chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Blisters around hips, thighs, and elbows.; Intermittent chest pain and tightness; Intermittent chest pain and tightness; shortness of breath; Swollen lymph nodes under bilateral arms that have not decreased; Chills; sweating; Headache; This is a spontaneous report from a contactable nurse (patient).  A 26-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number= ELO140), via an unspecified route of administration at left arm on 14Jan2021 12:00 at single dose for covid-19 immunization. Medical history included known allergies: cephalosporins, coconut. Other medical history was none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Jan2021 at time of 05:00 AM, the patient experienced blisters around hips, thighs, and elbows; Intermittent chest pain and tightness with shortness of breath beginning one day after vaccine and continuing into day 4 DOST vaccine, swollen lymph nodes under bilateral arms that had not decreased, chills and sweating, headache. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures post vaccination which included COVID nasal swab test and COVID PCR test, both were negative on 14Jan2021. The outcome of events was not recovered.; Sender's Comments: The reported blisters around hips, thighs, and elbows; Intermittent chest pain and tightness with shortness of breath beginning one day after vaccine was probably related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship.  The case will be reassessed should additional information become available.  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.
Information has been received from a pharmacist concerning a 65 year old retired male patient who on an unspecified date in 9/03 was vaccinated IM with a first dose of pneumococcal 23v polysaccharide vaccine (lot # 643783/0709M). The pharmacist indicated that at the time of the report, the patient had severe soreness in his arm at the injection site and is unable to raise his arm. The pharmacist reported that, the arm can swing back/forth, but cannot be raised. The pharmacist reported that the patient had been doing some remodeling work on his daughter's home and he may have done something to his arm while working on that project. The pharmacist did not have the specifics as to when the remodeling project started in relation to the date of vaccination and the onset of symptoms. The pharmacist reported that she had heard of the remodeling project through someone else and not the patient. The patient was seen by his primary care physician. It was noted that the patient had no illnesses at the time of vaccination. It was also noted that the patient had an unspecified chronic illness. Upon internal review, severe soreness in the arm at injection site, and unable to raise arm were determined to be other important medical events (OMIC). The pharmacist also mentioned that as many as 50% of the patient's that received pneumococcal 23v polysaccharide vaccine at their store also had an experience. Additional information has been requested.
After a week my arm started itching badly and swelled up.  I had a red rash down the arm from the site of the vaccination to almost the elbow.  My arm was very hot and red.  I started taking Benadryl and am still taking it. The rash is still there but not as bad as it was.  Wondering about the the second dose?
after vaccine pt had pain in injection site X 1 day but was diagnosed w/ Pneumonia 5 days after vaccination.
we already had the COVID; we already had the COVID; This is a spontaneous report received from non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 32-year-old (reported as 30-34 years) female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "we already had the COVID". Clinical course: Patient reported inefficacy after COVID vaccine. Probably, because they already had the COVID in May.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200950020 same drug/event, different patient;US-PFIZER INC-202200950021 same drug/event, different patient;
On the 14th, I started to have abdominal cramping and diarrhea and I assumed it was something I ate. On Thursday, I stayed home from work, and I continued to have abdominal pain and cramping. I didn't want to take any medication. I woke up in the middle of the night with a fever of 100 and pain. I took a bath, and I started to vomit. I couldn't stop vomiting. I became incoherent; I waited a couple of hours to talk to the physician. They told me this was not normal and I went to an ER. My fever went down, but because my heart rate was abnormal, they worried. They gave me fluid and did at CT scan; I spent the night with the heart monitor due to failing a blood clotting test. They CT scanned my abdomen, but they should've been looking in my chest. I was bleeding more than I ever bled in my life from a period and they performed a transvaginal scan. The following day, they discharged me and I stayed in bed for the rest of the weekend. This was the first time in my life I was hospitalized.
Left deltoid with about nickle-sized swelling, surrounded by about 2 inch area of erythema to DTaP site.  Also complained of mild pruritis.
Eyes  swelled one hour after vaccination, looked as if I had huge bags,both arms itched in the middle of the night, butterfly shaped raised rash on face in the night. Shortness of breath All symptoms went away by morning, except shortness of breath and hoarseness.
Information has been received from a physician concerning a 6 year old male who on 25-JUN-2007 was vaccinated with a second subcutaneous dose in the left arm of VARIVAX (Oka/Merck) (lot#656997/0336U).  On 13-DEC-2007 the patient presented to the physicians office after the previous day (12-DEC-2007) he felt a little sick, and then the patients mother noticed a couple pimply looking lesions on his chest and a few more on his back.  On physical examination the physician indicated that the patient's pharynx was clear.  His skin had a total of 10 to 12 lesions that were very typical for chicken pox.  They were a pink base with a small red papule in the middle with a vesicle in the middle of that.  Some the vesicles were intact.  There was a classic one on the patient's back which had an unroofed vesicle with a tiny scab over top.  The physician's diagnosis was post vaccine chicken pox.  The physician instructed the patient's mother to watch for any signs and symptoms and to report them to the physician in case the physician needed to change his mind about the patient's diagnosis.  The physician felt that this was a case of vaccination failure.  On an unreported date the patient had recovered.  The patient's vaccination history included on 11-JUN-2002, a first dose of VARIVAX (Oka/Merck) (lot number reported as "not legible on patient record").  A product quality complaint was not reported.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 05/16/08. Follow-up information received indicated that there was no additional information.
Arm is extremely sore. Cannot lift arm above shoulder height.  On 7/13/14 shoulder and neck became swollen.  Today 7/15/14 pt still cannot move arm above shoulder height.  Very sore still like tight muscle soreness.  Has been taking Ibuprofen and Tylenol for the pain.  Helping when taken.  Has not taken any Benadryl or has not put ice on it or heat.
Pain that was extreme and miscular 9 out of 10  over my entire body. The arm where I had the shot was most painful but it. Was not red or swollen.  No joint swelling.   The pain decreased to 6 out of 10 with Tylenol. I also had joint pain in the feet, the knees, the elbows, the fingers and the shoulders. Also had a sinus Headache that resolved with my nasal spray. I felt like I had the flu. No fever just aches this is still going on but it's reducing and I just started steroids today.
Pruritic lesions on hands (bilateral), bilateral arms, face and neck which started at day 10, after smallpox vaccination. Questionable erythema multiforme. The pt described local pain after inoculation. On 12/22/02, had erythematous, raised papule at inoculation site with local pruritus. On 12/23/02, papule had progressed to vesicle. On 12/25/02, had lesion that was wet and oozing. On 12/26/02, had scab in center of lesion, surrounding erythema, localized soreness, pruritus but no satellite lesions. On 12/27/02, pt seen at bandage exchange in AM; no lesions noted at that time. Approx. 12:00, pt noted small pinpoint, flat, non-pruritic lesions on left hand in circular pattern. Pt assumed lesions were from irritation from watch during workout. Pt did not notice progression of lesions or new lesions by 01:00, when he went to sleep. On 12/28/02, pt awoke at 04:30-05:00, secondary to left hand pruritus. He scratched the hand and went back to sleep. He awoke at 08:30 and noted erythematous, smooth, raised papules with erythematous base on hands bilaterally, forehead and face, neck, elbows and 2 lesions on left knee. He complained of global, dull, constant headache upon awakening, last approx. 15 minutes and gradually improved and resolved. He complained of pruritus of hands, 8/10 but did not scratch the lesions. He administered Benadryl 50mg at 10:00, 14:30 and 19:00 with some improvement in pruritus. He noted increase in size and a number of lesions until approx. 17:00-18:00. The lesions on his hands were the most prominent with some lesions coalescing together. He denies fevers, neck pain, photophobia, myalgias, nausea, emesis, diarrhea or dysuria. He presented to the ER at 23:45 for evaluation. He had small,  posterior cervical lymphadenopathy, pea-sized left axillary lymph node, small bilateral inguinal lymphadenopathy, eschar on erythematous base approx. 40mm X 60mm, dry lesion on left deltoid covered with dry bandage, no satellite lesions, no pain or warmth, numerous erythematous, raised, smooth papules 3mm-4mm on erythematous base 7mm on bilateral hands, several coalescing lesions, forehead, neck, elbows, left knee, no lesions on palms, back, chest or oral lesions. Assessment: Mild generalized vaccinia, no systemic symptoms at this time. Admitted for close observation. Dermatology service contacted, infectious disease service and photos in the AM. Treated with Allegra 180mg po QD and Motrin 800mg po TID. Also treated with clobetasol 0.05% topical cream BID with marked improvement in pruritus and Atarax 25mg po QHS prn pruritus. Annual follow up on 02/26/04: "It is unknown if pt recovered from adverse events. No records on this person in database or files.
Graft-versus-host disease flare including rash >50% of body, itching, and liver lab elevation. Patient woke up the morning of 10/12/18 (day after influenza vaccination) with some itching to his chest, which quickly progressed to severe itching with bright red rash to his arms, legs, buttocks, back and torso, so he was asked to come in for evaluation. He tried taking 50 mg of Benadryl without any relief.  Triamcinolone cream and lotion did not help either. He reported some relief from the cold air when he was outside. He was admitted to the hospital and given high dose intravenous steroids (methylprednisolone 100 mg daily x 2 days) and this immediately helped the rash and itching. He was discharged on 10/13/18 on prednisone 60 mg daily, to be tapered outpatient per clinic direction. From review on 2/7/19, it appears that patient may still be on prednisone 35 mg PO daily (unclear if this drug has been further tapered - prescription remains in chart as 35 mg daily).
Sat down after booster, had tachycardia with heart rate increase, flushing and dizziness. Pharmacy tech gave me Gatorade and monitored for an additional 10 minutes until I felt safe to leave and heart rate had returned to normal. About 5 days later I started having shortness of breath and bouts of tachycardia. This has persisted to date.
Very inflamed at site of injection. Had to go to Dr.-told inj. site had abscessed, given CEPHALEXIN.
Client c/o tightness to the chest.  Client seen and assessed by EMT.  No signs or symptoms of distress noted.  Client observed talking without difficulty. V.S. are:  BP 122/79, HR 64,  O2Sat 100%.  Client denies any other symptoms and cleared to go by EMT.  Client also advised to seek medical attention if symptom worsen.
Patient developed Tinnitus for 20 minutes immediately after COVID vaccine. Severe joint pain (history Rheumatoid Arthritis) began 4 hours later, and she could barely move hands. She had a severe asthma attack (history asthma) 1 hour later. Breathing has been poor since then with many asthma attacks and oxygen level as low as 79%. Still cannot sleep lying down without oxygen level dropping. Seen at Lung Center 12/31/2020 began tapering prednisone dose beginning at 60mg. Didn't tolerate 40mg so was at 60mg through 1/9/2021. Now decreased to 40 mg and is having increased shortness of breath and more breakthrough nebulizers. 1/4/2021 feeling no better. Given dexamethasone and kept on steroids. Returned to working just at home on 1/11/2021. No history of asthma reaction this severe in past other than post- ablation, but duration then was shorter.
On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Covid-19 virus test positive). At the time of the report, SARS-COV-2 TEST POSITIVE (Covid-19 virus test positive) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
itching; Red Injection Site; Swollen Injection Site; Warm to the touch Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Red Injection Site), INJECTION SITE SWELLING (Swollen Injection Site), INJECTION SITE WARMTH (Warm to the touch Injection Site) and INJECTION SITE PRURITUS (itching) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (Red Injection Site), INJECTION SITE SWELLING (Swollen Injection Site) and INJECTION SITE WARMTH (Warm to the touch Injection Site). On 26-Mar-2021, the patient experienced INJECTION SITE PRURITUS (itching). On 22-Mar-2021, INJECTION SITE ERYTHEMA (Red Injection Site), INJECTION SITE SWELLING (Swollen Injection Site) and INJECTION SITE WARMTH (Warm to the touch Injection Site) had resolved. At the time of the report, INJECTION SITE PRURITUS (itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant drugs included hydrocortisone cream  used as treatment
Found on floor by CNA at 6 am. On assessment by charge nurse, VS: 99.6-94-16 212/105 manual. Noted increased confusion.  Temp. 99.6 FBS 114.  Resident had been provided tylenol just prior in shift for general discomfort (sore muscles) and low grade temp. On call for Dr notified of all and received order to send to ER.
Lot FK9894 was administered after the "beyond use" date of 7/3/2022.  Vaccine was picked up from the local County Health Department on 4/25/2022 and was to be used by 7/3/2022.  Vaccine was administered on 7/14/2022.  Awaiting feedback from Pfizer regarding vaccine viability.
Donor states he developed a slight headache 45 minutes after vaccine. Headache resolved on its own in approximately 2 hours. Donor denies any other symptoms. Donor states it did not effect and daily activities.
Client received the booster dose COVID vaccine Pfizer Lot # FK9729 in left arm, and Flucelvax Lot # 308497 in Right arm at 8:30am. Client came to vaccination table at 9:10 c/o ?feeling dizzy.? PHN assisted client to lay down, vitals taken at 9:12 am:  BP 130/80, RR 16, HR 66 bpm, 100% SpO2. Client alert and oriented to person, place, time, and situation. Client denies itchiness, pain, denied nausea, skin dry, appropriate to Ethnicity. Client reports eating breakfast that day, but states hadn?t eaten for 24 hours prior to that. Client has history of DM type 2, COPD, CHF, and Knee replacement surgery. Client takes Lisinopril, Lasix, Artvostatin, gabapentin, carvidalol, metformin, ASA 81 mg. Client reports ?trouble breathing and swelling up? when takes penicillin. Client?s primary care at Clinic. Client states spoke with PMD about COVID vaccine, stating she was recommended to get one. At 9:15 am PHN assisted client to sit up, sips of juice given. Client c/o dizziness getting worse while sitting, PHN assisted client to lay back down. HR taken after sitting up, increased to 78 bpm.  At 9:18 Vitals taken: BP 124/78 RR 16, HR 64 bpm, 99% SpO2. Client reports dizziness ?gets better? while laying down.  At 9:19 am client drank 2 more sips of juice. Client remained laying down, at 9:25 vitals taken: BP 118/78, RR 16, HR 63, 99% SpO2. Client reports dizziness continuing, not going away while laying down. PHN educated client on vasovagal reactions. At 9:30 am PHN Called 9-1-1. At 9:38 am vitals taken BP 130/80, HR 67 bpm, RR 16, SpO2 99%. At 9:40 Clt c/o ?chills and dizzier.? EMS Fire Department on scene at 9:43 am. Client transported by EMS to Hospital at 9:45 am.
my arm is swelled up to about a goose egg size and this in the ''site''; red and itchy and sore; my arm is swelled up to about a goose egg size and this in the ''site''; red and itchy and sore; my arm is swelled up to about a goose egg size and this in the ''site''; red and itchy and sore; my arm is swelled up to about a goose egg size and this in the ''site''; red and itchy and sore; my arm is swelled up to about a goose egg size and this in the ''site''; red and itchy and sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administered in arm, administration date 08Oct2021 (Lot number: FF8839) at the age of 70 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Seizure" (unspecified if ongoing). Concomitant medication(s) included: ALOGLIPTIN; ESOMEPRAZOLE; ASPIRIN [ACETYLSALICYLIC ACID]; LISINOPRIL; GLIMEPIRIDE; SODIUM CHLORIDE; ATORVASTATIN; KEPPRA [LEVETIRACETAM] taken for seizure; FLORANE. Vaccination history included: Bnt162b2 (The first LOT# she got on 3rd of February this year (confirmed as 03Feb) and the lot number: EL9265), administration date: 03Feb2021, when the patient was 70 years old, for Covid-19 immunization; Bnt162b2 (second shot she got was on 24th of February of this year (confirmed as 24Feb) and the lot number: EN6201), administration date: 24Feb2021, when the patient was 70 years old, for Covid-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 08Oct2021, outcome "not recovered" and all described as "my arm is swelled up to about a goose egg size and this in the ''site''; red and itchy and sore". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of peripheral swelling, vaccination site swelling, vaccination site erythema, vaccination site pruritus, vaccination site pain.  Additional information: Patient wanted to report bad reaction, shot that she got it a week ago and she went in to see her doctor today or yesterday and they wanted her to report the finding that she had, her arm was swelled up to about a goose egg size and this in the site and it's been red and itchy and sore for a whole week. There were no lab tests.  No follow-up attempts are possible. No further information is expected.
1 days post vax pt devel an inj site rxn characterized by redness, swelling, pruritus & pain;the inj site rxn extended from shoulder to elbow;tx w/oral DPH, warm compresses & applications of ice;
This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 28-OCT-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 "23-10pk-0.5ml-SD PFS LLok w Tip" which had a lot number of M005287 and expiration date on 08-OCT-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effect reported. No product quality complaint was involved. On an unspecified date, the PNEUMOVAX 23 had two temperature excursions; one for 32 hours with lowest recorded temperature of 34 F (1.1 celsius) and other one for 24 hours with lowest recorded temperature of 32 F (0 Celsius). The lowest recorded temperature was 32 F (0 Celsius) and the highest recorded temperature was not mentioned. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
Rash started 2 days after flu shot 10/10/08. Runny nose and a few lesions on trunk exterior,hand.
this is one of two pt from this site to devel inject site rxn w/ more than usual redness and swelling after recv vax; physician stated that the vax may have been above the optimal temp range when it arrived @ the office