chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The patient received vaccine after being more than 30 days stored in the fridge; No adverse event; 40 patients received the moderna monovalent vaccines (1st and 2nd doses) after being more than 30 days stored in the fridge; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st and 2nd doses) after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005c21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st and 2nd doses) after being more than 30 days stored in the fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st and 2nd doses) after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st and 2nd doses) after being more than 30 days stored in the fridge) and PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge).    No concomitant medications were reported. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Vaccine was stored in the fridge on 30-Jun-2021, Best Used Date reported as 30-Jul-2021. Doses were administered between 02-Aug-2021 and 20-Sep-2021. Patient did not report any side effects. Treatment information was not provided. This case included information for patient 15 out of 31 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-698994 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698994:Master Case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date).    This case contains information of the 14th patient out of 20 patients.  No concomitant and treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 20 Patients received Spikevax past the 30 day expiration date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date).    This case contains information of the 17th patient out of 20 patients.  No concomitant and treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-700683 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-700683:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date).    This case contains information of the 20th patient out of 20 patients.  No concomitant and treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 56 adults patients received doses after its expiration date Jul 13, 2022; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022).    No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Caller mentioned that "the CDC had just approved extended expiration dates" and wanted to know if it was extended. When asked the caller stated that there were no remaining vials unused of that lot number and MI agent reminded the caller that no patients should receive doses from expired vials. Dose was administered after 30-day Use by Date or after manufacturer date of expiry. Vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 56 adults patients received doses after its expiration date Jul 13, 2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022).    This case was created for 5th patient out of 56 patients. Concomitant medication was not provided. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Doses were administered after 30-day Use By Date or after manufacturer date of expiry. It was unknown to HCP when the vials were stored in the refrigerator and when the doses were administered. The vial had not underwent temperature excursion. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 56 adults patients received doses after its expiration date 13-Jul-2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13-Jul-2022).    No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Caller mentioned that "the CDC had just approved extended expiration dates" and wanted to know if it was extended. When asked the caller stated that there were no remaining vials unused of that lot number and MI agent reminded the caller that no patients should receive doses from expired vials. Dose was administered after 30-day Use by Date or after manufacturer date of expiry. Vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case (1 of 56 patient)
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 56 adults patients received doses after its expiration date Jul 13, 2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022).    This case was created for 33rd patient of 56 patients involved. Concomitant medication was not provided. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Doses were administered after 30-day Use By Date or after manufacturer date of expiry. It was unknown to HCP when the vials were stored in the refrigerator and when the doses were administered. The vial had not underwent temperature excursion. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 56 adults patients received doses after its expiration date 13Jul2022; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13Jul2022) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13Jul2022) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13Jul2022) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13Jul2022).    Concomitant medications were not reported.  Vial size was 5 ml. The vial did not undergo any temperature excursions. This case contains information for the 49th of 56 adult patients. Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Adult patient received doses after its expiration date 13-Jul-2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Adult patient received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Adult patient received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Adult patient received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Adult patient received doses after its expiration date 13-Jul-2022).    No concomitant medications were reported.  It was reported that, the patient received vaccine from expired vial. Further it was stated that, there were no remaining vials unused of expired lot number.  The vial did not undergo any temperature excursions.  No treatment medications were reported.  This case contains information for the 17th of 56 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case (1 of 56 patient)
Sex: M
Vaccine: COVID19
Symptoms: Debridement, Fall, Walking aid user, Wound
Clinical narrative: VACCINE use for COVID-19 under Emergency Use Authorization (EUA): the patient had a fall the next day after receiving a EAU COVID-19 vaccine in November 2022. The fall was so severe that the pt ended up with a wound that required surgical debridement and vacuuming of fluid off and physical therapy and a walker for ambulation. He is now back ambulating with a can and only with a walker early in the morning. The patient still has some orthostatic hypotension likely due to other drugs DIGOXIN 125mcg 1 tab po qd, METOPROLOL TARTRATE 25mg ss tab po twice daily, and furosemide 20 mg 1 tab po qd. I do not have the details of the specific covid-19 vaccine. This information was gathered during a MTM conversation.
Sex: F
Vaccine: COVID19-2
Symptoms: Feeling cold, Injection site pain, Mobility decreased, Muscle spasms, Pain
Clinical narrative: extremely sore on and around the left arm towards the elbow; pain when raised up. lost sleep all night; painful cramp in left calf. Feeling chill all day, requiring extra heat from a portable heater. As of today, 1/23/2023, I still have the soreness on my arm with injection site and nit feeling free to raise it to my head.
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity
Clinical narrative: extremely sore on and around the left arm towards the elbow; pain when raised up. lost sleep all night; painful cramp in left calf. Feeling chill all day, requiring extra heat from a portable heater. As of today, 1/23/2023, I still have the soreness on my arm with injection site and nit feeling free to raise it to my head.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Electrocardiogram ambulatory abnormal, Heart rate increased, Seizure, Syncope
Clinical narrative: 14 year old female had Covid vaccine 8 months prior to the start of arrhythmia and syncopal episodes and seizures.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Antinuclear antibody positive, Mucosal inflammation, Nasal crusting
Clinical narrative: My father is 85 and took the maderna booster third shot about a week and a half after he began finding blood clots in his nose they started as white spots and then turned red and scabbed over. Afterwards it would reoccur the problem persists to current day I believe this was caused by the booster has anything like this been reported? He had bloodwork done and his ana with reflex was positive.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blindness, Deafness, Loss of personal independence in daily activities, Malaise
Clinical narrative: My Govt forced me to take a Covid Vaccine!!! and since then i've been nonstop sick. I have never had a fever and cold this many occasions in my entire existence of 40 years and yet now EVERY FREAKIN 2 WEEKS I'M ON TYLENOL TREATING MYSELF....WALKING SLOW to work... being late b/c overnight i have developed a fever and i'm weak!! i have had hearing and vision loss since i took this vaccine 6 months ago!!! and then you guys made us sign DONT SUE AGREMENTS? wow? so screw up my health, jeopardize the health of my infant children b/c the GOVT DECIDED TO FORCE US TO TAKE THESE VACCINES WHEN I WAS PERFECTLY FINE AND DIDN'T HAVE ANY COVID ISSUES OR EVE A COLD SINCE 2020 UNTIL 6 MONTHS AGO WHEN I TOOK A CITY JOB AND WAS FFOORRCCEEDD TO TAKE THIS JAB! forced! completely told that either i take this NON-EVALUATED FOR LONG TERM AND with many many side effects VERY SERIOUS side effects....or I DON' GET A JOB!  YOU GUYS BETTER COME UP WITH A HEALTH JAB NOW THAT UNDOES SCRWING UP MY IMMUNE SYSTEM!
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Nasopharyngitis, Pyrexia
Clinical narrative: My Govt forced me to take a Covid Vaccine!!! and since then i've been nonstop sick. I have never had a fever and cold this many occasions in my entire existence of 40 years and yet now EVERY FREAKIN 2 WEEKS I'M ON TYLENOL TREATING MYSELF....WALKING SLOW to work... being late b/c overnight i have developed a fever and i'm weak!! i have had hearing and vision loss since i took this vaccine 6 months ago!!! and then you guys made us sign DONT SUE AGREMENTS? wow? so screw up my health, jeopardize the health of my infant children b/c the GOVT DECIDED TO FORCE US TO TAKE THESE VACCINES WHEN I WAS PERFECTLY FINE AND DIDN'T HAVE ANY COVID ISSUES OR EVE A COLD SINCE 2020 UNTIL 6 MONTHS AGO WHEN I TOOK A CITY JOB AND WAS FFOORRCCEEDD TO TAKE THIS JAB! forced! completely told that either i take this NON-EVALUATED FOR LONG TERM AND with many many side effects VERY SERIOUS side effects....or I DON' GET A JOB!  YOU GUYS BETTER COME UP WITH A HEALTH JAB NOW THAT UNDOES SCRWING UP MY IMMUNE SYSTEM!
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral small vessel ischaemic disease, Computerised tomogram normal, Dizziness, Exercise tolerance decreased, Feeling abnormal
Clinical narrative: Moderna vaccine. Following vaccine I complained of feeling dizzy, lightheaded, "off" for several weeks. So much it impacted my ADIs/training for a marathon. There were days I would run and couldn't focus my eyes and texted friends I was dizzy/didn't feel well. Prior to this I was having pulsile tinnitus - with no other symptoms- just noise in my ear. When dizziness/ light headedneaa came on, I was very concerned and saw my doctor. I had CT, MRI, hearing tests. They could not pinpoint cause of tinnitus (ironically it started when I started running more than 50 miles a week and after my marathon as soon as I stopped running, the tinnitus stopped); all labs normal; CT; however incidental finding on head MRI included small vessel ischemia in . Very unusual for 48 year old. Could be related to vaccines/ similar to Pfizer vaccine - increased risk of stroke? More that happy to share MRI /CT with your team
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test normal, Magnetic resonance imaging head abnormal, Malaise, Tinnitus, Vision blurred
Clinical narrative: Moderna vaccine. Following vaccine I complained of feeling dizzy, lightheaded, "off" for several weeks. So much it impacted my ADIs/training for a marathon. There were days I would run and couldn't focus my eyes and texted friends I was dizzy/didn't feel well. Prior to this I was having pulsile tinnitus - with no other symptoms- just noise in my ear. When dizziness/ light headedneaa came on, I was very concerned and saw my doctor. I had CT, MRI, hearing tests. They could not pinpoint cause of tinnitus (ironically it started when I started running more than 50 miles a week and after my marathon as soon as I stopped running, the tinnitus stopped); all labs normal; CT; however incidental finding on head MRI included small vessel ischemia in . Very unusual for 48 year old. Could be related to vaccines/ similar to Pfizer vaccine - increased risk of stroke? More that happy to share MRI /CT with your team
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Atrial fibrillation
Clinical narrative: Had the covid-19 Mma Bivalent vaccine injection on 01/04/2023 and by 01/05/2023 had heart go into afib. Saw a Doctor on 01-09-2023 and set up a time to go to hospital for cardo-inversion on 01/12/2023. By then it had settled down and didn't need the inversion.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location).
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location).
Age: 19.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location).
Age: 32.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location).
Age: 16.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location).
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Performance status decreased
Clinical narrative: Extremely high heart rate for about two days following each does. I am an endurance athlete and have not felt that I can achieve the same level of performance as before the shot.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Alcohol use, Aphasia, Asthenia, Balance disorder, COVID-19
Clinical narrative: Discharge Provider: MD Primary Care Provider: MD Admission Date: 1/16/2023 Discharge Date: 01/24/2023  COVID positive 01/16/2023 PRESENTING PROBLEM: Dysarthria [R47.1] Malignant neoplasm of esophagus, unspecified location (HCC) [C15.9] COVID-19 [U07.1]   HOSPITAL COURSE: This is a 77 year old male with PMHx of metastatic esophageal adenocarcinoma s/p esophagectomy 2016 with brain mets s/p craniectomy and whole brain radiation/chemotherapy who was admitted for weakness and confusion.   It is reported on New Year's Day the patient had difficulties with balance leaning to the right while sitting. He has been described as "being off" in the time since, with episodes of weakness (b/l lower extremities), poor speech, falls and poor activity. On the day of admission at approximately 0530 he was found laying on the floor on the stairs unaware how he got there. He denies any history of seizures but family reports some concern for seizures throughout the last few years. It was reported he drinks 4 12oz beers/day.   Work up revealed some resolution of previous noted stokes, otherwise stable previous noted chronic changes. He was started on aspirin and statin, noting previous myalgias he agreed to starting low and increasing over time. His course was complicated by failure to thrive with poor urine output and caloric intake. He slowly improved with time, suspected some encephalopathy was due to incidental COVID (not requiring any treatment or O2). He was able to be discharge in stable condition to facility.   Other work up that was nonrevealing included hematuria. When patient was more orientated it was revealed to be from squeezing his penis too hard to prevent his historic incontinence. This resolved in further UAs. Also, treatment for his HFrEF mild was attempted but this caused hypotension.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cardiac failure, Cerebrovascular accident, Confusional state, Decreased activity, Disorientation
Clinical narrative: Discharge Provider: MD Primary Care Provider: MD Admission Date: 1/16/2023 Discharge Date: 01/24/2023  COVID positive 01/16/2023 PRESENTING PROBLEM: Dysarthria [R47.1] Malignant neoplasm of esophagus, unspecified location (HCC) [C15.9] COVID-19 [U07.1]   HOSPITAL COURSE: This is a 77 year old male with PMHx of metastatic esophageal adenocarcinoma s/p esophagectomy 2016 with brain mets s/p craniectomy and whole brain radiation/chemotherapy who was admitted for weakness and confusion.   It is reported on New Year's Day the patient had difficulties with balance leaning to the right while sitting. He has been described as "being off" in the time since, with episodes of weakness (b/l lower extremities), poor speech, falls and poor activity. On the day of admission at approximately 0530 he was found laying on the floor on the stairs unaware how he got there. He denies any history of seizures but family reports some concern for seizures throughout the last few years. It was reported he drinks 4 12oz beers/day.   Work up revealed some resolution of previous noted stokes, otherwise stable previous noted chronic changes. He was started on aspirin and statin, noting previous myalgias he agreed to starting low and increasing over time. His course was complicated by failure to thrive with poor urine output and caloric intake. He slowly improved with time, suspected some encephalopathy was due to incidental COVID (not requiring any treatment or O2). He was able to be discharge in stable condition to facility.   Other work up that was nonrevealing included hematuria. When patient was more orientated it was revealed to be from squeezing his penis too hard to prevent his historic incontinence. This resolved in further UAs. Also, treatment for his HFrEF mild was attempted but this caused hypotension.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dysarthria, Encephalopathy, Failure to thrive, Fall, Feeling abnormal
Clinical narrative: Discharge Provider: MD Primary Care Provider: MD Admission Date: 1/16/2023 Discharge Date: 01/24/2023  COVID positive 01/16/2023 PRESENTING PROBLEM: Dysarthria [R47.1] Malignant neoplasm of esophagus, unspecified location (HCC) [C15.9] COVID-19 [U07.1]   HOSPITAL COURSE: This is a 77 year old male with PMHx of metastatic esophageal adenocarcinoma s/p esophagectomy 2016 with brain mets s/p craniectomy and whole brain radiation/chemotherapy who was admitted for weakness and confusion.   It is reported on New Year's Day the patient had difficulties with balance leaning to the right while sitting. He has been described as "being off" in the time since, with episodes of weakness (b/l lower extremities), poor speech, falls and poor activity. On the day of admission at approximately 0530 he was found laying on the floor on the stairs unaware how he got there. He denies any history of seizures but family reports some concern for seizures throughout the last few years. It was reported he drinks 4 12oz beers/day.   Work up revealed some resolution of previous noted stokes, otherwise stable previous noted chronic changes. He was started on aspirin and statin, noting previous myalgias he agreed to starting low and increasing over time. His course was complicated by failure to thrive with poor urine output and caloric intake. He slowly improved with time, suspected some encephalopathy was due to incidental COVID (not requiring any treatment or O2). He was able to be discharge in stable condition to facility.   Other work up that was nonrevealing included hematuria. When patient was more orientated it was revealed to be from squeezing his penis too hard to prevent his historic incontinence. This resolved in further UAs. Also, treatment for his HFrEF mild was attempted but this caused hypotension.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Haematuria, Hypophagia, Muscular weakness, Myalgia, Oesophageal carcinoma
Clinical narrative: Discharge Provider: MD Primary Care Provider: MD Admission Date: 1/16/2023 Discharge Date: 01/24/2023  COVID positive 01/16/2023 PRESENTING PROBLEM: Dysarthria [R47.1] Malignant neoplasm of esophagus, unspecified location (HCC) [C15.9] COVID-19 [U07.1]   HOSPITAL COURSE: This is a 77 year old male with PMHx of metastatic esophageal adenocarcinoma s/p esophagectomy 2016 with brain mets s/p craniectomy and whole brain radiation/chemotherapy who was admitted for weakness and confusion.   It is reported on New Year's Day the patient had difficulties with balance leaning to the right while sitting. He has been described as "being off" in the time since, with episodes of weakness (b/l lower extremities), poor speech, falls and poor activity. On the day of admission at approximately 0530 he was found laying on the floor on the stairs unaware how he got there. He denies any history of seizures but family reports some concern for seizures throughout the last few years. It was reported he drinks 4 12oz beers/day.   Work up revealed some resolution of previous noted stokes, otherwise stable previous noted chronic changes. He was started on aspirin and statin, noting previous myalgias he agreed to starting low and increasing over time. His course was complicated by failure to thrive with poor urine output and caloric intake. He slowly improved with time, suspected some encephalopathy was due to incidental COVID (not requiring any treatment or O2). He was able to be discharge in stable condition to facility.   Other work up that was nonrevealing included hematuria. When patient was more orientated it was revealed to be from squeezing his penis too hard to prevent his historic incontinence. This resolved in further UAs. Also, treatment for his HFrEF mild was attempted but this caused hypotension.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Penis injury, SARS-CoV-2 test positive, Urine analysis, Urine output decreased
Clinical narrative: Discharge Provider: MD Primary Care Provider: MD Admission Date: 1/16/2023 Discharge Date: 01/24/2023  COVID positive 01/16/2023 PRESENTING PROBLEM: Dysarthria [R47.1] Malignant neoplasm of esophagus, unspecified location (HCC) [C15.9] COVID-19 [U07.1]   HOSPITAL COURSE: This is a 77 year old male with PMHx of metastatic esophageal adenocarcinoma s/p esophagectomy 2016 with brain mets s/p craniectomy and whole brain radiation/chemotherapy who was admitted for weakness and confusion.   It is reported on New Year's Day the patient had difficulties with balance leaning to the right while sitting. He has been described as "being off" in the time since, with episodes of weakness (b/l lower extremities), poor speech, falls and poor activity. On the day of admission at approximately 0530 he was found laying on the floor on the stairs unaware how he got there. He denies any history of seizures but family reports some concern for seizures throughout the last few years. It was reported he drinks 4 12oz beers/day.   Work up revealed some resolution of previous noted stokes, otherwise stable previous noted chronic changes. He was started on aspirin and statin, noting previous myalgias he agreed to starting low and increasing over time. His course was complicated by failure to thrive with poor urine output and caloric intake. He slowly improved with time, suspected some encephalopathy was due to incidental COVID (not requiring any treatment or O2). He was able to be discharge in stable condition to facility.   Other work up that was nonrevealing included hematuria. When patient was more orientated it was revealed to be from squeezing his penis too hard to prevent his historic incontinence. This resolved in further UAs. Also, treatment for his HFrEF mild was attempted but this caused hypotension.
Age: 36.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Abdominal pain upper, Ageusia, Anosmia, COVID-19, Fatigue
Clinical narrative: On 12/09/2022 had terrible sore throat, swollen glands, and stomach ache. Later that day I tested positive on at home COVID-19 test. By that afternoon I was very fatigued and had a fever of 101.5. Called PCP and was prescribed a Z-pack. Lost taste and smell for a day. Muscle aches and fatigue continued 14 days. I lost my sense of hot and cold in my hands for three days. I still suffer from minor fatigue.
Age: 36.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Lymphadenopathy, Myalgia, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: On 12/09/2022 had terrible sore throat, swollen glands, and stomach ache. Later that day I tested positive on at home COVID-19 test. By that afternoon I was very fatigued and had a fever of 101.5. Called PCP and was prescribed a Z-pack. Lost taste and smell for a day. Muscle aches and fatigue continued 14 days. I lost my sense of hot and cold in my hands for three days. I still suffer from minor fatigue.
Age: 36.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Sensory loss
Clinical narrative: On 12/09/2022 had terrible sore throat, swollen glands, and stomach ache. Later that day I tested positive on at home COVID-19 test. By that afternoon I was very fatigued and had a fever of 101.5. Called PCP and was prescribed a Z-pack. Lost taste and smell for a day. Muscle aches and fatigue continued 14 days. I lost my sense of hot and cold in my hands for three days. I still suffer from minor fatigue.
Age: 22.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Deafness, Dizziness, Heart rate increased, Pharyngeal swelling
Clinical narrative: Patient reported a reaction to the COVID bivalent vaccine on 1/23/23 via a survey:  Swelling of your face and throat; A fast heartbeat; Dizziness and weakness; Other: Loss of hearing and sight problems.  Reported to have occurred within 4 hours of administration.  No visibility to any sort of clinic visit or care sought?
Age: 22.0
Sex: F
Vaccine: COVID19-2
Symptoms: Swelling face, Visual impairment
Clinical narrative: Patient reported a reaction to the COVID bivalent vaccine on 1/23/23 via a survey:  Swelling of your face and throat; A fast heartbeat; Dizziness and weakness; Other: Loss of hearing and sight problems.  Reported to have occurred within 4 hours of administration.  No visibility to any sort of clinic visit or care sought?
Age: 1.17
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Acne, Blister, Rash, Varicella
Clinical narrative: Childs parents stated it started the day after vaccination 1/18/23 with a rash to L inner thigh and spread outward.  Childs developed small pimple like blisters with the rash. Parents stated child was taken to local ER on 1/19/23 where physician diagnosed child with chicken pox and provided treatment. Parents did state that they told the physician that the child recently received vaccines.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Colonoscopy, Fatigue, Oropharyngeal pain
Clinical narrative: I experienced acute abdominal pain, fatigue and sore throat.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Alopecia, Headache, Myalgia, Neck pain, Pain
Clinical narrative: Severe left bicep pain radiates into left trapezius and cervical neck, Loss of large amout of hair on head, chronic H/A
Age: 14.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Patient was seen in office on 01/23/23 and received a tdap that expired on 01/21/23. Patient had no reaction just received a expired vaccine.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Patient received 1st dose of pfizer bivalent covid vaccine on  09/16/2022 and received 2nd dose 01/09/2023. Pt showed no s/s of reaction to vaccine immediately after administration. Upon finding that the 2nd dose was administered pt notified over the phone by provider and manufacturer alerted for guidance.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: Patient and ADON stated during the Prevaccination Checklist questioning that he had not had COVID-19 in the past 90 days.  Vaccine was given and then the ADON found that he had actually had COVID-19 on 11/21/22.  Treated with Paxlovid per standing orders at the nursing home.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin, Rash
Clinical narrative: In February after receiving the vaccine I broke out in a rash on my ankles, chest, neck, cheeks (occasionally), hands and wrist. I made an appointment to see my doctor who gave me an appointment to my doctor who gave me a steroid injection. It cleared up for a couple of months but did come back. I have used both the steroid cream and ointment, but it does not go away completely. I have recently had a biopsy done on the rash and awaiting the results the I will get tomorrow (01/26/23). We are hoping to find what is causing the rash and a method to get rid of it for good.
Age: 69.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Influenza virus test negative, Oropharyngeal pain, Productive cough, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: I was having a sore throat and it was happening deep down in my throat and then I was having more issues down in my chest. I was having a productive cough and coughing up a green mucus. I then began feeling it in my head as well with the runny nose and congestion and more coughing. I have coughing fits throughout the night or when I change positions. I did go to urgent care on January 4th, and I was tested for both COVID-19 and Influenza and they were both negative. By that time things had died down but then had come back and I had a trip coming up so I wanted to make sure I could travel.  I do have a little bit of a productive cough left but am able to make it through the night and not be woken up with a coughing fit.
Age: 69.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: SARS-CoV-2 test negative, Secretion discharge, Sleep disorder
Clinical narrative: I was having a sore throat and it was happening deep down in my throat and then I was having more issues down in my chest. I was having a productive cough and coughing up a green mucus. I then began feeling it in my head as well with the runny nose and congestion and more coughing. I have coughing fits throughout the night or when I change positions. I did go to urgent care on January 4th, and I was tested for both COVID-19 and Influenza and they were both negative. By that time things had died down but then had come back and I had a trip coming up so I wanted to make sure I could travel.  I do have a little bit of a productive cough left but am able to make it through the night and not be woken up with a coughing fit.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Contracted COVID in 1/1/2023
Age: 82.0
Sex: M
Vaccine: COVID19-2
Symptoms: Insomnia, Restlessness, Skin irritation
Clinical narrative: Extreme outer skin irritation like extreme skin irriration  Much more than itching... have been unable to sleep or rest for more than a week up to now 01_/25/2024...
Age: 77.0
Sex: M
Vaccine: UNK
Symptoms: Extra dose administered
Clinical narrative: the patient has been given second bivalent booster vaccine, one in October 2022 and one in January 2023 . patient didnt report side effects
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Headache, Hypertension, Malaise
Clinical narrative: I noticed I starting to feel not well, but 2 days later after the vaccine, I noticed it when I exercised. I went to a doctor and said I had high Blood Pressure, which I never had before, and this time it lasted for 3 months. I had headaches. I lost my strength (physical capacity), it resolved itself.
Age: 2.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Bivalent vaccine given as primary series
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Fatigue, Feeling abnormal, Insomnia
Clinical narrative: Thursday January 19, after work I felt like I had a sore throat. I went to bed and felt fine the next day. The next day I woke up feeling terrible. After having coffee I was fine. Later Sunday morning I felt exhausted. I took a few naps that were 2 hours each and then I started to feel like something was wrong. That evening it was coughing and sneezing and a runny nose. When I woke up on Monday I was coughing and sneezing and had a runny nose. I took an at home COVID-19 home test and it was positive. I then went to a pharmacy and had a PCR test which was also positive. I contacted my doctor and they prescribed PAXLOVID and prednisone. I started the medication in the afternoon on the same date. I started feeling much better by yesterday. I am still sneezing and when I do its about 10 times in a row. I don't do it that often and I am not getting much sleep.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test positive, Sneezing
Clinical narrative: Thursday January 19, after work I felt like I had a sore throat. I went to bed and felt fine the next day. The next day I woke up feeling terrible. After having coffee I was fine. Later Sunday morning I felt exhausted. I took a few naps that were 2 hours each and then I started to feel like something was wrong. That evening it was coughing and sneezing and a runny nose. When I woke up on Monday I was coughing and sneezing and had a runny nose. I took an at home COVID-19 home test and it was positive. I then went to a pharmacy and had a PCR test which was also positive. I contacted my doctor and they prescribed PAXLOVID and prednisone. I started the medication in the afternoon on the same date. I started feeling much better by yesterday. I am still sneezing and when I do its about 10 times in a row. I don't do it that often and I am not getting much sleep.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal tenderness, Blood calcium decreased, Blood glucose normal, Chest X-ray, Computerised tomogram abdomen abnormal
Clinical narrative: Patient experienced nausea, vomiting and abdominal tenderness in the early morning hours.  She went to the ER and a CT abdominal scan diagnosed a high grade, closed loop small bowel obstruction in the upper right quadrant, and a small nonobstructing left renal calculi.  A NG tube was placed on 1/7, and a laparoscopy was performed on 1/8/23 and approximately 20 inches of ischemic small bowel was excised.  Patient was hospitalized from 1/7/23-1/12/23 and then discharged to home.