chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 3 INDIVIDUALS WERE ADMINISTERED EXPIRED JANSSEN COVID-19 VACCINE; This spontaneous report received from a physician concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1821286 expiry: 21-OCT-2021) dose was not reported, administered on 11-JAN-2022 for prophylactic vaccination. No concomitant medications were reported. On 11-JAN-2022, the patient experienced 3 individuals were administered expired janssen covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 3 individuals were administered expired janssen covid-19 vaccine was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: PATIENTS RECEIVED A DOSE OF THE VACCINE HAVING TEMPERATURE EXCURSIONS; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned multiple patients.  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: 213D12A, and expiry: UNKNOWN) dose was not reported, administered on 04-JAN-2022 for prophylactic vaccination. No concomitant medications were reported. On 04-JAN-2022, the patient experienced patients received a dose of the vaccine having temperature excursions, and incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the patients received a dose of the vaccine having temperature excursions and incorrect product storage was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Metastatic squamous cell carcinoma, Pain
Clinical narrative: UNBEARABLE PAINS; BREATHING PROBLEMS AND NEEDED A TRACHEOSTOMY; TUMOR ON FACE; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. 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 and expiry: unknown) dose was not reported, 1 total administered on 03-OCT-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On OCT-2021, the patient experienced and developed a tumor the following week on his face that needed to be surgically removed and complicated on the 07-NOV-2021 had breathing problems and needed a tracheostomy and he has unbearable pains daily. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from unbearable pains and the outcome of breathing problems and needed a tracheostomy and tumor on face was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220122356-covid-19 vaccine ad26.cov2.s-tumor on face and breathing problems and needed a tracheostomy. 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).
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: TESTED POSITIVE FOR COVID-19 AFTER RECEIVING THE JANSSEN COVID -19 VACCINE; This spontaneous report received from a consumer concerned a male of unspecified age. 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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced tested positive for covid-19 after receiving the janssen covid -19 vaccine. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid-19 after receiving the janssen covid -19 vaccine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: GOT ALL MESSED UP; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced got all messed up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got all messed up was not reported. This report was non-serious.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: appointment for the 2nd dose that time so he ended up getting it 5-6 weeks after his 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (appointment for the 2nd dose that time so he ended up getting it 5-6 weeks after his 1st dose) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (appointment for the 2nd dose that time so he ended up getting it 5-6 weeks after his 1st dose). In March 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (appointment for the 2nd dose that time so he ended up getting it 5-6 weeks after his 1st dose) had resolved.            No concomitant medications were reported. Treatment information was not provided. Lab details were not provided.   This case was linked to MOD-2022-449251 (Patient Link).
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 69 expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The LOT 012H21B vials were placed in refrigerator on 6-Dec-2021. The vaccine was used past 30-day use by date. No treatment medications was reported.   This case was linked to MOD-2022-448109, MOD-2022-449740, MOD-2022-449524 (Patient Link).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria, Throat tightness
Clinical narrative: tightness of the throat; dermatographia hives; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (tightness of the throat) and MECHANICAL URTICARIA (dermatographia hives) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21A, 022C21A and 040B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MECHANICAL URTICARIA (dermatographia hives). On an unknown date, the patient experienced THROAT TIGHTNESS (tightness of the throat). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, THROAT TIGHTNESS (tightness of the throat) and MECHANICAL URTICARIA (dermatographia hives) outcome was unknown.            No concomitant medications reported.  Consumer reports that she has been having dermatographia hives since 16Dec2021, 11 days after she got the booster dose of the Moderna Covid-19 vaccine. She states that she has itching hives anywhere her skin is touched. She also experienced tightness of the throat. She consulted with her primary doctor which did not make any connection to the vaccine but when she consulted her allergist - she  said that this may be vaccine related as she has seen a lot of patients with hives after having the booster or the 2nd round of the Moderna Covid-19 vaccine. She mentioned that she is a member of a support group which has 1200 members who had chronic spontaneous urticaria as side effect of the vaccine.   This case was linked to MOD-2022-437628, MOD-2022-437391 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: all tests came back positive for COVID-19 / diagnosed with COVID-19 infection; lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (all tests came back positive for COVID-19 / diagnosed with COVID-19 infection) and DRUG INEFFECTIVE (lack of drug effect) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 031L20A and 027A21A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: flu shot in October 2021. Past adverse reactions to the above products included No adverse event with flu shot. Concurrent medical conditions included Type II diabetes mellitus. Concomitant products included LIRAGLUTIDE (VICTOZA), METFORMIN, SIMVASTATIN, LISINOPRIL and INSULIN DETEMIR (LEVEMIR) for an unknown indication.   On 10-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) (Intramuscular) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Jan-2022, the patient experienced COVID-19 (all tests came back positive for COVID-19 / diagnosed with COVID-19 infection) and DRUG INEFFECTIVE (lack of drug effect). At the time of the report, COVID-19 (all tests came back positive for COVID-19 / diagnosed with COVID-19 infection) and DRUG INEFFECTIVE (lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive.         Patient went to urgent care for an additional COVID-19 tests and was positive. No treatment information was provided.; Sender's Comments: This is a spontaneous case concerning a 66-year-old, female patient with a history of Type 2 diabetes, who was diagnosed with COVID-19 a month after receiving the booster dose of mRNA1273. Primary vaccination was also completed with Moderna product, with an appropriate schedule, which characterizes a lack of effect of the vaccine. The benefit-risk relationship of mRNA-1273 in not affected by this report.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fall, Loss of consciousness
Clinical narrative: passed out; felt weak; fell out; This spontaneous case was reported by a nurse and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out), ASTHENIA (felt weak) and FALL (fell out) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (had covid last year) and Illness (having some illnesses).   On 05-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2022, the patient experienced LOSS OF CONSCIOUSNESS (passed out). 05-Jan-2022, the patient experienced ASTHENIA (felt weak) and FALL (fell out). At the time of the report, LOSS OF CONSCIOUSNESS (passed out), ASTHENIA (felt weak) and FALL (fell out) 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.   Reporter daughter was 50 years old. She had been having some illnesses along the way and had covid last year, she could not tell she had it. She had the first dose of the Moderna COVID-19 vaccine and 6 hours later she passed out. She felt weak and fell out.  No Concomitant medications were reported.  No treatment medications were reported.  Company Comment: The only reported events in this case are non-serious, hence no CC is required.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jan-2022: Follow up received contains no new information.; Sender's Comments: The only reported events in this case are non-serious, hence no CC is required.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Metastases to lymph nodes, Vaccination complication
Clinical narrative: Strange and rare side effect; Swollen lymph node; "Virchow's" lymph node that was swollen; This spontaneous case was reported by a consumer and describes the occurrence of METASTASES TO LYMPH NODES ("Virchow's" lymph node that was swollen), VACCINATION COMPLICATION (Strange and rare side effect) and LYMPHADENOPATHY (Swollen lymph node) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 031A21A and 039A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.  On 02-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Jan-2022, the patient experienced METASTASES TO LYMPH NODES ("Virchow's" lymph node that was swollen) and LYMPHADENOPATHY (Swollen lymph node). On an unknown date, the patient experienced VACCINATION COMPLICATION (Strange and rare side effect). At the time of the report, METASTASES TO LYMPH NODES ("Virchow's" lymph node that was swollen), VACCINATION COMPLICATION (Strange and rare side effect) and LYMPHADENOPATHY (Swollen lymph node) outcome was unknown.     Patient stated that the lymph node sends a signal when it get swollen and was an indication of abdominal cancer.   No relevant concomitant medications were reported.  No treatment information was provided  Company Comment: The only reported events in this case are non-serious, hence no CC is required.   This case was linked to MOD-2022-440527 (Patient Link).; Sender's Comments: The only reported events in this case are non-serious, hence no CC is required.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Urticaria
Clinical narrative: Developed a case of Urticaria; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Developed a case of Urticaria) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 041L20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Felt tired). On 13-Dec-2021, the patient experienced URTICARIA (Developed a case of Urticaria) (seriousness criterion medically significant). The patient was treated with DEXAMETHASONE at an unspecified dose and frequency; PREDNISONE at an unspecified dose and frequency and HYDROXYZINE at an unspecified dose and frequency. On 05-Dec-2021, FATIGUE (Felt tired) had resolved. At the time of the report, URTICARIA (Developed a case of Urticaria) outcome was unknown.            No concomitant medications were provided. Treatment medication also included unspecified steroids.  The patient received his Moderna Booster Dose on 03 Dec 2021. The patient felt tired for 2 days after receiving the booster dose. and developed a case of Urticaria on 13 Dec 2021. The patient went to see his Physician and was prescribed steroids and antihistamines. The patient received a Dexamethasone injection and Prednisone tablet. The antihistamine that the patient's Physician prescribed is Hydroxyzine.   This case was linked to MOD-2022-440621, MOD-2022-440662 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: had the Moderna vaccine on September 18th then acquired Covid on October; This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (had the Moderna vaccine on September 18th then acquired Covid on October) 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 18-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced COVID-19 (had the Moderna vaccine on September 18th then acquired Covid on October). At the time of the report, COVID-19 (had the Moderna vaccine on September 18th then acquired Covid on October) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Oct-2021, SARS-CoV-2 test: positive (Positive) acquired Covid on October 18th.     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 No treatment medication were reported. Reporter stated that one of the student had the Moderna vaccine on September 18th then acquired Covid on October 18th and went to get her second shot. She was denied.  Company comment: This case concerns a  female patient of an unknown age, with no reported medical history, who experienced the non-serious, unexpected ADR event of COVID-19. The event occurred 1 month after the first dose of the mRNA-1273 COVID-19 vaccine. No further information was provided. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a  female patient of an unknown age, with no reported medical history, who experienced the non-serious, unexpected ADR event of COVID-19. The event occurred 1 month after the first dose of the mRNA-1273 COVID-19 vaccine. No further information was provided. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of BRONCHITIS (Bronchitis), COVID-19 (COVID-19 infection/ result was positive) and DRUG INEFFECTIVE (Lack of Drug effect) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 042L20A) for COVID-19 vaccination. The patient's past medical history included Flu (She used the inhalers in the past when she had the flu). On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, the patient experienced COVID-19 (COVID-19 infection/ result was positive) and DRUG INEFFECTIVE (Lack of Drug effect). On an unknown date, the patient experienced BRONCHITIS (Bronchitis). The patient was treated with CEFTRIAXONE SODIUM (ROCEPHIN) for Adverse event, at an unspecified dose and frequency; DOXYCYCLINE for Adverse event, at a dose of for 7 days; FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Adverse event, at an unspecified dose and frequency; CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE - CODEINE [CODEINE PHOSPHATE;PROMETHAZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and MONTELUKAST SODIUM (SINGULAIR) for Adverse event, at an unspecified dose and frequency. On 24-Dec-2021, COVID-19 (COVID-19 infection/ result was positive) had resolved. At the time of the report, BRONCHITIS (Bronchitis) had resolved and DRUG INEFFECTIVE (Lack of Drug effect) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive. On 24-Dec-2021, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, Chest X-ray: bronchitis (abnormal) bronchitis. On an unknown date, Oxygen saturation: normal (normal) Oxygen saturation level was fine. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant Drug details were reported. It was reported it has been about 2 weeks since the recovery. Company comment: This case of drug ineffective concerns a 42-year-old female patient with no relevant medical history who experienced non-serious unexpected AESI of COVID-19, that occurred approximately 10 months after the 2nd dose of the mRNA-1273. The rechallenge was not applicable due to occurrence after the 2nd dose and nature of the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This case of drug ineffective concerns a 42-year-old female patient with no relevant medical history who experienced non-serious unexpected AESI of COVID-19, that occurred approximately 10 months after the 2nd dose of the mRNA-1273. The rechallenge was not applicable due to occurrence after the 2nd dose and nature of the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Feeling abnormal, Myalgia, Vaccination site pain
Clinical narrative: felt icky with mild aches for 24; mild aches for 24 hours; Sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt icky with mild aches for 24), MYALGIA (mild aches for 24 hours) and VACCINATION SITE PAIN (Sore left injection site arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 038K20A) for COVID-19 vaccination.     The patient's past medical history included Atrial fibrillation and Palpitations (Fluttering heart with the sensation of skipping.).   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced FEELING ABNORMAL (felt icky with mild aches for 24), MYALGIA (mild aches for 24 hours) and VACCINATION SITE PAIN (Sore left injection site arm). On 23-Mar-2021, FEELING ABNORMAL (felt icky with mild aches for 24) and MYALGIA (mild aches for 24 hours) had resolved. At the time of the report, VACCINATION SITE PAIN (Sore left injection site arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Dec-2021, Electrocardiogram: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drugs were reported. No treatment information was reported.  The patient received the vaccine in her left arm shoulder deltoid muscle. She felt icky with mild aches for 24 hours. Sore left injection site arm.   This case was linked to MOD-2022-447985, MOD-2022-447895 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Symptoms were very mild with Covid infection of 12-27-21.(Fever, chills, cough, muscle aches, Nasal congestion/ runny nose)) and DRUG INEFFECTIVE (shots 1-31-21, 2-28-21 and booster on 11-11-21. Symptoms were very mild with Covid infection of 12-27-21) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Dec-2021, the patient experienced COVID-19 (Symptoms were very mild with Covid infection of 12-27-21.(Fever, chills, cough, muscle aches, Nasal congestion/ runny nose)) and DRUG INEFFECTIVE (shots 1-31-21, 2-28-21 and booster on 11-11-21.  Symptoms were very mild with Covid infection of 12-27-21). At the time of the report, COVID-19 (Symptoms were very mild with Covid infection of 12-27-21.(Fever, chills, cough, muscle aches, Nasal congestion/ runny nose)) and DRUG INEFFECTIVE (shots 1-31-21, 2-28-21 and booster on 11-11-21.  Symptoms were very mild with Covid infection of 12-27-21.) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Dec-2021, SARS-CoV-2 test: 34.097 (Positive) Positive. Source of sample for RT PCR test was nasal. No concomitant medications was provided by the reporter. No treatment was provided by the reporter. Duration of fever, chills, muscle aches, nasal congestion/runny nose was for 2 days and cough was for 7 days. Company comment: This case of drug ineffective concerns a 68-year-old male patient with no reported medical history who experienced non-serious unexpected AESI of COVID-19, that occurred approximately 1.5 months after the booster dose of the mRNA-1273. The rechallenge was not applicable due to occurrence after the booster dose and nature of the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This case of drug ineffective concerns a 68-year-old male patient with no reported medical history who experienced non-serious unexpected AESI of COVID-19, that occurred approximately 1.5 months after the booster dose of the mRNA-1273. The rechallenge was not applicable due to occurrence after the booster dose and nature of the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (He had Covid) and DRUG INEFFECTIVE (Lack of drug effect) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21-2A and 006B21A) for COVID-19 vaccination. No Medical History information was reported. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced COVID-19 (He had Covid) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (He had Covid) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient had mild symptoms also. No concomitant medication were provided. No treatment details were provided. Company comment: This case of drug ineffective concerns a 63-year-old male patient with no reported medical history who experienced non-serious unexpected AESI of COVID-19 that occurred approximately 5 months after the 2nd dose of the mRNA-1273. The rechallenge was not applicable due to occurrence after the 2nd dose and nature of the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This case of drug ineffective concerns a 63-year-old male patient with no reported medical history who experienced non-serious unexpected AESI of COVID-19 that occurred approximately 5 months after the 2nd dose of the mRNA-1273. The rechallenge was not applicable due to occurrence after the 2nd dose and nature of the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 69 expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications are provided. No treatment medications are provided. Date of refrigeration: 06-DEC-2021.   This case was linked to MOD-2022-449524 (Patient Link).
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses administered) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses administered). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 06-Dec-2021,placed Lot 012H21B vials in refrigerator.  No relevant concomitant medications reported. No treatment information was provided.   This case was linked to MOD-2022-449524 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses administered) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination. No Medical History information was reported. On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses administered). On 07-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired doses administered) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant products were not provided. Treatment medications were not reported. On December 6, 2021, vaccine vials of Lot 012H21B were placed in refrigerator.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the left arm with 1st shot) and MATERNAL EXPOSURE DURING BREAST FEEDING (Patient breastfeeding administered with first 2 shots) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029H21B) for COVID-19 vaccination. Concomitant products included MAGNESIUM and ZINC for Supplementation therapy. On 26-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Dec-2021, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Patient breastfeeding administered with first 2 shots). On 27-Dec-2021, the patient experienced PAIN IN EXTREMITY (Pain in the left arm with 1st shot). On 26-Dec-2021, MATERNAL EXPOSURE DURING BREAST FEEDING (Patient breastfeeding administered with first 2 shots) had resolved. On 29-Dec-2021, PAIN IN EXTREMITY (Pain in the left arm with 1st shot) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medication use was not provided by the reporter. Patient had accidentally got second dose on 10Jan2022, 2 weeks after first shot, earlier and out of the normal indications to get vaccinated, 1 month apart. She realized of that mistake and went to see 3 different physicians to ask them if there was anything wrong about it. All of the 3 HCPs told her there was no problem. Still, she was concern and mentioned currently breastfeeding when vaccinated and experienced just pain in left arm 1 day following vaccination, and it stopped 1 or 2 days after every shot. This case was linked to MOD-2022-449534 (Patient Link).
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination. No Medical History information was reported. On 10-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered). On 10-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired dose administered) had resolved. 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. On 06-dec-2022 the vials placed in refrigerator. This case was linked to MOD-2022-448109 (Patient Link).
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Maternal exposure during pregnancy, SARS-CoV-2 test
Clinical narrative: This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19 positive) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Shingles from 26-Jan-2021 to February 2021. Concomitant products included SMARTY PANTS WOMEN'S FORMULA from 01-Jan-2020 to an unknown date for Vitamin supplementation. On 10-Dec-2021 at 4:30 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 10-Dec-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 30-Dec-2021, the patient experienced COVID-19 (Covid-19 positive). On 10-Dec-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, COVID-19 (Covid-19 positive) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive. No treatment information was provided. Company comment: This is a case of maternal exposure during pregnancy concerning a 35-year-old female patient, with no relevant medical history, who experienced the non-serious, unexpected event of COVID-19, 20 days after the third dose of mRNA 1273 COVID-19 vaccine. The patient was exposed to the vaccine on unspecified age of gestation. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report. This case was linked to MOD-2021-428256 (Patient Link). Sender's Comments: This is a case of maternal exposure during pregnancy concerning a 35-year-old female patient, with no relevant medical history, who experienced the non-serious, unexpected event of COVID-19, 20 days after the third dose of mRNA 1273 COVID-19 vaccine. The patient was exposed to the vaccine on unspecified age of gestation. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination. No Medical History information was reported. On 10-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 10-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter. This case was linked to MOD-2022-448109 (Patient Link).
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination. No Medical History information was reported. On 10-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 10-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported. This case was linked to MOD-2022-448109 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination. No Medical History information was reported. On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired doses administered) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant product use was reported. It was reported that on 06-Dec-2021, the vial with Lot 012H21B was placed in the refrigerator, upon receiving. No treatment information was provided. This case was linked to MOD-2022-448109 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination. No Medical History information was reported. On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Treatment medications were not reported. On 06-Dec-2021, they placed LOT 012H21B vials in the refrigerator, upon receiving. Between 06-Jan-2022 and 11-Jan-2022, there were a total of 69 administered doses of LOT 012H21B. Of these, 68 doses were boosters and 1 dose was a first dose.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 69 expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medications were not reported.  On December 6, 2021, vaccine vials of Lot 012H21B were placed in refrigerator.   This case was linked to MOD-2022-449524 (Patient Link).
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 69 expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.  It was reported that vial was placed in refrigerator on 06-Dec-2021.  Treatment information was not provided.   This case was linked to MOD-2022-448109, MOD-2022-449524 (Patient Link).
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 69 expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vials were placed in refrigerator on 6-Dec-2021. The vaccine was used past 30-day use by date. It was reported that patient received booster dose.  No concomitant medications information was reported. No treatment medications reported.   This case was linked to MOD-2022-449729, MOD-2022-449524, MOD-2022-448109 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: The first two I woke up in the middle of the night sick.; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (The first two I woke up in the middle of the night sick.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (The first two I woke up in the middle of the night sick.). At the time of the report, ILLNESS (The first two I woke up in the middle of the night sick.) outcome was unknown.            No concomitant medication was provided. No treatment information was provided.   This case was linked to MOD-2022-449887, MOD-2022-449915 (Patient Link).