chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient was exposed to someone with COVID, asymptomatic, tested positive for COVID on 8/3/2021
Patient presented with myalgias, fevers, and chest pain on 1/10/21 and was found to have diffuse ST elevation and elevation troponin.  He was evaluated by cardiology and diagnosed with acute myopericarditis.  He was treated with NSAIDs and colchicine.  He improved with this treatment and was discharged on 1/12/21 with ibuprofen and colchicine and outpatient cardiology follow up.
Case number PHEH2015US015166, is an initial spontaneous report from a physician received on 23 Jul 2015 with follow up report received from physician on 21 Sep 2015. This report refers to an 18-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with BEXSERO (batch number: 146101) at a dose of 0.5 ml intramuscularly into left deltoid on 08 Jun 2015 at 15:30 PM. On an unknown date she had body rash. On 13 Jun 2015, she experienced hives on whole body. Treatment medication included BENADRYL oral. The outcome of hives was reported as complete recovery on 07 Jul 2015. The outcome of body rash was not reported. The seriousness of the events was not reported. Causality was reported as probable. Seriousness of the event hives whole body was upgraded based on available information in the source document. Follow up report received from physician on 21 Sep 2015: Medical history and event hives whole body added. Vaccine batch number, dose and time, age, patient demography updated.
This case was reported by a pharmacist via call center representative and described the occurrence of pharyngeal paresthesia in a 69-year-old female patient who received SHINGRIX (batch number 49ST9, expiry date 4th July 2020). On 2nd May 2018, the patient received the 1st dose of SHINGRIX. On 2nd May 2018, less than a day after receiving SHINGRIX, the patient experienced pharyngeal paresthesia. In May 2018, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the pharyngeal paresthesia was recovered/resolved and the outcome of the injection site erythema and injection site swelling were recovering/resolving. The reporter considered the pharyngeal paresthesia to be possibly related to SHINGRIX. The reporter considered the injection site erythema to be related to SHINGRIX. It was unknown if the reporter considered the injection site swelling to be related to SHINGRIX. Additional information was reported as follows: The patient experienced throat tingling the evening after vaccination with SHINGRIX, which was resolved by its own. The following morning after vaccination with SHINGRIX, the patient experienced severe redness and swelling. On 5th May 2018, three days after vaccination, the patient presented to the pharmacy with a redness having the size of a grapefruit, which the patient stated that it was actually an improvement. The healthcare professional had not seen the patient since 5th May 2018, but believed that the redness was continuing to improve. The reporter stated that the patient felt fairly certain that the diameter of the red area was greater than 100 mm.
20 mins. after injection itching of face and gradual body. approx. 1 hour throat itching, approx. 4 hours mild headache, some rash only on neck and chest but within less than 8 hours full body rash, some milder aches but NEXT morning horrible pain all over like I had been thrown into my worst ever fibromyalgia flair. Complete muscle, joint, entire deep body. WORST i ever had. then a few welps and even though 90% was under the skin rash husband and I could feel the 10 % was red, small pimple like IF not the neck welps and then on the 4  day  had a few hives on face only.  Worst itching I have ever had and I have had chicken pox and antibiotic rashes. I think the problem has been came off of antibiotic and gradually got ok but can not get this out of system so easy of course. Today is 1 week. rash is better but not gone and itching is some better but still not good. I did not take benadryl or anything since I DO NOT want to interfere with me getting as much benefit from the injection since I now can not have number 2.
tested positive for covid 19/it was a swab in her nostrils; tested positive for covid 19/it was a swab in her nostrils; This is a spontaneous report from a contactable consumer reporting for self. This 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) on 06Jan2021 around 14:30-14:45 at left arm at single dose for COVID-19 immunisation. Medical history and concomitant medications were none. No prior vaccinations within 4 weeks and no AEs follow prior vaccinations. Family medical history included diabetes. The patient received 1st dose of vaccine on 06Jan2021, tested positive for COVID 19 on 19Jan2021. Unable to provide which COVID test she received. Stated she was tested at (Pharmacy) and it was a swab in her nostrils. She was scheduled for 2nd dose on 27Jan2021 at 15:45 and asking if she can/should get the 2nd dose. The outcome of event was unknown.
Patient presents to the ED for worsening abdominal pain, associated with diarrhea, nausea and vomitting.  Pt also complains of nausea and vomiting with decreased/poor PO intake. She is concerned she is becoming dehydrated. Pt also complains of fever with Tmax of 100F at home with associated myalgias. Pt also endorses headache with light sensitivity stating it hurts to lift her head up. She also endorses SOA with exertion and when the pain gets really bad. She states she has had a dry cough as well. Pt was tested for covid-19 outpatient yesterday which came back positive.  Pt was tachycardic, but otherwise hemodynamically stable at time of assessment. However, it was obvious that she was in pain.   Review of Systems  Constitutional: Positive for appetite change, chills, fatigue and fever (100F).  HENT: Negative.   Eyes: Negative.   Respiratory: Positive for cough and shortness of breath. Negative for chest tightness and wheezing.   Cardiovascular: Negative.   Gastrointestinal: Positive for abdominal pain, blood in stool, diarrhea, nausea and vomiting. Negative for constipation.  Endocrine: Negative.   Genitourinary: Negative.   Musculoskeletal: Positive for myalgias. Negative for arthralgias, back pain and neck pain.  Skin: Negative.   Allergic/Immunologic: Negative.   Neurological: Positive for weakness and headaches. Negative for dizziness, syncope and light-headedness.   Hospital course with COVID:  # COVID-19 infection - positive PCR 1/29 - chest x-ray with no acute cardiopulmonary findings - has not required any treatment Plan - continue isolation precautions as per Health Department guidelines  Discharge Disposition/Condition Disposition: Home Condition: Stable (s/sx potential problems absent or manageable)
Patient said that all of a certain he got loose diarrhea and kept on going till 5/14/18, which was when he notified us, however, it's resolved yesterday 5/15/18.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported.      On 28-SEP-2018, the patient was vaccinated with M-M-R II, intramuscular route (incorrect route of drug administration), lot#: R000556 and expiration date: 08-JAN-2020 (strength, dose and anatomical location were not reported) indicated for prophylaxis, which was reconstituted with sterile diluent(MERCK STERILE DILUENT). No adverse effects reported.
03/11/ pm- behavior changes, swelling of face & neck, head & joint pain, high temperature, weakness, can't stop sleeping. I called Dr's office, they told me this was normal & use pain medication & Benadryl.
This case was received from a consumer on 22 April 2008.  A consumer reported that her four-year-old daughter experienced "ongoing sicknesses such as pneumonia" after receiving DAPTACEL and ACTHIB.  On 01 July 2003, the patient received DAPTACEL (lot number C1383AA) and ACTHIB (lot number UA841AC); on 04 September 2003 she received DAPTACEL (lot number C1387AA) and number UA863AA); and on 12 August 2004 she received ACTHIB (lot number UE117AA).  The patient's parent stated the the vaccines "did not work". and noted that the patient had received boosters and was being "retested".  No additional information was provided.  Follow-up information was received from a physician on 14 July 2008.  The physician stated, "According to my records, the patient never had any immediate or delayed reactions to any vaccination.  She was never diagnosed with, treated for or hospitalized for pneumonia while she was my patient.  She was in my care until 10/05.  She was 2 1/2 yrs old at that time."  No additional information was provided.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program. A patient (no qualifiers provided) received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), Jul 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient developed abdominal distension (severe bloating/stomach distention), onset 2021, with outcome of not recovered. Additional information: The patient received Pfizer COVID-19 booster and within an hour their stomach ballooned by 5 inches. In August, the second dose was oh so much worse. 3 pant sizes up in a week. Still up 3 due to the bloat. The lot number for BNT162B2 not provided and will be requested during follow-up.
Began feeling pain in left armpit, realizing it was a swollen lymph node.  Then noticed bright red circle around site of vaccine injection, which occurred 8 days prior.  Also some itching and hot to the touch at red circle.  Took 2 benedryl and hydroxizine that night for sleep relief.  It has been 2 days and the lymph node is still tender but not as swollen.  Circle is more flushed out, but still there, however it is not as clear of a line around injection site now.
next day, my wife went to the hospital and found out she had covid; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (Husband) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown), via an unspecified route of administration on 25Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The next day, the reporter stated that my wife went to the hospital and found out she had covid on 26Jan2021. The outcome of event was unknown.   No follow up attempts are needed. No further information is expected.
9 DAYS AFTER VACCINATION ITCHING, HIVES ON BACK AND ARMS; ARM HEAVY; TONGUE HEAVY; DIZZY, HEART POUNDING; CHEST TIGHTNESS ED visit 01/21 --given Decadron and Benadryl IV for allergic reaction Urgent Care visit 01/25 for chest tightness
No adverse reaction. No issues with patient. Patient was given 0.25 mL of Moderna Bivalent Booster. Patient will be called and notified.
Vaccine administered 8/28/21  Persistent dizziness since 9/3/21,  when getting up from lying or sitting Subjective complaint of fatigue and leg weakness, not noted on on exam
Patient came to pick up medication on Sunday 8/20/17 and when we asked how he was doing, he showed up the location that his flu shot was given and there was a light bluish-black circular bruise. Patient said there was no pain.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th September 2018, the patient received the 2nd dose of SHINGRIX (subcutaneous). In June 2018, less than a month after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced pain in arm and injection site erythema. On 4th September 2018, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the pain in arm, injection site erythema and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the pain in arm and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: Sometime in late June 2018, the patient received 1st dose of SHINGRIX. The patient experienced arm soreness and redness at the injection site. The patient received 2nd dose of SHINGRIX subcutaneously behind the right arm, which led to inappropriate route of vaccination. The physician's contact details was provided. This case has been linked with US2018163141, reported by the same reporter.
Beginning the day following the 2nd does of the Pfizer vaccine, my daughter has been experiencing shortness of breath with minimal activity that she had not experienced before the vaccine.  Today, July 14, 2021, is day 6 and her symptoms have continued.  Her pediatrician ordered a chest x-ray and EKG to rule out any serious issues, and both tests (conducted on July 13, 2021) were normal. He prescribed an Albuterol inhaler to be used twice daily for one week. She started the Albuterol today, on July 14, 2021.
chronic hives.hives that come and go, breaks out in hives throughout his whole body,hives last 30-45 minutes; red patches; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (chronic hives.hives that come and go, breaks out in hives throughout his whole body,hives last 30-45 minutes) and RASH ERYTHEMATOUS (red patches) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088D21A, 044A21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced URTICARIA (chronic hives.hives that come and go, breaks out in hives throughout his whole body,hives last 30-45 minutes) and RASH ERYTHEMATOUS (red patches). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and FAMOTIDINE (PEPCID [FAMOTIDINE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (chronic hives.hives that come and go, breaks out in hives throughout his whole body,hives last 30-45 minutes) had not resolved and RASH ERYTHEMATOUS (red patches) outcome was unknown.            No concomitant medications reported by reporter Treatment medications also includes antihistamines, histamine blocker  He breaks out in hives throughout his whole body, red patches, developed anywhere from neck down and last 30-45 minutes.     This case was linked to MOD-2021-437106 (Patient Link).
The day of the vaccine, in the afternoon, and intense body aches and had chills and back pain. Felt tired, had fever (at around 5 pm and lasted 24 hours) and didn't sleep much - I was trying to massage my body( the aches started at around 5 pm and lasted 24 hours) at 04:00 in morning because of the aches - even in bottom of feet. By next day, fever wasn't coming back and I was very tired. By Sunday, no body aches, just tired.  June 25th,  I noticed a rash - itching on my hand on and of through the night. I started feeling my neck itching but no signs of anything until past 5 in the afternoon. My daughter noticed how red it was and it started spreading to my back, too and parts of my leg and my belly. I took Benadryl and applied Hydrocortisone cream. That didn't help. It night, past 9:00 pm,  it was still spreading and I could feel like the top of my hands  and between my fingers were burning. And rash had spread on my arms and towards my hands. My upper lip was full of the rash and my chin. I went to 25th of June, ER  - they gave me some medication - Prednisone Steroids and more Benadryl and Pepcid. I was able to sleep through the night without itchiness but it woke me up in the morning with the itching. I was going to take the Benadryl and the Pepcid (twice a day) - and I was still applying the Cortisone. By 06:00, it started to get pretty bad again - everywhere was very itchy and I took more Benadryl and used the cream and 98% of my face of was covered by rashes- even eyelids and they felt hot. From my chest up and on top of head was red. My arms didn't' have anything at that point but by almost midnight  - on the 26 I went to ER again and they gave me an EpiPen - and Steroids. They waited and when they saw the medication was taking affect they released me home. My temperature was 99 degrees - slightly higher than  my usual. By three o'clock in morning,  the 27th, the itching woke me up again - two more Benadryl and applied more Cortisone cream and waited for it to kick in and in the morning, I picked up for the pharmacy a prescription for Steroids for three more days - I took some Sunday, Monday and Tuesday. The hives - I sometimes had to take the cream every four hours instead of 6 -  they all over my body. Yesterday,  very early morning, I woke up with hives throughout the whole night. And in the morning - The sides of my feet were itchy. My legs - from knees down were full of redness and hives and a few patches on my inner thigh. By two pm I was better yesterday, and I haven't seen any rashes since then.
FEVER; FELT LIKE GOING TO THROW UP; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced fever, and felt like going to throw up. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102.5 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and felt like going to throw up. This report was non-serious.
Symptoms began at 20:00. Onset of fever, chills, headache, muscle pain, weakness, fatigue. Symptoms relieved by ~20:00 the following day.
Received Moderna Vaccine on April 1st., and two hours later developed slight ringing in ears. On morning of April 6th, ringing in head/ears became much louder. Ringing (loud) in ears has been constant and ongoing since April 6th.
3-19-19 -All joints stiff and painful, backache, fingers stiff and sensitive, throat, hard to swallow, rash on upper back-took TYLENOL. 3-20 -Same as above -called pharmacist -Took TYLENOL. 3-12 -Same as above -called my family Dr -took Naproxen at night to sleep -stopped TYLENOL. 3-23 and 24 -feeling better -Naproxen at night. 3-25 -better -stopped meds.
on Sept 26, felt I was getting a cold - sore throat and congestion, fatigue. Gradually got better, then on October 8th, had a very sore throat in the back of my throat (hurt to swallow food), and soreness under my jaw on the right side, body aches, a slight headache, chills, and fatigue. This lasted about 2 days. Called doctor on Oct 11th and he said that I should rest and stay home, but he didn't think it was anything serious. After the sore throat and other symptoms got better, the congestion and congested cough seemed to come back worse than before. I'm mostly over it, but still have a little cough and congestion. (as of 10-23)
Information has been received from a registered nurse and a physician concerning a 7 year old female who on 07-JUN-2001 was vaccinated with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck) (lot# 635948/1333K). On 06-OCT-2007 the patient experienced a fever and developed less than 50 lesions on her face, back and underneath both arms (reported by nurse as varicella outbreak post vaccination with varicella virus vaccine live (Oka/Merck)). The child's primary physician contacted the county health department for medical attention. Subsequently, the patient fully recovered. There was no product quality complaint. This is one of four reports from the same source. Additional information has been requested.
Unable to process movement and sound at the same time for a window of 2-4 hrs. Increase temp 102 x 12 hours. Nausea and vomiting x 12 hours. Headache, swelling at injection site/severe redness. Swollen and very painful lymph nodes x 48.
In April I noticed an erratic heartbeat, sometimes it would flutter. Sometimes I would wake up and thought I had a nightmare because my heart was beating so fast. I visited the doctor and gave me a monitor to wear for 7 days. A cardiologist analyzed the data and determined Supra Ventricular Tachycardia, SVT. I now have hot flashes and my blood pressure runs lower than normal now.
Vertigo starting 18 hours after vaccine and has persisted still today-18 days after the vaccine
Nasal swab test positive; Nasal swab test positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EL9261), in right arm, as dose 2, single (Lot number: EN6200), in right arm, as dose 3 (booster), single (Lot number: FF2588), in right arm and as dose 4 (booster), single (Lot number: FJ4991), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Pancreatic carcinoma" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM; VIT D3; ASPIRIN [ACETYLSALICYLIC ACID]; PANTOPRAZOLE. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Feb2022, outcome "unknown", COVID-19 (medically significant) with onset Feb2022, outcome "recovered" (Apr2022) and all described as "Nasal swab test positive". The event "nasal swab test positive" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2022) Positive; (Apr2022) Negative. Therapeutic measures were taken as a result of covid-19.  Clinical information: Facility type vaccine: Pharmacy or Drug Store. The patient had not received other vaccine in four weeks of vaccination. Other medications in two weeks: Calcium, Vit D3, low dose aspirin, pantoprazole. AE resulted in: Doctor or other healthcare professional office/clinic visit. AE treatment: Physical therapy. Patient had not covid prior vaccination. The patient covid tested post vaccination.
Patient came into the clinic for a MMR vaccine per her employer's request. The nurse took the MMR vaccine box out of the freezer and noticed that box was expired. She then grabbed the unopened box behind it, reconstituted the vaccine, educated the patient about the vaccine, and administered the dose to the patient. The patient left the clinic after the vaccine. While the nurse was entering the order into the computer system, she noticed she had given the wrong vaccine to the patient.
5 hours after injection itchy rash generalized rash, no difficulty, swallowing or breathing.
09/16/21 pm hours noted right deltoid injection site painful to touch, site warmth and increase in upper arm size.  late am 09/17/21 chest tightness episode.  early am 09/18/21 worsening right deltoid injection site swelling, hard to touch and increased pain with reddened circular area diameter 5-6 mm plus similar reddened areas 2 - 3 each leg on bilateral lower legs.  Onset of throat tightness during late pm 09/18/21/early am 09/19/21.