chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immunized 1/21 morning. Rash to neck 1/22 evening, extending to chest and trunk, very itchy, rash worsened 1/23 to almost entire body, went to ER 1/24 in morning after uncomfortable night
I was extremely tired. Slept 24/7. Tried to get up from bed for a week. Didn't eat, lost appetite, I have a strange cough, joint pain and feel depressed.
Large, hard lump under skin at injection site (size of a lemon), very red skin over lump with rashy area; pain and stiffness; itching. Headache; abdominal cramps; extreme fatigue.
down to their hand, since receiving dose; Pain from their shoulder; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of pain in hand in a female patient who received Herpes zoster (Shingrix) (batch number 2HC4L) for prophylaxis.   On 12-APR-2023, the patient received Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in hand (Verbatim: down to their hand, since receiving dose) and shoulder pain (Verbatim: Pain from their shoulder). The outcome of the pain in hand and shoulder pain were not resolved.   It was unknown if the reporter considered the pain in hand and shoulder pain to be related to Shingrix.     It was unknown if the company considered the pain in hand and shoulder pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-JUN-2023 The patient received the dose and reported experiencing a sharp, shooting pain from their shoulder down to their hand, since receiving the dose. The reporter did not know which arm dose was received in, nor did they state whether this was the patient's first or second dose. The reporter did not consent to follow up.
PATIENT ADMINISTERED  MODERNA VACCINE. PATIENT NOT ELIGIBLE DUE TO AGE.
The patient requested a booster dose of COVID vaccine,  PFIZER COVID BIVAL ( 12Y UP)  but vaccinated  PFIZER COVID (12Y UP).   the patient has not experienced any adverse events so far.
my A1C has been hanging around 5.8-6.0 for a couple of years. my A1C has suddenly jumped to 6.8. my doctor is starting me on a new medication to bring my sugar down.
Tightening in chest, cough at first.  Then my eyes started itching and it felt like something was in one of them.  So I rubbed my eye, washed it out, put drops in it.  It just got worse and then started watering and oozing and then both eyes started to hurt and I couldn't open them without pain. Went to the doctor at 2pm and they put some kind of numbing drops in to look to see if I had scratched my cornea from having something in my eye.  I had already taken Benadryl and was prescribed antibiotic drops for the conjunctivitis.  After sleeping a while I woke up and became nauseous at around 5 or 6pm with a fever of about 100; cold compresses reduced the fever but I had a tingling in my fingers and feet for just a while and felt like I needed to take very deep breaths;  then went back to sleep until the next day. Today, eyes are red but not painful.  I'm still using the eyedrops.  Not coughing as much.  Scary!  I'd like to know what caused this and what to do about this flu vaccination in the future.
I (patient) began feeling flushed, nauseous, and dizzy ten minutes after injection. Experienced diarrhea and GI upset. Nausea and dizziness increased. I laid down on a cot at the vaccination site for about half an hour. While walking back to my car, I was very fatigued (the walk felt long and difficult and had been fine when coming in). Over the next 12 hours, experienced fatigue, chills, and nausea with mild body aches. 12 hours after injection, I began experiencing fever, chills, sweating, nausea without vomiting, and severe muscle and joint aches throughout my entire body. The muscle aches were extremely painful and seemed to worsen nausea. Fever increased to 100.5 at highest reading. All of these symptoms continued until about 48 hours after initial injection. 5 days after injection, I am still experiencing mild to moderate nausea, dizziness, fatigue with shortness of breath, and mild to moderate muscle aches that increase with exercise.  I have also had two instances of feeling like I might faint with tingling sensation in feet, legs, and arms.
Patient reported that she has nerve issue in her neck after the Moderna vaccine; She also reported that she can't raise her arm much after the vaccine, and her left arm feels numb
passed away; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On 11th September 2021, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The patient died on 11th September 2021. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's husband. The reporter stated that they lost time when they got the Shingles shots.  The patient suffered and contribute to her life. The patient passed away. The reporter advised to get the Shingles shot especially for seniors like him. The follow-up would not possible as no contact details were available. Note: The term suffering was unspecified hence not coded as an event. Also, as per convention it cannot be coded with Ill-defined disorder or unspecified adverse event.; Reported Cause(s) of Death: Unknown cause of death
Initial and follow up information has been received from a medical assistant and a physician's assistant concerning a white female patient in her 60s with an allergy to penicillin who on 10/18/04 was vaccinated IM in the left deltoid with the first dose of pneumococcal 23v polysaccharide vaccine (lot # 649692/0371P). Subsequently, the patient developed a reaction at the site of the injection. The arm was red, warm, and swollen. The patient was diagnosed with cellulitis and was treated with Cephalexin. Unspecified medical attention was sought. It was reported that the patient recovered by 10/26/04. The cellulitis was felt to be an other important medical event (OMIC). No further information is expected. The health care professional also reported that another female patient in her 60s also developed injection site erythema, warmth, and swelling following vaccination with pneumococcal 23v polysaccharide vaccine (WAES0410USA03389).
This spontaneous case, initially received on 08-Sep-2016, was reported by a Non-Health Professional and concerns a(n) 28-year-old male patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA on 08-SEP-2016. Dose: 0.5 ml, Route of administration: Intramuscular, Batch number: 13049221A. No additional suspect drugs. Adverse reactions/events and outcomes: On 08-Sep-2016, the vaccine has been administered that had particles in the vials - no adverse event (outcome: unknown, special circumstances: poor quality drug administered).
Patient came to the pharmacy and said that 2 days after receiving her Shingrix shot she broke out in shingles. She did visit an urgent care clinic where they confirmed the shingles diagnosis and gave her a steroid shot. She said the rash was around her face and eyes and was very painful but resolved in two weeks. She also states that she had a severe headache during this time frame.
Hives started in October 2021 then in august of 2022 tested positive for alpha gal syndrome.  December 2022 blood clot to LAD resulting in coding 3 times.
Headache, Myalgia, weakness, swelling under axilla of left arm, fatigue. Started 4 h after COVID vaccine administered on 1/21 and ongoing still today 1/24 Narrative:
Pt received vax in 1994. Post vax, the pt experienced arm swelling to the point where she could not bend the arm. Three days after onset, the pt recovered.
Bright red spot about the size of a baseball that formed around the injection site, one week after the shot. Was hard and warm to the touch for one week. Since it began, I have taken Benadryl daily. After three weeks the circular formation is still on my arm but it is not hard anymore and it is only light red/pink (still darker than my skin color).
She got her booster dose of her Pfizer vaccine on Saturday 6/18/2022.  She reports when she woke up on Sunday that she had very severe pain in her right armpit area and right breast area.  Her symptoms have continued to worsen and she feels that the area is warm to the touch and very tender.  She tried taking some Tylenol and ibuprofen without any relief.  Pt went to ER for evaluation 6/20/2022
Passed out for a few days with pain; Pain in kidney area.; This spontaneous case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out for a few days with pain) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Passed out for a few days with pain) (seriousness criterion medically significant) and FLANK PAIN (Pain in kidney area.). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out for a few days with pain) and FLANK PAIN (Pain in kidney area.) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient passed out for a few days with pain. Pain in kidney area.  Treatment information was not provided. Company Comment: This is a spontaneous case concerning male patient of an unknown age with no reported medical history, who experienced the serious (due to medically significant) unexpected, event of loss of consciousness, which occurred on an unknown date after a dose of mRNA-1273 Bivalent .222 (original and omicron BA.4/BA.5). It was reported that patient passed out for a few days and had pain in kidney area. The outcome of the event was reported as recovered. The benefit-risk relationship of mRNA-1273 Bivalent .222 (original and omicron BA.4/BA.5) is not affected by this report.
Patient presented with a very red, open wound (almost the size of a dime) where vaccine was given. He said it wasn't oozing or painful, but looked like it had previously been weeping. Stated it hadn't gotten any better or any worse. He also stated his wife had received hers on the same day and had no issues, same lot and expiration date.
Pt developed shingles (mild). Pt then prescribed Valacyclovir via MD
Headache, Myalgia, Fever, c/o fatigue,chills. Told to see primary care physician if no improvement Narrative:
Shortly after administration, pt fainted, had a small seizure, and we were unable to attain a blood pressure reading.
9/3/14 Took 1st tab - no adverse effect. 9/5/14 Took 2nd tab - no adverse effect. 9/7/14 - hives on forearms only- BENADRYL/Cortisone topical. Took 3rd dose. 9/9/14 - Took 4th dose - rash spreading on arms. 9/10/14 - chills, diarrhea, nausea, headache - rash turns to hives. 9/11/14 - headache, dizziness, achy joints, diarrhea, continued hives - supportive care, Ibuprofen, BRAT diet. Offered Rx for nausea - declined. Using ginger tabs.
Approximately 30 minutes post immunization, she developed throat tightness and tongue swelling.  Patient was assessed by the Medical Assistance Team and  transferred to ED. Did not require epinephrine  prior to transfer.
Flu like symptoms, 100 degree fever, body ache, general weakness, lasted for one and a half days.
Redness at injection site, left deltoid, measuring approximately 4cm. long, 3cm. wide. Warm to touch, no pain, knot approximately 2cm. round, itching.
Bleeding on the arm; soft ball sized lump on my left armpit; It is very very tender; Pain in armpit; shoulder pain; Nausea; Bodyache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Bleeding on the arm), VACCINATION SITE MASS (soft ball sized lump on my left armpit), TENDERNESS (It is very very tender), AXILLARY PAIN (Pain in armpit) and ARTHRALGIA (shoulder pain) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced VACCINATION SITE MASS (soft ball sized lump on my left armpit), TENDERNESS (It is very very tender), AXILLARY PAIN (Pain in armpit), ARTHRALGIA (shoulder pain), NAUSEA (Nausea) and MYALGIA (Bodyache). On an unknown date, the patient experienced VACCINATION SITE HAEMORRHAGE (Bleeding on the arm). At the time of the report, VACCINATION SITE HAEMORRHAGE (Bleeding on the arm) outcome was unknown and VACCINATION SITE MASS (soft ball sized lump on my left armpit), TENDERNESS (It is very very tender), AXILLARY PAIN (Pain in armpit), ARTHRALGIA (shoulder pain), NAUSEA (Nausea) and MYALGIA (Bodyache) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Concomitant product use was not provided.  Treatment information included putting ice on the lump. Physician said not to consider second shot and he did not take his second shot.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Follow-up new information received: Event bleeding on the arm and vaccine dose 2 was withdrawn; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Following her vax in 2/00 the pt experienced pains, backaches, muscle aches, neck pain, and joint pain, which reportedly she described as very similar to her symptoms from Lyme disease. She was seen by her physician on 5/22/00. He performed several blood tests, the results of which are pending. The most recent information received on 1/26/00 reports the outcome of the event is unknown.
Onset - chills, joint pain, headache. Decreased limb movement 24 hrs after onset, headache worsened, joint pain increased, increased bruising at injection site. 72 hrs headache still present. Cellulitis, swelling, warm to the touch. She now denies joint pain and moves her left arm well. She is recovering.
Mild fever around 100 degrees, severe chills, headache, fatigue,  sore arm at injection site.  Ongoing from around 7pm so about 2 hours at this point. Arm felt a bit sore for the first time around 2pm today.
Pt had tdap and Flu shot 020811. Broke out in rash/itching 2 days after shots. Was seen by Dr. on 021011. Prescribed BENADRYL. Not resolved. Saw pt again on 021111 at which time I went to his office to evaluate rash on extrem. & trunk. Dr. tx'd pt with Cortisone shot that resolved rash.
This spontaneous report as received from a nurse refers to a patient of unknown age. No information about medical history, concurrent conditions were reported. On an unknown date the patient was vaccinated with PROQUAD (Merck). No concomitant medications were reported. The nurse reported that 5 doses of PROQUAD (Merck), that had been improperly stored, were inadvertently administered to unspecified patients of unspecified dates. No adverse effects reported. There was no product quality complaint. This is one of the two reports from the same reporter (MARRS # 1408USA007660). Additional information has been requested.
Severe left arm pain with inability to move left arm, nausea, vomiting, diarrhea.
Rashes from head to toe, fever, hyper-sensitivity to noise, severe insomnia, severe mental degredation/confusion. Episodes are recurring and last nearly a week long each episode. She just finished her third episode. Slept less than 5 hours in 5 days. No appetite. Complete mental shut down like she is drugged. Terrible.
pneumonia; flu; Initial information was received on 19-Nov-2020 regarding an unsolicited valid serious case from the physician via non-healthcare professional.  This case involved an adult male patient (age was not specified) who had pneumonia and flu (influenza), after he received INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s), family history and concomitant medication were not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient developed serious pneumonia and flu (influenza), (unknown latency) following the administration of INFLUENZA VACCINE.  The event of pneumonia was assessed as medically significant.  It was unknown if there were lab data/results available.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the outcome of the events was unknown.  Information on the batch number was requested.; Sender's Comments: This case concerns an adult patient who presented with pneumonia and influenza, after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is unknown. The patient's medical condition at the time of vaccination and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
RECEIVED FIRST COVID VACCINE MODERNA LOT# ER8729 ON 04/17/2021. SECOND DOSE PFIZER LOT # EW0175  ON 05/08/2021
employee reported mild swelling and tenderness of right armpit area lymph nodes approximately 24 hours post receiving second dose of covid 19 Pfizer vaccine on 1/7/2021 in right arm.  When questioned the employee stated she also experienced the same mild swelling and tenderness of the armpit area lymph nodes with first dose of vaccine also.  The first dose of vaccine was given 12/18/2020 at approximately 1600 in left arm and lymph node mild swelling and tenderness noted in left armpit the following evening.  On both occasions the swelling and tenderness lasted 48-72 hours and occurred in the corresponding armpit of the arm which vaccine was administered
Joint PAIN -upon awakening the next day I had severe neck and bilateral hip pain. It hurt to hold my head up and even lay on a pillow. Took 800mg Advil prn for about 4 days. Tonsillitis- Right tonsil was inflamed and sore . This started  5 days after the vaccine and lasted 3 -4 days. Used warm water rinses and gargled with Listerine As I am a Nurse with Rheumatoid arthritis , I know there is not much info about subjects with my underlying conditions . I just wanted to report that it did cause a flare in my symptoms but it lasted less than a week. I did hold my Humira for one week after the vaccine as I know it is a "t-cell " inhibitor and I wanted a good result from the  vaccine. I had my second shot today and can update you as to how things go
Dizziness, pressure on back of neck, flushed. EMS attended and cleared patient.
there was a little bit of leakage when she administered typhim vi pfs with no reported adverse event; Initial information received on 08-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 75 years old female patient who for whom there was a little bit of leakage when she was administered with vaccine typhoid VI polysaccharide vaccine [Typhim VI] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Encephalitis Vaccine for Prophylactic vaccination (immunization).  On 07-Jun-2023, the patient received 0.5 mL dose 3 of suspect typhoid VI polysaccharide vaccine, solution for injection (batch number: V2A451M; expiry date: 24-Oct-2027) via intramuscular route in unknown administration site for Immunization.  On 07-Jun-2023 the patient developed a non-serious there was a little bit of leakage when she administered typhim vi pfs with no reported adverse event (incorrect dose administered) (same day latency) following the administration of typhoid VI polysaccharide vaccine.  It was reported, Nurse reported that there was a little bit of leakage when she administered TYPHIM VI PFS to a patient.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event there was a little bit of leakage when she administered typhim vi pfs with no reported adverse event.  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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
1st shot left patient with big swelling redness and warm to touch reaction at injection site. patient counseled on using cold compress and tylenol and zyrtec to reduce reaction and told her it is okay to come back for 2nd shot (this is part of the risks of getting shingrix)
Dizzy patient. Felt faint. Sweating. Gave water and juice and held upright. Needed about 15 minutes of care. Then color came back to face and stated he would be okay.
I began to develop whole body hives and urticaria approximately 10 days after vaccine administration. No new medications or causes. My sister also experienced the same side effects within 10 days. We live in separate households.
soreness in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 09Feb2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "soreness in the arm".  Additional information: This report was received from a Pfizer-sponsored program.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
1-At about 1 you post administration: Chest tightness, sneezing.  Felt systemic "weird" -not well. Treatment: Ventolin (2-puffs), 50 mg Benadryl (oral). Resolved in 24 hours 2-Day 1-2: Mild injection site pain. No treatment.  Days 3-7: pain migrated from injection site down left arm and into upper shoulder.  not positional or movement related - described as an ache like bone pain and disputes sleep.  Treatment; Arthritis Strength Tylenol, local area massage, heat.
Sore shoulder to elbow, seems weaker than should be. Other arm fine. Noted arm soreness at site for 1-2 days post vaccination. States above symptoms have continued. Declines physician evaluation.