chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Inappropriate schedule of vaccine administered; itch; blisters; redness; pain; rash generally came up on leg and face / Skin behind rear covered in rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itch), BLISTER (blisters), ERYTHEMA (redness), PAIN (pain) and RASH (rash generally came up on leg and face / Skin behind rear covered in rash) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MIRTAZAPINE, CITALOPRAM, OMEPRAZOLE and SIMVASTATIN for an unknown indication.   On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced PRURITUS (itch), BLISTER (blisters), ERYTHEMA (redness), PAIN (pain) and RASH (rash generally came up on leg and face / Skin behind rear covered in rash). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, PRURITUS (itch), BLISTER (blisters), ERYTHEMA (redness), PAIN (pain) and RASH (rash generally came up on leg and face / Skin behind rear covered in rash) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.            No treatment information was provided
Swelling at left shoulder and possible cellulitis. Keflex x 3 plus cortisone. Received treatment at clinic.
Pfizer-BioNTech Covid-19 Vaccine Swelling of face, lips and throat / Numbness
4 days post vax exp urticaria, arthralgias, myalgias & peripheral edema; also exp SOB, fever, pleural effusion, hypoxemia, & renal insufficienty; hypoxemia, pleural effusions, lung infiltrates; hypersensitivity reaction, pt still febrile;
Information has been received from a licensed practical nurse concerning a female in her 40's who on 11/20/06 was vaccinated with Pneumococcal 23v Polysaccharide vaccine (Lot 654977/0888F). On 11/21/06, the day after the pt had received the pneumococcal 23 polysaccharide vaccination she developed a swollen arm, pain and inability to lift her arm. The pt swollen arm, pain and inability to lift her arm continued for 3 days. Benadryl and warm and cold compresses were the prescribed treatment. Subsequently, the pt recovered from swollen arm, pain and inability to lift her arm (date unk). The pt sought unspecified medical attention. The physician is requesting a lot check. This report is one of two pts. A lot check of concern has been requested. Subsequently, swollen arm, pain and inability to lift her arm after vaccination were considered to be disabling. Additional information has been requested.
presented to the ED for SOB x4 days, nausea and vomiting. Admit for severe sepsis, acute hypoxic respiratory failure and COVID pneumonia. Tx: steroids, zinc, vitamin c, remdesivir, actemra, O2. Respiratory status worsened, and family requested to hold BiPAP/comfort care only.  Expired
This case was reported by a consumer via call center representative and described the occurrence of leg pain in a 4-year-old male patient who received KINRIX (batch number MH9T7, expiry date unknown). Previously administered products included DTAP vaccine with an associated reaction of adverse reaction (received in 2013 at an age of 6 months, refer case US2016GSK143537). On 21st September 2016, the patient received KINRIX. On 22nd September 2016, 1 days after receiving KINRIX, the patient experienced leg pain and walking difficulty. On an unknown date, the outcome of the leg pain and walking difficulty were unknown. It was unknown if the reporter considered the leg pain and walking difficulty to be related to KINRIX. Additional details were provided as follows: This case was reported by the patient's mother. The patient's mother was trying to get him caught up on vaccines for school. A day before reporting, they went to the doctor and the patient was vaccinated with KINRIX in his left thigh. The patient had left leg pain and difficulty in walking because of the leg pain. The mother provided MH9TZ as the lot number, but it was not found in JDE. The specific number of batch was confirmed a couple of times with the reporter to make the right letters and numbers were heard, but reporter said that was the information which was written in the chart she was provided. The lot number was updated to MH9T7 as per sales database. A product representative would contact the patient because the patient wanted to know additional dosing and schedule information and what they need to do to get him caught up on vaccines.
About an after the injection I notice pain in my left shoulder, location of the injection. I thought this was normal being that this was my booster shot, 3rd injection, and I had the same pain during my first covid19 vaccine injection. As the day went on the pain got worst, I became very tired, was unable to eat solid food without feeling like I was going to vomit. Later that night I notice pain in my left arm pit, that' s when I notice a small baseball size lump on my left arm pit. I put castor oil on the area, the next day I did not any change. So I started to used antibiotic ointment, and the pain stopped and the lump is starting go down. As of today March 24 I feel much better, I regained my appetite and do not feel tired. I have not gone to the hospital as of now, because it's the fear of going in and not coming out alive. Some notes on my experience with this vaccine: After the first injection I had pain in my left shoulder that last for six days. The second injection I had pain in the same shoulder that lasted for a few hours. This third injection was a nightmare and I don't plan to getting more after this. No!
dx infantile spasms-p/vax; had been sz free for 1 month; ped DT given 5APR93 per orders from MD devel spasms next AM;
Lump in left armpit; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 17-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 27Dec2021 at 01:45 (Lot number: 33025BD) at the age of 17 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19? Yes. Patient did not receive any concomitant medications. The following information was reported: AXILLARY MASS (non-serious) with onset 28Dec2021 at 09:00, outcome "recovered", described as "Lump in left armpit". Therapeutic measures were not taken as a result of axillary mass.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
On Friday, November 23, 2012 I received two vaccines.  The two vaccines were for Shingles and Pneumococcal disease. A few hours after I had the two vaccines I got sick.  Because of the timing, this illness was a possible side effect to the vaccines, although I can't rule out getting some unrelated disease by coincidence.  I am usually healthy and didn't have any cold or flu symptoms before I received the vaccines. Here is an approximate timeline: I received the two shots at about 11:00 AM on Friday, November 23, 2012.  I felt fine the rest of the day but may have begun to experience minor symptoms by evening.  I went to bed early. When I got up on Saturday, November 24, 2012 I didn't feel good.  However, I wasn't so sick that I couldn't follow a fairly normal schedule for awhile.  By mid-morning I was having fever and chills.  This intensified for the rest of the morning and was most severe between noon and 6:00 PM when I went to bed.  Specifically, I alternated between feeling very cold and very hot.  When I felt cold I put on two sets of long underwear, two sweaters and a stocking cap, got under a big blanket and still felt cold.  When I felt hot I took everything off and still felt hot. Although I sometimes felt cold, I think I had a fever the entire time.  I took my temperature one time in the afternoon and it was a little over 101.  That doesn't sound high but it was actually about five or six degrees of fever because my normal temperature reading with the thermometer I used is about 96.  This morning it was 95.8. The fever and the chills were the most severe symptom but I also was achy, and sometimes dizzy.  One time when I was standing up I had to quickly sit down because I felt like I was about to faint.  I also had a minor headache at times but I think that was associated with the fever. The fever broke in the middle of the night, perhaps 36 hours after the vaccinations. I am writing this on Sunday morning, November 25, 2012, about 48 hours after the vaccinations.  The fever is gone and I feel much better, but I still have a slight feeling of queasiness.
One of three healthy, young, adult pt who developed vasovagal syncopal episode within 5 minutes of immunization.  Recovered uneventfully.
7 hrs following injection I started having a sore throat,  7.5 hrs temp of 99.9,  8 hrs injection site swelling and pain,  headaches, muscle/joint pain,  12 hrs post injection temp off 100.9
Cellulitis of thigh at vaccine site: pain, swelling, redness extending from upper thigh towards knee.
This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients. In 2014 an unspecified number of patients received improperly stored VAQTA (lot #, expiration date and dose unspecified). No symptoms reported. This is one of several reports received from same source. Additional information has been requested.
Warm to the touch, red, inflammation, to RD onset 2 days after KINRIX given.
On June 23, my arm was swollen; very red and i could see tiny raised bumps around the injection site and i felt dizzy now and again. When i woke on july 1st i noticed a rash with raised very itchy bumps on my chest, neck and face including my eyelid, and they were extremely itchy. The next few days i continued finding more red itchy bumps  my shoulds all around my neck my left arm mostly my wrist, my stomach on the left side and my left thigh. This is a servere very inflamed rash. I am still dizzy and the rashes are huge. Ans my left side stomach just started hurting today
Received the vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Received the vaccine while pregnant) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011j20a and 031l20a) for COVID-19 vaccination.     The patient's past medical history included Spotting vaginal (Spotting in early weeks). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 08-Dec-2020 and the estimated date of delivery was 14-Sep-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Received the vaccine while pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Received the vaccine while pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Ultrasound scan: normal (normal) Normal.         No treatment information was provided.
All of a sudden my arm and hands went numb. Traveled up my face.  Could not gain control of myself.
body aches, inc temp 103.0, nausea & tightness in chest;felt dreadful for approx 24hr;body aches cont for 48hr;have had rxn to flu shot in the past but, not as severe & not every year;
headache  ? Sore Throat ? Fatigue ? Shortness of Breath  ? Cough  RN      8/24/21 8:42 AM Note    Wife reporting that patient tested + for covid; having hard time with o2_ 88-89%.   Patient is having DOE while walking. Pt reporting that his P/O was low this morning when he woke up despite being on cpap at night. (88%)   Pt with + wheezing that can be heard across the room while on the phone. Denies any chest pain.    + mild sob while up and moving and is winded very quickly while ambulating.    Advised ER, verbalized understanding and will take over for treatment. Verbalized understanding to call back if condition worsens.    Reason for Disposition ? Wheezing can be heard across the room  Answer Assessment - Initial Assessment Questions 1. RESPIRATORY STATUS: "Describe your breathing?" (e.g., wheezing, shortness of breath, unable to speak, severe coughing)      Wheezing, sob, doe, sever coughing 2. ONSET: "When did this breathing problem begin?"      2 days ago 3. PATTERN "Does the difficult breathing come and go, or has it been constant since it started?"      constant 4. SEVERITY: "How bad is your breathing?" (e.g., mild, moderate, severe)    - MILD: No SOB at rest, mild SOB with walking, speaks normally in sentences, can lay down, no retractions, pulse < 100.    - MODERATE: SOB at rest, SOB with minimal exertion and prefers to sit, cannot lie down flat, speaks in phrases, mild retractions, audible wheezing, pulse 100-120.    - SEVERE: Very SOB at rest, speaks in single words, struggling to breathe, sitting hunched forward, retractions, pulse > 120      modertae 5. RECURRENT SYMPTOM: "Have you had difficulty breathing before?" If so, ask: "When was the last time?" and "What happened that time?"      "not like this" 6. CARDIAC HISTORY: "Do you have any history of heart disease?" (e.g., heart attack, angina, bypass surgery, angioplasty)      Open heart 7. LUNG HISTORY: "Do you have any history of lung disease?"  (e.g., pulmonary embolus, asthma, emphysema)     copd 8. CAUSE: "What do you think is causing the breathing problem?"      covid 9. OTHER SYMPTOMS: "Do you have any other symptoms? (e.g., dizziness, runny nose, cough, chest pain, fever)     cough  Protocols used: BREATHING DIFFICULTY     ED Discharged   8/24/2021 (6 hours) Hospital ER  MD  Last attending ? Treatment team Pneumonia due to COVID-19 virus  Clinical impression Shortness of Breath   Chief complaint
Information has been received froma health care professional concerning a 3 year old male patient who on 01-NOV-1996 was vaccinated with on dose of VARIVAX. On 21-JAN-1999 the patient developed 10 to 15 lesions, with no fever. The patient sought unspecified medical attention. The reporting physician felt that the rash was not related to therapy with VARIVAX. No further information is availble.
This case was reported by a nurse via sales rep and described the occurrence of generalized rash in a 16-year-old female patient who received BEXSERO for prophylaxis. On an unknown date, the patient received the 2nd dose of BEXSERO. On an unknown date, 1 day after receiving BEXSERO, the patient experienced generalized rash, injection site swelling, injection site erythema and pain in arm. The patient was treated with dexamethasone, BENADRYL and SOLU-MEDROL. On an unknown date, the outcome of the generalized rash, injection site swelling, injection site erythema and pain in arm were unknown. It was unknown if the reporter considered the generalized rash, injection site swelling, injection site erythema and pain in arm to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. Approximately 24 hours after vaccination, the patient experienced rash in all body, swelling, redness, erythema and puffiness in vaccine administration site. The patient went to the emergency room and they administered BENADRYL and SOLU-MEDROL. The day before reporting, the patient went to physician office and was administered Dexamethasone. The reporter consented to follow up.
I woke up Friday kind of very something similar to sciatic nerve, like pinch nerve in my back; I started to get numbness in my whole right side, my face, my arm and my leg; My arm was a little bit sore; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiry date was not reported), via an unspecified route of administration, administered in Arm Right on 11Feb2021 in afternoon as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 12Feb2021, the patient woke up kind of very something similar to sciatic nerve, like pinch nerve in back in which the patient felt it might be just normal, it happens, it is nothing abnormal. On an unknown date in unspecified date on Feb2021, the patient arm was a little bit sore which the patient know is regular and normal, the patient arm was fine and everything but around noon, the patient started to get numbness in whole right side, face, arm and leg. So, the patient was just wondering is that something to do with the vaccine or not. The patient was informed about Pfizer Medical information department. The outcome of event I woke up Friday kind of very something similar to sciatic nerve, like pinch nerve in my back was resolved on 15feb2021 and other events were unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Patient got a flu shot at 12:33 PM said he started throwing up at 5 PM (12/19/11) and continued throwing up at about 15 minute intervals till 7 AM 12-20-11 and also had chills and body aches. He said after he threw up everything he had dry heaves.
Information unavailable.  Medical records have not been received from facility.  Patient tested positive for Covid-19 on 09/01/2021, and passed away on  10/01/2021 with Covid-19 listed as a cause of death on death certificate.
Joint pain involving all joints, burning sensation in my feet and toes, dry eyes causing pain and blurred vision, large oozing sores on the face that dry to red, flaky areas over 24-48 hours, fatigue, decreased exercise tolerance, left ear pain, fingernails ripping. Had seen my primary care Dr. 12-23-21 and started Medrol Pak. Saw rheumatologist Dr.  2/24/22 and 4/8/22. Planning to see eye doctor, Dr. in May and Dr. again in June. Given a diagnosis of Rheumatoid arthritis with lupus-like characteristics and possibility of Sjogren's as well. Have been treated with a course of Prednisone for 7 wks without relief, given a shot of kenalog 60mg 4/8/22, now on hydroxychloroquine for 3 wks. Skin symptoms have mostly resolved since early March. Joint pain is still present but reduced after Kenalog injection. Dry eye symptoms are unchanged. Many of these symptoms had been present in milder forms prior to receiving the vaccine. I just happened to get a big flare up since.
Pt had swelling at injection sight & developed a fever evening of injection, got to 101'F, had chills and wrapped in a blanket all next day, fever came back 2nd night. Pt did not seek medical treatment or report taking any medications.
Information has been received from a pharmacist from a pharmacist concerning a patient of unknown age and gender. Information regarding the concurrent conditions and medical history was not reported. On 15-MAR-2015 the patient was inadvertently vaccinated with an expired dose of M-M-R II (lot # H015833, expiration date 24-AUG-2014; route and dose not reported). No adverse effect was reported. Additional information has been requested.
pt recvd flu vax 1130AM 7OCT95-approx 130AM 8OCT95 pt exp shaking, chills, gen body aching lasting approx 1hr-by 8AM 8OCT, chills gone, aching subsiding, by 12noon, sxs gone-no residula effects
A non-serious, spontaneous report of administration of expired FLUMIST was received from a health professional concerning an adult male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 29-Nov-2010. On 01-Dec-2010, the patient received the expired FLUMIST vaccine. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
HA, eye puffiness and redness, generalized body aches, malaise. Treatment - Ibuprofen. Outcome- does not interfere with ADL's continue to work. No improvement in symptoms will continue to monitor.
hives treated with 1 dose of benadryl 5ml and symptom disappeared.
The day after getting the second shot my husband started complaining that he had chest pain and upper back pain. This lasted from the day after his second shot till October 9th, 2021 where my husband suffered a heart attack.
GUILLIAN BARRE SYNDROME, STARTED  WITH NUMBNESS, TINGLING AND BURNING IN LEGS MOVED TO ARMS WITHIN 24 HOURS. TREATED WITH 5 TREATMENTS OF IGG. I AM STILL IN A WHEELCHAIR, I AM TAKING PHYSICAL THERAPY Follow-up: I just got out of the hospital of relapse of GBS/AIDP. I went in on Sunday the 13th and I got out this afternoon after 5 IVIG treatments.  12/08/09 Neurology consult, service dates 10/19/09 to 11/6/09. Assessment: Guillain-Barre Syndrome. Patient presents in wheelchair, states "I have numbness and tingling, and now I can't walk." Patient previously developed fever, was achy and tired. Then paresthesias ankles and  toes. Legs felt cold. Symptoms progressed to thighs. Lips are numb. Unable to stand. Distally decreased sensation - light touch, pin prick, temp, vibration, from mid thighs bilaterally. Pain and reduced muscle strength lower extremities. Tandem walking and heel-to-shin impaired. IVIG administration with improvement.  11/8/09 ED records received, service date 11/8/09. Assessment: Dyspnea, acute, from anxiety. Chronic inflammatory demyelinating polyneuropathy, acute. Patient presents with shortness of breath. Lower extremity motor weakness and sensory deficits. Tachypnea, tachycardia.  12/28/09 DC summary, hospital records received. Service dates 12/13/09 to 12/17/09. Assessment: Weakness, etiology uncertain. History of lupus. History of hypertension. Asthma. Recurrent urinary tract infections. Patient presented with a diagnosis of Guillain-Barre syndrome made as an outpatient and managed by immune globulin.  Feeling weaker past 2-3 days. Reflexes intact. Weakness in upper extremities. Gait associated with significant weakness and abnormal posture. Quickly became ambulatory with walker.
Restricted bronchial inhalation on two occasions occurring on day one and day three following injection.  Skin lesions appearing to be a rash that occurred on day two then again on day six.
Child had a seizure - no fever - several hours after vaccines - seizure lasted about 1 min.  Drowsy afterwards in PM.
9/10/2021 - Client stated developing hives across chest and right arm as well as chest tightness / difficulty breathing on 8/10/2021 in the afternoon. Symptoms persisted for a couple days before resolving without intervention. Presented to clinic 9/10/2021 for second dose but had not spoken with PCP about reaction from first dose. Encouraged client to speak with PCP first and if PCP recommends to proceed with second dose will do so.
Information has been received from a registered nurse referring to a currently 48 year old male patient. On an unknown date, a few years ago the patient was inadvertently administered a dose of ZOSTAVAX instead of VARIVAX (wrong drug administered and inappropriate schedule of drug administration). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.