chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported urticaria and pruritic to staff 10/10/2019 around midnight, exam 10/09/2019 at 9 AM revealed pruritic urticaria along posterior neckline, R elbow, ventral R forearm, ventral L forearm, bilateral flanks, bilateral anterior and posterior thighs, anterior calves, and anterior surface of bilateral feet.  Received fexofenadine (Allegra) 180 mg PO as one time dose, along with famotidine (Pepcid) 40 mg PO as one time dose, combined with  diphenhydramine lotion topically QID PRN, and diphenhydramine 12.5 mg PO Q6 hrs PRN pruritis/urticaria.   10/10/2019 - Worsening of symptoms, urticaria wheals present at previous mentioned locations, Urticaria wheals have increased erythema and are now raised on anterior and posterior calves, but not coalescing.  Initiated fexofenadine (Allegra) 180 mg PO daily x 14 days, along with famotidine (Pepcid) 40 mg PO x 14 days. Continue to utilize diphenhydramine lotion topically QID PRN. Will increase diphenhydramine 12.5 mg PO Q 6 hrs PRN pruritis/urticaria to 25 mg PO Q 6 hrs PRN. 10/11/2019 - There are multiple coalescing erythematous lesions present along face/cheek, bilateral flanks, bilateral anterior and posterior thighs, anterior calves, and anterior surface of bilateral feet that are raised, but erythema has decreased significantly since 10/10/2019 exam.  Continue with fexofenadine (Allegra) 180 mg PO daily x 14 days (starting 10/10/2019), along with famotidine (Pepcid) 40 mg PO x 14 days, diphenhydramine lotion topically QID PRN, and diphenhydramine 25 mg PO Q 6 hrs PRN urticaria/pruritis. Will change hydroxyzine (Atarax) 50 mg PO BID PRN to hydroxyzine pamoate (Vistaril) 25 mg PO TID PRN. Will initiate triamcinolone (Kenalog) 0.5% ointment BID. Will add calamine lotion topically QID PRN. Will also add Cetaphil lotion for moisturization. 10/14/2019 - Visual exam of face reveals skin intact, normotemp, and color consistent with genetic background. Marked improvement from 10/11/2019 exam.  Continue with previously prescribed interventions.
Got vaccine yesterday 01/11/2021. Tuesday 01/12/2021:  chill, fever, fatigue.  Took Tylenol.  Today 1/13/21 still a little fatigue.  at work today. COVID negative 1/11/21 negative, getting tested every week. denies COVID exposure.
Experienced a metallic taste in my mouth within a minute after receiving a Pfizer booster shot.  I previously had the J & J vaccine in March.
DIARRHEA; This spontaneous report received from a patient concerned a 40 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206421A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-APR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210427520.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 18-APR-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (injection, lot # L044058, expiration date 02-MAY-2017) (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 9.9 degrees Fahrenheit for 163 hours and 30 minutes. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
large local react-swelling, discoloration; t101-102 for 48 hrs beginning approx 24hrs inject;
Information has been received from a certified medical assistant concerning a 26 month old male infant, who on 11 Aug 2006 was vaccinated intramuscularly into the right thigh with a second 0.5mL dose of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (Lot #653774/0010F). The next morning, on 12 Aug 2006, the patient experienced a reaction. The size of his reaction was 8 by 8cm and had the red, warm, painful, and induration at the site of the injection. The physician advised the mother to use over the counter antihistamine. The patient had one past hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) vaccination and had no reaction. The patient's clinical outcome was reported as recovering. No product quality complaint was involved. Additional information has been requested.
11 year old Pediatric patient inadvertently received Adult Bivalent vaccine instead of Pediatric Bivalent vaccine
can't drink or eat anything right now; was absolutely freezing; very unusual for her; felt really sick/can't believe so sick she feels; chills; fever; can't even take medication because she threw up; terrible headache/such a bad headache couldn't go away; very ache; sweating a lot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (very ache), HYPERHIDROSIS (sweating a lot), DECREASED APPETITE (can't drink or eat anything right now), FEELING COLD (was absolutely freezing) and FEELING ABNORMAL (very unusual for her) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Arthritis and Fibromyalgia. Concomitant products included cyclobenzaprine and meloxicam for Arthritis, metoprolol for Heart disorder, pantoprazole for an unknown indication.   On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced PAIN (very ache), HYPERHIDROSIS (sweating a lot), FEELING COLD (was absolutely freezing), FEELING ABNORMAL (very unusual for her), MALAISE (felt really sick/can't believe so sick she feels), CHILLS (chills), PYREXIA (fever), VOMITING (can't even take medication because she threw up) and HEADACHE (terrible headache/such a bad headache couldn't go away). On an unknown date, the patient experienced DECREASED APPETITE (can't drink or eat anything right now). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (very ache), HYPERHIDROSIS (sweating a lot), DECREASED APPETITE (can't drink or eat anything right now), FEELING COLD (was absolutely freezing), FEELING ABNORMAL (very unusual for her), MALAISE (felt really sick/can't believe so sick she feels), CHILLS (chills), PYREXIA (fever), VOMITING (can't even take medication because she threw up) and HEADACHE (terrible headache/such a bad headache couldn't go away) outcome was unknown.            Treatment was reported as 2 Tylenol.   This case was linked to MOD21-075226 (Linked Report).; Sender's Comments:  MOD21-075226:invalid document
Vaccine had been punctured for 26 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine had been punctured for 26 hours) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine had been punctured for 26 hours). On 17-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine had been punctured for 26 hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Narrative: Patient was administered the vaccine and observed for 15 minutes without any issues. Two days later, on December 22, he contacted the clinic reporting that yesterday he had body aches, last night he started with a headache, nasal drainage and coughing, He was advised to monitor for worsening symptoms and to call back if no improvement in 48-72 hours. To date, 1/4/2022, there has not been any further communication from the patient. It would seem the reported ADE has resolved.
I received the 2nd shot on the 27th. I was instructed to stay at the pharmacy for an additional 20 mins because of the adverse event I had with the first vaccine. After leaving the pharmacy, I noticed my left arm was swollen at the injection site. By the next day it was slightly painful, but it did not prohibit my daily activities. After 12 hours of receiving the shot, I started having more raised welts on my face. I also began feeling congested, It was recommended I take Benadryl and for the pain, ibuprofen and Benadryl. I noticed I was very congested and having stomach issues. I had frequent and loose bowel movements which I still have to this day. After that, I started experiencing TMJ or lockjaw. It was incredibly problematic. My gums, teeth were very inflamed. I was not able to eat any solid food for about a full month. I went to an urgent care because I live in 2 different cities and was at my secondary resident. I was prescribed antibiotics. The pain was worse than having a child. I had pain in both ears, tooth pain and my gums were in pain. I was using Orajel, Benadryl and ibuprofen. I took some amoxicillin and then went to the urgent care after 2 days when they reopened, where I was prescribed amoxicillin for 10 days. My gums feel sore still, but the antibiotics took care of everything else as well as the raised welts. The welts look like they have something yellow in them. These welts are something I have never experienced ever before. I am not 100 percent that I am better. My stomach is still not up to par. I also have allergies to all kinds of bugs. On July 3rd I was bitten by a bug and immediately I was covered in welts. I seem to be much more sensitive since receiving the vaccine. I took a Benadryl and acetaminophen. Within 4 hours the welts were gone. It seemed like every medical ailment I have ever had before came back in some form following the vaccine. I am a typically fit person prior to the vaccine.
At 48 hrs pain in left arm to hand. Tingling pain in neck and face. Blurring vision in left eye. Memory confusion. Paralysis in left arm and left side of face. Saw doctor after 6 days of getting worse and was given urgent appt. to see neurologist. Diagnosed as nerve damage. Must be alert to possible progression of paralysis. No treatment available.
12/28/2020 Moderna Covid vaccine #1 Lot 025J20-2A given 1/23/2021 Moderna Covid vaccine  #2  Lot 030L20A given 3/9/2021 illness and had a positive Covid PCR test
Erythematous maculopapular rash on chest, abdomen and back. Benadryl 3cc Q 6.
Patient was given PENTACEL vaccine by mistake, it was intended for his nephew. Child was severe static encephalopathy Ex preemie 24 weeks.
Redness and swelling at site. Achy feeling. Feverish feeling. All these symptoms occurred on the Saturday after the Thursday I received the vaccine. And also 3 days after I developed a cold sore on my left lip. I have not had a cold sore in a very long time.
Death; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided          Concomitant product was not reported. Treatment was not reported. Company Comment : Very limited information regarding these events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
16FEB94 pt recvd vax & mom states approx 9PM  apnea monitor alarm went off & HR dec then apnea; mom states tried to wake baby but pt wouldn't wake up; limp & looked like was unconscious; mom stated pt became blue;
patient passed out a few times .  Ambulance was  called and confirmed he only passed out . Patient reveled that he has a history of passing out with vaccines.
Puffy, red at injection site left arm. Varivax, Adacel given at this site.
Very Lethargic; Weak; couldn't get out of bed,wasn't as active, and couldn't do things she could do before; Over exerted if I did things/very tired; Slept for 16 hours straight; Foggy; Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-May-2021 and was forwarded to Moderna on 20-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Foggy), SOMNOLENCE (Slept for 16 hours straight), LETHARGY (Very Lethargic), ASTHENIA (Weak) and MOBILITY DECREASED (couldn't get out of bed,wasn't as active, and couldn't do things she could do before) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided by the reporter.     On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced HEADACHE (Headache). On 17-Apr-2021, the patient experienced FEELING ABNORMAL (Foggy). On 18-Apr-2021, the patient experienced SOMNOLENCE (Slept for 16 hours straight). On 19-Apr-2021, the patient experienced LETHARGY (Very Lethargic), ASTHENIA (Weak), MOBILITY DECREASED (couldn't get out of bed,wasn't as active, and couldn't do things she could do before) and FATIGUE (Over exerted if I did things/very tired). On 16-Apr-2021, HEADACHE (Headache) had resolved. On 18-Apr-2021, FEELING ABNORMAL (Foggy) and SOMNOLENCE (Slept for 16 hours straight) had resolved. On 17-May-2021, LETHARGY (Very Lethargic), ASTHENIA (Weak) and FATIGUE (Over exerted if I did things/very tired) had resolved. At the time of the report, MOBILITY DECREASED (couldn't get out of bed,wasn't as active, and couldn't do things she could do before) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Apr-2021, Antinuclear antibody positive: (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient developed muscle pain on the right side of her hip. Patient went to urgent care and is prescribed Cyclobenzaprine.
Approximately 9 days after vaccination, patient developed fever to 103 and varicelliform rash.
Roughly 3 hours after vaccination I developed chills, body aches, and a measured fever of 39.1 C. The fever lasted roughly 6 hours; remaining symptoms largely resolved 12 hours after onset.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 10-SEP-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) with lot number: L007230, expiry date: 03-SEP-2016 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Light headache and dizziness.  EMT took vitals BP 90/51, O2Sat 96. EMT took vitals BP 100/64, pulse 63. Client looked much better after 2nd check up and was sent home.
This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. Information regarding the patients current condition and medical history was not provided. On an unknown date the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (dosing regimen unspecified) Lot number-K006132, expiry date 29-APR-2016, Lot number-K010337, expiry date-22-JUL-2016, Lot number K021932, expiry date-10-NOV-2016, Lot number-L003777, expiry date-04-FEB-2017, Lot number-L009204, expiry date-17-MAR-2017, Lot number-L013066, expiry date-14-APR-2017, Lot number-L017146, expiry date-13-MAY-2017, Lot number-L023592, expiry date-26-JUN-2017, Lot number-L025208, expiry date-07-JUL-2017, Lot number-L032396, expiry date-26-AUG-2017, Lot number-L039093, expiry date-06-OCT-2017. The vaccines were at a temperature of -2.7 degree centigrade for a time frame of 790 hours. The call was placed as result of a data logger. No adverse effects were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. Additional information is not expected as the reporter did not wish further contact.
Five days after the vaccine, I have have a warm, red, splotch on my arm below the injection site. It is slightly raised and about 2 inches in diameter.
received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date). On 25-Jun-2021, EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information provided.  Date of refrigeration of vial is 07-MAY-2021.
The pt experienced a warm, 3 inch area of edema and tenderness. The symptoms began and improved within 3 days post vax.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021 at 11:45 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 11:45 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of the patient was provided as 73.74 for batch number  014M20A. The age of the patient was provided as 73.82 for batch number 019B21A.  Concomitant products were not provided.  On 28-Feb-2021, excursion time was 09 AM and 01 PM  and temperature was 27 and 26 respectively, total doses given for the day was 152, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 27-Feb-2021. 20 vials were moved to clinic. Vaccine BUD date was 26-Mar-2021.  On 28-Mar-2021, excursion time was10 AM  and temperature was 35 , total doses given for the day was 150, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 27-Mar-2021. 15  vials were moved to clinic. Vaccine BUD date was 22-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a  temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
I was having severe jaw pain on the right side of my face. I started having a tingling feeling in my fingers and my toes. I started having memory loss, confusion, migraines and swelling on the right side my face and my eyes was swollen shut. I am also having ringing in the right ear.
Swelling at injection site; Burning sensation in that area; certain arm movements; This case was reported by a consumer and described the occurrence of injection site swelling in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date, dose was fine with only typical side effects that went away after 24 hours, refer link case US2023AMR001997). Concurrent medical conditions included atrial fibrillation. Concomitant products included apixaban (Eliquis), losartan and metoprolol (Metoprol).   On 22nd December 2022, the patient received the 2nd dose of Shingrix. On 22nd December 2022, less than a day after receiving Shingrix, the patient experienced injection site swelling, injection site burning and injected limb mobility decreased. On an unknown date, the outcome of the injection site swelling, injection site burning and injected limb mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, injection site burning and injected limb mobility decreased to be related to Shingrix.     Linked case(s) involving the same patient:  US2023AMR001997   Additional Information: GSK receipt date: 09-JAN-2023 Reporter's comment: The patient self-reported this case. Three weeks after injection still had swelling at injection site. In addition, over the past week, the patient had started having a burning sensation in that area with certain arm movements. The symptoms were not treated. The reporter gave permission to contact. Additional Supportive information: This is one of 2 link cases reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR001997:Same reporter
Pt developed a rash (red splotches) covering her whole body. Treated with Benadryl po for 24 hours and at site was red, hot and hard.
Upper L arm noted with 7cmx8cm red, warm to touch indurated area.  Mom states she did not notice it until she got home from work on 11/12/2017. Child c/o itching at the site but denies pain.  Mother was instructed to give Benadryl and Rx for antibiotics was given in no improvement noted.