chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant concerning an unspecified patient of unknown age and gender. The patient's concurrent medical conditions, concomitant therapies, and medical history were not provided. The patient was administered dose one of PEDVAXHIB (dose, strength, frequency, route, lot# and expiration date were unknown) in April 2016 and dose two in July 2016 for prophylaxis, which was one month after recommended date (drug use for unapproved schedule). No adverse effects reported. Addition information is not expected because there is no consent to contact the reporter.
2 hours after second vaccine developed headache. 4 hours after vaccination developed double vision. Was seen in Emergency Department. No other symptoms such as nausea, vomiting, fatigue, fever, focal weakness, or confusion. Headaches intermittent on left side near orbit. Resolved about  6/7/2021.  Evaluated by ophthalmologist, neuro-ophthalmologist and neurologist.  Thought to be peripheral nerve inflammation C-8 Still double vision 6/21/2021, mostly affects near vision which is difficult for his work and leisure.
PAIN, SWELLING AT INJECTION SITE, AND DIFFICULTY RAISING LEFT ARM. NO IMMEDIATE TREATMENT PER PATIENT.  WILL BEGIN USING IBUPROFEN, APPLY ICE PACKS PER INSTRUCTION.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On 21-OCT-2014, an unspecified number of patients were vaccinated with improperly stored ROTATEQ lot # K001716, expiration date: 24-NOV-2015, oral (dose was not reported). No symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Injection site reaction a few days after the shot; warm to the touch at the injection site; bump sensation; swollen; hot; itching at the injection site; red at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE REACTION (Injection site reaction a few days after the shot), VACCINATION SITE WARMTH (warm to the touch at the injection site), SKIN SWELLING (bump sensation), SWELLING (swollen) and FEELING HOT (hot) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A211A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE WARMTH (warm to the touch at the injection site), SKIN SWELLING (bump sensation), SWELLING (swollen), FEELING HOT (hot), VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE ERYTHEMA (red at the injection site). On an unknown date, the patient experienced VACCINATION SITE REACTION (Injection site reaction a few days after the shot). At the time of the report, VACCINATION SITE REACTION (Injection site reaction a few days after the shot), VACCINATION SITE WARMTH (warm to the touch at the injection site), SKIN SWELLING (bump sensation), SWELLING (swollen), FEELING HOT (hot), VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE ERYTHEMA (red at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information was provided.
Patient and 4 other siblings were each getting their flu shots. Patient got hers, was surprised it didnt hurt, and didnt show any signs of distress. She popped up happy with her ice cream ticket and seemed completely fine. Nurse moved on to the siblings and finished the last sibling when patient face planted to the ground face first all of a sudden. Nurse thought maybe she tripped while getting up or that a sibling pushed but quickly realized that she had fainted. Patients arms were very rigid. Could not determine with absolute certainty that a seizure did not occur but the rigid arms were cause for concern. Patient lifted to recumbent chair where she came back to with ammonia. Patient laid recumbent and drank juice and ate crackers. NP assessed patient vitals and asked A&O questions along with assessing face and head. No obvious injuries other than a bruised ear cartilage. A&O x4 and vital signs all WNL.
Strong pain in my arm where I got the shot; 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 VACCINATION SITE PAIN (Strong pain in my arm where I got the shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported. No concomitant medication reported.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Strong pain in my arm where I got the shot). At the time of the report, VACCINATION SITE PAIN (Strong pain in my arm where I got the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information not provided.  Treatment information not provided.
No additional AE reported; HCP reported that a adult patient received a pediatric dose of VAQTA. No additional AE reported. No PQC reported. No further information was provided.; This spontaneous report was received from healthcare professional (HCP) and refers to a 57-year-old female patient. Information regarding the patient's historical conditions, past drugs reactions or allergies, concurrent conditions or concomitant therapies was not provided. /was unknown by the reporter.  On 31-MAR-2022, the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) injection at a dose of 0.5 milliliters (mL) (incorrect dose administered) administered for prophylaxis (lot #U012525 verified as valid, expiration date reported and stablished as 06-FEB-2023) (strength, and route of administration were not provided). No additional adverse events (AE) reported.
Felt tired for a day; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt tired for a day) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 021B21A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (Sulfa).   On 06-Apr-2021 at 7:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021 at 10:20 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021 at 10:20 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Felt tired for a day). On 06-May-2021, FATIGUE (Felt tired for a day) had resolved.            No concomitant medications were reported. No treatment details provided.   This case was linked to MOD-2021-069864 (Patient Link).
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were reported. On 07-AUG-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # M007764, expiration date 30-JAN-2018) (dosage, frequency and route were not reported) for prophylaxis (incorrect product storage). No adverse effect reported. The vaccine was stored at a temperature from 0 degree centigrade to 1 degree centigrade for 1 hour 45 minutes and -1 degree centigrade or colder (-6.09 degree centigrade) for 9 hours 45 minutes. There was no previous temperature excursion. Data logger was involved. No product quality complaint was involved. No further information was provided. This is one of several reports received from same reporter. Sender's Comments: US-009507513-1708USA005685:
Joint pain on my left foot, right knee cap, my two elbows, and finger next to little finger.
I experienced chest tightness and mild pain. I just recently went to the doctor within the last month. My doctor ordered a series of tests and found that an abnormality of my heart and placed me on a beta blocker and baby aspirin. I had to have a cardio-angiogram performed as outpatient surgery. I also had an antibodies test performed last month.
This spontaneous report was received from a Licensed vocational nurse (L.V.N) and refers to 4 patients of unknown age and gender. The patients' medical history, concurrent conditions, and allergies were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 16-MAY-2017, one patient was vaccinated with an improperly stored dose of PROQUAD, on 17-MAY-2017, other patient was vaccinated with an improperly stored dose of PROQUAD, and on 18-MAY-2017, two patients were vaccinated with improperly stored doses of PROQUAD, all for prophylaxis (doses and routes of administration were not reported). It was unknown by the nurse which specific vaccine lot numbers were administered on each specific date of administration. Lot #M044720 with expiration date 07-MAY-2018 (which was reconstituted with sterile diluent (manufacturer unknown) lot #L025372 with expiration date 20-MAR-2018) and Lot # M043310 with expiration date 24-APR-2018 (which was reconstituted with sterile diluent (manufacturer unknown) lot # N003192 with expiration date 05-JUL-2019). The sterile diluent (manufacturer unknown) used to reconstitute the vaccines was properly stored. No symptoms were reported. The doses of the vaccine were exposed to a temperature of 8.8 degree Fahrenheit (°F) for a time frame of 30 minutes. There were no previous temperature excursions. A digital data logger was involved. Furthermore, No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Lot number M044720 has been verified to be a valid lot number for PROQUAD and lot number L025372 has been verified to be a valid lot number for sterile diluent (manufacturer unknown). Additional information has been requested. Sender's Comments: US-009507513-1706USA002919.
Hospitalized (10.31.21-still admitted);  COVID-19 positive (10.28.21);  fully vaccinated  CHIEF COMPLAINT:  Acute hypoxemic respiratory failure due to COVID-19 HISTORY OF PRESENT ILLNESS: Patient is a 75 y.o. female who presents today with fatigue, cough, SHOB for the last several days. She tested (+) for Covid a few days ago, finally came in because she felt so badly. PMH of COPD/OSA not on CPAP, diastolic heart failure, controlled diabetes mellitus 2, CKD III.  In the ED, she was hypoxic to 85% on room air with increased work of breathing. CXR read as only mild perihilar infiltrates, however limited by technique. No major lab abnormalities, though inflammatory markers not initially drawn. However she appears ill and is at high risk of decompensating given concomitant respiratory disease and obesity. She requires admission for treatment of hypoxic respiratory failure due to Covid.  At time of my exam, she is asleep, has slid down in bed and is too weak to push herself up more than a few times. She speaks in half sentences, has prolonged expiratory phase. States she was recently put on nightly O2 for hypoxia, hasn't tried CPAP yet. At baseline, she gets around her house fairly easily, but today, had to take frequent breaks on the way to the car. She's having diarrhea. She's very concerned about how her daughter perceives her, as doesn't want to frighten her with the look of the BiPap. She's troubled that her 11 year old granddaughter is now afraid of her because she has Covid.  * Acute hypoxemic respiratory failure due to COVID-19 Assessment & Plan -S/s for about a week before presenting -needing 2-3L NC to maintain sats >93% -Inflammatory labs pending -Remdesivir, decadron BID, Lovenox BID, Vit C/D/Zinc -PRN duonebs, IS/mucinex/tessalon perles -CXR essentially negative, however limited by technique -If dimer elevated/trends up, will check CTA chest -Provide CAP coverage pending procalcitonin -She has moderate work of breathing, likely multifactorial; BiPap now Progress NOTE from 11.5.21:  11/05/2021 started this morning she was doing pretty good but apparently she had little bit of increasing shortness of breath he is on high-flow now.  Her chest x-ray done this morning showed some developing fibrosis.  Will give her an additional 20 mg of Lasix IV today continue on remdesivir Decadron.  SUBJECTIVE: Patient is doing okay this morning she says she is comfortable she has a cough no fever chest x-ray shows some developing fibrosis her oxygen demand increased later on in the afternoon today.  Will continue to closely monitor continue on remdesivir and Decadron given additional dose of Lasix
Information has been received from an office staff member concerning a 14 year old female relative who, on an unspecified date, was vaccinated with a first dose of Gardasil. A couple of days after vaccination, the patient was diagnosed with scleroderma, an autoimmune disease. The patient was referred to a specialist and was currently being treated. At the time of this report, the patient's scleroderma persisted. No product quality complaint was involved. Additional information is not expected.
improperly stored dose of ROTATEQ on 26-MAY-2020; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies and drug reactions or allergies were not reported.  On 26-MAY-2020, the patient received an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1660704 with expiration date 20-MAR-2021 oral for prophylaxis). The vaccine was exposed to a temperature of 12.1 centigrade (C) during a time frame of 16 hours and 11 minutes, which was detected by a digital data logger. There were no previous temperature excursions.
Pt has a 3x4 1/2 area of redness, warmth, and induration of Left upper arm spreading out from injection site. Diagnosis: Cellulitis. Start on Augmentin 250 mg PO Q 8hrs x 10 days.
12 hrs p/DT very swollen, red lt deltoid area 20 x 10 cm, tender, chills, generalized malaise, tachycardia, flushing, sweating, weakness;
WOKE UP EARLY AM MONDAY, AUGUST 16TH WITH NUMBNESS TO RIGHT SIDE OF FACE AND MOUTH AND SEVERE (CONSTANT) DIZZYNESS TO POINT OF VOMITTING.  CALLED MY DR OFFICE AND WAS TOLD TO GO TO EMERGENCY ROOM.  HAD FOLLOWING TESTS:  ELECTROCARDIOGRAM, ECHOCARDIOGRAM, CHEST X RAY, BRAIN MRI, CT ANGIOGRAPH, HEAD TOMOGRAPHY, HEAD CT, CT ANGIOGRAPHY.  NO SCARRING SHOWING STROKE WAS FOUND.  CONSTANT DIZZYNESS SUBSIDED BUT BLURRY VISION IN RIGHT EYE.  HAVE OCCASIONAL DIZZYNESS AND RIGHT SIDE OF FACE STILL SLIGHTLY NUMB.  ENT DR DO NOT BELIEVE THE DIZZYNESS IS FROM VERTIGO.  FOLLOWING UP WITH PRIMARY DR., NEUROLOGIST AND CURRENTLY WEARING A HEART MONITOR FOR 30 DAYS AND FOLLOWING UP WITH CARDIOLOGIST.
Initial report received from a health care professional on 13 October 2009. A cluster of three patients out of 200 vaccinated with H1N1 (lot number UP001AA) experienced a "black dot" immediately after the withdrawal of the needle from the injection site (deltoid). The "black dot" only occurred in patients where some of the vaccine ran down the needle prior to injection. The needles had not been used to draw up the vaccine. They were 23 gauge, 1 inch needles. The "black dots" could be wiped off with alcohol. The three patients recovered.  List of documents held by sender: none.
I had a sore arm.; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (I had a sore arm.) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Hepatitis B (Patient get tested every 6 months) in 1980.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced PAIN IN EXTREMITY (I had a sore arm.). At the time of the report, PAIN IN EXTREMITY (I had a sore arm.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, Hepatitis B virus test: positive (Positive) Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.  Patient received her second dose of vaccine on 02FEB2021. Patient tested Negative for Hepatitis B in April 2021 & July 2021.   This case was linked to MOD-2021-425684 (Patient Link).
This spontaneous report was received from a registered nurse and refers to an 18 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 19-JUL-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N000683 with expiry date: 06-JAN-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
Tinnitus  experienced twice lasting 20 min.  Some slight ringing also.  Diminished hearing on L ear.
Severe bursitis-like pain in shoulder even after eight days. May just be ongoing muscle inflammation or actual bursitis. Recommended treatment NSAIDs and waiting to heal; still ongoing at this time.
The day of the vaccine I felt really tired after a few hours. I normally have low grade fevers so I was not concerned with that. During the night I woke up and I passed out and had some symptoms of seizure when I got up. I am still experiencing symptoms and it has been twelve weeks and my heart rate is high. I continued having a high fever for two weeks, it was running at 102-103 degrees  instead of my normal  low grade fever at times 99-100 degrees. My heart rate was also very high exaggerated heart rate since getting the vaccine Even if I do normal activity I feel palpitations and my heart rate is elevated. My blood Pressure had been elevated and I have been experiencing dizziness. Some tests are showing leaky valves and PVCs. I have experienced chest pain which is recently resolved. I feel tired and dizzy. At one time the backs of my hands turned blue for a few days.  I was unable to work for the first month after the second dose of the vaccine. I have been working but I am still very tired and I have used all of my time off.  I have seen a Cardiologist, Neurologist.
Patient developed painful, non-itchy rash on R arm accompanied by clear fluid-filled blisters 3 days after receiving 2nd COVID vaccine. Arm became increasingly painful and blisters spread down entirety of arm over next 2 days. Patient diagnosed with shingles in Emergency Department.
Tachycardia and lower than normal blood pressure; continuously for the past 11 days. Normal HR is 65-70 and since vaccination is irregular from 85 to 152. Most of the time in the low 100 with normal to low Blood Pressure
Increased heart rate and pounding at times, high sensitivity to caffeine and current medication (Concentra)
Fever99.1, 44 hours after injection, 100.2F 48 hours after injection
Did not have record of second shingles vaccine given, gave a 3rd on in error.
pt began to have swelling, red, warm area rt deltoid where Td given;given ATB, heat;
Unbearable crippling  joint pain...in every joint at once to where I'm crippled in bed all day unable to move. Never had it before this injection.
In approximately March, 1999, the pt received a treatment with Lymerix at an unspecified dose. Sometime thereafter, he experienced diarrhea.  The most recent information received on 6/30/99 reports the symptoms are ongoing.
Wheezing 45 to 60 minutes after vaccines.  Physician prescribed Cortisone but mother did not fill prescription. Child was fine 4-5 hours later.  Had congestion and "runny nose" 1-2 weeks prior to vaccines.  Wheezing stopped by time arrived at ER.
patient hospitalized secondary to fever, generalized weakness and myalgias and had a fall.    she was hospitalized for 2 days.
Local reaction with approximately 3cm erythema & induration. Fever to 101 x36 hrs.
ADMINISTRATION OF EXPIRED PRODUCT; This spontaneous report received from a pharmacist concerned a 69 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 23-JUN-2021) dose was not reported, administered on 05-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-JUN-2021, the subject experienced administration of expired product. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired product was not reported. This report was non-serious.
No adverse events reported. patient initially received Pfizer vaccine for 1st dose but patient received Moderna vaccine as the second dose at vaccine clinic. This is because patient answered questions regarding the first dose he received inaccurately and patient also did not bring covid-19 vaccination card, and error was discovered after administration. patient informed of error.
Employee presented with generalize full body rash and itching. No other symptoms. Employee went home, took Benadryl and most of rash disappeared soon after.
Redness and pain in the left upper arm. Started the night after she got her PNEUMOVAX. Erythema and warmth along upper left arm. Tx: Doxycycline Hyclate 100 mg BID x 10 days.