosed with Covid with no symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported  No treatment medication was reported
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Received the 1st shot in April and as of today not gotten the 2nd dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Received the 1st shot in April and as of today not gotten the 2nd dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Received the 1st shot in April and as of today not gotten the 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Received the 1st shot in April and as of today not gotten the 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was reported.  No treatment details were provided.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: stiff fingers on both of her hands; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiff fingers on both of her hands) 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 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MUSCULOSKELETAL STIFFNESS (stiff fingers on both of her hands). At the time of the report, MUSCULOSKELETAL STIFFNESS (stiff fingers on both of her hands) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow up received updated event onset date.
Sex: F
Vaccine: COVID19
Symptoms: Oral pain, Pain
Clinical narrative: pain in my mouth; chronic pain in my upper left arm; This spontaneous case was reported by a non-health professional and describes the occurrence of ORAL PAIN (pain in my mouth) and PAIN (chronic pain in my upper left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Lactose intolerance, Gluten intolerance, Chronic fatigue (increasing with age but more so post COVID vaccine.), Fibromyalgia (increasing with age but more so post COVID vaccine.) and Oral pain. Concomitant products included VITAMIN D [VITAMIN D NOS] for Antiviral treatment, HYDROCORTISONE from 05-Jul-2020 to an unknown date for Fatigue, LEVOTHYROXINE, LIOTHYRONINE (NP THYROID) and LEVOTHYROXINE from 06-Jun-2021 to an unknown date for Hypothyroidism, NALTREXONE from 02-Dec-2020 to an unknown date for Inflammation.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ORAL PAIN (pain in my mouth) and PAIN (chronic pain in my upper left arm). At the time of the report, ORAL PAIN (pain in my mouth) and PAIN (chronic pain in my upper left arm) outcome was unknown.            No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow-up received and added reporter details, other relevant history, concomitant medications and new event, vaccine facility information, dose dates,
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypertension, Myalgia, Nausea
Clinical narrative: my blood pressure a bit high; pressure over my left eye is extremely intense; Nausea after second vaccine/nausea is periodic; Fatigue after second vaccine; Headache (Scale of 1-10 it is a 6) after second vaccine/non-stop headache; body aches; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (my blood pressure a bit high), OCULAR DISCOMFORT (pressure over my left eye is extremely intense), NAUSEA (Nausea after second vaccine/nausea is periodic), FATIGUE (Fatigue after second vaccine) and HEADACHE (Headache (Scale of 1-10 it is a 6) after second vaccine/non-stop headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050021A and 002C26A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy, Allergy (To Cardboard) and Allergy (To Paper). Concomitant products included ESTRADIOL (ESTROGEN), PROGESTERONE, PROBIOTICS NOS, VITAMIN C [ASCORBIC ACID] and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced NAUSEA (Nausea after second vaccine/nausea is periodic), FATIGUE (Fatigue after second vaccine), HEADACHE (Headache (Scale of 1-10 it is a 6) after second vaccine/non-stop headache) and MYALGIA (body aches). On an unknown date, the patient experienced HYPERTENSION (my blood pressure a bit high) and OCULAR DISCOMFORT (pressure over my left eye is extremely intense). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form. On 08-Jun-2021, FATIGUE (Fatigue after second vaccine) had resolved. At the time of the report, HYPERTENSION (my blood pressure a bit high) and OCULAR DISCOMFORT (pressure over my left eye is extremely intense) outcome was unknown, NAUSEA (Nausea after second vaccine/nausea is periodic) and HEADACHE (Headache (Scale of 1-10 it is a 6) after second vaccine/non-stop headache) had not resolved and MYALGIA (body aches) had resolved.            The patient reported that when she progesterone and estrogen pills were stopped, nausea stopped.   Other concomitant medications included: antihistamines twice daily  It was also reported that treatment medication Tylenol also gave nausea, therefore stopped taking   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow up received and Updated patient details: Height, Weight, Race; Updated Medical History: Allergies; Updated Events: Body aches, Blood pressure, Intraocular pressure; Updated outcomes: Nausea- From recovered to ongoing;
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular discomfort
Clinical narrative: my blood pressure a bit high; pressure over my left eye is extremely intense; Nausea after second vaccine/nausea is periodic; Fatigue after second vaccine; Headache (Scale of 1-10 it is a 6) after second vaccine/non-stop headache; body aches; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (my blood pressure a bit high), OCULAR DISCOMFORT (pressure over my left eye is extremely intense), NAUSEA (Nausea after second vaccine/nausea is periodic), FATIGUE (Fatigue after second vaccine) and HEADACHE (Headache (Scale of 1-10 it is a 6) after second vaccine/non-stop headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050021A and 002C26A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy, Allergy (To Cardboard) and Allergy (To Paper). Concomitant products included ESTRADIOL (ESTROGEN), PROGESTERONE, PROBIOTICS NOS, VITAMIN C [ASCORBIC ACID] and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced NAUSEA (Nausea after second vaccine/nausea is periodic), FATIGUE (Fatigue after second vaccine), HEADACHE (Headache (Scale of 1-10 it is a 6) after second vaccine/non-stop headache) and MYALGIA (body aches). On an unknown date, the patient experienced HYPERTENSION (my blood pressure a bit high) and OCULAR DISCOMFORT (pressure over my left eye is extremely intense). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form. On 08-Jun-2021, FATIGUE (Fatigue after second vaccine) had resolved. At the time of the report, HYPERTENSION (my blood pressure a bit high) and OCULAR DISCOMFORT (pressure over my left eye is extremely intense) outcome was unknown, NAUSEA (Nausea after second vaccine/nausea is periodic) and HEADACHE (Headache (Scale of 1-10 it is a 6) after second vaccine/non-stop headache) had not resolved and MYALGIA (body aches) had resolved.            The patient reported that when she progesterone and estrogen pills were stopped, nausea stopped.   Other concomitant medications included: antihistamines twice daily  It was also reported that treatment medication Tylenol also gave nausea, therefore stopped taking   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow up received and Updated patient details: Height, Weight, Race; Updated Medical History: Allergies; Updated Events: Body aches, Blood pressure, Intraocular pressure; Updated outcomes: Nausea- From recovered to ongoing;
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Retching, Vomiting
Clinical narrative: arm is hurting; dry heaves; throwing up; headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is hurting), RETCHING (dry heaves), VOMITING (throwing up) and HEADACHE (headaches) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011DZIA) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jun-2021, the patient experienced PAIN IN EXTREMITY (arm is hurting), RETCHING (dry heaves), VOMITING (throwing up) and HEADACHE (headaches). At the time of the report, PAIN IN EXTREMITY (arm is hurting), RETCHING (dry heaves), VOMITING (throwing up) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment information not reported.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever re-occurred after 4 days; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever re-occurred after 4 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever re-occurred after 4 days). At the time of the report, PYREXIA (Fever re-occurred after 4 days) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: someone received a third dose is that harmful; 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 EXTRA DOSE ADMINISTERED (someone received a third dose is that harmful) 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 EXTRA DOSE ADMINISTERED (someone received a third dose is that harmful). At the time of the report, EXTRA DOSE ADMINISTERED (someone received a third dose is that harmful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhea, at a dose of UNK dosage form. At the time of the report, DIARRHOEA (diarrhea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Urticaria
Clinical narrative: "some of my friends had the same experience after their vaccine having severe diarrhea and nausea; experience hives on my back, on right shoulder; "some of my friends had the same experience after their vaccine having severe diarrhea and nausea; 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 DIARRHOEA ("some of my friends had the same experience after their vaccine having severe diarrhea and nausea), URTICARIA (experience hives on my back, on right shoulder) and NAUSEA ("some of my friends had the same experience after their vaccine having severe diarrhea and nausea) 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 DIARRHOEA ("some of my friends had the same experience after their vaccine having severe diarrhea and nausea), URTICARIA (experience hives on my back, on right shoulder) and NAUSEA ("some of my friends had the same experience after their vaccine having severe diarrhea and nausea). At the time of the report, DIARRHOEA ("some of my friends had the same experience after their vaccine having severe diarrhea and nausea), URTICARIA (experience hives on my back, on right shoulder) and NAUSEA ("some of my friends had the same experience after their vaccine having severe diarrhea and nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case is a cluster case.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Terribly itchy; My arm has a rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Terribly itchy) and RASH (My arm has a rash) 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 PRURITUS (Terribly itchy) and RASH (My arm has a rash). At the time of the report, PRURITUS (Terribly itchy) and RASH (My arm has a rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported by reporter.  No treatment medication was reported by reporter.  Patient had adverse events a week after the first shot.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: losing clumps of hair/hair loss; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (losing clumps of hair/hair loss) 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 ALOPECIA (losing clumps of hair/hair loss). At the time of the report, ALOPECIA (losing clumps of hair/hair loss) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: I am not feeling well today; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (I am not feeling well today) 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 MALAISE (I am not feeling well today). At the time of the report, MALAISE (I am not feeling well today) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Illness, Vaccination site pain, Vomiting
Clinical narrative: sore arm; sick; chills; throwing up almost everyday for a month; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (sore arm), ILLNESS (sick), CHILLS (chills) and VOMITING (throwing up almost everyday for a month) 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 PAIN IN EXTREMITY (sore arm), ILLNESS (sick), CHILLS (chills) and VOMITING (throwing up almost everyday for a month). At the time of the report, PAIN IN EXTREMITY (sore arm), ILLNESS (sick), CHILLS (chills) and VOMITING (throwing up almost everyday for a month) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-242091 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia
Clinical narrative: Bad stomach pain; Achy upper shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Bad stomach pain) and ARTHRALGIA (Achy upper shoulder) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (Patient stated that recently in march beat breast cancer.And did 27 radiation treatments a month an a half ago. Still fatigued from that.).    On 18-Jun-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 ABDOMINAL PAIN UPPER (Bad stomach pain) and ARTHRALGIA (Achy upper shoulder). At the time of the report, ABDOMINAL PAIN UPPER (Bad stomach pain) and ARTHRALGIA (Achy upper shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Lack of Drug Effect; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of Drug Effect) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 014MOA) for COVID-19 vaccination.     Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jun-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced DRUG INEFFECTIVE (Lack of Drug Effect). At the time of the report, COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of Drug Effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jun-2021, SARS-CoV-2 test: positive (Positive) Positive.         Patient was exposed to COVID-19 on 20-Jun-2021 and tested positive on 29-Jun-2021. She had nausea and loss of smell as COVID-19 symptoms. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.  This is a case of lack of efficacy of the vaccine with an associated adverse event of Covid-19, therefore causal association between the event is assessed as not applicable.; Sender's Comments: This is a case of lack of efficacy of the vaccine with an associated adverse event of Covid-19, therefore causal association between the event is assessed as not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose administrated 55 days after first dose; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administrated 55 days after 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 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jun-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administrated 55 days after first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administrated 55 days after first dose) outcome was unknown.            Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm) 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 PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information, if any, was not provided by the reporter. Treatment information, if any, was not provided   This case was linked to MOD-2021-242072 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Myalgia
Clinical narrative: chilss; body aches; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chilss), MYALGIA (body aches) and HEADACHE (headache) 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, the patient experienced CHILLS (chilss), MYALGIA (body aches) and HEADACHE (headache). At the time of the report, CHILLS (chilss), MYALGIA (body aches) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.8 High.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Product dose omission issue
Clinical narrative: first vac was in 4/21 is it too late for 2nd; Sick or in hosp; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first vac was in 4/21 is it too late for 2nd) and ILLNESS (Sick or in hosp) 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 21-Apr-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 PRODUCT DOSE OMISSION ISSUE (first vac was in 4/21 is it too late for 2nd) and ILLNESS (Sick or in hosp). At the time of the report, PRODUCT DOSE OMISSION ISSUE (first vac was in 4/21 is it too late for 2nd) had resolved and ILLNESS (Sick or in hosp) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated that she need her 2nd Moderna vaccine. Each time she tried she ended up sick or in hospital. No concomitant medications were provided. No treatment information were given.
Sex: U
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: residual leg pain; bilat leg stiffnes; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (residual leg pain) and MUSCULOSKELETAL STIFFNESS (bilat leg stiffnes) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (residual leg pain) and MUSCULOSKELETAL STIFFNESS (bilat leg stiffnes). At the time of the report, PAIN IN EXTREMITY (residual leg pain) and MUSCULOSKELETAL STIFFNESS (bilat leg stiffnes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided.  Treatment information was not provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Vaccination site reaction
Clinical narrative: full body rash; covid arm; itchy at rash area; This spontaneous case was reported by a consumer and describes the occurrence of RASH (full body rash), VACCINATION SITE REACTION (covid arm) and RASH PRURITIC (itchy at rash area) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 021B21A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriasis (Psoriasis has been under control until the vaccine) and Autoimmune disorder. Concomitant products included AMITRIPTYLINE for Sleep disorder NOS, LORATADINE, FUROSEMIDE, SPIRONOLACTONE, VITAMINS NOS, COLLAGEN, MAGNESIUM, POTASSIUM, VITAMIN D3, ZINC, CRAMP BARK and MELATONIN for an unknown indication, BIOTIN.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-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 RASH (full body rash), VACCINATION SITE REACTION (covid arm) and RASH PRURITIC (itchy at rash area). The patient was treated with PREDNISONE at a dose of two rounds of Prednisone. At the time of the report, RASH (full body rash), VACCINATION SITE REACTION (covid arm) and RASH PRURITIC (itchy at rash area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment medication includes Antihistamines was provided.   This case was linked to MOD-2021-242114 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Significant : patient Gender and event related information.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Feeling abnormal
Clinical narrative: I have been feeling really off; Anxious; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I have been feeling really off) and ANXIETY (Anxious) 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 28-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, the patient experienced FEELING ABNORMAL (I have been feeling really off) and ANXIETY (Anxious). At the time of the report, FEELING ABNORMAL (I have been feeling really off) and ANXIETY (Anxious) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided.  Treatment information was not provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Haematoma infection, Pruritus, Psoriasis, Rash
Clinical narrative: itchy at rash area; Full body rash; hematoma is underneath; She states that the vaccine activated her psoriasis; both of her forearms were just itching like crazy; She looked at her elbows and it looks like a blister is underneath; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOMA INFECTION (hematoma is underneath), PSORIASIS (She states that the vaccine activated her psoriasis), PRURITUS (both of her forearms were just itching like crazy), BLISTER (She looked at her elbows and it looks like a blister is underneath) and RASH PRURITIC (itchy at rash area) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune disorder and Psoriasis. Concomitant products included AMITRIPTYLINE for Sleep problem, LORATADINE, FUROSEMIDE, SPIRONOLACTONE, VITAMINS NOS, COLLAGEN, MAGNESIUM, BIOTIN, POTASSIUM, VITAMIN D3, ZINC, VIBURNUM OPULUS BARK (CRAMP BARK) and MELATONIN for an unknown indication.   On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jul-2021, the patient experienced HAEMATOMA INFECTION (hematoma is underneath), PSORIASIS (She states that the vaccine activated her psoriasis), PRURITUS (both of her forearms were just itching like crazy) and BLISTER (She looked at her elbows and it looks like a blister is underneath). On an unknown date, the patient experienced RASH PRURITIC (itchy at rash area) and RASH (Full body rash). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, HAEMATOMA INFECTION (hematoma is underneath), PSORIASIS (She states that the vaccine activated her psoriasis), PRURITUS (both of her forearms were just itching like crazy), BLISTER (She looked at her elbows and it looks like a blister is underneath), RASH PRURITIC (itchy at rash area) and RASH (Full body rash) outcome was unknown.            Patient weight provided as 175, with no unit.  Patient was treated with two doses of prednisone, Antihistamine and Listerine.  Patient was given antihistamines, but symptoms just keeps getting worse and the rash was spreading all over. Patient had autoimmune disorder and psoriasis at baseline and did not take any medications for these conditions.   This case was linked to MOD-2021-242099 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow-up received that included added events, concomitant medications, patent weight, treatment information