chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Recieved vaacine afternoon of 10/6. Awoke 5;30 am on 10/7 with pain and severe intense itching at vaccination site. Notice left side of face felt numb, similar to having dental Novocain type sensation. had numbness from left upper arm, left neck and left side of face.  Also associated with left ear fullness. Saw provider later that day as symptoms were persisting. started on steroid. one week later, better but still there. On 10/14 symptoms about 50 percent better. still with numbness to left side of face. hear fullness still there. started having ringing in Left ear. occasional ringing. high pitched. having more frequently during the week. 10/19 ringing increasing, not going way. ,made appointment to see ENT
Almost completely over stroke; affecting left side; blood clot in lower left leg; after shots balance worsened; pressure on left side of face; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (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: Bnt162b2 (dose 1), for covid-19 immunisation, reaction(s): "pressure on left side of face", "blood clot in lower left leg"; Bnt162b2 (dose 2), for covid-19 immunisation, reaction(s): "pressure on left side of face", "blood clot in lower left leg". The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "Almost completely over stroke"; HEMIPLEGIA (medically significant), outcome "unknown", described as "affecting left side"; THROMBOSIS (medically significant), outcome "unknown", described as "blood clot in lower left leg"; BALANCE DISORDER (non-serious), outcome "unknown", described as "after shots balance worsened"; FACIAL PAIN (non-serious), outcome "unknown", described as "pressure on left side of face". The events "almost completely over stroke", "affecting left side", "blood clot in lower left leg", "after shots balance worsened" and "pressure on left side of face" required emergency room visit. Clinical course: Having reaction to shots (2 + 1 booster). Almost completely over stroke on "10Dec2", affecting left side, & after shots balance worsened (98% now 80%) & now need a cane, blood clot in lower left leg & pressure on left side of face. All of these things occurring After shots. ER many times from COVID shot.  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.
No additional AE's/PQC's reported; Temperature excursion for VARIVAX; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, and concomitant medications were not reported.   On 09-SEP-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX)  (strength, dose, anatomical location, and route of administration were not reported) (lot# U015682 with an expiration date on 18-MAY-2023 and lot# U002394 with an expiration date on 22-JAN-2023) for prophylaxis wich experienced a temperature excursión of 4°C Celsius degrees for 20 minutes on 07-SEP-2021 during transport and 4°C for 20minutes on 09-SEP-2021 during transport as well as -10°C to 8°C (4°C) for 20 minutes (product storage error).  It was reported previous temperature excursions of -10°C to 8°C (4°C) for 7 hours and 30 minutes.   No additional adverse events were reported.; Sender's Comments:  US-009507513-2109USA005628:
Woke morning after injection with aches and pains all over body, fatigue and fever of 101.  Persisted for about 12 hours.
This spontaneous report was received from a nurse concerning a 6 months old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 06-JUN-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # K023534, expiration date: 22-MAY-2016) (strength and dose were unspecified), the route was defaulted to oral. No concomitant medications were reported. No adverse effect had been observed or reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Patient had Shingrix shot.  After 10 minutes she started to have reaction. Her tongue started to have bumps and then she felt her tongue is getting swollen and then feeling of her throat being swollen. She was ablet to breath all the time wasn't dizzy or anything. She was able to drink water. But she did feel she is having difficulty swallowing and had to clear her throat.  She denied to get EPI pen as she was able to breath all the time. She took 3 benadryl and was fully recovered after 2 hours.
feel absolutely horrible; didnt sleep at all last night; body is aching so nadly; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feel absolutely horrible), INSOMNIA (didnt sleep at all last night) and PAIN (body is aching so nadly) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (feel absolutely horrible), INSOMNIA (didnt sleep at all last night) and PAIN (body is aching so nadly). At the time of the report, FEELING ABNORMAL (feel absolutely horrible), INSOMNIA (didnt sleep at all last night) and PAIN (body is aching so nadly) outcome was unknown.            No relevant concomitant medication was reported. Treatment information was not provided.
The adverse reaction is NOT a health or efficacy issue. I am merely reporting that this injection has proved -- for both doses -- to be quite painful. The pain does not begin upon injection, but perhaps an hour or two later. For the first dose (maybe 9-10 weeks ago) the pain lasted a few days. (I have had just about every sort of vaccination available, and I've never previously experienced such discomfort.)The pain is sufficiently intense that it is impossible to sleep on my left side. It is sufficient as to make me feel like I've contracted a cold (i.e., aches and pains being a symptom of fever -- but without a fever in this case). Lifting my left arm is painful. When I mentioned to the pharmacist the pain I experienced after the first injection, she suggested moving the arm around. I did that quite a bit this time, but with no obvious effect. Re: Item 20. I recovered from the pain of the first dose within a week. I just got the second dose today, so the pain from that is still bothersome.
I initially woke up with intense burning/pain on my forehead.  Over the next few days, the site of the pain became red, swollen, and blistered.  I went to the urgent care at Hospital on September 11.  They thought I had a skin infection (but could possibly be Shingles) and prescribed antibiotics.  The antibiotics were not helping and the blisters were spreading (across my face, around my eye, under my hair--all on the right side) so I went to a different urgent care location on September 13.  They told me that it looked like I had Shingles and prescribed Valacyclovir 1000 mg twice/day.  That started helping, but the Shingles persisted for quite a while.  I also had to visit an eye doctor because the Shingles were around my eye.  He prescribed additional medication for me, which I am still taking now (Acyclovir).  Two out of the three doctors I saw said that this could have definitely been triggered by the vaccine.  Consequently I was not able to get the second dose, and I'm not sure that I want to.  While my immune system was down because of the Shingles, I ended up contracting COVID.  I am currently fighting that as well.
The patient is a 42 y.o. female who presents for evaluation of headache and neck pain.  This patient received her Pfizer vaccine in her left arm 12 days ago and the day after that started having some increased neck pain and posterior headache.  At this point she has had a persistent right-sided neck muscle pain that is causing a headache in her right lower occiput.  For last 3 days she has had some increasing pain that is now rated at 9/10 in that location and also complaining of some increased pain with neck movements.  She has had some photophobia and nausea for last 3 days as well.  Does have a long history of chronic migraines as well as cervicalgia for which she usually uses Tegretol and Zanaflex.  She has taken Tylenol recently as well.  She does have some baclofen at home that she uses for breakthrough pain.  She is been doing all this with no significant improvement of her headache.  Followed by Dr. from neurology, last checked in with him in February 2021.   There are no other modifying factors or associated symptoms.
Pt recvd MMR vax 19JUL91 this was the 2nd dose recvd during 1 yrs time;2nd dose given inadvertently; immed following 2nd inject pt exp nausea, sluggishness, pain & tenderness @ inject site; pt recovered;
Soreness at the injection site, Joint pain, including hip, leg soreness with a  change in mobility.
Sore arm, high fever, SEVERE hip pain, general joint pain, and severe headache. All lasting 24-48 hours.
dermographia with welts & hives; dermographia with welts & hives; This spontaneous case was reported by an other health care professional and describes the occurrence of MECHANICAL URTICARIA (dermographia with welts & hives) and URTICARIA (dermographia with welts & hives) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MECHANICAL URTICARIA (dermographia with welts & hives) and URTICARIA (dermographia with welts & hives). At the time of the report, MECHANICAL URTICARIA (dermographia with welts & hives) and URTICARIA (dermographia with welts & hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    No concomitant medications were reported.  Treatment medications were not provided by the reporter.    This case was linked to MOD22-005471 (Patient Link).
Patient complained of hot flash and feeling "heat across chest." Pt refused ambulance treatment or transport to hospital ER. Patient would go to ER on their own.
Vaccine exp. use by date 10/7/22 8 weeks and defrost exp. date: 10/31/2024
Atrial Fibrilation (rapid heart beat)- she has not seen a physician yet.  She stated that she is taking medication that she has for this condition (did not state what it was) and she was waiting to see if it subsides on its own.
4 days p/vax exp grand mal sz; treated w/Tegretol & event resolved; further details have been requested;
A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Bases on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding products from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
Soreness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and had soreness at the injection site.  The reporter consented to follow up. For tolerance of 2nd dose refer case US2020141489.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020141485:same reporter US-GLAXOSMITHKLINE-US2020141489:same patient
On the 25th around 4:00 experienced extreme sweating and dizziness.  Thought maybe I had a heart attack so went to er. Was dx with benign paroxysmal and treated with zofran, antivert, Valium and sodium chloride. Was released with a prescription for meclizine.  Refer to an ENT.  Also received booster for COVID on Sept 7, and again I experienced dizziness on the 9th and it continued  on and off to the 17th. It was not as severe and self medicated with meclizine.
persistent atrial fibrillation over a period of about 2 weeks, eventually requiring cardioversion.
Loud ringing in my ears.  This happened after the 2nd dose and now the booster of the vaccine I was given but I was told there is no proof it is connected by my doctor.  Yesterday, 1/4 22, I was given the booster and it started again.
Tenderness, swelling the evening of immunization at site of injection on right leg. Progressive swelling and redness over following two days. Seen again on 8/25/04 and had 4.5x6cm area of warmth and erythema. Non tender. Given Duricef 250 mg bid for 5 days.
Mom called in stating that she had called local physician, explained area to L. leg (HIB) site and he stated it was a local reaction. She described site as a pimple type raised area or bug bite, red no other s/s.
The patient received his booster of the pfizer covid vaccine on 1/6. Beginning the next morning he noted swelling of his arms. He presented to the emergency room on 1/13, and there was concern for compartment syndrome of his arms initially. He underwent a multidisciplinary evaluation and was ultimately found to have bleeding from a new  factor VIII deficiency. He required ICU care and emergent transfusion of factor VIII concentrate, as well as pulse dose steroids and cyclophosphamide,. He also developed mediastinal hemorrhage at one point. He had a prolonged hospital course with multiple issues. The hematology consult team investigated for other etiologies and found none so suspected the vaccine to have been the cause.
Three days the vaccine I got very short of breath with confusion, dizziness and light headed and disoriented.  I felt like there was pressure in my chest and I had some brain fog. I felt like I had water in my lungs. My right arm bicep was contracting and twitching. I had Vertigo which made it very hard to sit down without feeling off balance. I was unable to drive. I tried to hope it would pass but I went to the ER on 4/14/2021. The dizziness was getting worse after five days and the pressure on my chest was unbearable. I was advised to drink some water and take Tylenol.  My blood pressure was lower than normal. I finally felt better on 4/21/2021. I could finally get out of bed and not feel like I was going to fall down. I could not drive for about two and a half weeks. I still feel a little out of breath and my brain is a little foggy but it has gotten a little better.
Within approximately two minutes of receiving IM flu vaccine employee experienced intense abdominal pain, bright red flushing of face, neck and arms. Additionally she felt a sensation of choking / throat swelling. Was unable to walk due to intense dizziness and feeling faint.
Narrative: Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 85 but no other contributors to death can be determined. No clinical notes/history available on patient in system listing comorbidities or pertinent medical history. Patient did not appear to receive medical care through facility system, so no apparent comorbidities are on record.
One day post vax, pt complained of redness, swelling, and itching at injection site.  Approximately 5 days later pt complained of shortness of breath, malaise, dizziness, nausea and muscle weakness.
1st dose of Shingrix in 2017,  second dose on May 17th 2022.; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date in 2017).   On 17th May 2022, the patient received the 2nd dose of Shingrix. On 17th May 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 13-MAY-2022 Reporter's Comment: Registered pharmacist reported that a patient was administered second dose on 17th May 2022. Health care professional (HCP) wanted to knewwhat would be the best way to handle this situation Demographics from patient were asked but not provided by HCP neither lot number or expiration date The reporter accidentally forgot to ask for follow up Additional Supportive Information: The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule
Possible fever, chills, sweats, weakness, very bad headache, Brain fog, drained/extreme tired.
Pt got pneumonia shot yesterday and today she is unable to use her left arm. She called the orthopedic doctor. Was told she take 2 CELEBREX tablets and use ice. And the feeling should return to arm in about one week. Apparently she got the shot too high up on her arm which caused this reaction. Pt wants to know if you would have any other instructions for her.
Received immunizations on Thursday, 6/3/04at 5pm. Early morning on 6/6/04 at 12:30 PM noticed redness and swelling (hives) covering left thigh. Worsening for 1-2 hours, given Benadryl at 2:30 am, continued to have reaction with continued treatment with Benadryl until 6/9/04. Still red: no more hives.
Per medical assistant: Pt came in for college vaccines. I administered two vaccines Varicella and MC4 at 11:15AM. Pt was very anxious at first I suggested her to relax and had her relax her arm as I administered the first vaccine which was MCV4; I asked if she was ok her response was "Yes". After I said "Okay this is the last one" then I administered Varicella, after I was done she stated "Oh I felt that one". She then began to have trouble breathing. I immediately called Dr. and she came in, and so did the charge nurse, and MA. I began to get vitals as MA held her legs elevated upward. First set of vitals were BP: 136/76 HR: 41 min after went up to 50 T: 98.9 P: 97 min after went up to 100. We also administered 2 liters of 02 (Nasal). We stayed in the exam room with the pt. until she was able to respond to us, and until she was okay. Before she left clinic we asked if she was okay to walk pt. stated yes, pt. stated she does not feel dizzy or nauseous. Last vital sets were T: 98.1 P: 65 R: 16 BP: 114 74 O2: 99 at 11:45am.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot # K011311, expiration date 14-FEB-2016, dose and route were unknown). No adverse effects reported. This is one of the two reports received from the same source. Additional information has been requested.
Patient complained of not being able to breathe ten minutes after getting the shot. Stated " I felt anxious before the shot. Her vital signs were checked  at1:30 pm, blood pressure 149/93, heart rate 79, respiration 18, pulse ox 99% on room air. She denied dizziness, tachycardia or tightness in the chest.  Cold compress was applied to the back of her neck , and she drank water offered to her. BP at 2pm  152/ 107, HR 70. No ditress noted, patient refusedcto have 911 called for more evaluation due to high blood pressure.
Tactile temp for the 1st 12 hours after injection; none since. Marked erythema and induration on entire left anterior thigh with more mottled areas with erythema just superior to knee. Pt complained of itching, not pain.
Father purposely entered the patient's DOB incorrectly so his daughter could receive the Pfizer vaccine even though she's only 11 years old.  Our pharmacy discovered it when we located active insurance coverage before the 2nd shot was received.   We did not administer the 2nd shot due to not meeting the required protocol.
Sharp pain in left shoulder down tricep to but not including elbow joint. Lasted two months after vaccine though greatly improved by the time this was reported two months after vaccine. xray ordered. Diagnosis pending: rule out calcif tendonitis left shoulder.
felt like she blacked out for a fewseconds; felt dizzy; Blood pressure high; Heart racing; Low sugar; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (felt like she blacked out for a fewseconds) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pre-eclampsia.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (felt like she blacked out for a fewseconds) (seriousness criterion medically significant), DIZZINESS (felt dizzy), HYPERTENSION (Blood pressure high), PALPITATIONS (Heart racing) and BLOOD GLUCOSE DECREASED (Low sugar). At the time of the report, LOSS OF CONSCIOUSNESS (felt like she blacked out for a fewseconds), DIZZINESS (felt dizzy), HYPERTENSION (Blood pressure high), PALPITATIONS (Heart racing) and BLOOD GLUCOSE DECREASED (Low sugar) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Treatment of these events were not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Redness, swelling, soreness, no itching, no pus, a little hard on surface, no tenderness.
Body aches; fatigue; headache; sore arm; treating with acetaminophen OTC.
On 12/8/14 Patient contacted the office to complain that her left deltoid is very sore and red and warm to the touch. On 12/11/14 Patient called again to inform the office that her left arm is swollen and still red.