chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: We see a volume left over in the vial after 20 doses were drawn; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (We see a volume left over in the vial after 20 doses were drawn) 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 (We see a volume left over in the vial after 20 doses were drawn). At the time of the report, INCORRECT DOSE ADMINISTERED (We see a volume left over in the vial after 20 doses were drawn) had resolved. Not Provided    Reporter stated that they saw volume left over in the vial that varies from zero through to 1.5 mls when 20 doses were drawn. Hence, they were concerned on whether the vaccine amount was correct. They used BD-Flu needles to draw up to 0.25 mls of vaccine.  No concomitant medications were reported No treatment drugs were reported
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Musculoskeletal stiffness, Vaccination site swelling
Clinical narrative: fingers got tighter; tired; 30-40 minutes after the injection her arm kept getting bigger,getting bigger; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (fingers got tighter), FATIGUE (tired) and VACCINATION SITE SWELLING (30-40 minutes after the injection her arm kept getting bigger,getting bigger) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058M21A and 039F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Dec-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (fingers got tighter), FATIGUE (tired) and VACCINATION SITE SWELLING (30-40 minutes after the injection her arm kept getting bigger,getting bigger). On 05-Dec-2021, MUSCULOSKELETAL STIFFNESS (fingers got tighter), FATIGUE (tired) and VACCINATION SITE SWELLING (30-40 minutes after the injection her arm kept getting bigger,getting bigger) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient stated that She called the pharmacist who recommended certain things and was told to call moderna or go to the ER if things got worse  No concomitant medications were used  For treatment patient used ice on her arm to help with the swelling
Age: 40.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Fatigue, Inappropriate schedule of product administration, Malaise, Pain in extremity, Somnolence
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Had to pull over and take a nap for 20 minutes), MALAISE (Did not feel well), PAIN IN EXTREMITY (Arm hurt all the way down to the wrist for 2 days, noting that it felt like carpel tunnel), FATIGUE (Super tired) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose: Pfizer, 2nd dose: Pfizer, Moderna Booster dose) in a 5-decade-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product INFLUENZA VACCINE (FLU) for an unknown indication. Previously administered products included for COVID-19 vaccination: Pfizer (2nd dose) and Pfizer (1st dose). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced SOMNOLENCE (Had to pull over and take a nap for 20 minutes) and FATIGUE (Super tired). 01-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose: Pfizer, 2nd dose: Pfizer, Moderna Booster dose). On 04-Dec-2021, the patient experienced MALAISE (Did not feel well) and PAIN IN EXTREMITY (Arm hurt all the way down to the wrist for 2 days, noting that it felt like carpel tunnel). On 01-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose: Pfizer, 2nd dose: Pfizer, Moderna Booster dose) had resolved. At the time of the report, SOMNOLENCE (Had to pull over and take a nap for 20 minutes), MALAISE (Did not feel well) and FATIGUE (Super tired) outcome was unknown and PAIN IN EXTREMITY (Arm hurt all the way down to the wrist for 2 days, noting that it felt like carpel tunnel) had resolved. No concomitant medications were provided. No treatment medications were reported. The patient was involved in their 40's. Patient's arm hurt all the way down to the wrist for 2 days.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Palpitations, Vaccination complication
Clinical narrative: maternal exposure during pregnanacy; 7 months pregnant, and she got the booster of the Moderna covid19 vaccine on the 11Dec2021 and got complications; palpitations; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (7 months pregnant, and she got the booster of the Moderna covid19 vaccine on the 11Dec2021 and got complications), PALPITATIONS (palpitations) and MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnanacy) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Dec-2021, the patient received third 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 12-Dec-2021, the patient experienced VACCINATION COMPLICATION (7 months pregnant, and she got the booster of the Moderna covid19 vaccine on the 11Dec2021 and got complications) and PALPITATIONS (palpitations). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnanacy). At the time of the report, VACCINATION COMPLICATION (7 months pregnant, and she got the booster of the Moderna covid19 vaccine on the 11Dec2021 and got complications) and PALPITATIONS (palpitations) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnanacy) had resolved.            No concomitant medications were provided by reporter. No treatment medications were provided by reporter  Patient mother had mentioned that her daughter received  for the first and second dose the Moderna covid19 vaccine, and that she was pregnant before the first dose
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 28 patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Product dose omission issue
Clinical narrative: Bad anxiety; It's been 7 months since I got the first shot; This spontaneous case was reported by an other health care professional and describes the occurrence of ANXIETY (Bad anxiety) and PRODUCT DOSE OMISSION ISSUE (It's been 7 months since I got the first shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 ANXIETY (Bad anxiety) and PRODUCT DOSE OMISSION ISSUE (It's been 7 months since I got the first shot). At the time of the report, ANXIETY (Bad anxiety) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (It's been 7 months since I got the first shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.   Reporter did not allow further contact
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 28 patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: JANSSEN COVID-19 Vaccine (first dose) on 14-Mar-2021. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 Vaccine.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Second dose was reported as NA
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Myalgia, Nausea, Vomiting
Clinical narrative: Headache; nausea; vomiting; body aches; red mark appeared around injection site 3 days after being injected.; This spontaneous case was reported by a non-health professional and describes the occurrence of HEADACHE (Headache), NAUSEA (nausea), VOMITING (vomiting), MYALGIA (body aches) and INJECTION SITE ERYTHEMA (red mark appeared around injection site 3 days after being injected.) 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 HEADACHE (Headache), NAUSEA (nausea), VOMITING (vomiting), MYALGIA (body aches) and INJECTION SITE ERYTHEMA (red mark appeared around injection site 3 days after being injected.). At the time of the report, HEADACHE (Headache), NAUSEA (nausea), VOMITING (vomiting), MYALGIA (body aches) and INJECTION SITE ERYTHEMA (red mark appeared around injection site 3 days after being injected.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LIOTHYRONINE, LEVOTHYROXINE, AMLODIPINE and LOSARTAN for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-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 INFLUENZA LIKE ILLNESS (flu-like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms) outcome was unknown.            No treatment details were reported for dose-2 event.   This case was linked to MOD-2021-409280, MOD-2021-409287 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Epistaxis
Clinical narrative: nose bled again and went to emergency room; her nose stared pouring blood; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (her nose stared pouring blood) and EPISTAXIS (nose bled again and went to emergency room) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LIOTHYRONINE, LEVOTHYROXINE, AMLODIPINE and LOSARTAN for an unknown indication.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Nov-2021 at 8:00 AM, the patient experienced EPISTAXIS (her nose stared pouring blood). On 06-Nov-2021, the patient experienced EPISTAXIS (nose bled again and went to emergency room). On 05-Nov-2021, EPISTAXIS (her nose stared pouring blood) had resolved. At the time of the report, EPISTAXIS (nose bled again and went to emergency room) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Nov-2021, Blood Presuure: 195/114, 178/73 & 140/82. (abnormal) abnormal. On an unknown date, Computerised tomogram: negative Due to a fall she had prior doctors thought she hit her head but she said she never did..         No Treatment information was provided.  she states her blood pressure is usually controlled around 130/75.   This case was linked to MOD-2021-409286, MOD-2021-409280, MOD-2021-409286 (Patient Link).
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 28 patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer (First dose) on 10-Apr-2021 and Pfizer (Second dose) on 10-May-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Feeding disorder, Illness, Weight decreased
Clinical narrative: lost 20% of his body wake for starvation,; he had to force feed himself, look like he was  in a camp for loosing so much weight.; not going to take the booster because the vaccine  made him sick; having no apatite again/lost appetite, and no one as severe as him,  that lost for 5 weeks; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (having no apatite again/lost appetite, and no one as severe as him,  that lost for 5 weeks), WEIGHT DECREASED (lost 20% of his body wake for starvation,), FEEDING DISORDER (he had to force feed himself, look like he was  in a camp for loosing so much weight.) and ILLNESS (not going to take the booster because the vaccine  made him sick) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053C21A and 041B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FUROSEMIDE for Bladder infection, FINASTERIDE, TAMSULOSIN and CALCIUM for an unknown indication.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jun-2021, the patient experienced DECREASED APPETITE (having no apatite again/lost appetite, and no one as severe as him,  that lost for 5 weeks). On an unknown date, the patient experienced WEIGHT DECREASED (lost 20% of his body wake for starvation,), FEEDING DISORDER (he had to force feed himself, look like he was  in a camp for loosing so much weight.) and ILLNESS (not going to take the booster because the vaccine  made him sick). The patient was treated with NITROFURANTOIN (NITROFUR) at an unspecified dose and frequency. On 22-Aug-2021, DECREASED APPETITE (having no apatite again/lost appetite, and no one as severe as him,  that lost for 5 weeks) had resolved. At the time of the report, WEIGHT DECREASED (lost 20% of his body wake for starvation,), FEEDING DISORDER (he had to force feed himself, look like he was  in a camp for loosing so much weight.) and ILLNESS (not going to take the booster because the vaccine  made him sick) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-408617 (Patient Link).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Patient was mistakenely administered a half dose of the Moderna COVID-19 vaccine instead of a full dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was mistakenely administered a half dose of the Moderna COVID-19 vaccine instead of a full dose) in a 42-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 12-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (Patient was mistakenely administered a half dose of the Moderna COVID-19 vaccine instead of a full dose). On 12-Dec-2021, ACCIDENTAL UNDERDOSE (Patient was mistakenely administered a half dose of the Moderna COVID-19 vaccine instead of a full dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. The patient reports experiencing no symptoms as of yet.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Vaccination site pain
Clinical narrative: Enough to keep me awake at night; Pain on injection site; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Enough to keep me awake at night) and VACCINATION SITE PAIN (Pain on injection site) 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 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Dec-2021, the patient experienced INSOMNIA (Enough to keep me awake at night) and VACCINATION SITE PAIN (Pain on injection site). At the time of the report, INSOMNIA (Enough to keep me awake at night) and VACCINATION SITE PAIN (Pain on injection site) outcome was unknown.            Concomitant medication was not provided. Treatment information was not provided.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Head discomfort, Headache
Clinical narrative: sensation on top of head like it's wet; headache, which has not subsided; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (sensation on top of head like it's wet) and HEADACHE (headache, which has not subsided) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: J&J COVID-19 Vaccine (First dose (Batch Number: 043A21A)) on 08-Apr-2021. Past adverse reactions to the above products included No adverse event with J&J COVID-19 Vaccine. Concurrent medical conditions included Blood pressure. Concomitant products included METFORMIN and ROSUVASTATIN for an unknown indication.    On 09-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (headache, which has not subsided). On 12-Dec-2021, the patient experienced HEAD DISCOMFORT (sensation on top of head like it's wet). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, HEAD DISCOMFORT (sensation on top of head like it's wet) outcome was unknown and HEADACHE (headache, which has not subsided) had not resolved.            Concomitant medication of the patient also included blood pressure medication at a frequency of once a day.  The booster dose was injected in the left nondominant arm.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired dose administered to patients; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) 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 EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter who was a Physician stated that 3 vials of the Moderna COVID-19 vaccine were used to administer the COVID-19 vaccine to patients and after the vials had been used, they realized that some patients had received the Moderna vaccine more than 12 hours after the vials had been punctured.   The number of patients affected was unknown at the time of reporting and said that this incidence was still being investigated and only limited information was available at this time. The dosage for the patients ranged from 1st, 2nd, or booster dose and the date of administration ranged from 4-Dec-2021-10-Dec-2021. Reportedly, there were no known side effects that have been reported by the patients from the expired dose.  No Concomitant product use was reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: was supposed to give a full dose but gave the half booster dose; This spontaneous case was reported by a health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (was supposed to give a full dose but gave the half booster dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (was supposed to give a full dose but gave the half booster dose). At the time of the report, ACCIDENTAL UNDERDOSE (was supposed to give a full dose but gave the half booster dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter.  No treatment information provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient administered dose from a Moderna COVID-19 vaccine vial 18 hours after puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered dose from a Moderna COVID-19 vaccine vial 18 hours after puncture) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Dec-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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered dose from a Moderna COVID-19 vaccine vial 18 hours after puncture). On 12-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Patient administered dose from a Moderna COVID-19 vaccine vial 18 hours after puncture) 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 medications were reported.  Date the vial was initially stored in the refrigerator 09 DEC 2021. Date and time vial was first punctured 11 DEC 2021 5:30pm. Date of administration of vaccine 12 DEC 2021 11:30 am.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dehydration, Electrocardiogram, Feeling cold, Heart rate
Clinical narrative: was dehydrated; was frequently urinating; couldn't get warm; couldn't sleep; heart was beating fast/ had tachycardia/thought that she was going to have a heart attack; had chills; This spontaneous case was reported by a patient and describes the occurrence of DEHYDRATION (was dehydrated), POLLAKIURIA (was frequently urinating), FEELING COLD (couldn't get warm), INSOMNIA (couldn't sleep) and TACHYCARDIA (heart was beating fast/ had tachycardia/thought that she was going to have a heart attack) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 040A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021 at 9:30 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021 at 10:00 AM, the patient experienced POLLAKIURIA (was frequently urinating), FEELING COLD (couldn't get warm), INSOMNIA (couldn't sleep), TACHYCARDIA (heart was beating fast/ had tachycardia/thought that she was going to have a heart attack) and CHILLS (had chills). On 23-Nov-2021 at 1:00 AM, the patient experienced DEHYDRATION (was dehydrated). At the time of the report, DEHYDRATION (was dehydrated), POLLAKIURIA (was frequently urinating), FEELING COLD (couldn't get warm), INSOMNIA (couldn't sleep) and CHILLS (had chills) outcome was unknown and TACHYCARDIA (heart was beating fast/ had tachycardia/thought that she was going to have a heart attack) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Nov-2021, Heart rate: 143 (High) Patient had put on Apple Watch & it showed heart was beating at 143 beats/min.. On 24-Nov-2021, Heart rate: increased (High) got under 100 beats/min. On 03-Dec-2021, Electrocardiogram: normal (normal) Patient went to see a cardiologist. They ordered an EKG, which was normal. On an unknown date, Heart rate: 67 (normal) normal heart rate was around 67 beats/min and high heart was still beating fast.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported. On 23-Nov-2021 they also checked to see if she had the heart problems that some people get with the vaccine which was negative.    This case was linked to MOD-2021-409602 (Patient Link).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pollakiuria, Tachycardia
Clinical narrative: was dehydrated; was frequently urinating; couldn't get warm; couldn't sleep; heart was beating fast/ had tachycardia/thought that she was going to have a heart attack; had chills; This spontaneous case was reported by a patient and describes the occurrence of DEHYDRATION (was dehydrated), POLLAKIURIA (was frequently urinating), FEELING COLD (couldn't get warm), INSOMNIA (couldn't sleep) and TACHYCARDIA (heart was beating fast/ had tachycardia/thought that she was going to have a heart attack) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 040A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021 at 9:30 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021 at 10:00 AM, the patient experienced POLLAKIURIA (was frequently urinating), FEELING COLD (couldn't get warm), INSOMNIA (couldn't sleep), TACHYCARDIA (heart was beating fast/ had tachycardia/thought that she was going to have a heart attack) and CHILLS (had chills). On 23-Nov-2021 at 1:00 AM, the patient experienced DEHYDRATION (was dehydrated). At the time of the report, DEHYDRATION (was dehydrated), POLLAKIURIA (was frequently urinating), FEELING COLD (couldn't get warm), INSOMNIA (couldn't sleep) and CHILLS (had chills) outcome was unknown and TACHYCARDIA (heart was beating fast/ had tachycardia/thought that she was going to have a heart attack) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Nov-2021, Heart rate: 143 (High) Patient had put on Apple Watch & it showed heart was beating at 143 beats/min.. On 24-Nov-2021, Heart rate: increased (High) got under 100 beats/min. On 03-Dec-2021, Electrocardiogram: normal (normal) Patient went to see a cardiologist. They ordered an EKG, which was normal. On an unknown date, Heart rate: 67 (normal) normal heart rate was around 67 beats/min and high heart was still beating fast.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported. On 23-Nov-2021 they also checked to see if she had the heart problems that some people get with the vaccine which was negative.    This case was linked to MOD-2021-409602 (Patient Link).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: had the Covid arm for about 24 hrs. It was a red square patch on my left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (had the Covid arm for about 24 hrs. It was a red square patch on my left arm) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE ERYTHEMA (had the Covid arm for about 24 hrs. It was a red square patch on my left arm). On 20-Mar-2021, VACCINATION SITE ERYTHEMA (had the Covid arm for about 24 hrs. It was a red square patch on my left arm) had resolved.            Concomitant drugs were not reported. Treatment medications were not provided.  Patient DOB was reported as ??-???-1976.   This case was linked to MOD-2021-409598 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: I am having a 100 degree fever; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (I am having a 100 degree fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (I am having a 100 degree fever). At the time of the report, PYREXIA (I am having a 100 degree fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) 100 degree fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment medication was not provided by the reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Quality of life decreased
Clinical narrative: It took two jabs for autoimmunity to set into me. They stole my quality of life; This spontaneous case was reported by a consumer and describes the occurrence of QUALITY OF LIFE DECREASED (It took two jabs for autoimmunity to set into me. They stole my quality of life) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced QUALITY OF LIFE DECREASED (It took two jabs for autoimmunity to set into me. They stole my quality of life). At the time of the report, QUALITY OF LIFE DECREASED (It took two jabs for autoimmunity to set into me. They stole my quality of life) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   Reporter did not allow further contact
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Inappropriate schedule of product administration, Palpitations
Clinical narrative: heart palpitations; Pfizer first and second shot; weakness; dizziness; headache; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpitations), ASTHENIA (weakness), DIZZINESS (dizziness), HEADACHE (headache) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pfizer first and second shot) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (first and second shot). Past adverse reactions to the above products included No adverse event with Pfizer. Concurrent medical conditions included Blood pressure high (its controlled and take medication.), Penicillin allergy and Sulfonamide allergy (sulfa).    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Dec-2021, the patient experienced ASTHENIA (weakness), DIZZINESS (dizziness) and HEADACHE (headache). On an unknown date, the patient experienced PALPITATIONS (heart palpitations) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pfizer first and second shot). At the time of the report, PALPITATIONS (heart palpitations) had not resolved, ASTHENIA (weakness), DIZZINESS (dizziness) and HEADACHE (headache) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pfizer first and second shot) had resolved.            Concomitant medication include unspecified medication for high blood pressure.  No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Has side effects) 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 VACCINATION COMPLICATION (Has side effects). At the time of the report, VACCINATION COMPLICATION (Has side effects) outcome was unknown.            Concomitant information was not provided. Treatment information was not provided.   This case was linked to MOD-2021-409793 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Erythema, Feeling hot, Insomnia, Muscle rigidity
Clinical narrative: couldn't sleep on her side; right arm was warm; had a reaction/not normal; area that looks bruised (right arm); right arm was very solid; right arm was swollen; right arm was red/ looks like a blood vessel is in it; right arm was sore; soreness of the injection site area; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (couldn't sleep on her side), FEELING HOT (right arm was warm), VACCINATION COMPLICATION (had a reaction/not normal), CONTUSION (area that looks bruised (right arm)) and MUSCLE RIGIDITY (right arm was very solid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Dec-2021, the patient experienced INSOMNIA (couldn't sleep on her side), FEELING HOT (right arm was warm), VACCINATION COMPLICATION (had a reaction/not normal), CONTUSION (area that looks bruised (right arm)), MUSCLE RIGIDITY (right arm was very solid), PERIPHERAL SWELLING (right arm was swollen), ERYTHEMA (right arm was red/ looks like a blood vessel is in it), PAIN IN EXTREMITY (right arm was sore) and VACCINATION SITE PAIN (soreness of the injection site area). The patient was treated with Physical therapy (cold pack) for Feeling hot; Physical therapy (cold pack) for Contusion; Physical therapy (cold pack) for Muscle rigidity; Physical therapy (cold pack) for Peripheral swelling; Physical therapy (cold pack) for Erythema; Physical therapy (cold pack) for Pain in extremity and Physical therapy (cold pack) for Vaccination site pain. At the time of the report, INSOMNIA (couldn't sleep on her side), FEELING HOT (right arm was warm), VACCINATION COMPLICATION (had a reaction/not normal), CONTUSION (area that looks bruised (right arm)), MUSCLE RIGIDITY (right arm was very solid), PERIPHERAL SWELLING (right arm was swollen), ERYTHEMA (right arm was red/ looks like a blood vessel is in it), PAIN IN EXTREMITY (right arm was sore) and VACCINATION SITE PAIN (soreness of the injection site area) outcome was unknown.            Concomitant product use was not provided by the reporter.  Patient reported that she placed a cold pack on her right arm one night and she slept in a chair because she couldn't sleep on her side because of her swollen and sore arm. Patient received her first two Moderna doses prior to the Moderna booster dose.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Vaccination complication, Vaccination site pain
Clinical narrative: couldn't sleep on her side; right arm was warm; had a reaction/not normal; area that looks bruised (right arm); right arm was very solid; right arm was swollen; right arm was red/ looks like a blood vessel is in it; right arm was sore; soreness of the injection site area; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (couldn't sleep on her side), FEELING HOT (right arm was warm), VACCINATION COMPLICATION (had a reaction/not normal), CONTUSION (area that looks bruised (right arm)) and MUSCLE RIGIDITY (right arm was very solid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Dec-2021, the patient experienced INSOMNIA (couldn't sleep on her side), FEELING HOT (right arm was warm), VACCINATION COMPLICATION (had a reaction/not normal), CONTUSION (area that looks bruised (right arm)), MUSCLE RIGIDITY (right arm was very solid), PERIPHERAL SWELLING (right arm was swollen), ERYTHEMA (right arm was red/ looks like a blood vessel is in it), PAIN IN EXTREMITY (right arm was sore) and VACCINATION SITE PAIN (soreness of the injection site area). The patient was treated with Physical therapy (cold pack) for Feeling hot; Physical therapy (cold pack) for Contusion; Physical therapy (cold pack) for Muscle rigidity; Physical therapy (cold pack) for Peripheral swelling; Physical therapy (cold pack) for Erythema; Physical therapy (cold pack) for Pain in extremity and Physical therapy (cold pack) for Vaccination site pain. At the time of the report, INSOMNIA (couldn't sleep on her side), FEELING HOT (right arm was warm), VACCINATION COMPLICATION (had a reaction/not normal), CONTUSION (area that looks bruised (right arm)), MUSCLE RIGIDITY (right arm was very solid), PERIPHERAL SWELLING (right arm was swollen), ERYTHEMA (right arm was red/ looks like a blood vessel is in it), PAIN IN EXTREMITY (right arm was sore) and VACCINATION SITE PAIN (soreness of the injection site area) outcome was unknown.            Concomitant product use was not provided by the reporter.  Patient reported that she placed a cold pack on her right arm one night and she slept in a chair because she couldn't sleep on her side because of her swollen and sore arm. Patient received her first two Moderna doses prior to the Moderna booster dose.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Nausea, Pyrexia
Clinical narrative: ringing in the ear,heart pounding fast in my ear; Fever/Temperature of 105.5; hard time getting up to going to bathroom; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in the ear,heart pounding fast in my ear), PYREXIA (Fever/Temperature of 105.5), FATIGUE (hard time getting up to going to bathroom), CHILLS (Chills) and NAUSEA (Nausea) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     The patient's past medical history included Ventricular contractions premature. Concurrent medical conditions included Cancer. Concomitant products included OLMESARTAN MEDOXOMIL (BENICAR), ALLOPURINOL (ZYLOPRIM) and VITAMIN D NOS for an unknown indication.    On 09-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced TINNITUS (ringing in the ear,heart pounding fast in my ear), PYREXIA (Fever/Temperature of 105.5), FATIGUE (hard time getting up to going to bathroom), CHILLS (Chills) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at an unspecified dose and frequency. At the time of the report, TINNITUS (ringing in the ear,heart pounding fast in my ear), PYREXIA (Fever/Temperature of 105.5), FATIGUE (hard time getting up to going to bathroom), CHILLS (Chills) and NAUSEA (Nausea) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Dec-2021, Body temperature: 105.5 (High) 105.5.         Patient did state in the past they have Pre-mature Ventricular Contraction (PVC) but this time it was not like that since their blood pressure was normal. Patient also stated they did not decide to contact their HCP since the fever and other symptoms have been subsided. Patient did mention during the end of the call that they will contact their HCP since they have cancer and other underlying conditions.