chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 042A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Follow-up included no new information.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: An 8 year old was administered 0.25ml of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (An 8 year old was administered 0.25ml of the Moderna COVID-19 vaccine) in an 8-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 10-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (An 8 year old was administered 0.25ml of the Moderna COVID-19 vaccine). On 10-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (An 8 year old was administered 0.25ml of the Moderna COVID-19 vaccine) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.  The patient did not experience any side effects.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Minimal arm sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Minimal arm sore) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced VACCINATION SITE PAIN (Minimal arm sore). At the time of the report, VACCINATION SITE PAIN (Minimal arm sore) outcome was unknown.            No concomitant medications reported. No treatment medications reported.   This case was linked to MOD-2021-375103.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure before pregnancy, Pregnancy
Clinical narrative: Pregnant; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PREGNANCY (Pregnant) and MATERNAL EXPOSURE BEFORE PREGNANCY (Maternal exposure during pregnancy) 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.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced PREGNANCY (Pregnant) and MATERNAL EXPOSURE BEFORE PREGNANCY (Maternal exposure during pregnancy). At the time of the report, PREGNANCY (Pregnant) outcome was unknown and MATERNAL EXPOSURE BEFORE PREGNANCY (Maternal exposure during pregnancy) had resolved. Not Provided    No concomitant medications were reported. Treatment information was not provided. Company Comment: This case concerns a female patient of unknown age with no details on relevant medical history, who experienced Vaccine exposure before pregnancy associated with mRNA- 1273 Moderna vaccine. The patient received the second dose of the vaccine approximately 7 to 8 months before gestation. No adverse events were reported. The benefit-risk relationship of mRNA- 1273 vaccine Moderna Vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a female patient of unknown age with no details on relevant medical history, who experienced Vaccine exposure before pregnancy associated with mRNA- 1273 Moderna vaccine. The patient received the second dose of the vaccine approximately 7 to 8 months before gestation. No adverse events were reported. The benefit-risk relationship of mRNA- 1273 vaccine Moderna Vaccine is not affected by this report.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered to 14 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 14 patients) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.No Medical History information was reported.On 12-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 14 patients). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 14 patients) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.Concomitant medication information was not reported. Treatment information was not reported.This is a case of Expired Product Administered concerning a 56-year-old male patient with no relevant medical history, who experienced no other adverse events. The event occurred the same day after receiving an unknown dose number of mRNA-1273 Vaccine. The rechallenge was unknown since no dose number was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. This case was linked to MOD-2021-350795 (Patient Link). Sender's Comments: This is a case of Expired Product Administered concerning a 56-year-old male patient with no relevant medical history, who experienced no other adverse events. The event occurred the same day after receiving an unknown dose number of mRNA-1273 Vaccine. The rechallenge was unknown since no dose number was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine administered to 10 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to 10 patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to 10 patients). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to 10 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant medication were reported no treatment medication were reported
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Excursion from the freezer; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion from the freezer ) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination. No Medical History information was reported.On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion from the freezer ) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion from the freezer ) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided.For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.It was reported that, there was excursion from the freezer on 01-Oct-2021 and nurse used the excursion tool but there was no option for the excursion they experienced. The only tool gives the options for excursion above one hour and not less than that so the nurse dose not known about the analysis. The nurse stated that her team know the recommended temperature and wants to know if the vials were still okay to use because they were administered to 118 patients. The storage condition at the time of the excursion was frozen, vial size was 7.5 mL and maximum or minimum temperature reached was as follows; minimum 4.2 degree F and maximum 5.7 degree F. It was also stated that excursion duration was 6 minutes. On visual inspection the vials were thawed before administration and there were no color changes or anything abnormal. Total 10 vials/doses were impacted and they were moved from freezer to refrigerator only on day they were used and they were not returned to freezer or refrigerator for storage. No concomitant medications were reported.  No treatment information was reported.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Expired vaccine used; Product temperature excursion issue; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination. No Medical History information was reported.On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue). On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) had resolved. On 01-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medication was provided.No treatment information was provided. The vial was stored in the freezer and subjected to a maximum temperature of 5.7 degree Fahrenheit and minimum of 4.2 degree Fahrenheit and undergone a temperature excursion of 6 minutes.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: There was an excursion from the freezer; administered to 118 patients; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (administered to 118 patients) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination. No Medical History information was reported.On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (administered to 118 patients). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (administered to 118 patients) had resolved. 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.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Product temperature excursion issue; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination. No Medical History information was reported.On 01-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided.For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.Concomitant medication details were not provided. Treatment details were not provided.There was an excursion from their freezer on 01-Oct-2021. They used the excursion tool but there is no option for the excursion they experienced. The tool only gives options for excursions above one hour and not less than, so she does not knowhow to do the analysis. She states that her team already knows the recommended temperatures and wants to know if the vials were still okay to be used because they were administered to 118 patients.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Ocular hyperaemia, Rash
Clinical narrative: Right eye was reddish; Right eye was very swollen; Rash on her left side; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (Right eye was reddish), EYE SWELLING (Right eye was very swollen) and RASH (Rash on her left side) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In October 2021, the patient experienced OCULAR HYPERAEMIA (Right eye was reddish), EYE SWELLING (Right eye was very swollen) and RASH (Rash on her left side). The patient was treated with CORTISONE for Rash, at an unspecified dose and frequency. At the time of the report, OCULAR HYPERAEMIA (Right eye was reddish), EYE SWELLING (Right eye was very swollen) and RASH (Rash on her left side) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. 7 days later, patient right eye was reddish and was very swollen; patient had to seek medical attention and see an eye specialist. Patient has never seen an eye doctor or eye specialist before. Patient also developed rash on her left side about a week ago. She will eventually go to the medical facility. Patient was using cortisone cream for 7 days.  Company comment- This case concerns a 64-year-old, female patient with no medical history, who experienced the unexpected non serious events of ocular hyperemia and eye swelling and expected non serious event of rash. The events occurred approximately 7 day after the first dose of mRNA-1273. The patient's right eye was reddish and was very swollen; patient had to seek medical attention and see an eye specialist. Patient has never seen an eye doctor or eye specialist before and will eventually go to the medical facility. Patient also developed rash on her left side. The rechallenge was not applicable, as event outcome was unknown and no information regarding second dose was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 64-year-old, female patient with no medical history, who experienced the unexpected non serious events of ocular hyperemia and eye swelling and expected non serious event of rash. The events occurred approximately 7 day after the first dose of mRNA-1273. The patient's right eye was reddish and was very swollen; patient had to seek medical attention and see an eye specialist. Patient has never seen an eye doctor or eye specialist before and will eventually go to the medical facility. Patient also developed rash on her left side. The rechallenge was not applicable, as event outcome was unknown and no information regarding second dose was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 09-Nov-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.  This case involves adult patient (unknown age and gender) who had flu (influenza) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's medical treatment, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination  On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "and it gave me the flu".  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Injection site erythema
Clinical narrative: Flu-like symptoms started 31 hours after I received my booster shot of Moderna - body aches, fatige and exhaustion, headache, sever chills, low grade fever.  The next morning the injection site in my right arm was a hard lump, swollen, hot, red, and slightly itchy. The discomfort is localized to about 3 inches diameter. The rest of my arm is fine. The flu symptoms have resolved 24 hours after they started, but he arm is still red and itchy and swollen at the vaccine injection site.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site mass, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Flu-like symptoms started 31 hours after I received my booster shot of Moderna - body aches, fatige and exhaustion, headache, sever chills, low grade fever.  The next morning the injection site in my right arm was a hard lump, swollen, hot, red, and slightly itchy. The discomfort is localized to about 3 inches diameter. The rest of my arm is fine. The flu symptoms have resolved 24 hours after they started, but he arm is still red and itchy and swollen at the vaccine injection site.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Flu-like symptoms started 31 hours after I received my booster shot of Moderna - body aches, fatige and exhaustion, headache, sever chills, low grade fever.  The next morning the injection site in my right arm was a hard lump, swollen, hot, red, and slightly itchy. The discomfort is localized to about 3 inches diameter. The rest of my arm is fine. The flu symptoms have resolved 24 hours after they started, but he arm is still red and itchy and swollen at the vaccine injection site.
Sex: U
Vaccine: VARZOS
Symptoms: Joint injury
Clinical narrative: Knee injury; This case was reported by a consumer via call center representative and described the occurrence of knee injury in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced knee injury. On an unknown date, the outcome of the knee injury was not recovered/not resolved.   It was unknown if the reporter considered the knee injury to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient for himself/herself. The age at vaccination was not reported. The patient received a dose of Shingrix, and had knee injury. The patient asked that after how many days after 2nd dose of Shingrix could he/she take a 6 days course of methylprednisolone for a knee injury. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: COVID19
Symptoms: Angina pectoris, Body temperature, Muscle spasms, Skin mass
Clinical narrative: A PAIN IN THE HEART; LUMPS ON THE HANDS; LEG CRAMPS; This spontaneous report received from a patient 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 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 in OCT-2021, the patient experienced a pain in the heart, lumps on the hands, and leg cramps. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) up to 37 degrees. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lumps on the hands, leg cramps, and a pain in the heart. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20211137029-covid-19 vaccine ad26.cov2.s-pain in the heart.This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 67.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Injection site pain, Injection site pruritus, Rash
Clinical narrative: INJECTION SITE ITCHING; RASH; INJECTION SITE PAIN; This spontaneous report received from a patient via a company representative concerned an elderly female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no reported medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 01-MAR-2021 for prophylactic vaccination. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. 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 injection site itching, rash, and injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from injection site itching, and injection site pain, and had not recovered from rash. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Uterine inflammation, Uterine pain
Clinical narrative: RANDOM WEIRD INFLAMMATION IN UTERUS; PAIN IN UTERUS; SORE ARM; 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 not reported, batch number: Unknown) 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 random weird inflammation in uterus, pain in uterus, and sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm, random weird inflammation in uterus and pain in uterus was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: MILD ARM PAIN FOR 2 DAYS; This spontaneous report received from a patient 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 not reported, batch number: UNKNOWN) 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 mild arm pain for 2 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild arm pain for 2 days. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: MILD FLU LIKE SYMPTOMS; SORENESS IN INJECTED ARM; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 16-NOV-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 17-NOV-2021, the patient experienced mild flu like symptoms. On 17-NOV-2021, the patient experienced soreness in injected arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mild flu like symptoms, and soreness in injected arm. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ALMOST KILLED ME; 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 not reported, batch number: Unknown) 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 almost killed me. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of almost killed me was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE ADMINISTERED WHICH WAS STORED OUTSIDE OF THE RECOMMENDED STORAGE CONDITIONS; VACCINE STORED AT ROOM TEMPERATURE (BELOW 77 F) FOR ABOUT 24 -25 HOURS (STORED AT 36 C INSTEAD OF 36 F); This spontaneous report received from a physician concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191 expiry: 11-APR-2022) dose was not reported, administered on 17-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-NOV-2021, the patient experienced vaccine administered which was stored outside of the recommended storage conditions. On 17-NOV-2021, the patient experienced vaccine stored at room temperature (below 77 f) for about 24 -25 hours (stored at 36 c instead of 36 f). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine stored at room temperature (below 77 f) for about 24 -25 hours (stored at 36 c instead of 36 f) and vaccine administered which was stored outside of the recommended storage conditions was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Vestibular disorder
Clinical narrative: Vaccination injuries to vestibular system; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VESTIBULAR DISORDER (Vaccination injuries to vestibular system) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VESTIBULAR DISORDER (Vaccination injuries to vestibular system). At the time of the report, VESTIBULAR DISORDER (Vaccination injuries to vestibular system) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No Treatment information was reported. There are entries related to Moderna vaccine. Not all the symptoms are exactly same. Has an incredible number.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Skin swelling, Swelling face
Clinical narrative: Swelling in scalp and forehead; Swelling on face including eyes and nose; This spontaneous case was reported by a physician and describes the occurrence of SKIN SWELLING (Swelling in scalp and forehead) and SWELLING FACE (Swelling on face including eyes and nose) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A, 016M20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced SWELLING FACE (Swelling on face including eyes and nose). On 06-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SKIN SWELLING (Swelling in scalp and forehead). At the time of the report, SKIN SWELLING (Swelling in scalp and forehead) and SWELLING FACE (Swelling on face including eyes and nose) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information provided by the reporter.  She has no history of receiving dermatological fillers  It was reported that Patient visited emergency room on the night of booster dose and received IV fluid, antibiotics and allergy medicine.  Symptoms settled slightly but still ongoing.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 6 Doses administered beyond the expiration date/ 2 days expired Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 Doses administered beyond the expiration date/ 2 days expired Moderna vaccine) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Nov-2021 at 1:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 Doses administered beyond the expiration date/ 2 days expired Moderna vaccine). On 08-Nov-2021 at 1:00 PM, EXPIRED PRODUCT ADMINISTERED (6 Doses administered beyond the expiration date/ 2 days expired Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), 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.  No side effects experienced or reported by the patient.   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Non-significant follow up- contact info. and Fax no. added On 12-Nov-2021: Updated reporter's address and patient demographics.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 6 doses administered neyond the expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 doses administered beyond the expiration date) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 doses administered beyond the expiration date). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (6 doses administered beyond the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  Vials were taken out of freezer on the same day doses were administered (08-Nov-2021). Patient had received booster dose. No side effect reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Non-significant follow up appended.Contact information added. On 12-Nov-2021: Patient demographics and vaccine information were updated.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 6 Doses administered beyond the expiration date; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 Doses administered beyond the expiration date) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: MENINGOCOCCAL Lot number: ABXB58AA ROA: Intramuscular Body site: Right arm).    On 08-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 Doses administered beyond the expiration date). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (6 Doses administered beyond the expiration date) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.  Vial taken out of freezer on the same day doses were administered and no side effects had been experienced by the patient.   This case was linked to MOD-2021-381144 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Reporter's Demographics and Narrative were updated. On 12-Nov-2021: Significant follow up Route of administration, historical vaccine has been updated.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Thrombosis
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of cerebrovascular accident (bilateral stroke) and thrombosis (blood clot) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 063C21A and 037A31B) for COVID-19  immunization. No medical history reported. On Apr 13, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On May 11, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. October 2021, patient experienced thrombosis/blood clot (prolonged hospitalization and medically significant). On Oct 21, 2021, patient experienced cerebrovascular accident (bilateral stroke) (prolonged hospitalization and medically significant). At the time of the report, cerebrovascular accident (bilateral stroke) and thrombosis (blood clot) outcome: unknown. No concomitant medications or treatment information provided. Patient has been in the hospital for the last two weeks. Sender's comments: This case concerns a 65-year-old, female patient with no medical history reported, who experienced the unexpected events of cerebrovascular accident and thrombosis. The events occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: fever; headache; muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), HEADACHE (headache) and MYALGIA (muscle ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), HEADACHE (headache) and MYALGIA (muscle ache). At the time of the report, PYREXIA (fever), HEADACHE (headache) and MYALGIA (muscle ache) was resolving.            No Treatment medications were provided. No  Concomitant medications were provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Muscle spasms, Pelvic pain, Walking aid user
Clinical narrative: Leg cramps on & off involving her left leg after second shot; Hard to walk after second shot/Needs a walker to walk after second shot; Pelvis hurts when walking after second shot; Hard to walk after second shot/Needs a walker to walk after second shot; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Leg cramps on & off involving her left leg after second shot), GAIT DISTURBANCE (Hard to walk after second shot/Needs a walker to walk after second shot), PELVIC PAIN (Pelvis hurts when walking after second shot) and WALKING AID USER (Hard to walk after second shot/Needs a walker to walk after second shot) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 006B21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 10-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Oct-2021, the patient experienced MUSCLE SPASMS (Leg cramps on & off involving her left leg after second shot), GAIT DISTURBANCE (Hard to walk after second shot/Needs a walker to walk after second shot), PELVIC PAIN (Pelvis hurts when walking after second shot) and WALKING AID USER (Hard to walk after second shot/Needs a walker to walk after second shot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (Leg cramps on & off involving her left leg after second shot), GAIT DISTURBANCE (Hard to walk after second shot/Needs a walker to walk after second shot), PELVIC PAIN (Pelvis hurts when walking after second shot) and WALKING AID USER (Hard to walk after second shot/Needs a walker to walk after second shot) outcome was unknown. No Concomitant medications were provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered dose that was 12 hours left at room temperature so it is technically expired; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered dose that was 12 hours left at room temperature so it is technically expired) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered dose that was 12 hours left at room temperature so it is technically expired). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (administered dose that was 12 hours left at room temperature so it is technically expired) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported.No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Oropharyngeal discomfort
Clinical narrative: coughing; laryngitis type of thing; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (laryngitis type of thing) and COUGH (coughing) 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.In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, the patient experienced COUGH (coughing). In November 2021, the patient experienced OROPHARYNGEAL DISCOMFORT (laryngitis type of thing). At the time of the report, OROPHARYNGEAL DISCOMFORT (laryngitis type of thing) and COUGH (coughing) outcome was unknown. Patient reports laryngitis type of thing going for about a week now. Patient thinks she may have COVID-19 and had herself tested on 08-Nov-2021 but still with no results. Patient wants to know what the symptoms of COVID-19 are and if she is contagious.No concomitant medications were reported.No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Technicians gave doses of the Moderna Covid-19 vaccine that were after the beyond use by date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Technicians gave doses of the Moderna Covid-19 vaccine that were after the beyond use by date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Technicians gave doses of the Moderna Covid-19 vaccine that were after the beyond use by date). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Technicians gave doses of the Moderna Covid-19 vaccine that were after the beyond use by date) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.Concomitant medications were not reported.Reporter confirmed that no adverse event reported by Individuals after getting Expired vaccine used.Most recent FOLLOW-UP information incorporated above includes:On 12-Nov-2021: Significant Follow up received, No adverse event reported after Medication error.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Appetite disorder, Fatigue, Feeling of body temperature change, Lethargy
Clinical narrative: Felt real cold and then hot then cold again; Lethargic; Didn't want to eat; Felt run down; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (Felt real cold and then hot then cold again), LETHARGY (Lethargic), APPETITE DISORDER (Didn't want to eat) and FATIGUE (Felt run down) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 040A21A) for COVID-19 vaccination. No Medical History information was reported.On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Felt real cold and then hot then cold again), LETHARGY (Lethargic), APPETITE DISORDER (Didn't want to eat) and FATIGUE (Felt run down). At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (Felt real cold and then hot then cold again), LETHARGY (Lethargic), APPETITE DISORDER (Didn't want to eat) and FATIGUE (Felt run down) outcome was unknown. Concomitant medication was not provided by the reporter.Treatment medication was cold compress.This case was linked to MOD-2021-382394 (Patient Link).