chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Bruxism, Jaw disorder, Pain in jaw, Tooth loss, Toothache
Clinical narrative: Felt like all her teeth were falling out; She's clinching her teeth; Teeth were hurting very badly; Jaws were hurting; Feels like clinched jaw; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH LOSS (Felt like all her teeth were falling out), BRUXISM (She's clinching her teeth), TOOTHACHE (Teeth were hurting very badly), PAIN IN JAW (Jaws were hurting) and JAW DISORDER (Feels like clinched jaw) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A2IA) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced TOOTH LOSS (Felt like all her teeth were falling out), BRUXISM (She's clinching her teeth), TOOTHACHE (Teeth were hurting very badly), PAIN IN JAW (Jaws were hurting) and JAW DISORDER (Feels like clinched jaw). At the time of the report, TOOTH LOSS (Felt like all her teeth were falling out), BRUXISM (She's clinching her teeth), TOOTHACHE (Teeth were hurting very badly), PAIN IN JAW (Jaws were hurting) and JAW DISORDER (Feels like clinched jaw) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment details were not provided.   This case was linked to MOD-2021-429723 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Bruxism, Pain in jaw, Tooth disorder, Toothache
Clinical narrative: Felt like all her teeth were falling out; She's clinching her teeth/feels like clinched jaw; Teeth were hurting very badly; Jaws were hurting; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH DISORDER (Felt like all her teeth were falling out), BRUXISM (She's clinching her teeth/feels like clinched jaw), TOOTHACHE (Teeth were hurting very badly) and PAIN IN JAW (Jaws were hurting) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B021A and 027A2IA) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 07-Apr-2021, the patient experienced TOOTH DISORDER (Felt like all her teeth were falling out), BRUXISM (She's clinching her teeth/feels like clinched jaw), TOOTHACHE (Teeth were hurting very badly) and PAIN IN JAW (Jaws were hurting). At the time of the report, TOOTH DISORDER (Felt like all her teeth were falling out), BRUXISM (She's clinching her teeth/feels like clinched jaw), TOOTHACHE (Teeth were hurting very badly) and PAIN IN JAW (Jaws were hurting) outcome was unknown.            No Concomitant product use was reported.  The patient called to report that after their second dose they felt like all their teeth were falling out. The patient was clinching their teeth, teeth were hurting very badly, and jaws were hurting, and it felt like clinched jaw. The patient had same symptoms after the first dose. Reportedly, the patient conveyed that the patient was seeing their doctor as well.  No treatment information was provided.   This case was linked to MOD-2021-429682 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Experiencing side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Experiencing side effects) 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.    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 (Experiencing side effects). At the time of the report, VACCINATION COMPLICATION (Experiencing side effects) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported. No treatment information was reported by the reporter.  Patient was currently experiencing side effect
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: had complications with her breast lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (had complications with her breast lymph nodes) 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 LYMPHADENOPATHY (had complications with her breast lymph nodes). At the time of the report, LYMPHADENOPATHY (had complications with her breast lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant product use was reported.  The reporter stated that their female friend who was the patient had complications with their breast lymph nodes after getting a Covid-19 Vaccine of unknown manufacturer.  No treatment information was provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Pyrexia, Vomiting
Clinical narrative: feeling horrible; fever; headaches; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling horrible), PYREXIA (fever), HEADACHE (headaches) and VOMITING (vomiting) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 031b21a and 31b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Dec-2021, the patient experienced FEELING ABNORMAL (feeling horrible), PYREXIA (fever), HEADACHE (headaches) and VOMITING (vomiting). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (feeling horrible), PYREXIA (fever), HEADACHE (headaches) and VOMITING (vomiting) outcome was unknown.            No concomitant medications information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Dec-2021: Follow-up received contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: 0.25ml booster administered as first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (0.25ml booster administered as first dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 28-Dec-2021, the patient experienced INCORRECT DOSE ADMINISTERED (0.25ml booster administered as first dose). On 28-Dec-2021, INCORRECT DOSE ADMINISTERED (0.25ml booster administered as first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination complication
Clinical narrative: Very bad side effects after the second vaccine; second shot was more than 28 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Very bad side effects after the second vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second shot was more than 28 days) 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 10-Apr-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 10-Apr-2021, the patient experienced VACCINATION COMPLICATION (Very bad side effects after the second vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second shot was more than 28 days). On 10-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second shot was more than 28 days) had resolved. At the time of the report, VACCINATION COMPLICATION (Very bad side effects after the second vaccine) outcome was unknown.            The patient received 2 doses of COVID-19 vaccine but did not confirm the brand. She had very bad side effects after the second vaccine. The second shot was more than 28 days.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Pain in extremity, Vaccination site pain
Clinical narrative: body ache; Joint ache throughout my body felt pretty crappy; mild slight headache; fatigue; soreness at injection site on arms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (body ache), HEADACHE (mild slight headache), FATIGUE (fatigue), VACCINATION SITE PAIN (soreness at injection site on arms) and ARTHRALGIA (Joint ache throughout my body felt pretty crappy) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Dec-2021, the patient experienced HEADACHE (mild slight headache), FATIGUE (fatigue) and VACCINATION SITE PAIN (soreness at injection site on arms). On 13-Dec-2021, the patient experienced PAIN IN EXTREMITY (body ache) and ARTHRALGIA (Joint ache throughout my body felt pretty crappy). In December 2021, PAIN IN EXTREMITY (body ache), HEADACHE (mild slight headache), FATIGUE (fatigue), VACCINATION SITE PAIN (soreness at injection site on arms) and ARTHRALGIA (Joint ache throughout my body felt pretty crappy) had resolved.            No concomitant medication information was provided.  No treatment medication information was given.      Most recent FOLLOW-UP information incorporated above includes: On 28-Dec-2021: Follow up received contains non significant information
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Cough, Pyrexia
Clinical narrative: coughing; temperature of 101; This spontaneous case was reported by an other health care professional and describes the occurrence of COUGH (coughing) and PYREXIA (temperature of 101) 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 27-Dec-2021, the patient experienced COUGH (coughing) and PYREXIA (temperature of 101). At the time of the report, COUGH (coughing) and PYREXIA (temperature of 101) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Dec-2021, Body temperature: 101 (High) temperature of 101.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.  The patient queried about how likely it was to experience COVID symptoms such as coughing and having a temperature of 101 after receiving the booster dose of Moderna vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Gastroenteritis viral
Clinical narrative: Stomach virus; This spontaneous case was reported by a consumer and describes the occurrence of GASTROENTERITIS VIRAL (Stomach virus) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced GASTROENTERITIS VIRAL (Stomach virus). At the time of the report, GASTROENTERITIS VIRAL (Stomach virus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient had stomach virus and was scheduled for second shot on the day of reporting.  Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication, Vomiting
Clinical narrative: She had some problems; Threw up; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (She had some problems) and VOMITING (Threw up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (She had some problems) and VOMITING (Threw up). The patient was treated with PREDNISONE for Adverse event, at a dose of 10 and AZATHIOPRINE (IMURAN [AZATHIOPRINE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (She had some problems) and VOMITING (Threw up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: Chronic sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Chronic sinus infection) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SINUSITIS (Chronic sinus infection). At the time of the report, SINUSITIS (Chronic sinus infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported.  Patient received first dose a week or so ago and since patient had chronic sinus infection. Healthcare professional (HCP) told patient to take antibiotics. Patient wanted to know if taking these could affect vaccine's efficacy.
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vomiting; This spontaneous case was reported by a physician and describes the occurrence of VOMITING (vomiting) 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.   In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced VOMITING (vomiting). At the time of the report, VOMITING (vomiting) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient did not have vomiting with first 2 Moderna shots.  Concomitant and treatment medication was not reported.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: healthy 37 M was given a first dose of .25/booster dose administered instead of full dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (healthy 37 M was given a first dose of .25/booster dose administered instead of full dose) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (healthy 37 M was given a first dose of .25/booster dose administered instead of full dose). At the time of the report, ACCIDENTAL UNDERDOSE (healthy 37 M was given a first dose of .25/booster dose administered instead of full dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Patient received the second dose of 0.5 ml on 28 Dec 2021. Patient was not experiencing any symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 28-Dec-2021: Follow up received included reporter information, patient demographics and second dose details added in inarrative.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: More than 36 days after the first dose without receiving the second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose without receiving the second dose) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose without receiving the second dose). On 20-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose without receiving the second dose) had resolved.       No concomitant drug were reported.   Patient received Treatment drug Tylenol and Excedrin for the events which occurred after booster dose.   This case was linked to MOD-2021-430178 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Pain in extremity, Swelling face
Clinical narrative: arm was kind of sore, like after a flu shot (1st dose); swelling of face and eyes (1st dose); all face swollen for 2 days (1st dose)/ swelling of face and eyes (1st dose); This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (arm was kind of sore, like after a flu shot (1st dose)), EYE SWELLING (swelling of face and eyes (1st dose)) and SWELLING FACE (all face swollen for 2 days (1st dose)/ swelling of face and eyes (1st dose)) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, 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 (arm was kind of sore, like after a flu shot (1st dose)), EYE SWELLING (swelling of face and eyes (1st dose)) and SWELLING FACE (all face swollen for 2 days (1st dose)/ swelling of face and eyes (1st dose)). At the time of the report, PAIN IN EXTREMITY (arm was kind of sore, like after a flu shot (1st dose)) and EYE SWELLING (swelling of face and eyes (1st dose)) outcome was unknown and SWELLING FACE (all face swollen for 2 days (1st dose)/ swelling of face and eyes (1st dose)) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported that symptoms started after 24 hours. Included sore arm, swelling of face and eyes. At  the beginning it was only on the right side but then all face was swollen. This lasted 2 days.  No concomitant medications reported by reporter No treatment medications provided by the reporter.   This case was linked to MOD-2021-430637 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Reaction to the vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION COMPLICATION (Reaction to the vaccine) 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 (Reaction to the vaccine). At the time of the report, VACCINATION COMPLICATION (Reaction to the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported.  No treatment medication were reported.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) 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. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (pain). At the time of the report, PAIN (pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were Reported. The patient got the 1st shot on Sunday and wants to know if can take Tylenol for pain.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose on day 24; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose on day 24) 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 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose on day 24). On 27-Jan-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose on day 24) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore Arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore Arm). The patient was treated with IBUPROFEN for Vaccination site pain, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Sore Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Wrong technique in device usage process
Clinical narrative: I punctured the vial 21 times; This spontaneous case was reported by a consumer and describes the occurrence of WRONG TECHNIQUE IN DEVICE USAGE PROCESS (I punctured the vial 21 times) 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 DEVICE USAGE PROCESS (I punctured the vial 21 times). At the time of the report, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (I punctured the vial 21 times) had resolved.            No concomitant drug information was provided.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Five patients being administered doses from a vial left out overnight from 12/20/21 to 12/21/21; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Five patients being administered doses from a vial left out overnight from 12/20/21 to 12/21/21) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032h21a) for COVID-19 vaccination.     Concurrent medical conditions included Obesity, Obstructive sleep apnea syndrome, Depression and Alcohol abuse. Concomitant products included LISINOPRIL, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (DESCOVY) and ESCITALOPRAM for an unknown indication.    On 21-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Five patients being administered doses from a vial left out overnight from 12/20/21 to 12/21/21). On 21-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Five patients being administered doses from a vial left out overnight from 12/20/21 to 12/21/21) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported. Age at vaccination: 32 years 4 months. Patient had no known drug allergies.   This case was linked to MOD-2021-422292 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Five patients being administered doses from a vial left out overnight from 12/20/21 to 12/21/21\administered beyond the 12 hours use times; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Five patients being administered doses from a vial left out overnight from 12/20/21 to 12/21/21\administered beyond the 12 hours use times) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H21A) for COVID-19 vaccination.     Concurrent medical conditions included Ulcerative colitis, Anemia and Hyperlipidemia. Concomitant products included SERTRALINE, ROSUVASTATIN and LORAZEPAM for an unknown indication.    On 21-Dec-2021 at 9:51 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Dec-2021 at 9:51 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Five patients being administered doses from a vial left out overnight from 12/20/21 to 12/21/21\administered beyond the 12 hours use times). On 21-Dec-2021 at 9:51 AM, EXPIRED PRODUCT ADMINISTERED (Five patients being administered doses from a vial left out overnight from 12/20/21 to 12/21/21\administered beyond the 12 hours use times) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Medical History information was reported. No treatment medication was reported.   This case was linked to MOD-2021-422292 (Patient Link).
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Six patients being administered doses from a vial left out overnight from 12/20/21 to 12/21/21\administered beyond the 12 hours use times; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Six patients being administered doses from a vial left out overnight from 12/20/21 to 12/21/21\administered beyond the 12 hours use times) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032h21a) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic, Generalized anxiety disorder, Hyperlipidemia, Depressive disorder and Obstructive sleep apnea syndrome. Concomitant products included FLUOXETINE, EMTRICITABINE and TENOFOVIR DISOPROXIL FUMARATE for an unknown indication.    On 21-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Six patients being administered doses from a vial left out overnight from 12/20/21 to 12/21/21\administered beyond the 12 hours use times). On 21-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Six patients being administered doses from a vial left out overnight from 12/20/21 to 12/21/21\administered beyond the 12 hours use times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Time of vaccination and occurrence of event was reported as 10:49 AM. No treatment medications were reported. Six patients  were administered doses from a vial left out overnight from 12/20/21 to 12/21/21, roughly 18 hours from open to the last patient it was used for on tuesday morning.   This case was linked to MOD-2021-422292 (Patient Link).
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Six patients being administered doses from a vial left out overnight from 12/20/21 to 12/21/21/administered beyond the 12 hours use times; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Six patients being administered doses from a vial left out overnight from 12/20/21 to 12/21/21/administered beyond the 12 hours use times) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032h21a) for COVID-19 vaccination.     Concurrent medical conditions included Gender dysphoria, Cystic acne, Endocrine disorder and Drug allergy. Concomitant products included ISOTRETINOIN (ACCUTANE) for an unknown indication.    On 21-Dec-2021 at 9:50 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Dec-2021 at 9:50 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Six patients being administered doses from a vial left out overnight from 12/20/21 to 12/21/21/administered beyond the 12 hours use times). On 21-Dec-2021 at 9:50 AM, EXPIRED PRODUCT ADMINISTERED (Six patients being administered doses from a vial left out overnight from 12/20/21 to 12/21/21/administered beyond the 12 hours use times) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was provided. Reported that Six patients being administered doses from a vial left out overnight from 20-DEC-2021 to 21-DEC-2021 roughly. 18 hours from open to the last patient it was used for on Tuesday morning.   This case was linked to MOD-2021-422292 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Bad side effects with the first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Bad side effects with the first dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Bad side effects with the first dose). At the time of the report, VACCINATION COMPLICATION (Bad side effects with the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Caller would like to report AE; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Caller would like to report AE) 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 ADVERSE EVENT (Caller would like to report AE). At the time of the report, ADVERSE EVENT (Caller would like to report AE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medications and Treatments were Reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: nuclear Stress test; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (nuclear Stress test) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (nuclear Stress test). At the time of the report, VACCINATION COMPLICATION (nuclear Stress test) outcome was unknown.            No concomitant medications were reported.  It was reported that, the patient had nuclear Stress test scheduled a week after 2nd dose. She stated, they would be injecting something to her.  No treatment information was reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Heart racing; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart racing) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016C21A and 019B21A) for COVID-19 vaccination.     Concomitant products included ESTRADIOL BENZOATE (ESTRADIOL [ESTRADIOL BENZOATE]) and PROGESTERONE (PROGESTERONE DCI) for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced PALPITATIONS (Heart racing). At the time of the report, PALPITATIONS (Heart racing) outcome was unknown.            No medical history was reported by the reporter. Treatment medications were not provided by the reporter.   This case was linked to MOD-2021-431944 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: dosage interval reduced; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (dosage interval reduced) 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 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (dosage interval reduced). On 02-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (dosage interval reduced) 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 drugs were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (experiencing AE) 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 (experiencing AE). At the time of the report, VACCINATION COMPLICATION (experiencing AE) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: Flared up drastically psoriasis after their 1st, 2nd, & booster doses; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Flared up drastically psoriasis after their 1st, 2nd, & booster 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 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 PSORIASIS (Flared up drastically psoriasis after their 1st, 2nd, & booster doses). At the time of the report, PSORIASIS (Flared up drastically psoriasis after their 1st, 2nd, & booster doses) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided. No treatment medication was provided.   This case was linked to MOD-2021-432423, MOD-2021-432424 (Patient Link).   Reporter did not allow further contact
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: booster out of date; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (booster out of date) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A, 010M20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (booster out of date). On 04-Nov-2021, EXPIRED PRODUCT ADMINISTERED (booster out of date) had resolved.            No concomitant medication provided. No treatment medication provided. Booster dose was expired on October 2021.   Most recent FOLLOW-UP information incorporated above includes: On 28-Dec-2021: Follow up received on 28 dec 2021 included patient demographics.
Sex: U
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: flared up drastically psoriasis after their 1st, 2nd, & booster doses; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (flared up drastically psoriasis after their 1st, 2nd, & booster doses) 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 Psoriasis.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PSORIASIS (flared up drastically psoriasis after their 1st, 2nd, & booster doses). At the time of the report, PSORIASIS (flared up drastically psoriasis after their 1st, 2nd, & booster doses) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.   This case was linked to MOD-2021-432405, MOD-2021-432424 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Underdose
Clinical narrative: Patient didn't receive full or if any of the Vaccine upon injection; Patient didn't receive full or if any of the Vaccine upon injection; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (Patient didn't receive full or if any of the Vaccine upon injection) and UNDERDOSE (Patient didn't receive full or if any of the Vaccine upon injection) 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 INCORRECT DOSE ADMINISTERED (Patient didn't receive full or if any of the Vaccine upon injection) and UNDERDOSE (Patient didn't receive full or if any of the Vaccine upon injection). At the time of the report, INCORRECT DOSE ADMINISTERED (Patient didn't receive full or if any of the Vaccine upon injection) and UNDERDOSE (Patient didn't receive full or if any of the Vaccine upon injection) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Spinal operation
Clinical narrative: little surgery on back; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL OPERATION (little surgery on back) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SPINAL OPERATION (little surgery on back). At the time of the report, SPINAL OPERATION (little surgery on back) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  It was reported that the patient had went to a dermatologist and a little back surgery was performed on the patient. It was also reported that the patient was on antibiotics for seven days and this antibiotics were to prevent infection.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: normal side effects; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (normal side effects) 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 (normal side effects). At the time of the report, VACCINATION COMPLICATION (normal side effects) 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 medication was reported. No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: presumably on antibiotic after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (presumably on antibiotic after the vaccine) 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 (presumably on antibiotic after the vaccine). At the time of the report, VACCINATION COMPLICATION (presumably on antibiotic after the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was reported.   Reporter did not allow further contact