chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, COVID-19, Headache, Myalgia, Oropharyngeal pain
Clinical narrative: tested positive for covid after 2 doses of Moderna vaccine; loss of taste; sore throat; headache; moderate to severe muscle aching; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (tested positive for covid after 2 doses of Moderna vaccine), AGEUSIA (loss of taste), OROPHARYNGEAL PAIN (sore throat), HEADACHE (headache) and MYALGIA (moderate to severe muscle aching) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced COVID-19 (tested positive for covid after 2 doses of Moderna vaccine), AGEUSIA (loss of taste), OROPHARYNGEAL PAIN (sore throat), HEADACHE (headache) and MYALGIA (moderate to severe muscle aching). At the time of the report, COVID-19 (tested positive for covid after 2 doses of Moderna vaccine), AGEUSIA (loss of taste), OROPHARYNGEAL PAIN (sore throat), HEADACHE (headache) and MYALGIA (moderate to severe muscle aching) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medication were not reported.  Patient got her doses of Moderna COVID-19 vaccine in March 2021. Patient had the booster shot of Moderna after having had COVID.  Company comment: This case concerns a 68-year-old female patient, with no reported medical history, who experienced the non-serious, unexpected AESI events of Covid-19 and ageusia, 5 months after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). Patient had moderate Covid, but did not require hospitalization. Patient had headache, loss of taste, sore throat, and moderate to severe muscle aching. She had the booster dose after having Covid. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 68-year-old female patient, with no reported medical history, who experienced the non-serious, unexpected AESI events of Covid-19 and ageusia, 5 months after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). Patient had moderate Covid, but did not require hospitalization. Patient had headache, loss of taste, sore throat, and moderate to severe muscle aching. She had the booster dose after having Covid. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: tested positive for covid after 2 doses of Moderna vaccine; loss of taste; sore throat; headache; moderate to severe muscle aching; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (tested positive for covid after 2 doses of Moderna vaccine), AGEUSIA (loss of taste), OROPHARYNGEAL PAIN (sore throat), HEADACHE (headache) and MYALGIA (moderate to severe muscle aching) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced COVID-19 (tested positive for covid after 2 doses of Moderna vaccine), AGEUSIA (loss of taste), OROPHARYNGEAL PAIN (sore throat), HEADACHE (headache) and MYALGIA (moderate to severe muscle aching). At the time of the report, COVID-19 (tested positive for covid after 2 doses of Moderna vaccine), AGEUSIA (loss of taste), OROPHARYNGEAL PAIN (sore throat), HEADACHE (headache) and MYALGIA (moderate to severe muscle aching) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medication were not reported.  Patient got her doses of Moderna COVID-19 vaccine in March 2021. Patient had the booster shot of Moderna after having had COVID.  Company comment: This case concerns a 68-year-old female patient, with no reported medical history, who experienced the non-serious, unexpected AESI events of Covid-19 and ageusia, 5 months after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). Patient had moderate Covid, but did not require hospitalization. Patient had headache, loss of taste, sore throat, and moderate to severe muscle aching. She had the booster dose after having Covid. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 68-year-old female patient, with no reported medical history, who experienced the non-serious, unexpected AESI events of Covid-19 and ageusia, 5 months after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). Patient had moderate Covid, but did not require hospitalization. Patient had headache, loss of taste, sore throat, and moderate to severe muscle aching. She had the booster dose after having Covid. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chills, Death, Dyspnoea, Fatigue
Clinical narrative: several hours(2-4) later went to bed not feeling well; weak; Chills; Fatigue; Labored Breathing; shortly lost consciousness; Died; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (several hours(2-4) later went to bed not feeling well), ASTHENIA (weak), CHILLS (Chills), FATIGUE (Fatigue), DYSPNOEA (Labored Breathing), LOSS OF CONSCIOUSNESS (shortly lost consciousness) and DEATH (Died) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. #069H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer. Past adverse reactions to the above products included No adverse event with Pfizer. Concurrent medical conditions included Lupus syndrome (lupus).    On 15-Dec-2021 at 4:40 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Dec-2021, the patient experienced MALAISE (several hours(2-4) later went to bed not feeling well) (seriousness criterion death), ASTHENIA (weak) (seriousness criterion death), CHILLS (Chills) (seriousness criterion death), FATIGUE (Fatigue) (seriousness criterion death), DYSPNOEA (Labored Breathing) (seriousness criterion death), LOSS OF CONSCIOUSNESS (shortly lost consciousness) (seriousness criteria death and medically significant) and DEATH (Died) (seriousness criteria death and medically significant). The patient died on 15-Dec-2021. The reported cause of death was several hours (2-4) later went to bed not feeling well, weak, Chills, Fatigue, Labored breathing and shortly lost consciousness. It is unknown if an autopsy was performed.            No concomitant medication was provided by reporter. Patient shortly lost consciousness Paramedics called, Husband and Daughter applied CPR in the interim could not Resuscitate. No treatment drug was provided by reporter.; Sender's Comments: This case concerns a 75-year-old patient (gender not provided) with no relevant medical history, who experienced the unexpected events of Malaise, Asthenia, Chills, Fatigue, Dyspnea, Loss of Consciousness. The events occurred several hours after the booster dose of mRNA-1273 (Moderna Covid-19 vaccine); and resulted in death. The rechallenge was not applicable as events occurred after booster dose with fatal outcome. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.; Reported Cause(s) of Death: several hours (2-4) later went to bed not feeling well; Weak; Chills; Fatigue; Labored Breathing; shortly lost consciousness; Died
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Loss of consciousness, Malaise
Clinical narrative: several hours(2-4) later went to bed not feeling well; weak; Chills; Fatigue; Labored Breathing; shortly lost consciousness; Died; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (several hours(2-4) later went to bed not feeling well), ASTHENIA (weak), CHILLS (Chills), FATIGUE (Fatigue), DYSPNOEA (Labored Breathing), LOSS OF CONSCIOUSNESS (shortly lost consciousness) and DEATH (Died) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. #069H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer. Past adverse reactions to the above products included No adverse event with Pfizer. Concurrent medical conditions included Lupus syndrome (lupus).    On 15-Dec-2021 at 4:40 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Dec-2021, the patient experienced MALAISE (several hours(2-4) later went to bed not feeling well) (seriousness criterion death), ASTHENIA (weak) (seriousness criterion death), CHILLS (Chills) (seriousness criterion death), FATIGUE (Fatigue) (seriousness criterion death), DYSPNOEA (Labored Breathing) (seriousness criterion death), LOSS OF CONSCIOUSNESS (shortly lost consciousness) (seriousness criteria death and medically significant) and DEATH (Died) (seriousness criteria death and medically significant). The patient died on 15-Dec-2021. The reported cause of death was several hours (2-4) later went to bed not feeling well, weak, Chills, Fatigue, Labored breathing and shortly lost consciousness. It is unknown if an autopsy was performed.            No concomitant medication was provided by reporter. Patient shortly lost consciousness Paramedics called, Husband and Daughter applied CPR in the interim could not Resuscitate. No treatment drug was provided by reporter.; Sender's Comments: This case concerns a 75-year-old patient (gender not provided) with no relevant medical history, who experienced the unexpected events of Malaise, Asthenia, Chills, Fatigue, Dyspnea, Loss of Consciousness. The events occurred several hours after the booster dose of mRNA-1273 (Moderna Covid-19 vaccine); and resulted in death. The rechallenge was not applicable as events occurred after booster dose with fatal outcome. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.; Reported Cause(s) of Death: several hours (2-4) later went to bed not feeling well; Weak; Chills; Fatigue; Labored Breathing; shortly lost consciousness; Died
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Product temperature excursion issue; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. 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 11-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue). On 11-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  No Treatment information was reported.   This case was linked to MOD-2021-421651 (Patient Link).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Maternal exposure during pregnancy
Clinical narrative: maternal exposure during pregnancy; Expired vaccine used; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A, 003B21 and 038B21A) for COVID-19 vaccination.     The patient's past medical history included Diarrhea. Family history included Family history of cancer (Family history of breast cancer, paternal aunt and grandmother). Concurrent medical conditions included Hyperlipidemia, Hypothyroidism, Migraine headache and Breast nodule (Benign nodule of breast of right). Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXIN ALMUS), RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE ODT), FEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (ALLEGRA D), RIBOFLAVIN SODIUM PHOSPHATE (RIBOFLAVIN [RIBOFLAVIN SODIUM PHOSPHATE]), MAGNESIUM, UBIDECARENONE (COQ 10) and VITAMIN D3 for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. Last menstrual period and estimated date of delivery were not provided. On 24-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). On 24-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no treatment details were reported. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Exposure via ingestion: not reported not reported. On an unknown date, Investigation: not reported not reported, not reported not reported, not reported not reported, not reported not reported, not reported not reported, not reported not reported and not reported not reported. On an unknown date, Laboratory test: not reported not reported. On an unknown date, Physical examination: not reported not reported.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Myalgia
Clinical narrative: Chills; Body aches; swollen lymph node on right side by neck; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), MYALGIA (Body aches) and LYMPHADENOPATHY (swollen lymph node on right side by neck) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040b21a) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to nuts, Fruit allergy, Drug allergy (Omicillin), Allergy to antibiotic (Allergic to Bactrim), Sulfonamide allergy, Drug allergy (Allergy to Keflex), Drug allergy (Morphine), Seasonal allergy, Vegetable allergy (Allergy to Carrots), Vegetable allergy (celery allergy) and Fruit allergy (Allergic to lemon). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy.    On 12-Aug-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Sep-2021 at 7:00 PM, the patient experienced CHILLS (Chills), MYALGIA (Body aches) and LYMPHADENOPATHY (swollen lymph node on right side by neck). On 21-Sep-2021, CHILLS (Chills), MYALGIA (Body aches) and LYMPHADENOPATHY (swollen lymph node on right side by neck) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment details were reported.   This case was linked to MOD-2021-405344 (Patient Link).
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown.            No concomitant medications were mentioned. No treatment details were reported.   This case was linked to MOD-2021-427028 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding
Clinical narrative: Breastfeeding mother got the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding mother got the vaccine) 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 MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding mother got the vaccine). At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding mother got the vaccine) had resolved.            concomitant medications list was not provided. Treatment information was not provided.   Patient had a 6-month-old and just got her Moderna Covid19 vaccine. She was wondering if there was data about transmitting through breast milk and even though she was vaccinated can she still possibly transmit the virus to her baby.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Insomnia, Sinusitis
Clinical narrative: issues sleeping at night; can't breathe; something with her sinus; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (issues sleeping at night), DYSPNOEA (can't breathe) and SINUSITIS (something with her sinus) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A, 003B21A and 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-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 experienced INSOMNIA (issues sleeping at night), DYSPNOEA (can't breathe) and SINUSITIS (something with her sinus). At the time of the report, INSOMNIA (issues sleeping at night), DYSPNOEA (can't breathe) and SINUSITIS (something with her sinus) outcome was unknown.            Treatment information was reported that patient had taken cold medicine for adverse event on unknown date through unknown route of administration. It was reported that the patient would go to see her doctor next week. No Concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Fall, Upper limb fracture
Clinical narrative: fell; broke her arm; This spontaneous case was reported by a consumer and describes the occurrence of FALL (fell) and UPPER LIMB FRACTURE (broke her arm) 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 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced FALL (fell) and UPPER LIMB FRACTURE (broke her arm). At the time of the report, FALL (fell) and UPPER LIMB FRACTURE (broke her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The next day after vaccination she broke her arm because she fell.  No Concomitant medications were reported. No Treatment information was reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 5 doses administered more than 12 hours after 1st puncture of the vials; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 doses administered more than 12 hours after 1st puncture of the vials) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021 at 8:59 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 doses administered more than 12 hours after 1st puncture of the vials). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (5 doses administered more than 12 hours after 1st puncture of the vials) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reported stated that dose was administered after 12 hours post puncture, number of doses/vials: 1 doses/1 vials, , Date the vial was initially stored in the refrigerator: 22Sep2021. On 30-Sep-2021 at 10:17 am the vial was first punctured. The vial was stored in fridge post puncture. The vial did not go under any temperature excursions. The total amount of time the vial was exposed to room temperature range was 15 minutes.  No concomitant drugs were reported. No treatment drugs were reported.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: a lot of people are having heart problems after Covid vaccines; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (a lot of people are having heart problems after Covid vaccines) 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 CARDIAC DISORDER (a lot of people are having heart problems after Covid vaccines). At the time of the report, CARDIAC DISORDER (a lot of people are having heart problems after Covid vaccines) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-403109 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort
Clinical narrative: stomach stuff after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach stuff after 1st dose) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN, HCTZ and METOPROLOL for an unknown indication.    On 25-Mar-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 ABDOMINAL DISCOMFORT (stomach stuff after 1st dose). At the time of the report, ABDOMINAL DISCOMFORT (stomach stuff after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included Tylenol after booster dose.   This case was linked to MOD-2021-402868, MOD-2021-402869 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: She had a sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (She had a sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (She had a sore arm). At the time of the report, PAIN IN EXTREMITY (She had a sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported.   This case was linked to MOD-2021-402946, MOD-2021-402949 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication was not reported. Treatment information was not reported.   This case was linked to MOD-2021-403139 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: Gout breakout; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (Gout breakout) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Gout (He has had gout for 10 years and does not believe it is related to getting the COVID 19 vaccine.).    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 GOUT (Gout breakout). The patient was treated with COLCHICINE for Adverse event, at an unspecified dose and frequency. At the time of the report, GOUT (Gout breakout) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter.; Sender's Comments: Case routed out of MR workflow as medical review is not required per new CMOP process for non serious cases.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Insomnia, Nervousness, Pain
Clinical narrative: can't sleep; feeling shaky and cold and achy; feeling shaky and cold and achy; feeling shaky and cold and achy; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (can't sleep), NERVOUSNESS (feeling shaky and cold and achy), FEELING COLD (feeling shaky and cold and achy) and PAIN (feeling shaky and cold and achy) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history was not reported by the reporter.  Concomitant products included INSULIN for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, the patient experienced INSOMNIA (can't sleep), NERVOUSNESS (feeling shaky and cold and achy), FEELING COLD (feeling shaky and cold and achy) and PAIN (feeling shaky and cold and achy). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) for Adverse event, at a dose of 2 baby aspirin. At the time of the report, INSOMNIA (can't sleep), NERVOUSNESS (feeling shaky and cold and achy), FEELING COLD (feeling shaky and cold and achy) and PAIN (feeling shaky and cold and achy) outcome was unknown.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: dizzy/lightheaded; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy/lightheaded) and FATIGUE (fatigue) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     The patient's past medical history included Knee surgery NOS (knee surgery due to arthritis.).    On 26-Mar-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 DIZZINESS (dizzy/lightheaded) and FATIGUE (fatigue). The patient was treated with RIVAROXABAN (XARELTO) for Adverse event, at a dose of 20 mg once a day and HYDROCHLOROTHIAZIDE for Adverse event, at a dose of 12.5 mg once a day. At the time of the report, DIZZINESS (dizzy/lightheaded) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter.   This case was linked to MOD-2021-403388 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Hypokinesia, Muscle spasms, Pain in extremity
Clinical narrative: I have pain in both hands, my thumbs are worse/My right thumb is worst, more painful/It's painful to use my thumbs; Had muscle spasms from my injection site shoulder & into my neck; I could hardly move my thumbs; I had so much pain in my joints; Arm pain / had muscle spasms from my injection site shoulder & into my neck; A severe headache for 24 hrs; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (I have pain in both hands, my thumbs are worse/My right thumb is worst, more painful/It's painful to use my thumbs), MUSCLE SPASMS (Had muscle spasms from my injection site shoulder & into my neck), HYPOKINESIA (I could hardly move my thumbs), ARTHRALGIA (I had so much pain in my joints) and VACCINATION SITE PAIN (Arm pain / had muscle spasms from my injection site shoulder & into my neck) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939909) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Osteoarthritis, Arthritis (arthritis in left thumb) and Joint disorder (basil joint issues in left hand).On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced MUSCLE SPASMS (Had muscle spasms from my injection site shoulder & into my neck), HYPOKINESIA (I could hardly move my thumbs), ARTHRALGIA (I had so much pain in my joints), VACCINATION SITE PAIN (Arm pain / had muscle spasms from my injection site shoulder & into my neck) and HEADACHE (A severe headache for 24 hrs). On 02-Dec-2021, the patient experienced PAIN IN EXTREMITY (I have pain in both hands, my thumbs are worse/My right thumb is worst, more painful/It's painful to use my thumbs). The patient was treated with HYDROCODONE for Adverse event, at a dose of 2 unit; PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and DICLOFENAC (VOLTAREN [DICLOFENAC]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (I have pain in both hands, my thumbs are worse/My right thumb is worst, more painful/It's painful to use my thumbs), MUSCLE SPASMS (Had muscle spasms from my injection site shoulder & into my neck), HYPOKINESIA (I could hardly move my thumbs) and ARTHRALGIA (I had so much pain in my joints) outcome was unknown and VACCINATION SITE PAIN (Arm pain / had muscle spasms from my injection site shoulder & into my neck) and HEADACHE (A severe headache for 24 hrs) had resolved. For 5 days patient couldn't even put on her socks.Concomitant medication details were not reported by the reporter. Treatment also included patient soaked her hands in hot water, & used a heating pad neither worked.This case was linked to MOD-2021-403846, MOD-2021-403852 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: I have pain in both hands, my thumbs are worse/My right thumb is worst, more painful/It's painful to use my thumbs; Had muscle spasms from my injection site shoulder & into my neck; I could hardly move my thumbs; I had so much pain in my joints; Arm pain / had muscle spasms from my injection site shoulder & into my neck; A severe headache for 24 hrs; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (I have pain in both hands, my thumbs are worse/My right thumb is worst, more painful/It's painful to use my thumbs), MUSCLE SPASMS (Had muscle spasms from my injection site shoulder & into my neck), HYPOKINESIA (I could hardly move my thumbs), ARTHRALGIA (I had so much pain in my joints) and VACCINATION SITE PAIN (Arm pain / had muscle spasms from my injection site shoulder & into my neck) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939909) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Osteoarthritis, Arthritis (arthritis in left thumb) and Joint disorder (basil joint issues in left hand).On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced MUSCLE SPASMS (Had muscle spasms from my injection site shoulder & into my neck), HYPOKINESIA (I could hardly move my thumbs), ARTHRALGIA (I had so much pain in my joints), VACCINATION SITE PAIN (Arm pain / had muscle spasms from my injection site shoulder & into my neck) and HEADACHE (A severe headache for 24 hrs). On 02-Dec-2021, the patient experienced PAIN IN EXTREMITY (I have pain in both hands, my thumbs are worse/My right thumb is worst, more painful/It's painful to use my thumbs). The patient was treated with HYDROCODONE for Adverse event, at a dose of 2 unit; PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and DICLOFENAC (VOLTAREN [DICLOFENAC]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (I have pain in both hands, my thumbs are worse/My right thumb is worst, more painful/It's painful to use my thumbs), MUSCLE SPASMS (Had muscle spasms from my injection site shoulder & into my neck), HYPOKINESIA (I could hardly move my thumbs) and ARTHRALGIA (I had so much pain in my joints) outcome was unknown and VACCINATION SITE PAIN (Arm pain / had muscle spasms from my injection site shoulder & into my neck) and HEADACHE (A severe headache for 24 hrs) had resolved. For 5 days patient couldn't even put on her socks.Concomitant medication details were not reported by the reporter. Treatment also included patient soaked her hands in hot water, & used a heating pad neither worked.This case was linked to MOD-2021-403846, MOD-2021-403852 (Patient Link).
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Lethargy
Clinical narrative: Lethargic for few minutes; This non-serious spontaneous safety report was received by a partner on 25-OCT-2021 and forwarded on 26-OCT-2021 from a nurse.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event of two month old baby received a dose of Vaxelis and had a reaction.  Further information is expected.  FOLLOW-UP INFORMATION was forwarded on 12-NOV-2021 from a nurse.  The case is maintained as non-serious.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event of Lethargic for few minutes.  No further information is expected.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, RV5
Symptoms: Gait disturbance, Lethargy
Clinical narrative: Extremities limp; Lethargic; This spontaneous safety report was received by the Regulatory Authority on 25-OCT-2021 and forwarded to Agency on 27-OCT-2021 from a nurse.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the events lethargy and gait disturbance.  No further information is expected since the reporter denied consent to be contacted.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: First dose received at 1 year and 2 months; Temperature excursion; This spontaneous safety report was received by the partner on 29-Oct-2021 and forwarded on 1-Nov-2021 from a consumer.  This case was considered non-valid due to no patient identifiers (temperature excursion only).  Due to the nature of the event, the causality between the event and Vaxelis was not applicable.  No further information is expected.  FOLLOW-UP INFORMATION was forwarded on 03-Dec-2021 from a nurse. Case became valid since patient identifiers were provided.  Reporter was not contacted by the patient's parent regarding any adverse event experienced.  No treatment was provided to the patient.  Due to the nature of the event, the causality between the event of First dose received at 1 year and 2 months and Vaxelis was not applicable.  No further information is expected.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Pyrexia
Clinical narrative: High Fever rate. Parent called on the 2nd day after vaccination. Sometimes parents want to talk with provider.; This non-serious spontaneous safety report was received by a partner on 03-NOV-2021 and forwarded on 05-NOV-2021 from a health care professional.  The reporter did not provide as assessment of the causal relationship between Vaxelis and the reported event High fever rate, parent called on the 2nd day after vaccination.  Further information is expected.
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, HIBV, RV5
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient received Vaxelis plus PEDVAXHIB in error. PREVENAR was intended to be given instead of PEDVAX; Received 2 doses of HIB (Vaxelis and PEDVAXHIB); This spontaneous safety report was received by the partner on 22-Nov-2021 and forwarded on 23-Nov-2021 from a health care professional.  Due to the nature of the event, the causality between "patient received Vaxelis plus PedvaxHIB in error" and Vaxelis was not applicable.  No further information is expected.  FOLLOW-UP INFORMATION was received by partner on 02-DEC-2021 and forwarded on 03-DEC-2021 and ADDITIONAL INFORMATION was received by partner on 06-DEC-2021 and forwarded on the same date.   A 2-month-old female patient was vaccinated with Vaxelis (batch# U7124AA) and PEDVAXHIB (batch# T042015) in error. The reporter stated that Prevnar 13 was intended to be given instead of PEDVAXHIB.  Therefore, the patient accidentally received 2 doses of HIB. No adverse event was experienced by the patient.   Due to the nature of the event, the causality between "received 2 doses of HIB (Vaxelis and PEDVAXHIB)" and Vaxelis is not applicable.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Temperature excursion; This spontaneous non-serious safety report was received on 03-Dec-2021 via Fax by the reporter, from a nurse.  A source case was databased with the following number: MCM-002828.  Due to the nature of the event (temperature excursion only), the causality between the event and Vaxelis was not applicable.  No further information is expected.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Pyrexia
Clinical narrative: Patient was given the 4mo dose of Vaxelis and parent called in the next day and reported the patient had 104 degree fever.; This non-serious spontaneous safety report was received by a partner on 09-DEC-2021 and forwarded to Agency on 10-DEC-2021 from a healthcare professional .  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event of patient was given the "4mo dose of Vaxelis" and the next day the patient had 104 degree fever.  No further information is expected.
Age: 0.17
Sex: U
Vaccine: DTPPVHBHPB, HEP
Symptoms: Wrong product administered
Clinical narrative: Patient inadivertently admnistered Vaxelis and Engerix; This non-serious spontaneous safety report with the following reference numbers #02078030 and #02078019 was received by a partner on 20-DEC-2021 and forwarded to Agency on 21-DEC-2021 from a health care professional.  The causal relationship between Vaxelis and the reported event "Patient inadvertently administered Vaxelis and Engerix" was assessed as not applicable due to the nature of the event.  Further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: pain behind my left knee in the bend; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Jun2021 (Batch/Lot number: unknown) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anaemia" (unspecified if ongoing). There were no concomitant medications. The following information was reported: ARTHRALGIA (non-serious) with onset 26Jun2021, outcome "not recovered", described as "pain behind my left knee in the bend". Therapeutic measures were not taken as a result of arthralgia.  Additional information:The patient had no known allergies.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100913031 same patient, different dose vaccine and similar event.
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: neck was swollen; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SWELLING (non-serious), outcome "unknown", described as "neck was swollen".  Additional information: No patient identifiers were provided but the reporter has first hand knowledge of the patient and was reporting on a specific patient. Below is the verbatim report. Caller wanted to know if she took the vaccine will that vaccine cause tb germs to become active. Caller also said that her husband took the vaccine and the glands in his neck was swollen. Submitted AE.  Medical Information (MI): There were any medical questions addressed by this program forwarded/addressed by this program forwarded/referred to medical information. Customer and/or medical inquiry forwarded or referred to MI.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Anosmia
Clinical narrative: Has anyone reported the loss of smell, from having the second vaccine.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANOSMIA (non-serious), outcome "unknown", described as "Has anyone reported the loss of smell, from having the second vaccine.".  Additional information: Reporter just have a question, has anyone reported the loss of smell from having the second vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Swelling of eyelid
Clinical narrative: eyelids were swollen; whole eye area was very swollen; This is a spontaneous report received from contactable consumer from medical information team. The reporter is the patient.  A 68 year-old female patient received pneumococcal 13-valent conjugated vaccine (diphteria crm197 protein) (PREVNAR 13), administered in arm left, administration date 2019 (Batch/Lot number: unknown) at the age of 66 years as dose number unknown, single for immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing); "thyroid problem" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN taken for blood cholesterol increased; PANTOPRAZOLE taken for gastrooesophageal reflux disease, start date: 2012; IRBESARTAN taken for blood pressure measurement, start date: 2010. The following information was reported: SWELLING OF EYELID (non-serious) with onset 2019, outcome "unknown", described as "eyelids were swollen"; EYE SWELLING (non-serious) with onset 2019, outcome "unknown", described as "whole eye area was very swollen". Additional information: In 2019 the patient received a Prevnar 13 vaccine and her eyelids and pretty much around her whole eye area were very swollen, though her eyelids were like whoa. She says it was very swollen like she had consumed a lot of salt, like eating gallons of Chinese food. She says her doctor said this could have been a possible side effect. She says she googled swollen eyelid without incidence and it said it could be a reaction to polyethylene glycol or polysorbate, and to see an allergist  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.