chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient received dose from the expired vaccine (20-May-22), which was administered on 03-Jun-22, after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received dose from the expired vaccine (20-May-22), which was administered on 03-Jun-22, after 30-day Use By Date or after manufacturer date of expiry) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033k21-2a) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (First booster dose) on 26-Oct-2021. Past adverse reactions to the above products included No adverse event with Pfizer. Concurrent medical conditions included Drug allergy (Amiodarone), Drug allergy (Dabigatran) and Sulfonamide allergy (Sulfa drugs, Sulfonamides).    On 03-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received dose from the expired vaccine (20-May-22), which was administered on 03-Jun-22, after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received dose from the expired vaccine (20-May-22), which was administered on 03-Jun-22, after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was unknown if the patient ever had COVID-19 positive test or diagnosis. Patients medical history was not relating to mentioned adverse event and both acute and chronic illness at the time of vaccination. The patient does not received any vaccine within 1 month prior to Moderna  COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  It was unknown if the patient had experienced similar adverse event in the past. The event does not caused the patient to seek medical care. Number of doses or vials and date the vial was initially stored in the refrigerator were unknown. The vial did not undergone any temperature excursions.  Treatment information was not provided.   This case was linked to MOD-2022-583804.
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Carpal tunnel syndrome
Clinical narrative: Experienced COVID; Carpal tunnel syndrome; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Experienced COVID) and CARPAL TUNNEL SYNDROME (Carpal tunnel syndrome) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Experienced COVID) and CARPAL TUNNEL SYNDROME (Carpal tunnel syndrome). At the time of the report, COVID-19 (Experienced COVID) had resolved and CARPAL TUNNEL SYNDROME (Carpal tunnel syndrome) was resolving. Not Provided      The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a Covid-19 vaccine trial. The reporters causality for the events carpal tunnel syndrome and Covid with Humira (ADALIMUMAB) solution for injection in pre-filled pen was no reasonable possibility.   No concomitant medication were reported.   No treatment drug were reported.  Company Comment: This spontaneous case concerns an elderly, female patient with no medical history reported who experienced the unexpected, non-serious adverse event of special interest of COVID-19 which occurred on unspecified interval after receiving an unknown dose number of mRNA-1273 vaccine. The clinical course, diagnostic evaluation including COVID-19 test and treatment details were not reported in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an elderly, female patient with no medical history reported who experienced the unexpected, non-serious adverse event of special interest of COVID-19 which occurred on unspecified interval after receiving an unknown dose number of mRNA-1273 vaccine. The clinical course, diagnostic evaluation including COVID-19 test and treatment details were not reported in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 83.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vaccine was in refrigerator on 07-FEB-2022 and administered on 20-APR-2022; Vaccine was administered beyond the use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond the use date) and PRODUCT STORAGE ERROR (vaccine was in refrigerator on 07-FEB-2022 and administered on 20-APR-2022) in an 83-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083J21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 20-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond the use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine was in refrigerator on 07-FEB-2022 and administered on 20-APR-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond the use date) and PRODUCT STORAGE ERROR (vaccine was in refrigerator on 07-FEB-2022 and administered on 20-APR-2022) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  Patient had received total three doses. This dose was a booster.  It was reported that as per Moderna lot analysis regarding doses administered on 20-APR-2022 from lot number 083J21A, Moderna cannot guarantee patients received full protection against the Covid-19 virus.  No treatment medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2022: Follow-up received contains non significant Information. Narrative updated
Sex: F
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: Reporting an adverse modern a shot/Lost her hearing with the second shot and has not regained it back; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Reporting an adverse modern a shot/Lost her hearing with the second shot and has not regained it back) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEAFNESS (Reporting an adverse modern a shot/Lost her hearing with the second shot and has not regained it back) (seriousness criterion medically significant). At the time of the report, DEAFNESS (Reporting an adverse modern a shot/Lost her hearing with the second shot and has not regained it back) had not resolved.            No Concomitant medications were reported.  No treatment information was provided.  Company Comment: This is a spontaneous case concerning  an  elderly female patient, with no reported medical history, who experienced the unexpected serious (medically significant) event of Deafness. The event occurred on an unknown  day after the second dose of mRNA-1273 COVID 19 Vaccine. The event was reported as not resolved. No treatment information was provided. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: This is a spontaneous case concerning  an  elderly female patient, with no reported medical history, who experienced the unexpected serious (medically significant) event of Deafness. The event occurred on an unknown  day after the second dose of mRNA-1273 COVID 19 Vaccine. The event was reported as not resolved. No treatment information was provided. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Gait disturbance, Loss of personal independence in daily activities, Vomiting
Clinical narrative: patient feels like she was dying; can hardly walk across the house without having to sit down; barely able to keep anything down; very, very tired; vomiting all morning; This spontaneous case was reported by a pharmacist and describes the occurrence of FEELING ABNORMAL (patient feels like she was dying), GAIT DISTURBANCE (can hardly walk across the house without having to sit down), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (barely able to keep anything down), FATIGUE (very, very tired) and VOMITING (vomiting all morning) in an elderly female patient who received mRNA-1273 (Spikevax) (batch no. 014B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced FEELING ABNORMAL (patient feels like she was dying), GAIT DISTURBANCE (can hardly walk across the house without having to sit down), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (barely able to keep anything down), FATIGUE (very, very tired) and VOMITING (vomiting all morning). At the time of the report, FEELING ABNORMAL (patient feels like she was dying), GAIT DISTURBANCE (can hardly walk across the house without having to sit down), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (barely able to keep anything down), FATIGUE (very, very tired) and VOMITING (vomiting all morning) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  No treatment was given to the patient.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Pharmacist administered a first Moderna booster dose to a patient with a volume of 0.5ml instead of 0.25ml. This came from a Primary Series and a booster dose vial so the patient received too high) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056M21A) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Pfizer vaccine (The patient received Pfizer vaccine for her Primary series of Covid-19 vaccine). Past adverse reactions to the above products included No adverse event with Pfizer vaccine. On 10-Jun-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 10-Jun-2022, the patient experienced ACCIDENTAL OVERDOSE (Pharmacist administered a first Moderna booster dose to a patient with a volume of 0.5ml instead of 0.25ml. This came from a Primary Series and a booster dose vial so the patient received too high). At the time of the report, ACCIDENTAL OVERDOSE (Pharmacist administered a first Moderna booster dose to a patient with a volume of 0.5ml instead of 0.25ml. This came from a Primary Series and a booster dose vial so the patient received too high) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. Patient does not report any other adverse reactions or side effects. No treatment medication was reported.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered more than 24 hours after the vial initially punctured; 2 doses of the Moderna Covid-19 Vaccine were administered more than 24 hours after the vial was initially punctured; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 doses of the Moderna Covid-19 Vaccine were administered more than 24 hours after the vial was initially punctured) and PRODUCT STORAGE ERROR (Dose administered more than 24 hours after the vial initially punctured) in a 21-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 doses of the Moderna Covid-19 Vaccine were administered more than 24 hours after the vial was initially punctured). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered more than 24 hours after the vial initially punctured). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 doses of the Moderna Covid-19 Vaccine were administered more than 24 hours after the vial was initially punctured) and PRODUCT STORAGE ERROR (Dose administered more than 24 hours after the vial initially punctured) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Dose was administered more than 12 hours post puncture,the vial was initially stored in the refrigerator on 27-May-2022, the vial was first punctured on 8-Jun-2022 at 1:10 PM. The vaccines were administered on 9-Jun-2022 at 2 PM and  2:01 PM. The vial did not undergo any temperature excursion. Treatment information was not provided.   This case was linked to MOD-2022-587397 (Patient Link).
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental exposure to product, Syringe issue, Wrong technique in device usage process
Clinical narrative: pressure was high and squirted mostly in the air, but in her face and little got in her mouth; the syringe that come with the vaccines (she referred to them as not high-quality kind) leaked, pressure was high and squirted mostly in the air; the syringe that come with the vaccines (she referred to them as not high-quality kind) leaked; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL EXPOSURE TO PRODUCT (pressure was high and squirted mostly in the air, but in her face and little got in her mouth), WRONG TECHNIQUE IN DEVICE USAGE PROCESS (the syringe that come with the vaccines (she referred to them as not high-quality kind) leaked, pressure was high and squirted mostly in the air) and SYRINGE ISSUE (the syringe that come with the vaccines (she referred to them as not high-quality kind) leaked) in a 32-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 038A22A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Pfizer vaccine. Past adverse reactions to the above products included No adverse event with Pfizer vaccine.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL EXPOSURE TO PRODUCT (pressure was high and squirted mostly in the air, but in her face and little got in her mouth), WRONG TECHNIQUE IN DEVICE USAGE PROCESS (the syringe that come with the vaccines (she referred to them as not high-quality kind) leaked, pressure was high and squirted mostly in the air) and SYRINGE ISSUE (the syringe that come with the vaccines (she referred to them as not high-quality kind) leaked). At the time of the report, ACCIDENTAL EXPOSURE TO PRODUCT (pressure was high and squirted mostly in the air, but in her face and little got in her mouth), WRONG TECHNIQUE IN DEVICE USAGE PROCESS (the syringe that come with the vaccines (she referred to them as not high-quality kind) leaked, pressure was high and squirted mostly in the air) and SYRINGE ISSUE (the syringe that come with the vaccines (she referred to them as not high-quality kind) leaked) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. Pharmacist reported no symptoms.  No treatment information was provided by the reporter.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Punctured vial was store in Fridge; 2 doses of the Moderna Covid-19 Vaccine were administered more than 24 hours after the vial was initially punctured; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 doses of the Moderna Covid-19 Vaccine were administered more than 24 hours after the vial was initially punctured) and PRODUCT STORAGE ERROR (Punctured vial was store in Fridge) in a 23-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 doses of the Moderna Covid-19 Vaccine were administered more than 24 hours after the vial was initially punctured). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Punctured vial was store in Fridge). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 doses of the Moderna Covid-19 Vaccine were administered more than 24 hours after the vial was initially punctured) and PRODUCT STORAGE ERROR (Punctured vial was store in Fridge) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. The vaccine administered more than 24 hours after the vial was initially punctured. On 8Jun2022 @ 1:10pm,the vial was first punctured. On 27May2022,the vial was initially stored in the refrigerator. On 9Jun2022@ 2pm & 2:01pm, the vaccine administered. The vial does not undergone any temperature excursions. Treatment information was not provided.   This case was linked to MOD-2022-587247 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: bruise on both her right and left arms, she had a small bruise on the back of her right arm, two larger bruises on the back of her left arm, the second bruise on her left arm was slightly smaller; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (bruise on both her right and left arms, she had a small bruise on the back of her right arm, two larger bruises on the back of her left arm, the second bruise on her left arm was slightly smaller) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On 30-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-May-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 08-Jun-2022,  after starting mRNA-1273 (Spikevax), the patient experienced CONTUSION (bruise on both her right and left arms, she had a small bruise on the back of her right arm, two larger bruises on the back of her left arm, the second bruise on her left arm was slightly smaller). At the time of the report, CONTUSION (bruise on both her right and left arms, she had a small bruise on the back of her right arm, two larger bruises on the back of her left arm, the second bruise on her left arm was slightly smaller) outcome was unknown.            No concomitant medications were reported.  The patient did not experience any side effects or adverse events from the first dose. One bruise was the size of a coin on her left arm several days after receiving her second dose of the Moderna Covid-19 vaccine.   No treatment medications were reported.   Reporter did not allow further contact
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Puctured vial was left in the refrigerator overnight; Dose administered from a vial that was punctured for more than 24 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered from a vial that was punctured for more than 24 hours) and PRODUCT STORAGE ERROR (Puctured vial was left in the refrigerator overnight) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered from a vial that was punctured for more than 24 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Puctured vial was left in the refrigerator overnight). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered from a vial that was punctured for more than 24 hours) and PRODUCT STORAGE ERROR (Puctured vial was left in the refrigerator overnight) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Time of administration of vaccine was 1:10-1:15 PM. Vial was initially stored in the refrigerator on 08-JUN-2022. Vial was first punctured on 9-JUN-2022 at 2:32 PM  and 3 doses were administered at that time.Post punctured vial was stored in refrigerator.  Vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature (8 to 25 degree Celsius= 46 to 77 degree Fahrenheit) was 15-20 minutes. No treatment information was provided.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site urticaria
Clinical narrative: after first booster, developed a really big red welt at the site of the vaccination; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE URTICARIA (after first booster, developed a really big red welt at the site of the vaccination) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939904) for COVID-19 prophylaxis.     Concurrent medical conditions included Gluten sensitivity (was not an allergy), Allergy to antibiotic (medication allergy to Cipro) and Drug allergy (medication allergy to Crestor). Concomitant products included VITAMINS NOS for an unknown indication.    On 28-Oct-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 VACCINATION SITE URTICARIA (after first booster, developed a really big red welt at the site of the vaccination). At the time of the report, VACCINATION SITE URTICARIA (after first booster, developed a really big red welt at the site of the vaccination) had resolved.            Patient has not had a positive covid test. Concomitant products included Statin drug, Low dose beta blocker and Antibiotic.  After first booster, patient developed a really big red welt at the site of the vaccination, lasted for 4 days before it subsided.  No treatment was received and had no hcp notification.   This case was linked to MOD-2022-587456, MOD-2022-587428, MOD-2022-587447 (Patient Link).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Pruritus, Vulvovaginal pruritus
Clinical narrative: Started having excema; Having bad itchiness on my vaginal area/dealt with this for over a year/still an ongoing itch around vagina, and vigina; Still an ongoing itch under arms/still an ongoing itch under breasts/still an ongoing itch on stomach/still an ongoing itch on legs; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ECZEMA (Started having excema), VULVOVAGINAL PRURITUS (Having bad itchiness on my vaginal area/dealt with this for over a year/still an ongoing itch around vagina, and vigina) and PRURITUS (Still an ongoing itch under arms/still an ongoing itch under breasts/still an ongoing itch on stomach/still an ongoing itch on legs) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ECZEMA (Started having excema), VULVOVAGINAL PRURITUS (Having bad itchiness on my vaginal area/dealt with this for over a year/still an ongoing itch around vagina, and vigina) and PRURITUS (Still an ongoing itch under arms/still an ongoing itch under breasts/still an ongoing itch on stomach/still an ongoing itch on legs). The patient was treated with CLOTRIMAZOLE at an unspecified dose and frequency and BETAMETHASONE at an unspecified dose and frequency. At the time of the report, ECZEMA (Started having excema), VULVOVAGINAL PRURITUS (Having bad itchiness on my vaginal area/dealt with this for over a year/still an ongoing itch around vagina, and vigina) and PRURITUS (Still an ongoing itch under arms/still an ongoing itch under breasts/still an ongoing itch on stomach/still an ongoing itch on legs) had not resolved.            No concomitant medications were reported.  The patient reported that patient had never got COVID. patient was fully vaccinated with all 3 moderna vaccines. Patient have never been allergic to any medications. However, after 2nd vaccine, patient started having excema. Especially having bad itchiness on patient's vaginal area. Patient dealt with this for over a year. Patient saw an OBGYN. She medicated Clotrimazole and betamethasone and that helped. The best. It still didn't stop it all together. Patient was daily using it. And when don't have any refills patient used betamethasone depropionate itself. It helped a little better than any other. It was still an ongoing itch. Under arms, under breast, stomach, legs around vagina, and vigina. Patient have been feeling with this all from the 2nd vaccine afterwards.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity
Clinical narrative: Achy; Tired; Had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy), FATIGUE (Tired) and PAIN IN EXTREMITY (Had a sore arm) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: J&J Covid-19 vaccine (Lot: 1805020 and Site: left arm) on 08-Mar-2021. Past adverse reactions to the above products included No adverse event with J&J Covid-19 vaccine.    On 28-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, the patient experienced PAIN (Achy), FATIGUE (Tired) and PAIN IN EXTREMITY (Had a sore arm). At the time of the report, PAIN (Achy), FATIGUE (Tired) and PAIN IN EXTREMITY (Had a sore arm) outcome was unknown.            No concomitant medications were provided. On 08Mar2021 the patient got the J&J Covid-19 vaccine. On 28May2021 the patient took 1st dose of Moderna Covid-19 vaccine and was tired, achy, & had a sore arm. No treatment medications were reported.   This case was linked to MOD-2022-587535, MOD-2022-587536 (Patient Link).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Magnetic resonance imaging normal, Pain, Pain in extremity, Vaccination site pain
Clinical narrative: I started having sharp pains in my right triceps.; achy; tired; had a sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN (achy), FATIGUE (tired), VACCINATION SITE PAIN (had a sore arm) and PAIN IN EXTREMITY (I started having sharp pains in my right triceps.) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 077C21B, 016C21A and 505C21A) for COVID-19 prophylaxis.     Patient had no allergies, cardiac issues or COVID-19 history.  Previously administered products included for Product used for unknown indication: COVID-19 VACCINE JANSSEN (Lot: 1805020 and Site: left arm) on 08-Mar-2021. Past adverse reactions to the above products included No adverse reaction with COVID-19 VACCINE JANSSEN.   On 28-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Dec-2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Dec-2021, the patient experienced PAIN (achy), FATIGUE (tired) and VACCINATION SITE PAIN (had a sore arm). On an unknown date, the patient experienced PAIN IN EXTREMITY (I started having sharp pains in my right triceps.). At the time of the report, PAIN (achy), FATIGUE (tired), VACCINATION SITE PAIN (had a sore arm) and PAIN IN EXTREMITY (I started having sharp pains in my right triceps.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging normal: normal normal. On an unknown date, X-ray limb: normal normal.         Vaccine administration site was right shoulder. No concomitant medication was reported. In March or April 2022 patient had sharp pains in right triceps. Patient was doing physical therapy, but it's not helping.   This case was linked to MOD-2022-587494, MOD-2022-587535 (Patient Link).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray limb
Clinical narrative: I started having sharp pains in my right triceps.; achy; tired; had a sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN (achy), FATIGUE (tired), VACCINATION SITE PAIN (had a sore arm) and PAIN IN EXTREMITY (I started having sharp pains in my right triceps.) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 077C21B, 016C21A and 505C21A) for COVID-19 prophylaxis.     Patient had no allergies, cardiac issues or COVID-19 history.  Previously administered products included for Product used for unknown indication: COVID-19 VACCINE JANSSEN (Lot: 1805020 and Site: left arm) on 08-Mar-2021. Past adverse reactions to the above products included No adverse reaction with COVID-19 VACCINE JANSSEN.   On 28-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Dec-2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Dec-2021, the patient experienced PAIN (achy), FATIGUE (tired) and VACCINATION SITE PAIN (had a sore arm). On an unknown date, the patient experienced PAIN IN EXTREMITY (I started having sharp pains in my right triceps.). At the time of the report, PAIN (achy), FATIGUE (tired), VACCINATION SITE PAIN (had a sore arm) and PAIN IN EXTREMITY (I started having sharp pains in my right triceps.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging normal: normal normal. On an unknown date, X-ray limb: normal normal.         Vaccine administration site was right shoulder. No concomitant medication was reported. In March or April 2022 patient had sharp pains in right triceps. Patient was doing physical therapy, but it's not helping.   This case was linked to MOD-2022-587494, MOD-2022-587535 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vaccine was in refrigerator and administered on 18-Oct-2021; 1 dose administered after vaccine reached Beyond Use Date (BUD); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 dose administered after vaccine reached Beyond Use Date (BUD)) and PRODUCT STORAGE ERROR (vaccine was in refrigerator and administered on 18-Oct-2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 dose administered after vaccine reached Beyond Use Date (BUD)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine was in refrigerator and administered on 18-Oct-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 dose administered after vaccine reached Beyond Use Date (BUD)) and PRODUCT STORAGE ERROR (vaccine was in refrigerator and administered on 18-Oct-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. No Treatment medications were reported. Beyond Use Date was reported as 09-Oct-2021 and vaccine administered mentioned as 18-Oct-2021
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Fatigue, Pain, Pyrexia
Clinical narrative: NOSE BLEEDS; PAIN; FATIGUE; FEVER; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (NOSE BLEEDS), PAIN (PAIN), PYREXIA (FEVER) and FATIGUE (FATIGUE) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Sep-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 20-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (FEVER). On an unknown date, the patient experienced EPISTAXIS (NOSE BLEEDS), PAIN (PAIN) and FATIGUE (FATIGUE). At the time of the report, EPISTAXIS (NOSE BLEEDS), PAIN (PAIN), PYREXIA (FEVER) and FATIGUE (FATIGUE) outcome was unknown.            Concomitant medications were not reported.  Action taken with Humira (Adalimumab) was reported as discontinued. The reporter's causality for the events of fatigue, nose bleeds and pain was not provided for Humira (Adalimumab).  The reporter's causality for the event of fever with Humira (Adalimumab) was no reasonable possibility.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  Treatment medications were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose administered after vaccine reached beyond use date (BUD); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered after vaccine reached beyond use date (BUD)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered after vaccine reached beyond use date (BUD)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose administered after vaccine reached beyond use date (BUD)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The reporter reported that the vaccine was in refrigerator and then administered. Off label stability date of the vaccine was reported as 09-Oct-2021. The reporter did not have any specific details about the patient.  No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 1 dose administered after vaccine reached Beyond Use Date (BUD); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 dose administered after vaccine reached Beyond Use Date (BUD)) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 033F21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 dose administered after vaccine reached Beyond Use Date (BUD)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 dose administered after vaccine reached Beyond Use Date (BUD)) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was reported. It was reported that the vaccine was in refrigerator and was administered after Beyond Use Date (BUD) which was 06-Dec-2021. No treatment information was reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: With first COVID-19 vaccine her arm was hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (With first COVID-19 vaccine her arm was hurt) in a 74-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    The patient's past medical history included Surgery in 1992. Concurrent medical conditions included Crohn's disease (Intestines out due to Crohn's disease in 2018.) since 2018.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (With first COVID-19 vaccine her arm was hurt). At the time of the report, PAIN IN EXTREMITY (With first COVID-19 vaccine her arm was hurt) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Concomitant medication was not provided. The Causality as per reporter for Humira was Not reported and the Causality as per Mfr. for Humira was No reasonable possibility. Treatment information was not reported.   This case was linked to MOD-2022-587763 (Patient Link).   Reporter did not allow further contact
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Unspecified reaction to COVID [coronavirus disease] vaccine; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Unspecified reaction to COVID [coronavirus disease] vaccine) in a 62-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product TREPROSTINIL SODIUM inhalation gas for Secondary pulmonary arterial hypertension.    Concurrent medical conditions included Secondary pulmonary arterial hypertension. Concomitant products included MACITENTAN (OPSUMIT) for an unknown indication.   On 27-Jan-2022, the patient started TREPROSTINIL SODIUM (unknown route) 54 microgram four times per day. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 18-May-2022, the patient experienced IMMUNISATION REACTION (Unspecified reaction to COVID [coronavirus disease] vaccine). At the time of the report, IMMUNISATION REACTION (Unspecified reaction to COVID [coronavirus disease] vaccine) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       NDA number was reported as 022387.  Patient began therapy with IH Tyvaso (treprostinil sodium, concentration of 0.6 mg/ml) delivered by Tyvaso Inhalation Device (TD-300/A), on 27 Jan 2022 for secondary pulmonary arterial hypertension. The current dose was reported as up to 54 µg (up to 9 breaths), four times a day (QID) via inhalation (IH) route. On 18 May 2022, 3 months, and 22 days after initiating Tyvaso, the patient was seen in the emergency department regarding an unspecified reaction to COVID. The reporter's causality for the event of immunization reaction was considered as possibly related to COVID-19 vaccine. It was reported Treprostinil sodium dose up to 54 µg, qid, Inhalation, with expiry date 31/08/2023. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 1 dose administered after vaccine reached Beyond Use Date (BUD); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 dose administered after vaccine reached Beyond Use Date (BUD)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 dose administered after vaccine reached Beyond Use Date (BUD)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 dose administered after vaccine reached Beyond Use Date (BUD)) 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 reporter stated that vaccine was in refrigerator and administered on 01-OCT-2021.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vaccine was in refrigerator post beyond use date and then administered; 1 dose administered after vaccine reached Beyond Use Date (BUD); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 dose administered after vaccine reached Beyond Use Date (BUD)) and PRODUCT STORAGE ERROR (vaccine was in refrigerator post beyond use date and then administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 dose administered after vaccine reached Beyond Use Date (BUD)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine was in refrigerator post beyond use date and then administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 dose administered after vaccine reached Beyond Use Date (BUD)) and PRODUCT STORAGE ERROR (vaccine was in refrigerator post beyond use date and then administered) outcome was unknown.        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.  Off label stability date was reported as 09-Oct-2021. The reporter asked whether if any of these doses were still viable or would the patients need to be revaccinated again.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Pain, Pain in extremity
Clinical narrative: BODY ACHES; Flu like symptoms; PAIN IN RIGHT FOOT AND HAND; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (BODY ACHES), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN IN EXTREMITY (PAIN IN RIGHT FOOT AND HAND) and FATIGUE (Fatigue) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 09-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jun-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 06-Apr-2021, the patient experienced PAIN (BODY ACHES), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN IN EXTREMITY (PAIN IN RIGHT FOOT AND HAND) and FATIGUE (Fatigue). At the time of the report, PAIN (BODY ACHES), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN IN EXTREMITY (PAIN IN RIGHT FOOT AND HAND) and FATIGUE (Fatigue) outcome was unknown.            No concomitant medications were reported. No treatment information was reported. It was unknown if patient was enrolled in a COVID-19 clinical trial.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered  greater than 12 hours post puncture; vial exposed to room temperature for Just over 24 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered  greater than 12 hours post puncture) and PRODUCT STORAGE ERROR (vial exposed to room temperature for Just over 24 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jun-2022 at 12:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered  greater than 12 hours post puncture) and PRODUCT STORAGE ERROR (vial exposed to room temperature for Just over 24 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered  greater than 12 hours post puncture) and PRODUCT STORAGE ERROR (vial exposed to room temperature for Just over 24 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided.  It was reported that patient received Moderna COVID-19 booster vaccination that was expired past 12 hours use date. Vial was initially stored in the refrigerator on 07 Jun 2022 and was first punctured on 10 Jun 2022 at 11 00 AM approximation. Vial was stored post puncture in room temperature and did not undergo any temperature excursions. Total amount of time vial was exposed to room temperature range (8 degree to 25 degree C was equal to 46 degree to 77 degree F) was unknown and was exposed to room temperature for just over 24 hours.  No treatment medications were provided.