chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red whelp developed at injection site approximately 24 hours ago, it was approximately a quarter in size and has progressed to redness down the arm.  site is red and tender to the touch.  The patient has applied an ice pack to the area.
Admitted for confusion 2/2 COVID infection. Did not require any specific therapy. Remained on RA. DC home.
A few days after my first dose my left arm went completely numb and there is a shooting pain all the way down to my fingertips and up my neck. The pain is so bad it makes me nauseous. This has been going on for a few weeks now and I havent been told anything that will help me get better
Throat closing, face swollen, lips enlarged, puffy eyes, dizzy, arms and hands swollen.
Chills, head ache, back pain and kidney pain, all within 1 week  On April 25, 2021 attended emergency and was sent home.  They found nothing   Chills, head ache, chest and kidney pain on October 13, 2021   Went to Hospital and received a d-dimer test.  Cat Scan showed Pulmonary Embolism left lung
Severe pain down arm, then numbness and neuralgia and muscle at top of arm was as though it was frozen. Kept me awake at night. Visited Dr twice. He finally sent me to neurologist after 8 weeks. He did full neurological exam and send the vaccine administrator nailed my axillary nerve (spelling ?) in my upper arm with the vaccine.  I am taking gabapentin and it is slowly getting less painful. I have trouble carrying anything with the right arm, and difficulty raising it up to put things in microwave, or pull laundry out of machine etc.
two days after the first dose, I started to get an allergic reaction that makes me want to scratch all my body. I get like red spots but it is a nonstop scratching.
Patient received ProQuad (MMR/varicella) on 2/1/06 and on 2/22/06 presented to pediatricians office with ecchymosis, petechiae and epistaxis, admitted to hospital with diagnosis ITP.
Patient states that she has gotten injected to her tendon and she experiences pain and unable to lift her arm.
arm is still sore; not all of the vaccine went inside their arm; there was a significant amount of leakage; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).   A 31 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 22Apr2021 17:25 (Lot number: EW0164) at the age of 31 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CHICKEN POX VARICELLA VACCINE taken for immunisation, administration date 07Apr2021. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "arm is still sore"; INCORRECT DOSE ADMINISTERED (non-serious) with onset 22Apr2021, outcome "unknown", described as "not all of the vaccine went inside their arm"; UNDERDOSE (non-serious) with onset 22Apr2021, outcome "unknown", described as "there was a significant amount of leakage".  No follow-up attempts are possible. No further information is expected.  Follow-up (23Apr2021): This is a spontaneous follow-up report from a contactable consumer via Pfizer-sponsored program 159558. Updated information included: New event (sore arm).  No follow-up attempts are needed. No further information is expected.
Headache continued for 1 month until patient was started on prednisone. Dizziness, Headache & chills, body aches ACETAMINOPHEN 1000 MG QID, PREDNISONE 60 MG EVERY DAY
Under age 18; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Under age 18) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 16-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Under age 18). On 16-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Under age 18) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was not provided by the reporter.  No treatment was provided by the reporter.  Patient completed primary series with Moderna COVID-19 vaccine.
High fever (104F), body aches, chills from day after booster injection lasting for 48 hours. Severe sore throat after 72 hours, lasting for 48 hours.
The injection site was tender & sensitive for about 1 hr; The injection site was tender & sensitive for about 1 hr.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (The injection site was tender & sensitive for about 1 hr) and VACCINATION SITE PAIN (The injection site was tender & sensitive for about 1 hr.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A, 013A21A and 939909) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced VACCINATION SITE REACTION (The injection site was tender & sensitive for about 1 hr) and VACCINATION SITE PAIN (The injection site was tender & sensitive for about 1 hr.). On 05-Apr-2021, VACCINATION SITE REACTION (The injection site was tender & sensitive for about 1 hr) and VACCINATION SITE PAIN (The injection site was tender & sensitive for about 1 hr.) had resolved.            No concomitant medications were reported.  Treatment information was not provided. No side effects were experienced after the third dose.   This case was linked to MOD-2021-396105 (Patient Link).
patient had red, swollen, hard, golf ball sized reaction at injection site; patient had red, swollen, hard, golf ball sized reaction at injection site; patient had red, swollen, hard, golf ball sized reaction at injection site; patient had red, swollen, hard, golf ball sized reaction at injection site; Initial information regarding this unsolicited valid non-serious case was received from other health professional on 16-Oct-2020.  This case involved a 31 year old female patient who had red, swollen (Vaccination site inflammation associated with Vaccination site erythema and Vaccination site swelling), hard, golf ball sized reaction at injection site (Vaccination site mass), while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Relevant medical history, past medical treatment, vaccination, concomitant medications and family history were not provided.   On 01-Oct-2020, the patient received a 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6706AA, expiry date: 03-Jul-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  On an unknown date, the patient developed red, swollen (Vaccination site inflammation associated with Vaccination site erythema and Vaccination site swelling), hard, golf ball sized reaction at injection site (Vaccination site mass), unknown latency following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. It was reported that it was two weeks later, and the size had gone down, it was no longer golf ball sized but it continued to be hard and somewhat swollen. She had no fever.  Final diagnosis was patient had red, swollen, hard, golf ball sized reaction at injection site.   The patient was recommended with alternate ice and heat and ibuprofen, warm compresses as a corrective treatment.  At the time of reporting, the patient was recovering from the event, vaccination site mass and the event outcome was unknown for the other reported events.
Second dose less than 25 days after the first; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose less than 25 days after the first) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose less than 25 days after the first). On 06-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose less than 25 days after the first) had resolved.            No concomitant medications were reported. No treatment medications were reported.
This spontaneous report was receive from a physician via Pfizer (Manufacturer report number # 2015131602) refers to a 72 year (also reported as 65+) old male patient. The patient's concurrent condition included diabetes mellitus. No previous drug allergies were reported. On 19-FEB-2015, the patient was vaccinated with first dose of PNEUMOVAX 23 (lot # K012424 expiry date: JUNE 2016) (dose 1, 0.5 ml in the left arm). It was also reported that the patient would not get second dose for 5 years. No concomitant medications were reported. On 20-MAR-2015, the patient experienced fever. On an unknown date, the patient experienced chills, rashes, decreased appetite, muscle aches and joint pain. Patient received unspecified treatment for the events. On an unknown date, the patient was subjected to unspecified diagnostic test, results were not reported. The event of fever was not recovered at the time of this report. The outcome of the other events were unknown. The reporter considered fever to be related to PNEUMOVAX 23 and the causality was not reported with respect to other events with PNEUMOVAX 23. Additional information has been requested.
Tingling lips while in waiting area then entire body on way home, heavy legs, strong urge to vomit (didn't happen), a bit later hoarse voice. Took Zyrtec and about 20 mins later symptoms slowly subsided.
2/16 at 10:30pm started getting chills, couldn't get warm, and felt nauseous, headache (moderate) 11:00  Chills, throwing up, couldn't get warm 11:00pm 2/16 until 7:00pm 2/17 chills, throwing up hard when even a teaspoon of water was swallowed, very weak and could barely walk to the bathroom, texting made me dizzy and I couldn't focus on the screen trying to dial the doctor at 3pm. I did not go to work (on zoom) 5:30pm 2/17 Spoke to Dr. on the phone- he perscribed Zophran  and said to go to the ER if I still wasn't holding down water in the morning 6:30pm took Zophran. By 7:00pm I was able to hold down tiny sips of water and Gatorade. Still having chills and feeling cold and so tired I couldn't get out of bed. Normally I am a very healthy, energetic person. Continued sipping all through the night and had about 1/2 cup of liquid. Still felt nauseous but did not throw up. Took a second Zophran about 4 am 2/18 By mid morning I was able to drink a little more and consummed about 12 ounces of Gatorade and 6 saltine crackers over the course of the day. I spent the day sleeping and did not go to work. By evening, I was able to walk out to the livingroom. I slept through the night and conitued sipping liquids whenever I could. Chills stopped around midday. 2/19 Felt considerable better. worked on zoom for 4 hours and slept the rest of the day 2/20 headache and chills were gone, nausea was gone, very tired 2/21 tired 2/22 mostly normal
itch; Redness around injection site on Left Arm; I had a rash in both of my arms, from my wrists to my shoulders; Redness to right arm at injection site; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itch), RASH (I had a rash in both of my arms, from my wrists to my shoulders) and VACCINATION SITE ERYTHEMA (Redness to right arm at injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to insect sting (Allergic to Mosquito). Concomitant products included LEVOTHYROXINE, ROSUVASTATIN, LEVOTHYROXINE SODIUM (SYNTHROID) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE ERYTHEMA (Redness to right arm at injection site). On 01-Mar-2021, the patient experienced RASH (I had a rash in both of my arms, from my wrists to my shoulders). On 03-Mar-2021, the patient experienced PRURITUS (itch). The patient was treated with TRIAMCINOLONE ACETONIDE (topical) on 27-May-2021 for Rash, at a dose of .1 % once a day and CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) at an unspecified dose and frequency. At the time of the report, PRURITUS (itch) outcome was unknown and RASH (I had a rash in both of my arms, from my wrists to my shoulders) and VACCINATION SITE ERYTHEMA (Redness to right arm at injection site) had not resolved.            Treatment included methyl prednisone 4mg , cholesterol medication used with unknown brand name.   This case was linked to MOD-2021-028111, MOD-2021-028111 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Followup Received on 21-APR-2021 contains significant information. Patient Medical history added. Updated outcome of event  Pruritus from Unknown to Resolved.Updated outcome of event Rash, Injection site erythema from Unknown to Not Recovered. On 30-Apr-2021: Follow-up received on 30-APR-2021 contains significant information. Added Reporter mail id and event outcome rash from unknown to not recovered updated. On 05-Aug-2021: Follow up information received contains significant information. Treatment medication was updated.
Joint pain approximately, 48 post vaccination developed fever 72 hours post vaccination. maintained fever ranging from 100 degrees f to 102.5 degrees f while receiving Motrin and tylenol. Joint pain, muscle pain & cephalagia continued. Developed tremors starting after 96 hours.
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 27-NOV-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L023385, expiration date: 25-JUN-2017) (incorrect product storage). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Initial information received on 30-Jan-2019 and additional information also received on same date regarding an unsolicited valid non-serious case received from other health professional. This case involves a 2 months old male patient who received vaccine PENTACEL lot C5517AA via unknown route in unknown administration site on 29-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE for Immunisation; and PREVNAR 13 for Immunisation. It was a case of actual medication error due to inappropriate reconstitution technique. It was reported that the patient received the DTaP-IPV portion and not the ACTHIB portion of the PENTACEL vaccine. It was unknown if any adverse event was occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
The pt broke out with blister bumps on 02/18/2002 during night time. The pt visited a physician and was diagnosed with chicken pox. No treatment was given.
Patient did not have adverse event as noted at 6pm, but the patient received the bivalent shot as a first dose in primary series. Patient guardian knows to get a pfizer primary series for 2nd shot
I do experience seasonal allergies - ragweed etc. in the fall. I started getting congestion - headache, earache and lots of congestion; I started coughing. I was taking Claritin and Sudafed and it kept getting worse. Didn't get tested for COVID-19 because it felt like sinusitis - just a bad one. Eventually, I went to Urgent Care, and they prescribed 10 days of Augmentin - for sinus and ear infection.  It took a long time for me to get better - about 6 days on the Augmentin before it started to help me feel better.
The patient received her first dose in NOV 2020 and she will getting the 2nd dose in March 2021; This spontaneous report has been received from a physician referring to a female patient of unknown age. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.      On an unspecified date in November 2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route, frequency, anatomical location, lot # and expiration date were not provided) for prophylaxis. It was reported that on an unspecified date in March 2021, the patient received the second dose (inappropriate schedule of product administration).
migratory numbness Narrative:  Dr. developed right-sided numbness of her trapezius extending up to the base of her skull ~ 10 minutes after vaccination (right deltoid). She was brought into an examination room. This is not her typical sx or in the typical distribution of when she has had a MS flare in the past. She denied sx of immediate allergic reaction and anaphylaxis. On exam: T 98.1 F BP 108/62 (states she normall runs low) HR 61 RR 12 SpO2 98-99% on RA Gen: not in distress, answering questions appropriately, pleasant, no changes in speech including slurring or confusion demonstrated HEENT: atraumatic/normocephalic, equal reaction of pupils in already bright room, Neck: nontender to palpation Ext: moves all 4 spontaneously, no edema Skin: no lesions or rashes Neuro: no focal deficits, CN II-XI grossly intact, 5/5 strength UE and LE. Stated decrease in sesation over right trapezius as compared to the left with light tough MSK: observed to be ambulating w/o any difficulty, no obvious differences in muscle tone in one area of body as observed from another Psych: appropriate, thoughts linear and non-tangential Over course of next 20 minutes, the numbness travelled distally to her right forearm without changes in other sx and w/o development of any other focal deficits (with resolution of the neck/trapezius numbness). Provider touched base with another Dr. for awareness of the situation (has phone or virtual visit that was previously scheduled with neurology for tomorrow). She was observed for another 15 minutes (total of over 45 minutes post-vaccination). During the last 15 minutes, the numbness had migrated to the palm of her right hand with resolution of the other previously affected areas. There was still no development of other sx and no focal deficits developed. Discussed ER precautions with Dr. at length. Despite migration, given improvement of sx w/only intervention of time, no current indication A/P: migratory numbness of unclear etiology experienced on vaccination side with improvement prior to leaving clinic area. Per f/u call with neurologist that evening, numbness had completed resolved.
On Saturday, Sep 29 a small quarter size rash and 3 - pea size rashes appeared on left side of abdomen just above the waist.
3 expired doses administered as 1st dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 expired doses administered as 1st dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 expired doses administered as 1st dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (3 expired doses administered as 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported  No Treatment medication was reported
Given PCV-13 6/16/15 early afternoon. Awoke with swollen red area at vaccine site and swollen initially bluish discoloration of skin over left lymph gland. -> skin became reddened and swollen w/in 24 hours over lymph gland. Also has yeast diaper rash. Cephalexin (antibiotic) and yeast cream rx given.
This spontaneous report was received from a male physician of unknown age referring himself via company representative. The patient's drug allergies and medical history was unspecified. On an unknown date the patient was vaccinated with chickenpox vaccine (manufacturer unknown) (brand name and manufacturer of the vaccine unspecified). Concomitant medications were unspecified. On an unknown date the patient developed chickenpox a few years after receiving chickenpox vaccine (manufacturer unknown). The patient sought medical attention. The patient had a blood test that determined that the strain of varicella he was infected with, was not covered by the vaccine. The outcome of developed chicken pox after receiving chickenpox vaccine (manufacturer unknown) was reported as recovered. The causality was not provided. No product complaint was reported for chickenpox vaccine (manufacturer unknown). Additional information has been requested.
Initial injection site swelling and pain, resolved with cold pack and movement in 2 days. Lymph node swelling in my clavicular and elbow areas with tenderness to palpation which continues through today. No treatment such a heat has reduced symptoms, although initial pain was worse.
Immediately, after injection, I felt lightheaded.  I was not dizzy or nauseous.  This feeling continued into the next morning.  I had some pain at the injection site, no swelling or bruising.  The next morning, I also experienced double vision.  I only noticed it when I was writing out checks.  Otherwise, it wasn't noticeable.  That afternoon, I slept for over two hours.  Following that nap on day 2, I felt perfectly fine and continue feeling fine.
Son stopped talking. He has been getting speech therapy 2x a week since 8/2017. He still cannot speak correctly and is starting special education pre k.
Pt received a 3rd dose of Hepatitis A on 7-28-2011.  #1 dose given on 2-18-2009 #2 dose given 9-1-2009.
Muscle aches and joint aches with spasms since taking the first vaccine.  Has been seen and treated but the problem comes back started after 1st vaccine .  Affects his ADLs
Developed Shingles one month post vaccine.  Prescribed Valtrex and  Capsaicin