chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received vaccinations 9/8/11. Parent alternating TYLENOL with MOTRIN after vaccines but developed fever 9/9. Spiked to 104 degrees - had 5 min seizure. Taken to Hosp for evaluation.
Excessive pain at injection site with some lasting for days; redness have spread for several inches around the injection site; swelling have spread for several inches around the injection site; redness and sweling have spread for several inches around the injection site; Initial information regarding an unsolicited valid non-serious case was received from the other health professional via email on 16-Oct-2020.  This case is linked to cases 2020SA293763 and 2020SA293704.  This case involves a female patient of an unknown age who experienced excessive pain at injection site with some lasting for days (Vaccination site pain), redness and swelling have spread for several inches around the injection site (Vaccination site reaction, erythema, swelling), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (unknown latency), the patient developed excessive pain at injection site with some lasting for days (Vaccination site pain), redness  and swelling have spread for several inches around the injection site (Vaccination site reaction, erythema, swelling).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of all the events was reported as unknown.  There will be no information available on the batch number for this case.
3/16/21 ER nurse triage note: "Pt c/o diarrhea onset Saturday night after receiving covid vaccine on Friday. Pt states has had 4 diarrhea stools today. Denies vomiting. "
Shot taken 1200, sever dizziness started 1500, currently dizzy at 1600. 33 weeks and 2 days pregnant estimated due date 12.09.19.
Fatigue, headache, arm was swollen. I had a lump in armpit, swollen lymph nodes.
Mild stroke on morning of day following administration of the vaccine (first in series). Stroke resulted in weakness and limited mobility on left side and slurred speech. Patient was bedridden following the stroke. Patient had terminal cancer but the stroke following the vaccine seemed to trigger a swift decline and patient died one week later.
Patient had fevers, chills, headache for 3 days after booster that subsided with assistance of acetaminophen. He then woke on the night of presentation (12/24/2021 -12/25/2021) with severe burning midsternal chest pain worst when laying flat.  Chest pain not relieved with antacids, acetaminophen or position change. Patient presented to the emergency department where he was found to have a normal appearing EKG, but elevated troponin lab value raising concern for vaccine/booster related myocarditis. Patient was observed on monitor in ED, given ketorolac IV which resolved symptoms, and admitted 03:33 am 12/25/2021, to the hospital for further studies.  Patient was admitted and had normal echocardiogram, down trending troponin as below, was discharged  14:43 12/25/2021 with plan for outpatient cardiac follow up and outpatient cardiac MRI
This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an adult patient who received Herpes zoster (Shingle's vaccine).    On an unknown date, the patient received Shingle's vaccine. On an unknown date, unknown after receiving Shingle's vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingle's vaccine.  Additional details were provided as follows: The reporter was patient itself. The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had shingles and it was so painful. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary vaccination schedule for shingles, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting.
Child developed hives/urticaria somewhere between 2 and 26 hours S/P injection.
pt recvd vax 230PM 17NOV94 & pt devel recurrent emesis 915PM til 4AM; 1230PM pt devel migratory urticaria, initially on rt arm;
Nausea/vomiting, swelling of R arm and up into neck.  Fever up to 105.2, shaking, headaches, severe body aches.
This spontaneous report has been received from a nurse practitioner referring to a 12 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions, and concomitant medications. The patient had no drug and allergy history to be reported. Approximately on an unspecified date in December 2017 (reported as 1 month ago), the patient was vaccinated with GARDASIL 9 (strength, dose, frequency, route of administration and expiration date were not provided), lot # N013276 for prophylaxis. The reporter stated that on an unknown date, the patient developed a lump at the injection site (injection site mass) that was painful (injection site pain). No treatment was given for the adverse event. No laboratory diagnostic were performed. The outcome of injection site mass and injection site pain was reported as not recovered. The causality between the aforementioned events and GARDASIL 9 was not reported.
Patient received pfizer vaccine on 12/1/21 and 12/22/21. Presented to ER on 6/2/22 and found to be COVID positive. Patient has been having coughing spells since January . He had COVID infection in Sept 21, and again in Feb 22. He received Pfizer vaccine in December 21.  A CT scan done in Feb 22 was unremarkable. He had a follow-up PET scan for his lymphoma with Dr. on May 9th 2022 which showed multicentric ground-glass opacities as well as airspace disease which are scattered in a multilobar fashion bilaterally. Patient has received at least 3 courses of different antibiotics (Z pack, Doxycycline and Ceftin) but continued to cough.   Due to concern for drug-induced (Rituximab) pneumonitis, he was started on high-dose steroids which he has taken about 2 weeks without any improvement. Patient noted to be desatting to mid 80's at home with activity hence he presented to the ED on 6/2/22. Again he tested positive to COVID on 6/22. Work up done included BNP (wnl), CRP 50 (elevated ) ESR 37 (elevated ). procalcitonin wnl.  ABG showed pH 7.45, PCO2 42, PO2 62. Patient did require 2 L of nasal cannula oxygen at first.    He was started on doxycycline as well as short course prednisone taper. He was seen by ID, pulmonology and oncology services. CT chest wo contrast showed worsening bilateral ground-glass opacities probably organizing pneumonia or atypical infection. Work up for fungal infection and vasculitis was started. Results still pending as at time of  discharge. Patient did well. Hypoxia resolved.  On 6/6/22, he was discharged hoe in stable condition; plan to complete short course of prednisone taper and 3 more days lf antibiotics. 6 minute walk test showed he needed no oxygen. Discharged on 6/6/22
72 hours later I was hit hard with severe chills, extreme nausea, some vomiting (foam) and diarrhea.  Day after vaccine, I had mild symptoms - woke up with mild chills and was very tired - slept most of the day.  Following night I had the worst night sweats ever - woke up drenched.
Nausea fatigue sore throat  runny nose, chills. Heart pulsation
Moderna COVID?19 Vaccine. While I was sitting, suddenly I had light-headedness for a second and then chest pain and rapid heart rate. Cold sweat started running over my face and wet my shirt. I went to the Emergency Department at the hospital. While I was waiting in the Emergency Room, all symptoms were gone after 1hr except rapid heart rate. Discharged around 11 pm after signing
Left upper arm erythematous, swollen extending 4 inches, no loss of ROM, denies pain. No distress. No stretching.
I couldn?t get warm, cold to the point of shivering for approximately 16 hours.  I have fully recovered.
Pounding headache, fever, chills, sweats, joint pain, shortness of breath.
Rheumatoid arthritis flare up; Pain in arm; Shoulder pain; This is a solicited report from a contactable consumer (patient) based on the information received by Pfizer from regulatory authority, manufacturer report number: 21K-163-4100453-00. A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), intramuscular on 01Apr2021 (Batch/Lot number was not reported; at the age of 56 years old) as dose 2, single for COVID-19 immunisation; and adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) and ongoing, citrate free for moderate to severe rheumatoid arthritis. Medical history included moderate to severe rheumatoid arthritis. Concomitant medication included methotrexate for unknown indication. The patient previously received first dose of BNT162B2, intramuscular on 01Mar2021 (Batch/Lot number was not reported; at the age of 56 years old) for COVID-19 immunisation. Solicited report from the (country) by a consumer of an adult male with events of non-serious (as reported) flare up of rheumatoid arthritis, sore arm, and shoulder pain with Humira (adalimumab). On an unspecified date in 2021, the patient experienced flare up of rheumatoid arthritis (also reported as rheumatoid arthritis flare up), sore arm, and shoulder pain. Pfizer-BioNTech COVID-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken in response to the events for adalimumab was unknown. The patient has not recovered from rheumatoid arthritis flare up. The outcome of sore arm and shoulder pain was unknown. The reporter's causality for the events of flare up of rheumatoid arthritis with adalimumab was a reasonable possibility; the reporter's causality for the events of sore arm and shoulder pain with adalimumab was no reasonable possibility.   The reporter's assessment of the causal relationship of the events flare up of rheumatoid arthritis, sore arm, and shoulder pain with BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The events are assessed as unrelated to BNT162B2, but likely related to the patient underlying rheumatoid arthritis.
Received the vaccine on 9/8/21.  Woke up 9/10/21 w/a wheeze. When she didn't respond to nebulizer Rx at home, she was taken to a walk in.  She was found to have a wheeze and pedal edema and was subsequently transferred to hospital and admitted w/dx of CHF and pulmonary edema.  Discharged home on 9/14/21.  Per granddaughter, doctors do not believe dx was related to vaccine, but advised against the 2nd dose.
Client called with c/o of muscle aching and being "cold" yesterday 6-24-08. Denies fever and states has just minimal soreness at injection site. States aching started on 60-24-08 at injection site of HPV vaccine and spread to entire body and lasted only one day 6-24-08.
redness around the site of the shot on lt thigh about a size of a quarter since yesterday;no fever;gave pediacare p/shot;mom stated it has never happened to pt&the 2yr old son before
Four days after my  vaccine, my eyes were very water with a clear, thick discharge.  They were itchy as well. I went to see my optometrist who told me I had some sort of allergic reaction. I do not know if the vaccine caused my allergic reaction. My optometrist prescribed eye drops. I had no soreness or pain to my left arm after myvaccine.  Today I still have some clear, thick discharge that is present.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2006, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the long-term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. Later in 2011, the patient was treated by the physician for the onset of severe vesicular rash which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
2 to 3 inch diameter red itchy rash on left arm near injection site; firm and swollen under rash.
The patient ended up receiving a regular dose of the Fluzone flu vaccine even though he was qualified to get the high dose since he is over 65 years old. He didn't have any adverse effects of the vaccine before he left the pharmacy.
On day 9 after injection an itchy, hot  rash appeared over injection site.  Today is day 13 and the rash has spread down and round my arm.  It is real sore and hot to touch.
Approximately 4 hours after the shot I had an intense burning sensation in my head. It felt like my brain was on fire. It lasted for about 15-20 minutes. After that I experienced tingling/numbness in the back of my neck. Now 4 days later I still have tingling/numbness in my hands and fingers and a slight twitch in my left eye.
Pt received Dtap and IPV on 9/19/05 in right arm at 2 different sites. Developed local urticarial rash on arm around vaccine (not at injection sites)
Severe upper arm pain (pressure type pain). Severe pain for 2 days, moderate pain for an additional 2 weeks
Marked local reaction with intense warmth, swelling and tenderness of upper arm, shoulder extending almost to elbow.
Dizziness, Headache, Myalgia, Fever, NauseaVomiting, unable to sleep, chills Narrative:
received the first dose / in January 2020 / has not received dose two; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in January 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that the patient who was in her late sixties received 1st dose of Shingrix on January2020 and did not receive 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up.
Information has been received from a physician concerning a female "in her 60's" with a history of shingles who in 2007 "sometime before Christmas", was vaccinated with 0.65 ml of Zostavax. Prior to vaccination the patient had had symptoms of shingles and was given an antiviral and returned to clinic after one week to show that the rashes went away. The physician administered the vaccination with Zostavax, during the time that the patient showed that the rashes were already gone, "to boost the patient's immunity". One week after receiving Zostavax the patient returned to clinic with symptoms of "bell's palsy" on the same side of her face that she had previously had the rashes. The patient was given a steroid by the physician, and after a few days complained of pain in her face. At the time of reporting the physician noted that the patient's symptoms have improved, but she has "not returned back to normal yet". The lot number was not available. Lab diagnostics studies were not performed. There was no product quality complaint. Upon internal review the event of Bell's Palsy was considered as a other medically important event (OME). Additional information has been requested.
Patient describes sharp pain to neck like nerve pain.  Told patient to call me if persists.  Never heard back.
Gout breakout; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (Gout breakout) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Gout (He has had gout for 10 years and does not believe it is related to getting the COVID 19 vaccine.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GOUT (Gout breakout). The patient was treated with COLCHICINE for Adverse event, at an unspecified dose and frequency. At the time of the report, GOUT (Gout breakout) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter.; Sender's Comments: Case routed out of MR workflow as medical review is not required per new CMOP process for non serious cases.
The day after I received my first covid vaccine I was extremely tired and my whole entire body ached. As of October second I am still very tired, my body aches, I have a headache, and I feel weak. My legs and back ache the most and it has prevented me from going on long walks and I have a hard time getting to sleep because I'm in a lot of pain. I have been taking Tylenol but that only helps get rid of the headache.
Pt received the shot on Thurs 4/1/21. This is a 64-year-old patient who presents with 1-1/2 days of body aches, fevers, tachycardia, fatigue and does not have any exposure to COVID-19 but she just got on Thursday her first shot of her vaccination she also has vomiting and malaise. TTP rash started on 4/7/21.
Vital noted, T-98.6, P-84, BP-128/78.  A&O, Generally appears well, non-toxic. Noted multiple erythematous papules (some with pustular center) over upper extremity.  Majority located over shoulder and neck area.  Area of immunization left arm approximately 1 cm pustular lesion.  + adenopathy on left axilla and post cervical chain.  No supra clavicular nodes, only discrete individual lesions <5 on lower extremety.  Diagnosis:  Generalized vaccinia.   This is patient's primary vaccination. [not GV per DoD working definition, JDG]Vital noted, T-98.6, P-84, BP-128/78.  A&O, Generally appears well, non-toxic. Noted multiple erythematous papules (some with pustular center) over upper extremity.  Majority located over shoulder and neck area.  Area of immunization left arm approximately 1 cm pustular lesion.  + adenopathy on left axilla and post cervical chain.  No supra clavicular nodes, only discrete individual lesions <5 on lower extremety.  Diagnosis:  Generalized vaccinia.   This is patient's primary vaccination. [not GV per DoD working definition, JDG]
I had my first Covid 19 vaccine on 12/31/2020; I was obviously a little nervous and after the shot I was a bit light headed (likely related to stress and after some deep breathing it went away).  The next few days I had pain in my arm and it hurt to lift it.  As well I had pain in my elbow and shoulder joints. Stomach issues and a headache followed.  About 8 days after my injection, my arm swelled up, bright red and tender to touch with a fever. Noted small red welt encompassing injection site and about a 1/2 dollar coin size red mark (similar to the one above).  It continued to spread across my upper arm and the swelling was quite significant. Went to the doctors, they thought it was Cellulitis and treated for this. However, after 5 days being on antibiotics it was back with a vengeance. This time it started on outer and inner part of my arm; welts on back of arm and rash on part of arm closest to chest; it burned, itched like crazy and was again feverish. Back to the doctors, doctor thought it odd that it came back even though I have 5 more days of antibiotics to take and stated she believes it to be a post injection site reaction (not necessarily an allergic reaction, but definitely a reaction to either the need or what was in the needle). I was put on another antibiotic, prednisone and benadryl. This was Wednesday 1/13/2021 (2 weeks after my vaccine, noticed the welts on Tuesday 1/12/2021) and today is 1/17/2021; it is still very much there.  Less red, less irritated, less painful...still quite itchy.  With that said, doctor advised not to get the shot, but if I decide to I need to take benadryl and ibuprofen before the shot and be monitored for another reaction, possibly worse than this one. I also spoke to the place where I got my vaccine and they advised the same per-steps before getting the second dose on 1/28/2021.
Pfizer-BioNTech COVID-19 Vaccine EUA  Fatigue 12/29 in the evening Fever 12/29 starting at 11 pm to late morning 12/30 Light nausea 12/29 from 11 pm to 3:00 am Headaches 12/29 through 12/31 Muscle aches 12/29 through 12/31 particularly lower back  I rested and drank so much water and the symptoms went away on their own
Flu shot given 2 days ago. Red and warm to the touch, localized to her shoulder. No fever. Doesn't seem to be bothering her.
I had my first vaccine taken on may 11/If I missed my second dose and passed the 6 weeks do i have to restart my vaccines; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I had my first vaccine taken on may 11/If I missed my second dose and passed the 6 weeks do i have to restart my vaccines) 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.    On 11-May-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 (I had my first vaccine taken on may 11/If I missed my second dose and passed the 6 weeks do i have to restart my vaccines). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I had my first vaccine taken on may 11/If I missed my second dose and passed the 6 weeks do i have to restart my vaccines) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Initial unsolicited report received from a physician via other company (Pfizer) (manufacturer report number- 2016517225) on 21 November 2016. This case involves a female patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (FLU SHOT) (batch number, dose in series, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had experienced fever and Gastro-intestinal disorder. Relevant laboratory data and corrective treatment was not reported. The outcome of event was not reported. List of documents held by sender: none.