chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This non-serious spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerns a 54-year-old, adult, female patient. The patient had no relevant medical history. The patient was not taking any medication at the time of vaccination. On 09-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 1.5 ml instead of 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252235, expiry date: 30-Jun-2019]. At the time of this report, no adverse events were reported. This case 201804659 was linked to the source case 201804657 due to the same reporter.
Severe coughing, wheezing, choking, coughing leading to vomiting.
Systemic: Fainting / Unresponsive-Medium, Systemic: Weakness-Medium, Additional Details: she passed out while she was in observation area and fell off the chair ,felt better after few min sat on the chair and passed out again.. no color on her face and week but responsive. she felt better after 10-15 min , parematic came and parent refuse to go to er . called mom same night and she said ,"we arranged her 2nd dose with peditaric office , just incase)
Developed painful joint pain in fingers, ribs and feet on Day 2 and feeling very tired
patient, that is greater than 7 years old, received Daptacel; Initial information received on 29-May-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to case 2019SA150249.  This case involves a 12 years old female patient who experienced received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for Immunisation; and HPV VACCINE (HPV VACCINE) for Immunisation.  On 24-May-2019, the patient received a single 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5307AA via unknown route in the right deltoid.  It was of actual medication error due to Inappropriate age at vaccine administration.  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 holder's compliance with the requirements set out in Directive and Module VI of the 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.  List of documents held by sender: none.
Golf ball size Lump on arm; Soreness of the Arm; Hot to Touch; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Golf ball size Lump on arm), PAIN IN EXTREMITY (Soreness of the Arm), INJECTION SITE WARMTH (Hot to Touch) and INJECTION SITE ERYTHEMA (Redness at injection site) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced PERIPHERAL SWELLING (Golf ball size Lump on arm), PAIN IN EXTREMITY (Soreness of the Arm), INJECTION SITE WARMTH (Hot to Touch) and INJECTION SITE ERYTHEMA (Redness at injection site). At the time of the report, PERIPHERAL SWELLING (Golf ball size Lump on arm), PAIN IN EXTREMITY (Soreness of the Arm), INJECTION SITE WARMTH (Hot to Touch) and INJECTION SITE ERYTHEMA (Redness at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were provided. No treatment medication details were provided.       Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Non-significant Follow-up appended
Pt recvd 3 doses of Engerix-B 4NOV90, 27NOV90, 1MAY91 & 10SEP91 it was determined that pts titer was neg p/3 doses of Engerix-B;
Patient complaint of dizziness, shuddered, and passed out per sister. PT passed out in car. EMS arrived and assessed PT. Parent was present. VS 108/40 , HR 49 , 02 Sat 99% on RA. PT provided cold pack and water. PT's Mom declined EMS transportation to ER. VS WNL per EMS when PT left site.
Left arm acute muscular pain radiating down arm to fingers localized and inflammation of area similar to pain & sensitivity of shingles. Rx antiflammatory (Ibuprofen) Coproxinol (pain reliever). Treated 3 hrs from initial injection, take every 6 hrs. Monday morning pain & redness still there. 1-10 scale 10 on Friday 6 Monday morning
2.5cm x 2cm blanching redness with mild swelling on right anterolateral thigh.
got my first / in Dec; This case was reported by a consumer via(Shingrix GSK Chatbot) interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in December 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting,the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
About 10 hours after my Johnson & Johnson COVID vaccine, I had sever chills, teeth chattering, body tense and aching, and trouble breathing. These were severe symptoms that lasted for two hours.
I received the Moderna Booster shot at the Pharmacy on Monday. The Pharmacy near home. (I am a 72yr old white woman.)  I reacted with a red rash over most of my body.  The Doctor at the Urgent Care stated that I was the 2nd patient this week to come in with a weird reaction after the Moderna Booster from the Pharmacy.  I think this is crucial information to document not only to the Pharmacy, but to the CDC. I did, as with the Second Shot, also react with chills, fever, headache, fatigue, and aches.
Dilated pupils (photograph available).  Took photo about 15 minutes after vaccination, but did not notice until we had left the clinic.  Resolved in 24 hours.  Same reaction by his older (9 year old) sister, who was vaccinated at the same time. (temporary report # 706436)
-stroke like aunt for 2 hours (confusion, numbness in extremities) -nausea and vomiting for 12 hours -bradycardia on and off for a week (dropped to 40 bpm, followed by fainting) -bouts of my heart flipping into SVT
Developed rash on forearms, forehead, trunk, legs. Self resolving, no Benadryl taken.
Rashes and hives all over my arms, legs, and stomach.; Rashes and hives all over my arms, legs, and stomach.; Skin very itchy; Forearms especially were swollen; The arm which got the vaccine on was very sore and painful to raise; The arm which I got the vaccine on is very sore and painful to raise.; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the right arm on 19Jun2021 at 12:00 (at the age of 17-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Jun2021 at 13:00 the patient experienced rashes and hives all over the arms, legs, and stomach. The patient skin was very itchy and forearms especially were swollen. The arm which the patient got the vaccine on was very sore and painful to raise. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events rashes all over arms, legs and stomach, hives all over arms, legs and stomach, skin very itchy, forearms especially was swollen, the arm which got the vaccine on was very sore and painful to raise was not recovered at the time of this report.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2016, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for prevention of shingles (dose, route, and lot # not provided).The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. Later in 2016, the patient was treated at for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of 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 of the events was unknown.  Causality assessment was related. Additional information has been requested.
This 82 year old  female received the Covid shot on  3/31/21    and went to the ED on 4/8 /21 and again to the ED and admitted on 5/7/21 with the  diagnoses listed below and died on 5/9/21. J90 - Pleural effusion, not elsewhere classified N18.6 - ESRD (end stage renal disease)  D61.818 - Pancytopenia  A41.9, R65.20 - Severe sepsis
TOOK UNREFRIGERATED DOSES; This spontaneous case report was received from a pharmacist (PVX2019-504) on 25-Feb-2019. The report described a female consumer who "took unrefrigerated doses". The consumer was receiving Vivotif for an unknown indication.  It was reported that the consumer left Vivotif out of the refrigerator for 8 days and then, she took all the doses.   The action taken with Vivotif with respect to the event "took unrefrigerated doses" was not applicable.  The clinical outcome of the event "took unrefrigerated doses" was unknown.  Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.
This was the booster shot. My first vaccination was the Johnson & Johnson. Nov 6th and 7 and 8 my hands got all swollen and red, they were in so much pain. They told me that this could've been a side effect to the vaccine. I had a slight fever. The second day about 99. My arm got really swollen when I got the shot, and I couldn't move my arm  for about 3 to 4 days. They gave me Colchicine .6 mgs to deal with the pain. I took some medicine yesterday and today and it's gotten much purpose. I can grab thing now and cook on Sunday. I couldn't do much because of the pain. My lymph nodes around my neck and ear also got swollen. It feels like I have liquid on my bottom ear, no pain but it does feel like there's something there. I also feel like I get dizzy at times when I get up.
Patient said the shot was painful and had soreness and pain the night of the shot. Her son and husband got the same vaccine at the same time and they all had some degree of soreness which they thought was normal. However unlike her son and husband, he pain didn't resolve in a couple of days. A couple of days after she said the pain even radiated into the neck and elbow. She says it's hard to sleep. She had very limited range of motion. She has tried warm and cold compresses and OTC analgesics with limited relief.
Couple minutes after the shot, I became light headed and sweating; but did not have much water or food beforehand so I?m not surprised by this. However, about two hours later, as I was having dinner, I began to lose sense of touch in my fingers. Then a few minutes later my speech started to become jumbled, and my brain was starting to not form sentences. About 2 and a quarter hours after the shot, my speech was becoming more and more mumbled  and incoherent, and I was unable to think of the words I wanted to say to my friends. Was able to walk to the car, starting to feel nauseous  and having heavy mumbling of words. After getting driven home, laid down in bed two and a half hours after the shot. After thirty or so minutes of trying to go to bed, vomited and proceeded to go back to bed. Woke up after nine or so hours of sleep, and my clarity, sense, and felt much better in general, only having a slight headache and hunger. In total, main side effects commenced two hours after the shot and lasted for about two hours.
Nine days post vax, this pt developed low grade fever at about 8:00 PM. Rash began the following morning at 10:00 with 4 to 5 spots. Four days later, 4 to 5 more pox spots broke. All spots scabbed and healed within 2 weeks. Child ran fever for 3 days.
8/5/99 mom noticed rash beginning on chest;child fussy & irritable;8/6/99 child woke up w/T102 given APAP;rash spread to back, upper arms & thighs;
Red, hot swollen area to upper left deltoid. Prescribed Benadryl PRN and Augmentin 400/5 tsp BID for 10 days.
Patient requested ZOSTAVAX as per PCP and CDC recommended for adult 65 y.o and older. The screening questionnaire was answered with NO for all questions. on 7/28/16, Pharmacist was informed by patient POP that patient ha shingles and has been treated with Acyclovir with no severe symptoms.
After dose 1 had intense facial numbness on left side of face (consistent with original case Bells Palsy), numbness around my mouth and also on the right side of my face; After dose 1 had intense facial numbness on left side of face (consistent with original case Bells Palsy), numbness around my mouth and also on the right side of my face; This is a spontaneous report from a non-contactable consumer, the patient. This case is for vaccine first dose. A 66-years-old non-pregnant female elderly patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection,Batch/Lot number was not reported)via an unspecified route of administration, administered in arm left on 27Feb2021 at 14:30 (at the age of 66-years-old) as Dose 1,Single for COVID-19 immunization. Facility type vaccine was a pharmacy or drug Store. Medical history included ongoing bell's palsy (had a previous episode of bell's palsy years ago). Concomitant medications included valaciclovir hydrochloride (VALACYCLOVIR) and dihydroergocristine, lomifylline (ANTIVERT) both taken for an unspecified indication, start and stop date were not reported. Patient did not receive other vaccine in four weeks. There were no known allergies. Patient did not have COVID prior vaccination and patient was not tested for COVID post vaccination. It was reported that the patient had a previous episode of bell's palsy years ago, still had periodic facial numbness without facial drooping. After dose 1 patient had intense facial numbness on left side of face (consistent with original case Bells Palsy) and numbness around her mouth and also on the right side of my face. Subsided in 2 days. The events did not result in emergency room/ physician office visit. The patient did not receive treatment for the events. The outcome of the events was recovering.  No follow up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. On multiple unspecified dates, improperly stored PEDVAXHIB (lot # L012838, expiration date 10-MAR-2018) (dosage, strength and route unknown) (temperature: low 32.2 degree F, time frame: 53 hours 25 minutes) were administered to the patients. There was no concomitant medication reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
I had mild sore throat, congested cough, fatigue, muscle aches are pretty much all I had for my symptoms of COVID. I started on Paxlovid for COVID.  I am currently testing negative.
LOSS OF CONSCIOUSNESS; HYPOTENSIVE; This spontaneous report received from a physician concerned a multiple patients of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the subject experienced loss of consciousness. On 11-MAR-2021, the subject experienced hypotensive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patients was recovering from loss of consciousness, and hypotensive. Reporter considered causality between covid-19 vaccine ad26.cov2.s and  loss of consciousness, and hypotensive as possible. Company causality between  covid-19 vaccine ad26.cov2.s and  loss of consciousness, and hypotensive considered as possible. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210321527-covid-19 vaccine ad26.cov2.s-loss of consciousness, hypotensive. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
BRUISED; SWELLING ON LEFT SIDE OF LOWER ABDOMEN; HEART PALPITATION; MINOR EAR ACHE; This spontaneous report received from a patient concerned a 59 year old female.  The patient's height, and weight were not reported. The patient's past medical history included heart stent, and concurrent conditions included rag weed allergy.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported,1 total administered to left arm on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the patient experienced minor ear ache at night. On 24-MAR-2021, the patient experienced heart palpitation. On 17-APR-2021 the patient experienced again ear ache. On 13-APR-2021, the patient experienced swelling on left side of lower abdomen. She got on the shower and she found it , she put ice and the ice maintained the swelling. Patient explains her swelling as stuck out a good 2 inches, a size of a soft ball. On 14-APR-2021, the patient experienced bruising on left side of lower abdomen. On 01-APR-2021, Laboratory data included: EKG (Electrocardiogram) and it is Normal. On 18-APR-2021, Laboratory data included: Heart rate that was 20bpm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from bruised, had not recovered from minor ear ache, and heart palpitation, and the outcome of swelling on left side of lower abdomen was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Headache, UrticariaPruritus, Diarrhea, Pain Narrative:
Heart attack; Cholesterol and triglycerides were a little elevated; Cholesterol and triglycerides were a little elevated; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4820691 (Genentech).  A 64-year-old female patient received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID", start date: Jan2020 (not ongoing), notes: I got COVID Jan2020.; "Multiple sclerosis" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: MOMETASONE; TRAMADOL; TOPIRAMATE; METFORMIN; LOSARTAN; ROPINIROLE; SINGULAIR; SPIRONOLACTONE; EZETIMIBA; ALBUTEROL [SALBUTAMOL]; FUROSEMIDE; ASPIRIN [ACETYLSALICYLIC ACID]; BUPROPION; PANTOPRAZOLE; ROSUVASTATIN; RYBELSUS; ALLEGRA [FEXOFENADINE HYDROCHLORIDE]; SYMBICORT. Past drug history included: Levaquin, reaction(s): "Allergy to Levaquin", notes: Allergy to Levaquin; Macrobid for Allergy to Macrobid. Vaccination history included: Bnt162b2 (DOSE 1, My first vaccine was Pfizer), for COVID-19 immunization. The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "Heart attack"; BLOOD CHOLESTEROL INCREASED (non-serious), BLOOD TRIGLYCERIDES INCREASED (non-serious), outcome "unknown" and all described as "Cholesterol and triglycerides were a little elevated". The patient underwent the following laboratory tests and procedures: Blood cholesterol: little elevated; Blood triglycerides: little elevated; Catheterisation cardiac: Unknown results; Echocardiogram: Unknown results. Therapeutic measures were taken as a result of myocardial infarction.  Clinical course: On unknown date, patient started therapy with Pfizer COVID-19 Vaccine for unknown indication. On unknown date, it was reported that patient experienced COVID Jan2020. She took antibiotic and medicine to get it down and antiviral to keep it down and finally did get over it. She  took the vaccine and booster in- May2021. First vaccine was Pfizer and 3 weeks later took Pfizer 2nd vaccine. 3 days after taking the Pfizer vaccine, had a heart attack. The HCP told that if we had COVID should not have taken the second shot. She had a echocardiogram and heart cath and needed up needing 2 stents. My doctor told me my heart was in good condition but cholesterol and triglycerides were a little elevated.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hives and redness around injection site, huge swollen gland in armpit, swollen around injection site, hot to touch.
Extreme fatigue, fever,chills, nausea, dizziness, tension and lack of mobility in neck, headache
After receiving my second shot of moderna, I developed a skin rash 7-9 days after receiving the vaccine. The rash/hives were located on my arms, back, legs, face, and stomach. This lasted for about a month.   After receiving my booster shot, I received the same rash 9 days after receiving the booster. However, this time it felt worse. The rash was found on my arms, feet, legs, back, thighs, ears, around my eyes (almost all over my face), hands, and wrists. The rash is still ongoing.