chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via a social media via a company representative concerned a male of unspecified age, race and ethnicity. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient died from an unknown cause of death two days after receiving the vaccine. It was unspecified if an autopsy was performed. The reporter stated that, "My best friend got your vaccine. He was dead two days later." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20220136974-COVID-19 VACCINE AD26.COV2.S-Death. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Fatigue, Throat irritation
Clinical narrative: COUGH; SHORTNESS OF BREATH; SCRATCHY THROAT; TIREDNESS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-JAN-2022, the patient experienced cough, shortness of breath, scratchy throat, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cough, shortness of breath, scratchy throat, and tiredness. This report was non-serious.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; SEVERE DAILY HEADACHES; This spontaneous report received from a patient concerned a 41-year-old white, female. The patient's height, and weight were not reported. The patient had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) 1 total, dose was not reported, administered on 20-MAR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported.  The patient reported that 3-5 days (on MAR-2021) after receiving the vaccine, she developed severe daily headaches for 1 month. The patient stated that massages on her head provided some relief at the time and that she rarely ever had headaches prior to receiving the vaccine. The patient noted that on 18-APR-2021 she saw doctor regarding the headaches and took 2 weeks off work. No testing was done and no medications were prescribed. When the patient returned to work, she noted that the headaches became less often, diminished and light, occurring once every 3 months. On 06-JAN-2022, tested positive for Covid-19- via PCR (polymerase chain reaction) testing (confirmed covid-19 infection and confirmed clinical vaccination failure). On an unspecified date the patient developed a cough, little bit of a headache, fever for 4 days, body aches and runny nose. The patient was still coughing at the time of reporting. Laboratory data included: SARS-CoV-2 PCR test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe daily headaches, and confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000213264.; Sender's Comments: V0:20220139528-COVID-19 VACCINE AD26.COV2.S-Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity, Pyrexia, Vaccination site erythema
Clinical narrative: small red area at the injection site.; temperature of 99°F; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PYREXIA (temperature of 99°F) and VACCINATION SITE ERYTHEMA (small red area at the injection site.) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H217, 003A21A and 04262A) for COVID-19 vaccination.     The patient's past medical history included Hypothyroidism in 1984, Hypertension in 1989, Colitis microscopic in 2014 and Osteoarthritis in 1995. Concurrent medical conditions included Drug allergy (Dulcolax - hives), Drug allergy (betadine - inflamation), Latex allergy (Rash after contact), Hives, Hay fever and Osteoporosis (Was on Fosomax, now on Prolia) since 1998. Concomitant products included DENOSUMAB (PROLIA) from 11-Jul-2021 to an unknown date for Osteoporosis, LISINOPRIL, AMLODIPINE, LEVOTHYROXINE, ALENDRONATE SODIUM (ALENDRONATE), BUSPIRONE and BACLOFEN for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (sore arm). On 14-Dec-2021, the patient experienced PYREXIA (temperature of 99°F). On 15-Dec-2021, the patient experienced VACCINATION SITE ERYTHEMA (small red area at the injection site.). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) from 07-Mar-2021 to 10-Mar-2021 for Adverse event, at a dose of 500 milligram,1-4 Daily. At the time of the report, PAIN IN EXTREMITY (sore arm), PYREXIA (temperature of 99°F) and VACCINATION SITE ERYTHEMA (small red area at the injection site.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Dec-2021, Body temperature: 100.6 (High) 100.6 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other treatment medication included Steroid cream and Benadryl was administered as anti histamine with 1 dose for 4 to 6 hrs from 07-Mar-2021 to 10- Mar-2021 was reported.   This case was linked to MOD-2021-404621 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jan-2022: Follow up received contains significant information, reporter information added, patient height, weight, medical history and concomitant medication were reported were updated.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Tested positive; Sick as a dog; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive) and COVID-19 (Sick as a dog) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068#23A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 12-Jan-2022, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive) and COVID-19 (Sick as a dog). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive) and COVID-19 (Sick as a dog) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2022, SARS-CoV-2 test: negative (Negative) Negative. On 12-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive.   No Concomitant product use was reported.  The patient received the Moderna booster and 3 days later tested positive for Covid. It was reported that the patient prior to getting the booster had a negative result, on the 07-Jan-2022.   The patient was sick as a dog 3 days after the shot and tested positive.  The patient received the booster on Sunday 09-Jan-2022, they wrote 11-Jan-2022 but patient got it on 09-Jan-2022.  No treatment information was provided.  Company Comment: This spontaneous case concerns a 67 year old female with no reported medical history , who experienced, non-serious  , unexpected , AESI events  of Covid 19 and  SARS COV-2 test positive which occurred 3 days post vaccination with the 3rd dose of mRNA-1273 vaccine .The re-challenge for this case is not applicable since the events occurred after the 3rd dose and no additional doses will be given and also the outcome of the events was reported as unknown. The age of this patient is considered as a confounder for this case ( elderly population are vulnerable to Covid 19  infection due to altered immune response). The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jan-2022: Follow up received includes no new significant information.; Sender's Comments: This spontaneous case concerns a 67 year old female with no reported medical history , who experienced, non-serious  , unexpected , AESI events  of Covid 19 and  SARS COV-2 test positive which occurred 3 days post vaccination with the 3rd dose of mRNA-1273 vaccine .The re-challenge for this case is not applicable since the events occurred after the 3rd dose and no additional doses will be given and also the outcome of the events was reported as unknown. The age of this patient is considered as a confounder for this case ( elderly population are vulnerable to Covid 19  infection due to altered immune response). The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Pulmonary congestion
Clinical narrative: Have congestion in lung now; This spontaneous case was reported by an other health care professional and describes the occurrence of PULMONARY CONGESTION (Have congestion in lung now) 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 PULMONARY CONGESTION (Have congestion in lung now) (seriousness criterion medically significant). At the time of the report, PULMONARY CONGESTION (Have congestion in lung now) 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 details were reported. No treatment information was provided. Scheduled for booster shot this Afternoon. Patient don't have temperature.  Company Comment: This case refers to a patient of unspecified age and gender with no known medical history who experienced the unexpected event of Pulmonary congestion on an unspecified date after a dose of mRNA-1273 vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case refers to a patient of unspecified age and gender with no known medical history who experienced the unexpected event of Pulmonary congestion on an unspecified date after a dose of mRNA-1273 vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: got covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got covid) 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 COVID-19 (got covid). At the time of the report, COVID-19 (got covid) 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.  Patient's husband was not vaccinated and got COVID. The reporter stated that the shots were not really helping people but made the illness less severe. Company comment:This is case concerning a female patient with unknown age with no medical history, experienced the unexpected ADR event of COVID-19 which occurred on unknown date after unknown dose ofmRNA-1273 vaccine and the outcome was reported unknown. Patient was not tested for SARS-CoV-2 before or at the time of vaccination, so she may have infected before the vaccination. The outcome was reported as unknown .The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jan-2022: Follow up received include No New Information.; Sender's Comments: This is case concerning a female patient with unknown age with no medical history, experienced the unexpected ADR event of COVID-19 which occurred on unknown date after unknown dose ofmRNA-1273 vaccine and the outcome was reported unknown. Patient was not tested for SARS-CoV-2 before or at the time of vaccination, so she may have infected before the vaccination. The outcome was reported as unknown .The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report
Sex: U
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for covid-19 after completing primary series with moderna cov-19 vaccine/Asymptomatic; This spontaneous case was reported by a pharmacist and describes the occurrence of ASYMPTOMATIC COVID-19 (tested positive for covid-19 after completing primary series with moderna cov-19 vaccine/Asymptomatic) 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, 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 ASYMPTOMATIC COVID-19 (tested positive for covid-19 after completing primary series with moderna cov-19 vaccine/Asymptomatic). At the time of the report, ASYMPTOMATIC COVID-19 (tested positive for covid-19 after completing primary series with moderna cov-19 vaccine/Asymptomatic) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Company Comment: This case concerns a patient of an unknown age and gender, with no medical history reported, who experienced the unexpected AESI event of Asymptomatic COVID-19. The event occurred on an unknown date after receiving the second dose of mRNA-1273 Vaccine. At the time of the report the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a patient of an unknown age and gender, with no medical history reported, who experienced the unexpected AESI event of Asymptomatic COVID-19. The event occurred on an unknown date after receiving the second dose of mRNA-1273 Vaccine. At the time of the report the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Epstein-Barr virus antibody, Epstein-Barr virus infection
Clinical narrative: Epstein-Barr levels were high; This spontaneous case was reported by a consumer and describes the occurrence of EPSTEIN-BARR VIRUS INFECTION (Epstein-Barr levels were high) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Epstein-Barr virus infection. Concomitant products included ACYCLOVIR [ACICLOVIR] for an unknown indication.   In August 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced EPSTEIN-BARR VIRUS INFECTION (Epstein-Barr levels were high). At the time of the report, EPSTEIN-BARR VIRUS INFECTION (Epstein-Barr levels were high) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Epstein-Barr virus antibody: high (High) count went high.         No Treatment information was provided.  The patient mentioned that prior and after primary series, Epstein-Barr virus lab work level was stable  for which was able to get the vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: we had a nurse combine two doses of 0.25ml that was already in a syringe.into one syringe for a 0.5 ml dose/combining booster dose syringe to administer to patient for regular dose; This spontaneous case was reported by a nurse and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (we had a nurse combine two doses of 0.25ml that was already in a syringe.into one syringe for a 0.5 ml dose/combining booster dose syringe to administer to patient for regular 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (we had a nurse combine two doses of 0.25ml that was already in a syringe.into one syringe for a 0.5 ml dose/combining booster dose syringe to administer to patient for regular dose). At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (we had a nurse combine two doses of 0.25ml that was already in a syringe.into one syringe for a 0.5 ml dose/combining booster dose syringe to administer to patient for regular dose) had resolved.        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.   Nurse states that she is old-fashion and prefers to go by the guideline that has been set. Generally they draw up Moderna COVID-19 vaccine at the clinic in the morning for primary dose in a syringe as well as booster dose in a syringe. However, they have other Nurses working at the clinic that are combining booster dose syringe to administer to patient for regular dose. Nurse would like to know if there is a specific documentation that states not to do that in a such event like this.  No concomitant were reported.  No treatment were reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jan-2022: Follow-up received and included reporter information updated.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received 2 full doses of Moderna after receiving Janssen/2nd dose of Moderna administered past 36 days; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2 full doses of Moderna after receiving Janssen/2nd dose of Moderna administered past 36 days) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Jansen on 22-Mar-2021. Past adverse reactions to the above products included No adverse event with Jansen.   On 25-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2 full doses of Moderna after receiving Janssen/2nd dose of Moderna administered past 36 days). On 25-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2 full doses of Moderna after receiving Janssen/2nd dose of Moderna administered past 36 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was reported.   This case was linked to MOD-2022-456253 (Patient Link).
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Sluggishness
Clinical narrative: they felt a little sluggish; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (they felt a little sluggish) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 045B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-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 SLUGGISHNESS (they felt a little sluggish). At the time of the report, SLUGGISHNESS (they felt a little sluggish) outcome was unknown.            Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2022-456314, MOD-2022-456291 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Cough
Clinical narrative: Coughing and stuff; Coming down with bronchitis; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing and stuff) and BRONCHITIS (Coming down with bronchitis) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included Bronchitis (Coughing and hacking with past infections and the bronchitis usually lasted for two weeks.).   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 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 received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2022, the patient experienced COUGH (Coughing and stuff) and BRONCHITIS (Coming down with bronchitis). At the time of the report, COUGH (Coughing and stuff) and BRONCHITIS (Coming down with bronchitis) had not resolved.            No concomitant medications were reported. No treatment medications were reported.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administered 1st dose of Moderna Covid -19 vaccine to a 15 year old patient; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered 1st dose of Moderna Covid -19 vaccine to a 15 year old patient) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered 1st dose of Moderna Covid -19 vaccine to a 15 year old patient). On 05-Jan-2022, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered 1st dose of Moderna Covid -19 vaccine to a 15 year old patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.  Patient does not have any allergies and not taking any medications or vitamins.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: 1st dose, a little pain in left arm (injection arm); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (1st dose, a little pain in left arm (injection arm)) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Blood pressure high (High blood pressure) and Candida infection. Concomitant products included LISINOPRIL for Blood pressure high, METFORMIN for Diabetes.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE PAIN (1st dose, a little pain in left arm (injection arm)). On 10-Mar-2021, VACCINATION SITE PAIN (1st dose, a little pain in left arm (injection arm)) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment was not given to the patient. Patient started taking a naturopathic pills for candida around the same time as the booster, but she stop medication.   This case was linked to MOD-2022-456404, MOD-2022-456407 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: little pain in left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (little pain in left arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Blood pressure high and Candida infection. Concomitant products included LISINOPRIL for Blood pressure high, METFORMIN for Diabetes.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (little pain in left arm). On 08-Apr-2021, VACCINATION SITE PAIN (little pain in left arm) had resolved.            Treatment information was unknown.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Urticaria; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Urticaria) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), FAMOTIDINE (PEPCID [FAMOTIDINE]), DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Urticaria). At the time of the report, URTICARIA (Urticaria) had resolved. Not Provided      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 Treatment medications were reported.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: started to experience hives/hives started out of the blue/break out in hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (started to experience hives/hives started out of the blue/break out in hives) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H21A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 13-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2022, the patient experienced URTICARIA (started to experience hives/hives started out of the blue/break out in hives). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (started to experience hives/hives started out of the blue/break out in hives) outcome was unknown.            No medical history was reported by the reporter. Patient had no allergies and did not eat anything different.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive/positive test; This spontaneous case was reported by an other health care professional and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive/positive test) 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 SARS-COV-2 TEST POSITIVE (tested positive/positive test). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive/positive test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) The patient tested 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.   Concomitant medication was not reported. Treatment medication was not reported
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Malaise, Vaccination complication
Clinical narrative: Felt sick; Hefty reaction; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt sick) and VACCINATION COMPLICATION (Hefty reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for Prophylactic 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 and first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Felt sick) and VACCINATION COMPLICATION (Hefty reaction). At the time of the report, MALAISE (Felt sick) and VACCINATION COMPLICATION (Hefty reaction) had resolved.            No Concomitant Medications were provided by the reporter  No Treatment Information were provided by the reporter   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Extreme body aches all over but concentrated on side of injection all the way down to ankle; This spontaneous case was reported by an other health care professional and describes the occurrence of MYALGIA (Extreme body aches all over but concentrated on side of injection all the way down to ankle) 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 19-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced MYALGIA (Extreme body aches all over but concentrated on side of injection all the way down to ankle). At the time of the report, MYALGIA (Extreme body aches all over but concentrated on side of injection all the way down to ankle) 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.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Dysgeusia, Feeling abnormal
Clinical narrative: injection site tender; injection site swollen; joint achiness; dull headache; a little bit of chills; a little bit of nausea; feels so crappy; funny metallic taste in her mouth; little dizzy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feels so crappy), DYSGEUSIA (funny metallic taste in her mouth), DIZZINESS (little dizzy), VACCINATION SITE PAIN (injection site tender) and VACCINATION SITE SWELLING (injection site swollen) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022J21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2022, the patient experienced DIZZINESS (little dizzy). On 20-Jan-2022, the patient experienced FEELING ABNORMAL (feels so crappy), DYSGEUSIA (funny metallic taste in her mouth), VACCINATION SITE PAIN (injection site tender), VACCINATION SITE SWELLING (injection site swollen), ARTHRALGIA (joint achiness), HEADACHE (dull headache), CHILLS (a little bit of chills) and NAUSEA (a little bit of nausea). At the time of the report, FEELING ABNORMAL (feels so crappy), DYSGEUSIA (funny metallic taste in her mouth), DIZZINESS (little dizzy), VACCINATION SITE PAIN (injection site tender), VACCINATION SITE SWELLING (injection site swollen), ARTHRALGIA (joint achiness), HEADACHE (dull headache), CHILLS (a little bit of chills) and NAUSEA (a little bit of nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug details were reported. No treatment details were reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vaccination site pain, Vaccination site swelling
Clinical narrative: injection site tender; injection site swollen; joint achiness; dull headache; a little bit of chills; a little bit of nausea; feels so crappy; funny metallic taste in her mouth; little dizzy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feels so crappy), DYSGEUSIA (funny metallic taste in her mouth), DIZZINESS (little dizzy), VACCINATION SITE PAIN (injection site tender) and VACCINATION SITE SWELLING (injection site swollen) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022J21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2022, the patient experienced DIZZINESS (little dizzy). On 20-Jan-2022, the patient experienced FEELING ABNORMAL (feels so crappy), DYSGEUSIA (funny metallic taste in her mouth), VACCINATION SITE PAIN (injection site tender), VACCINATION SITE SWELLING (injection site swollen), ARTHRALGIA (joint achiness), HEADACHE (dull headache), CHILLS (a little bit of chills) and NAUSEA (a little bit of nausea). At the time of the report, FEELING ABNORMAL (feels so crappy), DYSGEUSIA (funny metallic taste in her mouth), DIZZINESS (little dizzy), VACCINATION SITE PAIN (injection site tender), VACCINATION SITE SWELLING (injection site swollen), ARTHRALGIA (joint achiness), HEADACHE (dull headache), CHILLS (a little bit of chills) and NAUSEA (a little bit of nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug details were reported. No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: itchy rash on her legs and stomach; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash on her legs and stomach) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (itchy rash on her legs and stomach). At the time of the report, RASH PRURITIC (itchy rash on her legs and stomach) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported she had events two days after the getting the Booster Moderna. No concomitant products were reported. No treatment information was reported by the reporter.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: The patient experienced severe Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (The patient experienced severe Headache) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Prophylactic vaccination: Janssen COVID-19 Vaccine (Suspension for injection, Dose-1  andRoute of administration -intramuscular) in April 2021. Past adverse reactions to the above products included No adverse event with Janssen COVID-19 Vaccine. Concurrent medical conditions included Non-smoker and Abstains from alcohol.    On 06-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Dec-2021, the patient experienced HEADACHE (The patient experienced severe Headache). At the time of the report, HEADACHE (The patient experienced severe Headache) had not resolved.            No concomitant medications were reported.  No treatment medications were reported.  It was reported that patient had a close contact with a person who had flu like symptoms and he tested positive for COVID-19.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Adverse event, Inappropriate schedule of product administration, Unevaluable event
Clinical narrative: Few tough symptoms; 1st dose Janssen, Booster dose Moderna; Mild symptoms; This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (Mild symptoms), ADVERSE EVENT (Few tough symptoms) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose Janssen, Booster dose Moderna) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for Prophylactic vaccination.    No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On 03-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose Janssen, Booster dose Moderna). In December 2021, the patient experienced UNEVALUABLE EVENT (Mild symptoms). On an unknown date, the patient experienced ADVERSE EVENT (Few tough symptoms). On 03-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose Janssen, Booster dose Moderna) had resolved. At the time of the report, UNEVALUABLE EVENT (Mild symptoms) outcome was unknown and ADVERSE EVENT (Few tough symptoms) had resolved.            No concomitant medications were reported. No treatment details were reported.  On an unspecified date following vaccination with Janssen COVID-19 vaccine (Dose number in series 1), the patient experienced few tough symptoms (unspecified) and afterwards felt fine.  The patient received booster dose of vaccine mRNA 1273 (dose number in the series 2), following vaccination patient experienced mild symptoms(unspecified).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Incorrect route of product administration, Vaccination site discharge, Vaccination site erythema, Vaccination site warmth
Clinical narrative: Hot to touch; Likely less than full dose injected; Leaked onto skin; Not injected into muscle; Red patch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to touch), ACCIDENTAL UNDERDOSE (Likely less than full dose injected), VACCINATION SITE DISCHARGE (Leaked onto skin), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Not injected into muscle) and VACCINATION SITE ERYTHEMA (Red patch) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2022, the patient experienced VACCINATION SITE WARMTH (Hot to touch), ACCIDENTAL UNDERDOSE (Likely less than full dose injected), VACCINATION SITE DISCHARGE (Leaked onto skin), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Not injected into muscle) and VACCINATION SITE ERYTHEMA (Red patch). On 18-Jan-2022, ACCIDENTAL UNDERDOSE (Likely less than full dose injected), VACCINATION SITE DISCHARGE (Leaked onto skin) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Not injected into muscle) had resolved. At the time of the report, VACCINATION SITE WARMTH (Hot to touch) had not resolved and VACCINATION SITE ERYTHEMA (Red patch) 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.   Patient reported that ice pad application helped little. Concomitant information was not reported. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Erythema, Neck pain, Pruritus, Skin mass
Clinical narrative: little knot on the backside, like a big area; fever in it; a little red; back of the neck is sore and hurting; still has the knot, which is swollen and sore; It is swollen and itchy / which is swollen and sore; knot was itchy; This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (little knot on the backside, like a big area), SKIN WARM (fever in it), ERYTHEMA (a little red), NECK PAIN (back of the neck is sore and hurting) and BACK PAIN (still has the knot, which is swollen and sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 052B21A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Diabetes.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced SKIN MASS (little knot on the backside, like a big area), SKIN WARM (fever in it), ERYTHEMA (a little red), NECK PAIN (back of the neck is sore and hurting), BACK PAIN (still has the knot, which is swollen and sore), SWELLING (It is swollen and itchy / which is swollen and sore) and PRURITUS (knot was itchy). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, SKIN MASS (little knot on the backside, like a big area), BACK PAIN (still has the knot, which is swollen and sore) and SWELLING (It is swollen and itchy / which is swollen and sore) had not resolved and SKIN WARM (fever in it), ERYTHEMA (a little red), NECK PAIN (back of the neck is sore and hurting) and PRURITUS (knot was itchy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. The patient had several medication but did not have the list.