chrisvoncsefalvay/vaers-outcomes huggingface dataset:
flu like symptoms; patient lost 16 lbs due to a recently being diagnosed with NASH/Fatigue was not as bad; This spontaneous report was received from a health care professional, referring to a patient of unknown age and gender. The patient's concurrent conditions included rheumatoid arthritis. The patient's pertinent medical history, previous drug reactions, allergies, or concomitant medications were not reported.  On an unspecified date (also reported as a couple of weeks ago), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection and zoster rgE vaccine (mammalian) (SHINGRIX) (doses, vaccination schemes, frequencies, routes of administration, anatomical sites of injection, lot numbers and expiration dates were not reported), both administered as prophylaxis.   On an unspecified date, after the vaccines were administered, the patient experienced flu like symptoms (influenza like illness), that lasted 2-3 days (recovered). On an unspecified date in 2020, the patient lost 16 pounds (lbs), due to recently being diagnosed with non-alcoholic steatohepatitis (NASH). The patient's cholesterol was checked for 2 weeks and the hepatologist was monitoring the blood levels. Also, the patient stated that, the "fatigue was not as bad" and had some minor improvements, such as less pain and swelling in the hands, wrists, elbows, shoulders, kness, ankles, feet, neck, and hips on occasion. In addition, the patient mentioned that, all the team of "mds" had great communication, and since starting therapy, the patient has not had any side effects.   The outcome of the event non-alcoholic steatohepatitis was not reported. The causal relationship between the events influenza like illness and non-alcoholic steatohepatitis and therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and zoster rgE vaccine (mammalian) (SHINGRIX), was not provided.  Upon internal review, the event non-alcoholic steatohepatitis was determined to be medically significant.
I was diagnosed with dysautonomia, VTACH, and other cardiac arrhythmias; cardiac arrhythmias; VTACH; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 37 year-old patient received bnt162b2 (BNT162B2), administration date 15Jul2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "I also had covid 7 months prior to my vaccine" (unspecified if ongoing), notes: I also had covid 7 months prior to my vaccine with no lasting side effects. The patient's concomitant medications were not reported. The following information was reported: AUTONOMIC NERVOUS SYSTEM IMBALANCE (hospitalization) with onset 16Jul2021, outcome "unknown", described as "I was diagnosed with dysautonomia, VTACH, and other cardiac arrhythmias"; ARRHYTHMIA (hospitalization, medically significant) with onset 16Jul2021, outcome "unknown", described as "cardiac arrhythmias"; VENTRICULAR TACHYCARDIA (hospitalization, medically significant) with onset 16Jul2021, outcome "unknown", described as "VTACH". Therapeutic measures were taken as a result of autonomic nervous system imbalance, arrhythmia, ventricular tachycardia. The lot number for bnt162b2 was not provided and will be requested during follow up.  Additional information: The patient also had covid 7 months prior to my vaccine with no lasting side effects.; Sender's Comments: Based on the available reported information, the causal association between the events Dysautonomia, Arrhythmia, Ventricular tachycardia, and the suspect drug BNT162B2 cannot be excluded considering drug-event temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Parent reports woke up with hives the next day. Zyrtec given but continued to spread so seen. Gave shot of Benadryl and steroid. Hives improved after treatment. Denies respiratory symptoms, GI symptoms after vaccine. No recent illness. No other exposures or foods eaten in last week. Received COVID-19 vaccine 2 weeks prior.
pt recvd vax 18MAY93 & exp pain similar to the pain exp w/herpes zoster; did not devel lesions; 7JUN93 devel nausea & vomiting; No further details were provided;
Initial and follow-up information has been received from a nurse concerning an 82 year old white female patient, with unknown medical history and unknown drug reactions/allergies, who on 14-Oct-2005 was vaccinated intramuscularly in the right deltoid with 0.5 cc first dose of pneumococcal 23v polysaccharide vaccine (Lot # 650648/0967P). It was reported that the patient developed swelling of the arm on 15-Oct-2005, erythema, and unable to use the arm, which lasted about 4-5 days. The patient was given 50mg diphenhydramine hydrochloride (Benadryl), "with no results/did not help." It was previously reported that on 17-Oct-2005 the patient called and was seen by the physician, complaining she could not lift her arm, had a lot of pain in her entire arm. She was placed under a heat lamp. At the time of the report it is unknown if the patient recovered. No product quality complaint was involved. The reporter felt that the adverse event resulted in persistent or significant disability/incapacity. No additional information is expected.
After receiving the first dose of Pfizer Covid 19 vaccine, I started feeling fatigue especially noticeable when running or exercises elevating heart rate. I tried to run in the evening I received the first dose and felt fatigue but pushed myself.  For the next three weeks I felt tired and not like myself when trying to exercise. My resting heart rate, which i monitored regularly with a fitness tracker and usually about 55 bpm, did not drop below 80 bpm for about three days after the vaccine. When performing exercises which raise heart rate Iwas feeling unusual fatigue, shortness of breath, and dull ache at the heart area.  Sometimes while sitting  I would get a jabbing feeling and would sigh more often Three weeks later, at about the time i needed to get the second dose, my feelings did not improve so I visited my family care doctor, who ran some blood work to rule out any deficiencies and then referred me to a cardiologist. At this point I stopped any exercising. My cardio testing was done at about 6 weeks after the initial vaccine and thankfully showed my heart was ok. I actually started to feel better about the 5th week. Maybe stopping the cardio heart exercises for a while helped me recover. A video i came across from a doctor suggested that cardio and strenuous exercises should be avoided for at least a week after the vaccine is administered to reduce the chance of heart issues. I wish I had known that before as i would have stopped training. They should do more to make that information known so others don't experience these symptoms or worse because  sometimes the damage may be irreversible.
arm hot to the touch; aching arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (arm hot to the touch) and VACCINATION SITE PAIN (aching arm) 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 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced FEELING HOT (arm hot to the touch) and VACCINATION SITE PAIN (aching arm). At the time of the report, FEELING HOT (arm hot to the touch) and VACCINATION SITE PAIN (aching arm) outcome was unknown. Not Provided          No relevant concomitant medications were provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-046612 (Patient Link).
I got the Moderna vaccine, I had normal soreness in my arm and a little bit of swelling. The next day I woke up feeling dehydrated and sore, all of my joints ached and I was tired all day. The next day was Saturday, I was feeling much better. But then I woke up feeling terrible with awful stomach pains, nausea and cramps on Sunday. No vomiting but pain all day long. That continued all of Sunday and a good part of Monday. And then I ended up reaching out to Kaiser about the abdominal pain, it turned into what I thought was UTI because I was having terrible pains. After tests, turns out that I was just having bouts of diarrhea, constipation and lower abdominal pain. Everything came back negative, we just waited to see. I didn't really get any treatment. But I am getting stomach pains again.
accompanied by nausea; muscle aches; very tired; slept most of the day; experiencing chills/shivering which worsened until 3am following morning; This is a spontaneous report received from a non-contactable reporter (Consumer). The reporter is the patient.  A 58 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 15Apr2021 09:00 (Lot number: EW0164) at the age of 58 years as dose 2, single for covid-19 immunization. Relevant medical history included: "hypothyroid" (unspecified if ongoing); "migraine" (not ongoing), notes: have diminished and rare; "postmenopausal" (unspecified if ongoing); "rosacea" (unspecified if ongoing); "Gravida 4" (unspecified if ongoing); "Para 2" (unspecified if ongoing). Concomitant medications included: SYNTHROID; VIT D3; CALCIUM. Past drug history included: Ampicillin, reaction: "known allergies: minor rashes"; Sulfonamide, reaction: "known allergies: minor rashes". Vaccination history included: BNT162B2 (Dose 1, Lot number: ER8732, Anatomical location: Left arm, Administration time: 08:00 AM), administration date: 25Mar2021, when the patient was 58 years old, for covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 15Apr2021 20:00, outcome "recovered" (18Apr2021), described as "experiencing chills/shivering which worsened until 3am following morning"; NAUSEA (non-serious) with onset 16Apr2021, outcome "recovered" (17Apr2021), described as "accompanied by nausea"; MYALGIA (non-serious) with onset 16Apr2021, outcome "recovered" (18Apr2021), described as "muscle aches"; FATIGUE (non-serious) with onset 16Apr2021, outcome "recovered" (18Apr2021), described as "very tired"; SOMNOLENCE (non-serious) with onset 16Apr2021, outcome "recovered" (18Apr2021), described as "slept most of the day". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, nausea, myalgia, fatigue and somnolence.  Additional information: On 15Apr at 8pm, patient began experiencing chills/shivering which worsened until 3am following morning (16Apr) and accompanied by nausea (no vomiting). For remainder of 16Apr continued with intermittent chills (at no time did she have a temperature over 101.5), muscle aches, very tired, slight nausea and limited intake to water only and slept most of the day. On 17Apr she was very tired, nausea resolved resumed light meals, chills only had occurred on 3 instances but much less severity than previous. On 18Apr, it was fully resolved. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
Took me down for 24 hours; This case was reported by a consumer via interactive digital media and described the occurrence of malaise in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced malaise. On an unknown date, the outcome of the malaise was recovered/resolved.   It was unknown if the reporter considered the malaise to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 30-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that he/she detests shot but this Shingles vaccine scares him more. The patient reported that the 2nd dose was a doozie and took him down for 24 hours. Additional supportive information: Follow-up would not possible as no contact details were available.
Erythematous, indurated, high temperature area to left lower deltoid area, no tenderness.
ActHIB mixed it with the diluent from an MMR vaccine which is sterile water, no AE; Initial information received on 22-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves patient (age not reported) who received HIB (PRP/T) VACCINE [ACT-HIB], which was mixed with the diluent from  MMR vaccine which is sterile water.  Medical history, medical treatment, vaccination and family history were not provided.  On an unknown date, patient was supposed to receive ActHIB vaccine  and instead of using a ActHIB vaccine the LPN by mistake took out the HIB (PRP/T) VACCINE (ActHIB) vial (Lot # UJ111AA exp 14Oct2020) from a DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] box (lot # UJ111AAA exp 14Oct2020) and gave that. She mixed it with the diluent from an MMR vaccine which is sterile water.  It was an actual medication error case due to Wrong solution used in drug reconstitution (product preparation issue).   At the time of the report, no adverse event was reported.  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 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.
Weakness in right hand mostly  between thumb and forefinger.  Loss of control when try to pick things up or use right hand.
Started with rash on abdomen and under right breast.   Still have active rash in those areas as well as rash as on my scalp, back and buttocks.
low blood count; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient)  A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Medical history included cancer from 2020 to (she received 12 infusions and then was fine). Concomitant medication included prednisone.  The patient experienced low blood count on an unspecified date. The outcome was unknown.  Caller would like to know whether she should still get the 2nd dose of the Pfizer COVID vaccine as she has had a low blood count since the 1st dose. Being on prednisone, caller doesn't know if that will be a problem to getting her 2nd dose of the COVID vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This medically confirmed literature report (initial receipt 13-Oct-2015) concerns a 34 year old female patient. On an unknown date, the patient received an intramuscular injection of an influenza virus vaccine (brand and batch number unspecified) to the deltoid region of the arm. The patient reported 3 weeks of right shoulder pain beginning during vaccination. She noted more pain than usual during the vaccination and stabbing.  The patient experienced 9/10 shoulder pain with internal/external rotation and adduction afterwards. She denied any instability, clicking/popping, neurologic symptoms in the arm/hand, or any new repetitive activity. On examination, active internal/external rotation, resisted external rotation both with the shoulder adducted and abducted to 90 degrees and shoulder impingement maneuvers were painful. Reflexes, strength, sensation and AC joint provacative maneuvers were normal. Traumatic infraspinatus and/or teres minor tendon injury was suspected as the cause of her pain. She received little benefit from oral anti-inflammatory medication, a diagnostic subacromial lidocaine injection and 6 physical therapy sessions. T2-weighted shoulder MRI demonstrated infraspinatus tendinosis without frank tear. She was scheduled to undergo ultrasound-guided diagnostic lidocaine injection of the infraspinatus tendon sheath. The outcome was not reported. Reporter's Comments: Reporter's comments: In this case, improper injection proximally into the deltoid muscle resulted in infraspinatus tendon injury. Iatrogenic infraspinatus tendon injury during deltoid IM injection is a rare complication. Sender's Comments: Company comments: Seriousness: Serious. Medically significant. Listedness: Unlisted. Brand of vaccine not specified. Assessment according to the CCSI for CSL Inactivated Influenza Virus Vaccine and the Afluria Product Information, all events are unlisted, except for injection site pain. Causality: Possible. Increased pain was noted upon vaccine injection, with eventual development of impairment of shoulder joint motion and pain in the following 3 weeks. This patient developed signs and symptoms consistent with previously described cases of shoulder injury related to vaccine administration (SIRVA) in literature. SIRVA is due to an inflammatory effect from vaccine administration into the subdeltoid bursa. This inflammatory response may be due either to the antigenic or nonantigenic components of the vaccine. Given the temporal relationship and the plausible mechanism, this case is assessed as possibly related.
PATIENT HAD A VASOVAGAL REACTION, FELT DIZZY, CLAMMY, HAD TO LIE DOWN.  AFTER DRINKING COLD WATER AND APPLYING ICE TO FOREHEAD FELT IMMEDIATELY BETTER
A consumer report has been received concerning a 14 year old female patient. The patient's medical history and concomitant medications were not reported. The patient's sister received nasal FLUMIST for unknown indication on 05-Nov-2012 and patient developed symptoms. The patient's mother reported that patient had secondary transmission 3-4 days after her sister received FLUMIST on 05-Nov-2012. The patient developed symptoms of fever, sore throat, swollen tonsils, cough, chills, and congestion. The outcome of reported events was unknown. The company physician assessed the event to be non-serious.
I woke up the next morning with a fever of 101, some body aches and general malaise. This lasted the remainder of the weekend and then resolved. Each time I had additional doses, I had the same reaction. I would body aches and a low-grade fever. After each one I would experience a couple of days of severe body aches and up to a week of low-grade fever around 100.0. My doctor did a lot of tests and all of my inflammatory markers were high. They continued to happen and in the spring around April, I ended up getting extreme body aches, so I asked to be referred to a Rheumatologist who diagnosed me Zero Negative Rheumatoid Arthritis. I started hydroxychloroquine on this past Friday. I was advised that it would take 6 weeks for the medication to take effect. I am still actively having symptoms. I am taking TYLENOL ARTHRITIS which does help a little bit.
pt recv vax in 1990 & subsequently failed to seroconvert for measles; No further details were provided;
22JAN93 lt leg pain, refused to walk on leg; swelling to foot by 23JAN93; fever 102-104 on 24JAN93;
Diffuse pruritic papular rash noted on trunk, arms and legs after morning shower on 3/4/11. Rash lasted about 3-4 days before gradually disappearing.  Employee also felt fatigued.
pains; Left shoulder pain; muscle ache; A spontaneous report was received from a consumer concerning a 73-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events left shoulder pain, muscle ache, pains.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 17 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 016M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection and on same day she experienced  left shoulder pain, muscle ache, pains off and on ever since. She also had major surgery on 9Feb21 and is not sure if this could be part of it too.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), left shoulder pain, muscle ache, pains was unknown.
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 25-NOV-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September of 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) GARDASIL injection (lot # L016428, exp. date: 30-JUL-2017) (route, dose and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
No reaction first week, then suddenly a big red patch appeared around the location of the shot on my arm.  It is hot to the touch and very itchy, and the circle or redness keeps increasing.
Raised papular non-urticarial rash began several hours after H1N1 injection given. + itchiness. Rash still present on follow up 2/3/10. No distress. Dx vaccine reaction is viral exanthem/pityriasis rosea.
A non-serious spontaneous report of FLUMIST inadvertently given to a 52-year old male was received from a pharmacist.  The patient's medical history was not reported.  There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
A non-serious spontaneous report of gave 1/2 dose of H1N1 was received from a consumer concerning a 23-year-old female. On 27-Oct-2009 the patient received 1/2 dose (0.1 ml) of H1N1, Intranasal in a single nostril. The other half of the dose was discarded by the person administering the vaccine. There was no adverse event associated with this vaccine underdose; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Very sore vaccination site, whole body aches, including head, fatigue; Motrin was helpful; attempted work next day but incr aches; slept off & on most of day, w/ Motrin in between.
Sweating, stomach discomfort, diarrhea - pt noticed (R) arm hurting just prior to adverse symptoms, patient said this is her first flu shot.