chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HIGH BLOOD PRESSURE; HEADACHE; This spontaneous report received from a patient concerned a 50 year old female. The patient's weight was 140 pounds, and height was 152 centimeters.  The patient's past medical history included depression, and migraine, and concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included patient had no known allergies. patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1A02072, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 20-MAR-2021, the subject experienced high blood pressure. On 20-MAR-2021, the subject experienced headache.  Laboratory data included: Pain scale (NR: not provided) 10/10. On APR-2021, Laboratory data included: Pain scale (NR: not provided) 6/10. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and high blood pressure. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
skin sensitivity started in injection arm moved to upper body. still ongoing, not likely to seek medical attention.
Information has received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On 21-MAR-2018, the patient was vaccinated with ZOSTAVAX, lot number reported: N025698 with expiration date on 16-DEC-2018 (strength, dose, route of administration and anatomical location were not provided) for prophylaxis, reconstituted with sterile diluent (DILUENT MRK), instead of VARIVAX, which the patient was supposed to receive (wrong drug administered); due to human error. No adverse effects were reported.
ANAPHYLACTIC REACTION; ALLERGIC; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 total, first dose administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date following vaccination with first dose of covid-19 vaccine ad26.cov2.s, the patient experienced anaphylactic reaction (Dose number in series: 1). The patient received non-company suspect vaccine covid-19 vaccine (Unspecified manufacturer) (Dose number in series: 2) (form of admin, route of admin were not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, first booster administered for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series: 2). On an unspecified date following vaccination with covid-19 vaccine (Unspecified manufacturer), the patient experienced allergic (Dose number in series: 2). The patient additionally received non-company suspect vaccine covid-19 vaccine (Unspecified manufacturer) (Dose number in series: 3) (form of admin, route of admin were not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, second booster administered for covid-19 prophylaxis. On an unspecified date following vaccination with covid-19 vaccine (Unspecified manufacturer), the patient again experienced allergic (Dose number in series: 3). The action taken with covid-19 vaccine ad26.cov2.s, covid-19 vaccine, and covid-19 vaccine was not applicable. The outcome of the anaphylactic reaction, allergic and revaccination with different covid-19 vaccine was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:   20221109010-Anaphylactic reaction. The event has an unknown/unclear temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration
Administration error. Patient was 17 when vaccine was administered (authorized for 18 and older). No known adverse reactions.
Fever of 101; Chills; Muscle pain; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on an unknown date (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had known allergies to penicillin. The patient did not receive any concomitant medication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 14Apr2021 at 12:00 the patient experienced Fever of 101.The patient did not receive any treatment for the event. On 14Apr2021 at 12:00 the patient experienced fever of 101(units unknown), chills and muscle pain. The clinical outcome of the events fever of 101, chills and muscle pain was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a physician referring to a 4.5 year old patient of unknown gender. On 04-JAN-2016 the patient was inadvertently vaccinated with the third doses of (Oka/Merck) VARIVAX and MMR II (dose and route unknown, lot# and expiration date not available, the physician did not have patient's chart). No adverse effects was reported. Additional information has been requested.
Pfizer Dose 1 10/25/22 (FF2593) COVID Positive 1/18/22  1/15/22: 63-year-old female patient who appears much older than his stated age with a history of CAD, chronic pain, fibromyalgia, GERD, COPD with 2 L of oxygen dependency, rheumatoid arthritis, CVA, anxiety, depression, Nissen fundoplication in 2014 and ostomy bag on the right side of her abdomen was recently discharged from the hospital on 1/12/2022.  Patient was recommended to be transferred to a skilled nursing facility but she adamantly refused and went home with VNA.  The patient had a visit from the nursing staff and noted the patient was extremely weak and fatigued and her oral intake was very poor and hence paramedics were called in and the patient is currently admitted to the hospital for weakness and subsequent placement.   Patient has no new medical complaints.  Case manager in the emergency room he is unable to place the patient at the skilled  nursing facility or the weekend and hence she has been admitted for observation.  Patient complains of chronic pain and also has leakage around the ostomy bag which the patient states that she has an appointment set up as an outpatient with surgery but has not even been able to keep it up.  Patient was also recently admitted to the Hospital.   The patient was admitted to the Hospital and discharged on 01/12 for left brachial artery stenosis with left upper extremity ischemia on anticoagulation, GI bleed with the normal EGD, acute renal failure.  The patient was advised to take aspirin for her peripheral arterial disease and no other medication recommended per vascular surgery due to history of GI bleed.  Patient has no new complaints of GI bleed currently.  1/20/22: 63-year-old female with history of COPD and chronic hypoxic respiratory failure on 2 L by nasal cannula, history of severe peripheral arterial disease, history of antral ulcer and GI bleed, history of ileostomy, presented to the emergency department due to generalized weakness.  Admitted for possible placement.  Patient was doing well, lab work showed severe renal failure secondary to volume depletion hypertension.  Nephrology consulted, patient was started on bicarb drip, was started on hydrocortisone does in addition to home dose liver enough and midodrine.  Blood pressure relatively improved.  Kidney function improved.  Patient had 1 episode of hematemesis and GI bleeding, GI consulted and she underwent upper endoscopy that showed Mallory-Weiss tear s/p clipping. Patient continues to not feel well overall with no specific symptoms, she tested positive for COVID-19 infection but she did not have any pneumonia.  She was stable for discharge.
COVID vaccine-associated myocarditis.  3 days after his second Pfizer COVID vaccine, pt presented for chest pain and pressure. Troponin was initially elevated to 4.2, EKG showed ST elevations in lateral leads. Over the course of his stay, troponin dropped, then rose to peak of 14, then dropped again. He was treated with Naproxen 500 mg BID and Pepcid 20 mg BID for gastroprotection. As chest pain resolved, troponins improved, and EKGs improved. Echo and Cardiac MRI were done.
Burning sensation when hot water touches the skin, rash to area where injection was given, redness around area of injection. Noticed onset of these symptoms later that morning. Application of Kenalog cream, x 3 per day. Rash is still around both armpits and back of the arms.  Redness has gone down butr the rash is still there.
immediately after receiving the second dose, i started feeling lightheaded, and feeling hot and tired. these symptoms were mild so i waited for an hour for the symptoms to get better before going home. i was fine for several hours until i started getting chills. then, around 10:30pm i was lying down and had a hard time getting up. my muscles were aching and i got really bad chills to the point that my teeth were clenching so hard i was grinding them. i was also having a hard time relaxing to pee and as a result went to the bathroom about once an hour. the aching muscles were moderate. i was able to move but it took effort to get up. the chills were severe. the clenching teeth was severe and the grinding i consider mild as i was not yet grinding them much before i started doing breathing to relax myself and calm down. the difficulty peeing was moderate to severe as i had to also relax myself to be able to pee but i wasn't able to completely empty during any session (which resulted in frequent bathroom visits). i had a mild headache as well.  at night, i slept wearing a sweatshirt, under an electric blanket set at 9 (the highest setting is 10), under another thick blanket. when i got up for the day i had not even broken a sweat. that is how cold i was.  even during the night i woke up several times to go to the bathroom. the chills  were more manageable since i had stopped clenching or grinding my teeth, but considering the amount of heat i slept under without breaking a sweat, i would consider them severe still.   the day after i was able to work from home. the main symptoms i had were moderate chills and mild muscle aches and a mild headache. the peeing issue was now mild. i was still going frequently to the bathroom but not as often and it was getting easier to relax to pee.   the day following that day (which is today) i feel mostly well. the only lingering issue i have is muscle aches but they are very mild. i have no other symptoms.
Records review indicated potential receipt of an adult Pfizer vaccine: FM0698 for two children. 1 received Pfizer adult (FM0698) and 1 received pediatric (FL8094). Due to inability to confirm which child received the adult vs pediatric vaccine, submitted reports for both children. As of 3/3/2022 18:45, no adverse reactions in either children.
Swollen neck, chills, body aches, arm pain. Took benadryl and felt better. Took one tylonal felt much better. Drinking hot tea seems to help with the swollen neck. The symptoms started about 4 hours after injection.
a little soreness in our arms.; This is a spontaneous report from a contactable Consumer, the patient. A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 1 via an unspecified route of administration on an unspecified date in 2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced a little soreness in our arms on an unspecified date. Caller stated that she and husband had Pfizer vaccine two weeks ago. Stated that their arm was a little sore at first with no other symptoms. Wanted to know if one can get side effects after two weeks. Clarified that it was the right arm. Clarified that it is for Pfizer Covid vaccine. Outcome of the event was unknown. Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.
Pt developed rash close to site of administration that persisted 3 days post vaccination.  Pt given BENADRYL & PREDNISONE.  0 systemic symptoms.
14hrs after the injection, I woke up and didn't know why. Within a minute or so, I started sweating profusely. I started getting massive pain and achiness in my lower abdomen and down through the tops of my legs , down to the top of my knees. I have a very high pain tolerance and it was excruciating. No position lessened the pain. I thought I had to go to the bathroom twice and felt like I would have explosive diarrhea, but nothing happened either time. I just sat there in pain and sweating. I managed to get a drink of water when I started having this low level feeling that I would throw up and decided not to drink too much. I never threw up either. I laid in bed and went from sweating to freezing and back again. I was seriously considering calling 911, but after about 1.5 hours, the pain went from constant to waves and then I got extremely tired and just fell asleep. The next day I was tired and the fatigue lasted probably 3 days, but I had none of the other symptoms again. My arm hurt from the injection (though I really didn't feel the injection itself) for probably 3-4 days, but I ended up with a bruise for more than a week. I never had any Covid symptoms prior to that and I only had neck and shoulder achiness and some fatigue for about 2 days after the 2nd shot - along with the arm soreness, but no bruise.
Acute kidney failure, unspecified Systemic inflammatory response syndrome (sirs) of non-infectious origin without acute organ dysfunction
Pericarditis. Initial symptoms were noticeable upon waking up the morning after receiving the vaccine, ~ 20 hours after vaccination. Initial symptoms: extremely elevated heart rate (~160 bpm). Heart rate fell to more reasonable, but still high, ~120 bpm after 2-3 hours. Roughly 36 hours after vaccination, began noticing soreness in the chest. Upon waking the following day (~48 hours after vaccination), chest soreness had progressed to pain (rating: 4/10), which remained roughly 6 hours to roughly 1400 that day, when the pain subsided along with all symptoms. Later, at roughly 2000 the same day (~58 hours after vaccination), there was a sudden and extreme flair up of chest pain (rating: 8/10) which radiated down the inside of both arms, this lasted 1.5 hours and then subsided just as suddenly as it came on. I went to sleep, then was woken up by another extreme episode of pain (rating: 7/10) at 0230 the morning of 15 May, again extreme chest pain radiating down both arms.
Notice yesterday, a large round red circle about 2 inches across, raised and swollen, hot to the touch, soreness and tender.
pt states later in the day after taking the vax he developed a bad headache and dizziness.  Next day pt is still having some headache and dizziness.  Pt will call his PCP if his symptoms don't improve.
Pt states her arm was swollen, red and itchy, also had a palpable lump
Developed shingles; This spontaneous case was reported by a physician and describes the occurrence of HERPES ZOSTER (Developed shingles) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.    Co-suspect product included non-company product ACICLOVIR (ACYCLOVIR AKRI) for an unknown indication.    Concurrent medical conditions included Hypertension, Diabetes mellitus and High cholesterol. Concomitant products included METFORMIN, SIMVASTATIN, CARVEDILOL (COREG) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started ACICLOVIR (ACYCLOVIR AKRI) (unknown route) at an unspecified dose. On 05-Feb-2021, the patient experienced HERPES ZOSTER (Developed shingles). At the time of the report, HERPES ZOSTER (Developed shingles) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 30Mar2021 11:30 (Lot number: EW0150) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COPD" (unspecified if ongoing). Concomitant medication(s) included: TOPROL. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 27Apr2021 18:30, outcome "recovered" (2021), described as "sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Facility type vaccine was Public Health Clinic. Patient had no covid prior to vaccination and not covid tested post vaccination. Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Swollen right tonsil, swollen lymph nodes in neck and jaw, pain, no fever, tested negative for strep
Headache, dizziness, body aches, fever, injection site red, swollen, and hot.  Beginning March 24 continues
Atrophy under delt-outcome-muscle loss/hole where shot was given. After given extremely soreness hurt very sore to touch, red, swelling where shot was given, hard to sleep for 2 months couldn't sleep on left side due to pain. After about 2 months pain subsided but hole in arm by Jan. after months hole became larger lower deltoid has been eaten away huge hole in lower delt arm weakness due to muscle loss.
Breakthrough case admission after 2 vaccines Pfizer 8/23/21 Lot# Ew0183;  Pfizer 9/16/21 Lot# Ew0186
My daughter was healthy prior to the vaccine, she developed coxsackievirus 4 days later. She had a high fever of 103-104 for 11 days, then developed mouth sores on her cheeks, tongue, and throat. Her gums and lips are inflamed(red and swollen) and bleeding.
pt recv vax 28AUG98 c/o rash beginning bends of the next day becoming generalized 2 days fever began yesterday-swelling parotid glands yesterday-lack of appetite-T100;seen today;
Hep A IM, Hep B IM, IPV IM, MMR Subcutaneous, Td (adult formulation) IM and Varicella Subcutaneous given per protocol using proper technique. After receiving vaccines at 9:56 am, patient reported not feeling well and started to feel dizzy, skin color was pale and clammy. V/S vital signs were taken immediately HR 49, BP 120/66 , O2 saturation at 95 percent. Provider was notified immediately while still remaining with patient. Patient started to close his eyes and nurse kept him aroused to keep him from losing consciousness, patient was still oriented person, place and location. Patient was sweating profusely and 2 ice packs were given to patient to hold on both hands by provider. Legs were elevated, and reminded patient to breath in and out and follow command given to remain consciousness, patient was instructed to move toes and squeeze hands without any problem or loss of grip. Patient was also given a small snack, and patient was able to intake with no issue. Father and Son reported not having breakfast before coming to appointment, Provider gave patient water to sip on and was able to tolerate it. Second set of Vital signs were taken at 10:03 am BP 126/79, HR 65 O2 saturation at 100 percent. Patient regained skin color and sweating has stopped. Patient was alert and oriented x3. Patient reported, " I'm feeling better now." Patient remained seated. Vital signs were taken at 10:08am BP 132/83, HR 71 O2 saturation at 100 percent. At 10:13 am, patient was instructed to stand up while nurse on the side, patient was able to stand up without assistance and take a few steps without assistance. Patient and dad were instructed to seek emergency care if symptoms arise and worsen immediately. Both Father and patient verbalized understanding. No EMS was called and were released from our care at 10:17am. VAERS report submitted. Supervisor notified.
Redness, swelling, warmth to site fever (100.2), chills, fatigue, achy.
24SEP92 2AM broke out in blotchy red rash on arms, trunk, knees; hands lt arm, & both knees swollen; c/o itching; 24SEP92 later in day seen by MD who gave DPH & Caladryl;
she got the Omicron variant after the 2 shots; she got the Omicron variant after the 2 shots.; she ached all over; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (002191). The reporter is the patient.  A female patient in her 70's received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "she got the Omicron variant after the 2 shots"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "she got the Omicron variant after the 2 shots."; PAIN (non-serious), outcome "recovered", described as "she ached all over". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  Clinical course: Caller stated that she got both her vaccines from Pfizer, but then she got the Omicron variant after the 2 shots. Caller states everyone now knows that the BA1 variant changed so much that the vaccines did not protect her. Caller states she was sure she got the Omicron variant because that what was prevalent in her area. Caller states her husband got it first and then gave it to her. Caller states she got it on a holiday, and she ached all over, but she got over it fast, it did not bother her too much and she was in her 70s. Caller states she probably now has natural immunity, which used to say was the best but now who knows what they say. This was a product complaint to report.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Severe itching inner thighs, calves, buttocks, and feet, followed by hives and a few large welts on belly and thighs. Slight hives torso and forearms. Treated with Zyrtec allergy medicine and managing so far at 11:49 pm.
I have a knot the size of a quarter that is raised, red and hot. My upper arm is sore and woke me several times during the night when I rolled on it.