chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Got COVID-19 after receiving the Moderna COVID-19 vaccination; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Got COVID-19 after receiving the Moderna COVID-19 vaccination) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In August 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced COVID-19 (Got COVID-19 after receiving the Moderna COVID-19 vaccination). At the time of the report, COVID-19 (Got COVID-19 after receiving the Moderna COVID-19 vaccination) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Reporter stated that patient had no allergies. No treatment medication were reported.  Company Comment: This is a spontaneous case concerning a 79-year-old female patient with no reported medical history, who experienced the unexpected non-serious adverse event of special interest of COVID-19, approximately 5 months after receiving a booster dose of mRNA-1273 vaccine. The dates of vaccination of the previous doses of COVID-19 vaccine was not provided in the case. Clinical course, diagnostic tests and treatment details were not provided in the case. At the time of reporting, the event had resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 79-year-old female patient with no reported medical history, who experienced the unexpected non-serious adverse event of special interest of COVID-19, approximately 5 months after receiving a booster dose of mRNA-1273 vaccine. The dates of vaccination of the previous doses of COVID-19 vaccine was not provided in the case. Clinical course, diagnostic tests and treatment details were not provided in the case. At the time of reporting, the event had resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: fever; sore injection site arm after each of her Covid-19 vaccines; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever) and VACCINATION SITE PAIN (sore injection site arm after each of her Covid-19 vaccines) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever) and VACCINATION SITE PAIN (sore injection site arm after each of her Covid-19 vaccines). At the time of the report, PYREXIA (fever) and VACCINATION SITE PAIN (sore injection site arm after each of her Covid-19 vaccines) outcome was unknown.            No concomitant drug was reported. The patient had her first booster dose of her Covid-19 vaccine on 24-Oct-2021. The patient was reporting fever, and sore injection site arm after each of her Covid-19 vaccines. No treatment drug was reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Patient had 3 full doses of Moderna Covid-19 vaccine. Got the third full dose, because boosters weren't out yet and had to go back to work and deal with the public; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Patient had 3 full doses of Moderna Covid-19 vaccine. Got the third full dose, because boosters weren't out yet and had to go back to work and deal with the public) 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 31-Mar-2022, 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. On 31-Mar-2022, the patient experienced ACCIDENTAL OVERDOSE (Patient had 3 full doses of Moderna Covid-19 vaccine. Got the third full dose, because boosters weren't out yet and had to go back to work and deal with the public). At the time of the report, ACCIDENTAL OVERDOSE (Patient had 3 full doses of Moderna Covid-19 vaccine. Got the third full dose, because boosters weren't out yet and had to go back to work and deal with the public) outcome was unknown.            No concomitant medications were reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2022: Follow-up received contain no new information.
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Rash
Clinical narrative: Rash; Received a third full Moderna Covid-19 vaccine dose and she is not an immunocompromised patient; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) and ACCIDENTAL OVERDOSE (Received a third full Moderna Covid-19 vaccine dose and she is not an immunocompromised patient) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced ACCIDENTAL OVERDOSE (Received a third full Moderna Covid-19 vaccine dose and she is not an immunocompromised patient). On an unknown date, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) and ACCIDENTAL OVERDOSE (Received a third full Moderna Covid-19 vaccine dose and she is not an immunocompromised patient) outcome was unknown.            No relevant concomitant medications were reported. Treatment information was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, SARS-CoV-2 test
Clinical narrative: She has experienced hair loss after she took the third vaccination. She noticed it a few months after; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (She has experienced hair loss after she took the third vaccination. She noticed it a few months after) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 006B21A and 031M20A) for COVID-19 vaccination.     The patient's past medical history included Barrett's oesophagus (diagnosed with Barrette's esophagus 7 months ago). Concurrent medical conditions included Penicillin allergy (Allergy to Penicillin,( all -cillin's)).   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, 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 experienced ALOPECIA (She has experienced hair loss after she took the third vaccination. She noticed it a few months after). At the time of the report, ALOPECIA (She has experienced hair loss after she took the third vaccination. She noticed it a few months after) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Tested positive for COVID-19: Never.         No concomitant information was provided.  Patient  has experienced hair loss after the third vaccination. Patient noticed it after a few months. Patient did mention it to the nurse practitioner. when Patient went to the doctors and the nurse said the the vaccine is causing some people to lose their hair. Nurse did not specify which COVID-19 vaccination. It was  reported in case MOD22-010200. The reporter does not know if this is from the Moderna shot and should go for dermatologist consultation patient mentioned.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Swelling face, Vaccination complication
Clinical narrative: face swelling (after dermal filler injection); in extreme pain (after dermal filler injection); had a bad reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of SWELLING FACE (face swelling (after dermal filler injection)), PAIN (in extreme pain (after dermal filler injection)) and VACCINATION COMPLICATION (had a bad reaction) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (face swelling (after dermal filler injection)), PAIN (in extreme pain (after dermal filler injection)) and VACCINATION COMPLICATION (had a bad reaction). At the time of the report, SWELLING FACE (face swelling (after dermal filler injection)), PAIN (in extreme pain (after dermal filler injection)) and VACCINATION COMPLICATION (had a bad reaction) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was in her mid 40's.  No concomitant medication was provided.  It was reported that, about a month and a half ago, they received a lady at the spa that got the 2 doses of the Moderna COVID-19 vaccine about a year ago (no booster), they injected her with Vobella dermal filler which was a very soft filler HCP said and after that she had a bad reaction, facial swelling, the filler immediately got rock hard, didn't soften up, they never seen anything like that, the patient was in extreme pain.  No treatment medication were provided.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: He reports with the other doses, he experienced fever, chills, achiness; He reports with the other doses, he experienced fever, chills, achiness; He reports with the other doses, he experienced fever, chills, achiness; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (He reports with the other doses, he experienced fever, chills, achiness), CHILLS (He reports with the other doses, he experienced fever, chills, achiness) and MYALGIA (He reports with the other doses, he experienced fever, chills, achiness) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-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 PYREXIA (He reports with the other doses, he experienced fever, chills, achiness), CHILLS (He reports with the other doses, he experienced fever, chills, achiness) and MYALGIA (He reports with the other doses, he experienced fever, chills, achiness). At the time of the report, PYREXIA (He reports with the other doses, he experienced fever, chills, achiness), CHILLS (He reports with the other doses, he experienced fever, chills, achiness) and MYALGIA (He reports with the other doses, he experienced fever, chills, achiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. No treatment was reported.   This case was linked to MOD-2022-531762, MOD-2022-531517 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (he experienced fever), CHILLS (chills) and MYALGIA (achiness) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 012M20A) for COVID-19 vaccination. No Medical History information was reported. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PYREXIA (he experienced fever), CHILLS (chills) and MYALGIA (achiness). At the time of the report, PYREXIA (he experienced fever), CHILLS (chills) and MYALGIA (achiness) outcome was unknown. No concomitant information were reported by the reporter. No treatment information were reported by the reporter. This case was linked to MOD-2022-531517, MOD-2022-531761 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) in a 63-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 31-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Administration expired vaccine, 4 days after the 30-day. Number of doses/vials: 6 doses Date the vial was initially stored in the refrigerator : 17-Mar-2022 The vial did not undergo any temperature excursions. Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (achy/ sore arm) and INFLUENZA LIKE ILLNESS (flu like symptoms) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (achy/ sore arm) and INFLUENZA LIKE ILLNESS (flu like symptoms). At the time of the report, PAIN IN EXTREMITY (achy/ sore arm) and INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant product use was reported. The patient stated that they received the Moderna primary two dose series approximately one month part and stated the patient had no untoward reaction after the first two doses in 2021. The patient however reported that the patient experienced the normal side effects, including an achy, sore arm and flu like symptoms that lasted for about one day. The vaccine administration dates, and lot numbers were not provided by the patient. The reporter mentioned that one must eat and hydrate well before they get their Moderna vaccines to lessen the side effects. No treatment information was provided. This case was linked to MOD-2022-531830, MOD-2022-531834 (Patient Link). Reporter did not allow further contact
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration expired vaccines) in a 42-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination. No Medical History information was reported. On 31-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 31-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration expired vaccines). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration expired vaccines) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. The vial was initially stored in the refrigerator on 17 Mar 2022. The vials did not undergo any temperature excursion. No treatment medications were reported.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) in an 82-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 31-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Administration of expired vaccine, 4 days after the 30-Day. Number of doses/vials: 6 doses.  Vial was initially stored in the refrigerator on 17-Mar-2022. Vial did not undergo any temperature excursions.   This case was linked to MOD-2022-531823, MOD-2022-531831, MOD-2022-531839, MOD-2022-531692, MOD-2022-531803 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Epstein-Barr virus test, Infectious mononucleosis, Influenza like illness, Pain in extremity
Clinical narrative: Epstein-Barr virus (mononucleosis); achy/ sore arm; flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFECTIOUS MONONUCLEOSIS (Epstein-Barr virus (mononucleosis)), PAIN IN EXTREMITY (achy/ sore arm) and INFLUENZA LIKE ILLNESS (flu like symptoms) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFECTIOUS MONONUCLEOSIS (Epstein-Barr virus (mononucleosis)), PAIN IN EXTREMITY (achy/ sore arm) and INFLUENZA LIKE ILLNESS (flu like symptoms). At the time of the report, INFECTIOUS MONONUCLEOSIS (Epstein-Barr virus (mononucleosis)) outcome was unknown and PAIN IN EXTREMITY (achy/ sore arm) and INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Epstein-Barr virus test: positive had Epstein-Barr virus (mononucleosis).         No Concomitant product use was reported.  The patient stated that they received the Moderna primary two dose series approximately one month part and stated the patient had no untoward reaction after the first two doses in 2021. The patient however reported that the patient experienced the normal side effects, including an achy, sore arm and flu like symptoms that lasted for about one day. The vaccine administration dates, and lot numbers were not provided by the patient. The reporter mentioned that one must eat and hydrate well before they get their Moderna vaccines to lessen the side effects.   The patient stated the patient had Epstein-Barr virus (mononucleosis) and their resistance became low. The exact date of Epstein-Barr virus was unknown but appeared to have occurred sometime after receiving the Moderna primary series vaccinations. The patient stated the Moderna vaccines worked, and the patient had never gotten COVID-19 infection. Reportedly, the patient regularly wore mask and practiced social distancing.   No treatment information was provided.   This case was linked to MOD-2022-531820, MOD-2022-531834 (Patient Link).   Reporter did not allow further contact
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration expired vaccines) in an 80-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination. No Medical History information was reported. On 31-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 31-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration expired vaccines). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration expired vaccines) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. The vial was initially stored in the refrigerator on 17 Mar 2022. The vials did not undergo any temperature excursion. No treatment medications were reported. Vial was initially stored in the refrigerator on 17-Mar-2022. Vial did not undergo any temperature excursions.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) in an 81-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 31-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially stored in the refrigerator on 17 Mar 2022. The vials did not undergo any temperature excursion.  No treatment medications were reported.   This case was linked to MOD-2022-531825 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Haemoglobin, Iron deficiency anaemia
Clinical narrative: She has a diagnosis of iron deficiency anemia and a hemoglobin of 6 percentage about 5 weeks after she received the booster dose; This spontaneous case was reported by a consumer and describes the occurrence of IRON DEFICIENCY ANAEMIA (She has a diagnosis of iron deficiency anemia and a hemoglobin of 6 percentage about 5 weeks after she received the booster dose) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Aug-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. In 2021, the patient experienced IRON DEFICIENCY ANAEMIA (She has a diagnosis of iron deficiency anemia and a hemoglobin of 6 percentage about 5 weeks after she received the booster dose). At the time of the report, IRON DEFICIENCY ANAEMIA (She has a diagnosis of iron deficiency anemia and a hemoglobin of 6 percentage about 5 weeks after she received the booster dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Haemoglobin: 6 (Low) iron deficiency anemia with hemoglobin of 6 percentage.         No concomitant medications were reported. It was reported that the patient was diagnosed with iron deficiency anemia and a hemoglobin of  6  percentage about 5 weeks after she received the booster dose. Patient was taking unspecified anemia medication.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: urinary tract infection; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (urinary tract infection) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (She had the cancer for 4 years now).    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (urinary tract infection). The patient was treated with DOXYCYCLINE for Urinary tract infection, at an unspecified dose and frequency. At the time of the report, URINARY TRACT INFECTION (urinary tract infection) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Cancer drug was reported as concomitant medication. It was reported that patient had been taking cancer drugs for 4 years now.  Patient received the Cancer diagnosis before receiving any Moderna vaccine. Patient experienced a urinary tract infection that her Health care professionals were not being able to resolve. Patient mentioned that they tried to treat it with many antibiotics and she was right now taking doxycycline and a cancer drug.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Impaired work ability
Clinical narrative: did not feel like getting up and doing thing; tired; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED WORK ABILITY (did not feel like getting up and doing thing) and FATIGUE (tired) 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 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced IMPAIRED WORK ABILITY (did not feel like getting up and doing thing) and FATIGUE (tired). At the time of the report, IMPAIRED WORK ABILITY (did not feel like getting up and doing thing) and FATIGUE (tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2022-531858, MOD-2022-531857, MOD-2022-531856 (Patient Link).
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vial stored in the fridge greater than 12 hours post puncture; Booster dose given  greater than 12 hr post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster dose given  greater than 12 hr post puncture) and PRODUCT STORAGE ERROR (vial stored in the fridge greater than 12 hours post puncture) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer COVID19 Vaccine (First dose) on 10-Sep-2021 and Pfizer COVID19 Vaccine (Second dose) on 01-Oct-2021. Past adverse reactions to the above products included No adverse event with Pfizer COVID19 Vaccine and Pfizer COVID19 Vaccine.    On 01-Apr-2022 at 9:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2022 at 9:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster dose given  greater than 12 hr post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial stored in the fridge greater than 12 hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Booster dose given  greater than 12 hr post puncture) and PRODUCT STORAGE ERROR (vial stored in the fridge greater than 12 hours post puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided.  Date the vial was initially stored in the refrigerator was 31-Mar-2022. Date and time vial was first punctured was on 31-Mar-2022 at 5 PM. The vial was stored in fridge post puncture. The vial did not undergo any temperature excursion. Total amount of time the vial was exposed to room temperature range (8 degree Celsius to 25 degree Celsius) was no more than 16 minutes, only to draw out doses.   No treatment medications was provided.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Impaired work ability
Clinical narrative: did not feel like getting up and doing thing; tired; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED WORK ABILITY (did not feel like getting up and doing thing) and FATIGUE (tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced IMPAIRED WORK ABILITY (did not feel like getting up and doing thing) and FATIGUE (tired). At the time of the report, IMPAIRED WORK ABILITY (did not feel like getting up and doing thing) and FATIGUE (tired) outcome was unknown.            No concomitant and treatment medications were provided by the reporter.   This case was linked to MOD-2022-531856, MOD-2022-531849 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.            No relevant concomitant medications were reported.  The patient reported that patient could feel the vaccine working.  Treatment information was unknown.   This case was linked to MOD-2022-531854, MOD-2022-531860, MOD-2022-531856, MOD-2022-531849 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Haemoptysis, Sneezing
Clinical narrative: Still sneezes sometimes; Feels tired all the time; Severe coughing; coughing ever since for the last two weeks; tickling cough; coughing up blood; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Severe coughing; coughing ever since for the last two weeks; tickling cough), SNEEZING (Still sneezes sometimes), HAEMOPTYSIS (coughing up blood) and FATIGUE (Feels tired all the time) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TREPROSTINIL SODIUM (TYVASO) inhalation gas for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included MACITENTAN (OPSUMIT) for an unknown indication.   On 26-Dec-2017, the patient TREPROSTINIL SODIUM (TYVASO) (unknown route) dosage was changed to UNK, Inhalation. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and TREPROSTINIL SODIUM (TYVASO) (unknown route) 18-54 µg (3-9 breaths), four times a day (QID) via inhalation. On an unknown date, TREPROSTINIL SODIUM (TYVASO) (unknown route) dosage was changed to UNK, Inhalation. In February 2022, the patient experienced COUGH (Severe coughing; coughing ever since for the last two weeks; tickling cough) and HAEMOPTYSIS (coughing up blood). On an unknown date, the patient experienced SNEEZING (Still sneezes sometimes) and FATIGUE (Feels tired all the time). At the time of the report, COUGH (Severe coughing; coughing ever since for the last two weeks; tickling cough) and SNEEZING (Still sneezes sometimes) had not resolved and HAEMOPTYSIS (coughing up blood) and FATIGUE (Feels tired all the time) outcome was unknown.            No medical history was reported.  Action taken with IH Tyvaso was not reported for the events of cough, haemoptysis, fatigue and sneezing. After COVID booster shot, patient went to urgent care.  Treatment information was not provided by the reporter.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Condition aggravated, Heart rate, Hypertension
Clinical narrative: high blood pressure at oral surgeries; Symptoms worsened due to vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (high blood pressure at oral surgeries) and CONDITION AGGRAVATED (Symptoms worsened due to vaccine) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Environmental allergy (Patient started allergy shots after receiving the vaccine for environmental allergies), Drug allergy (Allergy to codeine), Drug allergy (Allergy to fentanyl- Itching, Welts) and Blood pressure high (Start date was >10 years). Concomitant products included LISINOPRIL for Blood pressure high, ZOLPIDEM for Sleep difficult, SIMVASTATIN for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. In March 2021, the patient experienced HYPERTENSION (high blood pressure at oral surgeries) and CONDITION AGGRAVATED (Symptoms worsened due to vaccine). At the time of the report, HYPERTENSION (high blood pressure at oral surgeries) and CONDITION AGGRAVATED (Symptoms worsened due to vaccine) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood pressure measurement: 135/85 (High) reading was 135/85 and climbing. In March 2021, Heart rate: high (High) Patient reported her heart rate was high.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient started allergy shots after receiving the vaccine for environmental allergies so thought the symptoms were due to the allergy shots, but now they suspect it was the Moderna COVID-19 vaccine. Patient did not received any other vaccine within 1 month prior to Moderna COVID-19 vaccine. The patient had never been diagnosed with/ tested positive for COVID-19. There were no diagnosis of myocarditis or pericarditis. No treatment medication was provided by the reporter.   This case was linked to MOD-2022-531903, MOD-2022-531902 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered 8 doses of Vaccine 2 days after the vaccine expired; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 8 doses of Vaccine 2 days after the vaccine expired) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 25-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 8 doses of Vaccine 2 days after the vaccine expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered 8 doses of Vaccine 2 days after the vaccine expired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatments were reported.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: receiving expired doses; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving expired doses) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (receiving expired doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications were provided by the Reporter      No Treatment Medications were provided by the Reporter   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2022: Live Followup received contains Significant information of Patient Information added
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Got full dose for their 2nd booster; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Got full dose for their 2nd booster) 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 31-Mar-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2022, the patient experienced ACCIDENTAL OVERDOSE (Got full dose for their 2nd booster). At the time of the report, ACCIDENTAL OVERDOSE (Got full dose for their 2nd booster) outcome was unknown.            No concomitant medication was provided by the reporter.  It was reported that reporter's 2 friends took the 2nd booster dose on 31-Mar-2022 at a pharmacy and were informed that they got a full dose for their 2nd booster and were told that this recommendation was from Moderna. Reporter mentioned that these friends were not immunocompromised. Reporter had an appointment for her 2nd booster dose at another pharmacy and when she called them, she was told that the 2nd dose was half the dose and she was told they never heard about the 2nd booster dose being given at full dose. So, she was contemplating on going to that pharmacy which gave a full dose.  No treatment medication was provided by the reporter.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: administered expired vaccine; Vaccine expired on 18-Mar-2022/refrigerate on 18-Mar-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired vaccine) and PRODUCT STORAGE ERROR (Vaccine expired on 18-Mar-2022/refrigerate on 18-Mar-2022) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 026A21A, 047A21A and 062E21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 31-Mar-2022 at 12:49 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2022, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 18-Mar-2022/refrigerate on 18-Mar-2022). On 31-Mar-2022 at 12:49 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired vaccine) and PRODUCT STORAGE ERROR (Vaccine expired on 18-Mar-2022/refrigerate on 18-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received oncology medications post transplant.  The date of vial was initially stored in refrigerator on 18-Mar-2022. The vial did not undergo any temperature excursion.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2022: Follow-up document received includes: date of vaccine stored in refrigerator and time of administration of vaccine was added.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered after 2 days from manufacturer date of expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 2 days from manufacturer date of expiry) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2022 at 9:00 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 25-Mar-2022 at 9:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 2 days from manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 2 days from manufacturer date of expiry) outcome was unknown.        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.  On 25-Mar-2022, the patient received the booster dose of the vaccine.  On the day of visit at the clinic, the patient was not feeling sick. In the last 10 days, the patient did not undergo a COVID-19 test and did not have symptoms of COVID-19. The patient was not treated with antibody therapy or convalescent plasma for COVID-19 in the past 3 months. The patient did not have an allergic reaction to any vaccine, injection or shot or to any component of the COVID-19 vaccine or any severe allergic reaction to anything. The patient did not have a medical history of myocarditis, pericarditis, cancer, leukemia, HIV/Aids or any other condition that weakens the immune system. The patient neither takes medications that affect the patient's immune system nor had undergone any radiation treatments. The patient did not have a medical history of bleeding disorder, blood clots and was not taking a blood thinner. The patient had not received 2 doses of Pfizer vaccine or a previous dose of Jansenn vaccine or a previous dose of a non-FDA authorized or other WHO approved COVID-19 vaccine.   This case was linked to MOD-2022-530285 (Patient Link).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Oral surgery
Clinical narrative: high blood pressure after 2nd dose/blood pressure 150/76/blood pressure reading was 135/85; April 2021 for oral surgery; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (high blood pressure after 2nd dose/blood pressure 150/76/blood pressure reading was 135/85) and ORAL SURGERY (April 2021 for oral surgery) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Environmental allergy (Patient started allergy shots after receiving the vaccine for environmental allergies), Drug allergy (Allergy to codeine), Drug allergy (Allergy to fentanyl - itching,welts) and Blood pressure high (Started more than 10 years ago and recent change in status was worsening.). Concomitant products included LISINOPRIL for Hypertension, ZOLPIDEM for Sleep disorder, PLECANATIDE (TRULANCE) for Stomach discomfort, SIMVASTATIN for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 05-Apr-2021, the patient experienced HYPERTENSION (high blood pressure after 2nd dose/blood pressure 150/76/blood pressure reading was 135/85). In April 2021, the patient experienced ORAL SURGERY (April 2021 for oral surgery). At the time of the report, HYPERTENSION (high blood pressure after 2nd dose/blood pressure 150/76/blood pressure reading was 135/85) had not resolved and ORAL SURGERY (April 2021 for oral surgery) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication reported for dose 2.  TRULANCE was given in June or July 2021   This case was linked to MOD-2022-531903, MOD-2022-531876 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient given expired vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient given expired vaccine) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: pfizer vaccine (Dose-2) and pfizer vaccine (Dose-1). Past adverse reactions to the above products included No adverse event with pfizer vaccine and pfizer vaccine.    On 25-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 25-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient given expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient given expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was provided.