chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 28 day old female who on 06-JUN-2006 was vaccinated with first dose of RECOMBIVAX HB (LOT # 652403/0040F). There was no concomitant medication or medical history). On 06-JUN-2006 the patient was "extremely lethargic" and less energetic for most of that day. Subsequently, the patient recovered. The patient sought unspecified medical attention. Additional information has been requested.
Starting 06/22/2022, I developed a scratchy throat and mild cough. I took at home tests on 06/22 and 06/23 which were negative. I took another at home test on 06/25/2022 which was positive. From 06/24/2022 until the 27th I had a dry cough in my chest, dull headache and some fatigue. Yesterday 06/28/2022 I still had some fatigue. Today, 06/29/2022 I still have fatigue but better than yesterday. The fatigue from 06/25/2022-06/27/2022 was very extreme.
At injection site, 3" x 2" hematoma or fluid pocket developed. Palpated it and it was soft and fluid filled. No pain, no SOB, no tingling or discomfort. Color was dark purple.
No additional adverse effect reported; expired VARIVAX was inadvertently administered to a patient on 11/16/2020; expired VARIVAX was inadvertently administered to a patient on 11/16/2020; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 16-NOV-2020 the patient was inadvertently vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) 1 dosage form, lot number, expiration date 14-OCT-2020 R029518 (route of administration was not provided) for prophylaxis. No additional adverse effect were reported.        .
began with increased heart rate on the same day of vaccine throughout that same night. No symptoms for the next few days and on January 27, Increased heart rate and blood pressure that led to neck pulsating and swelling of neck muscles and glands, making it hard to turn neck, lay down. Since then, It is difficult to stay standing or sitting for more than a few minutes because whole body beings to tingle (nervous system?) and increases heart rate. Since january, these symptoms have persisted and are slowly decreasing. I have received MRI, ultrasound and went to see ENT doctors and they could find no results, yet symptoms persist. I have a next appointment with a Neruologist on August 31st because tingling all over body, increases heart rate and swelling in neck muscle and gland persists (although less severe and swelling has steadily decreased overtime but very slowly), making it very difficult to work.
Shingles rash above right eyebrow into scalp on right side of head.   Prescribed Valacyclovir.   Seen by opthamologist. No sign shingles affected my eye was found. Blisters cleared up within 15 days.
Significant generalized rash over multiple areas of body in absence of anaphylactic findings or angioedema.
11/22 Began itching all over 4-5 hours after injection. 11/23 Next day left arm swollen from elbow to armpit. Red area 6-7" long and 2" wide. Took Benadryl 50 mg. p.o. 11/24 Now is less swollen and redness is decreasing. Itching has resolved. Patient will call PCP or go to ER and be seen if symptoms return or worsen.
3 Months after Report (March 30th, 2022):  27M 6'0" 190(s)lbs, pretty active  Shot 1-2: Pfizer, Booster: Moderna (early January)  Doctor's appointment (2hrs later) after booster, my BP was 168/110. My BP in November was 124/84.  24 hours after the booster, I got real bad stabbing chest pain and dizzy headaches. Went to ER 48hrs after booster. BP : 170+/100+, HR: 100+ after getting up from sleep, sweating a lot.  ECG: abnormal with possible enlarged heart  CT (d-dimer elevated), X-Ray, blood tests came back fine.  Discharged with "anxiety" like others here. BP was 155/105 when discharged.  PCP put me on a beta-blocker. Beta blocker kept it in the high 140s and sometimes high 130s. Helped with keeping HR low. The beta-blocker gives me dizzy spells so not ideal.  Had muscle twitches randomly throughout the day (entire body) for a month or so, has settled to extremely rarely now. I also had bad migraines on the right side of my head daily (5 secs - 2 min). Never had migraines ever before. My hands would also sometimes feel like falling asleep numbness. I also would get random hypnic jerks when trying to fall asleep for two months.  Tried to exercise about 3 weeks after the booster(very light, 1 mile), heart beating crazy out of my chest. Hours later, heart pain was back like day 1. Subsided back to manageable levels 24 hours later.  Tried lifting light weights and again light exercise (walking) a few weeks later. Was able to lift and walk but at the end of my workouts, heart pain would come back for a few hours.  My baseline BP seemed to change after my booster to 150s and 160s. Doing anything (walking to my car, laundry, etc) seemed to elevate my BP and HR a lot more than it should have. Also took exceedingly long to return to "normal".  Gave blood once (barely passed HR/BP conditions). It seemed to help. Tried giving Plasma but didn't meet conditions. I basically have a BP in public phobia now.  Got an Echocardiogram and Kidney ultrasound from my Cardiologist. Both came back fine, no myocarditis thankfully.  I was put on an ACE Inhibitor/diuretic a few weeks back and my BP is back to 120/70+ in the mornings and a bit higher later in the day. I am hoping to get off these as soon as I can.  First month was debilitating and I was basically bed-ridden. Second month I could function but couldn't do anything strenuous or inflammatory. Third month, I felt almost back to normal me with help of meds.  Currently I have very faint heart pain. Greatly reduced after starting the ACE Inhibitor. HR can still be somewhat high at rest. My BP is basically normal with anti-ace meds.  Helpful Solutions:  - Hibiscus Tea (acts like an ACE Inhibitor)  - Low dose aspirin (when needed)  - Small meals, healthy foods.  - Giving Blood/Plasma  - Sleep aids  Avoid/Harmful:  - Inflammatory meals and/or large meals (BP, HR, and chest pain skyrockets for hours after)  - Exercise (try walking for 20 minutes and then increase gradually)  - ALCOHOL (tried drinking a couple times (6 beers) and my HR would go crazy that night. I seem to be able to drink now with milder side effects)
Seizures; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the parent.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SEIZURE (medically significant), outcome "unknown", described as "Seizures".  Clinical course: The [Pfizer COVID-19] vaccine made reporter so sick for months. Then reporter middle daughter gets the vaccine and now gets seizures. Reporter think they should be prosecuted and pay. Patient Age was 59 (unit unknown).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Weakness and pain starting in legs and traveling up body to neck. All my joints are painful - feet, knees, hips, shoulders, neck, and even jaw, but especially swollen hands/ fingers. Only short relief from hot showers or heat.
Approx-5:30 pm LPN received a call from mother stating that the child had been excessively crying non-stop since receiving immunization at 2 pm- mother states she gave tylenol at 3:30 pm but two relictivated. Mother instructed to bring child to clinic for further medical evaluation- child no longer crying (sleeping in clinic).
Swelling from thigh to knee on site where DTaP/Hib given no limitation of movement.
As reported by PCP, "Pt stated that within four hour of vaccine, he began to have symptoms of fatigue, nausea, palpitations, shortness of breath, fever, body aches and a metallic taste in mouth. Pt reported that symptoms persisted for 2 days."
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events was unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756520A, A0756522A - A0756562A. The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there were 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA): AFLUCA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
doesn't feel good; Vaccination site pain; Body ache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (doesn't feel good), VACCINATION SITE PAIN (Vaccination site pain), MYALGIA (Body ache) and NAUSEA (nausea) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History Information was reported.     On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 30-Mar-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain), MYALGIA (Body ache) and NAUSEA (nausea). On 31-Mar-2021, the patient experienced FEELING ABNORMAL (doesn't feel good). At the time of the report, FEELING ABNORMAL (doesn't feel good), VACCINATION SITE PAIN (Vaccination site pain), MYALGIA (Body ache) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included unspecified anxiety medication.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: F/U Received. No new information.
Initial report was received from a health care professional on 03 February 2012. A 29-year-old male patient had received an intramuscular injection in the right deltoid of DECAVAC, sanofi pasteur Inc. lot number U3696BA on 31 January 2012 at 12:50 PM. On 02 February 2012 at 5:00 AM, the patient's whole right arm and back had a sensation of being on fire. There was no redness at the vaccination site or arm. The patient had no illness at the time of vaccination. The patient had a penicillin (PCN) allergy and no other medical history. The patient took no concomitant medications and had no adverse events to prior vaccinations. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: None.
This case was reported by a other health professional via call center representative and described the occurrence of walking difficulty in a 15-month-old male patient who received INFANRIX (batch number 9D7CM, expiry date 27th February 2017). Concomitant products included PEDVAXHIB and PREVNAR-13. On 5th February 2015, the patient received the 4th dose of INFANRIX (intramuscular) .5ml. On 5th February 2015, the dose was .5 ml. On an unknown date, the dose was an unknown dose. On an unknown date, the dose was an unknown dose. On 6th February 2015, 1 days after receiving INFANRIX, the patient experienced walking difficulty, fever and limbs stiffness. On an unknown date, the outcome of the walking difficulty, fever and limbs stiffness were unknown. It was unknown if the reporter considered the walking difficulty and limbs stiffness to be related to INFANRIX. The reporter considered the fever to be possibly related to INFANRIX.
Initial information received on 05-Dec-2018 regarding an unsolicited valid non-serious case received from health professional. This case involves a male patient (age at time of reporting was 13 months old) who was vaccinated with QUADRACEL at 04th month of age (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. At two months of age patient had received his first DAPTACEL at 2 months and PENTACEL at 6 months. It was an actual medication error due to Inappropriate schedule of vaccine administered & Inappropriate age at vaccine administration. It was unknown if patient had adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
48 hrs (approx) after the injection of ZOSTAVAX, patient developed sudden onset of rash which was hot and painful and enlarged in 4 hrs. Patient used cold compress and took BENADRYL. She is still sore and will see physician at 3 PM on 10/01/13 for concern and cellulitis.
This spontaneous report as received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions and concomitant medication provided. On an unknown date in 2015, the patient was vaccinated with a dose of ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, anatomical location, lot# and expiration date were unknown). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles (onset date was not provided). On or about 25-AUG-2016, the patient was treated for a severe vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter considered the events to be related to the ZOSTAVAX.
Injury/Traumatize; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), on 04Dec2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INJURY (non-serious) with onset 04Dec2021, outcome "unknown", described as "Injury/Traumatize".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
No adverse effects were reported; a patient moved their arm and only received a partial dose of PROQUAD as a result; This spontaneous report was received from a physician and refers to a patient of unspecified age and gender. No details regarding the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were provided.   On 26-AUG-2019, the patient moved their arm and only received a partial dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rha)(PROQUAD), lot # R011214, expiration date 15-OCT-2019 (exact dose, dose number, route and site of administration were not provided) for prophylaxis. No adverse effects were reported.
Hx of vasovagal syncope prior to vaccinatons. MD was called to evaluate a patient who had fallen. Ran to patient and found her laying on floor with staff members around her. MD was told she received her vaccination, then laid down on a bench and rolled off the bench when she passed out. bench was about 2 feet tall.  When MD assessed patient, she was laying on ground, awake, slightly pale, clammy with faint but palpable pulses on my exam. She was awake and alert. able to answer MD's questions but felt dizzy and had a headache. She was able to track finger, follow commands. She was lifted into a wheelchair and moved to a cot. vitals were obtained which showed BP 122/70, pulse 72, o2 sat 100%, RR 18. EMS was called after her fall given c/f head injury. We were instructed to not give patient anything by mouth. Paramedics arrived at 0805. assessed patient. Obtained vitals. positive orthostatic vital signs with HR jump >20, SBP drop ~20. Given patient could not reliably stand without c/f repeat fall, patient was taken by ambulance for further evaluation at hospital.
I began experiencing severe muscle pain and stiffness near the injection site beginning 8 days after vaccination. Pain is in my shoulder and bicep and radiates all the way down my arm and up to my neck. I experienced moderate muscle pain for about 24 hours beginning about 8 hours after vaccination with both doses (first on was April 24), but that resolved both times and did not return after the first vaccination. When I was receiving the injection on May 12 I felt a sharp pain deep that radiated to my back as the injection was given. I did not have that experience with the vaccination on April 24.
2-24-03:  Generalized rash over body with lymph node swelling 2-28-03:  Severe cervical node swelling and tenderness and rt. axillary node swelling.
On day1st Very Sore and Painful arm by evening started with chills Day 2 chills, fever, over 100 and lethargic, body ache Day3 when visited physician head Headache, fever and high blood pressure which is still persistent after day5
Pain in both legs, swelling, and pain in joints both legs, knees, ancles an hips.
Client received 5 vaccines per request on 8/20/08.  Tolerated well with some perspiration.  Left building, was getting into her car et fainted.  Unsure about fall as I went looking for her.  While dad paid for immunization, found her on pavement beside car waking up.  Assisted into car.  She said she was OK.  Asked dad to turn on air conditioner, get food, fluids ASAP.  Ice pack to neck, car seat back.
Arm has been extremely sore from the day I got it. It hurts to lift my arm and do simple tasks like putting clothes on.
Headache; This is a spontaneous report from a contactable nurse. A 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced headache on an unspecified date with outcome of not recovered. The reporter seriousness for headache was medically significant.  Information about the Lot/batch number has been requested.; Sender's Comments: Based on the known product safety profile, a causal association between the reported event 'headache' and the suspect product BNT162B2 cannot be completely excluded. 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.
Patient received vaccines on 1/7/13. Mother states the next day 1/8/13 patient had redness and slight swelling at injection site on left thigh. She applied warm compress and brought patient to clinic 1-9-13. No treatment needed. F/u call 1/10/13-1/11/13 patient is improved-no redness or swelling.
Arm was sore for prolonged amount of time after receiving flu shot. Burning all the way down to the elbow for a few seconds, then ached for a month or more.
Patient experienced a seizure 7 days post second dose of moderna vaccine.  Patient is getting MRI currently and awaiting results.  Patient when to hospital and got seizure under control.
SOB, dizziness, nervous, headache Treatment: IV Prednisone, IV Benadryl
Whelps (R) deltoid at Tdap & MCV4 site & (L) arm where Ch. Px was given.
08/30/2022, I began to experience a scratchy throat. I tested positive two days later. I had sore throat, muscle aches, headache, fever, malaise, cough, lasting four weeks.
Temperature to 101.5 for 4 days and inconsolable irritability for 24 hours after vaccine and intermittent irritability for 12 hours on 4th day after vaccine. Fever resolved and pink macular rash appeared.  Possibly post viral exanthem.
Left leg swelled up; just got the booster; This is a spontaneous report from a contactable consumer (patient's mother). A 64-year-old male patient received the first dose of BNT162B2 at 64-year-old, via an unspecified route of administration on an unspecified date at single dose, and the second dose via an unspecified route of administration on an unspecified date at single dose, and the third dose via an unspecified route of administration on an unspecified date in 2021 at single dose (booster) for COVID-19 immunisation. Medical history included patient's grandparents both had heart attacks. The patient's concomitant medications were not reported. 7 days after he received his fist dose of the vaccine his left leg swelled up. He had gone to 3 specialists so far and they couldn't find out what caused it, but reporter reported that it had to be from the vaccine. Exactly date he got his first dose of the vaccine was unknown, but it was when the vaccine first came out. His left leg swelled up 7 days after the first dose and the swelling had never gone away. He had since gotten his second dose, and just got the booster. Patient had a CT scan of his leg, but unknow if there was anything found on it. He had 3 different types of testing done on his leg already and the doctors hadn't been able to find anything wrong with his leg or figure out why he still had the swelling. He called his Primary care doctor who sent him to 3 different specialists but they couldn't find anything, so he would be going to a 4th specialist next week, on 23Nov2021. Outcome of the event was not resolved.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
3am- 15 hrs post injection: excruciating pain in joints to point of tears 6am- 18 hrs post injection: 10 min after waking sudden onset of extreme nausea and abdominal pain and urgency to vomit. I sat down on toilet and passed out, was unconscious and aware for approximately 2 minutes, falling off toilet onto floor.  Woke hyperventilating and in dead sweat. Temp was 100.3.  With help sat up and moved back to sitting on toilet for 10 min; then walked 10' to bed, blacking out again for about 15 seconds as i made it into bed. I rested in bed for approximately 4 hours prior to moving again.  Moderate moments of lightheadedness and brief mild nausea continued through 24 hours but no further blacking out