chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This study case was received from the investigator in a trial on 07 March 2013. A male subject (age and birth date not reported) with no relevant past medical history, experienced mild palpitations, four days after he received an injection of ACAM2000, SP Biologics Co., (lot number, route, site and side not reported) on 14 September 2012. He concomitantly received an injection of FLUMIST, (other manufacturer, lot number, route, site and side not reported) on same day, 14 September 2012; and an injection of ANTHRAX, other manufacturer and HEPATITIS B vaccine, other manufacturer (lot numbers, routes, site and sides not reported) on 13 September 2012. On 18 September 2012, the subject reported onset of mild palpitations in absence of any other cardiac symptoms for short time while lying down, four days post ACAM2000 vaccination. Palpitations were reported as gone upon waking. Rapid Troponin I and electrocardiogram (ECG) were reported as normal on 20 September 2012. Central lab Troponin I was not performed due to specimen processing error on 20 September 2012. The subject did not take any medications to treat the adverse event. The stop date of palpitations, reported as resolved, was 18 September 2012. The subject was referred, but lost to follow-up. The subject was reported as recovered, resolved on 19 September 2012. According to the investigator, the event of palpitations was considered an other important medical event and possibly related to the trial product. Documents held by sender: Medical Record.
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had administered dose of GARDASIL on 17-SEP-2013 (lot # H021608, exp.: 13-AUG-2015). This is one of the report from the same source, linked reports. Additional information is not expected.
A lot of itching; Little bit of headache; Arm was hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was hurting), PRURITUS (A lot of itching) and HEADACHE (Little bit of headache) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     The patient's past medical history included Shingles (shingles 2 weeks before booster vaccine) in October 2021. Concurrent medical conditions included Asthma (mild case of asthma), Cognitive disorder (some cognitive issue that is because of fibromyalgia) and Fibromyalgia. Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA), ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), MAGNESIUM, VITAMIN B NOS and CODEINE PHOSPHATE, GUAIFENESIN, PHENIRAMINE MALEATE (ROBITUSSIN WITH CODEINE) for an unknown indication.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was hurting), PRURITUS (A lot of itching) and HEADACHE (Little bit of headache). The patient was treated with HYDROCORTISONE (topical) for Itching, at an unspecified dose and frequency and CAFFEINE, CODEINE PHOSPHATE, PARACETAMOL (TYLENOL NO.2) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm was hurting), PRURITUS (A lot of itching) and HEADACHE (Little bit of headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 98.8 (High) temperature of 98.8. and 99.6 (High) temperature of 99.6.         Treatment included cold Compression.     Reporter did not allow further contact
Ran fever 103-104 plus for 3 days irritable, no on going crying. Dr. say child and felt it was the DPT per parent, no other illness found.
Erythema and maculo papular rash over trunk and extremities. Tx: 50mg Benadryl IM, Prednisone 20mg TID w/rapid taper down. SIQ x 24hours
This spontaneous report was received from a physician concerning an approximately 12 month old female patient with no pertinent medical history and no drug reactions or allergies. On 06-JUN-2013, the patient was vaccinated with a dose of PROQUAD (Merck) (lot number and expiry date reported as J000132 and 04-JUL-2014 respectively), subcutaneously in lateral side of the left leg. No concomitant therapy was reported. Approximately on an unknown date in June 2013, the patient experienced not sleeping well and a one inch brownish induration on lateral side of left leg which was mildly tender to touch. On 07-JUN-2013, the patient experienced irritability, a red rash on an unspecified location and crying. The patient was seen in the emergency room two days ago (approximately on 15-JUN-2013). The patient sought medical attention (unspecified0. It was unspecified if any treatment was given. The outcome of all the events was unknown. The relatedness for the events was unknown for PROQUAD (Merck). Additional information has been requested.
Fever, fatigue,  12 hours after injections  Difficulty breathing 2 days after injection required 3 day hospitalization
pt recv vax & devel measles-like rash which persisted for 11 days;It was noted that natural exposure could not be r/o
KEFLEX rx lateral aspect leg-erythema secondary cellulitis not related to injection - per emergency room no surrounding erythema or sign of reaction at injection site - per emergency room.
Patient was hospitalized on 5/29 until present for N/V/D, hypoxia and fever associated with a positive COVID 19 diagnosis.
Severe swelling and redness all over his body and fussy. No resp. problems. The hospital discharge summary received on 1/8/04 states an allergic reaction.
5pm started felling nauseated, 7pm started feeling flush, fever of 100.9, arm started aching, hive appeared a size of a quarter, and felt dizzy. 8:30pm asthma problems(took normal asthma medication) and all symptoms got worse fever 102.4. 8am hive and arm pain worse, pain and redness at injection site, called doctor. Nurse called back at 3pm was told to take benadryrl and to go to the hospital if things get worse. 5pm took benadryl did not help. 10pm took benadryl did not help. Four days later and the hive and injection site redness is starting to get a little lighter no more fever. Arm is still extremely sore.
Treatment of COVID-19; Treatment of COVID-19; Pfizer / BioNTech/Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 08:00 as dose number unknown (booster), single (Lot number: GH9694) at the age of 81 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 07Jan2021 as dose number unknown, single (Lot number: 06620A) for covid-19 immunisation. The patient's relevant medical history included: "heart" (unspecified if ongoing), notes: other medical history: heart; "cml" (unspecified if ongoing), notes: other medical history: cml. The patient took concomitant medications within 2 weeks of vaccination. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (hospitalization, medically significant, life threatening) with onset 09Sep2022, outcome "unknown", described as "Pfizer / BioNTech/Moderna"; DRUG INEFFECTIVE (hospitalization, medically significant, life threatening), COVID-19 (hospitalization, medically significant, life threatening), outcome "unknown" and all described as "Treatment of COVID-19". The patient was hospitalized for interchange of vaccine products, drug ineffective, covid-19 (hospitalization duration: 2 day(s)). Clinical course: The patient experienced "full COVID", incessant cough, nausea, trouble breathing, headache chills. The adverse event resulted in Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was given treatment from 05Dec2022 to 10Dec2022. The patient has no known allergies. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of interchange of vaccine products, drug ineffective, covid-19.
Tight feeling in my chest; Hurts to breath deeply; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Tight feeling in my chest) and DYSPNOEA (Hurts to breath deeply) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (Tight feeling in my chest) and DYSPNOEA (Hurts to breath deeply). At the time of the report, CHEST DISCOMFORT (Tight feeling in my chest) and DYSPNOEA (Hurts to breath deeply) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  Treatment medications were unknown.
Information has been received from a pharmacist concerning a 10 year old male child with sickle cell anaemia, no known drug allergies, and no history of a reaction on previous exposure to Pneumovax 23 (2 prior doses, dates unknown), who on 22-OCT-2007 was vaccinated IM with a third dose, 0.5 ml, of Pneumovax 23 (lot #657529/0993U). Concomitant therapy included folic acid, hydroxyurea and influenza virus vaccine (date and manufacturer unspecified). On 22-OCT-2007, following the vaccination, the child experienced pain at the injection site, and his mother gave him ibuprofen (MOTRIN) as treatment. On 23-OCT-2007, when the child returned from school, his temperature and reached 102 degrees F, and he had pain and swelling of right arm from the elbow to the shoulder. The pain worsened with movement. The child was taken to an emergency room, and was admitted to the hospital. Treatment included morphine and intravenous antibiotics, including ceftriaxone (ROCEPHIN) and cefotaxime (CLAFORAN). At the time of this report, the child was still hospitalized, and had not recovered. The reporting pharmacist considered the events to be serious as an other important medical event. Additional information has been requested.
My left arm, deltoid, was the site of injection.  A 2 1/2 inch in diameter area was swollen, raised, hard, red, and hot to the touch. I got my first shot on 5/22 a week before, my reaction started on 5/30 at 12 AM and stayed that way until 6/1.  I did nothing to treat it and it seems to be fading as the medication spreads out.
Patient reports swelling and redness at site of injection with onset one day after. Swelling has spread to axilla. Patient will follow up with provider if persists or worsens.
L deltoid 10x8cm redness, swelling, warmth, nonpainful area with central bruising.
Client received two vaccines after older sibling received vaccine. Client standing and awake and alert and putting on coat to leave facility when sibing apparently fainted.  About 2  minutes after sibling fainted, this client sat in chair and lost consiousness as well.  Eyes open, muscles flacid, skin warm and dry, color pale.  Client responded to gentle shaking of arm by RN and calling of name within 1 minute.  Gave client juice drink to sip and ice pack to back of neck.  Client remained under staff observation for another 15 minutes after incident occured. Mom instructed to feed client when returns home.  No other treatent administered.
1/11-arm soreness, feeling of warmth in head and neck 1/12 Elevated heart rate, SOB, dizziness, body aches 1/13-elevated heart rate, SOB, dizziness--slightly better than 1/12 1/13-symptoms subsided
Initial information received on 18 February 2010 from health care professional. A 56 year old male patient, who resides in a nursing home with a history of morphine allergy, paraplegia, anxiety, neurogenic bladder, ulcer, and deep vein thrombosis. Concomitant therapy included Oxycodone, BENADRYL, FLOMAX, DILAUDID, CYMBALTA, PRILOSEC, CALCIFEROL, and Propranolol. The patient experienced sleepiness with episodes of sweating one day (on 18 February 2010 at 3:30 PM) after receiving H1N1 (lot UP063AA) intramuscularly in the right deltoid on 17 February 2010 at 1:30 PM. The patient also had a rash on both arms. The patient recovered from the events. Follow-up information was received from a health care professional on 01 April 2010. The patient received no treatments other than observation within the long term care facility. He did not require evaluation from his doctor. Malaise and sweating were not present the following day and the rash lasted less than 12 hours. List of Documents held by Sender: none.
aches and pains, perspiration at night, headache, some coughing, probably fever but never measured all for about 3 days
Pt recvd 3 doses of Recomb vax on 1JUN90, 1JUL90, & 28DEC90 & following 3rd dose exp flu-like sx w/persistent joint pain;
Eight days after my vaccination, the injection site became red and slightly itchy. This only seemed to last for about 12 hours as I noticed it at night and when I woke up, while my arm was still slightly red, it was reduced.
Swelling, large raised area at vaccine site. Hot to touch, uncomfortable. Symptoms began at 8pm
Pt had fever up to 103F which began on 10/30/00 and responded to Tylenol but went back up between doses. She had a poor appetite, was irritable, had a rash on her back and stomach. Saw doctor on 11/4/00 and was given antibiotics for possible ear infection. Fever for 4 days.
Information has been received from a health care professional concerning a 12 month old male who on 8/24/99 was vaccinated with one dose of varicella virus vaccine live. There was no concomitant medication administered. On 8/24/99 immediately following vaccination the patient developed hives. The patient was observed at the clinic for fifteen minutes. Subsequently, the swelling diminished and patient was sent home. The reporter expressed concern with the vaccine lot and felt there to be association between the patient's symptoms and the vaccine. No further information is available.
Patient returned to pharmacy approximately 10 minutes after receiving vaccine complaining of severe arm pain that was radiating up her neck and feeling very hot.  Had patient sit. Administered 400mg of ibuprofen and applied ice pack on arm.  Pt remained seated for about 35 minutes. I paged her physician and spoke with the on-call doctor who questioned patient over phone to assess severity.  Doctor told her to follow up with her if not seeing improvement. After 35 minutes, pt walked around area to make sure she was stable on her feet. Pt still complaining of severe arm pain. Her arm felt "dead" and she could not get it comfortable.  Pt drove herself home and called when she arrived safely.  Called us to tell us she had to pull over to vomit.
Patient had Dizziness, Nausea and Sweating Beginning immediately after Vaccine was administered. Patient was given an ice pack and after 15-20 minutes felt well enough to leave with her father.
Dizziness, NauseaVomiting, flu like symptoms, fatigue Narrative:
No symptoms for first two weeks post-vaccine. After ~16 days, I began having chest pain on the left side (later determined pleurisy denoting something underlying). I waited 24 hours and was still having chest pain, so went to the ER. After several tests/scans, they determined I had multiple PEs (pulmonary embolisms/blood clots in both lungs). I was hospitalized for two nights/three days while they gave me blood thinners through IV (argatroban). To note, no shortness-of-breath, oxygen at 99-100% throughout this experience. I was released on Day 3 with direction to take Eliquis/blood thinner pills (5mg 2x/day) and follow up with a hematologist, who recommended a blood coagulation work-up to determine if I had something underlying aside from the vaccine which may have caused the clots. My chest pain/pleurisy went away within a week after hospitalization. After seeing the hematologist (three weeks post-hospitalization,) all tests showed negative (no underlying trait causing clots,) so doctor recommending thinners for six months, then will re-evaluate. I will also add that I have had one other experience with blood clots ~ 15 years ago when I took birth control pills (multiple PEs that time, too.) I was put on blood thinners at that time as well for nine months, and was simply told I could not/should not take birth control pills thereafter, and I have not had any clotting issues since then until this vaccine experience. (I now also have tingling feet/ankles which began in the hospital, so not sure if this is due to the vaccine or the blood thinners. This occurs on and off throughout every day now. I plan to inquire with a PCP soon if it persists.)
Red swelling hot where shot given. Fever and chills 24 hours after shot for 12 hours then in 48 hours for 12 hours again fever and chills. After second dose of BEXSERO.
17NOV97 pt recv vax & 18NOV97 had rash on back, torso, ankle;19NOV97 mom reported rash only on ankle which was painful for walking;advised to see MD;20NOV97 dx sx as serum sickness;
One hour after shot, red swelling on cheeks of face; One hour after shot, red swelling on cheeks of face; This is a spontaneous report from a contactable consumer (patient). A 14-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number: CWD178, Expiry date: unknown) (age at the time of vaccination was 14 years), administered in Arm Left on 15Jun2021 at 13:15 as dose 1, single for COVID-19 immunization. The patient's medical history included seizure disorder. The patient's concomitant medication included valproic acid. The patient did not take any other vaccine in four weeks prior COVID -19 vaccine. The patient was not diagnosed with COVID prior vaccination and not tested with COVID post vaccination. The patient had known allergies. On 15Jun2021 at 14:30, the patient has red swelling on cheeks of face. No treatment received. The outcome of the events was not resolved.  Follow-up attempts were completed. No further information was expected.
2+ weeks after vaccine chronic debilitating headaches; every day 24/7 on and off thunderclap headaches constantly; Very stressful; trauma; physical pain; This is a spontaneous report from a contactable Nurse (patient). A 22-years-old female patient (no pregnant) received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 26Feb2021 13:30 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient previously took the first dose bnt162b2 on unspecified date for covid-19 immunization. The patient medical history was included covid.     The patient's concomitant medications were not reported.  On 03Jan2021, the patient experienced chronic debilitating headaches in a person that is fit and healthy with no regular headaches ever before. Was fine for 2 days after the second dose then every day 24/7 on and off thunderclap headaches constantly on 03Jan2021. Very aggressive and detrimental pain that is seemingly continuing to get worse. Very stressful and concerning as patient can't go back and not get the vaccine. Has cause a lot of physical pain and trauma as well as psychological on 03Jan2021. No treatment for events. The outcome of events was not recovered.  Adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. No other vaccine in two weeks; Had covid prior vaccination; No covid tested post vaccination  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a contributory role of BNT162B2 to the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of 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.
Moderate Pain left upper arm at site of injection worse with range of motion of left arm. Topical diclofenac muscle rub with no relief, no swelling or redness
I received my second Pfizer booster for COVID-19 on 5/11/2022. On 7/10/2022 at 4:30 AM, I woke up with a bad headache, inner ear pain, and sore throat. The inner ear pain was so bad that it hurt to swallow. My husband and I had recently gone on a cruise, and he had tested positive for COVID-19 within 3 hours of disembarking. Because of this, I suspected that I also had it. On 7/11/2022, I had a headache, runny nose, and a sore throat. I didn't feel the best, but I didn't feel unable to go about my normal activities, since my energy levels were fine. I also took a home test that day, and I got a negative result. Later that evening at about 8:30, things started to go downhill. The throat pain worsened, I was sneezing, I couldn't stop coughing, and my nose ran. I also had a headache.  On 7/12/2022, I woke up with the worst sore throat. It felt like it was on fire, and I could barely swallow. My ears also felt clogged, and I couldn't hear as well as usual. I took another test that day at 3 PM and got a positive result. My headache persisted, and so did my runny nose. At no point during my illness did I ever have a fever, though. I also regularly checked my oxygen levels, and they were always averaging 97-98%. My headache and sinus pressure were so intense that I couldn't lie down, so my husband kept me propped upright on pillows. I also lost my voice on 7/12/2022, and my voice was raspy on 7/13/2022. I took ibuprofen on 7/10/2022 and the morning of 7/11/2022. On the evenings of 7/11/2022, 7/12/2022, and 7/13/2022, my husband gave me Multi-Symptom Relief Nighttime Cold and Flu medicine. On the mornings of 7/12/2022 and 7/13/2022, I took Multi-Symptom Relief Daytime Cold and Flu medicine. I'm not sure if I really saw a difference in my symptoms after I took the medicines, since I still felt terrible, but perhaps they would have been worse had I not taken them. Today I woke up feeling much better. I still have an intermittent cough. My throat is still sore, but not as much as before, and my voice is still sort of raspy. My right ear canal now feels more raw than the left one. My nasal congestion is better, plus the headache is gone.
blood sugar leveled near 150 with no insulin; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05Mar2021 12:45 (Batch/Lot number: EN6200) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Triggered Hypoglycemic episode", start date: 12Feb2021, stop date: 12Feb2021, notes: Pertinent Details: Blood sugar went to 24. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Pfizer/BioNTech Covid-19 Vaccine, Date/Time of administration: 12Feb2021 12:45 PM, Anatomical site of injection: Upper right arm, Intramuscular, Batch/lot number: EN5318), administration date: 12Feb2021, for covid-19 immunisation, reaction(s): "Hypoglycemic episode", "Blood glucose decreased", "Sleepy", "Face red", "Tiredness", "Unresponsive". The following information was reported: BLOOD GLUCOSE INCREASED (non-serious) with onset 05Mar2021, outcome "unknown", described as "blood sugar leveled near 150 with no insulin". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information : Vaccine facility type was other. No other vaccines within 4 weeks prior to vaccination.  No follow-up attempts are possible. No further information is expected.