chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Major breakdown; was diagnosed with a 'behavior'  disorder; suffering and I am very upset; got worse; This is a spontaneous report from a contactable consumer (patient reported for herself). A 44-year-old female patient received bnt162b2 (PFIZER COVID VACCINE, Solution for injection, lot number: EW0181), via an unspecified route of administration on 03Jul2021 (age at the vaccination 44-year-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date 2021, the patient had a major breakdown, and the patient was diagnosed with a 'behavior' disorder (Not appropriately clarified hence disorder captured as event) due to Pfizer vaccine. The patient stated that it got worse and, the patient was rush to the hospital and blood work done all kind of stuff. The patient asked another question patient want to file a lawsuit as, the patient stated that "suffering and I am very upset". The patient lab test which included blood work was unknown on an unknown date 2021. The patient had taken a lots of treatment fostair 6 steroid was what the patient had but it was not working. That was steroid (unspecified). The medicine that patient had was steroid and the cream (unspecified), but it did not work for any way for the events. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Day 2 - Arm was very sore Day 3 - Headache all day Day 8 - Chills, Body Aches, Upset Stomach, Diarrhea Day 9-13 - Mild body aches in neck and shoulders, upset stomach and diarrhea
Vial had been removed from deep freezer and placed in cooler; remained in cooler beyond recommended time frame and not realized until after administered to patient (employee).
flu; Initial information was received on 13-Oct-2020 regarding an unsolicited valid non-serious case from the patient   This case was linked to case 2020SA290963 (same reporter).  This case involves an unknown demographic patient who experienced flu (influenza), while the patient received INFLUENZA VACCINE.  The patient's medical history, 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 non-serious flu (influenza), (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was not reported.  There will be no information available on the batch number for this case.
This spontaneous report was received from a pharmacist refers to a 68 year old male patient. In approximately November 2009 (reported as 5 years ago), the patient was vaccinated with PNEUMOVAX 23 (strength, dose and lot # was not reported). The reporter stated that a patient who received a dose of PNEUMOVAX 23, 5 years ago, was scheduled to begin chemotherapy for unspecified cancer (onset date not reported). At the time of the report, the patient's outcome was unknown. Upon internal review unspecified cancer was considered as an other important medical event. Additional information has been requested.
For about 6 hours I was shivering and had horrible body aches. My low back had the worse pain, it felt identical to passing a kidney stone or back labor, and I was running a fever. I took Advil and it helped.
This spontaneous report was received from a medical assistant referring to 32 year old patient of unknown gender. The patient's concurrent conditions and medical history were not provided. On 18-FEB-2016, the patient was vaccinated with an expired dose VAQTA 50/1.0 U/ml, lot # K014696, expiration date 11-NOV-2015, (route, dose and anatomical location were not provided). There was no concomitant medication described. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Patient woke up on 10/12/21 with sudden onset pain in her joints and was having trouble moving her knee joints in her legs. By day 2 patient was unable to move her Right Leg at the knee joint with full ROM; By day 3 both legs were show swelling at the joints, swelling in the elbow joint, neck, clavicle region and glands in the neck had swelling. Patient had fallen at home twice due to not having full range of motion of both legs. Went to the ER where they dismissed all of her signs and symptoms due to a CBC and CMP coming back normal and an ultrasound of the bilateral extremities showing no signs of a blood clot. Patient had a follow up and the physician ordered lab work such as a CRP, Ferritin Level, Rheumatoid Factor along with prescribing steroids and pain medication to help alleviate the inflammation in the body. The high doses of steroids did begin to alleviate the inflammation but when tapering off the steroids the inflammation came back immediately all over the body along with pain debilitating the patient to move. CRP level came back high. Rheumatoid factor came back negative. Patient has not had anything different except the Pfizer vaccine administered upon review. No injuries etc. No chronic health conditions or diseases. Patient hasn't had to be seen by a physician for anything except a normal yearly physical in past 3 years. Has never had COVID 19 and also tested negative x 3 within a 14 day period for COVID 19. No signs or symptoms of COVID 19. Severe adverse reaction has happened in this patient.
Vaccine was received from our Pharmacy on 6/9/22, vaccine expired in 10 weeks due to refrigeration storage which would have been 8/18. Patient received vaccine after expiration date. Spoke to CDC, they advise patient to be revaccinated for their booster.
thought i was going to die; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of impending doom in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced impending doom (Verbatim: thought i was going to die). Shingles vaccine was discontinued. The outcome of the impending doom was unknown.   It was unknown if the reporter considered the impending doom to be related to Shingles vaccine.     It was unknown if the company considered the impending doom to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-Mar-2023. The patient reported this case via interactive digital media. The patient had the 1st shot and would not take the 2nd. The patient thought he/she was going to die.
Information has been received from the nurse, reported that PROQUAD (Merck) (lot # J004321, Expiration date 17-OCT-2014) and VARIVAX (Merck) (capture in MARRS#1311USA002616) went through unsupported temperature excursion on 26-JUN-2013, 01-JUL-2013, 01-JUL-2013, 22-JUL-2013 thru 21-JUL-2013 and the entire month of August 2013. On 11-SEP-2013 one patient (age and gender not reported) was administered the unsupported PROQUAD (Merck) (dose and route not reported). No adverse effects reported. This is one of several reports received from the same source (MARRS# 1311USA012185, 1312USA003400, 1312USA003399, 1311USA002616, 1312USA003306, 1312USA003307, 1312USA003308, 1312USA003309, 1312USA003310, 1310USA003311, 1312USA003312, 1312USA003313, 1312USA003314, 1312USA003315, 1312USA003316, 1312USA003317). Additional information has been requested.
rash on his shoulder all the way to his elbow, that broke out; when he took the shot it hurt real bad; itching inside of his body, then all over arm where he has been scratching and scratching/ itching on left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (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 (Primary Immunization series completed; unknown manufacturer), for COVID-19 Immunization. The following information was reported: RASH (non-serious), outcome "not recovered", described as "rash on his shoulder all the way to his elbow, that broke out"; LIMB INJURY (non-serious), outcome "not recovered", described as "when he took the shot it hurt real bad"; PRURITUS (non-serious), outcome "not recovered", described as "itching inside of his body, then all over arm where he has been scratching and scratching/ itching on left arm". The events "rash on his shoulder all the way to his elbow, that broke out", "when he took the shot it hurt real bad" and "itching inside of his body, then all over arm where he has been scratching and scratching/ itching on left arm" required physician office visit. Therapeutic measures were taken as a result of rash, limb injury, pruritus.  Additional course: caller had called regarding the Pfizer booster shot. Caller confirmed he was a patient that had a rash on his shoulder all the way to his elbow, that broke out. Caller needs to know what was going on in his body the same way. Caller stated he took Benadryl like they told him and he was still having itching in his skin. Caller states he did not know what was going on but he understands he has itching inside of his body, then all over his arm where he has been scratching and scratching. Caller stated it was itching on his left arm. Caller stated when he took the shot it hurt real bad and when they shot him the rash came up the next day. Caller starts on his left side he had itching going down his leg. Caller states his doctor told him to contact Pfizer.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Arm was sore for 2 days after immunization given.  Pain resolved but then pain reappeared 2 days later.  Pain was much worse.  Patient c/o extreme pain when moving arm or putting pressure on area.  She was able to move the arm through full ROM but had pain.  Unable to sleep x 2 days.  No redness or induration at site on exam.
mom states pt started having sz 2AM 13DEC96;took pt to ER & returned home; sz cont & went back to ER & MD 13DEC96 AM;pt was given phenobarb & p/x-rays felt pt had pneumonia;placed on ATB;
Severe shoulder pain, aching, tenderness, weakness, discomfort. Tingling paint that moved down into the hand, all mentioned symptoms within 12 hours of vaccination.
Around 5 minutes after vaccination, patient had swelling around the injection site and the site was hot to touch. Patient applied ice and took aspirin, the swelling went down after about half hour but patient still felt soreness around left arm.
Hypergammaglobulinemia IgG-2 Subclass Deficiency and Recurrent Infections in Adults. Journal of Allergy Clinical Immunology 2006. Information has been reported in a published abstract article, title as stated above, concerning four patients in a study (three female, one male (WAES#0603USA00735) between the ages of 51-71 years who were vaccinated with pneumococcal 23v polysaccharide vaccine. All four patients had abnormal responses to pneumococcal 23v polysaccharide vaccine; one failed to respond to pneumococcal conjugate vaccine as well. There were four patients with hypergammaglobulinemia, IgG 2 subclass deficiency and a history of and/or frequent severe sinopulmonary infections. All four patients had normal responses to tetanus and diphtheria toxoids. Sinusitis was present in all; sinus surgery was required in two out of four patients. Bronchiectasis was present in two out of four patients. There was C4 hypocomplementemia in three out of four patients and autoimmune disease was present in three out of four patients. One patient had chronic lymphocytic leukemia. Two of three patients treated with IGIV had excellent responses. It was reported that the information provided was from the inpatient and outpatient consultation records of a single immunologist over a five year period (2000-2004). Upon internal review sinusitis was considered to be other medical event (OMIC). A copy of the published abstract is attached as further documentation of the patient's experience. No further information is available.
Information has been received from a nurse practitioner (N.P.) concerning an 11 year old female student who on 21 March 1997 (at 23 months of age), was vaccinated subcutaneously in the left arm with a first dose of varicella virus vaccine live (Oka/Merck) (lot# 617355/0567D). There was no illness at the time of vaccination. Subsequently, the patient developed a mild case of breakthrough chickenpox characterized by itchy papular lesions on her face, torso, arms and legs; and very few vesicular lesions. It was also reported that she papule on her pharynx, sore throat, headache and was "war". Unspecified medical attention was sought and the patient was treated with calamine (+) camphor (+) pramoxine hydrochloride (Aveeno) oatmeal and calamine lotion. No laboratory or diagnostic tests were performed. The patient's outcome was unspecified by the reporter. No product quality complaint was involved. Additional information has been requested.
Patient stated that she developed cellulitus in the left arm by injection site.  She visited the doctor and received an antibiotic to treat the infection.
- Missed periods for 2 months- periods came back 2 months after vaccines.  - Vomiting 3X day after -Fever -Chills/aching muscles
Got vaccine and breast feeding her son; Mild fatigue; Soreness at the injection site; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Got vaccine and breast feeding her son), FATIGUE (Mild fatigue) and VACCINATION SITE PAIN (Soreness at the injection site) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included Gestational diabetes on 06-Sep-2020, Anemia on 06-Sep-2020 and Pre-eclampsia on 06-Sep-2020. Concurrent medical conditions included Breast feeding since 06-Sep-2020.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 06-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Got vaccine and breast feeding her son), FATIGUE (Mild fatigue) and VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (Got vaccine and breast feeding her son) had resolved and FATIGUE (Mild fatigue) and VACCINATION SITE PAIN (Soreness at the injection site) had not resolved.        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.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Follow-up received on 31 Mar 2021 included no new information
Loss of mobility in right leg, unable to walk, 12 hours; went to family practice, on recommendation of doctor, went to ER for imaging, mri came out negative for stroke.  Regained mobility after 12 hours
Myocarditis; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Myocarditis) in a 27-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.        No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Spikevax), the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myocarditis) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  Patient developed myocarditis 3 days after 2nd dose of mRNA-1273 (Moderna) vaccine.  Company Comment: This literature non-study case concerns a 27-year-old female patient, with no medical history reported, who experienced the expected and serious (due to medically significant) AESI of Myocarditis, which occurred 3 days after mRNA-1273 vaccine, administered as second dose within COVID-19 vaccination schedule. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 is not affected by this report.           This case was linked to US-MODERNATX, INC.- MOD-2022-686179 (Linked Report).; Sender's Comments: This literature non-study case concerns a 27-year-old female patient, with no medical history reported, who experienced the expected and serious (due to medically significant) AESI of Myocarditis, which occurred 3 days after mRNA-1273 vaccine, administered as second dose within COVID-19 vaccination schedule. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.- MOD-2022-686179:(26 YO male)
Extreme chills, muscle pain/body aches, joint pain, nausea, vomiting, dizziness, fatigue, weakness.
This spontaneous report was received from a medical assistant and refers to a 3 months old female patient. No information regarding the patient's pertinent medical history, concurrent conditions and drug reactions/allergies was provided. On 04-AUG-2016 at 16:44, the patient was vaccinated with an improperly stored first dose of ROTATEQ lot # L039141 and expiration date 16-AUG-2017, (Strength and dose were not reported), via oral. It was reported that the vaccine was exposed to a temperature excursion described as a minimum (MIN) of 33 Fahrenheit (F) degrees for 10 minutes and a maximum (MAX) of 48 F degrees for 10 minutes. The healthcare worker also stated that the MIN and MAX were not cleared previously. No previous temperature excursion was noted. Patient's concomitant medication was not provided. No adverse effects were reported. A product quality complaint was not involved. This is one of the several reports received from the same source. Additional information is not expected because all follow ups requested to complete the case were received.
Janssen COVID-19 Vaccine EUA The morning after the vaccine was administered, I awoke with a scratchy throat,  itchy eyes and feeling very tired.   Throughout the morning,  the fatigue increased and I felt flushed in my face, but chilled in my arms and body.  I went home at noon and  found I had developed a fever of 100.9, which eventually increased to 101.3 later that afternoon.  I felt joint pain and general malaise.   Two days after the vaccine, the fever had broken and the joint pain was better. I still have fatigue, but it is improving throughout the day.
Vasovagal within 1 minute of vaccination. Elevated legs, ice pack. Able to ambulate on own 15 mins later
I asked for the flublok version of the flu shot. I had heard from others that they felt better than normal afterwords when the recieved this version so i thought i would try it. The nurse seemed to be upset that i was asking for a specific shot and  seemed to throw her off. I said i was fine with either . She finally agreed to it . The shot hurt when given .the shot was given very high on my left shoulder. the next day the my shoulder hurt at the site and was red and a little swollen. i thought it would go away but it never did. the pain eventually was too much and i contacted my workplace  who gave me the shot. I told them on 12/6/2021 about my pain and how im still having issues. They sent me to their workplace injury department the following day 12/7/2021. I was told by nurse practitioner that she thought it was inflamation from the shot. I was given a steroid for 5 days. the steroid helped a lot and took virtually all my pain away. Once i was off the steroid though some of my pain came back. I saw them again on 12/27/21. dr wanted to then have me sent to have an ultrasound done and see an orthopedic thinking it could be something more than just inflamation. clinic denied me being able to go through either of those options since i was going through the hospitals work i njury claims dept . after weeks of eventually being denied my injury claim I went to my own doctor on 2/10/22. Doctor ordered me an ultrasound on 2/21/22. The ultrasound showed a cyst in my shoulder where the injection was given . Doctor believed the cyst was an adverse effect of the shot. I then saw an orthopedic on 5/19/22. I was given an xray and went over the ultrasound with him as well. He also belived the cyst was related to the flu shot. He also said he believed Inflamtion was giving me more of the continious pain then the cyst though and put my back on steroids for 9 days. the steriods did not help as much  as last time but overall my pain is managable. Dr said my other options are having the cyst drained  and a steriod shot given or possible surgury to remove the cyst.
Large edematous area around site of administration area very sore to the touch and painful. Pt has received flu shot before with no reactions.
numbness and tingling of hands/feet, also muscle fasciculations.  daily sx x 8 months which are slowly worsening
Usual expected effects that increased in severity as time passed but on 4/13/2021 in the late afternoon/early evening, while resting in recliner, my body had a heaviness as if pressure was pushing me into the recliner. On 4/14/2021 at 4 am, woke, after about 10-15 minutes I felt nauseous, then cold clammy sweat outbreak, then dizziness and thought I would pass out. Sat on the floor so I wouldn't fall, laid on back, had the heavy pressure as if pushing me into the floor. I focused on ceiling and prevented a pass out (I think). After a few minutes, it was over and I was able to get up. Two hours later, severe migraine type headache came back. (all effects in Cont page note)
throbbing headache, nausea, dry heaves, sore arm, feels like she has flu, shoulder blades sore, coughing, headache goes to back of neck, thirsty
approx 26 days p/vax pt exp rash w/6 lesions, rash was described as erythematous papules on an erythematous base, pt afebrile w/no other sx
Shortly after shot began to experience shoulder and elbow pain in left arm.  Shoulder pain went away after 48 hours but the elbow pain has persisted for almost a week.  The pain in on the back side of my elbow at the crux.