chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; 6 month old patient was inadvertently administered Pneumovax23; This spontaneous report was received from a nurse referring to a 6-month-old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy details were not reported.  On 14-JAN-2020, the patient was inadvertently vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength was not reported) lot # S029265, expiry date: 31-MAR-2021) as prophylaxis (product administered to patient of inappropriate age). No adverse event was reported. No product quality complaint was reported.
48 hours after shot  of uncontrollable shaking, rapid heartbeat, blurred vision, rash on chest, a brief second of vision loss.
Child received a bivalent COVID immunization at vaccine clinic. The dose received was not correct and may not adequately protect against COVID.   No adverse effects reported at this time.
I woke up that morning and my arm hurt really bad and I had a big red and purple rash that was hard and felt hot to the touch
Arm started hurting; Arm started burning instantly; Arm sore; Trouble raising it up; Pain in neck; Pain in shoulder; This is a spontaneous report from a contactable consumer (patient). A 65-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6199), via an unspecified route of administration, administered in left arm on 04Mar2021 14:45 (at the age of 65-years-old) as single dose for COVID-19 immunization. The patient's medical history included diabetic, thyroid, high cholesterol, high blood pressure. The patient previously took demerol and experienced known allergies. The patient's concomitant medication included metoprolol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Mar2021 after the vaccination, the patient experienced arm started hurting/burning instantly. radiated to entire arm. arm sore, pain in neck and pain in shoulder. It was reported arm started hurting/burning instantly. Radiated to entire arm. arm sore. Trouble raising it up. Later pain in neck and shoulder. Been almost 18hours since injection. Still in pain. The patient underwent lab tests and procedures which included on an unspecified date blood cholesterol: high and blood pressure measurement: high. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any treatment for the adverse event. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Hives, itching and red spots that look like Shingles.  I had the Shingles shot, Zoster yesterday. Just wanted to report this reaction to the vaccine.
Spotted rash across torso, front and back that lasted 4 days. The patient complained of itchiness.
I felt like I had a bad head cold. I never really felt sick at all. I just had nasal congestion and sneezing a little bit. I didn't have any fever or body aches. Someone in my family that I was around had tested positive for covid. I went to get tested for covid on 10/7/2021. The results were positive. The next day on 10/8/2021 I got the infusion treatment to help with covid.
pt recv vax 23APR96 & 24MAY96 a titer showed no antibodies;
Pfizer-BioNTech COVID-19 Vaccine EUA The area received vaccination was sore, about two hours later became drowsy, had to leave work and go home,  woke up around 5 p.m. body ached on left and right side, took Aleve for pain..  Overnight had chills, headache, next morning, took Aleve for pain. Whole body ached for about a week, headaches, lethargic, tiredness. About week and half later only ache in right arm, sore like I sprained it, still tender today.
This spontaneous report was received from a pharmacist via a company representative referring to a 68 year old female patient. The patient's concurrent conditions and medical history were not provided. On 25-MAR-2016, the patient was vaccinated with a dose of ZOSTAVAX (strength, route, anatomical location, lot number and expiration date were not provided). Other suspect therapies included REFLAFEN. On 26-MAR-2016, the patient experienced rash on her face. It was reported that the patient's rash did not appear to be a shingles related rash but just a "regular rash" on her face. There was no intervention to prevent serious criteria, the case did not involve cancer or overdose. There was no product quality complaint involved. The outcome of the adverse event was not reported. Additional information has been requested.
Site: Pain at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: Patient called pharmacy 2 days after immunization. Reported body rash seen after showering, redness and bumps, but no pain or itching. Had pain at injection site.
Mother states after vaccines given seemed fine except for c/o soreness and nothing noticed when going to bed that night.   Woke up on 06/03/2020 with redness and swelling which progressed to about 2/3 of upper arm.   Seen in office 06/04/4020 and described by physician "5-6 cm round erythema with mild induration with internal band of clearing and central pinpoint erythema"   The surrounding redness was greater area (not measured) .   Mother has pictures available   Spoke with mother on phone on 06/09/2020 and much improved.   Redness has mostly resolved as of today and left with "hard knot"   I realize with 4th and 5th doses of DTaP you can rarely have exaggerated responses involving entire extremity - this may be the case.   I explained this to mother.   Physician assessed as possible reaction to vaccine or local reaction.   No systemic effects noted.
PATIENT COMPLAINING OF TINITUS/HEARING LOSS STATUS POST VACCINE ADMINISTRATION.  HAS PROGRESSIVELY GOTTEN WORSE AFTER INITIAL COMPLAINT.  FOLLOWED UP WITH AUDIOLOGIST SHOWING DIAGNOSED HEARING LOSS FROM PREVIOUS VISIT.
Expected symptoms of fatigue, muscle aches and low fever appeared around 14 hours after and lasted approximately 24 hours. Additional symptoms occurred about 44 hours post vaccine including a raised, hot, red mark at the site of the injection. Intense itching, heat, and redness then started on and around both ears and spread to the back of my head and hairline. Additional hives/rash occurred all around my body and increased in intensity of itching and heat throughout the day. A visit was completed on 2/8 due to the symptoms.
a few months after my first two vaccinations i noticed very slight weakness in lower left lip but thought it was just aging . I took my third booster vaccination august 30 2021 and two weeks later started noticing signs of bells palsy of my left side. I now have typical Bells Palsy  with typical facial dropping and muscle weakness and now also experiencing blurred vision .
03-26-2021 patient developed LLE pain, progressively worsened. Admitted to hospital on 03/29 and discharged 04/01. Pt diagnosed with superficial femoral artery occlusion and popliteal artery thrombosis. Left femoral artery stent placed 03/31/2021.
Pt complained of redness, pain, and swelling in right upper arm. 01/29/2018 10:10 AM Pt walkin. C/O redness, pain and swelling developed right upper arm where she received vaccination. Sought treatment at clinic but told to F/U PCP because she received the vaccination here. Pt ended up going to urgent care and will placed on cephalexin with some improvement. Pt denies any swelling of mucous membrane, shortness of breath, nausea, vomiting, fever. Associated symptoms itching.
died; bled out; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had bled out on an unspecified date with outcome of unknown. The patient died on an unspecified date. It was unknown if an autopsy was performed.  Information on the lot/batch number has been requested.; Sender's Comments: The limited information provided precludes a full clinical assessment of the case. As a cautionary measure and for reporting purposes, and assuming a drug-event temporal association, the Company cannot completely exclude a causal association between the reported events 'bled out' and 'died' (death of unknown cause) and BNT162B2 administration, until sufficient information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021210582 Same reporter/drug, different patient; Reported Cause(s) of Death: died
Pt had DTaP, IPV, MMR adm on 09/13/2002, DTaP adm. in right deltoid immunization. Redness approx 3 1/8, Swelling approx 2.
Severe itching, hives, pressure on my chest, red circle around injection site and raised bump
all symptoms started the morning after on 10/31/21 - fever 103, chills, severe hip pain ,  severe upper back pain, lower back pain that radiated into right knee,  pain in both knees, pain in both hands especially knuckles/ fingers,  pain at injection sight, very fatigued, no appetite. severe headache.  Took ibuprofen for symptoms which slightly helped for just a couple of hours then fever was back and all other symptoms increased.  There was little improvement with anything I did. This went on for just over 24 hours.  The Fatigue continued for the rest of the week.  I was more sick from the mandated shot then when I actually had covid.
since morning today all my fingertips felt numb and frozen. not able to button my shirt. went back to normal after 6 hours. very scary no treatment done-just warmed up with mittens and gloves, but why did this happen. what should i do if it happens again?
hives on buttocks & lower back per phone times 24hr;pt advised to use DPH;
Information has been received from a licensed visiting nurse concerning a 64 year old female with high blood pressure and hypertension. On 22-JAN-2007, the patient was vaccinated intramuscularly in the left deltoid with 0.5 mL of Pneumovax 23. On 25-JAN-2007, the patient developed an injection site reaction. It was reported that the patient developed irregular patches of redness 19 by 15 cm. On 25-JAN-2007, the patient was given ROCEPHIN. The patient sought unspecified medical attention. At the time of this report, the outcome of the events were unknown. Additional information has been requested.  07/30/2008 This is in follow-up to report(s) previously submitted on 7/30/2007. Initial and follow up information has been received from a licensed visiting nurse, concerning a 64 year old female, with no known drug allergies, high blood pressure and hypertension. On 22-JAN-2007, at 5:03pm, the patient was vaccinated intramuscularly in the left deltoid with 0.5 mL dose of PNEUMOVAX (Lot #655589/1137F). There was no illness at the time of vaccination. On 23-JAN-2007 (previously reported as 25-JAN-2007), the patient developed an injection site reaction. It was originally reported that the patient developed irregular patches of redness 19 by 15 cm, but follow up information clarified the patient developed swelling, redness, warmth and pain over an area of 38cm, up and down the lateral upper arm, and past the distal arm to the elbow and into the forearm. On 25-Jan-2007, the patient was given ROCEPHIN. On 02-FEB-2007, the patient had recovered from the events. No further information is expected.
Staff member was doing well after administration of the vaccine and was sitting at the administration site for monitoring. After almost 25 minutes later, the individual's hands started to shake. She was alert and oriented x4 and could answer questions correctly and appropriately. She was immediately assessed and no loss of consciousness. She denies any pain or discomfort but said she is not sure why her hands were shaking. Rapid response was called and 911 also called and staff, Oxygen via nasal cannula applied. 911 crew arrived and staff transferred to Hospital for further evaulation.
Patient developed rash on skin (not chicken pox) 2 weeks after varicella vaccine dose #1.
Patient tested positive for COVID-19 on home rapid test on 25Jan2022; Patient tested positive for COVID-19 on home rapid test on 25Jan2022; Reports headache and congestion that she states is mild; Reports headache and congestion that she states is mild; This is a spontaneous report received from non-contactable reporters (Consumer or other non HCP) from a sales representative.  A 32-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) at 31-years-old as dose 1, single, administration date Mar2021 (Batch/Lot number: unknown) at 31-years-old as dose 2, single and administration date Oct2021 (Batch/Lot number: unknown) at 32-years-old as dose 3 (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) with onset 25Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 25Jan2022, outcome "recovering" and all described as "Patient tested positive for COVID-19 on home rapid test on 25Jan2022"; HEADACHE (medically significant), NASAL CONGESTION (medically significant) all with onset 25Jan2022, outcome "recovering" and all described as "Reports headache and congestion that she states is mild". The patient underwent the following laboratory tests and procedures: COVID test: (25Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, COVID-19, headache, nasal congestion.  Clinical course: It was unknown if the patient received any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient tested positive for COVID-19 on a home rapid test on 25Jan2022, following a primary series in Mar2021 and booster in Oct2021. The patient reported a headache and congestion that she stated was mild.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt reports being hot, shaky, and weak since shot, symptoms started on 7/1/21
The vsafe program I participate in called and encouraged me to submit a report. Approximately 30 minutes after receiving my Pfizer shot (technically its my second shot - I am a J&J mix and match), my lips went numb and my entire face started tingling. My husband drove me back to the pharmacy. I met with the pharmacist and he instructed me to take two benadryl which I did promptly. I felt better later. The symptoms went away.
Erythema Lt. upper arm arising 10/26/12 - No signs abscess. Vaccine related.
This spontaneous report was received from a pharmacist and refers to a 20 year old patient of unknown gender. On 03-JUN-2015, the patient was vaccinated with improperly stored PNEUMOVAX 23 (route of administration, dose, lot number: K012424, expiry date: 05-JUN-2016). The vaccine was exposed to -10.4 C for 2 hours on 26-MAY-2015. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Shortness of breath, mild upper back pain, ache behind both knees, bloating and increased bowel movements, mild headache
1 day after receiving MENACTRA pt developed (L) facial Bell's Palsy.
A nurse reported pt had facial swelling post injection, itchy eyes and sore neck and shoulders. She was treated with Prednisone. Follow-up info received on 04/17/2001 indicated that the pt also developed redness and swelling at the injection site. She recovered.
lesions on arms, undiagnosed muscle weakness throughout body, poss autoimmune disease;poss fibromyalgia,chronic fatigue synd;+ANA;poss lupus,sarcoidosis;major stomach problems;reflux;muscle in esophagus weak;vomit;
4 days after receiving Rotateq patient developed projectile vomiting with each feeding. The patient was seen 7 days after recieving Rotateq and was well hydrated but had a 1 pound weight loss. He was evaluated for pyloric stenosis and obstruction. An Ultrasound and obstruction series was negative. His feeds were limited to 1 ounce per hr for 12 hours and then advanced slowly over 72 hours. Today, 11 days post vaccination he is taking his usual amount of feedings with no problems. He gained back 3 ounces and his exam is normal.
The 5-11 year dose that was drawn up for the sibling was administered in error to patient, who should have received the 12+ dose.
About 12 hours after the shot, I became very fatigued. About three hours later, I had some discomfort in my decending colon. The fatigue lasted for about 24 hours. At one point I had very mild flu like symptoms of ache in my muscles but this only lasted for several hours. About 36 hours after the shot, I am 100% normal energy level with no other symptoms.
Developed delayed skin reaction week after injection slightly distal to site of injection redness, swelling, warmth > 10 cm worsened for a few days before improving
Patient developed rectal bleeding. Pt was thrombocytopenic at a platelet count of 1. He was given steroids and transfused platelets and PRBCs in the hospital with improvement in his platelets.
Information has been received from a nurse concerning a 9 year old male with no medical history who on 08-MAY-2007, was vaccinated with a 0.5ml dose in the thigh of varicella virus vaccine live (Oka/Merck) (Lot #"0326U"). Concomitant vaccine administered on the same day in the same thigh included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 09-MAY-2007, the patient experienced a golf ball sized knot on his thigh at the injection site with a 3 inch radius of redness that ached was painful. No additional information was provided at the time of this report. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypertension-Severe, Additional Details: Patient received vaccine, came back after 10 minutes and said he didnt feel good. Sitting BP was 232/112. 6 minutes later it was 245/119. Patient stayed seated, 5 minutes later BP was 247-132 HR 84. Called 911 and EMS responded and brought patient out on stretcher. He remainder conscious the entire time.
Grandmother reported SX. after flu vaccine given on 11/18/16. On 11/20 pm - to urgent care facility. Denies pt. being allergic to eggs prior and had vaccine x 3 yr. before. SX reported were "whelps" "rash" to affected arm w/redness to injection site/rash to arms/thighs/ankles and hands. Had cortisone IM at facility plus RX x 5 more days orally given.
8 year old male (large for stated age) presented for Pfizer Booster vaccine; he received Pfizer Booster vaccine for 12+ instead of age appropriate Pfizer Booster vaccine for 5-11 yr. old today. Mother reports no adverse reaction to previous primary and secondary vaccines received in December 2021.
Hospitalized 01/18/2022; COVID-19 positive 01/18/2022; fully vaccinated  DATE OF ADMISSION:  01/18/2022 DATE OF DISCHARGE:  01/21/2022  Attending physician, covering for Dr.  HOSPITAL COURSE The patient is a very pleasant 49-year-old male with past medical history as listed above including non-small cell lung cancer, actively on chemotherapy and immunotherapy with Dr., who presented to ED with symptoms of intermittent fevers, cough, headache, diarrhea, and generalized weakness.  Initial laboratory studies and imaging can be found per Epic review.  Of note, COVID positive in the ED on January 18.  He was negative for influenza.  The patient is vaccinated, but has not had his booster.  Chest x-ray showed new patchy nodular airspace disease in the left lower lobe consistent with new organizing pneumonia.  Stable right upper lobe consolidation.  Legionella strep pneumo and MRSA were negative.  He was started on Zosyn empirically in the ED.  He was transferred for further evaluation.  He was started on remdesivir x3 doses.  Monoclonal antibodies have no affect against Omicron variant and he would not qualify.  Discussed this with Infectious Disease.  The patient had complaints of significant diarrhea.  C diff and stool for enteric pathogens were obtained and both were negative.  There was concern for immune mediated colitis.  He was started on high-dose Solu-Medrol with plan to transition to oral prednisone probably or with likely prolonged taper.  He had no fevers during the hospital stay.  UA showed leukocytes, blood, and few bacteria.  Urine culture showed resident flora.  Blood cultures have remained negative to date.  Zosyn was discontinued at discharge.  There was no need for Zarxio as the patient has already reached his nadir.  He had mild AKI on presentation and was treated with IV fluid hydration.  This has normalized.  Overall, he did well during the course of the hospital stay.  He remained hospitalized to receive 3 doses of remdesivir.  He was felt medically stable for discharge on 01/21/2022.  Planned desat walk prior to discharge to ensure he does not require any home oxygen with ambulation.  He is encouraged to call our office if he has any respiratory decline or present to the emergency department if needed. DISCHARGE INSTRUCTIONS The patient has followup with Dr. on January 31 at 11:40 a.m.  Chemotherapy on hold until followup with Dr.
second dose given outside vaccine window; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given outside vaccine window) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 025J202A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given outside vaccine window). On 22-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given outside vaccine window) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not reported.
After about 24 hours, developed hard, hot knot at injection site, about golf ball size. Fully resolved in 6 days. No therapy needed. Developed itchy skin on abdomen and back starting at about day 3. If scratched for relief, welts up quickly. 3 lesions present, now for 3 weeks. Rx with hydrocortisone 1% cream which provided symptomatic relief.
METAL STICKING TO INJECTION SITE; This spontaneous report received from a consumer concerned a 43 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced metal sticking to injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of metal sticking to injection site was not reported. This report was non-serious. This case, from the same reporter is linked to 20210830364 and 20210830487.