chrisvoncsefalvay/vaers-outcomes huggingface dataset:
potassium was low; blood pressure and heart rate went up; blood pressure and heart rate went up; she got sick, she clarified that after the first dose; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Batch/Lot Number: EL9264) via an unspecified route of administration, administered in arm left on 11Feb2021 (age at vaccination- 68 years) as dose 1, single for COVID-19 immunization. Medical history included Blood pressure and early glaucoma and was taking medicine for her eyes and had to stop taking it since the doctor where she went to get her eyes tested said it was causing a reaction or interaction with her blood pressure medication at the time. Clarifies that after she got sick, the doctor told her that the blood pressure medicine she was taking was causing a toxic reaction. The blood pressure medication she was taking called dorzolimide, she does not have manufacturer or lot number to provide. States she was on the blood pressure medication prior to vaccine without any problems, the doctor told her that it was causing a toxic reaction after taking the covid vaccine. This was documented as reported. Concomitant medication(s) included dorzolamide taken for blood pressure. On 11Feb2021 the after the first dose, it was just that night, she went to ER and was told her potassium was low. The reason why her blood pressure and heart rate went up was because her potassium was low. Treatment: Her blood pressure medication was changed. They could not find a blood pressure medicine and she kept trying different ones. She had blood pressure problems before the vaccine, but it only started going up like that after the vaccine and it would not go down. The outcome of the event sickness was unknown and rest events was recovered on an unspecified date.  Follow-up attempts are completed. No further information is expected.
Ataxia, falling to the right, difficulty walk. Local swelling and induration right thigh.
Patient woke up at 0430 with hives/welts all over trunk and legs.  She took 100mg of Benedry and sypmtoms resolved slowly over the next 12 hours
Sore arm; Slight headache; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received first dose of bnt162b2 (BNT162B2, solution for injection) via an unspecified route of administration on 16Feb2021 (Batch/Lot number was not reported) as SINGLE for covid-19 immunization. Before the vaccination, the patient was exposed to someone who tested positive. It was reported that they both had masked and the "contact was not very long from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. After getting the vaccine, on an unspecified date in Feb2021, the patient experienced sore arm and slight headache and patient was asking how long it would last. Patient was asking if there would be some protection after getting a single dose of the vaccine. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Pt report itching and redness around the site of injecton, still had the itching. Pt states not bad just irritating.
Next day patient got redness & some swelling on arm of injection where she received Pneumovax and shingles shot (2 inches apart). Redness has decreased with benadryl OTC but spread slightly about 1 inch. Looks better day #2
On 04/06/2021 Patient got his first Pfizer COVID-19 vaccination.  Within 24 hours, he got sharp pain in the injection site and shoulders with an increase in brain fog type issues.  He thought it was due to induced immune response depleting energy from the body.  However, a week or so in his usual daily activities started slowing down (e.g., going from daily showers to 3 times a week, not getting chores done in a timely manner).  On 04/27/21, he got his second shot, resulting in complete mental shutdown. Patient was  not showering  or shaving and only ate when forced.  All internal sense of motivation and intuition was gone. He experienced memory issues, trouble speaking, and suffered from a  ?complete state of nothingness which I?ve never experienced before? also known as abulia. He rarely took part in activities he did daily before the vaccine such as spending time on PC and reading the news. On 5/16/21, his condition started to improve and his precious feelings of "nothingness" turned to anger.  He got intense neuropathy escalation in fingertips at this time which lasted about a week and  half. His reaction lasted two months and now he is currently able to shower, shave, and exercise daily but still has memory and executive functioning issues.
Patient called to report day after her J&J vaccine that her already swollen leg became more swollen,she experienced N/V, dizziness that could be from her protonix she took the same day she took the vaccine.
Pt did not experience any adverse events.  Pt was given vaccine that was stored at freezer temperature for 6 days greater than advised per Pfizer's storage requirements.
& CELLULITIS DIPHENHYDRAMINE 50 MG TID 1 cap q 8 hours prn for allergy
Vaccines admin approx 845 AM. Laid down for nap at 1130 AM. Awakened at 330 PM. Had warm water bath with no relief. Taken to ER at 530 PM because child was covered in hives per Mom. Had slight temp in ER, BENADRYL admin and was released that evening.
Patient reported swelling of left side of his neck, noted to be same side as injection. Not noted if reoccurred with second vaccination.
Rec'd first dose on Tuesday at approx 2 p.m. , Wednesday early a.m. Began with nausea/vomiting just water; headache and in bed till Friday.   Could barely lift head off pillow.  Second dose on 3/9/2021, 8 hours after vaccine, started vomiting.   No headache but in bed till Friday again.
Seen in MD office 12/14 for severe headache & numbness in hands.12/15, seen again w/ slurred speech, clubbing of hand, numbness of right side,& crying.Admitted to PICU x 4 days, pt. recovered and discharged 12/19. Upper extrem weakness, facial weakness, 12 nerve palsy.
Injection Site - Large Swelling began 6 hours after vaccine administration 6:00 pm 2/8/2021; Injection Site- Pain approximately 6 hours after vaccine administration 6:00 PM 2/8/2021; Started on 600 mg Ibuprofen q 6 hours at 6:00 PM 2/8/2021; Body aches and chills at 6 AM on 2/9/2021 with a normal temp of 98.6 F; Continued on 600  mg Ibuprofen q 6 hours on 2/9/2021; By 12 Noon on 2/9/2021- my body temp was 102.0 F & remained elevated x 36 hrs. thru 2/10/2021 at 6 AM when it was 99 F- I was unable to attend work that day; Cont. on 600 mg Ibuprofen on 2/10/2021; Today- on 2/12/2021- I still have a swollen (hard boiled egg sized) lump that is painful at the injection site; Continuing on 600 mg Ibuprofen q 12 hours today.
I got them the next week; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 weeks after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were reported as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the Shingles shot and thought that he/she would not get shingles sure enough and got them the next week. The patient stated that it was horrible stuff and he/she did not trust any of these shots now. The follow-up would not possible as no contact details were available.
4-25-21.   LEFT DELTOID AREA OF INJECTION ON 4-24-21 NOTICED WAS NUMB (7 weeks after dose given).  no color change. no pain.  now and then feels itchy like coming from inside. i rub arm for several seconds, then feel relief.
Employee felt dizzy and lightheaded. Stated she "felt like she was going to pass out." Gave her orange juice placed her in Exam room lying down took B/P, O2 and Kept Eye on her. Dr. examined her and had her stay lying down for at least 30 mins. Employee was feeling much better and left at 4:00pm with someone to drive her home.
developed acute, unilateral vision loss; superior sectoral optic disc edema; This is a literature report for the following literature source(s):   A 64-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLINDNESS UNILATERAL (medically significant), 6 days after the suspect product(s) administration, outcome "unknown", described as "developed acute, unilateral vision loss"; PAPILLOEDEMA (medically significant), 6 days after the suspect product(s) administration, outcome "unknown", described as "superior sectoral optic disc edema". The patient underwent the following laboratory tests and procedures: All examination findings: normal OD; revealed superior sectoral optic disc edema; revealed peripapillary splinter hemorrhages in the, notes: optic nerve OS; Optical coherence tomography: showed diffuse thickening of the retinal nerve fib, notes: fiber layer OS; Visual acuity tests: 20/80; 20/100, notes: OS; Visual field tests: revealed dense constriction OS.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the available reported information, the causal association between the events blindness unilateral and pappilloedema and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200034068 Same patient/drug, events occurred in different time;
This medically confirmed health authority report (initial receipt 14-Aug-2015) concerns a 26-year old female patient. Last year, the patient received FLUVIRIN and had no complaints. On 13-AUg-2015, the patient received AFLURIA injection (batch number: U55806) at 0.5 ml annually in an unspecified arm. On 13-Aug-2015. the injection was immediately painful upon administration. As the day progressed, the patient could barely lift her arm that received the shot. This was the first time the patient had a reaction like this. The patient developed severe soreness at the injection site. The outcome was reported as unknown. Reporter's comments: The reporter assessed the events as non-serious.
had a bad reaction; swollen "giant" arm; redness; hives; when trying to touch the arm "it felt like my hands were knives", "it hurt really bad"; something moving towards her heart and down her back; Did not take second dose (over 6 months now); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION, PERIPHERAL SWELLING, ERYTHEMA, URTICARIA, and PAIN IN EXTREMITY in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fruit allergy (bananas) and Alcohol allergy (whisky).    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 COMPLICATION, PERIPHERAL SWELLING, ERYTHEMA, URTICARIA, PAIN IN EXTREMITY, SENSORY DISTURBANCE, and PRODUCT DOSE OMISSION ISSUE. At the time of the report, VACCINATION COMPLICATION, PERIPHERAL SWELLING, ERYTHEMA, URTICARIA, PAIN IN EXTREMITY, and SENSORY DISTURBANCE outcome was unknown and PRODUCT DOSE OMISSION ISSUE had resolved.            No Concomitants and Treatment medication were reported.
Difficulty breathing  Chest tightening  Body aches  Weakness Diarrhea
Vaccinating nurse accidentally administered 0.1ml of Pfizer Bivalent booster instead of 0.3ml.  Head clinician and Program manager was immediately informed and hotline was called. HC apologized and explained to the client  about the situation and client understood and was willing to receive the vaccine, however, the client wasn?t able to stay longer and chose to be informed whatever the hotline?s decision. Patient was advised to go ahead and re-administered the full dose of the vaccine which is 0.3ml. We reached out to the client to come back on Monday to receive the vaccine and client agreed to come back.
I don't know if this is related to the vaccine or not. I wanted to report it just in case.  Vaccine was on Thursday noonish. Subsequent Sunday afternoon, 72-75 hours later, I detected a cold sore emerging, without known provocation: no walnuts, no chocolate, no strawberries, no excess sun exposure, no unusual stress, none of the normal triggers. Valacyclovir didn't help much this time, although it normally stops the lesion immediately. Hadn't had a cold sore since one in August, caused by walnuts.
She felt headache and dizziness. Those side effect are ongoing after 2 days of vaccination. She complains she feels like Tinnitus. She has difficulty of hearing on and off.  She feel off the balance.
Information has been received from a physician concerning one of his children who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (dose, route and lot number not reported).  The physician stated that his child was in a clinical study for VARIVAX (Merck) and had an extreme case of chickenpox following the clinical trial.  It was not specified if the patient sought medical attention.  This is one of several reports from the same source.  Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 72-year-old male patient who received SHINGRIX (batch number C523T, expiry date 4th July 2020). Concurrent medical conditions included vertigo, hearing loss, multifocal motor neuropathy, mitral regurgitation, hypertension, atrial fibrillation, type ii diabetes mellitus, cardiac failure, hyperlipidemia, gout and swelling. Concomitant products included allopurinol, atorvastatin, colchicine, Diltiazem, furosemide, Magnesium, Metformin, postassium chloride, spironolactone, Vitamin D3, Warfarin, glipizide and metoprolol tartrate. On 2nd May 2018, 10:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, less than a month after receiving SHINGRIX, the patient experienced injection site swelling, injection site pain and swelling arm. On an unknown date, the outcome of the injection site swelling and injection site pain were recovering/resolving and the outcome of the swelling arm was unknown. The reporter considered the injection site swelling and injection site pain to be related to SHINGRIX. It was unknown if the reporter considered the swelling arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Concomitant medication included Multivitamin. The patient received SHINGRIX in the right arm. The patient had a follow up visit to his physician to talk about adverse reactions experienced after the injection of the vaccine. The patient noted that he had noticeable swelling in both arms, but increase swelling in the right arm his where he received the injection. The patient said that he had normal swelling with the conditions he had, but his swelling from the vaccine was worse than normal. It had been sixteen days since the injection was given before the time of reporting. The reporter provided all of the information that he had available to him.
pt recvd vax; high pitched crying 10-12 hrs; lt leg swelling,thigh to foot x 1 day , warm to touch; did not have high fever; apap given 1-2 doses;
Pt developed rash over chest, back, arms and thigh. Taken to the ER and given Atarax. Pt still has rash and is taking medication for it.
Soft tissue swelling of thigh, including the knee.  Some induration at the site of injection.  Mild redness/blotchiness.  Benadryl given by mom (approximately 1mg/kg x 3 doses).  On follow up visit next day, decreased swelling, induration, redness and discomfort.
Have been fine until over a week later and my arm has a huge knot and itches at the injection site
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced 5-10 chickenpox. The pts symptoms persisted. The pt was treated with Benadryl and calamine.
from about 10:00 PM on the day of the shot - - fever - 100.4 degrees, chills, muscle aches, joint pain, level 9 headache, 2 bouts of nausea, severe fatigue, this lasted until 11;30 PM on 1/12/2021, fever dropped to 99.4 degrees.  1/13/2021 - fatigue,  muscle aches. no fever.  Please note: I am a very small woman. - 5 feet + 1/2 inch, weight 102 pounds. perhaps this needs to be dosed by weight.
I received Covid 19 shot #1. Approximately 10 min later I felt numbness in my wrist that traveled up my arm. I notify the workers administrating the vaccine about my issues. They requested I follow them to the back of the auditorium. I sat down with a male ?medic? present then, another male worker who identified himself as an LVN nurse who said he was the nurse in charge arrived and both attended to me by taking my vitals. After some time, they said my vitals were okay. I started to feel better although my numbness was still there but to a much lesser degree, I was allowed to leave,
My lymph nodes in back of my throat swollen and I had joint pain. Also had a fever of 102.9.
(R) thigh - erythematous, hot to the touch, firm lump 5cm x 5 cm.
p/vax pt exp a varicella like rash, described as multiple, raised & erythematous 2-4mm blisters;
Patient received dose 1 on 21-Sep-2021 and second dose on 21-Mar-2022; Five months after being vaccinated she contracted mild covid symptoms; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Five months after being vaccinated she contracted mild covid symptoms) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on 21-Sep-2021 and second dose on 21-Mar-2022) in a 69-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 048L21A and 014F21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 21-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 21-Mar-2022, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 21-Mar-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on 21-Sep-2021 and second dose on 21-Mar-2022). In 2022,  after starting mRNA-1273 (Spikevax), the patient experienced COVID-19 (Five months after being vaccinated she contracted mild covid symptoms). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for Symptomatic COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Five months after being vaccinated she contracted mild covid symptoms) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on 21-Sep-2021 and second dose on 21-Mar-2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: Positive and Negative.     For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that the patient had no fever or sore throat. The patient took Paxlovid and three days later, the patient was tested negative. The patient was sneezing around her husband and gave covid to him..   This case was linked to US-MODERNATX, INC.-MOD-2023-734152 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734152:husband case
Breakthrough case admission after 3 vaccines Pfizer 1/12/21 Lot# EL3248;  Pifzer 2/14/21 Lot# El9267;  Moderna 12/2/21 Lot# 034F21A
This spontaneous non valid report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unknown date, the patient was vaccinated with improperly stored dose of PROQUAD lot # reported as N019282, expiration date 09-JAN-2019 and VARIVAX lot # N021581, expiration date 09-AUG-2019 (for both strength, dose number, route and anatomical location were not provided). The vaccines were reconstituted with properly stored sterile diluent (MERCK). Administered dose of PROQUAD and VARIVAX experienced the temperature excursion of -9 Celsius degrees to 8 Celsius degrees (also reported as 7.3 Celsius degrees) for 1 hour and 9 minutes. There were no previous excursions reported. The digital data logger was involved. No adverse effects were reported. Upon receipt of follow-up information it was determined that this case is now valid because the patient identifier was received. Follow up information has been received from a nurse on 12-JUN-2018 and refers to a 4-year-old patient. On 01-FEB-2018, the patient was vaccinated with improperly stored dose of PROQUAD lot # N019828 (previously reported as N019282) and VARIVAX. This is one of six reports received from the same reporter. Albumin status for measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live, for lot # N019828 has been verified as recombinant human albumin (rHA). Sender's Comments: US-009507513-1806USA007938: US-009507513-1801USA006139: US-009507513-1806USA007940: US-009507513-1806USA007936: US-009507513-1806USA007937.
Information has been received from a nurse practitioner concerning a female patient who was vaccinated with a dose of Varivax. On 10-MAY-2006 the patient experienced rash with may pustules scabbed over. Unspecified medical attention was sought. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.
On 6/15/2023, The 5 year old patient came in with his mom to receive his 1st dose of moderna vaccine. Recommended to start the series with the Moderna Dark Blue/Gray Label 0.25ml for Dose 1.  Instead the patient was given Moderna Dark Pink cap 0.2ml for dose 1.
Pt admitted 1 day after 2nd dose Moderna COVID-19 Vaccine, for fever, muscle aches and diagnosed PNA. Pt stable on discharge with abx for PNA tx.
At 22-23 hours, all over skin rash, flushing, like a painful sunburn.  This was followed by the typical fever, chills for 12 hours, but not part of event.  Migraines and brain fog set in the next day and persisted in 5 to 8 day intervals, with visual auras and numbness on one side, usually the left.  This went on for 2 months straight.  Also at day one, was spilling proteins into the urine; this turned into kidney pain after a few weeks of taking too much ibuprofen for the migraine pain.  At 6 weeks, joint pains and peripheral neuropathy began.  At this time, still experiencing more migraines than before vaccine, and the nerve pins and needles come and go in feet, hands, right arm.  Visual snow is much worse, related to aura migraines, but possibly neurological symptoms.