chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer Pfizer concerned a 55 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (codeine and sulfa). The patient previously received of covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin and batch number not reported, expiry: unknown) dose and start date of therapy not reported, 1 total, administered for prophylactic vaccination.  It was unknown if the patient experienced any adverse reactions following the administration of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received dose number 2 of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin and batch number were not reported, expiry: unknown) dose was not reported, 1 total administered on 18-APR-2022 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 55 years old. No concomitant medications were reported. The patient was not taking any medication within 2 weeks of starting Covid-19 treatment. On an unspecified date in 2022, the patient had suspected covid-19 infection with symptoms of very bad after taste and suspected clinical vaccination failure (dose number in series 2). The patient was treated with Paxlovid (nirmatrelvir/ritonavir) (form of admin and route of admin were not reported, batch number NDC00069108530, expiry: unknown) dose not reported, administered 01-JUN-2022 till 05-JUN-2022 for Covid-19 treatment. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This case is associated with product quality complaint.; Sender's Comments: 20220644891-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: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer via other manufacturer (Pfizer) concerned a male of unspecified age. Initial information was processed along with additional information received on 14-JUN-2022. 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) dose was not reported, 1 total, administered on 04-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 13-MAY-2022, after contracting virus, patient had symptoms of runny nose, sneezing, exhaustion and fever (lasted 3 days). On an unspecified date in MAY-2022, Laboratory data included: COVID-19 virus test positive. Thus patient had confirmed covid-19 infection and confirmed clinical vaccination failure.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000235440. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the evaluation/investigation performed. This case, from the same reporter is linked to 20220607940.; Sender's Comments: -20220647125-covid-19 vaccine ad26.cov2.s-confirmed 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: Thrombosis, Ultrasound Doppler
Clinical narrative: SUPERFICIAL BLOOD CLOTS IN BOTH LOWER EXTREMITIES; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnic origin. 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 developed superficial blood clots in both lower extremities couple of weeks after receiving the vaccine. This was all documented as patient went to the emergency room for evaluation and it was confirmed by doppler. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of superficial blood clots in both lower extremities was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20220647590-covid-19 vaccine ad26.cov2.s- superficial blood clots in both lower extremities. 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). Therefore, this event(s) is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Lung disorder
Clinical narrative: This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced lung issue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of lung issue was not reported. This report was non-serious.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye pain, Hypoaesthesia, Pain in extremity, Sensory disturbance
Clinical narrative: This spontaneous report received from a patient (pharmacist) via other company (Pfizer) concerned a 34 year old female of an unspecified race and ethnic origin. The patient's weight was 58.97 kilograms, and height was 155 centimeters. The patient's concurrent conditions included: asthma. The patient was a pharmacy technician. On an unspecified date, the patient received first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 in total administered for prophylactic vaccination. The batch number was not reported and has been requested.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1). On JUN-2022, the patient received first booster shot (second dose) of non-company suspect vaccine tozinameran (Pfizer) (dose number in series 2) (form of admin and route of admin were not reported, batch number: FM7553 expiry: UNKNOWN) dose was not reported, administered to left arm for prophylactic vaccination. No concomitant medications were reported.  On JUN-2022, the patient experienced sore arm and hand pain for 2 to 3 days (dose number in series 2). On 15-JUN-2022, the patient felt her right side of the face that somebody punched, eye hurt a lot and her face was numb on the right side only (dose number in series 2). The patient had not received any treatment. The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The patient recovered from sore arm/hand pain on JUN-2022, and the outcome of eye hurting a lot, face is numb on the right side and felt like right side of face that somebody punched was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; RECEIVED THE JANSSEN COVID-19 VACCINE AFTER THE PRODUCT WAS EXPOSED TO MULTIPLES TEMPERATURE OF EXCURSION; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809 expiry: UNKNOWN) dose was not reported, administered on 11-JAN-2022 for prophylactic vaccination. The drug was associated with Medication error. No concomitant medications were reported. On 11-JAN-2022, the patient experienced received the janssen covid-19 vaccine after the product was exposed to multiples temperature of excursion. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received the janssen covid-19 vaccine after the product was exposed to multiples temperature of excursion and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220649045, 20220649137, 20220649417, 20220649488, 20220649421, 20220649626, 20220649704, 20220649804, 20220649915, 20220649804, 20220649803, 20220649884, 20220650014, 20220650111, 20220650014, 20220650185 and 20220650111. This report was associated with product quality complaint: 90000237043.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; RECEIVED THE JANSSEN COVID-19 VACCINE AFTER THE PRODUCT WAS EXPOSED TO MULTIPLES TEMPERATURE OF EXCURSION; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809 expiry: UNKNOWN) dose was not reported, administered on 22-FEB-2022 for prophylactic vaccination. The drug was associated with Medication error. No concomitant medications were reported.  On 22-FEB-2022, the patient experienced received the janssen covid-19 vaccine after the product was exposed to multiples temperature of excursion. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received the Janssen covid-19 vaccine after the product was exposed to multiples temperature of excursion and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220649045, 20220649137, 20220649370, 20220649417, 20220649421, 20220649626, 20220649704, 20220650014, 20220649488, 20220649803, 20220649884, 20220649915, 20220650111 and 20220650185.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC reported; Caller reports vaccine administered after temperature excursion.; This spontaneous report was received from a source, from a Medical Assistant reporter.   With patient initials and name, unknown information (no date of birth, nationality, age or gender or patient ID.  The patient medical history, current conditions, historical drugs and drug reactions or allergies and concomitants therapies were not mentioned.  On 09-JUN-2022 at 04:14pm it was information received that described according to the caller that a vaccine was administered after temperature excursion. No other information provided. No additional AEs or PQC reported.   Therapy information: Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) lot# U034712 validated, expiration date: 7/30/2023, dose 0.5 ml, route of administration intramuscular, temperature 34.2F, time frame 12 hours, no previous temperature excursion. Indication for prophylaxis. Unknown start date, strength, formulation, and frequency.  There were no adverse events reported related to the situation described. No lab data, other medications and treatments reported.   The action taken, dechallenge, rechallenge and causalities were not reported.  No outcome, reported causality, cross reference, serious criteria or downgrade stament were described.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Moderna vaccine administered to patients post temperature excursion; Poor quality vaccine administered; 1st dose administered on 05-Nov-2021 and 2nd dose administered on 10-may-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 05-Nov-2021 and 2nd dose administered on 10-may-2022) in a 77-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     It was unknown if the patient has ever been diagnosed or tested positive for COVID-19. It was reported Acute illness at the time of vaccination and up to one month before and Chronic or long-standing health conditions were unknown.    On 05-Nov-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 10-May-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 10-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 05-Nov-2021 and 2nd dose administered on 10-may-2022). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna vaccine administered to patients post temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 05-Nov-2021 and 2nd dose administered on 10-may-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The temperature excursion occurred at the facility on 09-May-2022. Reporter stated that it was a refrigerator excursion where the lowest temperature reached 26 degree Fahrenheit for about 15 minutes and the average temperature was 28 degree Fahrenheit. The entire excursion duration was about 5 hours. Reporter stated that the Moderna vaccine was used post excursion and administered to patients. No vaccine state changes were noticed. Patient did not report any adverse events.  No treatment medication was reported.   This case was linked to MOD-2022-592938 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2022: Follow-up received contains significant information, included patient information, dose details, additional event and case narrative was updated.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients received the Moderna Covid 19 vaccine after temperature excursion; Patients received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 21-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported storage condition was frozen at the time of the excursion. Lot numbers was reported as 065K21A and 045L21A. Maximum: 30 Fahrenheit degrees minimum -18.9 Fahrenheit degrees temperatures was reached. The vaccines suffered 2 temperature excursions since April, both vaccine was lasted less than 1 minute. It was unknown when the vials moved from freezer to refrigerator. Currently vaccine was stored under frozen state. There was no any visual inspection noting any vaccine state change. No treatment information was reported.   This case was linked to MOD-2022-592921, MOD-2022-592979, MOD-2022-592932, MOD-2022-592958, MOD-2022-592999, MOD-2022-592988, MOD-2022-592873, MOD-2022-592948, MOD-2022-592922, MOD-2022-592920, MOD-2022-592941, MOD-2022-592914, MOD-2022-592972, MOD-2022-592949, MOD-2022-592946, MOD-2022-592879, MOD-2022-593012, MOD-2022-592900, MOD-2022-592965, MOD-2022-592937, MOD-2022-592904, MOD-2022-592924, MOD-2022-592873, MOD-2022-593011, MOD-2022-592913 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2022: Follow up received contains significant information as patient demographics, vaccine information and event onset date were updated.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Generalized aching), FATIGUE (Fatigue) and HEADACHE (Headache) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  The patient's past medical history included Pregnancy (On 14-Jul-2019 the baby was born.) on 14-Jul-2019. Previously administered products included for Psoriatic arthritis: Humira (Solution for injection in pre-filled pen. Route- Subcutaneous. The fetus was exposed to Maternal use of Humira in utero during unknown trimester. No maternal medical problems or complications during delivery or the postpartum period were reported. The reporter's causality for the event of maternal exposure during pregnancy was not provided.) from 10-Oct-2018 to 27-Nov-2018, Humira (Solution for injection in pre-filled pen. Route- Subcutaneous. On 14-Jul-2019 the baby was born. (Live birth) with no neonatal complications and congenital anomalies or birth defects. The reporter's causality for the event of live birth was not provided.) from 10-Oct-2018 to 27-Nov-2018. Past adverse reactions to the above products included Live birth with Humira; and Maternal exposure during pregnancy with Humira. Concurrent medical conditions included Psoriatic arthritis. On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Generalized aching), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, PAIN (Generalized aching), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown. No concomitant medications were provided by the reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of FATIGUE, HEADACHES and BODY ACHES with HUMIRA (ADALIMUMAB) was no reasonable possibility. No treatment medications were provided by the reporter.
Age: 31.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.  The patient did not have any known allergies and any relevant medical history.  On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.  No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine trial. The reporter's causality for event COVID-19 with ADALIMUMAB (HUMIRA) was not provided and considered possible with mRNA-1273 (Moderna COVID-19 Vaccine). No treatment medications were reported.  Company comment: This is a spontaneous case concerning an adult female patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, on unknown date after receiving the second dose of mRNA-1273 vaccine. Clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of report. Kindly note that the two doses of mRNA-1273 vaccine was given on a 28-day interval. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning an adult female patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, on unknown date after receiving the second dose of mRNA-1273 vaccine. Clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of report. Kindly note that the two doses of mRNA-1273 vaccine was given on a 28-day interval. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 68.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Inappropriate schedule of product administration, Muscle fatigue
Clinical narrative: had covid vaccine arm was tired; Tired when it was hot; second dpse 1-Apr-2021 and booster dose on 17- Aug- 2021; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE FATIGUE (had covid vaccine arm was tired), FATIGUE (Tired when it was hot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dpse 1-Apr-2021 and booster dose on 17- Aug- 2021) 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 ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) On 17-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose 1-Apr-2021 and booster dose on 17- Aug- 2021). On an unknown date, the patient experienced MUSCLE FATIGUE (had covid vaccine arm was tired) and FATIGUE (Tired when it was hot). At the time of the report, MUSCLE FATIGUE (had covid vaccine arm was tired), FATIGUE (Tired when it was hot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dpse 1-Apr-2021 and booster dose on 17- Aug- 2021) outcome was unknown.            Patient received booster dose of moderna on 17-Aug-2021 No concomitant medication was provided by reporter. No treatment medication was provided by reporter. It was unknown if the patient was enrolled in a Covid-19 vaccine trial.
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous)  Solution for injection in Prefilled pen. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Concomitant medication details was not reported.  Treatment details was not reported.  It was unknown if the patient was enrolled in a COVID-19 vaccine trial or not.  The reporter causality for the event of COVID-19 with the suspect vaccine Spikevax was reported as possible while the the reporter causality for the event of COVID-19 with the co-suspect drug Humira was reported as not related (no reasonable possibility).  Company comment: This spontaneous case concerns a female patient of an unknown age, with no relevant medical history, who experienced the unexpected non-serious of COVID-19 after receiving the dose of mRNA-1273 vaccine on an unknown date. The onset date of the event was not reported. Clinical course and treatment details were not reported. The outcome of event was reported as resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event was assessed as non-serious based on medical judgement. Sender's Comments: This spontaneous case concerns a female patient of an unknown age, with no relevant medical history, who experienced the unexpected non-serious of COVID-19 after receiving the dose of mRNA-1273 vaccine on an unknown date. The onset date of the event was not reported. Clinical course and treatment details were not reported. The outcome of event was reported as resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event was assessed as non-serious based on medical judgement.
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine after having two excursion for a total of 29 hours and 30 minutes) and PRODUCT TEMPERATURE EXCURSION ISSUE (The first temperature excursion lasted for 9 hours 45 minutes/The total amount of the excursion is 29 hours 30 minutes.) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 016J21-2A) for COVID-19 prophylaxis. No Medical History information was reported. On 04-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine after having two excursion for a total of 29 hours and 30 minutes). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (The first temperature excursion lasted for 9 hours 45 minutes/The total amount of the excursion is 29 hours 30 minutes.). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine after having two excursion for a total of 29 hours and 30 minutes) and PRODUCT TEMPERATURE EXCURSION ISSUE (The first temperature excursion lasted for 9 hours 45 minutes/The total amount of the excursion is 29 hours 30 minutes.) outcome was unknown. Concomitant products were not provided. The vial was first punctured on 04-Mar-2022. The vial were not exposed to room temperature. The vial was stored only in freezer. The vial did undergo temperature excursion. The maximum 10.8 degree Fahrenheit and minimum 5.5 degree Fahrenheit were reached. The vial was not moved from freezer to refrigerator. The vial was found to be refrozen in the visual inspection. At least 1 vial was impacted. No previous excursions were seen. Treatment medications were not reported. This case was linked to MOD-2022-592504 (Patient Link).
Age: 34.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Inflammation, Pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (A LOT INFLAMMATION) and PAIN (SOME SORENESS AND ACHING) in an adult 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, Plaque psoriasis and Ulcerative colitis. No Medical History information was reported. On 04-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced INFLAMMATION (A LOT INFLAMMATION) and PAIN (SOME SORENESS AND ACHING). At the time of the report, INFLAMMATION (A LOT INFLAMMATION) and PAIN (SOME SORENESS AND ACHING) outcome was unknown.    Concomitant products were not provided. Treatment medications were not reported.
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19 immunisation
Clinical narrative: vaccinated with moderna/rinvoq was not working at all for her rheumatoid arthritis so she quit taking it; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 IMMUNISATION (vaccinated with moderna/rinvoq was not working at all for her rheumatoid arthritis so she quit taking it) in a 57-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced COVID-19 IMMUNISATION (vaccinated with moderna/rinvoq was not working at all for her rheumatoid arthritis so she quit taking it). At the time of the report, COVID-19 IMMUNISATION (vaccinated with moderna/rinvoq was not working at all for her rheumatoid arthritis so she quit taking it) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported. It was unknown if patient was enrolled in a covid-19 vaccine trial. No treatment medications were reported.
Age: 53.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Immunodeficiency
Clinical narrative: Immunodeficiency; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNODEFICIENCY (Immunodeficiency) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced IMMUNODEFICIENCY (Immunodeficiency) (seriousness criterion medically significant). At the time of the report, IMMUNODEFICIENCY (Immunodeficiency) outcome was unknown.            No concomitant medication information was reported. The patient was concerned about Humira lowered immunity. No treatment information was reported.
Age: 33.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Bruxism, Tooth disorder
Clinical narrative: Teeth felt funny; Teeth grinding; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH DISORDER (Teeth felt funny) and BRUXISM (Teeth grinding) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products LEUPRORELIN ACETATE (LUPRON DEPOT) for an unknown indication and HYDROCODONE for an unknown indication.    No Medical History information was reported.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started LEUPRORELIN ACETATE (LUPRON DEPOT) (unknown route) at an unspecified dose and HYDROCODONE (unknown route) at an unspecified dose. In January 2021, the patient experienced TOOTH DISORDER (Teeth felt funny) and BRUXISM (Teeth grinding). At the time of the report, TOOTH DISORDER (Teeth felt funny) and BRUXISM (Teeth grinding) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not provided by the reporter. Sulfa was also considered suspect and patient was allergic to sulfa and hydrocodone.  It was unknown if patient was enrolled in a COVID-19 vaccine trial. Treatment information was not provided.   This case was linked to MOD-2022-593774 (Patient Link).
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain
Clinical narrative: Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced PAIN (Pain). At the time of the report, PAIN (Pain) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported. The patient had pain which was manageable but could be better. It was unknown if the patient was enrolled in a COVID-19 vaccine trail. The reporter's causality for the event of pain and suspect Rinvoq (Upadacitinib) was no reasonable possibility. No treatment medications were reported.
Age: 78.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriatic arthritis and Plaque psoriasis.  No Medical History information was reported.  On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. In June 2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving.  No concomitant medications were reported. It was reported that patient was recovering from COVID which patient had for the last two weeks of 15Jun2022. It was reported that Booster dose was discontinued. It was unknown if patient was enrolled in COVID-19 vaccine trial. The reporter's causality for the event of COVID-19 was not provided with Skyrizi (risankizumab) and considered possible with mRNA-1273 vaccine (Moderna COVID-19 vaccine). No treatment medication was reported.  Company Comment: This spontaneous case concerns a 78-year-old, male patient with history of co-suspect administration of Skyrizi (risankizumab) for Moderate-to-severe Chronic Plaque Psoriasis and Psoriatic Arthritis, who experienced the unexpected, non-serious of COVID-19. The event occurred on an unspecified date in Jun2022 after receiving the booster (third) dose of the mRNA-1273 vaccine on an unspecified date. Treatment information was not provided. It was reported that the patient was recovering from COVID-19 which he had for the last 2 weeks 'as of 15Jun2022'. The patient's advanced age (high risk for infections) remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a 78-year-old, male patient with history of co-suspect administration of Skyrizi (risankizumab) for Moderate-to-severe Chronic Plaque Psoriasis and Psoriatic Arthritis, who experienced the unexpected, non-serious of COVID-19. The event occurred on an unspecified date in Jun2022 after receiving the booster (third) dose of the mRNA-1273 vaccine on an unspecified date. Treatment information was not provided. It was reported that the patient was recovering from COVID-19 which he had for the last 2 weeks 'as of 15Jun2022'. The patient's advanced age (high risk for infections) remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 73.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Rash
Clinical narrative: Arthritic pains; Rash after receiving Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Arthritic pains) and RASH (Rash after receiving Moderna vaccine) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   In May 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 UNK. In 2022, the patient experienced RASH (Rash after receiving Moderna vaccine). On an unknown date, the patient experienced ARTHRALGIA (Arthritic pains). At the time of the report, ARTHRALGIA (Arthritic pains) and RASH (Rash after receiving Moderna vaccine) was resolving.            No concomitant drug reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for the event of arthritis pain and rash after receiving Moderna vaccine with HUMIRA (Adalimumab) was no reasonable possibility.  No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19
Clinical narrative: Patient exprienced COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient exprienced COVID) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No known allergies were reported. No relevant medical history reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced COVID-19 (Patient exprienced COVID). At the time of the report, COVID-19 (Patient exprienced COVID) had not resolved.            The co-suspect indication was reported as moderate to severe rheumatoid arthritis.  Concomitant drugs were not reported.  It was unknown if patient was enrolled in COVID-19 vaccine trial.  No treatment medication was provided.  Reporter's causality for co-suspect product was reported as reasonable possibility.  Company comment: This is a spontaneous case concerning a female adult patient of unknown age, with no reported medical history and with vaccine history of receiving first and second dose of mRNA-1273, with unknown dosage and dosage interval. Adalimumab (Humira) for moderate to severe rheumatoid arthritis was reported as co-suspect product, with unknown therapy dates. Patient experienced the unexpected non-serious AESI event of Covid-19. The event occurrence was unknown with respect to the booster dose of mRNA-1273 vaccine administration. No other information surrounding the event was reported. The outcome of the event was reported as not resolved from the time of last observation. The concurrent Covid-19 pandemic remain confounder for the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a female adult patient of unknown age, with no reported medical history and with vaccine history of receiving first and second dose of mRNA-1273, with unknown dosage and dosage interval. Adalimumab (Humira) for moderate to severe rheumatoid arthritis was reported as co-suspect product, with unknown therapy dates. Patient experienced the unexpected non-serious AESI event of Covid-19. The event occurrence was unknown with respect to the booster dose of mRNA-1273 vaccine administration. No other information surrounding the event was reported. The outcome of the event was reported as not resolved from the time of last observation. The concurrent Covid-19 pandemic remain confounder for the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient received the Moderna Covid 19 vaccine after temperature excursion; Patient received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Apr-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that there had been temperature excursions with the freezer that was happened for weeks since April 2022. Storage condition at the time of the excursion were frozen.  It was reported that Lot numbers: 065K21A and Lot numbers 045L21A had undergone temperature excursion and maximum and minimum temperatures reached were 30 Fahrenheit Degrees and minus 18.9 Fahrenheit Degrees respectively.  It was reported that the vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute and date the vials moved from freezer to refrigerator was unknown, they were now stored in frozen condition and no vaccine state change was observed.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Rash
Clinical narrative: menstrual cycle changed for 4 months; rashes all over my face; This spontaneous case was reported by a patient and describes the occurrence of MENSTRUAL DISORDER (menstrual cycle changed for 4 months) and RASH (rashes all over my face) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     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 MENSTRUAL DISORDER (menstrual cycle changed for 4 months) and RASH (rashes all over my face). At the time of the report, MENSTRUAL DISORDER (menstrual cycle changed for 4 months) and RASH (rashes all over my face) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.