chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pruritus, Skin irritation, Swelling, Urticaria
Clinical narrative: irritation; itching; swelling/bumps/bumps stay for 30 min and it dissapears/Within a few minutes, it reappears in another place; allergic reaction; hives/line of hives/stripes/hives in her back, stomach, armpit, hips and chest.; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives/line of hives/stripes/hives in her back, stomach, armpit, hips and chest.), SKIN IRRITATION (irritation), PRURITUS (itching), SWELLING (swelling/bumps/bumps stay for 30 min and it dissapears/Within a few minutes, it reappears in another place) and HYPERSENSITIVITY (allergic reaction) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 045A21A and 041A20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (hives/line of hives/stripes/hives in her back, stomach, armpit, hips and chest.). On an unknown date, the patient experienced SKIN IRRITATION (irritation), PRURITUS (itching), SWELLING (swelling/bumps/bumps stay for 30 min and it dissapears/Within a few minutes, it reappears in another place) and HYPERSENSITIVITY (allergic reaction). At the time of the report, URTICARIA (hives/line of hives/stripes/hives in her back, stomach, armpit, hips and chest.) had not resolved and SKIN IRRITATION (irritation), PRURITUS (itching), SWELLING (swelling/bumps/bumps stay for 30 min and it dissapears/Within a few minutes, it reappears in another place) and HYPERSENSITIVITY (allergic reaction) outcome was unknown.            No concomitant medication was reported.  The patient went to the doctor which prescribed antihistamine and made the hives subside. However, if patient goes one day without medicine, the hives reappear.Patient's husband mentioned that he searched the medical condition and it is called dermatographic urticaria.  Treatment medication included antihistamine.   This case was linked to MOD-2022-481849 (Patient Link).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: More than 42 days for administration of second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 42 days for administration of second dose) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 041A20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 42 days for administration of second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 42 days for administration of second dose) outcome was unknown.            No concomitant medication was reported No treatment medications was reported.   This case was linked to MOD-2022-481842, MOD-2022-481842 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patients were administered Moderna vaccine booster beyond 30 day use by date, stored in refrigerator; Patients were administered Moderna vaccine booster beyond 30 day use by date, stored in refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were administered Moderna vaccine booster beyond 30 day use by date, stored in refrigerator) and PRODUCT STORAGE ERROR (Patients were administered Moderna vaccine booster beyond 30 day use by date, stored in refrigerator) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 14-Feb-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 14-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were administered Moderna vaccine booster beyond 30 day use by date, stored in refrigerator). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patients were administered Moderna vaccine booster beyond 30 day use by date, stored in refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients were administered Moderna vaccine booster beyond 30 day use by date, stored in refrigerator) and PRODUCT STORAGE ERROR (Patients were administered Moderna vaccine booster beyond 30 day use by date, stored in refrigerator) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator on 13 JAN 2022. Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2022-482212, MOD-2022-482218 (Patient Link).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: administer the Moderna vaccine, to one patient, after 31 days in the refrigerator; administer the Moderna vaccine, to one patient, after 31 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer the Moderna vaccine, to one patient, after 31 days in the refrigerator) and PRODUCT STORAGE ERROR (administer the Moderna vaccine, to one patient, after 31 days in the refrigerator) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer the Moderna vaccine, to one patient, after 31 days in the refrigerator). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (administer the Moderna vaccine, to one patient, after 31 days in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer the Moderna vaccine, to one patient, after 31 days in the refrigerator) and PRODUCT STORAGE ERROR (administer the Moderna vaccine, to one patient, after 31 days in the refrigerator) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. The vial was initially stored in the refrigerator on 13Jan2022 Treatment medication was not provided.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Fatigue, Mammogram, Vaccination site lymphadenopathy, Vaccination site pain
Clinical narrative: Armpit is still swollen/ That got the lymph nodes; Armpit is painful/ Armpit hurts; Arm pain; Fatigue; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (Armpit is still swollen/ That got the lymph nodes), AXILLARY PAIN (Armpit is painful/ Armpit hurts), VACCINATION SITE PAIN (Arm pain) and FATIGUE (Fatigue) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 01L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Armpit is still swollen/ That got the lymph nodes), AXILLARY PAIN (Armpit is painful/ Armpit hurts), VACCINATION SITE PAIN (Arm pain) and FATIGUE (Fatigue). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (Armpit is still swollen/ That got the lymph nodes) and AXILLARY PAIN (Armpit is painful/ Armpit hurts) had not resolved and VACCINATION SITE PAIN (Arm pain) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Mammogram: normal (normal) normal, it was reported that patient's breast did not have anything.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter. Patient stated that they were instructed to not take anything so the vaccine could work.  Patient stated that she had No allergies and No history of COVID19. And also stated that she went to OB-GYN.   This case was linked to MOD-2022-482229 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Feb-2022: Follow up received contains no new information.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Armpit is still swollen/ That got the lymph nodes; Armpit is painful/ Armpit hurts; Arm pain; Fatigue; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (Armpit is still swollen/ That got the lymph nodes), AXILLARY PAIN (Armpit is painful/ Armpit hurts), VACCINATION SITE PAIN (Arm pain) and FATIGUE (Fatigue) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 01L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Armpit is still swollen/ That got the lymph nodes), AXILLARY PAIN (Armpit is painful/ Armpit hurts), VACCINATION SITE PAIN (Arm pain) and FATIGUE (Fatigue). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (Armpit is still swollen/ That got the lymph nodes) and AXILLARY PAIN (Armpit is painful/ Armpit hurts) had not resolved and VACCINATION SITE PAIN (Arm pain) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Mammogram: normal (normal) normal, it was reported that patient's breast did not have anything.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter. Patient stated that they were instructed to not take anything so the vaccine could work.  Patient stated that she had No allergies and No history of COVID19. And also stated that she went to OB-GYN.   This case was linked to MOD-2022-482229 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Feb-2022: Follow up received contains no new information.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Fatigue, Mammogram, Vaccination site lymphadenopathy, Vaccination site pain
Clinical narrative: headache; arm pain; This spontaneous case was reported by a pharmacist and describes the occurrence of HEADACHE (headache) and VACCINATION SITE PAIN (arm pain) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced HEADACHE (headache) and VACCINATION SITE PAIN (arm pain). At the time of the report, HEADACHE (headache) and VACCINATION SITE PAIN (arm pain) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had no allergies and no history of COVID-19.  Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-482168 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Feb-2022: Follow-up received included no new information.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: headache; arm pain; This spontaneous case was reported by a pharmacist and describes the occurrence of HEADACHE (headache) and VACCINATION SITE PAIN (arm pain) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced HEADACHE (headache) and VACCINATION SITE PAIN (arm pain). At the time of the report, HEADACHE (headache) and VACCINATION SITE PAIN (arm pain) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had no allergies and no history of COVID-19.  Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-482168 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Feb-2022: Follow-up received included no new information.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of product temperature excursion issue (vaccine administered after temperature excursion) and expired product administered (vaccine administered after temperature excursion) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced product temperature excursion issue (vaccine administered after temperature excursion) and expired product administered (vaccine administered after temperature excursion). At the time of the report, product temperature excursion issue (vaccine administered after temperature excursion) and expired product administered (vaccine administered after temperature excursion) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Rash erythematous
Clinical narrative: red rash on the face; Weakness after first shot; Chills after first shot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH ERYTHEMATOUS (red rash on the face), ASTHENIA (Weakness after first shot) and CHILLS (Chills after first shot) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism, Cholesterol (Generic Lipitor for cholesterol) and Seasonal allergy. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced ASTHENIA (Weakness after first shot) and CHILLS (Chills after first shot). On 22-Mar-2021, the patient experienced RASH ERYTHEMATOUS (red rash on the face). The patient was treated with DOXYCYCLINE for Red rash, at a dose of 100 milligram twice a day. On 10-Mar-2021, ASTHENIA (Weakness after first shot) and CHILLS (Chills after first shot) had resolved. At the time of the report, RASH ERYTHEMATOUS (red rash on the face) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient was also taking Generic Lipitor as concomitant medication for cholesterol. Patient's dermatologists had given an unspecified steroid shot for red rash.  For allergies, the doctor did not do a biopsy.  Patient took 2nd vaccine on 05-Apr-2021 in left arm and Batch number - 013B21A and Booster dose on 03-Dec-2021 in left arm, Batch number - 0031A21A.   This case was linked to MOD-2022-482209, MOD-2022-482235 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Cardiac discomfort, Dyspnoea, Palpitations
Clinical narrative: Palpitation; Heart is constriction; Hard to breathe sometimes; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitation), CARDIAC DISCOMFORT (Heart is constriction) and DYSPNOEA (Hard to breathe sometimes) 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 PALPITATIONS (Palpitation), CARDIAC DISCOMFORT (Heart is constriction) and DYSPNOEA (Hard to breathe sometimes). At the time of the report, PALPITATIONS (Palpitation), CARDIAC DISCOMFORT (Heart is constriction) and DYSPNOEA (Hard to breathe sometimes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication reported  No Treatment medication reported
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Mass
Clinical narrative: Egg shape lump on the right cheek-bone; This spontaneous case was reported by a consumer and describes the occurrence of MASS (Egg shape lump on the right cheek-bone) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013B21A and 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism, Cholesterol and Seasonal allergy. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, DOXYCYCLINE for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced MASS (Egg shape lump on the right cheek-bone). At the time of the report, MASS (Egg shape lump on the right cheek-bone) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   She reported that the Dermatologist administered Saline injections and another round of antibiotics.   This case was linked to MOD-2022-482189, MOD-2022-482235 (Patient Link).
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patients were administered Moderna vaccine booster beyond 30 day use by date, stored in refrigerator; Patients were administered Moderna vaccine booster beyond 30 day use by date, stored in refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were administered Moderna vaccine booster beyond 30 day use by date, stored in refrigerator) and PRODUCT STORAGE ERROR (Patients were administered Moderna vaccine booster beyond 30 day use by date, stored in refrigerator) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 14-Feb-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 14-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were administered Moderna vaccine booster beyond 30 day use by date, stored in refrigerator). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patients were administered Moderna vaccine booster beyond 30 day use by date, stored in refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients were administered Moderna vaccine booster beyond 30 day use by date, stored in refrigerator) and PRODUCT STORAGE ERROR (Patients were administered Moderna vaccine booster beyond 30 day use by date, stored in refrigerator) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported.  No concomitant medication was reported.  Date the vial was initially stored in the refrigerator was13-JAN-2022.   This case was linked to MOD-2022-482141, MOD-2022-482218 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patients were administered Moderna vaccine booster beyond 30 day use by date, stored in refrigerator; Patients were administered Moderna vaccine booster beyond 30 day use by date, stored in refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were administered Moderna vaccine booster beyond 30 day use by date, stored in refrigerator) and PRODUCT STORAGE ERROR (Patients were administered Moderna vaccine booster beyond 30 day use by date, stored in refrigerator) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 14-Feb-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 14-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were administered Moderna vaccine booster beyond 30 day use by date, stored in refrigerator). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patients were administered Moderna vaccine booster beyond 30 day use by date, stored in refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients were administered Moderna vaccine booster beyond 30 day use by date, stored in refrigerator) and PRODUCT STORAGE ERROR (Patients were administered Moderna vaccine booster beyond 30 day use by date, stored in refrigerator) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided.  It was reported that vial was initially stored in the refrigerator on 13 Jan 2022 and the vial did not undergo any temperature excursions.  No treatment information was provided.   This case was linked to MOD-2022-482141 (Patient Link).
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: Administration of an expired dose of vaccine ROTATEQ; No Additional adverse event; This spontaneous report was received from a office manger referring to a 6-month-old female patient. The patient's current condition, pertinent medical history, concomitant medications and drug reactions or allergies were not reported.  On 14-FEB-2022, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1742457 and expiration date reported as 16-JAN-2022 but upon ) dose 1, oral for prophylaxis (expired product administered). No additional adverse event and no product quality complaint reported.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Injected limb mobility decreased, Paraesthesia
Clinical narrative: Tingling in left hand in fingers; Experienced tiredness; Flu like symptoms; Decreased range of motion in left arm/ Is difficult to raise her left arm; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included methotrexate.   On 8th February 2022, the patient received the 2nd dose of Shingrix. On 9th February 2022, 1 days after receiving Shingrix, the patient experienced tiredness, influenza-like symptoms and injected limb mobility decreased. On 13th February 2022, the patient experienced tingling of extremity. On an unknown date, the outcome of the tiredness and influenza-like symptoms were recovered/resolved and the outcome of the injected limb mobility decreased and tingling of extremity were not recovered/not resolved.   It was unknown if the reporter considered the tiredness, influenza-like symptoms, injected limb mobility decreased and tingling of extremity to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received dose of Shingrix vaccine and upon following day she experienced tiredness, flu like symptoms and decreased range of motion in injected arm (left arm). She stated that was difficult to raise her left arm. On 13th Febuary 2022 the patient also experienced tingling in her left hand and fingers. Gave medical advice disclaimer. Referred to HCP (Health care professional). Spoke per content. Spoke per PI (package insert). The reporter gave limited information. The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Head injury, Pyrexia, Syncope
Clinical narrative: Fainting episode; hit her head; High Fever; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of fainting in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on an unknown date, for tolerance of 1st dose, refer case US2022AMR027150).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced fainting (serious criteria hospitalization and GSK medically significant), head injury (serious criteria hospitalization), fever (serious criteria hospitalization) and fatigue (serious criteria hospitalization). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fainting, fever and fatigue were recovered/resolved and the outcome of the head injury was unknown.   It was unknown if the reporter considered the fainting, head injury, fever and fatigue to be related to Shingrix.   Linked case(s) involving the same patient:US2022AMR027150  Additional details were provided as follows: The case was reported by the patient's friend. The age at vaccination was unknown. A couple days after receiving the second dose, the reporter stated that her friend experienced fatigue, high fever and fainting episode in which she hit her head and was subsequently hospitalized for a couple of days to get the fever down.  The patient continued with fever and fatigue for approximately 2 weeks, but did not experience any further fainting. The reporter provided limited information and did not wish to provide personal information. The reporter did not consent to follow-up. This case was 1 of 4 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022026665:same reporter US-GLAXOSMITHKLINE-US2022026674:same reporter US-GLAXOSMITHKLINE-US2022026673:same reporter US-GLAXOSMITHKLINE-US2022AMR027150:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2-3 years ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2-3 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No reactions reported. The reporter consented to follow-up via email.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dyspnoea, Insomnia, Lymphadenopathy
Clinical narrative: COULDN'T SLEEP/WOKE UP; SHIVERING; FEVER; TROUBLE BREATHING (FELT LIKE A CAT WAS SITTING ON CHEST BUT NOT TOO MUCH PRESSURE); LYMPH NODE SWELLING UNDER THE ARM WHERE GOT A SHOT; This spontaneous report received from a patient concerned a 21 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no health conditions and had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, and batch number: 213D21A expiry: 11-APR-2022) dose was not reported, administered on 09-FEB-2022 18:30 for prophylactic vaccination. No concomitant medications were reported. On FEB-2022, the patient experienced lymph node swelling under the arm where got a shot. Laboratory data included: Oxygen saturation (NR: not provided) 96 %. On 09-FEB-2022, the patient experienced trouble breathing (felt like a cat was sitting on chest but not too much pressure). On 10-FEB-2022, the patient experienced couldn't sleep/woke up, shivering, and fever. Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, had not recovered from lymph node swelling under the arm where got a shot, and the outcome of shivering, couldn't sleep/woke up and trouble breathing (felt like a cat was sitting on chest but not too much pressure) was not reported. This report was non-serious.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation, Pyrexia
Clinical narrative: COULDN'T SLEEP/WOKE UP; SHIVERING; FEVER; TROUBLE BREATHING (FELT LIKE A CAT WAS SITTING ON CHEST BUT NOT TOO MUCH PRESSURE); LYMPH NODE SWELLING UNDER THE ARM WHERE GOT A SHOT; This spontaneous report received from a patient concerned a 21 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no health conditions and had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, and batch number: 213D21A expiry: 11-APR-2022) dose was not reported, administered on 09-FEB-2022 18:30 for prophylactic vaccination. No concomitant medications were reported. On FEB-2022, the patient experienced lymph node swelling under the arm where got a shot. Laboratory data included: Oxygen saturation (NR: not provided) 96 %. On 09-FEB-2022, the patient experienced trouble breathing (felt like a cat was sitting on chest but not too much pressure). On 10-FEB-2022, the patient experienced couldn't sleep/woke up, shivering, and fever. Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, had not recovered from lymph node swelling under the arm where got a shot, and the outcome of shivering, couldn't sleep/woke up and trouble breathing (felt like a cat was sitting on chest but not too much pressure) was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: HAD COVID ONCE; This spontaneous report received from a patient via social media via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced had covid once. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of had covid once was not reported. This report was non-serious. The report was associated with product quality complaint number: 90000217487. This case, from the same reporter is linked to 20220234028.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: patient either did not tell them they were immunocompromised before getting the booster dose or became immunocompromised after getting the booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (patient either did not tell them they were immunocompromised before getting the booster dose or became immunocompromised after getting the booster dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced ACCIDENTAL UNDERDOSE (patient either did not tell them they were immunocompromised before getting the booster dose or became immunocompromised after getting the booster dose). At the time of the report, ACCIDENTAL UNDERDOSE (patient either did not tell them they were immunocompromised before getting the booster dose or became immunocompromised after getting the booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.  The patient had received 2 doses and a booster dose of Moderna vaccine. The booster dose was given about a month ago and 5 months after the second dose of Moderna Covid-19 vaccine.  The reporter wanted to know if whether they should give another booster dose to the patient that would be equal to a third dose or if they should go ahead and give a full third dose to the patient. The reporter was familiar with the administration errors and deviations information, which did not specify to make a recommendation except in cases of same day under dosing, and wanted to see if Moderna had any information.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses given after date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses given after date of expiry) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses given after date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses given after date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided No treatment medication was provided
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses given after date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses given after date of expiry) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses given after date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses given after date of expiry) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported.   Date the vials were initially stored in the refrigerator 06-OCT-2021.   No treatment information was reported.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: arm soreness and chills after a Moderna COVID-19 vaccine; arm soreness and chills after a Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness and chills after a Moderna COVID-19 vaccine) and CHILLS (arm soreness and chills after a Moderna COVID-19 vaccine) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm soreness and chills after a Moderna COVID-19 vaccine) and CHILLS (arm soreness and chills after a Moderna COVID-19 vaccine). At the time of the report, PAIN IN EXTREMITY (arm soreness and chills after a Moderna COVID-19 vaccine) and CHILLS (arm soreness and chills after a Moderna COVID-19 vaccine) outcome was unknown. Not Provided      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 medications were reported.  No treatment medications were reported.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 12 years old  got the Modena COVID-19  vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 years old  got the Modena COVID-19  vaccine) in a 12-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 years old  got the Modena COVID-19  vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 years old  got the Modena COVID-19  vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Headache after the first Moderna Covid-19 vaccine.; Sore left arm after the first Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache after the first Moderna Covid-19 vaccine.) and VACCINATION SITE PAIN (Sore left arm after the first Moderna Covid-19 vaccine) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In December 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 HEADACHE (Headache after the first Moderna Covid-19 vaccine.) and VACCINATION SITE PAIN (Sore left arm after the first Moderna Covid-19 vaccine). At the time of the report, HEADACHE (Headache after the first Moderna Covid-19 vaccine.) and VACCINATION SITE PAIN (Sore left arm after the first Moderna Covid-19 vaccine) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2022-482652 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Feb-2022: Follow-up document received contains no new information
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Gave him another booster dose; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (Gave him another booster dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Gave him another booster dose). At the time of the report, EXTRA DOSE ADMINISTERED (Gave him another booster dose) outcome was unknown.            No concomitant medications were reported.  It was reported that the patient had no antibodies therefore another booster dose was given.  No treatment drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Feb-2022: Follow Up document contain no new information.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: sore left arm after the second Moderna Covid-19 vaccine; headache after her second Moderna Covid-19 vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left arm after the second Moderna Covid-19 vaccine) and HEADACHE (headache after her second Moderna Covid-19 vaccine.) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In December 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jan-2022, the patient experienced VACCINATION SITE PAIN (sore left arm after the second Moderna Covid-19 vaccine) and HEADACHE (headache after her second Moderna Covid-19 vaccine.). At the time of the report, VACCINATION SITE PAIN (sore left arm after the second Moderna Covid-19 vaccine) and HEADACHE (headache after her second Moderna Covid-19 vaccine.) outcome was unknown.            No Concomitant medication were reported.  The patient received her second Moderna Covid-19 vaccine in her left arm shoulder deltoid muscle.  No treatment medication were reported.   This case was linked to MOD-2022-482637 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Feb-2022: Follow-up document received contains no new information
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Vaccination site pain
Clinical narrative: she was in bed for about a day after each Moderna Covid-19 vaccine; sore injection site arm; felt tired after receiving each Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (she was in bed for about a day after each Moderna Covid-19 vaccine), VACCINATION SITE PAIN (sore injection site arm) and FATIGUE (felt tired after receiving each Moderna Covid-19 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 ASTHENIA (she was in bed for about a day after each Moderna Covid-19 vaccine), VACCINATION SITE PAIN (sore injection site arm) and FATIGUE (felt tired after receiving each Moderna Covid-19 vaccine). At the time of the report, ASTHENIA (she was in bed for about a day after each Moderna Covid-19 vaccine), VACCINATION SITE PAIN (sore injection site arm) and FATIGUE (felt tired after receiving each Moderna Covid-19 vaccine) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided. No treatment medication provided.  It was reported that patient drank a lot of water and that she felt better.   This case was linked to MOD-2022-482739 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Feb-2022: Follow up received contains no new information