chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to a 10 months 17 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Feverish (tactile), rash 12cm x 8.5cm, pain, swelling, tenderness, redness, fatigue * to right arm, lightheaded.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 01-JUN-2014, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 05-MAR-2015, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as shingles. The patient has been prescribed valacyclovir for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome is unknown. Additional information has been requested.
Severe vertigo; This is a Spontaneous report from a contactable patient. A 30-years-old adult non-pregnant female patient received a dose of BNT162B2 via an unspecified route of administration for COVID-19 immunisation. Medical history included anxiety and ADHD (attention-deficit/hyperactivity disorder) and some nuts allergy. Concomitant medications included bupropion (WELLBUTRIN) and atomoxetine (STRATETTRA); both have been administered for unknown indication (within 2 weeks of vaccination). It was further reported that prior to vaccination, it was unknown if she was diagnosed with COVID-19 and since the vaccination, she has not been tested for COVID-19. Moreover, she did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Mar2021 at 07:00AM, she experienced severe vertigo while driving however no fever. No therapeutic measures were taken for this event. At the time of the report, the outcome of the event was recovering. Information about lot/batch number cannot be obtained. No further information is expected.
pt rcvd vax; 48 hrs after vax pt devel urticaria; was tx at urgent care ctr w/ diphenhydramine HCL (benadryl);
Large red area of inflammation appeared 12 days later at the injection site.  Area is an approximately 5 x 2 inch oval with the distal end of the oval ending at the injection site. The area is hot to the touch and the injection site is tender with minor itching.  Treating with tylenol for the inflammation. No other symptoms
About 12 hours after receiving the vaccine I experienced severe stomach cramps, followed by diarrhea, and vomiting. The episode lasted for about 4 hours. After it was over I felt very weak and stayed home but no further symptoms arose.
Injection site pain and muscle soreness over the following two days - symptomes decreased with exercise Red ring around injection site occurred a week after injection
Pt pale - dizzy - faint - at 5 mins after vaccine received - started to vomit several mins after that - severe vomiting and HA x 10 mins - decreased BP also - recovered after 30 mins after vaccine given - H/A and soreness persisted into next day. HA = headache.
Most of the vaccine leaked out onto my shirt; contact with skin; A spontaneous report was received from a healthcare professional concerning a 55-year-old female patient, who experienced most of the vaccine leaked out onto my shirt and contact to skin.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, the patient received her second of two planned doses of mRNA-1273 ( Lot/Batch number not provided).  On 03 Feb 2021, prior to the onset of the events, the patient received her second of two planned doses of mRNA-1273 (Lot number: 029L20A) intramuscularly for prophylaxis of Covid-19 infection.  The patient was administered the mRNA-1273 vaccine and stated that most of the vaccine leaked out onto her shirt, it was wet. The patient spoke with the pharmacist and a doctor at the vaccination site, asking if she is protected. Both told her she has some protection from what she received, but she is not so sure.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The events most of the vaccine leaked out onto my shirt and contact skin were considered resolved.; Reporter's Comments: This case concerns 55-year-old female patient who received her second of two planned doses of mRNA-1273 (Lot number: 029L20A) intramuscularly for prophylaxis of Covid-19 infection and experienced most of the vaccine leaked out onto my shirt and contact to skin. There were no reported adverse events after second dose of vaccine administration in this case of incorrect dose administered and exposure via skin contact.
Patient states about 15 minutes after receiving the vaccine she began to feel like her throat was closing, vison was blurry and felt like she might vomit. She reports "I brought myself out of it." Patient denies the need for any medical attention.
Patient recieved the vaccine  in the left arm and was asked to wait in the pharamcy waiting area for observation for 15 minutes (no previous hx of anaphylaxis). Upon returning to the main pharmacy floor a few minutes later one of the technicians alerted me to the patient had retrurned to the counter and was "feeling something". He was visibly struggling to maintain balance and I asked patient to take a seat to prevent any risk of falls and motioned to a chair. He took a seat on the floor  next to the pharmacy counter and I rushed over to him to tend to him. I asked him if was having any other symptoms and he noted he was feeling lightheaded and having chills all over his body. His body was cold and clammy to the touch and had a difficult time locatiing a pulse on the radial artery. While talking to him his responses were shorter and he seemed like was starting to almost lose conciousness. Management had already called 911 and we offered water to the patient while we waited. Prior to the paramedics arriving I was able to get a pulse using a cuff and it was around 53bpm, the patient also seemed hypotensive.
Information has been received from a physician concerning a 12 month old male who was vaccinated with a dose of varicella virus vaccine live.  Concomitant vaccines administered at the same well baby visit included measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live, and pneumococcal conj vaccine.  Within the last month, in February 2005, the patient developed a fever of 106 degrees and seizures.  The patient was in the hospital for 4 days.  The patient's fever lasted during the stay but the magnitude of fever during the stay was unknown.  The seizures were intermittent during the stay.  The patient's seizures were treated medically during the hospital stay.  It was reported that the patient was recovering.  No product quality complaint was involved.  Fever of 106 degrees and seizures were considered to be immediately life threatening, disabling, and other important medical events.  Additional information has been requested.
After shingles shot it damaged the nerve around my stomach and back. My doc. sent me to a pain specialist. I've had shots and medicine. I still have pain.
Approximately 10 minutes after receiving dose he experienced inflammation/pain in his left hip where he has baseline dysplasia. He complained of minor left ear swelling, not visibly different from right ear.  Gave 25 mg of Benedryl orally. Ten minutes later, he complained of throat chest tightness that improved after 5 minutes. Stated he was improved and his wife drove him home to rest and monitor. He has an Epi pen.
Redness, pair, pruritus at injection site. Left upper arm erythematous, scaling, skin intact. No drainage. Dispensed hydrocortisone 1% cream and TYLENOL for pain.
Pt recv vax on 1/19/99; on 1/27/99 pt exp fever (103F) x 2-3 days, papular squamous rash on arm, trunk, face & extremities
I started coughing about 5-10 mins after 2nd dose and couldn't swallow. I felt a scratchiness in back of my throat. I started coughing and felt throat closing up. I felt like I couldn't breathe. I went into a back holding area, and they called ambulance. EMT administered Benadryl and some type of steroid. They took me to the hospital, while I was waiting for doctor, I felt fine and felt like I could breathe but he gave me another dose of steroids and I took a pill (I think Claritin) and then I broke out in hives after the Claritin. It seemed like it was getting better, and they gave me one more dose of Steroids and Claritin. I was supposed to follow up with my doctor, but the ER doctor gave me a pack of steroids. That same night, my husband woke me up because I was struggling to breathe, I thought I was going to run out because I only had 1-2 days' worth. I called my PCP who told me to go to Urgent Care and they prescribed me Prednisone and each day took less. I was also told to take Zyrtec 3xs a day. I felt a little better but was still struggling to breath, so my regular doctor prescribed me Albuterol inhaler and also Alvesco, an Epi pen was given to me by the Emergency Doctor. I was also told to follow up with an allergist. Follow up: I followed up with the allergist doctor virtual visit, doctor thought I was having anxiety/slight reaction. She advised not to get the booster.
Around 2 inch large rash on left arm where shot was given. Itchy sensation, redness, pains on applying pressure on vaccine shot area.
patient was given an expired Tenivac vaccine, no AE; Initial information received on 30-Jan-2020 regarding an unsolicited valid non-serious case received from other healthcare professional (Medical assistant).  This case is linked to case 2020SA028678 (same reporter).  This case involves 42 year old male patient who received an expired dose of vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot U5856AA, Exp. Date 26-Jan-2020) via unknown route in unknown administration site on 30-Jan-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to expired vaccine used.  At the time of report, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Initially, a cough. Subsequently an itch moving all over my body. The cough went away overnight but the itch remains even now. No temperature or hives.
There was no adverse event related to the COVID vaccine injections. Patient was diagnosed with COVID and given bamlanivimab on 12/2/2020. Patient presented for her first COVID-19 vaccine (Pfizer, Lot EL1284) on 1/7/2021 and there were no screening questions in our EHR related related to antibody therapy infusions so patient received her first dose of Pfizer Patient presented for her second COVID-19 vaccine on 2/2/2021 and she was asked whether she had received antibody infusions in the last 90 days and she responded yes with the information above.   It was decided to go ahead and give the second Pfizer dose (Lot EL9261) on 2/2/2021.
Lightheaded, high pulse rate of 116 bpm, breathless, fatigue. I sat in the facility for 40 minutes after receiving the injection. Started an hour + after I departed the facility, (an hour and 40 minutes after injection). Laid down and sleep overnight. Pluse dropped to 88.  My average resting pulse rate is 68-72. Current resting pulse rate is 88-94. Still feel lightheaded. I feel like my heart is fatigued. My oxigenation is 95-96.   Meds Cont: Atorvastatin, Aspirin (81), CoQ10 (200mg), Albuterol, Flovent, Vit C, Vit B-12
pt recvd vax & 6OCT93 AM when got out of bed-dizzy, room spinning; this cont x 1 wk; occasional upset stomach; 12OCT93 inc dizzy, vomiting, dehydrated; 13OCT93 hospitalized; did not have any fever, nor muscle aches, bone aches; inner ear
Vomiting and diarrhea for 2 days. Chills, body aches, sore throat on left side only, ear ache left side only, low grade temps up to 99.9 F taken temporal, lasting 4 days.
cold; mucus or nasal discharge; mucus or nasal discharge; congestion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 23Feb2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold"; SECRETION DISCHARGE (non-serious), RHINORRHOEA (non-serious), outcome "unknown" and all described as "mucus or nasal discharge"; NASAL CONGESTION (non-serious), outcome "unknown", described as "congestion". Therapeutic measures were taken as a result of nasal congestion.  Additional information: Patient received second dose on 16Mar2021. He has cold and mucus discharge for which he took Nyquil for congestion on 15Mar2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt complain of lightheadness and palpitations. Reports that she takes metoprolol and a baby aspirin daily. VSS- 125/80 88 18 98% sat on RA. Reports feeling better after being observed. Pt left without incident.
On 11/22/99, the pt developed chicken pox. It was reported that the pt had approximately 200 pox.
Pt recvd vax on 23NOV90; immediately following vax devel 7 x 5 mm area of redness & induration; On 26NOV90 to MD ofc, exp fever, chills, h/a; On 28NOV90 5 x 4 area of redness & tenderness persisted; Given APAP; Pt recovered;
Patient received the vaccination and then got up from the chair to walk approximately 7 feet in front of him to sit in the waiting room area as recommended after vaccinations. Approximately 1-2 minutes after sitting back down in the waiting area, patient then fell from a sitting position onto the floor. Emergency personnel was immediately contacted. Patient was passed out for approximately one minute, but was able to respond verbally after being spoken to repeatedly and after rubbing of the back and tapping of the shoulder. Patient was then able to get up from a lying position after approximately 3 minutes of laying down. He sustained multiple abrasions to the forehead which we then iced while he sat down and attempted to clean. The patient was given some water and multiple ice packs. Emergency personnel was on scene approximately 10 minutes after and evaluated the patient, who they then cleared to return home.
Febrile seizure, status epilepticus X about 30 minutes. Seen in ER and received anticonvulsant medication. Negative infectious workup. Patient is a 12 1/2 month old child referred prior to evaluation of an atypical febrile seizure, approximately two weeks priori to evaluation. She had an MMR and Varivax vaccination approximately 10 days prior to the episode. She was irritable throwing herself backwards when mother laid her down, rhythmic jerking was noted of all extremities and then her eyes deviated upwards and she appeared unresponsive. She was taken to hospital where a CT and an LP were normal. It took her approximately one week to get back to normal. During that week, she had vomiting and diarrhea after a fever for two days. Her father had a cold at that time. She does attend a co-op but reportedly no other children were sick. An EEG was to be scheduled but this has not been done yet.
Booster caused my autoimmune flares up to start. I had had no issues for almost a year before getting this vaccine. Now I am covered in hives and the inflammation in my body wont settle down.
covid; covid; This is a spontaneous report from a contactable consumer or other non hcp via Pfizer sponsored program. A 95-years-old male patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, patient experienced covid and drug ineffective. Events covid and drug ineffective were considered as medically significant. The outcome of the event covid was reported as unknown.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.
Patient reports she received 2nd Moderna vaccine lot #013L20A on 01/25/21. On 01/26/21, Patient found a significant purple bruise about the size of a half dollar. On 1/27/2021, the skin adjacent to the bruise was  red, inflamed, painful and hot to the touch. Patient contacted PCP who recommended warm compress and monitor for 24 hrs. Patient reports "it's increasing in size and getting." Plan is to see health center. VAERS.
Brain fog, confusion, fever, sweats, rapid heart rate. These symptoms were continuous for 3 days.
Pt recvd 3 doses of Engerix-B & was found to have a neg titer;
A dark particle could be seen inside the solution/It did not mix; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 31Oct2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group.  A patient (no qualifiers provided) received pf-06928316 (ABRYSVO), as dose number unknown, single (Lot number: HF5016, Expiration Date: 28Feb2025) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIQUID PRODUCT PHYSICAL ISSUE (non-serious), outcome "unknown", described as "A dark particle could be seen inside the solution/It did not mix".  Additional information: the reporter said that when they tried to mix the product, it did not mix. Product Quality Group provided investigational results on 31Oct2023 for pf-06928316 (ABRYSVO): Summary of Investigation: The investigation could not indicate a probable root cause for the complaint to be related to the production process. All reviewed deviations indicated that the batches met the established requirements at time of release. However, without lot number and based on the limited available information it is not possible to perform a more profound investigation and/or root cause analysis. No related trend could be identified based on complaint history review. No impact assessment is required according to SOP-67372. No corrective or preventive actions were identified as all reviewed records met the established requirements at time of release. Conclusion: The complaint for "It did not mix." of "Abrysvo Injectable (Vaccine)" was investigated. The investigation included reviewing deviation investigation and an analysis of the complaint history for the product type. The final scope was determined to be the reported product and product type, as no lot was available. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation, stability and patient safety. PGS (Withheld) concludes that the reported defect is not representative of the Pfizer (Withheld) process quality and remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. Product Quality Group provided investigational results on 31Oct2023 for pf-06928316 (ABRYSVO): Based on the new information received on "A dark particle could be seen inside the solution", during a sample evaluation associated with site investigation record on 31Oct2023 has changed the reportability from non-reportable to 30-day reportable malfunction. The overall reportability on the case level has changed.
PATIENT REPORTS RASH BILATERAL ARMS AND LEGS THAT STARTED AT 0400 AFTER HER THRID DOSE.  RASH HAS SLIGHT REDNESS WITH SWELLING, BUT PATIENT DENIES ITCHING. SHE REPORTED SAME RASH AFTER HER FIRST AND SECOND DOSE. DENIES SHORTNESS OF BREATH OR CHEST PAIN. EDUCATATED PATIENT THAT RASH MAY OCCUR AFTER THE VACCINE. ADVISED PATIENT TO TAKE OTC BENADRYL FOR RASH AND ACETAMINOPHEN FOR PAIN. PATIENT DENIES EMERGENCY AND WILL CONTINUE TO MONITOR.
Moderna COVID-19 vaccine was accidentally administered to a 16 year old who stated he was 18 years old. Both the patient and mother indicated he was 18. The patient was being registered in system, as the vaccine was being given, which was not our standard process and the personnel involved have been reeducated.  The patient and his mother were counseled and made aware that Moderna is for ages 18 and older. No adverse symptoms were reported and the patient is doing well upon 5 day follow up phone call.