chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer and described the occurrence of extensive swelling of vaccinated limb in a 3-year-old male patient who received Influenza vaccine. Previously administered products included MMR, varicella vaccine and dtpa vaccine. Concurrent medical conditions included DiGeorge's syndrome. In 2013, the patient received the 1st dose of Influenza vaccine. In 2013, 1 day after receiving Influenza vaccine, the patient experienced extensive swelling of vaccination limb, arm red and arm hot. On an unknown date, the outcome of the extensive swelling of vaccination limb, arm red and arm hot were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, arm red and arm hot to be related to Influenza vaccine. Additional information received: Mother reports pediatric son experienced what she described as local injection site reaction after receiving a flu vaccine last year. His whole arm became red and hot and swollen the day after receiving a flu vaccine. The issues resolved after a few days. He experienced the same thing during a previous MMR and varicella vaccination. After MMR vaccine and varicella vaccine, the patient also experienced red, hot and swollen arm. No reaction noted after the dtpa vaccine.
Pt experienced an extremely sore throat and headache. Pt also developed itching with hives on legs, top of both feet, a few on the neck, right elbow and right shoulder.
Patient received Moderna vaccine as second dose. Patient received first dose Pfizer and was supposed to receive second dose Pfizer. Patient is also not in the approved age group for Moderna.
pt recv vax 12JUL96 & pt became extremely hyperactive, moving from one activity to another nonstop;appeared to be on a high or in over drive;activity level slowed later in the day;16JUL96 7PM gen sz;no illness/no fever;
REDNESS AND SWELLING AROUND THE SITE, LITTLE BIT OF WARMTH, RECOMMENDED PATIENT USE BENADRYL, NO PAIN OR ITCHING.
Severe vomiting and headache for 12+ hours.  Finally relieved with IV fluids, IV Zofran, IV Toradol, IV Rocephin
Fever for 3 days, Shortness of breath and Weakness  increasingly, Dizziness, became very pale, and so on... Visited PCP on March 24, 2021 . Blood work showed 4.8 Hemoglobin. Was hospitalized on March 25, 2021. Diagnosis - Autoimmune Hemolytic Anemia due to IgG.
Headache, Myalgia, Chills/rigors, fevers (subjective), myalgia, headache for 8-10 hours, then less severe feeling feverish, chills, myalgias for 48 hours total
Pt developed an approx 10 x 10 cm area of erythema surrounding the injection sites with a single wheal on it. No apparent dyspnea, no tachypnea. No facial swelling & no wheezing. Chest sounded CTAB. Left thigh only.
I had the same sore arm, head ache, body aches, fatigue after the second dose as I did after the first dose.  However on day 5 I developed the worst fever blister on my lower lip.  On day 13 I experienced an anaphylactic episode. I noticed my hands started itching about 30 mintues after eating breakfast (coffee, oatmeal, blueberries, almonds).  I took my dog for a walk and started to feel nausaus and extremely tired.  I went to bed. Hives started.   Had abdominal cramps,  loose stool.  Took benadryl 25 mg. then another 25 mg.  Initially felt better after taking the benadryl.  About 30 minutes later, more nausea and cramps.  I went to the bathroom and while sitting on the toilet I could tell I was going to pass out.  I lay down on the floor and was competely weak.  I was aware that my bowels were moving, but I could do nothing about it.  I was able to call for my husband (approximately 20 minutes later).  He called an ambulance.  Blood work from ER was normal except for WBC 15.4,  Neutrophils 88.9%, Lymphocytes 6.6%, Eosinophils 0.1%,  ANC 13.8,  absolute granulocytes 13.7, glucose 152, and MPV 9.2,  I saw an allergist because they thought I had developed a food allergy but that was ruled out.  I have an epi pen now.
Patient with a PMH of chronic bronchitis, morbid obesity, epilepsy, and T2DM.  Patient presented to Hospital on 01/26/2022 with c/o a cold and cough, chest tightness, post-tussive emesis, and HA.  In the ED patient tested positive for Covid-19.  Patient was triaged and discharged home.  Patient was sent home with albuterol inhaler.  Patient expired at home on 01/30/2022.
pt recv vax 26FEB98 & 26FEB98 less than 1hr post vax pt hands flushed bright red & felt cold & sweaty;pt became pale & lightheaded;BP was elevated 145/95 for approx 50min & then it started to come down;pt did not feel right;
Information has been received from a physician concerning a 67 year old female who was vaccinated with ZOSTER vaccine live (Oka/Merck), lot # not reported.  The physician stated that the patient experienced an injection site reaction within a few hours of receiving the vaccine.  The patient's injection site reaction included tenderness for about 5 days.  Also was reported that the patient experienced flu-like symptoms for about five days after receiving the vaccine.  The physician reported that the patient "is fine now".  The patient sought unspecified medical attention.  Additional information has been requested.
The day of the vaccine, in the evening, I got severe stomach cramps and then I got diarrhea really bad. The cramps went on all night into the next day. They were so painful - like labor pain. The next day, I had a GI hemorrhage - it was clots of blood coming out of the digestive system. I contacted my regular practitioner doctor and sent him a picture of the clots and he instructed me to go to ER. I ended up going to Urgent Care. I went to the Urgent Care on Saturday or Sunday. The Urgent Care doctor there thought I had food poisoning. But that day I didn't eat anything - I just had had ginger ale, cranberries and cashews. He was puzzled as to why I had these symptoms. He gave me medication to stop the cramping in my stomach.  Medication is: Hyoscyamine. I used it even two weeks after the fact because I would occasionally get real bad stomach cramps. I was also referred to get a colonoscopy - haven't been able to get in yet. The GI hemorrhaging lasted two or three days and then disappeared.
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a patient concerned multiple patients. 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: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 04-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-NOV-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20211121905.
flu like symptoms for 24 hours; This is a spontaneous report from a non-contactable consumer. This consumer reported two reports for herself. This is the second of two reports. An adult female patient received the second dose bnt162b2 (Pfizer, Batch/Lot number was unknown) administered on 02Apr2021 as single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. The patient received the first dose bnt162b2 (Pfizer, Batch/Lot number was unknown) administered in arm on 11Mar2021 as single dose for COVID-19 immunisation and experienced "covid arm" huge red itchy at injection in 2021 with outcome recovered in 2021 and treatment was unknown. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine or any other medications; and unknown if was diagnosed with COVID-19 prior to vaccination or has been tested for COVID-19 since the vaccination. The patient experienced flu like symptoms for 24 hours on 02Apr2021 and recovered on 03Apr2021. The treatment was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Myalgias/arthralgias - resolved. Migraine headache - unresolved at this time. On 60-day follow up report received 04/24/2003, reporter states, "Was improving but after returning to strenous heavy labor job, migraines have returned and is needing to be off work frequently. Needs to change jobs in order to remain employed. May need to be medically separated from service." Annual follow up on 03/05/04: "It is unknown if pt recovered.  Still had 2-3 migraines a month and takes amerge for headache abortment.  Member seen this as an improvement. Continues on Pamelor 150mg every day for headache prevention. Remains in with the same job. Follow-up: Persistent migraines headaches after AVA. Symptom: Headache, Migraine Comment: Severe, persistent, new-onset. Migraines have persisted and pt is now being separated from the Military due to non-deployability status.
upper arm is still slightly pink in color with some small bumps; upper arm is still slightly pink in color with some small bumps; Patient had a bad reaction after the 2nd dose; Patient had a pain after the 2nd dose; Swelling; Redness; Itch; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (Patient had a bad reaction after the 2nd dose), PAIN (Patient had a pain after the 2nd dose), SKIN DISCOLOURATION (upper arm is still slightly pink in color with some small bumps), SKIN MASS (upper arm is still slightly pink in color with some small bumps) and SWELLING (Swelling) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  Concomitant products included ATENOLOL for Blood pressure management, PRAVASTATIN for Cholesterol, TRAVOPROST (TRAVATANZ) for Glaucoma, LEVOTHYROXINE for Thyroid disorder.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 03-Mar-2021, the patient experienced SWELLING (Swelling). 03-Mar-2021, the patient experienced ERYTHEMA (Redness) and PRURITUS (Itch). On 26-Mar-2021, the patient experienced ADVERSE DRUG REACTION (Patient had a bad reaction after the 2nd dose). 26-Mar-2021, the patient experienced PAIN (Patient had a pain after the 2nd dose). On an unknown date, the patient experienced SKIN DISCOLOURATION (upper arm is still slightly pink in color with some small bumps) and SKIN MASS (upper arm is still slightly pink in color with some small bumps). On 09-Apr-2021, SWELLING (Swelling), ERYTHEMA (Redness) and PRURITUS (Itch) had resolved with sequelae. At the time of the report, ADVERSE DRUG REACTION (Patient had a bad reaction after the 2nd dose) and PAIN (Patient had a pain after the 2nd dose) had resolved and SKIN DISCOLOURATION (upper arm is still slightly pink in color with some small bumps) and SKIN MASS (upper arm is still slightly pink in color with some small bumps) had not resolved.            No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Patient DOB added, Updated suspect drug start date and Added batch/lot number , Added Concomitant medications and Added New events - Considered significant On 19-Jul-2021: significant follow up contains no new information.
This spontaneous report received from a patient, concerned a patient of unspecified age and gender. Medical history, weight, height, concomitant medications and concurrent conditions reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch/lot number: not reported) dose: not reported, on Mar 11, 2021, for immunization. Unable to perform follow-up to request batch/lot numbers. On an unspecified date, patient experienced itchiness. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The outcome: not reported.
Nausea, chills, fever, body aches, headache, pain at site and lymph nodes
Noticed raised welts on 3/24 or 3/25 on my left shoulder/upper chest, which spread to an area of 2 inches by 3 inches and by 3/25 or 3/26 turned into blisters. Also have 2 smaller areas of blisters, one on my upper left back and the other lower on my left chest area. Looks like I have shingles. Area is itchy/irritating and somewhat painful. Went back to pharmacist on 3/26, but there only advice was to visit my doctor if it continued to bother me. I have not  visited a doctor and rash is currently still bothering me. It looks blistered with puss.
Hand sized diffuse red rash around injection site, patient reported mild itching in addition to the redness. No other symptoms reported, patient declined further medical follow up.  She was instructed to take Diphenhydramine 25mg that evening to assist with redness and itch.
Patient called the pharmacy and said that her arm is swollen and think that her muscle was damaged. We called PCP to notify about patient complaints and was told that pt. already called. Patient mentioned on VM that she will be going to hosp.
Mother states pt has pain at injection site yesterday. Today 3/16/04 area is red & swollen & warm to touch since 10 AM. Treatment Benadryl Zyrtec.
This is a spontaneous report from a contactable nurse practitioner. This report was received via a Pfizer sales representative. A 65-year-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on 07Dec2016 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On 07Dec2016, the patient experienced 5cm reaction of redness and swelling at the injection site pretty quickly after receiving the vaccine. On 07Dec2016, the patient also experienced body aches. The clinical outcome of the events, redness at injection site, swelling of injection site, and body aches, was not recovered.
Itching; Flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching) and INFLUENZA LIKE ILLNESS (Flu-like symptoms) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis. No Medical History information was reported. In 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PRURITUS (Itching) and INFLUENZA LIKE ILLNESS (Flu-like symptoms). At the time of the report, PRURITUS (Itching) and INFLUENZA LIKE ILLNESS (Flu-like symptoms) outcome was unknown. No concomitant medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication was reported.
Approximately 15 minutes after receiving vaccine patient felt like thick saliva when swallowing.   Also reports lips feeling "big" (possibly numbness).  BP= 125/76    HR=77.  Patient reports that symptoms subsiding at 5:40pm, but lips still feel "a little fluffy".   Patient clinically stable.  Patient released from clinic at 5:43pm.
pt recv vax at 11am; mom called at 2:30pm stating pt has been screaming since vax; T 99.2 R;
Discharge Provider:  Primary Care Provider:  Admission Date: 7/26/2022 Discharge Date: Jul 28, 2022  PRESENTING PROBLEM: Acute respiratory failure with hypoxia [J96.01] Anemia, unspecified type [D64.9] COVID-19 virus infection [U07.1] Acute respiratory disease due to COVID-19 virus [U07.1, J06.9]   HOSPITAL COURSE: 80 year old male with possible exposure to Covid 19 three weeks ago. He felt like he had a URI at that time and it resolved. He said for the last week he felt more fatigued and a few days ago began to be more short of breath. He had a positive Covid home test and a positive test. He presents for worsening shortness of breath. He says he had 3 Covid shots in the past.  He quickly weaned to room air Continued treatment and CRP<
Information has been received from a Physician's Assistant concerning a female patient who was vaccinated with GARDASIL (lot no., route, injection site not reported). A couple minutes later the patient fainted. Unspecified medical attention was required. Additional information has been requested.
Redness, inflammation and warmth at site of left upper arm since 10/03/06. Treated with Benadryl Tylenol and cool compresses to arm.
Information has been received from a nurse concerning a female who on an unspecified date was vaccinated with HPV vaccine. Subsequently, one week later, the patient developed welts on the arm where the shot was administered. Unspecified medical attention was sought. At the time of this report, the outcome of the event was unknown. Additional information has been requested.
a couple of people he knew with psoriasis experienced a flare-up after receiving the COVID-19 vaccine; This is a spontaneous report from a contactable other health professional. This Other HCP reported similar events for two patients. This is the first of two reports. This Other HCP reported for a patient. A patient of unspecified age and gender received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number- Unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was unknown whether patient received any other vaccine in four weeks or other medications in two weeks. Covid prior vaccination and covid tested post vaccination was reported as unknown. It was reported that consumer was calling to see if he can get a COVID-19 vaccine while on Ilumya therapy. Consumer stated that he has heard of other patients taking Ilumya and other psoriatic treatments also taking the COVID-19 vaccine and experiencing "bad reactions" afterwards. When asked to elaborate, they had stated that a couple of people he knew with psoriasis experienced a flare-up after receiving the COVID-19 vaccine and another person developed shingles. No additional information known by patient. It was unknown whether patient received any treatment for the adverse event. It was unknown if patient recovered from the event. The outcome of the event psoriasis flare up was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021285797 same reporter/drug/event, different patient
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information about medical history, concurrent conditions was reported for the patient. On an unknown date the patient missed a dose of VARIVAX (dose strength unspecified) subcutaneously due to a dislodged cap on a vial. No symptoms were reported. The outcome of events reported was unknown. Product quality complaint was filed. Additional information has been requested.
Patient heard troubling news right before immunization so already anxious and worried . While getting immunization , Rph tried to calm her down so immunization went well . She was instructed to wait 30 minutes for observation. After 15 minutes , she approached pharmacist that she is not feeling well and about to seize . She was taken to immunization room where she sat on the floor shaking for few seconds. She was coherent and alert responding to pharmacist questions . Pharmacist asked if she had taken her Depakote for that day and she responded No ,and if she could take a dose . Rph brought her Depakote ER 750 mg (3 tabs of 250 ) along with water . she took medication and was observed for 20 minutes . Her son came to take her home . She was ok while leaving the pharmacy
This spontaneous report as received from a physician refers to a 63 years old male patient. The patient was vaccinated with (Merck) VARIVAX (lot number, dose and route not reported) on 17-AUG-2012, accidentally. The patient's relevant medical history, concomitant medications, and past drug history were unknown. No other co-suspects were reported. No concomitant medications were reported. The patient was supposed to have been administered ZOSTAVAX, but was accidentally given (Merck) VARIVAX. It was unknown if there was any relevant laboratory data. As of 17-AUG-2012, the outcome of the patient receiving the (Merck) VARIVAX instead of ZOSTAVAX was unknown, and it was unknown if the consumer to receive an unknown dose of (Merck) VARIVAX. Additional information has been requested.
Student broke out in hives and started itching this Am. Rash/hives cover entire body.
Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Severe, Additional Details: Patient stated that he had muscle pain in his legs for about 14 days after getting vaccine. Symptoms improving and complained about lethargy/exhaustion for 2 weeks after.
I have had events since I received the first does.  My blood presure has been going up and down, I have been having panic attacks and at time feel really weird, like I'm going to pass out.
postherpetic neuralgia; shingles / painful and severe blisters across her back and torso; Information has been received from a lawyer, regarding a case in litigation, and refers to a female patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. On or around 05-FEB-2009, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered painful and severe blisters across her back and torso. The pt was diagnosed with shingles and postherpetic neuralgia as a result of the suspect vaccine. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered/not resolved. The reporter considered the events of shingles and postherpetic neuralgia to be related to zoster vaccine live (ZOSTAVAX).  The events of shingles and postherpetic neuralgia were considered to be disabling.
Lack Of Response - Information has been received from a 41 year old female with a history of cephalosporin allergy and two previous vaccinations, as scheduled, with the varicella virus vaccine live which resulted in a negative titer. This patient was vaccinated with one dose of varicella virus vaccine live this past summer.  Unknown site concomitant therapies included omeprozole prilosec.  Indoril and Penalar.  subsequently the patient experienced a negative varicella antibody titer.  The patient sought unspecified medical attention.   Additional information has been requested.