chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain at the injection site; Rough flu like symptoms; Fever; Chills; Increased bowel movements; First 24 hours after brutal symptoms started, was in bed; Next 24 hours was still moping around; Was still barely eating; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number 27PA5, expiry date 3rd February 2023) for prophylaxis.   On 22nd October 2021, the patient received the 1st dose of Shingrix (intramuscular). In October 2021, 12 hrs after receiving Shingrix, the patient experienced injection site pain, influenza-like symptoms, fever, chills, frequent bowel movements, feels awful, asthenia and decreased appetite. On an unknown date, the outcome of the injection site pain, influenza-like symptoms, fever, chills, frequent bowel movements, feels awful, asthenia and decreased appetite were recovered/resolved.   It was unknown if the reporter considered the injection site pain, influenza-like symptoms, fever, chills, frequent bowel movements, feels awful, asthenia and decreased appetite to be related to Shingrix.  Additional details were reported as follows: The pharmacist, who was also the patient reported that he received the first dose of Shingrix in his left deltoid.  Twelve hours after the injection the patient started experiencing pain at the injection site, rough flu like symptoms, fever, chills and increased bowel movements.  The first 24 hours after the symptoms started, the patient was in bed, the next 24 hours symptoms started improving but he was still moping around and barely eating. Symptoms started improving after the third 24 hours and disappeared the next day.  The symptoms were reported as brutal. The reporter consented to follow up. This case had been linked with case US2021239187, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021239187:Same reporter.
This case was reported by a consumer via call center representative and described the occurrence of myalgia upper extremities in a 58-year-old female patient who received SHINGRIX for prophylaxis.  Concomitant products included sumatriptan succinate (Imitrex). On 5th June 2018, the patient received the 1st dose of SHINGRIX. On 5th June 2018, less than a day after receiving SHINGRIX, the patient experienced myalgia upper extremities, inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the myalgia upper extremities was recovered/resolved and the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. It was unknown if the reporter considered the myalgia upper extremities to be related to SHINGRIX. Additional details were provided as follows: The patient reported that she experienced a sore arm (muscle pain) which lasted for 7 days. The patient also reported that he did not see the pharmacist mix the liquid and powder together as she did at time of 2nd dose vaccination and thought that she might have just received the adjuvant suspension without the powder being mixed. This led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient was instructed to contact her pharmacist to discuss. The permission to send letter asking for doctor information was given. For tolerance to 2nd dose refer linked case US2018GSK154592.
STARTED TO EXPERINCING PAIN AND WARMTH, NUMB, AND HARD TO TOUCH. PT TOOK IBUPROFEN ON THE 3RD DAY WHEN HE STARTED EXPERICING SIDE EFFECT. HE FEELS SOMETHING IS CRAWLING UP AND DOWN HIS INJECTED ARM (LEFT ARM) ONCE IN A WHILE, HE FEELS FUNNY AND TINGLING SENSATION ON HIS ARM. NO SWELLING ON HIS LYMPH NODE. HE CAN SILL FEEL HARD ON THE INJECTED SITE. HE'S STILL EXPERIENCING THE SIDE EFFECTS FROM THE VACCINE
Extreme vertigo, weakness, unable to walk, extremely unbalanced when attempting to stand up, severe Headaches, blurred vision.. Also with sinus type drainage. Extreme nausea and fatigue. Literally couldnt even hold his head up.  All sypmtoms started within 48 hours of injection and came on with a vengance. He was so unsteady and unstable he fell with attempts to get up. Prior to the vaccine he was great!  Strong and healthy for all of his underlying medical condtions.  Completely Independant, driving , working around the house ect.    Unfortunaley this is still going on. He is very weak, and still unsteady when he is up. Nausea continues. He is doing Vestibular therapy for the balance issues. Took a round of seroids.
Trouble swallowing, tight  airway, shortness of breath, loss of bladder function, loss of leg function (falls), continued arm pain and limited movement (still doing physical therapy)
I couldn't taste salt anymore.; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (I couldn't taste salt anymore.) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064H21A) for COVID-19 vaccination.     Concurrent medical conditions included Environmental allergy.    On 01-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TASTE DISORDER (I couldn't taste salt anymore.). At the time of the report, TASTE DISORDER (I couldn't taste salt anymore.) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported. The patient stated that the AE has recovered and the symptoms had been improved. No treatment medications were provided.   This case was linked to MOD-2022-577298, MOD-2022-577829 (Patient Link).
On January 19, I went to the doctor and was told I had Diverticulitis and a Bladder infection. I was given Flagel which is an antibiotic and Ceftin. The culture came back within four day later and was told it was Klebsiella Pneumoniae. I went back on 1/30 and was told I had a bladder infection again. I was given Bactrian and sent the sample to be cultured. The sample showed no growth, and I was told to stop the medication because it was affecting my pulse blood pressure. I still had symptoms so I went back on Feb 23, I was told I had a bladder infection, and they sent the sample to see if they could find growth. It came back as Klebsiella Pneumoniae. I was called in some Doxycycline, and this didn't help it caused issues with blood pressure and my pulse. I called the clinic and spoke with a nurse and the doctor on duty didn't feel comfortable calling in medication and he wanted me to come back in. I did return on March 2 and was told for the fourth time I was having a bladder infection. The doctor I have seen through most of this I was put back on Ceftin 250 and the sample was sent out to measure growth. It came back different with a bacteria called Enterococcus Faecalis I was put back on Macrobid for 6 days and I have recently be refereed to see a Urologist on April 4th.   Although I don't think its related....
Pt developed delayed redness and swelling at injection site hives and skin rash irregular shapes w/bumps approx. 2 in. Developed fever. Given oral Benadryl and TYLENOL.
Myopericarditis: Symptomatic with chest pain beginning 24 hours after vaccination and persisting until treatment anti-inflammatory medication.
took  2 syringes out of their package, drew up 0.5ml in 1 syringe picked up empty syringe, sterile, had not been used, inserted needle into patient's arm, then realized no vaccine in syringe. gave patient the vaccine in the filled syringe. patient had to be poked twice no adverse  reaction
Within approximately 15 minutes of the first dose Moderna vaccine being administered, my heart rate rapidly went up and my head felt woozy.  I felt warm, my lips felt sort of numb.  I did not feel well.  I was shaking, feeling very anxious with a fluttering feeling in my chest.  The ONE thing I did NOT experience was difficulty breathing.    After about 45 minutes of the initial onset of symptoms, I felt okay.    THIS SAME THING happened when I received the Moderna Booster on 10/29/2021 (Lot No. 012F21A).  HOWEVER, I did not experience ANY ADVERSE reaction to the 2nd Moderna shot on March 29, 2021 (Lot No. 028A21A) other than a sore arm and tired feeling.
Information has been received from a physician concerning an approx. 4 year old male child who received the following vaccinations on unspecified dates: 2 dose of MMRII, 1 dose of varicella virus vaccine live and 1 dose of HIB conjugate vaccine. The physician reported that between 2-3 years of age, the child was developing normally. He was made aware of the fact that another physician had since dx'd the child with autism. Upon internal review, autism was determined to be an "Other Important Medical Event". No further information is available. Follow up info from the physician noted, "I am not aware of any adverse reaction to any vaccines this pt recieved." No further info is available.
Depressed mood, anhedonia, irritability, fatigue. Started 1-2 days after shot. Continues about 1 week later. This is not like my usual self. First thought it was PMS but not aligned with cycle. I'm concerned about this.   Had injection site soreness, chills, fatigue for 2-3 days after shot which was mild to moderate and is fine now.
This spontaneous report as received from a healthcare worker refers to a 9 week old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 13-NOV-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2015, orally. The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
10 minutes after injection, patient experienced a tingling in throat and esophagus felt tight. He could still swallow. Breathing was okay. Took 50mg Benadryl and felt better after about 45 minutes. No other symptoms.
Severe and persistent headache. Started on the evening of the first dose and has persisted continuously since that time. Is not relieved with Tylenol, Ibuprofen, or Exedrine migraine.
This spontaneous report as received from a other health professional refers to two unspecified patients of unknown age. On 08-AUG-2017 the patients were vaccinated with GARDASIL 9 lot # N007931 for prophylaxis. On an unknown date the patients experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent for contact the reporter.; Sender's Comments:  US-009507513-1708USA006387:
Severe headache, earaches, tinnitus, jaw pain, eye pain started 2/27/2021. Started taking 300 ml of ibuprofen & 500 ml acetaminophen 3 times daily. Went to PC doctor, on 3/3/2021 who prescribed antibiotics and later a CT sinus scan.   Went to ER  on 3/22/2021 where was given CT brain scan, injection of ketorolac and 60 mg prednisone for 6 days. Finished prednisone and symptoms returned. Again taking ibuprofen and acetaminophen for pain.  Symptoms are still on a daily basis and did not go to receive the next vaccination.  Have follow up with ENT doctor on 3/25/2021 and neurologist on 4/23/2021.
Varicella vaccine received on 4/4/01. Developed red, papular rash, no vesicles. Brother developed chickenpox rash on 4/16/01 and 2nd brother also developed chickenpox.
This is a spontaneous report obtained from a contactable pharmacist through a Pfizer sales representative. A patient of an unspecified age, gender, race and ethnicity received PREVNAR 13 at single dose, on an unspecified date, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced pain, swelling and redness at the injection site. Clinical outcome of the adverse events was unknown at time of this report.
Severe swelling of lymph node in left armpit, sore arm. This was accompanied by worsening COVID-like symptoms over the next 48 hours (tingling mouth/throat sensation, sore tongue, headache, fever, chills, fatigue, and worsening of symptoms associated with my current chronic gastrointestinal conditions). Increasingly prominent periorbital edema that is worse in the mornings (eyelids are so puffy that I do not feel they are fully open)... it's hard to tell but I think all of my lymph nodes are a bit puffy, or there is a noticeable amount of water retention all over my body.  I still do not feel back to normal but have not sought medical treatment.  Currently, my arm soreness has mostly dissipated, and my lymph node is still enlarged but slowly reducing in size every day. Currently struggling with the worsening edema around my eyes and neck, pounding headaches, and fatigue/low stamina/getting winded easily.
Received COVID booster (Moderna) on 1/3/22, then that Saturday (1/8/22), I began presenting with whole-body itchiness, especially on my scalp. Random spots on my body would begin itching intensely and break out into hives. After awhile, it would subside and the rash/hives would break out in another spot. This happened on my legs, ankles, stomach, back, neck - it seemed to change each time. After about 2 days, I began to take Benadryl which helped the itching, however, I still suffered from hives and breakouts throughout the day. The following Thursday, I went back to the same clinic where I was diagnosed with "winter skin" and contact dermatitis with cause unknown. The doctor provided an anti-itch cream which somewhat helped calm the hives during breakouts. I also began taking 24-hr allergy medication daily since she said this may help. Since this time, I've continued taking the 24-hr allergy meds daily which has kept the itching minimal, but I still suffer from extremely sensitive skin, which I never experienced before receiving the booster shot. After researching online, the sensitivity can best be described as "Dermatographia" or "skin writing." Whenever my skin is lightly scratched or rubbed, it swells in those areas and sometimes produces hives as well.
covid positive 11/10/2021.  63-year-old male patient presented to the ED with complaints of shortness of breath, productive cough, and myalgias for the past 2 days. He states that he was vaccinated back in June against COVID with Johnson and Johnson vaccine. Otherwise, no sick contacts. No nausea, vomiting, fever, or chills at this time. The patient does have history of COPD and history of opioid dependence, which he is on Suboxone now as well as history of hypertension.  The patient denies any chest pain, nausea, vomiting, diarrhea, or syncope at this time. D-dimer 275-- 368--340--291 Treatment: oxygen, remdisivir /decadron/ceftriaxone/azithromycin. Discharged
patient did not receive her 3rd dose as patient needed last Thursday with no reported adverse event; Initial information received on 18-Jul-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves patient of unknown age who did not receive her 3rd dose as patient needed last thursday with no reported adverse event after receiving vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history, medical treatment(s),concomitant medication,  vaccination(s) and family history were not provided.    On an unknown date, the patient received an unknown dose of suspect RABIES (HDC) VACCINE(formulation, strength, lot number and expiry date was unknown) via unknown route in unknown administration site for Immunization. Information for batch and expiry date was requested.  It was reported that patient had a non-serious event of patient received her first dose on the day of exposure in the emergency room, came in for her second dose on day 3, but patient did not receive her 3rd dose as she needed last Thursday with no reported adverse event (product dose omission issue) (onset and latency: unknown).  Action taken : not applicable.  Outcome: Unknown  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.
headache, severe arm pain, diarrhea, full body water retention and inflammation, joint pains, tingling in hands and fingers, severe bleeding from vagina to date still has water retention, inflammation, tingling in fingers, arm pain
Had fever between 100.2 and 101.2 (taken under arm)froma few hours after shots(given at about 4pm on 6/3/03) until around 10:00am on 6/6/03. He was also very restless and cranky. He was given infant Tylenol.
Sick all night; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Sick all night) in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced MALAISE (Sick all night). At the time of the report, MALAISE (Sick all night) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No corrective treatment was provided.
Pt recvd 2nd dose of MMR on 19AUG89; On 16NOV90 dx w/mumps; Pt later recovered;
Pt called pharmacy 8/11/15 & reported swelling and redness of arm where injection/vaccine provided. Pharmacist on duty reported called to vaccine provider on 8/13/15. Pt advised to see dr.
Information has been received from a CMA concerning a 60 year old female who on 06/02/03 was vaccinated IM in the deltoid with a 0.5 dose of pneumococcal 23 polyvalent (Lot # 644219/1079M). On approximately 06/02/03 the pt developed soreness at the injection site, redness, swelling and the anterior aspect of the arm had redness that radiated to the axilla area. The pt also complained of being tired. On 06/04/03, the pt was seen in the physician's office and no treatment was required. No product quality complaint was involved. It was also reported that a 55 year old female was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # 644219/1079M) and developed soreness at the injection site, redness, swelling, being tired, and had pain in her hands and feet (WAES #0306USA00991).  Additional information has been requested.
Shot 1 Experienced  a stuffy left ear, after shot 2 tinnitus began after 3 days.
SYMPTOMATIC COVID-19; PROGRESSIVE SOB BEGINNING FOUR WEEKS PRIOR TO POSITIVE TEST RESULT.
All extremely severe: stomach pains, vomiting, diarrhea, shakes, nausea, dizziness, fever Was going to take her to emergency however I was able to get her cleaned up in shower and got  her cooled down.  Was able to get her to bed and slept for a few hours.   She took some nausea medication (Lorazapam). She was weak and tired and ran a fever of 100.9.   Temp came down to 99.8 by the end of the day.  On Sunday temp was normal.  Still very tired and weak.  As of today she is back to normal routine but still not quite her normal self.
Right upper arm, deltoid, shoulder, neck muscles, pec, and upper back muscles continue to ache .  Upper arm hurts when I roll over on it during the night.  Tylenol and ThermaCare patches do help but intermittent pain persists.  I don't need any further treatment but I did want to report that both shots in this series were very painful and that the second shot  produced persistent , dull pain.
MUFFLED HEARING IN BOTH EARS; FULLNESS ON BOTH EARS; WATER IN THE EARS; This spontaneous report received from a patient concerned a 24 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-APR-2021, the subject experienced muffled hearing in both ears. On 23-APR-2021, the subject experienced fullness on both ears. On 23-APR-2021, the subject experienced water in the ears. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muffled hearing in both ears, fullness on both ears, and water in the ears. This report was non-serious.
Patient came in today after getting flu shot yesterday. Patient had localized redness (approx 2-3 in across x ~1.5 in tall oval on arm around where shot was given). Pt stated the area was itchy, but no fever, no chills, no pain. Only reaction was redness and itching. Pt had flu shot in the past and had used the bandaid in the past with no reaction. Patient stated the shot did not hurt at all when given and still wasn't sore or painful (also mentioned that significant other had gotten injection yesterday as well with no reaction). Confirmed that we cleaned the area with alcohol pad and that the shot was given in the correct location. Area was slightly warm to touch, so instructed patient any signs of illness (fever, chills, etc) or if the area gets worse (starts to hurt, etc) or spreads, that pt should contact the doctor.
Patient experienced diarrhea and vomiting a couple of hours after the injection.  These symptoms lasted through the next day.  Treated by mother with Imodium.
pt recv vax 745AM came back to nurse 9:45;stated vomited, felt chilled;pt is asthmatic;uses inhaler for wheezing;pt stated had stomach flu/bronchitis 1mo earlier;pt vomited x1, chills, T97.2;
Pain/soreness at the sight of injection for a few days. Chills, headaches and fatigue the day after the vaccine and a few days later sores inside and outside my nose.  I still have the sores inside and outside my nose. Item 20 asks if I've recovered - I'm going to say yes - it's not life-threatening just painful and inconvenient.
Varivax given on 08/13/02. Chicken pox on 07/23/04.
got the shingles vaccine. She now gets them constantly; gets them constantly; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The reporter stated that, his/her mother in law got the shingles vaccine. She now gets them constantly. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.
I noticed itching at the injection site first about 6 to 7 days after the shot; it was then that I noticed the area was red about 3" by 2"; it remains itchy and red at 11 days after the vaccination.  I'm using Cortisone cream for the itch; it is slightly uncomfortable.