chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen reaction at injection site. Red, swollen, hot to touch. Chills, aches & fever.
tremors temp of 104.9 rash pain all over and little zings weak shaking  immune system issues
Redness started 12/10/14 now 12/11/14 hot to touch, red area size 4-5 in. in diameter. Arm stiff left arm. Ibuprofen per mother. Taking her to doctor since "it is cellulitis".
This spontaneous report was received from a pharmacist refers to a 50 year old female patient. The patient's pertinent medical history included a lot of unspecified medical issues. Information on patient's concomitant medications was not reported. On an unknown date, few months ago, the patient was vaccinated with PNEUMOVAX 23 (1 injection)(route, frequency, lot and expiry date were unknown) for dyspnea. On an unknown date, about a week later, the patient experienced unusual swelling and puss coming from the injection site(vaccination site swelling and vaccination site pustule). " No additional AE information provided". Outcome of vaccination site swelling and vaccination site pustule was unknown. Causality assessment was not provided.
Sharp stabbing pains in left hip socket, approx. 3 - 5 times/hour, with buckling of left hip if walking.  Lesser joint pains in left ankle.  Gradually resolving by Day  4.  Tylenol 500 mg tablet taken on Day 3 was not effective.  Minor symptoms: fatigue, mild headache.
Myalgia, Fever, Dry mouth, fatigue Narrative:  I was called at approximately 0930 to clear this employee to work or home. He received his second dose of vaccine at 0745 on 1/12. At approximately 0840 he reported to his supervisor that he had back pain and a dry mouth. He drank water and felt better but the dry mouth recurred. His supervisor sent him to employee/occupational health. The EOH RN called the (emergency response) team who evaluated the employee and reported his vital signs were stable and they felt he could go back to work or home. The employee DENIED SOB, a sensation of his throat closing, tongue swelling or any symptoms other than soreness in his back and a dry mouth. PE: notable for a young man sitting comfortably in NAD. Tongue normal in appearance, no oral lesions, mucous membranes moist, No swelling noted in the oropharynx. Resp rate 16 and relaxed. A/P: Employee was cleared to RTW but he felt his back pain was bothersome enough that he wanted to go home. He was advised to contact his supervisor to discuss what leave he would use. 1/13 employee reports he had a fever and body aches overnight. Today he stayed home from work due to fatigue. 1/14 - employee reports resolution of symptoms and he has returned to work.
Patient reports that he experienced immediate numbness and tingling to his limbs.  He stated that he had a warm sensation to limbs.  Heart rate felt a little fast but was not taken. He had general shakiness and felt unsteady for about 24 hours after vaccine.
Today AM red dot on chest - increased # dots - 330p, slight fever last NOC.
immediate shoulder joint pain, improved for 2 wks then returned causing significant limited ROM, daignosed with adhesive capsulitis of L shoulder with MRI and u/s evidence of humeral head cortical reaction and supraspinatus tendon partial tear
Patient had vaccine at 0930 and symptoms began 9 hours later with unilateral Left jerking head motion. This occurred one time on Tuesday 10/24/17 and once Wednesday 10/25/17 followed by 5 episodes within 2 minutes of each other on Thursday 10/26/17.
Fever of 103F (Ax) at 23:00 (11 1/2 hours, post vax) X 24 hours. Treated with ibuprofen. Had redness and swelling of right arm, deltoid area, noted on 7/5/01. This was 6cm long axis of arm X 4cm across.
Skin has burning sensation, even though not hot to touch.  Started mid May and continues through this report date.
Swelling and warmth at site of administration. Swelling 6cm x 10cm.
Information has been received from a physician concerning a male who on 24-APR-2008 was vaccinated with his second dose of  VARIVAX (Oka/Merck) (lot# 659735/1785U). Post vaccination, unspecified when, the patient developed redness and some swelling at the injection site of the thigh. The patient sought medical attention in the physician's office. Subsequently, the patient recovered. No other information. There was no product quality complaint. Additional information has been requested. This is one of several reports from the same source.
my first covid vaccine caused tingly lips; This is a spontaneous report from a contactable Health Professional reporting for herself. A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number not provided, expiry date unknown) via an unspecified route of administration in the left arm at single dose on 23Dec2020 at 15:30 for COVID-19 immunization. The patient had allergy to codeine. Concomitant medications included metformin, atorvastatin, vortioxetine hydrobromide (TRINTELLIX), insulin glargine/lixisenatide (SOLIQUA). The patient reported that her first dose of the vaccine caused tingly lips. Onset date and outcome of the event were not reported.  Information about lot/batch number has been requested.
Next day post vax, the pt had a rash and swelling at site of DTAP injection. Seen in urgent care clinic on 4/16/00. She had a temperature of 97.8, area of erythema 4 x 4.5 inches, tender to touch and warm. Started on Augmentin.
First episode was on 4/18/21 - 911 called, no motor function, bp was 70/30, couldn't form sentences, couldn't walk or hold a glass,  2 more hospital visits within 2 weeks, many many test, another ER visit in August, I am still battling to this day for normalcy in my life.
Urticaria. A physician reported that pt received Prevnar, Tripedia, and IPV vaccines and subsequently developed urticaria swelling. The onset of the adverse event was 1 hr post immunization. He recovered.
patient said the day of vaccine she had redness/tenderness/and heat at the injection site. patient went to the doctor and was given cephalexin as the prescriber thought she could have cellulitus at the injection site. patient said she was ok and still wanted to get the second dose when due. patient was told to contact us if something changes
This spontaneous report was received from a Certified Medical Assistant (C.M.A) regarding a 4 year old patient of unspecified gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 14-JUN-2016, the patient was vaccinated with improperly stored PROQUAD (lot # L050910, expiry date 14-JUN-2017) dosing regimen unknown. Call was because of a data logger. It was reported that the vaccine administered was subjected to temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes. The vaccine was not subjected to any previous temperature excursion. No adverse effect was reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
PT had hives within hours of vaccines. Dad reports an egg allergy in his childhood. Hives resolved with in 24 hours.
Kinrix administered to 9 month old pt. Manufacturer recommendations ages 4-6 years old. Dose correct for pt.'s age but was given in combined vaccine instead of individual injections.
sick; Based on information previously received, the case was classified as valid, gender, age group, event coding, listedness and values for combination product was corrected  Initial information was received on 10-Nov-2020 regarding an unsolicited non-valid non-serious case from a consumer via Social Media. This case is linked to case 2021SA173404 (male patient).  This case involves a female patient (age unspecified) who was sick (llness) after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications 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 not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient was sick (illness, non-serious event) (unknown latency) following the administration of INFLUENZA VACCINE.  The reporter asked why the parents got sick almost every year after getting the vaccine   No laboratory data was provided.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of event was unknown.  There will be no information available on the batch number for this case.
My reaction did not require medical attention, but I happened to have an appt. with my doctor and mentioned it to her. She thought I should mention it to you in case it is part of a larger pattern. I had normal reactions of arm pain and headache (not serious) since I had the shot. I have also been experiencing sporadic numbness and tingling in my arm down to my fingers. It does not last long but it comes and goes. It has been three days since the shot and all symptoms have decreased.
Pt with presyncope event. Pt complained of sudden onset of nausea and feeling ?weird.? Clinician immediately at chair side. Initial vitals  102/58, HR 49, RR 18, O2 sat 98%. Pt assisted with receptacle for emesis-none. EMS medic 153 on scene and present. 4:25p BP 102/64, HR 62. 428p transferred to avail cot to lay supine. Aox3 and verbal entire time. Ice pack to neck. Water to drink without difficulty.  Orthostatic vitals assessed ,WNL. Parent present throughout event. Mom refused transport. 446p EMS called verbal report to hospital MD as part of release for transport refusal. Permission granted to refuse transport . Pt up, walking around. States he now feels fine at 452p
Urticaria - generalized - started the evening after immun. & worsened was tx with BENADRYL 6.25mg po q 6h until rash resolved.
Pt came to clinic for evaluation of rash, erythematous, with vesicles left elbow, left palm, with varicella zoster culture. Diagnosed with shingles.
Shingles; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 03Apr2021 (Batch/Lot Number: EW0153) (at the age of 67-years-old) as 1st dose, single dose for Covid-19 immunization. Medical history included ongoing hypothyroidism. The patient has known allergies for sulfa and penicillin. Concomitant medications included levothyroxine, liothyronine (NP THYROID 60mg) and "bioidentical hormone compound" both taken for an unknown indication and unknown if ongoing. On 02May2021 at 2:00 am  the patient woke up with shooting pains and on 03May2021 she broke out in shingles rash. The patient received valacyclovir hcl 1 gm as treatment. The patient was not diagnosed with Covid-19 prior to vaccination and has not been tested for Covid-19 since the vaccination. The outcome of the events was unknown.  Additional information has been requested.
Hearing loss; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), in 2021 as dose 5 (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 (Dose 4 (BOOSTER); manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (BOOSTER); manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Primary Immunization Series completed; Manufacturer unknown), for COVID-19 immunization. The following information was reported: DEAFNESS (medically significant), outcome "unknown", described as "Hearing loss". Clinical course: Consumer stated, "I had I believe an adverse reaction to my 5th COVID vaccination (Clarified as Covid-19 vaccine) back in 2021 and I have sudden hearing loss about 2 months later and the doctor don't know if it was related to it but I have done a lot of research on it, there has been sudden hearing loss due to the vaccination from Pfizer."  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
"more red spots"\ some of the red spots are the size of a quarter\rest of them (red spots) are smaller; Bumps on her scalp; Flaking scalp; This spontaneous case was reported by a pharmacist and describes the occurrence of ERYTHEMA ("more red spots"\ some of the red spots are the size of a quarter\rest of them (red spots) are smaller), URTICARIA (Bumps on her scalp) and SKIN EXFOLIATION (Flaking scalp) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Cholesterol. Concomitant products included ROSUVASTATIN for Cholesterol, EMPAGLIFLOZIN (JARDIANCE) for Diabetes.    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 ERYTHEMA ("more red spots"\ some of the red spots are the size of a quarter\rest of them (red spots) are smaller), URTICARIA (Bumps on her scalp) and SKIN EXFOLIATION (Flaking scalp). At the time of the report, ERYTHEMA ("more red spots"\ some of the red spots are the size of a quarter\rest of them (red spots) are smaller), URTICARIA (Bumps on her scalp) and SKIN EXFOLIATION (Flaking scalp) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No  treatment medications were provided.   This case was linked to MOD-2021-250583, MOD-2021-252826 (Patient Link).
I would not say my symptoms were severe. It was mostly a stuffy head. I wasn't even sure what it was but my sister and I were at an outdoor event and she had the same symptoms I had. She tested the next day and was positive so I checked as well and was positive. It was mostly a stuffy nose and that was mainly it. I didn't take the antiviral because I didn't feel it was needed.
Tested positive for COVID; This is a spontaneous report from a contactable consumer (patient's mother). A 13-year-old female patient received first dose of first dose of BNT162B2 (COMIRNATY, Solution for injection, lot number: FC3180 and expiry date was not reported), via an unspecified route of administration on 21Aug2021 (age at vaccination 13 years), as dose 1 single for COVID-19 immunization. medical history as none and concomitant medications were not reported. Caller reported on behalf of her daughter who had the 1st dose of the Pfizer COVID vaccine on 21Aug2021 and then tested positive for COVID, the caller was looking to see if and when her daughter will be allowed to get the 2nd dose which should of been given on 11Sep2021. Now the patient was already over the 21 days to receive the 2nd dose. On 02Sep2021, the patient underwent lab tests and procedures on a home kit for covid and tested positive and then they took her for a PCR on 03Sep2021 and that was positive, too. Outcome of the event was unknown.  Follow-Up (16Sep2021): Follow-up attempts are completed. No further information is expected
patient came to the pharmacy on 1/21/22 around 2:30 pm to get his 2nd dose pediatric pfizer covid immunization. I forgot to dilute the bottle before drawing 0.2ml from it. And I inadvertently administered the undiluted dose to the patient.  I discovered the mistake around 4 pm, and I contacted pfizer immediately and obtained related clinical data from it. Then I contacted patient's mother and discussed with her in regards to the event, at the time I called, patient did not appear to have any adverse reaction. I told the mother that patient might have higher chance of getting adverse reaction including local injection reaction, fever, headache, flu-like symptoms, etc. Patient's mother will monitor patient during the weekend, and I will contact patient's mother on Monday (1/24/2022) to follow up
The vaccine from the day before was left out on the immunization pod. It did not get discarded. When immunizing technician came in today , she used the vial that had been sitting out through the night and administered a dose to patient. I administered another dose from a new vial into his right arm.
Sluggish; Feeling wheezy; This spontaneous case was reported by a consumer and describes the occurrence of WHEEZING (Feeling wheezy) and SLUGGISHNESS (Sluggish) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (Light Asthma).   On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced WHEEZING (Feeling wheezy). On 20-Feb-2021, the patient experienced SLUGGISHNESS (Sluggish). At the time of the report, WHEEZING (Feeling wheezy) and SLUGGISHNESS (Sluggish) had resolved.            No concomitant medications were provided. Treatment medication included inhaler.   This case was linked to US-MODERNATX, INC.-MOD-2021-034258 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-034258:Linked, Same reporter,case of daughter
Cholesterol little elevated; Vitamin D two points low; just about face planted; dizziness worsened; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient). A 42-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL8982 or E68982), intramuscular on 13Jan2021 16:00 at single dose in left deltoid for COVID-19 immunisation. Patient age at time of vaccination was 42 years. Medical history included retinal blood clot in his retina which was why he was tested for rheumatoid arthritis (RA), and Meniere's disease for which he was asked to try meclizine which was for inner ear but he did not start taking meclizine, and six years ago, they did blood work and he was told he may have RA or he may have markers for RA but he has had no further issues and does not take any medication for this. The patient's concomitant medications were not reported.  Historical vaccine included  influenza immunisation (flu shot) in Sep2020 and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231) administered on 22Dec2020 around 15:15 at single dose intramuscular injection in left deltoid, and on 06Jan2021 he started to experience dizziness/feeling dizzy and going to throw up on 11Jan2021. He received the second dose of the Pfizer's COVID-19 vaccine on 13Jan2021 and for the last days it seems that the dizziness is being incrementing, reported as worsened. His physician recommended him to perform laboratory tests and the results came back without abnormal findings except for cholesterol and vitamin D. He was told his cholesterol was a little elevated and his vitamin D was two points low, regarding his lab work. He got a vitamin D supplement which he started to take. He will start on his cholesterol medication today that was prescribed. Reportedly he has a Roomba and when he went to go press the button for it, he just about face planted. He looked online and could not find anything about the dizziness aside from dizziness could be a sign of a severe allergic reaction. He does not have hypotension or anything like that. Dizziness was not resolved, while outcome of other events was unknown. It was stated dizziness is not reported as a side effect of the vaccine.
This spontaneous report was received from a healthcare worker refers to female patient of approximately 1 year old. No information on concurrent conditions and medical history was reported. On 13-JUL-2015 the patient was vaccinated with improperly stored MMR II (unknown strength, route and dose) lot # K004949 with an expiry date of 04-APR-2016, stored at improper temperature (<46 degrees). Concomitant medications were not reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
pt recv vax 24JUL96 & on 31JUL96 pt devel hives it was also indicated that the pt had no known drug allergies;no further details were provided;
Hard lump; Redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Hard lump) and VACCINATION SITE ERYTHEMA (Redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE MASS (Hard lump) and VACCINATION SITE ERYTHEMA (Redness). On 23-Jan-2021, VACCINATION SITE MASS (Hard lump) and VACCINATION SITE ERYTHEMA (Redness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No Concomitant medication information was provided.  Treatment information were not provided.   This case was linked.
After booster on 10/27: Shortness of breath, extreme fatigue, increased respiration rate (37/min), muscle weakness, dizziness/fall, loss of appetite, weight loss, cough, fever, anemia, bilateral lower extremity edema, wheezing, epigastric pain
little bit of headache; Fever; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via unspecified route of administration on 02Mar2021 at 17:30, as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date in 2021, patient experienced little bit of headache and fever. Consumer asked I was felling little bit headache, it was our first dose this time, So, if we (Clarification unknown) feel like any headache or fever after first dose or second dose. So, can we take Advil". Outcome of both the events were unknown.  Consumer was unwilling to share further information, hence, product details (Expiration date, NDC#, UPC#) and other details were unknown.  Limited information was available over the call.  No follow-up attempts are possible. No further information is expected.
Got the Vaccine on 1/8/21 around 11:00 am, At around 12:00 pm an hour later I Started filling nausea (very bad Vertigo) right leg started going num with heart palpitations. Was giving IV fluids and Ativan. Went to ER.
Body aches, headache, chills.  Time 09-APR 2000 - 11-APR 0800.  Worst of symptoms was at 10-APR 0600.
Fever 100 101, nausea, body ache, sore arm, fatigue
Started crying at 230 pm, gave Tylenol dose.  At about 330 pm right thigh red and inflamed thigh to knee.  Took directly to ED.  By the time they arrived, no redness or swelling present, took 15 min by car.  Examined and sent home.  Continued to cry uncontrollably until 630pm that evening.
She has the vaccine on 11/6/21 and on 11/10/21 developed tachycardia, chest pressure and palpitations. Heart rate would increase to 110-115 with minimal activity and even at rest. Symptoms resolved, including heart rate normalizing, with ibuprofen.  On 11/14 the symptoms suddenly resolved.
Tingling in arm 1 minute after injection.  Rapid response observed for 30 minutes. no other intervention
Lt thigh local reaction first papule below skin, about 14 days central crusted lesion surrounded by papules and erythema, Keflex, Bactroban, day 17 scattered Varicella Pox lesions, chest, legs behind ears, slight increase of central crust and ring of papules.
Headache, Myalgia, Arthralgia, NauseaVomiting, Malaise, Chills Narrative: No further details given