chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: first vaccine was two months ago. Can I still get the second; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first vaccine was two months ago. Can I still get the second) 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 DOSE OMISSION ISSUE (first vaccine was two months ago. Can I still get the second). At the time of the report, PRODUCT DOSE OMISSION ISSUE (first vaccine was two months ago. Can I still get the second) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       there are no treatment and concomitant medications given no previous history given..
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Ill-defined disorder, Tremor
Clinical narrative: Felt like she was coming down with something; Left arm started shaking/significant tremor; This spontaneous case was reported by an other health care professional and describes the occurrence of TREMOR (Left arm started shaking/significant tremor) and ILL-DEFINED DISORDER (Felt like she was coming down with something) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TREMOR (Left arm started shaking/significant tremor). On an unknown date, the patient experienced ILL-DEFINED DISORDER (Felt like she was coming down with something). At the time of the report, TREMOR (Left arm started shaking/significant tremor) outcome was unknown and ILL-DEFINED DISORDER (Felt like she was coming down with something) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided.   Treatment information was not provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure abnormal, Feeling abnormal, Headache, Vaccination complication
Clinical narrative: She had an unusual reaction to the first one; Weakness on one side; her blood pressure went up (she needed an epi because her blood pressure skyrocketed); Did not feel normal; Pain inside of her head/really bad headache; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (She had an unusual reaction to the first one), ASTHENIA (Weakness on one side), BLOOD PRESSURE ABNORMAL (her blood pressure went up (she needed an EpiPen because her blood pressure skyrocketed)), FEELING ABNORMAL (Did not feel normal) and HEADACHE (Pain inside of her head/really bad headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (She had an unusual reaction to the first one), ASTHENIA (Weakness on one side), BLOOD PRESSURE ABNORMAL (her blood pressure went up (she needed an EpiPen because her blood pressure skyrocketed)), FEELING ABNORMAL (Did not feel normal) and HEADACHE (Pain inside of her head/really bad headache). The patient was treated with EPINEPHRINE for Blood pressure, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (She had an unusual reaction to the first one), ASTHENIA (Weakness on one side), BLOOD PRESSURE ABNORMAL (her blood pressure went up (she needed an EpiPen because her blood pressure skyrocketed)), FEELING ABNORMAL (Did not feel normal) and HEADACHE (Pain inside of her head/really bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug reported. Nurse reported- Patient came for her second dose of the Moderna COVID-19 vaccine. They are unsure as to give the second dose or not. Treatment- EpiPen because her blood pressure skyrocketed.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Illness, Pyrexia
Clinical narrative: She was sick.; Cough comes back similar to when she had covid; Her fever was at 101.8; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (She was sick), COUGH (Cough comes back similar to when she had covid) and PYREXIA (Her fever was at 101.8 F) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 032M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (On DEC-2020 Tested positive for COVID-19) from December 2020 to January 2021. Concurrent medical conditions included Allergy to antibiotic (Allergic to antibiotic), Hypertension and Pre-diabetic. Concomitant products included VALSARTAN (DIOVAN), METFORMIN and VITAMINS NOS for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (She was sick.), COUGH (Cough comes back similar to when she had covid) and PYREXIA (Her fever was at 101.8). At the time of the report, ILLNESS (She was sick.), COUGH (Cough comes back similar to when she had covid) and PYREXIA (Her fever was at 101.8) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 101.8 (High) High Fever.         Treatment details was not reported by the reporter.   This case was linked to MOD-2021-322485 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated
Clinical narrative: Hip problems,hip problem became critical,he was almost crippled; Unbearable pain; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Hip problems,hip problem became critical,he was almost crippled) and ARTHRALGIA (Unbearable pain) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Pain in hip.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced CONDITION AGGRAVATED (Hip problems,hip problem became critical,he was almost crippled) and ARTHRALGIA (Unbearable pain). At the time of the report, CONDITION AGGRAVATED (Hip problems,hip problem became critical,he was almost crippled) and ARTHRALGIA (Unbearable pain) was resolving.            No concomitant medication was provided. No treatment information was provided.   This case was linked to MOD-2021-322919 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, Vaccination complication
Clinical narrative: pretty bad reaction to 1st shot; It has now been 5-6 months since he received the 1st dose/ 2nd dose has not been administered >36 days from first vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (pretty bad reaction to 1st shot) and PRODUCT DOSE OMISSION ISSUE (It has now been 5-6 months since he received the 1st dose/ 2nd dose has not been administered >36 days from first vaccination) 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 March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced VACCINATION COMPLICATION (pretty bad reaction to 1st shot) and PRODUCT DOSE OMISSION ISSUE (It has now been 5-6 months since he received the 1st dose/ 2nd dose has not been administered >36 days from first vaccination). In March 2021, PRODUCT DOSE OMISSION ISSUE (It has now been 5-6 months since he received the 1st dose/ 2nd dose has not been administered >36 days from first vaccination) had resolved. At the time of the report, VACCINATION COMPLICATION (pretty bad reaction to 1st shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that he had to consult different physicians to solve the issues with adverse event of vaccine first dose.  Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.     Reporter did not allow further contact
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Illness, Pyrexia, Somnolence
Clinical narrative: Cough came back and has not gone away/cough to be dry a hacking cough; Got sick after second dose; Could hardly hold her eyes open, slept a lot.; Fever; Fatigue was worse than anything; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough came back and has not gone away/cough to be a dry hacking cough), ILLNESS (Got sick after second dose), SOMNOLENCE (Could hardly hold her eyes open, slept a lot.), PYREXIA (Fever) and FATIGUE (Fatigue was worse than anything) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (High), Diabetic (patient had pre diabetic,) and Allergy to antibiotic. Concomitant products included VALSARTAN (DIOVAN) for Blood pressure high, METFORMIN for Diabetic.    On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced COUGH (Cough came back and has not gone away/cough to be dry a hacking cough), ILLNESS (Got sick after second dose), SOMNOLENCE (Could hardly hold her eyes open, slept a lot.), PYREXIA (Fever) and FATIGUE (Fatigue was worse than anything). At the time of the report, COUGH (Cough came back and has not gone away/cough to be dry a hacking cough), ILLNESS (Got sick after second dose), SOMNOLENCE (Could hardly hold her eyes open, slept a lot.), PYREXIA (Fever) and FATIGUE (Fatigue was worse than anything) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: positive (Positive) Tested positive for COVID in December2020 to JAN2021. In January 2021, SARS-CoV-2 test: positive (Positive) Tested positive for COVID in December2020 to JAN2021. In April 2021, Body temperature: 102.8 (High) fever 102.8.         Concomitant medications include vitamins. Treatment to the events not reported. Patient felt COVID symptoms after both doses, was nervous  last week the cough did Wake her up in the middle of the night. Patient made an appointment with a pulmonologist and was allergies to antibiotics so almost did not get vaccinated but checked ingredients and was told it was okay.   This case was linked to MOD-2021-322465 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine, Vaccination complication
Clinical narrative: Side effects; Minor allergic reaction; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Sep-2021 and was forwarded to Moderna on 17-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects) and ALLERGY TO VACCINE (Minor allergic reaction) 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 VACCINATION COMPLICATION (Side effects) and ALLERGY TO VACCINE (Minor allergic reaction). At the time of the report, VACCINATION COMPLICATION (Side effects) and ALLERGY TO VACCINE (Minor allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant products were reported. No Treatment medication were reported.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: took my 2nd dose 2 months apart; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (took my 2nd dose 2 months apart) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (took my 2nd dose 2 months apart). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (took my 2nd dose 2 months apart) had resolved.            No concomitant medications were reported .  No Treatment was reported by reporter.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: Achy; Slight fever that got to 100.1-100.4 lasting for 36-48hrs; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy) and PYREXIA (Slight fever that got to 100.1-100.4 lasting for 36-48hrs) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21 and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced PAIN (Achy) and PYREXIA (Slight fever that got to 100.1-100.4 lasting for 36-48hrs). At the time of the report, PAIN (Achy) outcome was unknown and PYREXIA (Slight fever that got to 100.1-100.4 lasting for 36-48hrs) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Body temperature: 100.1 (High) Lasting 36-48 hours. and 100.4 (High) Lasting 36-48 hours.         Concomitant product use was not provided.   Treatment information was not provided.     This case was linked to MOD-2021-322480 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: breakthrough COVID-19 infections; 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 COVID-19 (breakthrough COVID-19 infections) 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 COVID-19 (breakthrough COVID-19 infections). At the time of the report, COVID-19 (breakthrough COVID-19 infections) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Everyone who works at the hospital is getting breakthrough COVID-19 infections even after the have completed the Moderna COVID-19 vaccination series. No concomitant and treatment information were reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Got an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Got an expired dose) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Got an expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Got an expired dose) 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.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Peripheral swelling, Vaccination site warmth
Clinical narrative: Hot feeling on vaccinated spot; arm swollen; Arm numb; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot feeling on vaccinated spot), PERIPHERAL SWELLING (arm swollen) and HYPOAESTHESIA (Arm numb) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In September 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Sep-2021, the patient experienced VACCINATION SITE WARMTH (Hot feeling on vaccinated spot), PERIPHERAL SWELLING (arm swollen) and HYPOAESTHESIA (Arm numb). At the time of the report, VACCINATION SITE WARMTH (Hot feeling on vaccinated spot), PERIPHERAL SWELLING (arm swollen) and HYPOAESTHESIA (Arm numb) outcome was unknown.            Concomitant medications were not provided by reporter.  Treatment information was not provided by reporter.  Patient's First, second and third dose details were not reported.   Reporter did not allow further contact
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Rash erythematous, Throat tightness, Vaccination site pruritus
Clinical narrative: red rash with dots; feels like throat was closing; arm soreness; muscle aches and pain; injection site strated to itch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (injection site strated to itch), RASH ERYTHEMATOUS (red rash with dots), MYALGIA (arm soreness), MYALGIA (muscle aches and pain) and THROAT TIGHTNESS (feels like throat was closing) in a 5-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. B(unsure if8 or B)53E21A) for COVID-19 vaccination.     Concurrent medical conditions included Dust allergy (mildew, mold are also allergic), Multiple sclerosis, Dysplasia and GERD. Concomitant products included COLECALCIFEROL (VITAMIN D3), Vitamin B12 and POLYCARBOPHIL CALCIUM (FIBER) for an unknown indication.    On 11-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Sep-2021, the patient experienced MYALGIA (arm soreness) and MYALGIA (muscle aches and pain). In September 2021, the patient experienced VACCINATION SITE PRURITUS (injection site strated to itch). On 16-Sep-2021, the patient experienced THROAT TIGHTNESS (feels like throat was closing). On 18-Sep-2021, the patient experienced RASH ERYTHEMATOUS (red rash with dots). On 12-Sep-2021, MYALGIA (arm soreness) and MYALGIA (muscle aches and pain) had resolved. On 18-Sep-2021, RASH ERYTHEMATOUS (red rash with dots) had resolved. At the time of the report, VACCINATION SITE PRURITUS (injection site strated to itch) and THROAT TIGHTNESS (feels like throat was closing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was unknown The  patient ate mushroom and immediately  started to itch. So with that incident, the doctor told  that  he could develop allergies later on as  his  body changes. With my autoimmune disorder, he thought  it will change his  body's response to certain foods."
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Chills, Cough, Dyspnoea
Clinical narrative: difficulty breathing; pleurisy; cough; chest pain; chills; nausea; It's like a pain in the joints, likely from the cough; fatigue; Had Fever; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (difficulty breathing), PLEURISY (pleurisy), COUGH (cough), CHEST PAIN (chest pain) and CHILLS (chills) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma (I had asthma but it's unrelated) my pulmonologist said it was unrelated.).    In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced DYSPNOEA (difficulty breathing), PLEURISY (pleurisy), COUGH (cough), CHEST PAIN (chest pain), CHILLS (chills), NAUSEA (nausea), ARTHRALGIA (It's like a pain in the joints, likely from the cough), FATIGUE (fatigue) and PYREXIA (Had Fever). At the time of the report, DYSPNOEA (difficulty breathing), PLEURISY (pleurisy), COUGH (cough), CHEST PAIN (chest pain), CHILLS (chills), NAUSEA (nausea), ARTHRALGIA (It's like a pain in the joints, likely from the cough), FATIGUE (fatigue) and PYREXIA (Had Fever) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient has reported Treatment steroids and NSAIDs for pain management. And Lab data ECG, cardiac test, cardiac enzymes that went normal. Concomitant information was not reported.   This case was linked to MOD-2021-322785 (Patient Link).
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pleurisy, Pyrexia
Clinical narrative: difficulty breathing; pleurisy; cough; chest pain; chills; nausea; It's like a pain in the joints, likely from the cough; fatigue; Had Fever; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (difficulty breathing), PLEURISY (pleurisy), COUGH (cough), CHEST PAIN (chest pain) and CHILLS (chills) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma (I had asthma but it's unrelated) my pulmonologist said it was unrelated.).    In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced DYSPNOEA (difficulty breathing), PLEURISY (pleurisy), COUGH (cough), CHEST PAIN (chest pain), CHILLS (chills), NAUSEA (nausea), ARTHRALGIA (It's like a pain in the joints, likely from the cough), FATIGUE (fatigue) and PYREXIA (Had Fever). At the time of the report, DYSPNOEA (difficulty breathing), PLEURISY (pleurisy), COUGH (cough), CHEST PAIN (chest pain), CHILLS (chills), NAUSEA (nausea), ARTHRALGIA (It's like a pain in the joints, likely from the cough), FATIGUE (fatigue) and PYREXIA (Had Fever) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient has reported Treatment steroids and NSAIDs for pain management. And Lab data ECG, cardiac test, cardiac enzymes that went normal. Concomitant information was not reported.   This case was linked to MOD-2021-322785 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I have been sick for a week. Got my first vaccine 3 weeks ago; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I have been sick for a week. Got my first vaccine 3 weeks ago) 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 ILLNESS (I have been sick for a week. Got my first vaccine 3 weeks ago). At the time of the report, ILLNESS (I have been sick for a week. Got my first vaccine 3 weeks ago) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information and concomitant medication reported.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose 2 weeks after first; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose 2 weeks after first) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21D) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose 2 weeks after first). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose 2 weeks after first) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was mentioned.  No treatment medication was mentioned.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination complication
Clinical narrative: Severe reactions/still experiencing problems; Greater than 35 days between doses; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (severe reactions/still experiencing problems) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 35 days between doses) 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 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 35 days between doses). On an unknown date, the patient experienced VACCINATION COMPLICATION (severe reactions/still experiencing problems). At the time of the report, VACCINATION COMPLICATION (severe reactions/still experiencing problems) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 35 days between doses) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-322780 (Patient Link).
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue, SARS-CoV-2 test
Clinical narrative: Patient hasnot received 2nd dose yet; Patient got COVID positive after first dose; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Patient got COVID positive after first dose) and PRODUCT DOSE OMISSION ISSUE (Patient hasnot received 2nd dose yet) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In July 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient hasnot received 2nd dose yet). In 2021, the patient experienced COVID-19 (Patient got COVID positive after first dose). In May 2021, PRODUCT DOSE OMISSION ISSUE (Patient hasnot received 2nd dose yet) had resolved. At the time of the report, COVID-19 (Patient got COVID positive after first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was provided.  No Treatment medication was provided.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling abnormal, Illness, Neck pain, Off label use
Clinical narrative: off label use; he feels bad today; feels sick all over his body; feels like his adrenal glands are swelling; pain in his neck, chin and shoulders; little breathing problem, heavy breathing; pain in his neck, chin; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (feels sick all over his body), SWELLING (feels like his adrenal glands are swelling), NECK PAIN (pain in his neck, chin and shoulders), DYSPNOEA (little breathing problem, heavy breathing) and PAIN IN JAW (pain in his neck, chin) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ALLOPURINOL, GABAPENTIN, TESTOSTERONE, VITAMIN C [ASCORBIC ACID] and CALCIUM for an unknown indication.    On 17-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Sep-2021, the patient experienced ILLNESS (feels sick all over his body), SWELLING (feels like his adrenal glands are swelling), NECK PAIN (pain in his neck, chin and shoulders) and DYSPNOEA (little breathing problem, heavy breathing). 17-Sep-2021, the patient experienced PAIN IN JAW (pain in his neck, chin) and FEELING ABNORMAL (he feels bad today). On an unknown date, the patient experienced OFF LABEL USE (off label use). At the time of the report, ILLNESS (feels sick all over his body), SWELLING (feels like his adrenal glands are swelling), NECK PAIN (pain in his neck, chin and shoulders), DYSPNOEA (little breathing problem, heavy breathing), PAIN IN JAW (pain in his neck, chin) and FEELING ABNORMAL (he feels bad today) outcome was unknown and OFF LABEL USE (off label use) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication also included Prostate medication and antacid No treatment medication was reported   This case was linked to MOD-2021-322939 (Patient Link).
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in jaw, Swelling
Clinical narrative: off label use; he feels bad today; feels sick all over his body; feels like his adrenal glands are swelling; pain in his neck, chin and shoulders; little breathing problem, heavy breathing; pain in his neck, chin; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (feels sick all over his body), SWELLING (feels like his adrenal glands are swelling), NECK PAIN (pain in his neck, chin and shoulders), DYSPNOEA (little breathing problem, heavy breathing) and PAIN IN JAW (pain in his neck, chin) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ALLOPURINOL, GABAPENTIN, TESTOSTERONE, VITAMIN C [ASCORBIC ACID] and CALCIUM for an unknown indication.    On 17-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Sep-2021, the patient experienced ILLNESS (feels sick all over his body), SWELLING (feels like his adrenal glands are swelling), NECK PAIN (pain in his neck, chin and shoulders) and DYSPNOEA (little breathing problem, heavy breathing). 17-Sep-2021, the patient experienced PAIN IN JAW (pain in his neck, chin) and FEELING ABNORMAL (he feels bad today). On an unknown date, the patient experienced OFF LABEL USE (off label use). At the time of the report, ILLNESS (feels sick all over his body), SWELLING (feels like his adrenal glands are swelling), NECK PAIN (pain in his neck, chin and shoulders), DYSPNOEA (little breathing problem, heavy breathing), PAIN IN JAW (pain in his neck, chin) and FEELING ABNORMAL (he feels bad today) outcome was unknown and OFF LABEL USE (off label use) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication also included Prostate medication and antacid No treatment medication was reported   This case was linked to MOD-2021-322939 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication listed.   No treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: have a high fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (have a high fever) 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 PYREXIA (have a high fever). At the time of the report, PYREXIA (have a high fever) outcome was unknown.        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: Inappropriate schedule of product administration, Vaccination complication
Clinical narrative: >35 days between doses; severe reactions; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (severe reactions) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>35 days between doses) 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 22-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (severe reactions). On 22-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>35 days between doses). On 22-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>35 days between doses) had resolved. At the time of the report, VACCINATION COMPLICATION (severe reactions) outcome was unknown.            No concomitant medications were not reported. No treatment medications were not provided.   This case was linked to MOD-2021-322725.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: bumps on face that left red scares/Bumps were white and content looked like floss when it came out. Bumps stared on upper lip under nose and moved to forehead, cheek and other parts of the face. Would start as one bump then move into cluster.; This spontaneous case was reported by a consumer and describes the occurrence of RASH (bumps on face that left red scares/Bumps were white and content looked like floss when it came out. Bumps stared on upper lip under nose and moved to forehead, cheek and other parts of the face. Would start as one bump then move into cluster.) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (bumps on face that left red scares/Bumps were white and content looked like floss when it came out. Bumps stared on upper lip under nose and moved to forehead, cheek and other parts of the face. Would start as one bump then move into cluster.). At the time of the report, RASH (bumps on face that left red scares/Bumps were white and content looked like floss when it came out. Bumps stared on upper lip under nose and moved to forehead, cheek and other parts of the face. Would start as one bump then move into cluster.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medications were not reported. treatment medications were not reported.   This case was linked to MOD-2021-322568.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Nausea, Vomiting
Clinical narrative: stomach hurts; moderate nausea; moderate vomiting./ threw up everything he tried to eat; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ABDOMINAL PAIN UPPER (stomach hurts), NAUSEA (moderate nausea) and VOMITING (moderate vomiting./ threw up everything he tried to eat) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination.     The patient's past medical history included Bleeding.    On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Sep-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach hurts), NAUSEA (moderate nausea) and VOMITING (moderate vomiting./ threw up everything he tried to eat). At the time of the report, ABDOMINAL PAIN UPPER (stomach hurts), NAUSEA (moderate nausea) and VOMITING (moderate vomiting./ threw up everything he tried to eat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatments were reported.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Pruritus
Clinical narrative: Itching was in the arms, head, legs, everywhere; Allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching was in the arms, head, legs, everywhere) and HYPERSENSITIVITY (Allergic reaction) 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 02-Mar-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. On an unknown date, the patient experienced PRURITUS (Itching was in the arms, head, legs, everywhere) and HYPERSENSITIVITY (Allergic reaction). The patient was treated with HYDROCORTISONE, OXYTETRACYCLINE (HYDROCYCLIN) for Adverse event, at a dose of 25 mg four times per day. At the time of the report, PRURITUS (Itching was in the arms, head, legs, everywhere) and HYPERSENSITIVITY (Allergic reaction) had resolved.            No relevant concomitant medications were reported.  Patient is immunocompromised and wants to get third dose   This case was linked to MOD-2021-322221 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: Now months later I'm smelling it again; After my Moderna vaccine I smelled horrible smells; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (Now months later I'm smelling it again) and PAROSMIA (After my Moderna vaccine I smelled horrible smells) 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 PAROSMIA (Now months later I'm smelling it again) and PAROSMIA (After my Moderna vaccine I smelled horrible smells). At the time of the report, PAROSMIA (Now months later I'm smelling it again) had not resolved and PAROSMIA (After my Moderna vaccine I smelled horrible smells) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: vaccine given to underage patient; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine given to underage patient) in a 12-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine given to underage patient). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine given to underage patient) 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 treatment and concomitant medications were provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Myalgia, Nausea, Tremor
Clinical narrative: Nausea; Shakes; Muscle cramps; Aches; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), TREMOR (Shakes), MUSCLE SPASMS (Muscle cramps) and MYALGIA (Aches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939906, 010M20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 16-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021, the patient experienced NAUSEA (Nausea), TREMOR (Shakes), MUSCLE SPASMS (Muscle cramps) and MYALGIA (Aches). At the time of the report, NAUSEA (Nausea), TREMOR (Shakes), MUSCLE SPASMS (Muscle cramps) and MYALGIA (Aches) outcome was unknown.            No Concomitant medications were reported. No Treatment medications were reported.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: pain in my arm; painful to move it/painful to raise it; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in my arm) and PAIN (painful to move it/painful to raise it) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included PANTOPRAZOLE for an unknown indication.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in my arm) and PAIN (painful to move it/painful to raise it). The patient was treated with TRAMADOL at an unspecified dose and frequency; GABAPENTIN at a dose of 100 mg three times a day; FLUOXETINE at a dose of in the morning and AMITRIPTYLINE at a dose of In the night. At the time of the report, PAIN IN EXTREMITY (pain in my arm) and PAIN (painful to move it/painful to raise it) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-323028 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Lip swelling, Pain, Pyrexia
Clinical narrative: lip is swollen; Discomfort; Body aches; High temperature; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (lip is swollen), MYALGIA (Body aches), PYREXIA (High temperature) and DISCOMFORT (Discomfort) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIP SWELLING (lip is swollen), MYALGIA (Body aches), PYREXIA (High temperature) and DISCOMFORT (Discomfort). At the time of the report, LIP SWELLING (lip is swollen), MYALGIA (Body aches), PYREXIA (High temperature) and DISCOMFORT (Discomfort) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information were provided. Patient stated that she missed work one of those days. No treatment information were provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: bad reactions after third 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 VACCINATION COMPLICATION (bad reactions after third dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (bad reactions after third dose). At the time of the report, VACCINATION COMPLICATION (bad reactions after third dose) outcome was unknown.            No relevant concomitant medication was reported. Treatment information were not provided.  Reporter stated that co-workers have had bad reactions after receiving Moderna's COVID-19 third dose.