chrisvoncsefalvay/vaers-outcomes huggingface dataset:
inadvertent administration of a Bivalent orange cap vaccine to a vaccine-naive patient; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (orange cap; booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "inadvertent administration of a Bivalent orange cap vaccine to a vaccine-naive patient". The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Patient states she had nausea and vomiting shortly after getting the vaccine. She states this required a visit to the hospital. She states she felt sick for approximately 30 days after vaccination.
Injection site redness, and swollen, with an extension of around 2 inches. Hypersensitivity in the area, and mild pain. On the second day was still swollen.
Sunday night: It started with hives on my left shoulder that progressed to my whole torso, treated with calamine and Benadryl.  Monday after noon the hives came back under my armpits and down my arms, treated at work with Benadryl. Monday night the hives started again on my hips, lower back all the way to my knees, then they started on my upper chest to my ears and in my ears. Never reaching my face. Did not have any shortness of breath--the hives were extremely itchy and hot to the touch.
Projectile vomiting with diarrhea, temperature 105F, lethargy, uncontrolled crying.
4 x 6cm erythema in left arm with soft tissue swelling that is larger than area of erythema.  No induration.  Empiric cephalexion therapy initiated.
Patient was immunized with Yellow Fever vaccine and dose #2 of Twinrix (HepA/HepB) vaccine on 4/28/2009.  The patient reports that she developed a large whelp at the site of YF-VAX.  She reports a rash and that the area around the injection site became very hard. She reported that she used warm compresses at the site for 2 weeks, three times daily.  She also reports a "mild fever".  Today, 5/20/09 she reports to our clinic to notify us of the reaction. She appears to have a diffuse, patchy red rash on the dorsal portion of the arm from the elbow to just below the shoulder.  She states that the rash is larger than it was originally, but that overall she feels as though the reaction has subsided substantially from her original reaction.  Both vaccines were administerd in the right arm.  Given that this reaction occured a few weeks ago and that her only current physical symptoms are a mild rash and some occassional itching, we instructed the patient to take diphenhydramine 25 to 50 mg up to every 4 to 6 hours if needed for the itching.  She appeared in no apparent distress and palpation of the area revealed normal feeling tissue.
Two days after his covid vaccine injection, he began to feel soreness in his left calf. He thought he was just experiencing a side effect from the vaccine. The soreness got worse and worse until about 2 weeks later when he had significant swelling and pain and could not not walk on the leg. He went to the hospital ED on 3/18 for care. He was admitted to  Hospital on that date for tests and blood thinners. He was discharged on 3/20 but was instructed to return by his PCP for continuing treatment with blood thinners (Eloquis) until she could see him  on Monday - they agreed to keep him in the ED and he was discharged home on Monday to see his PCP.
the area where the rash was is itchy; congestion; breathing issues; could not stand; had to crawl on the floor to get to the bathroom.; had ringing in her left ear; Pin Point Rash on her neck and torso; headache; fever; dizzy; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), PYREXIA (fever), DIZZINESS (dizzy), RASH (Pin Point Rash on her neck and torso) and RASH PRURITIC (the area where the rash was is itchy) in a 62-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Asthma.    On 04-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 04-Dec-2022, the patient experienced HEADACHE (headache), PYREXIA (fever) and DIZZINESS (dizzy). On 05-Dec-2022, the patient experienced RASH (Pin Point Rash on her neck and torso). On an unknown date, the patient experienced RASH PRURITIC (the area where the rash was is itchy), NASAL CONGESTION (congestion), DYSPNOEA (breathing issues), DYSSTASIA (could not stand), GAIT DISTURBANCE (had to crawl on the floor to get to the bathroom.) and TINNITUS (had ringing in her left ear). At the time of the report, HEADACHE (headache), PYREXIA (fever), DIZZINESS (dizzy), RASH (Pin Point Rash on her neck and torso) and RASH PRURITIC (the area where the rash was is itchy) was resolving and NASAL CONGESTION (congestion), DYSPNOEA (breathing issues), DYSSTASIA (could not stand), GAIT DISTURBANCE (had to crawl on the floor to get to the bathroom.) and TINNITUS (had ringing in her left ear) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 degrees Farenheight.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19. It was reported that patient received Pfizer vaccine for primary series. No treatment medication was provided.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with GARDASIL (Lot # 0768Z/ 10/17/2012) on 05-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. On 05-DEC-2012 the patient experienced expired drug administered, 1 day after onset of therapy. No treatment information was reported. The outcome of expired drug administered is unknown. Expired drug administered is not related to GARDASIL. No adverse symptoms reported. No further information provided. Additional information is not expected.
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Additional Details: anxious before the shot. started sweating and felt dizzy  2-3 minutes after the shot. gave water to patient and asked them to take deep breaths. patient then started to become unresponsive,pale with no blood flow to face. no improvement was seen and then epinephrine shot (adult) was administered. patient started to regain consciousness and became slightly responsive after a couple minutes. had the patient sit down and put theit legs up on a chair. EMT arrived and out of caution took them to ER.
Right upper thigh cellulitis going into knee. Put in hospital and given IV antibiotics, released in 24 hours.  7/18/06 Medical records from hospital received which reveal patient w/cellulitis of right lower extremity which involved swelling & erythema and painful knee extension & flexion.  Hospitalized for antibiotics w/rapid resolution of all symptoms.  Discharged home on oral antibiotics for 10 days but on day 9 developed hives & antibiotics were d/c'd.  Blood c/s were neg.
Back pain, dizziness, tiredness, headache, all better after 24 hours.
1st dose: intense but bearable pain at the injection site  2nd dose: 2/3/2021 10:05am: similar pain at injection site, left neck stiffness and bearable palpitations (thought to be due to nervousness)immediately following shot, by 10:30pm fatigue and headache(took Tylenol) woke up at 2:00am next day with similar pain, re-dosed Tylenol at 5:50am on 2/4/2021. Slept entire day. Appetite normal. Next day 2/5/2021 12:30p left house to travel to market and couldn?t remember how to get there, had to slowly return home. Called family member to make them aware as I tried to safely return home. Couldn?t immediately recount events or where exactly I was or where I had been. Writing this is increasingly confusing and taking longer than usual.
It started just below my breast bone, it felt like a bubble and it was tingly.  Then it started to have tenderness in my ribs.  It is tender all the time.  My brain feels warm.  There has not been any trauma to my ribs or anything.  I feel like my ribs are inflamed.
The patient was inadvertently administered PROQUAD instead of VARIVAX; The patient was inadvertently administered PROQUAD instead of VARIVAX; No adverse reaction; This spontaneous report was received from a registered nurse referring to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On an unknown date, the patient was vaccinated for prophylaxis with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) subcutaneously (dosage regimen, anatomical location, lot number and expiration date were not reported). It was reported that the patient was inadvertently administered Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) instead of varicella virus vaccine live (Oka/Merck) (VARIVAX) (interchange of vaccine products and wrong drug administered). No adverse reactions reported.
Rash on the back, that slowly (over 2 days) got more red, and spread further down the back and onto the stomach.
It was reported that a pt with fibromyalgia post vaccine subsequently noticed that her fibromyalgia symptoms got worse. It was noted that the pt did not have a reaction after the 2nd vaccine.
Site of Tdap has knot, red, raised, warm approximately 5.5cmx5cm.  Site of flu vaccine is red, raised and warm with 4.5cmx6.5cm area.
From note by ED attending Dr.: The patient was seen and examined in the Hospital Emergency Department on 09/11/2012. I have discussed the management with him. I have also seen the patient personally and reviewed the ED record. This is an addendum to the record. HISTORY OF PRESENT ILLNESS:  This is a 64-year-old, who received Zostavax vaccine, she had then a sense that her tongue was swelling and felt dizzy and short of breath.  EMS was called, gave her 50 IM Benadryl and had difficulty establishing an IV and she was sent to the Emergency Department where she said she had no difficulty breathing, but did have some sense of tongue swelling. PAST MEDICAL HISTORY: As indicated. PHYSICAL EXAMINATION: The patient appeared anxious. Her tongue appeared mildly swollen, but her ABCs were intact. She is normocephalic and atraumatic. Chest is clear without wheezing. Heart is regular. Abdomen is soft and nontender. Extremities are nontender.  Neurologic: A&O x4. Cranial nerves, sensory, motor exam are normal. ASSESSMENT AND PLAN: This is a woman, who came in after an acute allergic reaction to zoster vaccine. We are notifying the pharmacy so any reporting can be addressed appropriately with regard to her care.  The patient received IV Solu-Medrol 125 emergently and also had epinephrine ready should she need IV therapy. As we treated her over the next half hour or so, the patient's tongue swelling improved and it was not necessary to give further IV epinephrine. Because of the critical nature of this patient's presentation, she required 40 minutes of my personal involvement in critical care by the bedside preparing medications and generally in her treatment. The patient is admitted to Observation having symptoms essentially resolved, but to watch her airway to be sure that this was safe and that she would not require admission and she is admitted to Observation Unit in stable condition. As an addendum: The patient was monitored in the ED observation unit after receiving 50mg IM Benadryl in the field and 125mg IV Solu-medrol in the ED as described above. Her tongue swelling improved, and she had no further shortness of breath or concerns for airway obstruction. She felt well. She was discharged home in good condition, with a course of PO prednisone 60mg x 3 days, with instructions to follow-up with her PCP.
A week post vaccination patient complain of itchiness on his chest. Patient said this itchiness would radiate up towards his neck. Would wake up in the middle of the night very itchy. Pt spoke with doctor in regards to receiving 2nd dose of moderna, after explaining his concerns patient opted to still received 2nd dose. Monitored and patient left with no complaints.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: patient started with tingling on right middle finger, then started to moved up to arms and jaw. Offered  benadryl. 10 mins later, symptoms escalated to lips and tip of tongue. Patient took an additional benadryl. PCP was contacted as well at this point. After 10 mins, tingling started in the throat. 911 was called.  Epipen was administered to her right tight. EMT arrived a few mins after the injection and patient was transported to hospital
Immediately after the vaccine was administered the client felt nauseated and started developing a dull headache and feeling lightheaded. The nurse gave her a drink of water, took mask off to get fresh air. Started feeling better, sat there for 30 mins with the nurse at the same table.  Got to her car, and ate a muffin and became very nauseated Left the vaccination site  and was 5 mins down the road when she felt so sick that she had her husband turn around and drive back to vaccination site. She was sucking on lifesaver candy and by the time she was almost back to the site, she was feeling better, she did not feel like she needed to go back in so they went home.
experience allergy symptoms; scratchy throat which is chronic; This is a spontaneous report from contactable pharmacist. A 32-year-old male patient received the second of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscular on 11Jan2021 at single dose in left deltoid for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of bnt162b2 for COVID-19 immunization. Facility type vaccine was Workplace clinic. It was unknown if other vaccine in four weeks. The patient was seen at SVH COVID Vaccine Clinic today for his second dose of the COVID 19 vaccination. He denied any history of previous adverse reactions to vaccines. He was given the Pfizer vaccination in the left deltoid muscle. On 11Jan2021, during his 30 minutes waiting period after the injection, the patient began to experience allergy symptoms scratchy throat which was chronic. He denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and he was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to scratchy throat. No treatment received for the adverse events. The outcome of the events was recovered in Jan2021.
43 yo female with a c/c of Anxiety with weakness status post vaccination.  pt had no signs of allergic reaction. Pt denied any sob or difficulty breathing noted. pt states good oral intake and food intake today.  pt wanted to be transported for anxiety.  pt was transported to PMC for further eval.
mom said pt had herpes zoster p/1st vax gave pt cream to apply to lesions;
Felt severe pressure on chest, abdomen, & legs; Felt severe pressure on chest, abdomen, & legs; Felt severe pressure on chest, abdomen, & legs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 84-year-old male patient received BNT162b2 (BNT162B2), on 27Oct2021 at 13:00 as dose 3 (booster), single (Lot number: 33026BD) at the age of 84 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "kidney disease" (unspecified if ongoing); "Multi cystic liver" (unspecified if ongoing). Concomitant medication(s) included: RAMIPRIL; ATENOLOL; ATORVASTATIN. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EN5318, Location of injection: Arm Left), administration date: 03Feb2021, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL8982, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 13Jan2021, for COVID-19 immunization. The following information was reported: CHEST DISCOMFORT (non-serious), ABDOMINAL DISCOMFORT (non-serious), LIMB DISCOMFORT (non-serious) all with onset 28Oct2021 at 04:00, outcome "recovered" and all described as "Felt severe pressure on chest, abdomen, & legs". Therapeutic measures were not taken as a result of chest discomfort, abdominal discomfort, limb discomfort.  Additional information: The patient had not diagnosed with covid prior vaccination. And post vaccination, patient had not tested with covid. No known allergies reported for the patient.   No follow-up attempts are possible. No further information is expected.
Dizziness, Myalgia, NauseaVomiting, "foggy", chills Narrative:
A 76 year old male pt was treated with OncoTICE for bladder cancer since 27Apr2004. Follow the third instillation (approx 11May04) the pt experienced an intermittent coughing including some sputum. Other than the coughing the pt tolerated the initial series of 6 instillations well. On 12Jul04 the pt was diagnosed with inflamed bladder tissue. After the first instillation of a new treatment cycle on 10Aug04 that evening the pt experienced chills and a raised temp of 39.3C. His urologist advised the pt to take Tylenol and if the fever continued the pt should go to the ER. At the ER the consumer was given Levaquin IV and was sent home with a prescription for Levaquin 500mg for 7 days. The pt's temp had slowly been decreasing to 37.1C on 16Aug04. On the evening of 17Aug04 the pt experienced chills and fever (38.5C). He also noted bright red blood in his urine. The pt felt it was necessary to go to the hospital though the physician did not recommend it. The pt was treated with IV Rocephin 1g and the same evening he was sent home. On 18Aug04 his temp upon waking was 38C, he did not have any chills and there were only some small clots of blood in his urine.
patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 9:36 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 9:36 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  On 31-Mar-2021, Excursion time was 8 AM, temp was 32, total doses given for the day was 199, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 31-Mar-2021. 4 vial was moved to clinic. Vaccine BUD date was 22-Apr-2021.  Vial was stored on cooler 1, on 31-Mar-2021, Excursion duration At 8 AM: 32, 9 AM: 32, 10 AM: 40, 11 AM:42, 12 AM: 43, 1PM : 44, 2 PM : 46, 3 PM: 46, 4 PM: 44 and 5 PM : 44  Vials only punctured right before administration.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.    Treatment medications were not reported.
As injection was happening, a nerve pain immediately went up from the injection site in my left upper arm across my trapezius and stopping at T1 vertebrae. I am still experiencing pain on the left side of my T1 just lateral to the spine and tension in the upper trap on the left.