chrisvoncsefalvay/vaers-outcomes huggingface dataset:
flu like symptoms; tiredness; achiness/he just had body aches; swelling; bruising at the injection site; bruising at the injection site /still tender if touched hard and there is still some bruising left; bruising at the injection site /still tender if touched hard and there is still some bruising left; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6201, Expiration Date: 30Jun2021), via an unspecified route of administration in left arm, on 24Feb2021 at 10:45 (at the age of 66-years-old) as dose 1, single for COVID-19 immunization in facility reported as covid relief set up clinic in a community college but not in a military facility. No patient's medical history/other history/family history was reported. There were no concomitant medications/other products reported. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). The patient had no prior vaccinations within 4 weeks of COVID vaccine. The patient felt okay for a couple of days after the vaccination. The patient received the vaccine a week ago and in the last couple of days, the patient noticed of getting flu-like-symptoms on 01Mar2021. The patient didn't had fever or chills, but had achiness and tiredness on 01Mar2021. The patient had pain, swelling, and bruising at the injection site in 2021 that went away after 2-3 days. The patient reported it was still tender if touched hard and there is still some bruising left in 2021. It was reported there was no emergency room (ER) or physician's office visit. The patient wanted to know whether these events were side effects and how long these symptoms are supposed to last. The outcome of pain and swelling was recovered in 2021 while the events flu-like-symptoms and tenderness was not recovered; tiredness and paresthesia was unknown and the event bruising at injection site was recovering at the time of report. It was reported that there was no investigation assessment.   No follow-up attempts are possible. No further information is expected.
Patient reported 6 days after vaccination she began experiencing some tingling in bilateral lower legs, aches in legs and lower back. States "similar" symptoms when taking the Flu vaccination
Seizure 7 days after 4 mo immunizations. Day 8-9 2 more episodes of shaking - fever day after shots. Mild temp day 7 child had 6 month immun. No adverse RXN except fever.
Moderate to severe body aches Low grade fever Headache and head pressure near spine Approximately 3 hours after receiving vaccine
pt recvd 1 dose of Engerix-B & 5 days later exp flu like sx, nausea & aches throughout body; tx ASA:
Developed a fever of about 99.4 degrees and was not feeling well. She seemed more irritable than usual.
Pt got hoarse, to the point of squeaking when he cried. He also got hives. This happened almost right away. I noticed the hives when we got home throughout the next day his hoarsness got worse but it was the 4th of July the next day July 5th he went to clinic where he was given antihistimens. It took 2-3 weeks for the hoarseness to be tottaly gone. The doctor recomended a crash cart for future vaccines. Also for them to be done by a Dr (vs nurse) in an emergency room and to wait 2 hours before leaving.
On day 3 after the vaccine, I had been experiencing sinus issues and toward the end of the day  I experienced body aches, chills, sweating, shortness of breath,  and tachy up to 175 last night when walking.  It has been better today in the low 100s but still persistent with some shortness of breath,  covid test pending.
Mother states pt stated complaining about rash with itching 1-2 hours after injection to buttocks/thighs. No SOB.
Patient Covid + on 10/26/2021. Received Pfizer vaccine with 1st dose on 04/27/2021 and 2nd dose on 05/27/2021 Per ED Note: Patient is a 95-year-old woman with a past medical history significant for TIA, COPD on 2 L of oxygen at night at home, hyperlipidemia that presents emergency department with a fall from home.  Patient states she lives with her son and that she has been falling more frequently as of late.  The patient states that she lost balance at home while walking fell backwards onto her behind and then laid back on the ground.  Patient states she could not get up and EMS was called.  Patient's son is at bedside and states that the patient has been "losing her balance more".  The son states they witnessed this fall and states that the patient did not hit her head or lose consciousness.  Patient denies any pain or injuries at this time.  Patient denies any unilateral weakness or sensory changes.  The patient denies fever, chills, sweats, dizziness, headache, double or blurry vision, difficulty swallowing, throat or mouth or tongue swelling, shortness of breath, chest pain, palpitations, abdominal pain, nausea vomiting, diarrhea, constipation, and urinary symptoms.  Due to patient's history and presentation, focused physical, work-up, and assessment initiated.  Imaging ordered. Imaging returning largely within normal limits.  IV established and labs drawn.  Due to patient's recurrent falls, she needs to be admitted to the hospital with physical therapy, Occupational Therapy and social work consulted. Labs returned demonstrating the patient is Covid positive.
It started at 3am that Sunday morning, I was getting spasms on the right side of my head. I couldn't lift my head up the pain was excruciating. It went on all day Sunday and Monday, I attempted to go to work on Tuesday but I had to leave because it was painful. It went on for about a week.
SOB w/exertion, feels foggy in the head, nausea, bodyaches, joint pain, dry cough & severe intermittent L side "ache" (feels like a pulled muscle)   Pneumonia due to COVID-19 virus  -     carvediloL (COREG) 3.125 mg tablet; Take 1 tablet (3.125 mg total) by mouth 2 (two) times a day -     HYDROcodone-acetaminophen (NORCO) 5-325 mg per tablet; Take 1 tablet by mouth 2 (two) times a day as needed  for moderate pain or severe pain
Headache; Nausea; 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 HEADACHE (Headache) and NAUSEA (Nausea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
4AGU92 pt recvd 1st dose of Engerix-B & 7AUG92 had elective hysterectomy surgery; 9AUG92 had stevens-johnson synd, massive edema & skin discoloration on abd & groin; pt d/c 13AUG92 w/some skin lesions remaining;
A couple hours after shot injections site was tender, red, and slightly swollen. The next day I woke up with a headache and hives on top half of my left arm (around where I got the shot). That evening I spiked a low grade fever, had body aches, fatigue, and still had a headache despite already taking Ibuprofen. The next morning I woke up and was felt fine until the evening when I got all the symptoms from above again. It was the 2nd day after the shot I had a small flare up from my Lichen planus (wasn't as bad as the flare up from the first shot though). The hives on my left arm continued to grow until Saturday (3 days after shot), and the hives stayed until Tuesday (6 days after shot). After that the hives were gone but I had skin discoloration where they had been. About a week after that the discoloration went away and I had no other symptoms. I had called my doctor about it on Monday and she didn't feel it was serious enough to go in.
Diarrhea; Extreme Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and FATIGUE (Extreme Tiredness) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided).    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced DIARRHOEA (Diarrhea) and FATIGUE (Extreme Tiredness). On 21-Jan-2021, FATIGUE (Extreme Tiredness) had resolved. At the time of the report, DIARRHOEA (Diarrhea) 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.
Initial information and follow up information received on 30-Jan-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a four-years-old patient for whom it was reported that the patient was seen in the ER 9 days ago for a laceration and was given tdap BOOSTRIX (DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID) instead of DT or DTAP (DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE). (dose, dose number, route and site of administration, lot number and date of vaccination not provided). The patient's past medical history included laceration and medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered. It was reported that the patient was seen in the ER 9 days ago for a laceration and was given Tdap BOOSTRIX instead of DT or Dtap. Patient is scheduled to receive the QUADRACEL vaccine today. It was not reported if any adverse event experienced by the patient following wrong vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
nerve pain; recurring painful blistering rash; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 70-year-old patient (pt) of unknown gender. No information regarding the pt's pertinent medical history, drug reactions or allergies, and concomitant medications was provided. On or about 03-OCT-2013, the pt was inoculated by a nurse with zoster vaccine live (ZOSTAVAX) (dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided), at a family practice, for the long-term prevention of shingles and zoster-related conditions. On an unknown date, reported as subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a healthcare provider for the following injuries resulting from the zoster vaccine live (ZOSTAVAX) use: recurring painful blistering rash and nerve pain. The pt claimed damages as a result of injury to themselves, loss of services and economic loss. The outcomes of the events were not provided. The reporter assessed that the events were related to the zoster vaccine live (ZOSTAVAX).
case of shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 53l2z, expiry date 15th May 2022) for prophylaxis.   On 6th April 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provide are as follows: The age at vaccination was not reported but it could be 65 or 66 years old. The patient received 1st dose of Shingrix and experienced a case of shingles. The Health care professional did not clarify how much time had past after the administration of 1st dose and the begging of the shingles episode. The patient had not yet received the 2nd dose. No further events were reported. The reporter consented to follow-up. The case was linked with case US2021007444 and US2020185477 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021007444:same reporter US-GLAXOSMITHKLINE-US2020185477:same reporter
Diziness, vitals 79/46 HR 56 water given , pt reported feeling better  . repeat BP 101/60 Pulse 74 Alert and oriented x4 . Uber ride given.
Patient reported hive-like rash that itched. She states that it became worse in the evening but by the following morning had subsided.
Patient states that the got the shivers, nausea and aches after receiving vaccination.  Informed patient that these are known possible side effects to vaccination. Call doctor if they persist
Has a large ecchymotic area on Right upper arm at vaccine site.  No loss of function. Mild discomfort relieved with Advil and Tylenol. Denies numbness and tingling.  States she will call her PCP if gets worse.  Area is 5inches by 5 inches.
This spontaneous report as received from a physician via a company representative refers to a 74 year old male patient with diabetes type II. The patient's medical history included shingles at the age of 72 years old. ON 28-SEP-2012 the patient was vaccinated with ZOSTAVAX lot # 0365AE, 0.65 ml, subcutaneous . On 04-NOV-2013, 403 days after onset of therapy the patient developed shingles and experienced pain. The patient sought medical attention and was prescribed valtrex and prednisone as treatment. The outcome of developed shingles and pain was reported as not recovered/not resolved. No action taken with ZOSTAVAX was provided. Additional information has been requested.
12/1/2021- lots of itching (generalized) and sweating especially at night , insomnia, fatigue. Slight muscle weakness-started in  February 2022.
metallic taste; This spontaneous case was reported by a patient and describes the occurrence of DYSGEUSIA (metallic taste) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (metallic taste). At the time of the report, DYSGEUSIA (metallic taste) outcome was unknown.      The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.  No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Patient with 2 Moderna vaccinations, last dose 04/07/2021 who admitted to the hospital with positive COVID PCR and complications from COVID.  Provider discharge note below:  "Patient developed shortness of breath and had evidence of acute respiratory failure with hypoxia.  This was due to pneumonia from a COVID 19 virus infection with, ""Diffuse bilateral groundglass opacities with interspersed areas of consolidation and small pleural effusions"" seen on CT chest.  Patient was placed on supplemental oxygen, started on a course of DECADRON.  Patient also completed five days of REMDESIVIR. Though the patient was afebrile and had lower procalcitonin relative to his CHRONIC KIDNEY DISEASE IV (history of right nephrectomy due to renal cancer) he did receive three days of CEFTRIAXONE and three days of .CEFEPIME in addition to five days of DOXYCYLINE.  Despite the antibiotics the patient' white blood cell count remained elevated at 21K.  He was not placed on antibiotic and he was requested to have a follow up CBC in one week, after he has finished his course of steroids.  The patient was weaned down on his supplemental oxygen but was going to require home oxygen.  Patient also noted to have elevated liver enzymes.  This can be commonly seen with COVID infections but these elevations were more than generally seen. Hepatitis panel was negative and ultrasound reported normal appearing liver. Patient requested to have a follow up CMP in one week."
Chills, muscular pain, fever, headache, injection site swelling and hot to the touch, nausea throughout the night. The next day fatigue, headache and muscle aches.  3rd day, muscle aches better, headache and fatigue still evident.
MMRV and Varicella were given at the same time in error.   MMR and Varicella should have been given.
Diagnosed on 10/03/2022 with Henoch-Schönlein purpura (HSP) aka IgA Vasculitis. Acute symptoms at onset include: pain and  swelling in legs, purpuric rash on legs and arms, and acute abdominal pain with vomiting and diarrhea. Rash, joint pain & swelling and acute abdominal pain remained colicky over the next week. Had a Fever on 10/8/22. On 10/13 rash came back and spread to thighs, buttocks, ankles, torso, throat, arms, and hands. Rash has included nodules on elbows and knees. Occasional joint pain and swelling persists. He has also experienced occasional headaches, poor appetite, nausea (after eating) and irritability.
About 4 hours after receiving  the vaccine, I experienced a high pitched ringing in both ears that has not stopped.
hives approx 30 hrs p/vax all over body; taken to ER treated w/DPH; full recovery according to mom w/in 3-4 days
Rash to injection site painful, edematous area approx. size of half dollar coin.
not received 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 50-year-old female patient who received HAB (Twinrix) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix and an unknown time after receiving TWINRIX, the patient experienced incomplete course of vaccination (Verbatim: not received 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 09-NOV-2023 A pharmacist reported that a patient received the first dose of Twinrix on August 14th 2023 and the patient attended the pharmacy on the day of reporting for the second dose. The reporter asked if they should resume the series or if they needed to start over the vaccination. The reporter did not provide information about first dose given. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination.
week of feeling sick; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (week of feeling sick), NAUSEA (Nausea) and VOMITING (Vomiting) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced MALAISE (week of feeling sick), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, MALAISE (week of feeling sick), NAUSEA (Nausea) and VOMITING (Vomiting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications or treatment details were reported.
pt's mom reported that pt recvd vax 8FEB95 & t012; denied a rash or soreness @ the inject site; 9FEB95 pt irritable & lethargic, lacked an appetite & refused fluids; 15FEB95 devel a cold 9FEB95;
Painful knot at injection site, heat at injection site. Tiredness. Local reaction 3cm x 2cm.
AE#1:  Intermittent headaches every day since day 2 following the vaccine. Taking OTC medications does not always remove the headache completely.  Treatment: Motrin or Tylenol Outcome: Ongoing AE#2: Severe Fatigue  starting on day 2 following vaccine.  Treatment: Rest Outcome: Resolved by day 3 following the vaccine.  AE#3: Elevated body temp of 99.8°. Starting on day 2 following vaccine.  Treatment: Motrin  Outcome: Resolved by day 3 following the vaccine.  AE#3: Pain/hot to touch in arm at injection site. Started day 2 following the vaccine and resolved by day 5 following the vaccine.
high pitched cry x 5 days; fever 104 w/APAP drops; MD recommends DT only;
face numbness unable to make complete sentences called 911 they thought he was having a stroke discharge from the hospital with all bloodwork normal
Cellulitic reaction at injection site, 24 hr after administration. 4x2 centimeter redness, warmth at site, hardness at injection site. Headache/fatigue but no fever. Worsened at 48 hrs post injection but now starting  to improve 96 hrs post injection (still with 4x2 area redness/warmth but less hardness at injection site). Patient called pharmacy 11/28/17 to describe symptoms, was told that redness at injection site normal, but symptoms worsened. Treated with ibuprofen. No medical treatment sought, symptoms currently improving.
Had the injection at about 1:30 pm. By evening my arm was very sore. Woke up at 2:00 am feeling headachy, fatigued and nauseous. Threw up. Had fever of 100.7. My left arm had a 2 inch red welt and was painful. Had muscle aches, similar to the flu. Slept most of the morning. By evening my fever was normal. I was still very fatigues. Today, Monday, al the symptoms are gone except a very sore left arm. The red welt is still there.
3rd bivalent dose administered, 2 months after 2nd bivalent dose administered. Vaccine administration error, no known adverse side effects reported.
Redness, swelling, and warmth at site of DTaP injection - Right deltoid. Received PPD in same extremity - positive at 20x17mm.
Patient was given their 2nd dose Moderna vaccine after the ?use by date.? On 8/30/21    The manufacturer was contacted and advised that the dose was not valid and would need to be repeated.  The  Medical Information representative advised not to repeat the dose until the interval between doses was determined and that they will call back with that information. F/U Call today ? no answer yet. Will continue to follow up. Unable to contact patient. Left several messages. will continue to call patient.
Swelling, pain  and redness of left thigh starting Tuesday and lasting two days. Treated with ice and Ibuprofen.  Migrane headache with photophobia (never had one before) Thursday late afternoon. Treated with Ibuprofen, darkness and sleep.
experienced some fatigue day after vaccination beginning may 19.It became worse in the following days20/21/22, fatigue,dizzinezz,nausea.On may 23 suffered a stroke resulting in homonymous hemianopia.there are no other reasons for this stroke other than a reaction to the shot.I can not drive and the final prognosis is uncertain
The pt died within 24 hours post vax. Time is unknown. Grandmother advised office staff of possible SIDS. Cause of death given as sudden infant death syndrome. Infant found unresponsive.