chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Laryngoscopy, Vocal cord paralysis
Clinical narrative: VOCAL FOLD PARALYSIS; This spontaneous report was received from literature. This report concerned a patient of unspecified age, sex, race and ethnicity. The objective of this study is to determine the correlation of COVID-19 post vaccination recurrent laryngeal neuropathy resulting in VFP (Vocal fold paresis or paralysis). The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 total administered 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 vocal fold paralysis. Laboratory data (dates unspecified) included: Laryngoscopy (NR: not provided) confirmed VFP (Vocal fold paralysis). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vocal fold paralysis was not reported. Results of the study includes: On preliminary search of the database (Vaccine Adverse Event Reporting System), 19 patients found to had experienced vocal fold paresis or paralysis. Among the 19 patient 1 received Janssen vaccine and the mean lag time between vaccination and symptom onset was 12 days. Patient reported symptoms prompting evaluation includes (The total 19 patient %): Dysphagia 1 (5.3%), weak voice 3 (15.8%), hoarse voice 6 (31.6%), sore throat 1 (5.3%), laryngitis 1 (5.3%), voice change 1 (5.3%), ear pain 1 (5.3%) and 5 (26.3%) not reported any symptoms. And patient demographics and clinical information includes: Past medical history of diabetes 3 (15.8%), hypertension (HTN) 4 (21.1%), hypothyroidism 3 (15.8%), depression & anxiety 3 (15.8%), chron's Disease 1 (5.3%), chronic kidney disease (CKD on) dialysis 2 (10.5%), and 6 (31.6%) were not reported any past medical history. The author emphasized that, for patients presenting with voice or swallowing complaints after receiving the COVID-19 vaccine, require prompt evaluation by an otolaryngologist, as the potential VFP side effect of vaccination is very rarely cited in the literature, and no causation has been established. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220308297- covid-19 vaccine ad26.cov2.s- vocal fold paralysis. 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.
Age: 82.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned an 82 year old of unspecified 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 not reported, batch number: 202A21A expiry: 21-SEP-2021) dose was not reported, administered on 30-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-NOV-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20220309987, 20220309972, 20220310363, 20220310548, 20220310590, 20220310306 and 20220310631.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included colecalciferol, and melatonin. On an unspecified date, the patient experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: ADVERSE REACTION; 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 adverse reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse reaction was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SICK; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sick. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Rash
Clinical narrative: GOT REALLY SICK; LOT OF RASHES AND BUMPS ON LOWER BACK; 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. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced got really sick, and lot of rashes and bumps on lower back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the got really sick and lot of rashes and bumps on lower back was not reported. This report was non-serious.
Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Off label use
Clinical narrative: ADMINISTERED EXPIRED VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 57 year old of unspecified 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 not reported, batch number: 202A21A expiry: 21-SEP-2021) dose was not reported, administered on 08-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-NOV-2021, the patient experienced administered expired vaccine, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered expired vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20220310363, 20220309987, 20220309972, 20220310548, 20220310590, 20220309858 and 20220310631.
Age: 83.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a health care professional concerned an 83 year old of unspecified 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 not reported, batch number: 202A21A, expiry: 21-SEP-2021) dose was not reported, administered on 08-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-NOV-2021, the patient experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20220309858, 20220310306 and 20220309972.
Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Off label use
Clinical narrative: ADMINISTERED EXPIRED VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 57 year old of unspecified 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 not reported, batch number: 202A21A, expiry: 21-SEP-2021) dose was not reported, administered on 29-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 29-OCT-2021, the patient experienced administered expired vaccine, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered expired vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20220309987, 20220309972, 20220310631, 20220309858, 20220310306, 20220310363 and 20220310548.
Age: 23.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 23 year old of unspecified 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 not reported, batch number: 202A21A expiry: 21-SEP-2021) dose was not reported, administered on 08-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-NOV-2021, the patient experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20220309972, 20220309987, 20220310590, 20220310548, 20220310306, 20220310363 and 20220309858.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: HEADACHE; NAUSEA; FEVER; This spontaneous report received from a patient concerned a 25 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A, expiry: UNKNOWN) dose was not reported, administered on 23-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-MAR-2022, the patient experienced headache, nausea, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, nausea, and fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain
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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced body ache. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body ache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN; This spontaneous report received from a health care professional 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 was not reported, administered on 04-OCT-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 04-OCT-2021, the patient experienced expired vaccine given. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine given was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective
Clinical narrative: IT DID NOT WORK; This spontaneous report received from a patient via a company representative via a social media concerned a patient of unspecified age, sex, 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) 1 in total, 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 reported that, "I like their vaccine, but unfortunately it didn't work. I hope they are working on a new one I do not trust the antibodies in the other vaccines to be safe." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of it did not work was not reported. This report was serious (Other Medically Important Condition). This case was associated with product quality complaint.; Sender's Comments: V0: 20220312412- covid-19 vaccine ad26.cov2.s-it did not work. The event(s) has an unknown/unclear 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: U
Vaccine: COVID19
Symptoms: Illness, Neuralgia
Clinical narrative: SICK; BURNING NERVE PAIN IN FEET; 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 sick, and burning nerve pain in feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sick and burning nerve pain in feet was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Medication error
Clinical narrative: Vaccinator pulling doses from an uncapped vial to administer Moderna vaccine/ think this was in error; This spontaneous case was reported by an other health care professional and describes the occurrence of MEDICATION ERROR (Vaccinator pulling doses from an uncapped vial to administer Moderna vaccine/ think this was in error) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2021, the patient experienced MEDICATION ERROR (Vaccinator pulling doses from an uncapped vial to administer Moderna vaccine/ think this was in error). At the time of the report, MEDICATION ERROR (Vaccinator pulling doses from an uncapped vial to administer Moderna vaccine/ think this was in error) 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. No Treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Mar-2022: Follow Up contains Patient Gender added
Sex: U
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: Patient was diagnosed with stage 4 cancer after they got the booster; This spontaneous case was reported by a pharmacist and describes the occurrence of NEOPLASM MALIGNANT (Patient was diagnosed with stage 4 cancer after they got the booster) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEOPLASM MALIGNANT (Patient was diagnosed with stage 4 cancer after they got the booster) (seriousness criterion medically significant). At the time of the report, NEOPLASM MALIGNANT (Patient was diagnosed with stage 4 cancer after they got the booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication information was reported. Reporter wanted to know if the patient can get a third full dose. No treatment medications were provided.  Company comment.  This spontaneous case concerns a patient (unknown age and gender) with no medical history reported, who experienced the unexpected, serious medically significant event of neoplasm malignant. Timeframe between the event and the administration of the third dose of mRNA  1273 vaccine could not be assessed since the date of onset of the event was not disclosed. The report stated that the patient was diagnosed with stage 4 cancer after vaccination with booster. No further details were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient (unknown age and gender) with no medical history reported, who experienced the unexpected, serious medically significant event of neoplasm malignant. Timeframe between the event and the administration of the third dose of mRNA  1273 vaccine could not be assessed since the date of onset of the event was not disclosed. The report stated that the patient was diagnosed with stage 4 cancer after vaccination with booster. No further details were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: One vaccine was administered on 26-Feb-2022 after the 2 excursion events on 25-Feb-2022 and 26-Feb-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (One vaccine was administered on 26-Feb-2022 after the 2 excursion events on 25-Feb-2022 and 26-Feb-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Feb-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (One vaccine was administered on 26-Feb-2022 after the 2 excursion events on 25-Feb-2022 and 26-Feb-2022). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (One vaccine was administered on 26-Feb-2022 after the 2 excursion events on 25-Feb-2022 and 26-Feb-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reporter reported that there were three excursion events,1st excursion was on 25-Feb-2022 at 35.6 degrees F for 3 and 30 minutes, 2nd excursion was on 26-Feb-2022 at 46.6 degrees F for 10 minutes and 3rd excursion was on 28-Feb-2022 at 35.6 degrees F for 35 minutes.  Vials were moved from freezer to refrigerator on 24-Feb-2022. It was reported that the vaccines were at refrigerated condition at the time of excursion.   No treatment medications were reported.
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: The refrigerator & freezer alarm was going off & administered single booster dose (0.25mL) to a patient/ Freezer temperature was 34F for 24 hrs/Refrigerator temperature was 62F for 24 hr.; administered single booster dose (0.25mL) to a patient/ Freezer temperature was 34F for 24 hrs/Refrigerator temperature was 62F for 24 hr.; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (administered single booster dose (0.25mL) to a patient/ Freezer temperature was 34F for 24 hrs/Refrigerator temperature was 62F for 24 hr.) and PRODUCT STORAGE ERROR (The refrigerator & freezer alarm was going off & administered single booster dose (0.25mL) to a patient/ Freezer temperature was 34F for 24 hrs/Refrigerator temperature was 62F for 24 hr.) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 28-Feb-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (administered single booster dose (0.25mL) to a patient/ Freezer temperature was 34F for 24 hrs/Refrigerator temperature was 62F for 24 hr.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The refrigerator & freezer alarm was going off & administered single booster dose (0.25mL) to a patient/ Freezer temperature was 34F for 24 hrs/Refrigerator temperature was 62F for 24 hr.). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (administered single booster dose (0.25mL) to a patient/ Freezer temperature was 34F for 24 hrs/Refrigerator temperature was 62F for 24 hr.) and PRODUCT STORAGE ERROR (The refrigerator & freezer alarm was going off & administered single booster dose (0.25mL) to a patient/ Freezer temperature was 34F for 24 hrs/Refrigerator temperature was 62F for 24 hr.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was in freezer at 34 F for 24 hours and refrigerator at 62 F for 24 hours.  No treatment information was reported.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug hypersensitivity, Infected cyst
Clinical narrative: Became allergic to sulfur after the booster; Infected cyst in her neck; This spontaneous case was reported by a nurse and describes the occurrence of DRUG HYPERSENSITIVITY (Became allergic to sulfur after the booster) and INFECTED CYST (Infected cyst in her neck) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060h21a, 051c21a and 036c21a) for COVID-19 vaccination.     Concurrent medical conditions included Anemic (Started a few years ago.) and Thyroid disorder NOS. Concomitant products included IRON, VITAMIN D NOS and THYROID for an unknown indication.   On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jan-2022, the patient experienced INFECTED CYST (Infected cyst in her neck). On an unknown date, the patient experienced DRUG HYPERSENSITIVITY (Became allergic to sulfur after the booster). At the time of the report, DRUG HYPERSENSITIVITY (Became allergic to sulfur after the booster) and INFECTED CYST (Infected cyst in her neck) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had not tested COVID positive. It was reported that the patient did not took any other vaccines within 1 month prior to receiving the Moderna COVID-19 vaccine. Adverse event caused patient to seek medical care.  Patient received Antibiotics as treatment medication.   This case was linked to MOD-2022-500727.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperthyroidism
Clinical narrative: Became allergic to sulfur after the booster; Infected cyst in her neck; This spontaneous case was reported by a nurse and describes the occurrence of DRUG HYPERSENSITIVITY (Became allergic to sulfur after the booster) and INFECTED CYST (Infected cyst in her neck) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060h21a, 051c21a and 036c21a) for COVID-19 vaccination.     Concurrent medical conditions included Anemic (Started a few years ago.) and Thyroid disorder NOS. Concomitant products included IRON, VITAMIN D NOS and THYROID for an unknown indication.   On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jan-2022, the patient experienced INFECTED CYST (Infected cyst in her neck). On an unknown date, the patient experienced DRUG HYPERSENSITIVITY (Became allergic to sulfur after the booster). At the time of the report, DRUG HYPERSENSITIVITY (Became allergic to sulfur after the booster) and INFECTED CYST (Infected cyst in her neck) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had not tested COVID positive. It was reported that the patient did not took any other vaccines within 1 month prior to receiving the Moderna COVID-19 vaccine. Adverse event caused patient to seek medical care.  Patient received Antibiotics as treatment medication.   This case was linked to MOD-2022-500727.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: rash on the side of her body. It´s just one line of rash on the same side of the body were she received the injection. It´s very itchy.; rash on the side of her body. It´s just one line of rash on the same side of the body were she received the injection. It´s very itchy.; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PRURITUS (rash on the side of her body. It´s just one line of rash on the same side of the body were she received the injection. It´s very itchy.) and VACCINATION SITE RASH (rash on the side of her body. It´s just one line of rash on the same side of the body were she received the injection. It´s very itchy.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (rash on the side of her body. It´s just one line of rash on the same side of the body were she received the injection. It´s very itchy.) and VACCINATION SITE RASH (rash on the side of her body. It´s just one line of rash on the same side of the body were she received the injection. It´s very itchy.). At the time of the report, VACCINATION SITE PRURITUS (rash on the side of her body. It´s just one line of rash on the same side of the body were she received the injection. It´s very itchy.) and VACCINATION SITE RASH (rash on the side of her body. It´s just one line of rash on the same side of the body were she received the injection. It´s very itchy.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-500852.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patients received a booster dose of the Moderna COVID19 vaccine 10 days after the 30-day; vial initially stored in the refrigerator was 10-Jan-2022 but patients received vaccine 10 days after the 30-day; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received a booster dose of the Moderna COVID19 vaccine 10 days after the 30-day) and PRODUCT STORAGE ERROR (vial initially stored in the refrigerator was 10-Jan-2022 but patients received vaccine 10 days after the 30-day) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced PRODUCT STORAGE ERROR (vial initially stored in the refrigerator was 10-Jan-2022 but patients received vaccine 10 days after the 30-day). On 18-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received a booster dose of the Moderna COVID19 vaccine 10 days after the 30-day). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received a booster dose of the Moderna COVID19 vaccine 10 days after the 30-day) and PRODUCT STORAGE ERROR (vial initially stored in the refrigerator was 10-Jan-2022 but patients received vaccine 10 days after the 30-day) outcome was unknown.        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 the vial did not undergo any temperature excursions.  It was reported that there was a correction only 1 bottle of Moderna Lot Number 016J21-2A that was opened and administered on 18-Feb-2022 to 5 people. No Treatments were reported.   This case was linked to MOD-2022-501758, MOD-2022-501759 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Mar-2022: Follow up information received, case updated to spontaneous from invalid, patient information added.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Myalgia, Pyrexia
Clinical narrative: fever; body aches.; Patient received a Moderna booster dose from a vial that has been open more than 12 hours post puncture.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a Moderna booster dose from a vial that has been open more than 12 hours post puncture.), PYREXIA (fever) and MYALGIA (body aches.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003K21-2A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included LEVOTHYROXINE, LISINOPRIL and PHENTERMINE for an unknown indication.    On 01-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a Moderna booster dose from a vial that has been open more than 12 hours post puncture.). On an unknown date, the patient experienced PYREXIA (fever) and MYALGIA (body aches.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a Moderna booster dose from a vial that has been open more than 12 hours post puncture.), PYREXIA (fever) and MYALGIA (body aches.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   COVID-19+: Unknown. Other vaccines: No. No treatment drug information was provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis chronic, Chest X-ray
Clinical narrative: Diagnosed with chronic bronchitis 2 weeks after first shot; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS CHRONIC (Diagnosed with chronic bronchitis 2 weeks after first shot) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included Drug toxicity (11 years ago patient had Medication induced QIPP from Fluoroquinolone toxicity, she ended going from being a healthy individual to a cripple patient. It took her 3 years to walk again. She ended up having to get IVIG treatments for 8 years since then.) and Vaccination adverse reaction (Patient had issues with vaccines, had trouble with live vaccines). Previously administered products included for Polio immunization: Polio vaccine (polio vaccine got deadly sick with and that was due to the penicillin in it). Past adverse reactions to the above products included Sickness with Polio vaccine. Concomitant products included IMMUNOGLOBULINS NOS (IMMUNOGLOBULIN I.V), MULTIVITAMIN [VITAMINS NOS], BORON, TAURINE and PARACETAMOL (TYLENOL [PARACETAMOL]) for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced BRONCHITIS CHRONIC (Diagnosed with chronic bronchitis 2 weeks after first shot) (seriousness criterion medically significant). At the time of the report, BRONCHITIS CHRONIC (Diagnosed with chronic bronchitis 2 weeks after first shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Chest X-ray: diagnosed with chronic bronchitis (abnormal) diagnosed with chronic bronchitis.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient's weight was reported as 120. No treatment medications reported.  This is a spontaneous case concerning a 66-year-old female patient with no relevant medical history, who experienced serious (medically significant), unexpected event of chronic bronchitis which was diagnosed by a chest X-ray 2 weeks after the administration of first dose of mRNA-1273 vaccine. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-501466 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 66-year-old female patient with no relevant medical history, who experienced serious (medically significant), unexpected event of chronic bronchitis which was diagnosed by a chest X-ray 2 weeks after the administration of first dose of mRNA-1273 vaccine. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, Incorrect dose administered
Clinical narrative: Immunocompromised patient did not receive his third full dose in his primary series.; Immunocompromised patient did not receive his third full dose in his primary series. Patient did receive his booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised patient did not receive his third full dose in his primary series.) and INCORRECT DOSE ADMINISTERED (Immunocompromised patient did not receive his third full dose in his primary series. Patient did receive his booster dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised (The patient was immunocompromised).    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromised patient did not receive his third full dose in his primary series.) and INCORRECT DOSE ADMINISTERED (Immunocompromised patient did not receive his third full dose in his primary series. Patient did receive his booster dose). At the time of the report, ACCIDENTAL UNDERDOSE (Immunocompromised patient did not receive his third full dose in his primary series.) and INCORRECT DOSE ADMINISTERED (Immunocompromised patient did not receive his third full dose in his primary series. Patient did receive his booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient received primary Moderna Covid-19 vaccination series.  No treatment details were reported.
Age: 79.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Joint swelling, Pityriasis rosea, Psoriasis, Skin irritation, Swelling face
Clinical narrative: Pityriasis Rosea; skin irritation; Face became swollen; Ankles became swollen; Psoriasis; This spontaneous case was reported by a consumer and describes the occurrence of PITYRIASIS ROSEA (Pityriasis Rosea), PSORIASIS (Psoriasis), SKIN IRRITATION (skin irritation), SWELLING FACE (Face became swollen) and JOINT SWELLING (Ankles became swollen) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21-1A, 006M20-1A and 030L20-1A) for COVID-19 vaccination.    Co-suspect product included non-company product PREDNISONE for Itchy skin.    Previously administered products included for Flu: Seasonal IM Flu vaccine (On or around 15-Oct-2021 the patient received Seasonal IM Flu vaccine) in October 2021. Past adverse reactions to the above products included No adverse event with Seasonal IM Flu vaccine. Concurrent medical conditions included Vitiligo (Diagnosed with Vitiligo 40 years ago. Autoimmune disease) and Allergy to insect sting (Allergy to bee stings).   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On an unknown date, the patient started PREDNISONE (Oral) at an unspecified dose. On 28-Feb-2022, the patient experienced PSORIASIS (Psoriasis). On an unknown date, the patient experienced PITYRIASIS ROSEA (Pityriasis Rosea), SKIN IRRITATION (skin irritation), SWELLING FACE (Face became swollen) and JOINT SWELLING (Ankles became swollen). The patient was treated with BETAMETHASONE (topical) for Itchy skin, at an unspecified dose and frequency and FLUOCINOLONE ACETONIDE (topical) for Psoriasis, at an unspecified dose and frequency. At the time of the report, PITYRIASIS ROSEA (Pityriasis Rosea), PSORIASIS (Psoriasis) and SKIN IRRITATION (skin irritation) had not resolved and SWELLING FACE (Face became swollen) and JOINT SWELLING (Ankles became swollen) had resolved.            No concomitant medications were reported.  It was reported that it was difficult to read lot number on the vaccination card. It was reported that the treatment drug prednisone was prescribed for 21 days to the patient. Patient stated that the prednisone and betamethasone cream helped with the skin itching but the prednisone had caused her face and ankles to become swollen. It was also reported that the swollen face and swollen ankle caused by prednisone had not caused the patient to seek medical care, had not occurred in the past, this events had resolved on an unknown date, no death was caused and the symptoms were resolved. Patient had stated that she had never had psoriasis or skin rash in the past. She was diagnosed with vitiligo 40 years ago and stated it is an autoimmune disease.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Headache, Inappropriate schedule of product administration, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (arm swelling), PYREXIA (fever), HEADACHE (headache) and EXPIRED PRODUCT ADMINISTERED (Patient received expired 2nd dose) in a 54-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 049E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 23-Feb-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 23-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired 2nd dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 35 days between first and second dose). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (arm swelling), PYREXIA (fever) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (arm swelling), PYREXIA (fever), HEADACHE (headache), EXPIRED PRODUCT ADMINISTERED (Patient received expired 2nd dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 35 days between first and second dose) outcome was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. Treatment information was not provided. On 30-Nov-2021, the patient received first dose of Moderna (Intramuscular) .5 milliliter. Batch number was the same as second dose, 049E21A. It was reported that the patient did not want to get the second dose but was eventually forced to get the second dose by her employer. This case was linked to MOD-2022-501302 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (arm swelling), PYREXIA (fever), HEADACHE (headache) and EXPIRED PRODUCT ADMINISTERED (Patient received expired 2nd dose) in a 54-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 049E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 23-Feb-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 23-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired 2nd dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 35 days between first and second dose). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (arm swelling), PYREXIA (fever) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (arm swelling), PYREXIA (fever), HEADACHE (headache), EXPIRED PRODUCT ADMINISTERED (Patient received expired 2nd dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 35 days between first and second dose) outcome was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. Treatment information was not provided. On 30-Nov-2021, the patient received first dose of Moderna (Intramuscular) .5 milliliter. Batch number was the same as second dose, 049E21A. It was reported that the patient did not want to get the second dose but was eventually forced to get the second dose by her employer. This case was linked to MOD-2022-501302 (Patient Link).
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left injection site arm) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041120A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore left injection site arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. It was reported that there was no product complaint associated. No treatment medications were reported.   This case was linked to MOD-2022-501363 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered with vaccine refrigerated for 33 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with vaccine refrigerated for 33 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with vaccine refrigerated for 33 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with vaccine refrigerated for 33 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter.  The vial was initially stored in the refrigerator from 23-Jan-2022. The vial did not undergo any temperature excursions.  No treatment medication was reported by the reporter.