chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Erythema and confluent urticaria measuring >8cm at largest dimension surrounding injection site.
Moderna COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 1/16/21 and 3/02/21. Presented to ED on 1/21/22 with bloody diarrhea and symptomatic of Covid-19. Dx'ed as Covid + 1/12/22, given course of remdesivir and dexamethasone, discharged with dexamethasone and azithromycin. Admitted for acute hypoxic resp failure, pt was placed on HFNC. Bloody diarrhea resolved but dypsnea and lung opacities worsened. Pt refused intubation and was transitioned to comfort care/DNAR. Treated with dexamethasone, remdesivir, rocephin, and doxycycline. Patient expired 2/05/22.
I got my HPV shot and my Covid-19 Phizer shot in my left arm. The arm is swelling and there is pain which I know can be the symptoms. The pain I have is like a huge cramp going down my arm into my hands. It is also going into my back and chest. I couldn't even sleep the pain is that sharp. It hurts to breathe because the pain in right in the chest and back area.
breaking out after 2 Injections, last one 2 weeks ago; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In September 2022, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a month after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient wanted to know; anyone got a small breaking out after had their shingles shots. The patient thought that, he/she had shingles now and he/she had 2 injections of shingles.  The last one a little over 2 weeks ago. Additional Supportive Information: The follow up would not possible as no contact details were available.
pt recvd flu vax 7 approx 4-6 hrs later pt devel flu-like sx consisting of nauasea, weakness, & pains; these sx lasted approx 36 hrs;
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No medical history and concurrent conditions of the patient was reported. On 30-SEP-2015, the patient was inadvertently vaccinated with expired dose of PNEUMOVAX 23 vial (lot number: K004542 and expiry date: 19-AUG-2015, dose, site and route of administration was not reported). No concomitant medications were reported. The patient did not experienced any adverse event. The outcome of expired product administered and no adverse event was unknown. No product quality complaint (PQC) was filed. No additional information was provided. Additional information has been requested.
pt recvd vax & exp atrophy to bone in deltoid muscle the diameter of a fifty cent peice which devel slowly over 4 months;
Patient exhibited almost instantaneous syncope and seizure-like limb movement. Patient was attended immediately by Nurse staff, given O2 via NC @ 4lpm.  Patient regained consciousness after approximately 1 minute, was moved to an observation area and monitored for 30 additional minutes w/out any other complications or incidents.  Please note that the patient was given Benadryl prior to injection as she self-reported multiple allergies.
Fever of 101 started mid day on 2/9/21 with aches and pains all over,  especially in bilateral armpits and headache . I took Tylenol and Ibuprofen every 6 hours alternating every 3 hours for coverage. When I woke up Wednesday 2/10/21 morning my left armpit lymph nodes were swollen and very painful. I still had fever and all other aches and pain.. Fever broke around 5pm on Wednesday.
I have a large red area near the injection site.  Area is hot and sensitive to touch.  Left arm aches all the way down to the fingers.  Red area itches at times.  The event occurred 4 days after receiving the injection and has remained since then.  I have laid in the tanning bed   three times since receiving the injection and the last time I laid (Mon. Feb. 1st) the area became very red, almost bruised-like.  It felt as if my arm was tightening in that area.  I put a cold compress on it at which time the area began to sting and itch.
Fever, headache severe swelling and then by 6:30m PM joint pain that kept moving around from wrist, hands, knees, ankles, shoulders, back and even my jaw at one point.  Pain for three days has been 10 on a scale of 0 to 10.  Was in bed from Friday, Saturday and Sunday with severe pain moving from one joint to another consantly.  At 2 AM this morning I went to the hospital Emergency Room with severe pain, fever of 102 and nausea.
he had a fall because his legs gave out; Received booster dose on 06Oct2021, could hardly walk the next day.; Discomfort to injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 76 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 06Oct2021 (Lot number: FF8841) at the age of 76 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Parkinson's disease", start date: 2015 (ongoing), notes: Verbatim: Parkinson's disease, he has a Deep brain stimulator, it was an implant to help with Parkinson's but it made it worse; "Prediabetes" (unspecified if ongoing), notes: Verbatim: Prediabetes; "Remission from Bladder Cancer" (unspecified if ongoing), notes: Verbatim: Remission from Bladder Cancer, Had Infusion therapy.; "Diabetes" (ongoing), notes: Sugar On Metformin; "leukemia" (unspecified if ongoing); "Hodgkins disease" (unspecified if ongoing); "myelomas" (unspecified if ongoing). Concomitant medication(s) included: CARBIDOPA taken for parkinson's disease; METFORMIN taken for diabetes mellitus; ATORVASTATIN; LOSARTAN; DULOXETINE; SILODOSIN. Vaccination history included: Bnt162b2 (Dose:1, single, Lot number:ER8982, Anatomical site of injection: Left arm, Route of administration: Intramuscular), administration date: 28Jan2021, when the patient was 75 years old, for COVID-19 Immunization; Bnt162b2 (Dose:2, single, Lot number:EN6201, Anatomical site of injection: Left arm, Route of administration: Intramuscular), administration date: 18Feb2021, when the patient was 75 years old, for COVID-19 Immunization. The following information was reported: GAIT DISTURBANCE (non-serious) with onset 07Oct2021, outcome "unknown", described as "Received booster dose on 06Oct2021, could hardly walk the next day."; INJECTION SITE DISCOMFORT (non-serious) with onset 07Oct2021, outcome "recovered" (2021), described as "Discomfort to injection site"; FALL (non-serious), outcome "unknown", described as "he had a fall because his legs gave out". Therapeutic measures were not taken as a result of gait disturbance, injection site discomfort.  Additional information: Patient was with Parkinson's and hardly walk but this right now just terrible. He walked once to the bathroom but it was very slow. He uses a walker. No prior vaccination within 4 weeks.  No follow-up attempts are possible. No further information is expected.
palpitations with near syncope, event happened 3 days after vaccination and patient did not seek care so no treatment provided
Stomach hurting, chills very bad, tingles like fire in feet and hands, urinating frequently joint aching, wheezing, dizziness, weakness.
Arm soreness started early morning  following vaccine.  Pain grew and patient was unable to use left arm.  Muscle weakness was noted and she was unable to lift her arm above shoulder level.  Ice packs and pain relievers were used which seemed to help a little with the soreness, but arm weakness and pain was still present and at times the pain was excruciating.  Patient had bouts of dizziness and slight nausea.  These symptoms persisted throughout the day on Saturday (vaccine was given Friday, early afternoon).  These symptoms gradually dissipated on Sunday morning and were almost completely gone by Sunday afternoon. No fever was present during this time.
I tested positive for covid two weeks ago; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (I tested positive for covid two weeks ago) in a  patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 29-Oct-2023, the patient experienced COVID-19 (I tested positive for covid two weeks ago). At the time of the report, COVID-19 (I tested positive for covid two weeks ago) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Oct-2023, SARS-CoV-2 test: (Positive) positive for covid. In November 2023, SARS-CoV-2 test: Negative.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Nov-2023: Significant live follow up added: Reporter information, lab data and event details updated.
Lump on the arm; Loss of Taste; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (Lump on the arm), AGEUSIA (Loss of Taste), CHILLS (Chills) and PYREXIA (Fever) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concurrent medical conditions included Blood pressure. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), VITAMIN D [VITAMIN D NOS] and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced INJECTION SITE MASS (Lump on the arm), AGEUSIA (Loss of Taste), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] on 16-Jan-2021 at an unspecified dose and frequency.   At the time of the report, INJECTION SITE MASS (Lump on the arm), AGEUSIA (Loss of Taste), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Flu; Initial information received on 08-Dec-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (consumer).   This case involved a patient of an unknown age and gender for whom it was reported had experienced flu, while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via unknown route in unknown administration site.   On an unknown date, unknown latency, the patient had flu after getting a flu shot (flu).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  The outcome of the event was unknown.  There will be no information available on the batch number for this case.
Information has been received from a physician concerning a 6 year old male who on 19-JUL-2005 and 12-MAY-2008 was vaccinated with the first and second dose of MMR II respectively (route, site, and lot number not reported).  On 02-JAN-2010 the patient experienced mumps (the date diagnosed was reported as 23-NOV-2009).  The patient also experienced stomach pain and was afebrile.  On 23-NOV-2009, the first blood work was done which revealed serum IgM <1:10, serum IgG 7.16 and serum amylase 568.  The outcome for mumps was not reported.  Follow-up information was received which reported that on 31-OCT-2009 (previously reported on 02-JAN-2010) the 6 year old patient (also reported as 11 year old) experienced mumps.  The patient was diagnosed on 02-NOV-2009.  The patient had a fever of 100.1 degree F and right side parotitis.  On 02-NOV-2009, the first blood work was done which revealed serum IgM 1:20:00, serum IgG 1.43.  This is one of several reports from the same source.  No further information is available.
Information has been received from a 67 year old female with penicillin allergy and high blood pressure who on 1-JUN-2007 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (Lot not reported). Concomitant therapy included RAMIPRIL and hydrochlorothiazide. On 14-FEB-2009 or 15-FEB-2009 the patient developed shingles despite receiving ZOSTAVAX (Oka/Merck). The rash began on her upper left chest and spread to her back and shoulder. The pain had been mild to moderate. Her physician described it a a severe case. She had been taking VALTREX and ibuprofen. At the time of reporting, 23-FEB-2009, the patient was recovering. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/27/2009.  Information has been received from a 67 year old female with penicillin allergy and blood pressure high who on 01-JUN-2007 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot not reported).  Concomitant therapy included ramipril and hydrochlorothlazide.  On 14-FEB-2009 or 15-FEB-2009 the patient developed shingles despite receiving ZOSTAVAX (Merck).  The rash began on her upper left chest and spread to her back and shoulder.  The pain had been mild to moderate.  Her physician described it as a severe case.  She had been taking VALTREX and ibuprophen.  At the time of reporting, 23-FEB-2009, the patient was recovering.  Additional information has been received from the physician who reported that no testing had been done in their office, and suggested contacting the patient's primary care provider.  Additional information has been requested.
The patient reported feeling well.  I discussed with him the Covid-19 vaccine and he was able to state that he wanted it and to sign his consent form.  The facility reported they had discussed this with him and he had agreed prior to my visit.
About 30 minutes after the shot, sudden very weird feeling, visual distortion, confusion, disoriented (now believe was sudden drop in blood pressure), followed by mouth feeling odd, tongue felt too big, difficult to swallow, followed by sensation of intense heat. This all lasted about 5-10 minutes. Resolved on its own. Felt a little shaken but OK afterwards.
This 'adverse event' was not in response to a vaccine shot.  After traveling in mid-February, on Feb 24, 2022, I began to feel ill about 24 hours after traveling. I had sore throat, fatigue, fever, congestion and headache. After 1 week, symptoms did not improve with OTC medication. I sought medical assessment/treatment at Pharmacy clinic where doctor placed me on antibiotics and informed me to be tested for COVID if my symptoms did not improve after 3 days. Symptoms improved with antibiotics; I was never tested for COVID in response to these symptoms.
Client reported on same day of shot,  06-29-2017 at 4:30 pm., stated that about 2 hours after the shot, (on arm and leg of L side), about every hour but only lasts for a few seconds...."feels like when my shoes are too tight". I asked like numbness and tingling and she said yes. Reported no S/S of any allergic reaction. I call CDC and they said to go to ER...I called her back and told her to go to ER, however, she said she was at work and was ok. I tried calling her a few times, but only left messages.
Approximately 12 hours post injection the patient complained of itching of elbows, knees and hands.  Patient complained of pain in joints (specifically knees, elbows) and edema of hands which began on 9/20/19 at 6:00 am.  Patient presented with hives of knees, elbows and wrists on 9/20/19 at 1:00 pm.  Treated with diphenhydramine 50 mg Q 6 hours, ranitidine 150 mg QD and cetirizine 10mg QD. 9/21/19 the patient reported the symptoms had worsened (pain in joints worse, hives worse and spreading, edema of hands was worse.  Continued with the above treatment and also prednisone 40 mg one dose. The symptoms completely resolved by 9/22/19 at 2 pm.
Pts parent stated that the child started having a rash within two days after vaccination. The rash was maculopapular, itching, fever 101.9, child was playful and consolable.
I have tracked my menstrual cycle since 2017 and have been extremely regular. Approximately two weeks after receiving the booster Moderna Covid vaccine I started my flow on January 8, when I was expecting to start menstruating January 18.
Case number PHEH2016US029304 is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to 74 old female patient. Medical history and concomitant medication was not reported. The nurse stated that first temperature excursion of FLUCELVAX QUADRIVALENT on 18 Oct 2016 at 52 Fahrenheit (F) for 1 hour, second excursion of FLUCELVAX QUADRIVALENT on 23 Oct 2016 dropped low 6 times to 34 Fahrenheit (F) and lasted 30 minutes each time, it was unknown if vaccine was frozen. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: not reported) at a dose of 0.5 ml intramuscularly on 25 Oct 2016. Third time excursion on 02 Nov 2016 down to 32 Fahrenheit (F) 3 times over the course of 12 hour it was unknown if vaccine was frozen. Nurse did not known which lot was given to which patient. No adverse event was reported following this administration error.
A sudden hot rush came over me all over and I felt tightness in my chest, my eyes started running continuously, I got really congested in my face/nose and my throat felt thick, my heart was racing; it really scared me the nurse gave me Benadryl, I refused the epi-pen because I was starting to feel better and by 2 pm I was good to go
Patient states that she had itching from head to toe, her palms got red and she had hives on the top of her head.
Pt recv vax on 10/13/97; on same day pt exp arthralgia (left knee, left ankle, right elbow) & lower back pain
Patient accidentally received 3 doses of SHINGRIX instead of the recommended 2 doses (administration error).
Dizziness, hot, light headed, no SOB, no hives, no throat tightness, similar symptoms when blood drawn, PB 131/70, HR 60, PO2 95%. Allowed to rest, cool cloth to forehead. snack/drink denied.
Patient wanted it noted that since her first shot approximately 1.5 hrs after her arm hurts 90% of the time "right at the site of the injection"  and radiates to her elbow and shoulder; feels like a "toothache".  She also states her arm goes "limp" and has weakness.  She has discussed with her family physician and will discuss with her oncologist at her appointment this week.
a severe local reaction to the 2 vaccines she received in April 2021; This is a literature report for the following literature source(s):   A 66-year-old female patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "type 2 DM" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: LOCAL REACTION (medically significant) with onset Apr2021, outcome "unknown", described as "a severe local reaction to the 2 vaccines she received in April 2021". The patient underwent the following laboratory tests and procedures: Antibody test: (unspecified date) Negative; Biopsy kidney: (unspecified date) results pending; Blood albumin: (unspecified date) 2.2 g/dl; Blood creatinine: (unspecified date) 0.92 mg/dl; Light chain analysis: (unspecified date) negative; Serology test: (unspecified date) Negative; Urine albumin/creatinine ratio: (May2021) less than 30; (Apr2022) greater than 22000, notes: increased.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the reported event of local reaction and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200130550 Same article/patient/drug; different event;
Patient received MenQuadfii vaccine RD and HPV vaccine LD 03/28/2023. Patient mother called 04/13 and stated child noticed a knot at the place of injection site on LD. patient did not notice the knot until about 3 days ago (4/10/23). mother states it is also warm to touch. patient denies any other problems a this time. patient instructed she can follow up with pcp if she experiences any other problems.
pt recv vax 24JAN97 & subsequently was found to be pregnant;(LMP 2JAN97)-estimated delivery date 9OCT97;while pregnant tx w/phenergan;@ 34wk post conception pt exp pre-term labor which was tx w/morphine sulfate & Vistaril;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Jan2021 as dose 1, single (Lot number: EL1283), in right arm, on 20Feb2021 as dose 2, single (Lot number: EN6202), in right arm and on 24Sep2021 at 10:45 as dose 3 (booster), single (Lot number: FF2588) at the age of 63 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: (unspecified if ongoing); "Full Spleen Removal" (unspecified if ongoing); "Back Isuess" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures, Paxlovid from 20Feb2023 to 25Feb2023, were taken as a result of vaccination failure, covid-19.
At about 20:15 after getting the flu shot an hour prior shortness of breath was noted. Then I became tachycardic as well as tachypneic with general malaise. Symptoms lasted for roughly 1hr before resolving themselves.
Arm swelling, firmness, and itching around injection site 7 days after injection with standard soreness immediately after injection. No treatment yet.
sl rash for 1 1/2 days during 2nd wk p/MMR; severe ? rash all over @ day 14-16; no fever, not acting sick;
Fatigue on day 2 for 24 hours, chills day three, no fever, malaise and muscle aches on day two, slept for most of day 2,