chrisvoncsefalvay/vaers-outcomes huggingface dataset:
85 year old lady with PMH of COPD, CHF, pAF, DM2, COVID PNA in 9/2020, and DM who states that she is here for bronchitis and pneumonia. She says she has had bronchitis for at least two weeks. She has been coughing, it has been productive of thick yellow sputum. She thinks that she has only been treated with a steroid, no abx. States that she was better at first but has then gotten worse again. States that she came to the ED today because her body feels tired. She has not had any fevers. She feels ShOB. She has orthopnea. No PND. She has pedal edema. She has sinus congestion, no sore throat, no trouble swallowing. No CP, no palpitations, no nausea, no vomiting, no dysuria.  Arrived to the ER, she had a temperature 98.2°, heart rate of 110, blood pressure 123/86.  CBC significant for white count of 16.36, increased granulocytes, BMP relatively unremarkable, potassium is pending though, glucose 149.  COVID swab is negative.  Chest x-ray read as stable cardiomegaly without any other acute findings.  CT of the chest the nonspecific 2.3 cm area of soft tissue fullness of the right hilum, patchy bilateral airspace disease, small pleural effusions with compressive atelectasis, cirrhosis of the liver, left adrenal adenoma.  PT IS STILL INPATIENT AT THIS TIME.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Apr2021 at 00:15 as dose 1, single (Lot number: EW0171), in left arm, on 21May2021 at 00:30 as dose 2, single (Lot number: EW0186), in left arm and on 28Nov2021 at 12:15 as dose 3 (booster), single (Lot number: 330268D) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, suspected covid-19.
Seen 5JUL91 for temp due to DTP given 3JUL91 per mom; temp was 104 despite APAP;
pt recv vax 19DEC94 & 29DEC94 pt exp red spots on face & legs, redness & swelling around eyes, low grade fever; f/u info MD indicated 27DEC94 pt exp fever 99, morbilliform rash & nasal congestion;
Approximately 26 hours after receiving injection (around 6:30 pm on a Friday), he began to vomit and have extreme fatigue.  The nausea and extreme fatigue persisted  through Saturday and Sunday.  He was only able to keep minimal liquids and food down.  On Sunday afternoon (around 1pm) we had a low grade fever.  This was the first time he was noted to have a fever.  After consulting with telehealth, it was determined that there may be concern about his appendix.  He was admitted to the ER about 5:30pm on Sunday, and was diagnosed with a perforated appendicitis.  An appendectomy was performed at 1am Monday.
She noted no symptoms until after 4 days when she noted a red, raised, persistent rash on her trunk and extremities. The rash remained in the same areas for 2-3 days but spread to other parts of her body. She took diphenhydramine with minimal improvement of the rash. The rash gradually resolved after one week.
Patient's husband states she has itchy sores on her back that look like chicken pox.  They are not getting any worse but not getting any better.
Swollen Gland (Lump) by collar Bone on the same side as the shot.  On 2/22/2012 Swollen Gland under arm on the same side as the shot.
On 3/29/21 patient called and spoke to PHN stating that on Friday 3/26/21 (two days after receiving vaccination) was seen at the ER for tachycardia. Reports history of tachycardia and vertigo that has been well managed. Feels this exacerbation may have been caused from vaccine. Reports symptoms resolved on 3/28/21. Patient will be following up with her primary doctor and cardiologist. Discussed completing a VAERS report, patient did not give writer additional information but indicated that she would complete a VAERS report; link emailed to patient.  Emailed patient on 4/1/21 seeing if she would like assistance completing the VAERS report, she indicated that she hadn't and was going to wait to do so, that she saw her primary doctor on 3/31/21 and reports her doctor feels the reaction was not an adverse reaction, but her body's reaction to it.
pt devel an inj site rxn, characterized by induration & redness p/vax;
This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse effect.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported , No treatment medication was reported .   Patient is wondering if she can catch the virus from the vaccine??   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: follow up received on 1-jun-2021 Non significant  information was reported .
Later on in the dat at about 330pm pt was driving and "blacked out" causing a MVA.
This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On an unknown date, the patient was vaccinated with one dose of improperly stored PNEUMOVAX23, lot # L012042, expiration date 18-NOV-2016 (dose and route of administration were not provided). No adverse effects were reported. Addditional information has been requested.
Swelling in both knees after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Swelling in both knees after vaccination) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis and Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced JOINT SWELLING (Swelling in both knees after vaccination). At the time of the report, JOINT SWELLING (Swelling in both knees after vaccination) was resolving.            It was unknown if patient was enrolled in a COVID-19 vaccine trial. No concomitant medications were reported. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Post vax, the pt developed stiffening of lower extremities 1-2 weeks before dx of transverse myelitis was made. 60 Day FU states the last letter from the neurologist stated she has almost completely recovered by still has some residual decreased muscle tone.
On 5/6/2021 Presented to urgent care.  Clinically Dx with Herpes Zoster. PCR testing for Varicella pending.
Client started to develop itchy hives all over the body. hives started on her back an hour after receiving the vaccine.
feeling lightheaded after injection, observed, vitals checked and stable, juice given. patient feeling better after 5-10 minutes--observation in car.
got the flu shot once and got the worse case of the flu; Initial information received on 14-Feb-2022 regarding an unsolicited valid  non-serious case received from a patient.  This case involves an unknown age and unknown gender patient who experienced got the flu shot once and got the worse case of the flu while receiving influenza vaccine.  The patient's past medical history, medical treatment(s), concomitant medication ,vaccination(s) and family history were not provided.   On an unknown date, the patient received  Influenza Vaccine once (with an unknown formulation, route, strength, batch number ,administration site and expiry date) produced by unknown manufacturer for immunization.   On an unknown date the patient developed a non-serious event of  got the flu shot once and got the worse case of the flu (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (got the flu shot once and got the worse case of the flu).  At time of reporting, the outcome was Unknown for the (got the flu shot once and got the worse case of the flu).
Blood clot in left leg on 3/22/2021 and 3/29/2021
first dose / administered on 23Oct2019 / second dose on the same day as reported it; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number PK5B9, expiry date 15th November 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 23rd October 2019).   On 22nd June 2021, the patient received the 2nd dose of Shingrix. On 22nd June 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: On the day of reporting, the patient received 2nd dose of Shingrix, which led to lengthening of vaccination schedule. The reporter consented to follow up.
This spontaneous report was received from a other health professional referring to unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with ROTATEQ after being improperly stored at 33F (for an unspecified amount of time) (dose not reported). No other concomitant therapies reported. No adverse effects reported. The outcome of the event was unknown. The case has been linked with the cases (same reporter link) 1406USA008470, 1406USA008474, 1406USA008158 and 1406USA008477. Additional information is not expected.
swelling at the injection site in her left arm; redness and warmth the at injection site; redness and warmth the at injection site; pain at the injection site; This spontaneous report was received from a medical assistant and refers to a 35-year-old female patient. The patient's pertinent medical history included with depression, migraines, glaucoma, tobacco use, and allergy to tree nuts, almond oil, peanut oil, coconut oil, amoxicillin, neomycin, penicillin, aspirin, and bees. Concomitant therapies included levonorgestrel (MIRENA) intrauterine device (IUD).   On 19-JUL-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R032766, expiration date 31-AUG-2021, intramuscularly in the left arm (dose was not reported) for human papilloma virus (HPV) prevention.  On an unspecified date in July 2019, the patient began to develop adverse effects: swelling at the injection site in her left arm, redness and warmth the at injection site and pain at the injection site. The patient sought medical attention via telephone call to Obstetrician/Gynecologist (OB/GYN) office. No lab diagnostics/studies were performed. No treatment was given for the adverse effects. At the reporting time, the patient did not recovered from the events. The reporter considered the adverse effects to be related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).
Severe lower back pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Severe lower back pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     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 27-Mar-2021, the patient experienced BACK PAIN (Severe lower back pain). At the time of the report, BACK PAIN (Severe lower back pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided.  No treatment information provided. Case is based off of a social media post and filed with limited information
Patient called a physician on call 2 days after vaccination, complaining of swelling "golf ball size", redness, questionable vesicles.
My mouth had a metallic taste.; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non pregnant female patient received first dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205), via unspecified route of administration, administered in left arm on 19Mar2021 at 14:45 (at the age of 37 years old) as a single dose for COVID-19 immunisation. Medical history included svt, asthma. Concomitant medication included BYSTOLIC, ADVAIR, PROTONIX, vitamin d (MANUFACTURER UNKNOWN), and TYLENOL for unknown indication and unknown duration. The patient reported of allergic reaction to food but not exactly sure about the ingredient that caused. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID 19 prior to vaccination. Since the vaccination patient had not been tested for COVID-19. The patient experienced metallic taste in mouth on 19Mar2021 at 15:00. The clinical outcome of the event metallic taste was unknown at the time of reporting.   No follow up attempts are needed. No further information is expected.
shingles after doses several yrs prior/I developed shingles after having taken doses of shingrix several yrs prior. It was a mild case. My question is/ suspected vaccination failure; shingles, mild case; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, several years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 22-SEP-2022 Reporter's Comments: The patient developed shingles after having taken doses of Shingrix several years prior. The reporter reported that it was a mild case.  The reporter wanted to know should he/she took another dose of Shingrix and would it helped prevent reoccurrence. The reporter wanted to know whether patient received the first dose Shingrix or another vaccine.  Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Add Note: suspected vaccination failure coded as mentioned doses and no dose numbers reported , However patient confirmed only regarding 1st dose of Shingrix and unclear how many doses received as well information about 2nd dose and saying for scheme.
I started getting symptoms of fatigue and swollen lymph nodes. I went to my doctor and had blood work. Nothing came up at that moment. My doctor was thinking it could be due to my other chronic conditions but this was different. All I wanted to do is sleep all day. In December, I got more blood work that indicated and confirmed Epstein-Barr Syndrome. Nothing can be done except take prednisone which I can not take. It is slowly getting better but has been a challenge.
The pt experienced a red, edematous, macular rash at the injection site. (left proximal thigh) with pain and mile warmth with palpation.
3/10 could not stay awake beyond 9PM 3/11  10 AM, tired, nauseous, continued to 8PM when could no longer stay awake, slight aching at injection site 3/12 slept 10 hours,  continue to feel tired, less energy to present date 3/21/21.
Missed second Dose (Beyond Day42); This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second Dose (Beyond Day42)) 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.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second Dose (Beyond Day42)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second Dose (Beyond Day42)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No Treatment information was provided.
I received my second dose of Moderna on the 26th of July, I felt the expected run down fatigue and nausea for the first three days. Then on the 29th I noticed that my heart was pounding harder than normal and on the 30th my chest hurt. When I say my chest hurt I don't mean my heart, but rather my ribcage and the muscles in that area. It hurt to laugh and to contract those muscles. This pain lasted for approximately 36hrs after which I returned to normal. Because it didn't feel like my heart was hurting (no heart pain, just noticed it pounding on the 29th) I didn't seek medical attention. However, I considered it due to the pain as it was very uncomfortable. I would describe the pain as moderate.
-  Tinnitus increased from 2 to 10 in severity -   Intermittent stab in pain on lower.back of head slightly above left ear lobe
Thyroid levels change meds changed to 50 mcg, red dots all over on torso, both back sides left , right.  front breast right one , lower stomach area right, left. Emergency room doctor took photographs.
T78.3XXA ANGIOEDEMA, INIT 6/24/2022 NORMAL DELIVERY T78.3XXD ANGIOEDEMA, SUBSEQ 10/19/2022 NORMAL DELIVERY T78.3XXS ANGIOEDEMA, SEQUELA 6/30/2022 NORMAL DELIVERY
When I received my first dose of the Moderna vaccine 8 days ago, I had pain at my injection site and my arm hurt for a day or so. The pain then was more than what I would feel from a regular flu shot, as it was harder to move my arm, but eventually went away. Last night, I noticed my arm starting to hurt again. This morning, again 8 days since my first dose of the vaccine, the pain near my injection site was more noticeable, the area around it was feeling hard like a lump, and it was red.  Throughout the day and tonight the pain has increased, there is more swelling and redness around the injection site, the lump is more noticeable, and I feel itchiness. My main concern is that this is happening over a week later after having a period of no symptoms and seemed to be getting worse throughout the day today.
It's the joint at the base of my thumb where the wrist and thumb meet on my right arm. The pain started a couple weeks after my first dose. After the second dose there was another flare up of wrist pain. I don't remember the third dose. I did have another flare up after having COVID-19 in January 2022 and again after the fourth dose in March 2022. At the end of May 2022,  I saw the doctor at the Orthopedic Clinic regarding the pain.  I was diagnosed with arthritis at that time. They gave me a steroid shot that helped within three days. The pain is not gone but it's a lot better. Before I could not open jars or hold pliers. It has started in the left hand but it's not nearly as bad as the right hand was.
Phone call from MD. Client was seen in ER the evening of 6/18/02. Had right side focal seizure. Hospitalized over night for observation.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with dose 1 of GARDASIL on 24-JUL-2012 (dose, route and lot number not reported). On 24-SEP-2012, the patient received the second dose of GARDASIL (lot number 666162/0565Z, expiration date 15-SEP-2012) (dose and route not reported which was expired). No adverse event reported. Additional information has been requested.
HEADACHE BODY ACHE BURNS ON TONGUE ARM SWOLLEN ARM REDNESS AT INJECTION SITE
Headache started a couple hours after injection and lasted for days.  Muscle pain,  neck pain,  nausea,  fatigue, altered taste bitter,
I had this vaccine about 4:30 pm on 11/11/18. On 11/12/18 around 8:00am, I experienced chills and sweats. I checked my temperature with a thermometer around 11:30am and it was 101.2 F. I took ibuprofen to help reduce the fever, and I also experienced body aches and extreme pain, swelling (but no redness) at the injection site. The fever and body aches seemed to resolve about 4:00am on 11/13/18, although the swelling and pain at the injection site has only slightly improved.
10 minutes after receiving the vaccine, the client had a vaso vagal reaction in the waiting area. She fell out of her chair to the floor.  Staff immediately responded. She was able talk but shaking. BP and HR elevated initially. Assisted to wheelchair after monitoring. Vitals returned to normal range, client no longer shaking and speech clear.
Child accompanied by mother. Mother stated child's left arm was swollen this am prior to going to school. Mother stated when she picked child up from school left arm was red, swollen and warm to the touch.  Mother stated teacher applied ice to left arm during school hours. Mother brought child to express care. Antibiotics was prescribed.
Malaise. Skin - fine pinpoint erythematous papular rash involving dorsal hands, wrists, dorsal feet, ankles, lower anterior legs. Petechial lesions on lower legs. Papules on abd and face. Swelling of eyelids - left upper with small papular lesion. Myalgias - arthralgia - left leg/knee.
Lips became numb and right eyelid for short time. Lips stayed numb. C/O starting to have chills. Lasted x 3 hrs. Also numbness left arm and little two fingers. C/O on 10/29/2005 level numbness of lips.
SWELLING, PAIN, GRADUALLY WORSENING.  DEVELOPED AN ABSCESS OVER LEFT UPPER BACK IN SCAPULAR AREA.  CT SCAN, ABSCESS INCISION & DRAINAGE & PACKING, STARTED ON ANTIBIOTICS.   DIAGNOSED WITH SEPSIS ALSO. ALSO BLOOD SUGAR FOUND TO BE 400 WITH NO PRIOR HISTORY OF DIABETES
Sore throat, aches, fever, chills, then tingling starting in lower legs, and ascending up entire right side of body to face. Muscle cramps, esp in lower leg.  Tingling lasted 4 days, leg is still cramping.
pt recvd vax & mom brought pt in 13sep94; pt had been v x 24 hrs; pt listless; to MD; to er; given meds; MD dx viral illness; late 13sep94 to er having szs; szs d/t dehydration;