chrisvoncsefalvay/vaers-outcomes huggingface dataset:
has a superficial blood clot on the right leg; This is a spontaneous report received from a contactable reporter(s) (Pharmacist), Program ID.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1 unknown manufacturer), for COVID-19 Immunization. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "has a superficial blood clot on the right leg".  Clinical courses: Reporter reported that has a patient that got their first, second and booster dose of the Covid vaccine and now wanted a second dose the of booster. Wanted to know if they should administer it. Stated that she does not know where the patient got the shot before. Stated that the patient has the blood clot superficial on the leg that she does feel comfortable giving the shot. Clarified that this is for the right leg.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported event Thrombosis which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available. 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.
Left arm pain. Then developed ringing in left ear, fatigue, generalized weakness, and feels lightheaded. Symptoms started 7/18/21.
the vaccine in March or April last year and then I got Covid pretty bad in August; the vaccine in March or April last year and then I got Covid pretty bad in August; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single and administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2021, outcome "unknown" and all described as "the vaccine in March or April last year and then I got Covid pretty bad in August". The patient was concerned, had the shot, the vaccine in March or April last year & then got Covid pretty bad in August & then had the booster in October and now all of a sudden smell burning all the time, for like two months now had been smelling burning in house and searched everywhere & then all whatever the clothes wear whatever under arm started swelling up and today whole chest was swollen almost like it was like it was fluid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever 101F 6pm 1/28/21  Headache same - Ibuprofren resolved 1/29/21 - Sore arm lasting 2 days  1/30/21 - developed sollen/red/hot spot across upper arm, but below deltoid.  This was hot to touch and sore, it resolved in 3 days with last day being itchy.
pt recv vax 16JUN95 & 30MAY97 pt devel a mild case of chickenpox;
Patient was given 0.5ml instead of 0.25ml, Calle patient on 1/19/2022 and he denies any problems since vaccination, letter sent to patient notifying of dosage given.
some hives/Little bit of a reaction of hives on her neck; itchy whelps on one little area of her neck; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 03Feb2021 (Batch/Lot number was not reported) as single for COVID-19 immunization. Medical history included chronic problem with hives on neck (continuously off and on). The patient's concomitant medications were not reported. On 03Feb2021, patient experienced some hives/Little bit of a reaction of hives on her neck, but with no wheezing or tightness, by the time patient got home after the vaccine was administered (probably about 1 hour after vaccination). Patient has had a chronic problem with hives on her sensitive areas and it was just a bit more severe this time. Little bit of a reaction of hives on her neck further described as itchy whelps on one little area of the neck, not all over the neck. Patient checked with primary care provider and he thought it was still safe for her to get the second dose of the Pfizer COVID-19 Vaccine. Patient wanted to know about recommendations regarding getting the second dose of the Pfizer COVID-19 Vaccine related to this event. Patient physician also asked her to bring some Benadryl along for her second dose and report her experience prior to vaccination. The outcome of event was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Urticarial rash 1 day after Hepatitis A vaccine. No other exposures recalled.
right after receiving the vaccine , patient started complaining of neck stiffness and pain , and shortness of breath.  patient refused to go to hospital when EMT arrived.
strong chills, low fever, nausea and some vomiting, muscle aches, fatigue for the whole day after vaccine. Fatigue the second day after vaccine. Okay now (3rd say after vaccine)
"My" let armpit swelled up and has been painful for 4days and counting; "My" let armpit swelled up and has been painful for 4 days and counting; It hurts to put "my" arm down and "I" can only keep it up; The Lymph Nodes in left arm are inflamed; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on an unknown date in Mar2021 at 13:15 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The medical history included latex allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. The patient received unspecified birth control drug within two weeks of vaccination. On 05Mar2021 at 01:00, the patient's left armpit swelled up and was painful for 4 days and counting. It hurts to put arm down and could only keep it up and the lymph nodes in left arm are inflamed. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event left armpit painful was recovered on 09Mar2021, while the clinical outcome of the events left armpit swelled up, lymph nodes in left arm are inflamed and hurts to put arm down and could only keep it up were recovering at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
I experienced fever, chills, body aches, scratchy throat, headache and fatigue from 10/13/2015 (the evening of the day I received the vaccine) until the morning of 10/16/2015 when these symptoms eased.
2 hours after: right eye watering, nose running. 8 hours after: right eye red, swollen, very difficult to open, blurred vision, burning sensation, sensation of a foreign object. Went to ER. Could not read any letters on the vision chart out of right eye. Given numbing eye drops and antibacterial eye drops. 12 hours after vaccination: right eye still swollen and painful, but slightly less inflamed.
Red circle on arm around injection site. Site was tender after shot and red circle appeared the day after injection. The red circle rash is about 2 inches in diameter.
I developed cold like symptoms with a  cough sore throat and severe fatigue 1 month after this vaccine. The fatigue improved after 1 6 weeks but the cough, sore throat and feeling of malaise have persisted for over 2 months.  Lateral flow tests were negative.  I have consulted and am continuing to consult my GP about these prolonged symptoms which I am still experiencing. The cough is entirely in the upper respiratory tract. Although I cannot be sure that this is a mRNA induced set of symptoms I have never had any experience like this before and as such will not be willing to have further mRNA vaccination.
Narrative:  COVID infection after completion of COVID vaccination series: 01/11/2021 COVID vaccine dose #1 02/08/2021 COVID vaccine dose #2 06/30/2021 Pt reported onset of nausea and slight rhinorrhea 07/09/2021 COVID positive screen indicating need for testing. COVID positive per facility nasopharyngeal swab. 07/10/2021 Clinical resolution of COVID infection.
This spontaneous report was received from a licensed practitioner nurse referring to a patient of unknown age and gender. Information regarding medical history, drug reactions and concurrent conditions was not reported. On 01-FEB-2016, the patient was inadvertently vaccinated with a dose of PEDVAXHIB (lot number L030872 and expiration date 11-JUN-2018) and with a dose of PENTACEL; however, dose number, dose and route of administration were not provided for any of these vaccines. Concomitant therapies were not reported. No adverse effects were reported and there was no product quality complaint (PQC) involved. Additional information has been requested.
Red area noted around vaccination sight along with skin warm to touch.  Noted 48 hours after vaccination.  This vaccination was given at a clinic visit not within the nursing home facility.
the plastic syringe broke and the vaccine leaked out; upon pushing syringe plunger down to administer vaccine, the entire contents sprayed out onto the floor of the exam room out of the syringe; Initial information received on 20-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.   This case involves female patient for whom it was reported as needle was advanced into muscle and upon pushing syringe plunger down to administer vaccine, the entire contents sprayed out onto the floor of the exam room out of the syringe (Product leakage) and the plastic syringe broke and the vaccine leaked out (syringe issue), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, it was reported that as needle of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (dosing details unknown) was advanced into muscle and upon pushing syringe plunger down to administer vaccine, the entire contents sprayed out onto the floor of the exam room out of the syringe (Product leakage) and the plastic syringe broke and the vaccine leaked out (syringe issue),  Relevant laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The outcome was reported as Not Applicable for both events.
Information has been received from a director of pharmacy who reported that some of their healthcare professionals had inadvertently mixed up ZOSTAVAX (Oka/Merck) and VARIVAX (Oka/Merck) with their patients.  It happened three times.  No adverse event reported.  Attempts made to obtain additional identifying information to distinguish the individual patients mentioned in the report were unsuccessful.  The pharmacist did indicate that procedures were implemented to avoid confusion in the future.  Additional information is not expected.
Unconscious; Stood up and became very dizzy; Fell to the floor; Legs and arms were seizing; Legs and arms were seizing; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0150), via an unspecified route of administration, on 02Apr2021, at a single dose, for COVID-19 immunization. The patient's medical history included seizures (but they are rare). The patient had unspecified concomitant medications. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 03Apr2021 at 10:30 AM, the patient stood up and became very dizzy, she fell to the floor and was unconscious. When she came to a few moments after (unknown time), her legs and arms were seizing. The patient did have a history with seizures, but they are rare. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the events.
A nurse reports post vaccine in the evening pt developed significant swelling at the injection site. The swelling was approximately 5cm to 7cm across. The reporter indicates the child recovered.
Pt has a known seizure disorder, having seizures on anticonvulsive therapy; pt had a seizure 6 days p/MMR vax;
14:00 hours: bilateral foot/toe itching and discomfort; bilateral swelling of upper feet and toes; slight stiffness of tarsals; slight skin discoloration along arch lines and upper feet near the toes. 16:00 hours: Treatment of feet with Lotrimin AF spray [believing onset of tinea pedis]. 15:30 hours: No reversal of bilateral swelling of the feet and toes after antifungal application. Swelling continues, pustules populate upper feet, and rough/sticky skin starts to arise along top and bottom of feet. 20:00 hours: Feet and toes covered with pustules. Sought treatment from primary physician and frequent urgent care visits.
I had a swollen lymph node next to my left armpit under my collar bone. It was sore and semi-hard. I explained it to my doctor that if felt as if there was a marble under my skin. After about two weeks the soreness went away and after three weeks (and the second dose) there was no sign of the swelling.
Covid positive; Covid positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid positive", which was also reported as "Vaccinated Family members in same household also positive after a Covid exposure on 28Nov2021. 12 vaccinated family members now covid positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : -PFIZER INC-202101733546 same reporter/drug/AE with different patient.
I had the vaccine on a Tuesday afternoon at 3:30. At 3:30 in the morning of Wednesday, I was awoken by a feeling of a substance moving through my lymph nodes and a feeling of severe foreboding. This lasted 20 minutes. I didn't have any other symptoms. The next day I felt chills and a slight temp and lots of achiness. By that evening (Wed) I had a severe headache. I missed half the work day. The severe headache continue all the way till Friday evening and I missed two more days of work. I felt very nauseas and almost went to the ER. I do get migraines but it has been awhile. It was fairly severe and I just avoided the ER. My arm swelled up on Wednesday and was very swollen and red along with my lymph nodes. The migraine ended on Friday of that week but it has taken me the whole month to feel okay. I have continued to feel woozy and feel headachy sometimes. Just now feeling like myself.
area @ inj site red, large, sore knot in upper arm;size of quarter;fever in arm;
I started getting a menstruation occurrence in between my menses. Cramps, bloating, and headache occurred with a discharge of clear fluid necessitating pads for two days. This started between the first and second dose of the Moderna vaccine. I did not initially report the event because I assumed it was a temporary reaction that would go away in a month or two. It has been ten months and the menstruation is still happening monthly half-way between my last period and the next. I received my booster shot December 9th.
I instantly felt my esophagus burning and 12 hours later I woke up itching and covered in a full body rash that did not heal for four days. Headaches all of those four days. I didn?t want to report this because I want to believe in the vaccine, but after my reaction I just don?t. I had a tingling pain for about a month that moved around my body afterward that I believe to be a blood clot. And four months later, I just recently started breathing normal again and got my full vision back after it being blurred. I have never had these symptoms until I took that stupid vaccine. Now I refuse to get the second shot and I want to know how to get an exemption from a doctor since this was obviously not for lack of willing to get the vaccine..it just triggered something and left a several day rash and several months long effects. I believe I CANT take the second shot or it will kill me. So I expect information on an exemption since it?s not for lack of willing
Severe burning and pain in lower half of my body. Required ER visit. Still severe pain and muscle spasms going on.
more sick than expected; fever (100-101 degrees F); body aches; chills; cold sweats; This is a spontaneous report from a non-contactable consumer.  An adult male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNONW ), via an unspecified route of administration,  on an unspecified date in Feb2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was unknown if prior to the vaccination, the patient was diagnosed with COVID-19. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNONW), via an unspecified route of administration, on an unspecified date for COVID-19 immunization. It was reported that in Feb2021, the patient was more sick than expected. The weekend following the 2nd dose of Pfizer vaccine, the patient had a fever (100-101 degrees Fahrenheit), body aches, chills, and cold sweats. The patient underwent tests and procedures which included body temperature: 100-101 Fahrenheit  on unspecified date. No treatment was given for the events. The clinical outcome of more sick than expected, had a fever (100-101 degrees Fahrenheit), body aches, chills, and cold sweats was recovered. It was also reported that it was unknown if since the vaccination, the patient been tested for COVID-19.  No follow-up attempts are possible. Information about lot number could not be requested.
Left arm pain; Left cheek swollen and numb; Left cheek swollen and numb/Left side of the brain numb; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported for herself that: An adult non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EN6204), via an unspecified route of administration, administered in Arm Left on 14Mar2021 as single dose for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included apnoea, hypertension, albuminuria, naevus flammeus, salmon, milk protein, mushrooms, allergic rhinitis, allergy to animal and grama from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included paracetamol (TYLENOL) and paracetamol (PANADOL) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine within 4 weeks prior to COVID vaccination. On 14Mar2021 the patient experienced left arm pain, left cheek swollen and numb, left side of the brain numb. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of left arm pain with Tylenol/Panadol. The patient did not receive treatment for left cheek swollen and numb and left side of the brain numb. The outcome of the event Left arm pain was recovering and Left cheek swollen and numb, left cheek swollen and numb/Left side of the brain numb was recovered on an unspecified date in Mar2021.  No follow-up attempts are needed. No further information is expected.
PATIENT CAME IN TO STORE, AFTER OBSERVATION PERIOD PATIENT HAD NO COMPLAINTS. A COUPLE HOURS LATER PATIENT HAD BEGUN VOMITING AND DID NOT STOP FOR 3 HOURS. AFTER THAT TIME PATIENT WAS FEELING BETTER AND HAD NO OTHER COMPLAINTS BESIDES EXHAUSTION FOR THE REST OF THE DAY.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes mellitus" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19: Treatment with Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Patient is fully vaccinated.  COVID + on 1/4/2022.  ED visit on 1/3/2022 for fall.  Found on the floor behind a door this morning by family. Positive for cough. BP 134/66  | Pulse 68  | Temp 97.6 °F (36.4 °C) (Oral)  | Resp 18  | LMP  (LMP Unknown)  | SpO2 97% Discharged from ED.  Brought back and hospitalized on 1/4/2022 for weakness and SOB, fatigue.  Chest x-ray and CT were done, reviewed, unremarkable. Blood work unremarkable. Currently, she is on room air.  Correct electrolytes per protocol.urine culture was positive for E coli.  Continue with antibiotics. Discharged in stable condition.