chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shoulder operation; Pain in upper extremities; Shoulder pain; Vaccination site pain; Asthmatic attack; Pain; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4197893-00.  A female patient received bnt162b2 (BNT162B2), intramuscular, administration date 16Mar2021 (Batch/Lot number: unknown) as dose 1, single and intramuscular, administration date 06Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1155992) at citrate free for crohn's disease. The patient had no relevant medical history. Concomitant medication(s) included: CORTISONE. The following information was reported: SHOULDER OPERATION (medically significant), outcome "unknown", described as "Shoulder operation"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Pain in upper extremities"; ARTHRALGIA (non-serious), outcome "unknown", described as "Shoulder pain"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Vaccination site pain"; ASTHMA (non-serious), outcome "unknown", described as "Asthmatic attack"; PAIN (non-serious), outcome "unknown", described as "Pain". The action taken for adalimumab was unknown.  Clinical course: Causality as per reporter (Drug/Vaccine): Probable. The patient reported that she had shoulder surgery on right shoulder and had cortisone shot in both shoulders. Her both both arms/shoulders hurt she got trouble in getting out of a chair due to arm pain. She had side effects of covid-19 vaccination first 2 made arm hurt at injection site. She also got asthma attack got hurt when gets in cold. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, there is reasonable possibility of causal association between the event SHOULDER OPERATION, "Shoulder operation";"Pain in upper extremities"; "Shoulder pain";  "Vaccination site pain"; ASTHMA ,"Pain" and the suspect drug BNT162B2.  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.
I had pain in the right at the site of the injection. In August, I started having pain in my lower back, It was in my kidney. I also been diagnosed with pre-diabetic. I lost about 10 lbs. They said my kidney filtration was low.
21MAR96 pt recv vax 430PM & 7PM awake screaming-cried & screamed constantly would doze off 15min longest time interval;this cont until 7AM;cont to be fussy the next day but improved by 5PM;no fever w/this rxn;
Patient has not had a menstrual cycle since receiving her second dose of the vaccine. No periods, and she had been experiencing regular cycles since she turned 11.
1 week(7 days) after injection there is Redness( in slight ring formation), warmth, itchiness  and tenderness at injection site. In addition a small rash on the inside of elbows.  Day 8 symptoms are lessening, mainly redness left, slight itch. Day 9 in morning almost no indication of adverse reaction aside from a small warmth still, slight tenderness and very slight pink hue to skin. Overall was very mild.  Redness overall was the most alarming symptom.
Approximately 24 hours after injections, the patient's right arm was swollen, red, hot, and tender to touch.
Patient called on 9/13/2021 with c/o of N/V and joint pain following COVID vaccination (Pfizer) on 9/2/2021. She states these symptoms are similar to when she received flu vaccine in the past, and was wondering if they are a result of COVID vaccination. LG also states she felt she had a "cold" the past 2 weeks.
Severe nosebleed with gelatinous blood. She gets nosebleeds here and there, but we have never seen blood with this consistency coming out of her before. It was pretty strange and alarming.  She just sat and pinched the bridge of her nose until the bleeding stopped. She had one more minor nosebleed while on a walk that evening, but not of the same magnitude.
This spontaneous report as received from a health professional refers to a 17 month old male patient. Patient's relevant medical history, concomitant medications and drug history were not reported. On 05-SEP-2017, the patient was vaccinated with VARIVAX (lot # N008829, expiry date: 16-MAR-2019, strength: 0.5 ml, dose: 0.5ml, once) injection that underwent temperature excursion to vaccinate against varicella. No adverse effects were reported after receiving the vaccine. It was reported that the therapy with VARIVAX was ongoing and that the patient would receive a booster of the VARIVAX at the age of 4. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA002557: US-009507513-1709USA002643.
APPROXIMATELY 1 HOUR POST VACCINATION, DEVELOPED TIGHTNESS AROUND HEAD "RUBBER BAND AROUND HEAD". RESOLVED AFTER ABOUT 1 HOUR.
pt temp going up to 104; pt had sz, eyes rolled back; seemed to stop breathing; lips & nose turned purple
Diagnosed with blood clots; DVT; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), 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 (Primary immunization series complete; Unknown Manufacturer), for COVID-19 Immunisation. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "Diagnosed with blood clots"; DEEP VEIN THROMBOSIS (medically significant), outcome "unknown", described as "DVT". Therapeutic measures were taken as a result of thrombosis, deep vein thrombosis. Clinical course: Patient confirmed if the DVTs which patient experienced was related to the recent vaccine booster. She took Eliquis which was very expensive. He was healthy, very active adult. Medical inquiry was not forwarded to MI.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300110492 same reporter/drug/event, different patient;
4" x 6" swelling, erythema, pain. 1" center  multiple small blisters  No drainage, mild itching  Recommended benadryl q 6 - 8 hrs ibuprofen q 6 - 8 hrs Ice 20 mg 2 - 3/day.
When I took the second shot it took me about four almost five days to feel better; I had like extreme itching with the second and with all the shots; I had like within the first few hours and was just scratching like crazy; I had like extreme itching with the second and with all the shots; I had like within the first few hours and was just scratching like crazy; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. Medical history included sleep apnoea syndrome (Verbatim: Sleep apnea), sleep disorder (Why was the patient taking Concomitant Products Doxylamine succinate (Verbatim): Sleep), hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication(s) included cetirizine hydrochloride (ZYRTEC) taken for Allergy, start and stop date were not reported; doxylamine succinate 25 mg (DOXYLAMINE SUCCINATE) taken for sleep disorder, start and stop date were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient stated that when she took the second shot it took her about four almost five days to feel better. She had like extreme itching with the second and with all the shots, she had like within the first few hours and was just scratching like crazy. The patient underwent lab tests and procedures which included laboratory test: unknown results in Aug2021 (Recently would be early in the summer around lab work was before my physical sometime in august pre august). The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Tested positive; Tested positive; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE and as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated I am vaccinated with the 2 doses against COVID-19 and I and my wife tested positive. The patient underwent lab test and procedure which included: SARS-CoV-2 test which was positive on an unspecified date. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Development of PolyMyalgia Rheumatica Diagnosis delayed as first thought to complication of Lipitor.  When persistent was diagnosed
Tight feeling center chest all day 10/3/22. Only one day. Felt fine otherwise, but difficult to ignore. Forehead headache upon waking 10/4/22 so bad didn?t want to move. After drinking three glasses of water, lying down yet again, all was fine within 15 min.
Case number PHEH2015US026909, is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 50 years old male patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 07 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day, the temperature was fine. It was a new refrigerator and there had not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information provided. Follow up information received from the nurse on 26 Jan 2016: Reporter's comment updated.
Fevers 103 degrees with macular-papular rash to chest and LUE - forearm.
6 out of 10 got COVID; 6 out of 10 got COVID; 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 (booster), 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 "6 out of 10 got COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: got covid.  Clinical information: After receiving booster- sat at dinner and 6 out 10 & 5 children got Covid. I was told later by specially Pharmacist. Humira weakens effectiveness. I should have been told soon I would have suspend Humira immediately. I am 65 w/COPD + Psoriatic arthritis.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Swollen lymph nodes in left armpit Crushing continuous headache since then Extreme exhaustion Ear pain Loss of appetite Much worsened tinnitus Mild intermittent dizziness Joint/muscle pain and weakness (whole body)
Pt came in 12/20/20 to complain about lingering arm pain he said he felt after vaccination almost a month ago.  He complained of feeling of liquid moving through his deltoid and down his left arm.  He said he felt the pain come and go and was affecting his sleep.  There are no noticeable signs of swelling or redness.  Mobility of arm, hand, and fingers are unaffected; sensations in all parts are also unaffected.  Suggested pt to ice the area and apply topical lidocaine for pain.  And if pain continued, pt should consult his primary care provider.
Broken blood vessel on 3/15/21 in left ring finger.  Previous trauma to this finger 18 months earlier (broken finger).  Another broken blood vessel on 3/21/21 on same finger in a different location.  No trauma caused broken blood vessels.  No prior broken blood vessels before vaccine.
p/vax pt began w/numbness in feet;11/18 dx w/GBS per MD; 60 day follow-up dated 11/6/00 provided no additional data. Annual follow-up dated 1/29/01 provided no additional data.
8cm green line inferior to injection site left arm. Appeared like superficial thrombophlebitis but not red, palpable or warm.
Around 7:00-8:00  that evening, approximately four hours after recieving the vaccine, I started having shooting pain in my head.  It was mild at first, then harder and more frequent as the evening went on.  It did that until late the next morning and was completely gone by around noon.  This wasn't a 'headache' or migraine.  It was shooting pain like none I had ever had in my head.  I had a knee revision years ago and it also affected the knee through the night with that same type of pain.  I wasn't as concerned about the knee, but, the head was concerning.  I didn't report it because I didn't know I had to register to check in.
one dose of Twinrix in 2012 and one prior dose of adult Hep A vaccine in 2006; This case was reported by a other health professional via sales rep and described the occurrence of incomplete course of vaccination in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis and Hepatitis A vaccine for prophylaxis.   Previously administered products included Twinrix (1st dose received in 2012) and Hepatitis A (1st prior dose of adult Hep A vaccine in 2006).   On an unknown date, the patient did not receive the 2nd dose of Twinrix, Twinrix Pre-Filled Syringe Device and the 2nd dose of Hepatitis A vaccine. On an unknown date, unknown after receiving Twinrix, Twinrix Pre-Filled Syringe Device and Hepatitis A vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-Oct-2022 Reporter's comment: Afterhours Customer relationship management submitted on 10th October 2022 and retrieved by medical information at start of business on 11th October 2022.  The customer had a patient who received one dose of Twinrix in 2012 and one prior dose of adult Hepatitis A vaccine in 2006.  The customer asked what was the recommendation for Hepatitis A series completion.  The consent to follow up was granted. The field representative might had already submitted this to safety and this might be a duplicate case.  All details provided via Customer relationship management form were being forwarded to safety and no additional details were provided.  It was noted in the form that the reporter, an unspecified Health-care professional, consents to follow up. Additional Supportive information: Till the time of reporting, the patient did not receive 2nd dose of Twinrix and Hepatitis A vaccine, which led to incomplete course of vaccination.
Migraine; fever; muscle ache; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date (at the age of 36-years-old) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was previously vaccinated with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: EL3247) via unspecified route of administration in the left arm on 09Feb2021 (at the age of 36-years-old) as dose 1, single for COVID-19 immunisation and experienced severe migraine and body aches. The patient experienced migraine, fever and muscle ache on an unspecified date in 2021. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pfizer-BioNTech COVID-19 Vaccine EUA At 9:30pm Friday after having my 2nd vaccination on Tuesday at 4:45pm I started smelling a very strong very unpleasant chemical smell.  At 1st I thought there was something in the air and I checked all through the house but there was nothing causing the smell and only I could smell it.  It stayed the same till around 4am and then started to lessen and was gone by 6am.  I have never smelt anything like this before.
morphine and Tdap ordered post injury. both in prefilled syringes. RN accidentally gave part of Tdap IV because she had both in her hands. Both were scanned at bedside, but because they were being given at the same time, they were mixed up
fussy from 2PM-7PM 26OCT95; scream for 1 hr @ 4-5PM 26OCT95 no fever;
Patient was given injection in upper left arm on 10/16/2007.  Approximately 4 hours later, the patient started having some swelling in that area.  On 10/17, Nurse noticed that the area was still swolen but patient denied any pain, so an ice pack was provided.  The swelling increased, and the patient began to report burning pain and itching.  Benadryl 25 mg was given, but the pain and swelling still increased, so another Benadryl 25 mg was given as well as Lortab for the pain and ice packs were continued to decrease the swelling.  By the next day, the upper left arm injection site swelling had reduced to baseline and patient reported no more pain or itching.
pt recvd 2nd dose of Hep B vax on 7FEB92 & pt exp stinging pain @ site of inject;
48 YO F W/O SIGNIFICANT MEDICAL Hx C/O OF IMMEDIATE NAUSEA POST VACCINATION. PT VOMITTED FOR 2 MIN UPON HER ARRIVAL TO THE OBSERVATION SITE. SHE DENIES REACTIONS TO PREVIOUS VACCINES AND ADMITS TO A SENSE OF NERVOUSNESS PRIOR TO VACCINATION. PT ALSO ADMITS  TO RECEIVING THE VACCINE W/O EATING BREAKFAST AND DRINKING COFFEE. PT WAS GIVEN GATORADE AND MONITORED CLOSELY UNTIL SHE FELT BETTER/STABLE.  PTS' HUSBAND PRESENT AND DRIVING.  VS @ 10:22 BP 123/70  HR 67 SpO2 99% PT SYMPTOMS/REACTION COMPLETELY RESOVLED AND SHE WAS CONSIDERED STABLE TO LEAVE THE OBSERVATION SITE.
I woke up with excessive chills, shaking, sweating.  I felt extremely scared and thought I might not make it til morning.  I put on extra clothes and covers and stayed in bed.  I was extremely fatigued the next day or so.  I did not report this to my doctor since I did finally recover.
I have developed what I believe to be persistent gastritis starting roughly one week after the injection date. High protein foods (especially protein shakes and meal replacement bars) routinely trigger stomach pain within 15 minutes of consumption that does not resolve for hours. I consumed these foods regularly prior to vaccination without incident.  I have attempted to treat the symptoms with antacids, but they only partially resolve the symptoms.
3/22/21 next day from vaccine in the morning, 9am I had fever of 99.7 felt out of it and run down body aches and developed cellulitis at injection site. My doctor recommended just to wait and see if it resolved itself and it did 2 days later.
1:52 PM "I just received a Hep B booster and within 5 minutes after receiving the vaccine (right deltoid) my whole right arm and right side of my face began feeling weird (numb and tingly). I tapped on the side of my face right in front of my ear and my whole mouth twitched every time I tapped. At this time I haven't noticed any rash or reddening at the side of injection. I will update you in an hour or so of things. Thanks."
I started having some joint pain a week after getting the second dose. I took some Tylenol for the pain. The pain started on my knees and it went up like on the nerves. I went to the doctor and they did some blood work and X-rays on both hands. They came back normal. They gave me a gel for the pain. They told me to see a rheumatologist but I have not have the appointment yet.
Shot was administered on 10/8/2021.  The following day I was achy from head-to-toe,  I felt very sluggish.  The bee sting from the week prior (9/30/2021) flared back up and now I have a rash/hives where the bee stung me.  This area had cleared up the day after (10/1/2021) I was stung.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 01-MAR-2019, the patient was vaccinated with the first dose of improperly stored VARIVAX injection, subcutaneously, lot # R026715, expiration date:18-SEP-2020 (exact dose was not provided) for prophylaxis. Concomitant therapies included sterile diluent. The vaccine underwent temperature excursion of minus 10.5 degrees Celsius for 1 hour and 11 minutes. There was no previous temperature excursion. The digital data logger was involved in recording excursion details. No adverse effects were reported. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1903USA001655: Original Case : 1903USA001655.
My periods have been very irregular since receiving the vaccine. I have never experienced irregular cycles prior and could always assume my cycles would be 32 days start to finish. Any variation experienced was a couple days late at most.  My first cycle after the vaccine was two weeks late and every one since then has been very early or very late. My cycle length now has varied from 16 days to 50 days. All cycles except one have been normal in flow. The 16 day cycle was unusually light. I received the vaccine over six months ago and my cycles have not gone back to normal.
1st shot was ok. Just a little sore in the arm. Second shot, I can?t feel my upper arm, can not move my arm, I am in intense pain. Have a fever and sick to my stomach. I have not been to the doctor yet. I have iced and applied heat to it. Also have been using ibuprofen for the pain.
Pt stated feeling lightheaded after administration of immunizations. While another nurse was bringing cot and juice, patient had hypotonic-hyporesponsive reaction that lasted about 30 sec-1 minute. He became alert, drank juice, and sat in chair for about 15 minutes with no other signs and symptoms. Pt stated he felt better and advised to eat after leaving appointment.
30JAN98 pt recv vax lt deltoid;2FEB97 pt returned to office w/lt arm w/diffuse swelling & redness noted by MD;