chrisvoncsefalvay/vaers-outcomes huggingface dataset:
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.   This case was linked to MOD-2021-395985 (Patient Link).
patient called to inform us she has been going to orthopedic clinic for the last two weeks due to existing shoulder pain/problems but was worsened by the 3 vaccines she got 05/11 and the doctors at orthopedic clinic told her we gave a vaccine too high and it went into her rotator cuff and or bursa. She wanted us to review technique with the technician who gave it and wanted to make sure we had documentation of the event. I told her I would document the event and let the clinical pharmacy specialist know as well
Rapid heart rate beginning within a few hours of the vaccine. Rapid heart rate increasing over the new few days and subsiding within a week.
headaches, chills, fatigue, dizziness, fever of 101 at 1:30 am
37 y/o female with known hx of epilepsy c/o 2 episodes of witnessed grand mal seizure over a 2 minute period s/p receiving 1st dose of Moderna. Time of Moderna dose unknown. 1st witnessed seizure while sitting in chair in observation room @ 15:34, lasted approximately 30 seconds. Assisted patient to wheelchair and placed on cardiac monitor in med bay bed. Turned patient on side and @15:35 had second witnessed grand mal seizure. Lasted approximately 50 seconds, 911 called during this time and patient placed on oxygen. Pt post-ictal until 15:42, not alert or oriented to person place or time. Pt slowly became A & O x 4, states curently on Keppra and Diltiazem, no skipped doses. Informed pt 911 was called and on their way, pt stated that she did not want to go to ER. EMS arrived at this time @ 15:52 and took over evaluation of patient. Per EMS, long discussion with patient and is signing out  AMA. Pt informed EMS she will go by private transport, husband will drive her to nearest ER. Upon dc, pt alert and oriented x 4. EMS transported patient to outside of the center to join husband.    Vital Signs:  Time: 15:34 BP: 124/56 P: 98 O2 Sats: 100% on 3L  Time: 15:52pm BP: 127/62 P: 98 O2 Sats: 100% on no oxygen  Labs/tests done: none  Medications given: none    Outcome of the adverse event (if paramedic please list hospital taken to): EMS arrived on scene at 15:52 and took over care of patient. Informed pt EMS their rec is to transport to ER for further evaluation however pt refusing. Pts husband contacted and states will drive patient to nearest ER at the hospital.
nausea; diarrhea; fatigue; loss of taste and smell; loss of taste and smell; stomach upset; tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 31Dec2020 at single dose at left arm for covid-19 prophylaxis. There were no medical history and concomitant medications. Patient said that she got the first dose on 31Dec2020. She stated that she got Covid 2 weeks later. She said that she positive test on 12Jan2021. She stated that she was still having mild symptoms of Covid. She said that because of that, she was not cleared to go back to work yet. She stated that she was not having fever or shortness of breath. Patient clarified that her covid-19 symptoms were stomach upset, nausea, diarrhea, loss of taste and smell, and fatigue. She was supposed to get the second dose on 19Jan2021. Outcome of all events was recovering.   Information about Batch/Lot number has been requested.
Pain in left arm where shot administered; Pain due to pinched nerve; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8733) via an unspecified route of administration in the left arm on 12Apr2021 at 10:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 on an unknown date and the patient had no other relevant medical history. The patient was allergic to strawberries. The patient did not receive any other medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En204) via an unspecified route of administration in the left arm on 18Mar2021 at 09:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021, the patient experienced pain in left arm where shot was administered and the was pain due to pinched nerve. Therapeutic measures were taken as a result of events and included treatment with steroid pack. The clinical outcome of the events pain in left arm due to pinched nerve was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Redness/swelling/irritation/pain/itching. Used ice pack for 10-15 min. After 45 min was almost back to normal. Pt felt fine.
pt recv vax 31MAR95 & the same day exp chest discomfort,h/a,cough,neck pain & stiffness;pt noted did not have h/a prior to vax;ECG was ok & allergy screen revealed pt was allergic to tree pollen & other things;pt very fatigued;
Information has been received for diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid and was assigned manufacturer report number A0534190A. This was originally reported by a registered nurse concerning a 4 year old male patient with no known allergies, who on 2/10/04 at 14:00 was vaccinated SC with a second dose of MMR (lot # 644763/1231M). Concomitant vaccine therapy included a fifth dose in the left arm of diphtheria (+) pertussis acellular 3-component vaccine (+) tetanus toxoid and a dose of poliovirus vaccine inactivated. There were no illnesses at the time of vaccination. In February 2004, the patient experienced hives at the injection site of diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid. The patient complained of hives on and off to the present day. The hives were described as a darker rash at times and clearly hives at others. It was reported that the patient had 3 doctors appointments to the allergist and to infectious disease. It was reported that laboratory tests were performed at another office and noted a very slight hematuria. The hives resolved after several months. It was reported that the patient recovered from all his adverse events. It was also reported that the patient had no adverse events following receipt of previous administration of diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid.
Herpes Zoster; post herpetic neuralgia; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 72 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2017, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient experienced herpes zoster and post herpetic neuralgia. On an unspecified date, the patient was treated by a physician and nurse for herpes zoster and post herpetic neuralgia. The outcome of the events was not reported. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).  Additional information has been requested.
RECEIVED EXPIRED VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported and batch number: 204A21A expiry: 21-SEP-2021) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-SEP-2021, the patient experienced received expired vaccine. On 23-SEP-2021, the patient experienced off label use. The action taken with covid-19 vaccine was not applicable. The outcome of the received expired vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210946670.
20 minutes after receiving covid vaccine, I started to feel nauseated, lightheaded, dizzy and developed headache.  I finishing my shift (7pm) went straight home and I started to feel muscle ache/sensitive to touch. I took my night time medication along with my migraine medication along with 3 Advils. On Saturday morning, woke up with 100.2 fever and Left face side Migraine. I took my migraine medication 2 hours apart along with 3 Advils. as my Neurologist had instructed for migraine. For the fever I started taking 2 Tylenol every 8 hours.  I stayed in bed for rest of the day.  Didn't have much of an apatite but had broth, still feeling like I wanted to throw up. On Sunday, I still had fever of 100.2.  Still feeling exhausted and ache, I continued with the Migraine medication along with 3 Advils. Monday, early morning, my fever broke and went down to 98.6 but I still had a horrible migraine. Tuesday I had Headache and no migraine. Temp was 98.7
This spontaneous report as received from a certified medical assistant (C.M.A.) refers to an unspecified number of patients of unknown gender and age. It was reported that the office did not monitor the freezer temperature for the past two months (from August 2014), and it was not known if the freezer had been maintaining the correct temperature. The freezer stored VARIVAX (Merck) and unspecified number of patients were vaccinated (in approximately 2014) with VARIVAX (Merck) injection (dose, dose number, lot/batch number, expiration date and route of administration were not reported). No symptoms were reported. No product quality complaint (PQC) involved. Additional information has been requested.
sore arm 3 weeks after immunization; Initial information received on 09-Nov-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 71 years old female patient who experienced sore arm 3 weeks after immunization (pain in extremity), while she received vaccine Influenza Quadrival A-B High Dose HV Vaccine [Fluzone High-Dose Quadrivalent].  The patient's medical history, past medical treatment(s), vaccination(s), concurrent condition and family history were not provided.  Concomitant medication was unknown.  On 16-Oct-2020, the patient received a dose of suspect 0.7 mL influenza Quadrival A-B High Dose HV Vaccine (formulation: unknown) (batch number: UJ499AB and expiry date: 30-Jun-2021) via intramuscular route in the left arm for prophylactic vaccination.  On an unknown date of 2020, 3 weeks after the initiation of suspect drug, reporter stated that patient's arm was still sore. She stated that there was no swelling or redness. Pharmacist stated that she had never had someone complaint that their arm was still sore 3 weeks after immunization (pain in extremity).  No laboratory data was reported.  Action taken was not applicable.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.
Vax date 08/19/2021 On 8/25/2021, Pt. reported rash on trunk, predominately located around front and right side around rib cage, with general malaise and mild headache.   Medical exam same day determined rash and sx to be consistent with shingles / herpes zoster.  From date of vaccine on 8/19/2021 to 8/25/2021, participant had ongoing mild tenderness around injection site, with slight discoloration.
Redness, warmth, slightly raised skin at injection site, approximately one and a half inches in diameter.
patient received a Pfizer Covid vaccine on 3-3-2021.  Patient came back in on the wrong day and received a Moderna 2nd dose on 3-22-2021.  patient has no adverse reactions.  Data suggests patient has finished his Covid  vaccine series and needs no further vaccination.
Day after shot member experienced sore arm.  Following day member experienced pain in injection area followed by numbness radiating to little finger on left hand.  A few minutes later same pain radiated up into nexk area.  Within 20 minutes member experiend blurred vision.  11/07/2007 radiating pain to finger is gone.  Still a little blurred vision and stiffness in neck.
About 3-5 min after injection I felt tingling and warmth/flushing in my entire left arm and anterior chest, upper back and achy pain in my left upper trap- felt like a warm IV running through my arm. Associated with tongue tingling. Symptoms lasted about 10 minutes with the exception of the achy upper trap pain which lasted a couple hours - being a health care provider I associated these symptoms with anxiety/excitement about receiving the vaccine but subsequently developed other unexpected symptoms. Over the course of the next several hours noted metallic taste and transient extremity tingling (all extremities) also with some extremity and facial itching - no rash. Now >24 hours after still have the intermittent and transient extremity tingling (most notable in LE's and feet, but also in arms) and skin itchiness/prickly sensation though improved. Had one episode this afternoon (~28 hours after vaccine) of lightheaded, nausea, chills and profound sensation of extremities being "heavy" - felt like pre-syncope - which resolved in about 30 min with rest, hydration .
A few days after my #3 dose for Moderna, I began to feel sick and fatigued, where one of the nodes in my armpit swelled. After coming home from work, I came home took a nap and then went to the bathroom and all of a sudden a huge sense of dizziness came over me and I hit my doorway and fell on the floor and went unconscious.  I was unable to walk for a bit and crawled to my bed. I have continued to have multiple dizziness spells that are progressively getting worse that are lasting about 15-20 minutes each and have gotten worse in intensity and more frequent. My doctor is referring me to a cardiologist to make sure everything is okay. Planning to use a long-term monitor for heart during dizziness spells. At the moment my doctor does not want to give me anything as of yet since they are unsure of what is going on. I am still fatigued as well. It is now at the point where I cannot go through an entire day without taking a nap.
Patient had vaccine on 3/18/21 at 1600. She presented to the ED on 3/21/21 @ 2202 for chest pain that started at ~1600. She states the chest pain is in the center of her chest, feels like pressure, non-radiating, with occasional shortness of breath. It felt similar to when she had COVID in January. She denies other symptoms including fever, URI symptoms, palpitations, pain with deep inspiration, leg swelling, recent travel, nausea/vomiting, diarrhea, dizziness, feeling like she was going to pass out, rash or other symptoms. It is not exertional and was better with walking. Denies heavy lifting or injury. She was hypertensive in the ED BP 151/99 but all other vitals within normal limits. EKG shows NSR without evidence of arrhythmia or ischemic changes. She did have U waves seen so labs were drawn including CBC, CMP, cardiac enzymes. Chest x-ray showed no acute cardiopulmonary process. She received 30 mg Toradol IV for pain. Labs were all within normal limits except mild hypokalemia. She felt better on reassessment and BP was still elevated but improved 137/90. She was discharged and instructed to take OTC Tylenol as on the bottle as needed for pain and given return precautions and follow up with PCP on return to stateside.
I recently got the pfizer booster shot and was completely incapacitated for 24 hours. I had to leave work early. I had the same experience after receiving the second dose but the booster was worse. I couldn't walk without holding something so I didn't fall because my legs were in so much pain and they felt heavy. Like weights were on them. My entire body was in pain, I had chills and the worst part was the migraine. There was a sharp pain shooting up my legs. I contemplated going to the ER a few times but I couldn't muster the strength to do so. The migraine lasted all day and made it difficult to see, open my eyes and move. My head started burning from pain. I didn't take any pain killers because I wanted my body to fight it on it's own. Around 2am the next morning I could move better but still had the migraine. I've also been having two periods a month with heavy bleeding since taking the second dose. I don't need an appointment but I was told to inform you of the reaction. Thank you!
ear ringing, headache, panic, sobbing, weakness, shaking, chills, muscle spasms, nausea
PATIENT REPORTED TO HAVE GOT GUILLAIN-BARRE SYNDROME POST VACCINATION.
w/in 48hr p/vax pt devel severe knee arthralgias, severe & persistent fatigue & w/in wk lichen planus shortly p/that tested positive for hep C;
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On an unknown date, unspecified number of patients were administered doses of GARDASIL injection (dose, route and lot number were not reported) that were improperly stored. Concomitant medications were not specified. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 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: "previous lung cancer" (unspecified if ongoing); "known allergies: penicillin" (unspecified if ongoing); "known allergies: sulpha" (unspecified if ongoing). The patient took other concomitant medications in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures Paxlovid from 24Jan2023 to 28Jan2023 were taken as a result of drug ineffective, covid-19. 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.
Myalgia, Arthralgia, Fever, fatigue Narrative: Mild flu-like symptoms causing employee to miss a day of work
Within 5 minutes of receiving vaccine: Heart palpitations and feelings of very fast heartbeat, very high blood pressure (over 200/100), heat flash in chest, dizziness.
Vertigo would happen when I moved my head, for example if I lifted my head to look up at a shelf, or if lying down it would happen if I picked up my head off the pillow.  Even moving my eyes up to look at someone would cause a feeling of vertigo.  But, it did not happen after repeatedly lifting heavy objects (I work as a stock person). And did not occur when standing up, only when I would move my eyes or lifted my head.
Initially just started feeling tired. That night, started going back and forth between feeling very hot to feeling cold. Body aches, followed by a headache that got worse when coughing. Still had cough, but not frequent. Exhaustion continued. Next day, took over the counter cold/flu medication and slept for about 12 hours that night. Body aches subsided but headache and tiredness have continued. Today, (second day after dose) cough has stayed minimal but lungs feel congested.
I waited in the holding area (mass vax clinic) for 20 min.  No symptoms. The lights were very bad and bright flourescent so admittedly I was bothered by them or it could have been the beginning of the whooseyness  from the shot. My husband picked me up in the car out front, we were driving and I began to get pressure in my sinuses and mostly the sides of my nose. I did have some head congestion but this feeling had never happened (it should be noted I had negative covid tests to make sure stuffy head was nog covid related). Then I felt pressure in my ears and my face began to feel flush as my cheeks. All of this began at about 35 minutes after the injection. Then my lips began to feel strange. It was a cross between tingly and numb. I made as many faces in the car makeup mirror to make sure my face muscles were moving properly And they were. But there was definitely numbness occurring in my mouth. Tingly-numbness. This all happened within about 10 min of the first onset. Then I noticed some splotchiness on my lower arms. Mostly my left (shot was given in right- no redness at the injection site). I also got some splochiness on my chest and neck. Cheeks were also ruddy and flush. I did NOT have any problem breathing or swallowing at anytime. Nor did my pulse race (other than from a pit of panic from nerves over the reaction). I didnt have a thermometer but don?t think I had a fever either. We pulled over and I called a nurse on call. She told me if things worsened to go to hospital. I did have a little bit of the feeling you get when you are about to pass out and you feel like things are closing in a bit. But it never got past about a 2 on a scale of 1-10.  I decided I wanted something to eat (I HAD eatten before) and I went to get a sandwich. I still was a bit light headed but the symptoms did start to subside in about an hour. After that I was only tired and took a nap. Nothing else after those initial reactions.