chrisvoncsefalvay/vaers-outcomes huggingface dataset:
13 hours post immunization- fever 100-102 degrees, sweat, chills, SOB, & nausea. 9-30-09 seen by Dr. 10-5-09 seen by another Dr.   10/28/2009 Medical records and discharge summary received for DOS 10/13-10/15. FINAL DX: Multisystem illness with fever, hepatic and pulmonary involvement, Possible bronchiolitis obliterans, No significant coronary artery disease as determined by cardiac catheterization, History of gout, Recurrent urinary tract infections without evidence of ongoing infection.  H/O of recurrent UTIs with fever beginning 9/09. Varicella and flu vaccines 9/22/09. Shortly after had SOB and diaphoresis with activity. EKG normal. PFTs showed decreased vital capacity. Improvement with bronchodilator.  Fever but neg blood cx. Neg pyuria.  Increased transaminase and CRP.  Pulmonary CT angiogram neg. Elevated LVEDP. Arthralgia. Discharged to home with planned pulmonary follow-up.   11/02/09 Medical records received for DOS 10/05-10/21. CLinic notes and lab results.   COntinued to have fevers up to 102 and diaphoresis. SOB on exertion. EKG no acute ischemic changes. Blood cx neg, CXR neg. UA + bacteria and blood. Change to broad specturm abx.  Decreased lung fx r/t immune or autoimune  status. Coronary artery workup neg. Improved. Gradually increasing activity.
Patient complained about bleeding at injection site and pain in her left arm after 2nd SHINGRIX dose that caused her to miss work.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or drug reactions/allergies were reported. The registered nurse reported that doses of GARDASIL were stored improperly and were administered to an unspecified number of patients (doses, routes and lot numbers not provided) on unspecified dates. No adverse effects reported. This case is linked to cases MARRS # 1408USA000499 AND MARRS # 1408USA000500 (same reporter link). Additional information has been requested.
Tunnel vision, dizziness, fainting, convulsions, sweating. Low blood pressure.
causes chronic ringing in the ears; other side effects/was awful but living with aftereffects; This case was reported by a consumer via media and described the occurrence of ringing in ears in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced ringing in ears and adverse reaction. Shingles vaccine was discontinued. On an unknown date, the outcome of the ringing in ears and adverse reaction were unknown.   The reporter considered the ringing in ears and adverse reaction to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient reported that Shingrix caused chronic ringing in the ears and other side effects. The patient had one shot and he/she would not get another one after what it did to him/her. The patient had shingles and stated that, it was awful but living with after effects of the shot were awful too. The patient suggested to read all the information.
This spontaneous report was received from a nurse referring to an 18 months old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date the patient was vaccinated with GARDASIL 9 (strength, dose, route, lot # and expiration date were not reported) for prophylaxis (product use issue). No adverse symptoms were reported.
Rectal Piles or hemorrhoid's developed 11 days post administration of the first Moderna shot given to patient via intramuscular injection. Patient reports very intense dull/sharp pain and itching especially during and shortly after a bowel movement. Patient did report that there was an increase in fiber intake via red beans and rice his mother made for him and ate it for 5 days in a row last week. Patient is self treating with over-the-counter oral pain relievers, suppositories, tucks wipes with witch-hazel, and some butt cream coworkers husband gave to him. There is a history or rectal disorders with patient but had been 10 years since last occurrence. Patient does not currently feel that the vaccine has directly caused the  external hemorrhoids or the anus but felt it his duty to report any and all adverse events experienced following the vaccine given to his person.
Approximately 5 cm area with redness, swelling, itching and soreness located in right deltoid area. No draingage or abscess present.
This is a 91y.o. female with PMH of AAA, AVM, Caridomyopathy, CHFrEF 30%, Carotid artery disease, Chronic A-Fib s/p ablation, Colitis, CVA, Dementia, Depression, GERD, Glaucoma, hearing loss, HTN, HLD, hypothyrodism, hiatal hernia, mitral valve regurgitation s/p repair presenting to the ED for hypoxia respiratory distress. Patient was diagnosed with COVID on Tuesday.  Patient was seen and evaluated in the ED. Patient is hard of hearing but AOx3-4. States she is feeling well. Denies fever, chills, nausea, vomiting, diarrhea, sob or chest pain.    Seen and examined in the ER setting. Confused. Advanced age with  degenerative brain syndrome. No increased work of breathing. Suspect she was not boostered She is a resident of a group home. Found with hypoxia, 85% at the facility. + Covid 12/24/2021
March 12 - 1:30 - 2nd Shot Moderna Vaccine, 3/13 11:30 am chills, severe neck pain, aches all over. March 13 - All Day fever 99 to 102 at night, sweated through 3 nightshirts, headache March 14 - Aches and Pains and headache, fever down to 98 March 15 - Much better just wore left arm and right arm too even...Don't understand why.
Very severe body aches, skin, joints, muscles.  Took ibuprofen, and aspirin, to no avail.
pt recvd vax; devel fever 105 on 18feb; referred to er; T 105; WBC 30k toxic; severe local rxn, blood cts neg; h/o dec complement;
booster shot; wasn't feeling well; pains in the back of my leg; blood pressure was elevated; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administration date Aug2021 (Batch/Lot number: unknown) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Hydrochlorothiazide for blood pressure, notes: they told me stop taking everything I was taking. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 Immunization; Bnt162b2 (2nd dose), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset Aug2021, outcome "unknown", described as "booster shot"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "wasn't feeling well"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "pains in the back of my leg"; HYPERTENSION (non-serious) with onset 2021, outcome "unknown", described as "blood pressure was elevated". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Causality: Nurse stated, she don't know if this is because of her blood pressure is up or because of the fourth shot or what because she tested, she didn't even realize that she had, she forgot about the third shot. Medical condition: Nurse stated, she went to the doctor because she was having the medical condition the back of my leg were hurting. (Further not clarified) she wasn't feeling good she have been feeling bad that's why she went to the doctor in the beginning. Nurse stated, "Yes, she took up the other medicine and she took medicines for her blood pressure and they change the medicine so they told me stop taking all the medicine that she was taking and they have now changed the medicine, she haven't even gotten the prescription filled they told me stop taking everything she was taking  The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report was received from a licensed practical nurse referring to an adult patient of unknown age and gender. Patient's pertinent medical history, drug reaction/allergies or concomitant information were not reported. On an unknown date, the patient was vaccinated with a pediatric dose of RECOMBIVAX HB 5/0.5 micro-g/ml (Lot #, expiration date, dose and route were not provided) (drug administered to patient of inappropriate age). No adverse event was reported. There was no Product Quality Complaint (PQC) involved. Additional information has been requested.
never stopped crying p/got shot; cried & screamed the entire afternoon & evening of the shot; mom was up w/pt all noc; pt cranky for next w days & mom says has been irritable ever since got shots; temp & sore legs;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Nov2021 as dose 1, single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Recovering from legionnaires pneumonia" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive for covid again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300096844 same patient/product, different event;
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 21-MAR-2017 at 13:59, the patient was vaccinated with improperly stored VARIVAX injection (lot # M035142) (expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704USA000455: US-009507513-1704USA000456: US-009507513-1704USA000457.
Moderate, worsening pain in the left deltoid muscle soon after the injection...  I began to feel cold and develop chills about 4 hours after the vaccine, which was unusual since it was not cold in the home.  A little fatigue that first day, so I went to bed a bit early.  On the second day (today), fatigue has been increasing, but strangely accompanied by some agitation/restlessness.  Mild headache and muscle discomfort.  Hyperventilating a little.  Left arm still hurts, but it is partly better since yesterday.  Slight neck stiffness, of unknown significance, since it could be muscular.  Chills and trembling have increased as the day has gone on.  Now is about 28 hours after the Shingrix vaccine.  My forehead feels hot to my touch, but I am not measuring it.  Exacerbation of mild Raynaud's phenomenon in the hands and fingers.
p/vax pt began vomiting; restless; some distress; surgery for pyloric stenosis on 6/17/99
temperature excursion involving IPOL and ACTHIB, both of which were administered twice post excursion with no reported adverse event; Initial information received on 29-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old male patient and reported stated that there was a temperature excursion involving IPV (VERO) [IPOL] and HIB (PRP/T) VACCINE [ACT-HIB], both of which were administered twice post excursion with no reported adverse event.   The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.  On 12-Jul-2022, the patient received a 0.5ml dose of suspect IPV (VERO) (formulation, strength was unknown, lot V1A121M and expiry date was unknown) via intramuscular route in the right deltoid for Immunization. Information regarding batch and expiry date was requested. On 12-Jul-2022, the patient received an unknown dose of suspect HIB (PRP/T) VACCINE (strength, formulation, lot number and expiry date were unknown) via unknown route in unknown administration site for Immunization. Information regarding batch and expiry date was requested.  On 12-Jul-2022 the patient developed a non-serious event of temperature excursion involving ipol and acthib, both of which were administered twice post excursion with no reported adverse event (poor quality product administered) (latency: same day). The condition was 31.5F for 1 hour and 58 minutes due to a refrigerator malfunction (not human error). Neither of the products were supported by the extended stability data.  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.
Swollen lymph node in left armpit. Using ice and ibuprofen to help with over all swelling. After 5 days thought it was getting better but over night of day 5 to 6 unable to sleep due to the pain and ibuprofen not relieving anything only ice helped.
Itchy or tingly skin on arms and legs, and hives (15) on arms and legs.  Diphenhydramine 25 mg didn't relieve symptoms.
After receiving the 1st shot in my left shoulder, I have experienced chronic pain in my right elbow.
Patient had SOB, upper chest and back pain, diagnosed with small pulmonary embolism in right upper lung
BREAKTHROUGH COVID CASE. SYMPTOMS STARTED 7/15. HOSPITALIZED 8/1.
Injection site soreness almost immediately. About 12 hours after vaccine began feeling flu like symptoms.  I?ve only felt malaise like this 5 times in my life. My entire body hurts, especially joints and face. Filling this out is the most mentally taxing thing I?ve done all day.  Woke up every 20-45 minutes in pain. Have had a fever of 101, chills, and abdominal pain (I was having abdominal pain off and on prior to vaccine)  I?m sure everything will clear up in the next day or two but I wanted to make sure it was reported.
mild nausea, moderate body aches, moderate headache, fever/chills - lasting from about 12 hours to about 32 hours post vaccine
This vaccine was given 9 days past the BUD (6/23/2022).  Moderna was contacted and the lot was analyzed.  Per Moderna this lot was still active and the patient did not need to be revaccinated.
Pt exp inc t100 began about 2PM & mom gave APAP, pt vomited; @ 3AM 30AUG91 t103 & pt shaking & was taken to ER; ER gave supp & po med for inc temp & bloodwork done; observed until 7AM;
This spontaneous report was received from an administrator regarding a 12-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 25-SEP-2018, the patient was vaccinated with the first dose of ROTATEQ, lot # N022015, expiration date 10-MAR-2019 (strength, dose and route of administration were not reported) for prophylaxis (drug administered to patient of inappropriate age). No adverse effects were reported.
Patient said she has been menopausal x 4 years and experienced vaginal bleeding w/in 48 hr of both her first and second doses of Moderna COVID-19 vaccine. She bled x 7 days after the first dose and x 2 days after the second. She saw her OBGYN after the first incident and reports receiving several tests. She said the bleeding subsided on its own.
rash, itching, hot chest and neck, post nasal drippage, left arm feels hot, right arm itchy, itchy throat
Skin is warm. There is erythema (swelling on the left thigh where patient had the shots, 2 erythematous area: 1 cm next to a 3 X 2 cm area. minimal warmness, non-tenderness). Treatment: Tylenol or ibuprofen prn for pain. Cool compress.
*had mild arm soreness and stiffness at injection site in upper arm muscle for both vaccine series #1 and #2. The arm soreness was present for several days after the vaccines, but diminishing. *had what I would describe as NOT an ongoing headache, but rather  a few sharp shooting pains in head within first several hours of having Vaccine # 2. These only lasted a second or two each time although they re-occurred 3 or 4 times, and were tolerable. *had upset stomach with mild diarrhea the same evening after having vaccine#2, and later severe diarrhea again the next morning  after having had vaccine#2 the prior day. The severe diarrhea bout iI described in the morning after vaccine # 2 was sudden and uncontrollable, which woke me up and caused me to soil myself before reaching the bathroom. There was no stool consistency whatsoever, very watery diarrhea.
I woke up at around 3:30 in the morning to get some water and take Advil. While walking to the couch, my husband stated I dropped the water, basically blacked out, and he said I was unconscious, eyes opened and kept walking until I ran into the wall/tv and fell to the ground when I became conscious again.
Patient is 17 years old who received Moderna vaccine as his first dose on 11/01/21. No side effects reported.
Pt reports about 30 minutes, post vax, she began to feel weak and nauseated. She was training in a nursing home and her BP was 190/100, Pulse was 126. She was driven to the ER and given 2 injections of Benadryl.
My son started complaining of chest pain about 11 hours after receiving the 2nd dose of his vaccine.  Throughout the night his heart rate was very erratic, reaching as high as 138 and he had palpitations.  The symptoms resolved by the next morning.  There were no other adverse outcomes.  I was not aware of the heart rate and palpitations until a few days later when he showed me the data from the night of the vaccine on his  fitbit heart rate tracker.  Since the symptoms had already resolved, I did not bring him to the doctor for any testing.
Two days after receiving the vaccine, I woke up and could not walk due to pain in my left leg. My knee could not be extended, retracted, or left hanging. My left knee was swollen to the size of a softball and add immense pain on top and to the left but not under. There were no trauma related incidences, no working out nor was there anything out of the norm that happened . Since Tuesday, I have also had terrible headaches, fever and chills.
Developed Strep 11 months after the vaccination. I don't think the Covid-19 vaccination incurred the Strep diagnosis.
Felt fatigue and Tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt fatigue and Tired) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Felt fatigue and Tired). At the time of the report, FATIGUE (Felt fatigue and Tired) outcome was unknown. Not Provided          Concomitant medications were not reported.  Treatment medications were not provided.  Action taken with the product mRNA-1273 is not Applicable.
Information has been received from a registered nurse concerning a 6 year old female patient who on 03-MAY-2000 was vaccinated SC in the right thigh with a first dose of Varivax (Oka/Merck) (lot # 632369/1461J). The registered nurse indicated that the parent reported to the school nurse that on 15-MAR-2006, her child developed a rash which lasted for five days. Additional information received from the physician indicated that the patient experienced an "apparent vaccine failure", and that she was seen in March of 2006 with a clinical diagnosis of varicella. Subsequently, the patient recovered. No further information was available. Additional information is not expected.
I woke up the next morning, 18 hours after the shot, with the chills. I had the chills till about 10am on the day after the shot. Around 10:30 am I got really hot and felt over heated for the rest of the day. I was sweating and felt like I was sitting in a sauna all day. I also developed a massive red welt at the injection site that just kept growing till it took up 75% of my upper arm. It was hot, stiff, and felt very sore. I had this welt 45 mins after I got the shot and it kept growing until 4 days after the shot was given. Then it slowly started to disappear.