chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Starting the day the first dose rabies vaccine was given symptoms included swolen lymph glands, soreness in left arm, dizziness, exaustion, headache and fever. By the next day i had generalized aching in my joints as well as a low grade fever, dizziness and exhaustion that lasted for five days. On the fifth day diareah and vommiting as well as fever, head ache and dizziness that lasted for 48 hrs. Nine days after the first dose I was starting to feel better and was told I had to take the second dose in the series. By the afternoon of the second dose I was again struck with headache, fever, dizziness, exhaustion and swolen lymph glands. Two days after the second dose I wole up and was extremely jittery, had trouble concentrating on conversations, headache dizziness and an uncontrollable muscle twitch in my forehead as well as nystagnus or uncontrolled wtitching of the eyes. At about 3:30 that afternoon I had the first of two grand mal seizures followed by the second at about 4:15. I was then taken to the emergency room where blood was taken to check my phenobarbital level which came back to be perfectly within theraputic range. My neurologist examined me the following monday morning and checked my blood work. He gave me a clean bill of health but did not want me to take the final shot in the series as he was confident that it was what had caused my breakthrough seizure. My epilepsy has always been very mild and easily controlled by medication, this being the first seizure I've had in many many years. It's been a week and a half since the second dose of the vaccine and I still have a slight bit of dizziness and am a little bit off balance but it seems to be getting beter every day.
Patient noticed raised, red welts over the left deltoid during the morning of 4/24/15. The area covered the entire deltoid about 4 cm below the shoulder. The patient also complained that the rash was higly pruritic. Temperature was 98.7 F.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient's medical history and concurrent conditions were not reported. On 29-JAN-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # N010706, expiry date: 02-DEC-2018) (route: oral) (incorrect product storage). The vaccine was exposed to a temperature of 9 Cº to 25 Cº (8.3Cº) for 1 hour 17 min, on 06-JAN-2018, 9 Cº to 25 Cº (11.5Cº) for 1 hour 59 min on 11-JAN-2018, 9 Cº to 25 Cº (15.6Cº) for 1 hour 33 min on 17-JAN-2018, 9 Cº to 25 Cº (11.9Cº) for 1 hour 2 min on 23-JAN-2018 and 9 Cº to 25 Cº (12.1Cº) for 1 hour on 30-JAN-2018. There was no previous temperature excursion. The call was because of a data logger. No adverse effects reported. The outcome of the event was unknown. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1802USA004616: US-009507513-1802USA004629: US-009507513-1802USA004634: US-009507513-1802USA004636: US-009507513-1802USA002182: US-009507513-1802USA004647: US-009507513-1802USA004652: US-009507513-1802USA004654: US-009507513-1802USA004658: US-009507513-1802USA004663: US-009507513-1802USA004671: US-009507513-1802USA004673: US-009507513-1802USA004686: US-009507513-1802USA004692:
Patient stated he had ringing in his right ear and noted onset around 11:45 AM.  RN assessed and monitored patient noting no signs of distress such as hives, breathing difficulty or swelling of his face or throat.  BP 116/72, respiration 20 and pulse rate 60.
Patient was never vaccinated for COVID-19. Came into the office for a first time COVID vaccine, and was mistakenly given the Moderna Bivalent Booster vaccine, instead of the Monovalent (which we do not carry)
On 9/27/99, the pt experienced dizziness, a severe headache, fainting, and stomach pain. The pt sought unspecified medical treatment. On 9/28/99, the pt recovered. Additionally, it was noted that two pts experienced similar reaction after vaccination with hepatitis B vax.
Case number PHEH2013US021767 is an initial spontaneous report received from a pharmacist on 16 OCT 2013. This report refers to a patient whose identifiers were not reported. The patient's medical history and concomitant medications were not reported. The reporter stated that she had heard other pharmacist say that they administered FLUCELVAX 2013/2014 (batch number not reported) to a patient under 18 years of age on an unknown date.  No adverse event was reported following the maladministration.
Headache, Fever, NauseaVomiting, lethargy 2.5 days and vomitting x 1 week Narrative:
70 yo F was given Prevnar (pneumococcal 13) vaccine in right upper deltoid (lot #I82219) and high dose influenza vaccine (UI430AA) in her left upper deltoid on 09/10/2015.  On 09/20/2015, pt noticed redness in the right upper arm with mild warmth to the skin in this area.  The reaction is circumferential and mildly indurated.  The area is not particularly painful to palpation.  MD assessed this as mild self limited reaction to the Prevnar injection.  Pt to be treated with ice and antihistamines.
On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was a refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved by the state for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Shot was given around 12:40 pm on 1/4/2021. I woke up with shivers and low grade fever (99.6) at about 11:30pm. Took a Tylenol at that time. Low grade fever still persists (and rose to 100 degrees at the highest), mild body aches at 6am and headache.
Fever 106.2 seen in ER; CXR-OK; CBC 9,100; stool cult neg; stool WBC neg; RBC neg; blood cult neg; also devel diarrhea;
34 weeks pregnant. Due may 12. Red pin-prick rash in hand and lower arm of Right arm, mild numbness/tingling. Noticed 24 hours after 1st injection. No treatment. Returned to normal after a few hours.
Severe vomiting and diarrhea started at 1:45pm (about 3 hours after the fluzone vaccine) Also severe aches and pain in joints and  chills with teeth chattering intermixed with sweats ( high fever 102 degrees.) This lasted until 7pm. Then it subsided with just extreme fatigue for the next 24 hours.
Patient received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (Patient received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent) 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)) 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) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patient received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 UNDERDOSE (Patient received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent).    No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live significant Follow-up appended: Patient details (age group) was added..
This spontaneous report was received from a nurse, and refers to a patient of unknown age and gender. On 30-NOV-2018, the patient was vaccinated with an expired dose of PROQUAD lot # N016119 with expiration date on 21-NOV-2018, subcutaneously for prophylaxis (dose was not reported). However, no adverse effects were reported.
Rt. arm (deltoid) was swollen (2-3+), red, & hot to touch.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 07-Mar-2022.; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 07-Mar-2022.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 07-Mar-2022.) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 07-Mar-2022.) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2022 at 1:29 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 07-Mar-2022 at 1:29 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 07-Mar-2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 07-Mar-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 07-Mar-2022.) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 07-Mar-2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The patient received vaccine past its 30 day expiry date The vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021. The vaccine was administered up until it manufactured expiry date of 04-Apr-2022. The patient received booster dose.  No treatment information was provided.
Patient is a 87 y.o. male who presents to the urgent care with DIZZINESS (87 y/o male that presents w/ c/o not feeling well overall and a feeling of dizzines x's 1 week.)   History is obtained from Patient   HPI Started in the past week with intermittent dizziness, especially with movements such as putting on a shirt.   Cough productive of lots of small pieces of sputum.  Fevers.  SPO2 usually around 94-95%.     Does have some nocturina and urinary frequency at baseline, somewhat worse last night but otherwise stable, no other urinary symptoms.     Significant cardiac and CVA history.
The patient received COVID-19 Vaccine manufactured by Moderna.; The patient received COVID-19 Vaccine manufactured by Moderna.; Recurrent psoriatic arthritis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 21K-163-4158756-00 (Pharmaceutical Company).  A 65 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Oct2021 (Batch/Lot number: unknown) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2, Route of Administration: Intramuscular, High blood pressure - Recovering/resolving), administration date: 01Apr2021, when the patient was 65 years old, for COVID-19 immunization, reaction(s): "High blood pressure", "Arthritis in hands"; Bnt162b2 (Dose 1, Route of Administration: Intramuscular, High blood pressure - Recovering/resolving), administration date: 01Mar2021, when the patient was 65 years old, for COVID-19 immunization, reaction(s): "High blood pressure", "Arthritis in hands". The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown" and all described as "The patient received COVID-19 Vaccine manufactured by Moderna."; PSORIATIC ARTHROPATHY (medically significant), outcome "not recovered", described as "Recurrent psoriatic arthritis". The patient underwent the following laboratory tests and procedures: blood pressure measurement: high.  Clinical course: Causality as per reporter (Drug/Vaccine) for the event recurrent psoriatic arthritis (Psoriatic arthropathy) was possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received a 2nd Moderna Bivalent booster by accident. Her 1st dose had been on 10/07/2022 and does not recall getting it. She reports that the day after receiving the 2nd dose, that she vomited once, and had chills and fatigue. She is feeling better as of today, 12/22/2022.
Ringing in ears. Right worse than left. Occurs intermittently but can last a day or two at a time.  Have been evaluated by ENT and my ears appear fine.
No adverse event; a dose of PEDVAX HIB was inadvertently administered to an 18 year old consumer; This spontaneous report as received from a Medical assistant refers to a 18-year-old patient of unknown gender. The patinet's concurrent condition, medical history and concomitant therapies were not provided.  On 07-OCT-2021, a dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)(LIQUID PEDVAXHIB) 0.5 (units not provided), lot# T037651 and expiration date of 20-JUL-2023 (route was not provided) was inadvertently administered to an 18 year old consumer for prophylaxis. No additional adverse event was reported.
Administration of expired moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired moderna vaccine) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired moderna vaccine). On 24-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. The vaccines were stored in freezer, one to two vial as per need were taken out and placed in the fridge each day as needed.  No treatment was given to the patient.
Fast onset of dizziness (head spinning, difficulty walking), nausea, temple pain, stomach pain. Some chest ?burning? sensation.
3:30 PM - fatigue, headache Continues until next morning 3/28, 6:30 AM - neck soreness, fatigue, headache 9:00 AM - nauseous, chills, aches 11:00 AM -vomiting (3 times) Symptoms continued until next day 3/29 2:30 PM - chills, fever
vial used for injection was outside storage and handling limits. after speaking to manufacturer, recommend not revax and should not be safety issues. called patient and no side effects
PT VOICED SHE TOOK PFIZER VACCINE THIS PAST FRIDAY (4/9/21). LATER THAT EVENING SHE BEGAN HAVING COVID-LIKE SYMPTOMS AND RIGHT SIDE CHEST PRESSURE (ON/OFF). ON 4/12/21 SHE BEGAN HAVING NAUSEA AND VOMITING AND COULDN'T KEEP ANYTHING DOWN SO SHE DECIDED TO CALL HER PCP. SHE WAS ADMITTED TO THE HOSPTIAL ON 4/13/21. PT VOICED SHE DIDN'T HAVE ANY PROBLEMS OR SYMPTOMS BEFORE SHE RECEIVED THE VACCINE.
No adverse event, just that patient was 16 years of age at time of vaccination, and Moderna is currently only approved for ages 18 and older.
The background is he was hospitalized for 5 days in November 2020 for coronavirus, admitted with fever, chill, weakness, and inability to walk.  Discharged with 3 weeks physical therapy to regain his strength.   First vaccine on 2/4/2021 and within 24 hours experienced similar symptoms, profound weakness and fever.  Second vaccine on 2/25/2021 and within 12 hours he was unable to walk, with weakness, fever, and confusion.  He was taken by ambulance to the hospital on 2/26/2021.  I did question his internist and the person at HealthCare facility on whether or not to proceed given prior reactions.   During this admission determined to have heart attack with cardiac cath and stent placement.   Brain MRI showed new 1cm occipital left infarct and developing pneumonia.  Started on anticoagulation with Plavix and ASA 81mg.  Readmitted to the hospital on 3/8/2021 with suspected GI bleed.  Had colonoscopy and endoscopy with gastric erosion cauterized.
318 patients 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 (318 patients received dose from vials beyond 30-day use by date) in a 23-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 14-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 14-Jul-2021, EXPIRED PRODUCT ADMINISTERED (318 patients 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.   Date of Refrigeration was reported as  07-MAY-2021  No concomitant medications were reported   No treatment information was provided
some days it bothers and others it doesn't,tired left arm when lifting weight; Left arm is itchy; Left arm burns; red flat stain at the injection site and went bigger and bigger; warm to touch; swollen; sore left arm, left arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm, left arm hurts), INJECTION SITE ERYTHEMA (red flat stain at the injection site and went bigger and bigger), SKIN WARM (warm to touch), PERIPHERAL SWELLING (swollen) and LIMB DISCOMFORT (some days it bothers and others it doesn't,tired left arm when lifting weight) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergic to penicillin). Concomitant products included VITAMINS NOS for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore left arm, left arm hurts). On 05-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (red flat stain at the injection site and went bigger and bigger), SKIN WARM (warm to touch) and PERIPHERAL SWELLING (swollen). On an unknown date, the patient experienced LIMB DISCOMFORT (some days it bothers and others it doesn't,tired left arm when lifting weight), PRURITUS (Left arm is itchy) and BURNING SENSATION (Left arm burns). On 07-Feb-2021, PAIN IN EXTREMITY (sore left arm, left arm hurts) had resolved. At the time of the report, INJECTION SITE ERYTHEMA (red flat stain at the injection site and went bigger and bigger), SKIN WARM (warm to touch), PERIPHERAL SWELLING (swollen), LIMB DISCOMFORT (some days it bothers and others it doesn't,tired left arm when lifting weight), PRURITUS (Left arm is itchy) and BURNING SENSATION (Left arm burns) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient does not received any treatments.
Patient reports going home the day of the shot and went to take a nap and had a hallucination about her friends  bringing bugs to her house and cooking in her house.  She also started itching later that week and has continued to itch for the last month.  She has not had any rashes or difficulty breathing or swelling only itching throughout her body.  Her primary care doctor recommended she take antihistamines and use hydrocortisone cream which she is still using 1 month later.
She presented to the ED on 8/30/2021 for COVID testing per recommendation of PCP.  Only symptoms were cough and sore throat with coughing. Was discharged home.
Lost sense of smell; Lost sense of taste; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Lost sense of smell) and AGEUSIA (Lost sense of taste) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form(s). On 29-Mar-2021, the patient experienced ANOSMIA (Lost sense of smell) and AGEUSIA (Lost sense of taste). At the time of the report, ANOSMIA (Lost sense of smell) and AGEUSIA (Lost sense of taste) outcome was unknown.            no other medication reported treatment include Tylenol. Action taken with mRNA-1273 in response to the event was not applicable
Developed throat itching and fullness approximately 45 minutes post vaccination. Between 1-1.5 hours, itching of head, neck, and face. No shortness of breath or rash identified.  Diphenhydramine 50 mg PO and methylprednisolone 12 mg  PO taken upon arriving home.
Patient was diagnosed with cellulitis at injection site (left deltoid). Follow up on 11/03/05: the reporter was unable to obtain more information about the patient. It is unknown whether patient recovered, and the reporter will not make any additional attempts to obtain follow up information.
Rt deltoid and upper arm with erythema, tenderness given DTaP on 2/1/02. Seen in urgent care with symptoms on 2/3/02. given Cephalexin 250m/5ml syrup 1 tsp tid x 10 days.
expired vaccine of VARIVAX was given to a patient today; This spontaneous report was received from the medical assistant, referring to a  currently 38 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 11-AUG-2020, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX)  0.5 milliliter once, subcutaneously (lot # R018932 expiration date 02-JUL-2020) for prophylaxis (expired product administered).
Swelling rash-like  welts  Purple rash on both lower limbs and feet Hurting, itching, numbness, pins and needles tingling  Warm to touch Has taken Benadryl, Claritin, hydrocortisone cream, and lidocaine. Itching subsided with hydrocortisone
Pt reports redness at injection site and chills over the weekend. Reports to clinic today with redness/warmth/edema measuring 8.5x8", also has cluster of blisters on anterior left bicept area. Pulses and cap refill normal. Adved to alternate cold compress to help with ithc and warm compress to help with fluid movement. Started on 40mg prednisone x 3days and precautionary keflex BID x7 days
There were NO adverse events or reactions.  Kinrix was given when last DTap was Pentavalent therefore. Kinrix should not have been given. Per discussion with doctor, Kinrix administration was acceptable. All 7 previous dose of Polio were oral and given after 2016, so therefore did not count.