chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Day one - Day three  post vaccine, sore left arm, sore throat,  fatigue, slight body aches.  Day seven-7cm red, edemtamous,  hot -cellulitis appearing area at injection site.  Days eight-day ten with same symptoms. Day eleven-day 13-2x 8 cm area of redness without edema.
- Swollen injection site over 2 inches and growing, warm to the touch  - Doctor prescribed an antibiotic  - Outcome to be determined
Brought to flu clinic on 11/11/2019 and got flu shot At office appointment on 11/18/2019 chart review showed flu was also given on 10/28/2019
I awoke with abdominal pain at 4am.  After sitting up, drinking water, and eating some light crackers, I was able to return to sleep within the hour.  After the second dose the following day (08/06), I was awoken at 6am for the same reason.  This time, I was unable to relieve the pain enough to return to sleep. I then suffered from periodic waves of abdominal pain throughout the day until approximately 5pm.  I have taken the third pill today after calling my doctor and garnering no advice regarding management of this side effect.
On 10/21/2022, I woke up with a bad headache. When I stood up, I became lightheaded and experienced dizziness. The headache and dizziness continued through the week. I saw a practitioner that same week who prescribed a medication for the dizziness. I am still experiencing headaches and they are more frequent than before. I do still experience slight dizziness when I stand or turn too quickly but it is not severe as before.
Very itchy; Rash at the injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PRURITUS (Very itchy) and VACCINATION SITE RASH (Rash at the injection site) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Very itchy) and VACCINATION SITE RASH (Rash at the injection site). At the time of the report, VACCINATION SITE PRURITUS (Very itchy) outcome was unknown and VACCINATION SITE RASH (Rash at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported.  Treatment medication not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient was in a skilled facility.  The patient presented to Community Hospital on 9/24/2021 with Sepsis likely related to a sacral ulcer.  The patient was complaining of a cough and was diagnosed with left lower lobe pneumonia.  The patient then developed septic shock requiring vasopressors.  The patient was transferred to another Hospital in for a higher level of care.  While the patient was at facility they underwent a debridement of a sacral wound.  There was a concern for possible diverting colostomy, but Surgery felt with underlying rheumatoid arthritis, multiple abdominal surgeries and overall poor fuctional status the patient was not a candidate for diversion.  The patient was admitted to Select Specialty Hospital on 10/07/2021 to continue wound care.  The patient had declined while at Select Specialty Hospital. The patient was to be discharged to Hospice on 11/01/2021, the patient expired on 11/01/2021 at Select Specialty Hospital.
pt. presented to ED with sudden onset of severe chest pain.  While in the ED she experienced sudden rapid onset of loss of sensation and motor function in bilateral lower then uper extremities. She also became brdycardic and hyptensive.  She was able to weakly shrug shoulders and maintain airway, otherwise no strength or sensation below C4 level.  MRi/CT revealed intramedullary hemorrhage spanning C1-T10 with lesion around the cervicothoracic junction causing hematomyelia. This was treated with various procedures and medications throughout her stay in critical care and med surg units until her discharge on 06/17/21.  She is currently in rehab facility
Joint swelling and pain 4 days after vaccination, diagnosed with seropositive rheumatoid arthritis
This spontaneous report was received from a physician's assistant and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant therapies was reported. On 01-AUG-2016, the patient received a dose of M-M-R II (dose, route of administration, lot# and expiration date were not reported)for prophylaxis. On 05-AUG-2016, the patient received a dose of VARIVAX (dose, route of administration, lot# and expiration date were not reported)for prophylaxis. The vaccines were reconstituted with sterile diluent (manufacturer unknown) (lot# and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
The reaction started the morning after the shot. My armpit was swollen to the size of an orange. Before the vaccination I took Benadryl and drank lots of water.  The swelling in my armpit lasted for several days and has not gotten better. I also have had back pain that is achy and sore. I have sought care from my doctor. I was not prescribed any medication.
Patients caregiver had consented to DTaP, but COVID-19 was inadvertently been given. Mother was called and made aware of error. Mother reported that "her father was going to be very upset. He did not want a COVID vaccine given". Author offered to call father, but mother declined, stating that she would call him. Ensured mother had authors phone number and she ensured that she did. Mother reported that she would call with anything further.
Came in with chief complaint of shortness of breath cough was diagnosed with respiratory failure secondary to COVID-19. Tx w/remdesivir, abx, steroids, zinc, O2;
Received H1N1 vaccine on Monday 12-17-09.  At time of vaccination, pt congested because he felt was R/T. sinus drainage. Tuesday evening began to experience muscle aches, sneezing, productive cough with clear sputum.
Gave pt ordered vaccines, Tdap (RVL), then HAV (Rthigh)-noted needle was 5/8" on meningicoccal vaccine syringe, left exam room w/pt calm color good, sitting up; returned to exam room w/1" needle on syringe for IM injection of meningicoccal vaccine cleaned area on LVL to give vaccine. Pt asked why skin was being cleaned-explained this was giving vaccine. Pt then abruptly slumped to left, appeared to be losing consciousness. With mom's assist, laid pt on back on table, was lifting legs, when pt stiffened and began posturing, turning to the right side. Called for assist from Dr. and other staff members. pt then became incontinent of urine. The Dr. responded and was back in room; left room to call for 911 as per Dr., and had LPN stand in room w/Dr should assist be needed. Returned to room after calling 911, where pt was alert and talking quietly w/Dr and mom. Pt asked if I was going to give vaccine; advised her that this vaccine had already been given. Stayed in room until pt was under care of EMS.
injection given while half asleep in hospital bed, I reported it to VA Hospital nurse of Dr. on 3/09/20 to nurse,  I've used heat,  Biofreeze , magnesium spray,  massage,  exercise, sleep in recliner chair,  acetaminophen ,  I'm due to receive Moderna vaccine tomorrow and concerned about should I get it in left arm or right?
At the time of shot patient is report that around the injection site is red swollen and inching... symptoms got worse as she got home.. itching starting 06/22
This spontaneous report as received from a pharmacist refers to a 75 year old female patient. On 03-JUL-2013 the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml subcutaneous injection, in the left deltoid region), (lot number and expiration date were not reported). In approximately July 2013, with "a couple" days, the patient had itching to injection site, bu there was no pain. On 11-JUL-2013 (reported as "today") the patient noticed "redness that was approximately the size of 2 quarters surrounding the injection site" and itching continued, but there was no pain. The patient sought medical attention via contacting pharmacist. There was no treatment given for adverse events. At the time of the report adverse events persisted. The relatedness between therapy with ZOSTAVAX and itching and adverse events was not reported. Additional information has been requested.
The patient was admitted from the clinic visit where he was having chest pain. This clearly was pleuritic in origin. I could hear a left pleural rub. He was admitted to the hospital. We did a CT immediately, which showed no pulmonary emboli, but did show a left pleural effusion. His plain x-ray showed a less prominent pleural effusion and some mild residual from his COVID-19 pneumonia. Admission was within 6 weeks of receiving the COVID-19 vaccine. Patient passed away on 9/16/2021 due to recurrent aspiration pneumonia.
tingling sensation left skull; fever 101.8; Mild left arm soreness; This is a spontaneous report from a contactable nurse (patient herself). A 63-year-old female patient received her second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982, expiry date: 31May2021), via intramuscular route of administration in the left arm on 15Jan2021 10:05 at a single dose for COVID-19 immunization. Medical history included open cholecystectomy in 1990, hypertension, and sleep apnoea (CPAP). The patient's concomitant medications were not reported. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22 Dec2020 and experienced fever, nausea, vomiting, diarrhea, metallic taste in mouth, Loss of taste/smell, minimal soreness at the site of injection, strange sensation of tingling in her skull, chills, dry mouth, feels like she has no saliva, tongue felt a little bit too dry, extremely tired, thirst, and altered taste. The patient experienced mild left arm soreness on 15Jan2021 and fever 101.8 on 16Jan2021 23:00. Patient took ibuprofen 400mg and ondansetron (ZOFRAN) 4mg. The patient also experienced tingling sensation left skull continues as described. The patient had no cough, sore throat, stuffy or runny nose. She had no shortness of breath, no nausea vomiting or diarrhea, and no loss of taste/smell or metallic taste in mouth. The patient underwent lab tests and procedures which included body temp: 99.7 on 15Jan2021 18:00, 101.8 on 16Jan2021 11 PM,  99.5 on 16Jan20213 PM, 99.8 on 16Jan2021 10 PM, 99.5 on 17Jan2021 9:00, 99.8 on 17Jan2021 8 PM, 100 on 17Jan2021 10 PM, 99.4 on 18Jan2021 07:00, 99.7 on 19Jan2021 16:00, 98.6 on 20Jan2021 11 AM. Outcome of tingling sensation left skull was not recovered, of remaining events was unknown.
Migraines; Brain fog; Sensation of light pressure in his head when doing any physical activity; Mild nausea; This is a spontaneous report from a contactable consumer or other non HCP. A 23-year-old male received first dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, Solution for injection) via an unspecified route of administration as a single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. The patient experienced migraines, mild nausea for 2 days, brain fog, and the sensation of light pressure in his head when doing any physical activity on an unspecified date. The clinical outcome of the events was reported as unknown.   No follow up attempts are needed; information about lot/batch number cannot be obtained.
Patient was given moderna when he should have received pfizer. Doctor called and spoke with patients parents and advised them of symptoms to watch for. Patient has tolerated the vaccine to this point.
presented to the hospital 6/14/2021 with chest pain and troponin leak (peak of 14.9 after 2nd Pfizer vaccination (6/11/2021) with ST elevation on EKG and ventricular ectopy with non-sustained ventricular tachycardia, PVCs.  treated for suspected myocarditis.  remains hospitalized
This spontaneous report as received from a licensed practical nurse refers to a 22 year old patient of unknown gender. On 15-MAY-1992 the patient was vaccinated with dose 1 of RECOMBIVAX HB thimerosal status unknown (route, dosage and lot no. unknown). On 10-JUL-1992 the patient received dose 2 of RECOMBIVAX HB thimerosal status unkonwn (route, dosage and lot no. unknown). ON 04-FEB-1993 the patient received dose 3 of RECOMBIVAX HB thimerosal status unknown (route, dosage and lot no. unknown). It was reported that on a titer drawn on 11-JUL-2014 the patient failed to seroconvert. The outcome of the event was reported as not recovered. Additional information has been requested.
Client received the Pfizer COVID 19 vaccine on 4/10/2021 at 9:24 am, in left arm. Per Client on 4/10/2021 started experiencing symptoms of left armpit pain, like a "chafing" feeling, burning, soreness and painful to touch. Per Client still having symptoms, took Tylenol for pain and no follow up with PCP as of today. Client admitted after taking Tylenol pain in left armpit has decreased. PHN suggested to the Client if symptoms continue to persist should follow up with PCP, or with worsening symptoms go into urgent care, emergency room or call 911 for medical emergency. Client verbalized understanding information provided by PHN.
This spontaneous report was received from a Registered Nurse referring to a multiple, unknown patients of unknown age and gender.  The patients' pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.   In April 2017, reported as between 18-APR-2017 and 26-APR-2017,  the patients received multiple doses of improperly stored PNEUMOVAX 23 Lot #M043424 with an expiration date on 06-JUN-2018 (strength, dose, and route of administration were not reported) for prophylaxis.  The vaccines were stored at a Temperature of 47°F to 77°F during 84 hours. There was no previous temperature excursions and the call was not because of a data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA007430: US-009507513-1705USA015668:
Facial paralysis; Shaking all over her body/shaking for 8 days; Can not sleep; Whole body hurts and it does not go away; Terrible chills and shivers; A spontaneous report was received from a consumer who is a 61-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced facial paralysis, terrible chills, shaking for 8 days (tremors), shivers, cannot sleep (insomnia) and whole-body hurts(pain).  The patient's medical history was not provided. Concomitant medications were not reported.  On 13 Jan 2021, the patient received their first two planned doses of mRNA-1273 intramuscularly in her left arm for the prophylaxis of COVID-19 infection.  On 21 Jan 2021, the patient experienced terrible chills, shaking for 8 days, shivers and cold all the time, cannot sleep and whole-body hurts. On 28 Jan 2021, the patient experienced facial paralysis which was getting worse more on right side then moved to the middle of her face. The patient was given steroids.  Treatment for the events included steroids.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of events, facial paralysis, terrible chills, shaking for 8 days (tremors), shivers, cannot sleep (insomnia) and whole-body hurts(pain), were considered unknown.; Reporter's Comments: This case concerns a 61-year-old female who experienced a serious unexpected event of facial paralysis, the non-serious unexpected events of tremors, insomnia and pain, and a non-serious expected event of chills. Events began on 21-Jan-21 after the first dose of mRNA-1273 on 13-Jan-21. Treatment with steroids. Outcomes unknown. Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.
Patient fainted after administering HPV vaccine for about 1-2 mins.  Vital sysm. stable.  Mom witnessed some arching moves.  Blood pressure WNL while she fainted.
having them for the 3rd time/Suspected Vaccination Failure; shingles are in a class all their own/having them for the 3rd time; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: having them for the 3rd time/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles are in a class all their own/having them for the 3rd time). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 14-MAR-2023 This case was reported by a patient via  interactive digital media. The reporter stated that it was hard to describe a worse than scenario, shingles were in a class all their own. The reporter further stated that it was utterly miserable. At this moment, the patient was having shingles for the third time and he/she had three shingles vaccines. The reporter further stated that getting old was not for sissies that was for sure. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
rash on face & chest, shoulders x 1wk;went to PMD 21NOV98 shot depo-medrol;
I started with running nose, and I was coughing. I called the doctor, and they gave me Paxlovid.
Received at about 0800. I work night shift, went after work, went to sleep when I got home. Woke up at about 5 pm very tired, weak, with chills; painful arm. By the next day my arm was swollen and painful around the injection site and stayed that way for about 3 days. Chills primarily first 48 hours. Weakness, fatigue - sleeping a lot, feeling exhausted walking upstairs/short distances, things felt heavier than usual - lasted about 3-4 days
On day 12 (February 20), patient noticed some pain under her left bra strap (below the clavicle).   On day 13 (February 21), she noticed a bump about the size of a pea under the clavicle. At the injection site, she described her arm as being a little blotchy, sore and mildly swollen but it does not itch. She also felt a little tired and had a mild headache.  She took a nap and felt better.  On day 14 (February 22) the injection site reaction continues and the pea-sized bump under the bra strap (under the clavicle) remains, and the whole left side of the breast feels a little achy.   Patient wants to get dose 2 and plans to request it be administered in the right arm instead.
Initial report received from a consumer on 08 May 2009, who is also the patient's parent. A 37-year-old female patient with an unknown medical history, had received a booster dose left arm injection of DECAVAC, lot number U2348CA on 21 April 2009 and approximately 20 hours later, she developed stiffness on the left side of her neck with a deep burning sensation with numbness and tingling down the left arm which also extended to the left leg. The event required a doctors visit and the patient was reported to have been hospitalized three times (dates not reported); and she was hospitalized at the time of the report. Per the reporter, the patient had a seizure (date of onset and duration not reported) and tests had been performed to rule out stroke and a brain tumor. According to the reporter, the MRI "doesn't show anything". The patient's recovery status was unknown and the reporter declined to provide any additional information at the time of the report. Documents held by sender: None.
Flu like body aches, chills, difficulty concentrating starting 8 hours after vaccine, lasting 24 hours.  20 hours later development of but blood vessels on lips and eyes.
10-7 days p/vax had fever, rash & severe case of thrush & BOM;20 days p/vax had parotitis w/o fever;
Pt. experienced localized swelling, redness and heat (R) side at injection site 15-24 hours after injection. After 4 doses of BENADRYL 25mg pt. no better and was seen by Dr. for eval and treat.
Chills, Fever, Body Ache, Head Ache, Uncontrollable shaking
Headache, Myalgia, Fever, Fatigue, chills, arm swelling Narrative:
Ringing in ears; Chills; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "Ringing in ears"; CHILLS (non-serious), outcome "unknown", described as "Chills". Additional information: Clinical course: The experienced ringing in ears 5 days after the first BNT162B2 dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Nausea, vomiting, strong body aches, chills, elevated heart rate 10-20 BPM above normal for all activities.
patient wasn't given a 3rd dose of the Covid vaccine. No symptoms or adverse events have been noticed but I wanted to report this. The facilitator was notified and they will continue monitoring patient. Received 1st dose on 1/6, second dose 1/27, and third dose today (2/17)
Caller notes both patients asymptomatic. No additional AE's/PQC's; V ARlV AX was administered to (2) patients this morning, 8/9/2021.; This spontaneous report has been received from a nurse, referring to a 12 months old patient of unknown gender. Information about the patient's pertinent medical history, concomitant medications and previous drug reactions and allergies was not provided.  On 08-AUG-2021, a temperature excursion occurred for frozen products, involving varicella virus vaccine live (oka/merck)(VARIVAX). On 09-AUG-2021 (reported also as "this morning"), the patient was vaccinated with the improperly stored (product storage error) varicella virus vaccine live (oka/merck)(VARIVAX), at a dose reported as "1" (1 dosage form), lot number T029535 and expiration date on 01-SEP-2022 for prophylaxis (strength, frequency, route of administration and anatomical location were not provided).   The product was stored at a temperature of 6.134 F (Fahrenheit), for a timeframe of 30 Minutes, with no previous excursion. It was reported that the patient was asymptomatic.  This was one case of two from the same reporter.; Sender's Comments:  US-009507513-2108USA002868:
Swollen Rash and itching in Left arm, increasing in size over 2-3 days.  Has had to take Benadryl to relieve itching at night.
Received Janssen vaccine on 5-27-21 COVID-19 positive by PCR on  1/7/22 hospitalized 1/7-1/10/22 for pneumonia d/t COVID 19
1 of 5 pts immunized from the same vial exp a 1-2" area of induration & erythema @ DTP inject site; reaction occurred in pt; w/in 24-48 hrs following immun; required ER/MD;