chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood test, Fatigue, Intermenstrual bleeding, Menstruation irregular
Clinical narrative: Irregular Bleeding; Fatigue; heavy spotting; This spontaneous case was reported by a patient and describes the occurrence of INTERMENSTRUAL BLEEDING (heavy spotting), MENSTRUATION IRREGULAR (Irregular Bleeding) and FATIGUE (Fatigue) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) injection for Birth control.    Concurrent medical conditions included Type 2 diabetes mellitus and Anorexia (eats "like a squirrel"). Concomitant products included VITAMINS NOS and CYANOCOBALAMIN (B12-VITAMIIN) for an unknown indication.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) (unknown route) at an unspecified dose. On 03-May-2022, the patient experienced INTERMENSTRUAL BLEEDING (heavy spotting) and FATIGUE (Fatigue). On an unknown date, the patient experienced MENSTRUATION IRREGULAR (Irregular Bleeding). At the time of the report, INTERMENSTRUAL BLEEDING (heavy spotting) and FATIGUE (Fatigue) had not resolved and MENSTRUATION IRREGULAR (Irregular Bleeding) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) not anemic.         It was reported that patient was due again on 17-May-2022 for DEPO-PROVERA dose but decided to quit birth control all together because it was making her feel terrible.  It was reported that patient had been having heavy spotting and fatigue since 03-May-2022 and states that it was like having general, regular periods every day and has been bad since 03-May-2022. Patient had consulted with her HCP for the events.  Patient reported that she had all three Moderna Covid-19 vaccines and had complaints of irregular bleeding that resolved after a couple of months.   Patient reports that she read that the above could happen with the Moderna Covid-19 vaccine.  No treatment medication were reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose 1 on 10-FEB-2021 and Dose 2 on 14-JUN-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 10-FEB-2021 and Dose 2 on 14-JUN-2021) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 10-FEB-2021 and Dose 2 on 14-JUN-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 10-FEB-2021 and Dose 2 on 14-JUN-2021) outcome was unknown. No concomitant medications were reported. No treatment medications were reported. This case was linked to MOD-2022-580789, MOD-2022-580794 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Side effects from booster covid-19 shot; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Side effects from booster covid-19 shot) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.  No Medical History information was reported.  On 27-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced IMMUNISATION REACTION (Side effects from booster covid-19 shot). At the time of the report, IMMUNISATION REACTION (Side effects from booster covid-19 shot) outcome was unknown.     No concomitant medication was provided by reporter.  The reporter causality for the event Side effects from booster covid-19 shot with upadacitinib (RINVOQ) was reasonable possibility or probable.  It was unknown if the patient was enrolled in a COVID-19 vaccine trail.  No treatment medication was provided by reporter.
Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Allergic sinusitis
Clinical narrative: Allergies turned into sinus infection; This spontaneous case was reported by a patient and describes the occurrence of ALLERGIC SINUSITIS (Allergies turned into sinus infection) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2022, the patient experienced ALLERGIC SINUSITIS (Allergies turned into sinus infection). In May 2022, ALLERGIC SINUSITIS (Allergies turned into sinus infection) had resolved.            No Concomitant medication was reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The treatment information was patient went on antibiotics.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Rosacea
Clinical narrative: Face was moderately flushed, increase in rosacea; Face was moderately flushed, increase in rosacea; This spontaneous case was reported by a patient and describes the occurrence of FLUSHING (Face was moderately flushed, increase in rosacea) and ROSACEA (Face was moderately flushed, increase in rosacea) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026d21A, 040B21A and 038A21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Penicillin allergy.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 26-May-2022, the patient experienced FLUSHING (Face was moderately flushed, increase in rosacea) and ROSACEA (Face was moderately flushed, increase in rosacea). On 28-May-2022, FLUSHING (Face was moderately flushed, increase in rosacea) and ROSACEA (Face was moderately flushed, increase in rosacea) had resolved.            No concomitant medications information was reported.  Patient's date of birth was reported. The patient was not  taking any other medications/products within 2 weeks of starting COVID-19 treatment.  No treatment medications were provided.  Device date was reported as 31-May-2022.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacture (Pfizer) concerned a 27 year old female. The patient's height, and weight were not reported. Patient was taking other medications within 2 weeks of starting COVID-19 treatment. Patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose was not reported, 01 in total administered to left arm on 23-MAR-2021 for prophylactic vaccination.  Age at time of vaccination 25 years old. The batch number was not reported and has been requested. On 15-OCT-2021 the patient received additional non-company suspect vaccine included: Spikevax (elasomeran) (dose number in series 2) (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose was not reported, administered to left arm for prophylactic vaccination. Concomitant medications included Vitamin B,D and herbal supplement.  On 10-MAY-2022, patient received Paxlovid (nirmatrelvir/ritonavir) (form of admin, route of admin were not reported, batch number: Unknown and expiry: unknown) dose not reported for treatment of COVID-19. The patient received the Paxlovid treatment for 4 days and discontinued on 14-MAY-2022. The patient also taking Wormwood pill. After discontinuation of Paxlovid within four days patient's covid symptoms re-emerged which were severe congestion, headache, fatigue and sore throat (suspected covid-19 infection) (dose number in series 2) which led to suspected clinical vaccination failure (dose number in series 1).  The action taken with covid-19 vaccine ad26.cov2.s, and Spikevax (elasomeran) was not applicable. The patient was recovering from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report associated with product quality complaint:90000233850.; Sender's Comments: V0:20220601716-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: M
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: FULL BODY PARALYSIS; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age, race and ethnicity. 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, expiry: Unknown), 1 total, 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 full body paralysis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of full body paralysis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220604166-  covid-19 vaccine ad26.cov2.s- full body paralysis. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: STROKE IN RIGHT EYE; This spontaneous report received from a patient through other manufacturer (Novartis) concerned a female of unspecified age, race and ethnicity. 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, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient suffered an eye stroke in right eye. Patient got blind with her right eye. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke in right eye was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220604242-COVID-19 VACCINE AD26.COV2.S-stroke in right eye. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vial was first punctured: 24-May-2022 10:00 AM to 10:30 AM and administered on 25-May-2022 09:52 AM; Received expired vaccine more than 12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine more than 12 hours post puncture) and PRODUCT STORAGE ERROR (vial was first punctured: 24-May-2022 10:00 AM to 10:30 AM and administered on 25-May-2022 09:52 AM) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2022 at 9:52 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2022 at 9:52 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine more than 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was first punctured: 24-May-2022 10:00 AM to 10:30 AM and administered on 25-May-2022 09:52 AM). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine more than 12 hours post puncture) and PRODUCT STORAGE ERROR (vial was first punctured: 24-May-2022 10:00 AM to 10:30 AM and administered on 25-May-2022 09:52 AM) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided.  Number of doses/vials: 1 Dose / 1 vial Date the vial was initially stored in the refrigerator: 24-May-2022 10:00 AM. The vial was first punctured: 24-May-2022 10AM to 10:30AM The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): Approximately 24 hours. The vial exposed to room temperature for more than 24 hours: Approximately 24 hours. No treatment information provided.
Age: 30.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: Sniffles and positive test 5 days after stopping Paxlovid; Sniffles and positive test 5 days after stopping Paxlovid; This spontaneous case was reported by a patient and describes the occurrence of RHINORRHOEA (Sniffles and positive test 5 days after stopping Paxlovid) and COVID-19 (Sniffles and positive test 5 days after stopping Paxlovid) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Patient had medical history but not reported.  Concurrent medical conditions included Drug allergy (Drug not reported).   On 25-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 21-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RHINORRHOEA (Sniffles and positive test 5 days after stopping Paxlovid). On an unknown date, the patient experienced COVID-19 (Sniffles and positive test 5 days after stopping Paxlovid). At the time of the report, RHINORRHOEA (Sniffles and positive test 5 days after stopping Paxlovid) and COVID-19 (Sniffles and positive test 5 days after stopping Paxlovid) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were reported.  Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  Patient previously received a COVID-19 Vaccine.  No treatment drugs were reported.  Company comment: This spontaneous case concerns a 31-year-old male patient with no relevant medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19 which occurred at an unknown time with regards to the mRNA-1273 vaccination. The patient experienced rhinorrhea and retested positive after taking paxlovid. The outcome of the events was reported as resolving. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 31-year-old male patient with no relevant medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19 which occurred at an unknown time with regards to the mRNA-1273 vaccination. The patient experienced rhinorrhea and retested positive after taking paxlovid. The outcome of the events was reported as resolving. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19, UNK
Symptoms: COVID-19
Clinical narrative: Rebound in COVID after taking Paxlovid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Rebound in COVID after taking Paxlovid) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    No Medical History information was reported.   On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 24-May-2022, the patient experienced COVID-19 (Rebound in COVID after taking Paxlovid). At the time of the report, COVID-19 (Rebound in COVID after taking Paxlovid) had not resolved.            The patient did not took any other medications or products within 2 weeks of starting COVID-19 treatment.  The patient previously received a COVID-19 Vaccine. Company comment: This spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 186 days after administration of third dose of mRNA-1273, there was no information provided regarding the initial two doses. On May 16, 2022, patient was started on treatment regimen of Paxlovid to which the patient experienced rebound symptoms of COVID-19. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 186 days after administration of third dose of mRNA-1273, there was no information provided regarding the initial two doses. On May 16, 2022, patient was started on treatment regimen of Paxlovid to which the patient experienced rebound symptoms of COVID-19. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Angioedema, Urticaria
Clinical narrative: Angioedema; Urticaria; This literature-non-study case was reported in a literature article and describes the occurrence of ANGIOEDEMA (Angioedema) in a 25-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.      No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANGIOEDEMA (Angioedema) (seriousness criterion medically significant) and URTICARIA (Urticaria). At the time of the report, ANGIOEDEMA (Angioedema) and URTICARIA (Urticaria) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered ANGIOEDEMA (Angioedema) and URTICARIA (Urticaria) to be related.    Concomitant and treatment medications were not reported.  Company comment: This literature non study case concerns a 25 years old male with no medical history, who experienced the unexpected serious (medically significant) event of angioedema, which occurred unspecified days after first dose of mRNA-1273 vaccine. Additionally non serous event urticaria is also reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This literature non study case concerns a 25 years old male with no medical history, who experienced the unexpected serious (medically significant) event of angioedema, which occurred unspecified days after first dose of mRNA-1273 vaccine. Additionally non serous event urticaria is also reported. . The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Troponin
Clinical narrative: Recently had a chest pain; Muscle pain; After their booster develop tinnitus, a ringing in the ears; More recently nerve pain in the arms and legs; This spontaneous case was reported by a physician and describes the occurrence of TINNITUS (After their booster develop tinnitus, a ringing in the ears), NEURALGIA (More recently nerve pain in the arms and legs), CHEST PAIN (Recently had a chest pain) and MYALGIA (Muscle pain) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013H21B, 010M20A and 012L20A) for COVID-19 vaccination.     Patient never had COVID test or diagnosis. There was no history of Myocarditis/pericarditis.  Concurrent medical conditions included Drug allergy (Topiramate allergy).   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced TINNITUS (After their booster develop tinnitus, a ringing in the ears), NEURALGIA (More recently nerve pain in the arms and legs) and MYALGIA (Muscle pain). On 06-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHEST PAIN (Recently had a chest pain). At the time of the report, TINNITUS (After their booster develop tinnitus, a ringing in the ears), NEURALGIA (More recently nerve pain in the arms and legs), CHEST PAIN (Recently had a chest pain) and MYALGIA (Muscle pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Cardiac function test: normal (normal) abnormal- no. On an unknown date, Electrocardiogram: normal (normal) ECG show no voltage and abnormal (abnormal) abnormal. On an unknown date, Troponin: normal (normal) normal value.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. Hx relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. AE caused the patient to seek medical care. It was reported that symptoms were worsened.  There was no diagnosis of myocarditis or pericarditis. Patient did not experience dyspnea/shortness of breath/pain with breathing. Patient did not experience palpitations/pericardial rub. Patient did not experience syncope. There was no myocardial edema/cardiomyopathy/pericardial effusion/infective pericardial effusion/pericardial effusion malignant. The patient had not experienced a similar event in the past. It was reported that the symptoms had worsened and had not resolved. There was no cause determined for the reported adverse events MRI of the heart was not performed.  No treatment medications were provided.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Myalgia, Pain, Somnolence
Clinical narrative: patient only wants to sleep; in pain/in agony; every muscle hurts/everything hurts; patient was very tired; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (patient only wants to sleep), PAIN (in pain/in agony), MYALGIA (every muscle hurts/everything hurts) and FATIGUE (patient was very tired) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037832b, 006b21a and 003a21a) for COVID-19 vaccination.     It was reported as patient  never had COVID positive test or diagnosis,no history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination and patient received none of the other vaccines given within one month prior to Moderna COVID-19 Vaccine.  Concurrent medical conditions included Pollen allergy (Patient is allergic to pollen dust).   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (patient only wants to sleep), PAIN (in pain/in agony), MYALGIA (every muscle hurts/everything hurts) and FATIGUE (patient was very tired). At the time of the report, SOMNOLENCE (patient only wants to sleep), PAIN (in pain/in agony), MYALGIA (every muscle hurts/everything hurts) and FATIGUE (patient was very tired) had not resolved.            Patient height reported as 5 Foot 9 It was reported as patient was concern about her heart as it is muscle and it was also reported that no AE cause patient to seek medical care so far,patient never experienced a similar event in the past and symptoms was not really improved. No concomitant information was reported was by the reporter. Treatment includes: pain medication which has its own side effects and could stand it only for a few days.   This case was linked to MOD-2022-581273 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation reaction, Inappropriate schedule of product administration
Clinical narrative: patient only wants to sleep; in pain/in agony; every muscle hurts/everything hurts; patient was very tired; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (patient only wants to sleep), PAIN (in pain/in agony), MYALGIA (every muscle hurts/everything hurts) and FATIGUE (patient was very tired) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037832b, 006b21a and 003a21a) for COVID-19 vaccination.     It was reported as patient  never had COVID positive test or diagnosis,no history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination and patient received none of the other vaccines given within one month prior to Moderna COVID-19 Vaccine.  Concurrent medical conditions included Pollen allergy (Patient is allergic to pollen dust).   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (patient only wants to sleep), PAIN (in pain/in agony), MYALGIA (every muscle hurts/everything hurts) and FATIGUE (patient was very tired). At the time of the report, SOMNOLENCE (patient only wants to sleep), PAIN (in pain/in agony), MYALGIA (every muscle hurts/everything hurts) and FATIGUE (patient was very tired) had not resolved.            Patient height reported as 5 Foot 9 It was reported as patient was concern about her heart as it is muscle and it was also reported that no AE cause patient to seek medical care so far,patient never experienced a similar event in the past and symptoms was not really improved. No concomitant information was reported was by the reporter. Treatment includes: pain medication which has its own side effects and could stand it only for a few days.   This case was linked to MOD-2022-581273 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Headache, Paranasal sinus inflammation, Pyrexia
Clinical narrative: Reoccurance of sinus swelling; Headache; Mild fever; This spontaneous case was reported by a consumer and describes the occurrence of PARANASAL SINUS INFLAMMATION (Reoccurance of sinus swelling), HEADACHE (Headache) and PYREXIA (Mild fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Patient had no known allergy.    On 31-Mar-2022 at 12:00 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 27-May-2022, the patient experienced PARANASAL SINUS INFLAMMATION (Reoccurance of sinus swelling), HEADACHE (Headache) and PYREXIA (Mild fever). At the time of the report, PARANASAL SINUS INFLAMMATION (Reoccurance of sinus swelling), HEADACHE (Headache) and PYREXIA (Mild fever) was resolving.            No concomitant medication were reported. Device Date : 31May2022
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose 1 administered on 17-FEB-2021 and dose 2 administered on 30-MAR-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 17-FEB-2021 and dose 2 administered on 30-MAR-2021) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy.   On 17-Feb-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021 at 3:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 17-FEB-2021 and dose 2 administered on 30-MAR-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 17-FEB-2021 and dose 2 administered on 30-MAR-2021) outcome was unknown.            Reportedly, the patient did not received any other  medications or products within 2 weeks of starting COVID-19 treatment and patient  previously received a COVID-19 Vaccine. Patient had received unspecified drug for allergy. Concomitant medications details were not reported by the reporter.  Patient had took third dose of Moderna vaccine on 11-Nov-2021 at 02:00 PM on left arm (Batch number unknown). Treatment details were not reported by the reporter.   This case was linked to MOD-2022-581177 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Apr2021 as dose 1, single (Lot number: ER8735) and on 05May2021 as dose 2, single (Lot number: EW0170) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 08Nov2021 as dose number unknown (booster), single (Lot number: 033F21A) for covid-19 immunisation. The patient's relevant medical history included: "Penicillin" (unspecified if ongoing); "plastic adhesive bandages" (unspecified if ongoing); "Elevated blood pressure" (unspecified if ongoing); "raynaud's syndrome" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "eczema" (unspecified if ongoing); "rosacea" (unspecified if ongoing). Concomitant medication(s) included: JUNEL; LOSARTAN POTASSIUM, start date: 26Apr2022; LEVOTHYROXINE; SPIRONOLACTONE; DULOXETINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20May2022) Negative; (30May2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Apr2021 as dose 1, single (Lot number: ER8735) and on 05May2021 as dose 2, single (Lot number: EW0170) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 08Nov2021 as dose number unknown (booster), single (Lot number: 033F21A) for covid-19 immunisation. The patient's relevant medical history included: "Penicillin" (unspecified if ongoing); "plastic adhesive bandages" (unspecified if ongoing); "Elevated blood pressure" (unspecified if ongoing); "raynaud's syndrome" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "eczema" (unspecified if ongoing); "rosacea" (unspecified if ongoing). Concomitant medication(s) included: JUNEL; LOSARTAN POTASSIUM, start date: 26Apr2022; LEVOTHYROXINE; SPIRONOLACTONE; DULOXETINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20May2022) Negative; (30May2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: administration after temperature August excursion; administration after temperature August excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (administration after temperature August excursion) and POOR QUALITY PRODUCT ADMINISTERED (administration after temperature August excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (administration after temperature August excursion) and POOR QUALITY PRODUCT ADMINISTERED (administration after temperature August excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (administration after temperature August excursion) and POOR QUALITY PRODUCT ADMINISTERED (administration after temperature August excursion) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. The minimum temperature reached in this excursion was -14 °F. The maximum temperature reached in this excursion was 23 °F. The duration of the excursion was 365 Days. Treatment medication was not reported.  Basically the provider never downloaded their reports and only looked at the temperatures once a day. This starts in December 2020 and had gone on until now. They have a new now and kept their frozen vaccine in the freezer of their fridge/freezer combo unit and only stored in the fridge the day they used the vials.
Age: 63.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Joint swelling, Musculoskeletal disorder, Pain, Spinal synovial cyst
Clinical narrative: Spinal synovial cyst; Lower extremity dysfunction; Pain; Ankle swelling; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL SYNOVIAL CYST (Spinal synovial cyst), MUSCULOSKELETAL DISORDER (Lower extremity dysfunction), JOINT SWELLING (Ankle swelling) and PAIN (Pain) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB for RA.    Patient had no known allergies.    In October 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (unknown route) Citrate Free. In October 2021, the patient experienced JOINT SWELLING (Ankle swelling). On an unknown date, the patient experienced SPINAL SYNOVIAL CYST (Spinal synovial cyst), MUSCULOSKELETAL DISORDER (Lower extremity dysfunction) and PAIN (Pain). The patient was treated with DICLOFENAC SODIUM ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, SPINAL SYNOVIAL CYST (Spinal synovial cyst) and PAIN (Pain) was resolving, MUSCULOSKELETAL DISORDER (Lower extremity dysfunction) outcome was unknown and JOINT SWELLING (Ankle swelling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was unknown if patient had not enrolled in a COVID-19 Vaccine trial.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2022: Follow-up: Patient demographics (age), event information, reporter opinion ofcausality,treatment drug information, narrative description and medical history. The event of "PAIN" was added.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received the vaccine on 11-May-2022, which had got expired on the 29-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 11-May-2022, which had got expired on the 29-Apr-2022) in a 55-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 042j21a) for COVID-19 vaccination.     It was unknown whether patient was diagnosed or had tested positive for Covid -19  It was unknown whether patient had acute illness at the time of vaccination and upto one month prior. It was unknown whether patient had chronic or long standing health conditions.     On 11-May-2022 at 8:00 PM, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 11-May-2022 at 8:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 11-May-2022, which had got expired on the 29-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 11-May-2022, which had got expired on the 29-Apr-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Hcp reported they administered a vaccine that expired on the 29Apr2022 to less 5 patients. It was unknown on which date the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions Treatment details were not given.   This case was linked to MOD-2022-573908 (Patient Link).
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, SARS-CoV-2 test
Clinical narrative: The patient received the vaccine on 11-May-2022, which had got expired on the 29-Apr-2022.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received the vaccine on 11-May-2022, which had got expired on the 29-Apr-2022.) in an 83-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2022 at 2:18 PM, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 11-May-2022 at 2:18 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received the vaccine on 11-May-2022, which had got expired on the 29-Apr-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received the vaccine on 11-May-2022, which had got expired on the 29-Apr-2022.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Dec-2020, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drugs were not reported.  The patient had not taken any prescriptions, over the counter medication, dietary supplement or herbal remedies at the time of vaccination and also not had any acute illness at the time of vaccination and up to 1 month before.  Hcp reported they administer a vaccine that expired on the 29Apr2022 to less 5 patients which was the dose administered after 30-day Use By Date or after manufacturer date of expiry.   Number of vials and date the vial was initially stored in the refrigerator were unknown.   The vial did not undergo any temperature excursions.  The event does not caused the patient to seek the medical care.  It was unknown if the event most likely caused by Mrna-1273 and the patient experienced a similar events in the past.   Treatment details were not given.   This case was linked to MOD-2022-573908 (Patient Link).
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: every day, specifically on one side of her head/ headache radiates from her eye to back of the head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 25-year-old female patient received BNT162b2 (BNT162B2), on 16May2022 as dose 1, single (Batch/Lot number: unknown) at the age of 25 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset May2022, outcome "not recovered", described as "every day, specifically on one side of her head/ headache radiates from her eye to back of the head".  Additional information: The patient was trying to get in contact with her doctor, but hasn't been able to reach anyone.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Pain in extremity
Clinical narrative: Her arm is hurting really bad today; the issue continued, and got worse, after she got the booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2), on 05Oct2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (the second vaccine on 24Mar2021, and the Lot: EN6204), administration date: 24Mar2021, for Covid-19 Immunization, reaction(s): "Pain in arm"; Covid-19 vaccine (DOSE 1 , SINGLE, UNKNOWN MANUFACTURER), for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Her arm is hurting really bad today"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "the issue continued, and got worse, after she got the booster".
Sex: M
Vaccine: COVID19
Symptoms: Multiple sclerosis
Clinical narrative: my friends who turned out to have MS but he didn't get diagnosed with MS until he got the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MULTIPLE SCLEROSIS (medically significant), outcome "unknown", described as "my friends who turned out to have MS but he didn't get diagnosed with MS until he got the vaccine".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.