chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Abdominal symptom, Magnetic resonance imaging, Thrombosis
Clinical narrative: BLOOD CLOTS IN CHEST; SEVERE PAIN ON RIGHT HAND SIDE OF THE STOMACH; ABDOMEN PROBLEM; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's past medical history included: operation in intestine, and other pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 and expiry: UNKNOWN) dose was not reported, 1 total, administered in left arm on 04-MAY-2021 for prophylactic vaccination. The dose number series was 1. No concomitant medications were reported.  On 23-MAY-2021, the patient experienced blood clots in chest, severe pain on right hand side of the stomach and abdomen problem. The patient was admitted to hospital by a helicopter on 23-MAY-2021 and was hospitalized for 3 weeks (18 days) and discharged on 9-JUN-2021. The patient stated he had blood clots and abdomen problem for which he received an intestinal operation during his hospital stay which was not related to vaccine. On MAY-2021, the patient received MRI and injections on his leg and was diagnosed with 2 blood clots on his chest. The patient was treated with apixaban for a little over 5 months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe pain on right hand side of the stomach, blood clots in chest and abdomen problem was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s and abdomen problem as not related. Company causality between covid-19 vaccine ad26.cov2.s and abdomen problem as not related. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20211164945- covid-19 vaccine ad26.cov2.s  blood clot in chest, severe pain on right hand side of the stomach and abdomen problem. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 68.0
Sex: F
Vaccine: FLUA4, FLUA4
Symptoms: Ear pain, Facial pain, Facial paralysis, Rhinalgia
Clinical narrative: Bell Palsy in right side of face. Feeling of numbness is better but has not faded as of Dec. 2. Oral pain and tooth uncomfortable, is better, and am no longer biting tongue when eating
Age: 68.0
Sex: F
Vaccine: FLUA4, FLUA4
Symptoms: Bell's palsy, Dental discomfort, Hypoaesthesia, Oral pain, Tongue biting
Clinical narrative: Bell Palsy in right side of face. Feeling of numbness is better but has not faded as of Dec. 2. Oral pain and tooth uncomfortable, is better, and am no longer biting tongue when eating
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site reaction, Pain in extremity, Rash
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications was reported  No treatment medications was reported   This case was linked to MOD-2021-396005, MOD-2021-395983 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications was reported  No treatment medications was reported   This case was linked to MOD-2021-396005, MOD-2021-395983 (Patient Link).
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Myalgia, Pain, SARS-CoV-2 test
Clinical narrative: Little bit of pain [after the first two doses]; Swelling [after the first two doses]; Muscle ache [after the first two doses]; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Little bit of pain [after the first two doses]), SWELLING (Swelling [after the first two doses]) and MYALGIA (Muscle ache [after the first two doses]) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (Patient had asthma for a number of years.).   On 23-Jan-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 PAIN (Little bit of pain [after the first two doses]), SWELLING (Swelling [after the first two doses]) and MYALGIA (Muscle ache [after the first two doses]). At the time of the report, PAIN (Little bit of pain [after the first two doses]), SWELLING (Swelling [after the first two doses]) and MYALGIA (Muscle ache [after the first two doses]) outcome was unknown.       mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   No concomitant medications reported by reporter No treatment medications provided by the reporter.   This case was linked to MOD-2021-396226 (Patient Link).
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Swelling
Clinical narrative: Little bit of pain [after the first two doses]; Swelling [after the first two doses]; Muscle ache [after the first two doses]; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Little bit of pain [after the first two doses]), SWELLING (Swelling [after the first two doses]) and MYALGIA (Muscle ache [after the first two doses]) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (Patient had asthma for a number of years.).   On 23-Jan-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 PAIN (Little bit of pain [after the first two doses]), SWELLING (Swelling [after the first two doses]) and MYALGIA (Muscle ache [after the first two doses]). At the time of the report, PAIN (Little bit of pain [after the first two doses]), SWELLING (Swelling [after the first two doses]) and MYALGIA (Muscle ache [after the first two doses]) outcome was unknown.       mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   No concomitant medications reported by reporter No treatment medications provided by the reporter.   This case was linked to MOD-2021-396226 (Patient Link).
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pain, Swelling
Clinical narrative: Little bit of pain [after the first two doses]; Swelling [after the first two doses]; Muscle ache [after the first two doses]; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Little bit of pain [after the first two doses]), SWELLING (Swelling [after the first two doses]) and MYALGIA (Muscle ache [after the first two doses]) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (Patient had asthma for a number of years.).   On 23-Jan-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 PAIN (Little bit of pain [after the first two doses]), SWELLING (Swelling [after the first two doses]) and MYALGIA (Muscle ache [after the first two doses]). At the time of the report, PAIN (Little bit of pain [after the first two doses]), SWELLING (Swelling [after the first two doses]) and MYALGIA (Muscle ache [after the first two doses]) outcome was unknown.       mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   No concomitant medications reported by reporter No treatment medications provided by the reporter.   This case was linked to MOD-2021-396226 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Was given a full dose as a booster.  Following the booster I did experience body aches, headache and fatigue.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Was given a full dose as a booster.  Following the booster I did experience body aches, headache and fatigue.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Incorrect Dose Moderna booster dose administered was 0.5 milliliters. Booster dose should have been 0.25 milliliters.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Incorrect Dose Moderna booster dose administered was 0.5 milliliters. Booster dose should have been 0.25 milliliters.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Incorrect Dose Moderna booster dose administered was 0.5 milliliters. Booster dose should have been 0.25 milliliters.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Incorrect Dose Moderna booster dose administered was 0.5 milliliters. Booster dose should have been 0.25 milliliters.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered
Clinical narrative: Received the full dose of vaccine, rather than the half dose. Very sore are, could not sleep on that side, chills, myalgia and fatigue for 2 to 3 days.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Extra dose administered, Fatigue, Incorrect dose administered, Myalgia
Clinical narrative: Received the full dose of vaccine, rather than the half dose. Very sore are, could not sleep on that side, chills, myalgia and fatigue for 2 to 3 days.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Sleep disorder
Clinical narrative: Received the full dose of vaccine, rather than the half dose. Very sore are, could not sleep on that side, chills, myalgia and fatigue for 2 to 3 days.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF VACCINE DOSE THAT WAS OPENED 15 HOURS AGO; VIAL WAS OPEN FOR 15-16 HOURS AFTER THE INITIAL PUNCTURE; This spontaneous report received from a pharmacist concerned a 67 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, and expiry: UNKNOWN) dose was not reported, administered on 30-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-NOV-2021, the patient experienced administration of vaccine dose that was opened 15 hours ago. On 30-NOV-2021, the patient experienced vial was open for 15-16 hours after the initial puncture. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine dose that was opened 15 hours ago and vial was open for 15-16 hours after the initial puncture was not reported. This report was non-serious. This case, from the same reporter is linked to 20211201336.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTRATION OF VACCINE DOSE THAT WAS OPENED 15 HOURS AGO; VIAL WAS OPEN FOR 15-16 HOURS AFTER THE INITIAL PUNCTURE; This spontaneous report received from a pharmacist concerned a 67 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, and expiry: UNKNOWN) dose was not reported, administered on 30-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-NOV-2021, the patient experienced administration of vaccine dose that was opened 15 hours ago. On 30-NOV-2021, the patient experienced vial was open for 15-16 hours after the initial puncture. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine dose that was opened 15 hours ago and vial was open for 15-16 hours after the initial puncture was not reported. This report was non-serious. This case, from the same reporter is linked to 20211201336.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF VACCINE 15-16 HOURS AFTER THE INITIAL PUNCTURE OF VIAL; RECEIVED VACCINE DOSE THAT WAS OPENED 15 HOURS AGO; This spontaneous report received from a pharmacist concerned a 67 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A and expiry: UNKNOWN) dose was not reported, administered on 30-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-NOV-2021, the patient experienced administration of vaccine 15-16 hours after the initial puncture of vial. On 30-NOV-2021, the patient experienced received vaccine dose that was opened 15 hours ago. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine 15-16 hours after the initial puncture of vial and received vaccine dose that was opened 15 hours ago was not reported. This report was non-serious. This case, from the same reporter is linked to 20211201249.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTRATION OF VACCINE 15-16 HOURS AFTER THE INITIAL PUNCTURE OF VIAL; RECEIVED VACCINE DOSE THAT WAS OPENED 15 HOURS AGO; This spontaneous report received from a pharmacist concerned a 67 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A and expiry: UNKNOWN) dose was not reported, administered on 30-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-NOV-2021, the patient experienced administration of vaccine 15-16 hours after the initial puncture of vial. On 30-NOV-2021, the patient experienced received vaccine dose that was opened 15 hours ago. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine 15-16 hours after the initial puncture of vial and received vaccine dose that was opened 15 hours ago was not reported. This report was non-serious. This case, from the same reporter is linked to 20211201249.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram normal, Headache, Loss of personal independence in daily activities, Migraine, Vertigo
Clinical narrative: This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-smoker, and non-alcohol user, and other pre-existing medical conditions included: The patient has never had Migraines before getting the Vaccine and no other health issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: 23-MAR-2021) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.On 06-MAR-2021, the patient experienced severe migraine headache. On an unspecified date, the patient experienced hard to go through regular day. Laboratory data (dates unspecified) included: CAT scan (NR: not provided) doesn't have a blood clot. Treatment medications (dates unspecified) included: ketorolac tromethamine.The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe migraine headache, and the outcome of hard to go through regular day was not reported.This report was non-serious.This case was associated with product quality complaint number: 90000205056.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Impaired quality of life, Migraine
Clinical narrative: This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-smoker, and non-alcohol user, and other pre-existing medical conditions included: The patient has never had Migraines before getting the Vaccine and no other health issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: 23-MAR-2021) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.On 06-MAR-2021, the patient experienced severe migraine headache. On an unspecified date, the patient experienced hard to go through regular day. Laboratory data (dates unspecified) included: CAT scan (NR: not provided) doesn't have a blood clot. Treatment medications (dates unspecified) included: ketorolac tromethamine.The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe migraine headache, and the outcome of hard to go through regular day was not reported.This report was non-serious.This case was associated with product quality complaint number: 90000205056.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered
Clinical narrative: administration of improperly stored vaccines.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: administration of improperly stored vaccines.
Age: 6.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Vaccine was given in school COVID clinic at School co-hosted by School system and Health Department.  Adverse event was reported to School Med-Tech by child's father.  Med-Tech reported the event to Health Department. Per Med-Tech, patient's father reported onset of hives in genitalia, extremities, ankles, knees, inner thighs, buttocks, axilla in the evening of 12/1/2021.  Parent took child to local clinic where she was treated.  Hives had improved by 12/2/2021 but child continues to complain of  fatigue, lethargy, and body aches today.
Age: 6.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Lethargy, Pain, Urticaria
Clinical narrative: Vaccine was given in school COVID clinic at School co-hosted by School system and Health Department.  Adverse event was reported to School Med-Tech by child's father.  Med-Tech reported the event to Health Department. Per Med-Tech, patient's father reported onset of hives in genitalia, extremities, ankles, knees, inner thighs, buttocks, axilla in the evening of 12/1/2021.  Parent took child to local clinic where she was treated.  Hives had improved by 12/2/2021 but child continues to complain of  fatigue, lethargy, and body aches today.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A patient was administered an expired dose of the Modena COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient was administered an expired dose of the Modena COVID-19 vaccine) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) 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) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient was administered an expired dose of the Modena COVID-19 vaccine). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (A patient was administered an expired dose of the Modena COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Pharmacist stated that vials were arrived on 01-OCT-2021 and placed in freezer and 2 patients were administered with expired doses on 10-NOV-2021 and mentioned that  vial did not undergo any temperature excursion. No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Temperature excursions; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). In November 2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided.  Reporter stated that the dose of Moderna COVID-19 vaccine after a temperature excursion at the frozen range reaching a temperature <-50°C then the vaccine was then placed in a different freezer which experienced a temperature excursion on 19-Nov-2021, reaching a maximum of 10.8°F for 5 hours and 31 minutes.   Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: Follow up received on 23 Nov 2021 contain Patient demographics were updated.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Potentially got their doses from vials punctured longer than 12 hours ago; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.  HCP reported that while doing quality assurance on 19Nov2021, it was discovered an open vial in the refrigerator. Staff had been drawing doses from opened vials without taking in consideration the hours after the first punctured.   This case was linked to MOD-2021-395804 (E2B Linked Report).; Sender's Comments:  MOD-2021-395804:First patient case
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Potentially got their doses from vials punctured longer than 12 hours ago; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.   HCP  stated We are primary care clinic for senior citizens. We began administering Moderna on 03Nov2021. While doing quality assurance on 19Nov2021, they discovered an open vial in the refrigerator. Staff had been drawing doses from opened vials without taking in consideration the hours after the first punctured. Patients after 05Nov2021 were potentially getting their doses from vials punctured longer than 12 hours ago"
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Potentially got their doses from vials punctured longer than 12 hours ago; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications and no treatment medications were reported.  HCP stated that It is primary care clinic for senior citizens. They began administering Moderna on 03 Nov2021. While doing quality assurance on 19 Nov2021, discovered an open vial in the refrigerator. Staff had been drawing doses from opened vials without taking in consideration the hours after the first punctured. Patients after 05 Nov2021 were potentially getting their doses from vials punctured longer than 12 hours ago.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Fall, Head injury
Clinical narrative: Felt Dizzy; Fallen to the floor; Banged her head; Fever  99.6F; Passed out/ Unconscious; Chills; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out/ Unconscious) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 047B21A and 034C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021 at 9:30 PM, the patient experienced CHILLS (Chills). On 20-Nov-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out/ Unconscious) (seriousness criterion medically significant). On 20-Nov-2021 at 6:30 AM, the patient experienced DIZZINESS (Felt Dizzy), FALL (Fallen to the floor), HEAD INJURY (Banged her head) and PYREXIA (Fever  99.6F). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) on 20-Nov-2021 for Fever, at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (Passed out/ Unconscious), DIZZINESS (Felt Dizzy), FALL (Fallen to the floor), HEAD INJURY (Banged her head), CHILLS (Chills) and PYREXIA (Fever  99.6F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Nov-2021, Body temperature: 99.6f (High) 99.6F.         No concomitant medications were reported.  Company comment- This spontaneous case concerns a 59-year-old female patient with no relevant medical history who experienced serious unexpected events of loss of consciousness. The event occurred approximately one day after the third dose of the Moderna COVID-19 Vaccine (mRNA-1273). Rechallenge was not applicable since the event occurred after the third dose so, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.   This case was linked to MOD-2021-396447, MOD-2021-395855 (Patient Link).; Sender's Comments: This spontaneous case concerns a 59-year-old female patient with no relevant medical history who experienced serious unexpected events of loss of consciousness. The event occurred approximately one day after the third dose of the Moderna COVID-19 Vaccine (mRNA-1273). Rechallenge was not applicable since the event occurred after the third dose so, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Pyrexia
Clinical narrative: Felt Dizzy; Fallen to the floor; Banged her head; Fever  99.6F; Passed out/ Unconscious; Chills; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out/ Unconscious) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 047B21A and 034C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021 at 9:30 PM, the patient experienced CHILLS (Chills). On 20-Nov-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out/ Unconscious) (seriousness criterion medically significant). On 20-Nov-2021 at 6:30 AM, the patient experienced DIZZINESS (Felt Dizzy), FALL (Fallen to the floor), HEAD INJURY (Banged her head) and PYREXIA (Fever  99.6F). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) on 20-Nov-2021 for Fever, at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (Passed out/ Unconscious), DIZZINESS (Felt Dizzy), FALL (Fallen to the floor), HEAD INJURY (Banged her head), CHILLS (Chills) and PYREXIA (Fever  99.6F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Nov-2021, Body temperature: 99.6f (High) 99.6F.         No concomitant medications were reported.  Company comment- This spontaneous case concerns a 59-year-old female patient with no relevant medical history who experienced serious unexpected events of loss of consciousness. The event occurred approximately one day after the third dose of the Moderna COVID-19 Vaccine (mRNA-1273). Rechallenge was not applicable since the event occurred after the third dose so, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.   This case was linked to MOD-2021-396447, MOD-2021-395855 (Patient Link).; Sender's Comments: This spontaneous case concerns a 59-year-old female patient with no relevant medical history who experienced serious unexpected events of loss of consciousness. The event occurred approximately one day after the third dose of the Moderna COVID-19 Vaccine (mRNA-1273). Rechallenge was not applicable since the event occurred after the third dose so, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nephrolithiasis
Clinical narrative: Kidney stone; This spontaneous case was reported by a consumer and describes the occurrence of NEPHROLITHIASIS (Kidney stone) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Kidney stones (She's gotten a kidney stone after taking a medication a long time ago. After she stopped taking the medication, the kidney stone went away.).   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEPHROLITHIASIS (Kidney stone) (seriousness criterion medically significant). At the time of the report, NEPHROLITHIASIS (Kidney stone) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was reported as acidity medication. Treatment information was not provided.  Patient reported that she had gotten a kidney stone after taking a medication a long time ago. After she stopped taking the medication, the kidney stone went away. They said it was because of the acidity of the medication. They did not confirm that the kidney stones was from the Moderna COVID19 Vaccine.  This spontaneous case concerns a 54-year-old female patient with a relevant medical history of Nephrolithiasis, who experienced the unexpected serious (medically significant) event of Nephrolithiasis after mRNA- 1273 Moderna vaccine. The event occurred at an unknown date after the first dose of mRNA- 1273 vaccine. Very limited information was provided regarding clinical course and treatment. The rechallenge is not applicable, since it is unknown if the event had resolved prior to the second dose. Previous episode of nephrolithiasis remains a confounder. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-396187 (Patient Link).; Sender's Comments: This spontaneous case concerns a 54-year-old female patient with a relevant medical history of Nephrolithiasis, who experienced the unexpected serious (medically significant) event of Nephrolithiasis after mRNA- 1273 Moderna vaccine. The event occurred at an unknown date after the first dose of mRNA- 1273 vaccine. Very limited information was provided regarding clinical course and treatment. The rechallenge is not applicable, since it is unknown if the event had resolved prior to the second dose. Previous episode of nephrolithiasis remains a confounder. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: 1st period (post vaccine) she had a very heavy bleeding for 11 days,2nd period (post vaccine) very heavy bleeding for 10 days; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (1st period (post vaccine) she had a very heavy bleeding for 11 days,2nd period (post vaccine) very heavy bleeding for 10 days) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEAVY MENSTRUAL BLEEDING (1st period (post vaccine) she had a very heavy bleeding for 11 days,2nd period (post vaccine) very heavy bleeding for 10 days). At the time of the report, HEAVY MENSTRUAL BLEEDING (1st period (post vaccine) she had a very heavy bleeding for 11 days,2nd period (post vaccine) very heavy bleeding for 10 days) had resolved.            It was reported that the patient did not talk to her physician. It was also mentioned that both first and second dose were Moderna. After first period, patient didn't experienced bleeding for 2 weeks, then after 2 weeks again patient had heavy bleeding.  No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Interchange of vaccine products, Vaccination complication
Clinical narrative: adverse reaction after his Moderna booster; fri-sat - aching in every joint, sun until today- he is fine; 1st and 2nd dose Pfizer and Moderna booster dose; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (1st and 2nd dose Pfizer and Moderna booster dose), VACCINATION COMPLICATION (adverse reaction after his Moderna booster) and ARTHRALGIA (fri-sat - aching in every joint, sun until today- he is fine) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 2) and PFIZER BIONTECH COVID-19 VACCINE (Dose 1). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (1st and 2nd dose Pfizer and Moderna booster dose). On 19-Nov-2021, the patient experienced ARTHRALGIA (fri-sat - aching in every joint, sun until today- he is fine). On an unknown date, the patient experienced VACCINATION COMPLICATION (adverse reaction after his Moderna booster). On 18-Nov-2021, INTERCHANGE OF VACCINE PRODUCTS (1st and 2nd dose Pfizer and Moderna booster dose) had resolved. On 20-Nov-2021, ARTHRALGIA (fri-sat - aching in every joint, sun until today- he is fine) had resolved. At the time of the report, VACCINATION COMPLICATION (adverse reaction after his Moderna booster) outcome was unknown.            Concomitant medications and treatment medications were not provided by reporter.  Patient had aching in every joint from Fridayto Saturday and Sunday to 23-Nov-2021, patient was fine.
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Received a booster dose of the Moderna Vaccine that was pretty bad shaken for around 15 seconds; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT PREPARATION ISSUE (Received a booster dose of the Moderna Vaccine that was pretty bad shaken for around 15 seconds) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) 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 PRODUCT PREPARATION ISSUE (Received a booster dose of the Moderna Vaccine that was pretty bad shaken for around 15 seconds). At the time of the report, PRODUCT PREPARATION ISSUE (Received a booster dose of the Moderna Vaccine that was pretty bad shaken for around 15 seconds) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter.  No treatment medication was provided.  The patient received a booster dose of the Moderna Vaccine that was pretty bad shaken for around 15 seconds and the reporter said it feels it was more than a gentle swirl.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Mass
Clinical narrative: Lump in her collar bone, on the left side; This spontaneous case was reported by a consumer and describes the occurrence of MASS (Lump in her collar bone, on the left side) in a 42-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Nov-2021, the patient experienced MASS (Lump in her collar bone, on the left side). At the time of the report, MASS (Lump in her collar bone, on the left side) had not resolved.            Patient reported that lump in her collar bone was still there till 23Nov2021.   No concomitant medications were mentioned. No treatment details were reported.   This case was linked to MOD-2021-396004 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Heart rate, Pyrexia, Vaccination complication
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (booster side effects), CHILLS (Chill), HEADACHE (Headache) and PYREXIA (light 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (booster side effects), CHILLS (Chill), HEADACHE (Headache) and PYREXIA (light fever). At the time of the report, VACCINATION COMPLICATION (booster side effects), CHILLS (Chill), HEADACHE (Headache) and PYREXIA (light fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: elevated (High) elevated HR 65 (normally 52). 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 provided. No treatment medication provided.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash papular, Rash pruritic
Clinical narrative: A bumpy, itchy rash that has been all over his torso front & back & a little bit on the arms; Itchy rash; The rash started on his right side, then went to the front of his; This spontaneous case was reported by a consumer and describes the occurrence of RASH PAPULAR (A bumpy, itchy rash that has been all over his torso front & back & a little bit on the arms), RASH PRURITIC (Itchy rash) and RASH (The rash started on his right side, then went to the front of his) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 007M20A and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced RASH PAPULAR (A bumpy, itchy rash that has been all over his torso front & back & a little bit on the arms), RASH PRURITIC (Itchy rash) and RASH (The rash started on his right side, then went to the front of his). The patient was treated with CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH PAPULAR (A bumpy, itchy rash that has been all over his torso front & back & a little bit on the arms), RASH PRURITIC (Itchy rash) and RASH (The rash started on his right side, then went to the front of his) was resolving.            No concomitant medication were reported.   The date of his 1st dose was not written on his vaccination card, but he thinks it was in January of 2021.  About a week after getting the booster dose he began getting a bumpy, itchy rash that has been all over his torso front & back & a little bit on the arms.  It seems like it's was clearing up now.  He has used calamine lotion & a lotion prescribed by a dermatologist.  He does not have the contact information for the dermatologist with him at this time but could provide that for her & the vaccination facility if he receives a form.  The rash started on his right side, then went to the front of his torso, then left side, then into armpit area, then collar bone, which is itchy but no longer bumpy, then upper back.  The bumps are sort of like poison ivy but not patchy like poison ivy.  He says that the areas on his arms have been in the same place on each arm at the same time.