chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Painful swollen lymph nodes in armpit on same side as shot; Aches/pains; headache; low fever; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, #lot: EN5318) via an unspecified route of administration administered in Arm Left on 19Feb2021 at 11:15 (at the age of 56-years-old) as single dose for covid-19 immunisation. The patient's medical history includes CAD (coronary artery disease) and the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, #lot: EI3302) via an unspecified route of administration administered in Arm Left on 25Jan2021 at 03:00 PM for covid-19 immunisation. The patient underwent lab tests and procedures which included body temperature: 99.4 on 19Feb2021 low fever (maximum orally measured 99.4, on aspirin) for 30 hours. Onset at 10 hours. The patient's concomitant medications included simvastatin, omeprazole, cyanocobalamin, folic acid, pyridoxine hydrochloride (FOLBEE), fish oil and curcuma longa (TURMERIC [CURCUMA LONGA]). On 19Feb2021, the patient experienced aches, pains, headache, and low fever (maximum orally measured 99.4, on aspirin) for 30 hours. Onset at 10 hours. Painful swollen lymph nodes in armpit on same side as shot. Ongoing 3 days after vaccination. Pain mild. The outcome of the events was recovering. Therapeutic measures were taken as a result of low fever.
no taste or smell; no taste or smell; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (no taste or smell) and ANOSMIA (no taste or smell) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 20-Apr-2021 at 11:45 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021 at 6:00 PM, the patient experienced AGEUSIA (no taste or smell) and ANOSMIA (no taste or smell). At the time of the report, AGEUSIA (no taste or smell) and ANOSMIA (no taste or smell) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         No concomitant medications were provided by the reporter.  Treatment information was not provided.
No additional AEs; The patient was administered an expired dose of PROQUAD; This spontaneous report has been received from a medical assistant, referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies and drug reactions/allergies were not reported.  On 05-DEC-2022, the patient was administered an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant Human albumin (rHA) (PROQUAD) injection (lot# L032757 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 24-FEB-2017; strength, dose, and route of administration were not provided) for prophylaxis (Expired product administered). No additional adverse events were reported. The outcome of the event was unknown.
Chills, headache and Fever 100.4 at 9pm on 2/23/2021. Sore arm. Swelling below injection site 2/24/2021. Swelling is spreading further down the arm 2/25/2021.
Also has soreness at the site; Also some mild body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 52-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary series immunization completed, Unknown manufacturer), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 08Sep2022, outcome "unknown", described as "Also has soreness at the site"; PAIN (non-serious) with onset 08Sep2022, outcome "unknown", described as "Also some mild body aches".  Additional information: My husband also had soreness at the site and also some mild body aches.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
pt recv vax & devel urticaria localized to lateral aspects of back was placed on DPH; re-presented 24JUL w/florid urticaria & orthostatic sx/changes; hospitalized & placed on IV solumedrol & DPH & Zantac & Epi
pt recvd measles vax & approx 1 wk following vax & devel petechiae of both lowere extremmities below the knees; petechiae resolved in 2 to 3 days; No further details were provided;
This spontaneous report as received from a registered 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 was vaccinated with PROQUAD (Merck) (dose strength, route unspecified) lot # K003817, expiration date 14-SEP-2015 and VARIVAX (Merck) (dose strength, route unspecified) (lot K008824, expiration date 19-JUN-2016 during the same visit (overdose). No symptoms reported. The outcome of events reported was unknown. No product quality complaint was involved. Additional information has been requested.
Approximately 2 weeks after I received the 2nd vaccine, I experienced muffling of sounds and difficulty in hearing people's voices. I scheduled an audiogram and found that I head a moderate to borderline severe hearing loss in my left ear. I was diagnosed with a sudden sensorineural hearing loss. My ENT physician mentioned that there were anecdotal reports of hearing  loss in conjunction with receiving the vaccine. With the understanding that I may be predisposed to hearing loss, given that I experienced a similar event in my right ear in 2017, I believe that it is my responsibility to report the possibility that I may have experienced a problem with hearing in conjunction with receiving the vaccine. Approximately, 6 months after the loss, hearing in my left ear returned with only a mild loss in one frequency range (confirmed with an audiogram).
Mother called 6/24/13 to report that on 6/22/2013, the patient developed fever and fine rash.  She took the child to facility then to Dr. Mother stated patient received a prescription for diphendydramine 12.5 mg 1/2 teaspoon TID for allergic reaction then further stated patient had fever spike on 6/25 and 6/26.   After this, no further problems.
Began experiencing itchy ankles on Thursday, 1/7/21, afternoon.  Itching got worse overnight and awoke to find numerous raised red spots over my legs, thighs, and lower back. Spots became more numerous and pronounced through Friday, 1/8/21, and itching became nearly unbearable causing me to make deep scratches on the bac of my legs. Spots continued to spread and become more pronounced throughout the weekend. There have been no other notable symptoms. The itchiness is horrible and only occasionally becomes bearable for a short time - usually after taking Benadryl at bedtime.
PATIENT HAS SEVERE PAIN IN DELTOID MUSCLE.  STATES SHE HAS LOST MOST MOBILITY AND CANNOT LIFT HER ARM.  PER PATIENT
Left arm felt heavy; Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Left arm felt heavy) and PAIN IN EXTREMITY (Sore left arm) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014-935) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced LIMB DISCOMFORT (Left arm felt heavy) and PAIN IN EXTREMITY (Sore left arm). At the time of the report, LIMB DISCOMFORT (Left arm felt heavy) and PAIN IN EXTREMITY (Sore left arm) outcome was unknown.            No relevant concomitant medications reported.  No treatment information was provided.   This case was linked to MOD-2021-326861 (Patient Link).   Reporter did not allow further contact
Vaccine brand: Pfizer/BioNTech/product: COVID 19 Treatment, brand: Paxlovid; Vaccine brand: Pfizer/BioNTech/product: COVID 19 Treatment, brand: Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2021 at 13:00 as dose number unknown, single (Batch/Lot number: unknown), in left arm and on 28Feb2022 at 16:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: THYROID, start date: 01Jan1991. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Vaccine brand: Pfizer/BioNTech/product: COVID 19 Treatment, brand: Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (15May2022) negative, notes: was negative after 5 days of paxlovid; (19May2022) positive, notes: I tested today and I am positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient was given Fluzone quadrivalent vaccine and at time of vaccination it began to swell.
The pt received on 3/24/00 at 4:30 PM. 12 hours later, the pt experienced a fever, and dyspnea. 2 days later the pt experienced erythema, pain in left shoulder from injection site. Pt was seen in an urgent care facility. On 3/29/00, the pt received an IV of Unasyn. The pt was previously on Keflex.
Rash appeared on the 3rd day .started at feet and went all over body . rash has not gotten better .
Onset of chest pain, SOB, cough - 2/09. CT chest 2/11/09 - R pulmonary artery occlusion secondary to massive PE. 2/12/09 R atriotomy removal of R atrial mass.  9/11/09 Hospital records received DOS 2/11/09 to 2/17/09. Assessment: Pulmonary embolism/right atrial thrombus.  Birth control pill initiated 2-3 months prior. Cough with sputum production past month and a half. Hemoptysis with palpitations. Injured knee 4 days ago. 2 days ago suddenly became short of breath, persisted at rest and with exertion. Patient presents with dyspnea at rest. Sharp chest discomfort anteriorly over sternal area. Tachycardia, tachypnea, epigastric tenderness. Mild adenopathy. Right atriotomy and removal of right atrial mass. Right pulmonary thromoendarterectomy. Massive occlusive pulmonary embolus with suspicion of pulmonary infarct. Thrombus in left inferior vena cava.  9/22/09-ICD-9 codes received-429.89, 415.19, 287.5, 285.1, 286.9, 453.2, 416.8, 785.0, 785.6, 722.10, 447.6, V183, V1200 and V586.9.
Fever for 12 hours, diarrhea, nausea, loss of appetite, chills
My two month old came in for her wellness visit. Both parents acknowledged wanting to receive Pentacel because patient had already received HepB at birth and 1 month. Nurse practitioner and tech both acknowledged and agreed. Mother received a phone call after the appointment saying the wrong vaccine had been given. This was a medial error from the practice after being told by the parents they didn't want this vaccine at the time. No severe reactions, but reporting the medical error per instructions from the CDC.
I had a shingles breakout after the first vaccination (booster); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: HERPES ZOSTER (non-serious), outcome "not recovered", described as "I had a shingles breakout after the first vaccination (booster)".  Additional information: The patient had a shingles breakout after the first vaccination (booster) and continue to update the injection. Would getting the Shingrex vaccine prior to the next vaccination help detour this, the patient realize it is undetermined if shingles can be a side effect of the vaccine, but the patient do have an increase in shingles pain post vaccine.  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.
Participant received flu immunization around 3pm on 10/24/2011 in her right deltoid.  About an hour after her flu injection she wasn't feeling right.  Her chest, neck and back were hurting mainly her chest, but everything all over was hurting.  Her legs were weak.
Cannot move arm without pain. Taking Aleve for the pain. Extreme pain in biceps musclic ? Pain radiates up to neck region. Arm movement makes pain worse. Pain is severe enough so that he must sleep in chair warm moist heat does not relieve the pain.
Within 48 hours of receiving vaccine, patient developed intense swelling of left side of face and left neck with progressive dysphagia lasting more than 3 weeks
Within a few hours of getting the 1st booster shot, I developed a headache that has lingered on every day since then.
Few lesions on body that are itchy. Had Varivax injection 1-2 wks ago.
Patient presented to office 9/1/17 with left arm swelling, redness and warmth from site of upper outer aspect  down to and involving dorsum of left  hand. Mom notes swelling of eyelids and lips as well.- though practioner unable to fully appreciate this. Patient c/o itchiness at injection site. No mention in visit note about when symptoms began. Recommended: Diphenhydramine HCL 7.5 ml q 4-6 hrs until swelling improves, then may switch to Zyrtec 1-2 x/ day until symptoms completely resolved. If breathing trouble, severe mouth/ lip swelling or diffuse hives along with stomachache to go to ER.
01/9/2021 sweats/fever like I had Covid 19 again. on01/10/2021 sore and swollen under right armpit and swollen neck.
approx 3 wks p/3rd vax pt devel acute loss of vision (dx optic neuritis) w/in 1 yr devel multiple sclerosis & markers for lupus (pos ANA, pos anticardiolipins);
first dose of SHINGRIX in November 2020, second dose yesterday, August 7, 2022; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in November 2020).   On 7th August 2022, the patient received the 2nd dose of Shingrix. On 7th August 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 08-Aug-2022 Reporter's comment: The patient self-reported this case. The patient received her second dose yesterday (day before reporting). The patient did not consent to follow-up.  The reporter did not wish to provide further contact information as the reporter was moving.  The reporter needed to end the call before this agent was able to obtain further information. Additional supportive information: The patient received the 2nd dose later than the recommended interval, which led to lengthening of vaccination schedule.
Sunday and Monday I had fever, body aches and fatigue; at injection site - -normal red circle that was sensitive.  It became itchy by Monday Morning (wasn't itchy at first). I went back to work on Tuesday. Tuesday, started spreading; Wednesday - raised, swollen, red, painful - entire upper arm it had spread from elbow to shoulder. I went to Urgent Care on Wednesday, the 13th, I think,- Dr. drew a circle around it  and gave me antibiotic and had me take Claritin. It kept going and by the next day it was my entire arm and underneath and so encircled my arm - really itchy and it had become stingy like needles. About two days later, it started going away slowly. And I took the whole antibiotic and I kept taking the Claritin. That didn't happen with second dose of vaccine.
p/vax pt had sore throat, sweating felt very weak & almost past out & cont to have this sx;also has joint pains (hands/fingers);pt lost 20 lbs in a period of 1mo;coughed up blood x 8 days;
Information has been received from a physician concerning a 4-year-old male who on 02-JUN-2004 was vaccinated subcutaneous with a second dose of varicella virus vaccine live (Oka/Merck). On 17-SEP-2007 the patient developed approximately 20 varicella-like lesions. On approximately 21-SEP-2007 (about four days after the patient's visit on 17-SEP-2007) the patient came back in with an ear infection. The physician treated the patient with antibiotics. On an unspecified date the patient recovered. A product quality complaint was not involved. Additional information has been requested.
Became dizzy two weeks after the first vaccine and continue to be dizzy two weeks after the second.  Spent 24 hours in the hospital and could not find anything reason for it. Had cat scans and MRI. Went to an ENT and still cannot find out why I am still dizzy.
"Pfizer-BioNTech Covid-19 Vaccine EUA"  Had fatigue the morning after receiving the vaccine from 7:00 to approximately 7:00pm. Have injection site pain, swelling, and redness. Noticed on second day after the injection, but injection site was sore the first day after the injection, I just did not check for any swelling or irritation.
Sweating, mouth went  numb, itchy burning hands blotching on palms... Tight chest labored breathing tingling itching all over body... Extremely itchy cheeks and face
Irregular and fast heart rate started 10 hours after inoculation, followed by chills, headache, body ache, fatigue, no appetite.  All symptoms lasted 36 hours or so but irregular and fast heart rate lasted for days.  Today is day 12 after the shot, still feel a bit irregular.
Day of immunization - patient felt chills 2 days after immunization - tenderness at site of injection. 7 days after immunization puritus, erythema, lump at site of injection. Erythema @ 5 cm diameter.
swelling & inflammation from the hip to the knee fro 24hr in the leg that IPV & HIB given;
She says she had her second dose of the COVID vaccine on Saturday 3/13/2021 and she woke up that night around 1 am with lots of pain in her armpit and neck with dizziness. Before she could go sit down she passed out. She later woke up on the floor, got up and threw up. Since then her neck and shoulders area has been more tense and tight than normal. She says that other than muscle tension she feels "back to normal" now (three days later).
Erythematous macular mildly pruritic rash 3.5 x 3.5 inches, still mildly evident at time of second injection
After child received shot she stated that she felt a little dizzy. Patient was still seating in the chair. Nurse had patient to prop her feet up in another chair. Child was given a coke and some crackers. Child never lost color, just c/o of not feeing good. BP checked 108/84. Child finished coke but didn't want anymore crackers. Child was then escorted to  the school nurse and her parents were called by school nurse. Before leaving the school Health dept County nurse manager checked on child and school nurse stated that her mom was on her way to get her. Called the school on 11/06/2019 around 9:15 am and school nurse reported that child was back at school this morning and that she was fine.
COVID-19; COVID-19; TROUBLE SLEEPING; Right Lung Weak; Voice was different and felt like were going to die; Impending doom; This is a solicited report based on information received by Pfizer (manufacturer control number: 21K-163-4084076-00) from a contactable consumer(patient)   A 69-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 01Mar2021 at single dose intramuscular for COVID-19 immunization and adalimumab (HUMIRA) for moderate to severe rheumatoid arthritis. Relevant medical history included Moderate to Severe Rheumatoid Arthritis. Concomitant medications were not reported.  The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 02May2021 at single dose intramuscular for COVID-19 immunization. On an unspecified date the patient experienced vaccination failure, COVID- 19, trouble sleeping, right lung weak, voice was different and felt like were going to die and impending doom. At the time of the reporting event outcome was unknown.   The reporter's causality for all the reported events with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)  was provided as possible.  The reporter's causality for the event of covid-19 with Humira(adalimumab) was provided as no reasonable possibility. The Reporter's causality for the events of trouble sleeping, right lung weak, Voice was different and felt like were going to die with Humira(adalimumab) was not provided.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events vaccination failure, covid-19, insomnia (non-serious) , lung disorder (non-serious), dysphonia (non-serious) and anxiety (non-serious) and BNT162B2.
Pt was fussy and cried X 6 hours, post vax. This child is 1 of a set of triplets.
Nausea, Vomiting about an hour or so after receiving Moderna booster. Severe fatigue; chills, headache and fever. Vomiting lasted for a few hours. Lasted for about a day and a half
No adverse event; Patient received double the dose of Moderna Covid-19 vaccine (monovalent); This spontaneous case was reported by an other health care professional and describes the occurrence of OVERDOSE (Patient received double the dose of Moderna Covid-19 vaccine (monovalent)) and NO ADVERSE EVENT (No adverse event) in an infant patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.  On 27-Feb-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OVERDOSE (Patient received double the dose of Moderna Covid-19 vaccine (monovalent)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, OVERDOSE (Patient received double the dose of Moderna Covid-19 vaccine (monovalent)) and NO ADVERSE EVENT (No adverse event) 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 considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for OVERDOSE (Patient received double the dose of Moderna Covid-19 vaccine (monovalent)).    The date of the birth of the patient was reported as 2022.  No concomitant medications were reported.  No treatment medications were reported.