chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Circular area over R deltoid-reddish/tan in color approx 1 1/2 in ht et 2 2 1/2 in width. Initially warm to touch et swollen. Today no warmness or edema. No pain just discoloration. To PMD.
Pt fainted while sitting in a chair (after getting shot). Slight seizure-like hand cramping while fainted (about 30 sec - 1 min total time fainted). Woke up fine and oriented.
Major body aches, chills, massive headache, eyeballs hurt for the next 6 days!! Missed 4 days of work. I have a massive headache today...not sure when I'm going to feel better! I will not be getting the second shot!
10/31/2021 I was exposed to COVID. My granddaughter and great granddaughter came down with it. I lost sense of taste and smell. I took numerous COVID tests, they all came back negative. I had bronchitis in November, still no sense of taste and smell. My husband was diagnosed with COVID in December, and I tested positive for COVID in December. Since then I have had a dry cough, frequent low grade fever, raspy voice and I am being tested for COPD this Friday. Saw an ENT physician on March 11 or 18. He checked my throat and saw redness and irritation, put me on antacid for acid reflux.  Go back in 3-4 weeks to ENT.
The morning of 03/28/2003 , while giving child a bath, mom found his rt upper arm swollen and reddened.  The swelling was minimal but the reddness extended from deltoid area halfway to elbow.
I developed "Moderna Arm"  red rash that is warm and a little swollen at the injection site.  It is a little itchy and sore but not to the extent that I took anything to treat symptoms.
This spontaneous report was received from a registered pharmacist and refers to a 63 year old patient of unknown gender. Information regarding pertinent medical history, drug reactions or allergies and concomitant therapy was not reported. On 29-JUL-2017, the patient was vaccinated with an improperly stored ZOSTAVAX, lot number M041087 with expiration date 03-JAN-2018 (dosage schedule, anatomical location and route of administration not provided) for prophylaxis, reconstituted with properly stored diluent (MRK INJ). The administered vaccine was exposed to a temperature of 6 degree Fahrenheit to 14 degree Fahrenheit for 1 hour. Previous temperature excursion was reported as 6 degree Fahrenheit to 14 degree Fahrenheit for 45 minutes. The call was because of a data logger. No adverse effects were reported. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010696: US-009507513-1708USA010732: US-009507513-1709USA014570: US-009507513-1709USA014571: US-009507513-1709USA014572: US-009507513-1709USA014574: US-009507513-1709USA014575: US-009507513-1709USA014576: US-009507513-1709USA014577: US-009507513-1709USA014569.
headache, flushing, nausea , vomiting and chest pain after 2nd dose.  vitals  were stable with strong pulses pt took zofran that she brought home. encouraged rest, and fluids. provided  cold compress and reassurance pt laid down in a stretcher and rested for about an hour before getting discharged home.
The evening after I got my shot, I experienced a sudden and intense bout of depression. It was extremely unusual for me and it wasn't triggered by anything that I could determine. It lasted for about an hour, hour and a half before going away. Before that, I was feeling low grade general anxiety for several hours.
Became lethargic.  Wasn't answering simple question.  Did not have trouble breathing.  Looked as if she was falling asleep.  Son was with her and said this was very unusual for her.
Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe
Received Hep A, Prevnar, and Varivax on 7/30/07.  On 7/31/07 patient had generalized seizure, with fever, lasting one minute.
Patient received Pneumovax vaccine on Friday, Oct 17, 2008 at approximately 4:00 pm in her right arm. The pt insisted on receiving the vaccine.  On Sat, Oct 18, the patient presented to the emergency room with symptoms of generalized body aches and a 9x9 erythematous area in the right deltoid muscle area.  The redness stretched from the pt's shoulder to her elbow.  The cellulitis-type rash was "swollen, red-hot, and tender to the touch."  The pt was started on cephalexin and Bactrim for treatment of cellulitis.
pt recv vax 6MAR95; 2AM noticed round red areas the size of a pea on face, head, extremities, finger & toes; size of red areas enlarged to whelp size; taken to ER that noc; MD advised child having allerg react & to give DPH; rash cleared;
Tinnitus starting 10 days after vaccine that was so bad it brought him to the ER
After 7 days, a full body rash developed along with petechia on bilateral calf and bilateral upper arm.  Current treatment is antihistamines and pramoxine lotion
Continuous skeletal and muscular body pain, especially in the back, neck and knees.  Coginitive and memory difficulties, including depression. Per telephone F/U with pt he states that in spite of evaluations by many healthcare providers, no one has been able to definitely diagnose his condition, although one MD felt he had symptoms of juvenile arthritis. He has been treated with various muscle relaxants and NSAIDS, but continues to have pain. At one point he was treated with prednisone for swelling in his knees, with some success. Currently he has stiffness and pain in his back and his knees. The intensity varies during the day and from day to day. 60 Day Follow up: Joint, bone and Muscle pain, fatigue; memory and cognitive difficulties depression. Per the follow up report-No change in intialy reported symptoms-joint pain, cognitive difficulties, etc.
This spontaneous report as received from a pharmacist refers to an infant of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 26-JUN-2015, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (doses and routes of administration were not reported, lot number K010535, expiration date 27-AUG-2016 or lot number K020216 and expiration date 17-SEP-2016). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
it was rpt from pharmD 12 days p/ pt recv vax pt exp blistering on arms.
Pain local site, tenderness at local site, restriction of moving left arm, body ached, headache ,   Feeling feverish
After receiving the IMZs the patient got to the bench and was lightheaded and dizzy. She had to lay down and we called 911. EMS checked her over and she had some water and felt better after resting for about 10 minutes.
Does not know any other information. Patient is her father in law. The day of receiving the vaccine he started to feel fatigued. Before receiving the vaccine  patient was fine. Patient ended up passing away either the 1st or 2nd. Medical examiner told reporter that she believes it was the vaccine that caused the patient's death.
Injection site [went tall and swollen, bigger than half a dollar, red and] hot to the touch; Injection site went tall and swollen, bigger than half a dollar; Injection site went [tall and swollen, bigger than half a dollar,] red; Injection site went [tall and swollen, bigger than half a dollar, red and hot to the touch,] sore/ the area is also tender to the touch and very painful; This spontaneous case, initially received from other healthcare professional (nurse) on 28-Sep-2018, concerning a 49-year-old, adult, female patient.  The patient had no historical conditions. The patient was not taking any medication at the time of vaccination.  On 26-Sep-2018, the patient was administered Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 02444611A and expiry date: 06-Jun-2019) for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.  On 27-Sep-2018, one day after vaccination, the patient's injection site went tall and swollen, bigger than half a dollar. It was red, hot and tender to the touch as well as very painful. The patient used ice therapy for the events.   On an unspecified date in 2018, within one week after vaccination, the patient had recovered from the events. At the time of this report, the patient felt better.  This case is linked to case 201804181 (same reporter).  The reporter assessed this case as non-serious.  Follow-up received other health professional on 26-Oct-2018 (combinedly processed with follow-up 1 received on 24-Oct-2018): The batch number (02444611A) and expiry date (06-Jun-2019) of the suspect vaccine were updated in the product tab. The outcome of the events was changed from not recovered to recovered (within one week after vaccination). It was reported that, the patient felt better. The narrative was amended accordingly.  Significant case amendment (24-Oct-2018): Treatment received for all the events was corrected from 'unk to 'yes' in event tab. No changes were done in narrative.; Reporter's Comments: A 49-year-old female patient experienced injection site warmth, pain, swelling and redness, one day after the administration of Afluria Quadrivalent. The company assessed the causality of the events as related to the suspect vaccine due to plausible temporal relationship and localized injection site reaction.
A medical assistant reported that ORIMUNE inadvertently splashed into the eyes of a 24-year-old female on 29-MAR-1999, during attempted administration to the woman's child. The woman awoke with a sore throat on 31-MAR-1999, her throat felt swollen. When she got out of bed, she felt lightheaded and fainted. Her throat remained sore for approximately 5 days. The patient continued to feel lightheaded and sleepy. Blood cultures performed on 01-APR01999 were negative. A throat culture performed on 01-APR-1999 was negative for streptococci. On 05-APR-1999, the patient's eyes became red and burned, pus drained from both eyes. She was treated with oral amoxicillin and gentamicin ophthalmic drops.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obese" (unspecified if ongoing), notes: other medical history: Obese. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medication was received in 2weeks. Patient received treatment with paxlovid from 23Nov2022 to 27Nov2022  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
We noticed that patient had completely lost his appetite after being vaccinated and that he had lost a significant amount of weight. We can't pinpoint an exact date, but we guess it may have been around 6/15/2021.
This case was reported by a physician and described the occurrence of cellulitic type skin reaction in an adult (50 plus years of age) male subject who was vaccinated with (Fluarix, GlaxoSmithKline) for prophylaxis. Concurrent vaccination included pneumococcal vaccine (manufacturer unspecified) given on 9 October 2007. Concurrent medications were not specified. On 9 October 2007 the subject received unspecified dose of Fluarix in an unknown arm. Within a few days of vaccination with Fluarix, the subject experienced a cellulitic type skin reaction, fever to 102 degrees and body pain. The subject received antibiotics in the emergency room and missed work due to the events. This case was assessed as medically serious by GSK. At the time of working the events were resolved.
pt brought to ED via EMS with agonal respirations and unresponsive; O2 sats 40% on RA; O2 supplementation; required noninvasive mechanical ventilation with BiPAP; exposed in past few days to COVID; COVID test positive in ED; pneumonia; EKG showed sinus tachycardia; transferred to ICU; given steroids, ABX, remdesivir, tocilizumab; worsening respiratory status; DNR/DNI; pt passed away in the hospital
"COVID Arm" one week after injection. Raised, firm, pink lesion at injection site. Lesion is itchy and warm to the touch.
I had a fever, chills, body aches, swelling in pain. Swollen lymph nodes. I have recovered from everything except the swollen lymph nodes.
Arm is really sore. Hurts to lift; I had aches and pains in my upper backand shoulders; Joint pains in my wrist; I felt sick for 5 min and I had to lay down; I had aches and pains in my upper backand shoulders; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6205), via an unspecified route of administration in the left arm on 18Mar2021 at 09:00 (at the age of 29-years-old) as single dose for COVID-19 immunisation. Medical history included COVID-19 prior to vaccination. The patient was allergic to zithromax (MANUFACTURE UNKNOWN) since an unspecified date. Concomitant medications were not reported. The patient was not tested for COVID-19 since having the vaccine. On 19Mar2021 at 07:15, the patient experienced really sore arm which had hurt to lift. She had aches and pains in her upper back and shoulders and also had joint pains with her wrist. The patient felt sick for 5 min and then had to lay down. No treatment was taken for the reported events. The clinical outcome of the events pain in arm, shoulder pain, wrist pain, feeling sick and upper back pain was resolving at the time of the report. No follow-up attempts are needed. No further information is expected.
Same day of vax, the pt developed swollen lymph nosed, muscle pain and a stiff neck. On 4/5/00, the pt self-treated with Advil and Bengay and had reported some relief. As of 5/18/00, the reporter noted that the pt had significant muscle tightness throughout her shoulders neck and chest. She was being treated with ibuprofen and physical therapy.
Patient received Moderna booster vaccine and was being observed in adverse monitoring area. At 10:10am, patient reported arm soreness at site, feeling hot, and pre-syncopal. Patient was given water and moved to exam area to lay flat. Vital signs obtained (BP 133/96; HR 72).  Patient reports mild chest discomfort, nausea and continued feeling hot. Ice packs were applied and vital signs were retaken (BP 138/98; HR 100). Patient reports urge to have loose BM and nausea continued. Lead nurse practitioner was updated about symptoms and patient?s status. NP recommended calling EMS for further evaluation and treatment. Epinephrine was not recommended and not administered. At 10:45am, EMS arrived and patient transferred to a local hospital ER for evaluation. Vital Signs @10:20am BP 127/88, HR 80; @10:30am BP 139/84, HR 107; @10:40am BP 134/88, HR 119, pulse ox 98%.
RIGHT SIDED FACIAL SWELLING (PUFFY); FACE FEELS NUMB; SLIGHT TINGLING; SLIGHT SORENESS TO ARM; LITTLE TIRED (SLIGHT FATIGUE); This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no medical history and no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and batch number: 1805020) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced slight soreness to arm. On 15-MAR-2021, the subject experienced little tired (slight fatigue). On 17-MAR-2021, the subject experienced right sided facial swelling (puffy). On 17-MAR-2021, the subject experienced face feels numb. On 17-MAR-2021, the subject experienced slight tingling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from slight soreness to arm, and had not recovered from little tired (slight fatigue), right sided facial swelling (puffy), slight tingling, and face feels numb. This report was non-serious.
Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a healthcare professional regarding a 5-year-old female patient who experienced gagging. At 5 years of age, the patient received the first dose of 14-Oct-2003. Medical history: Relevant medical history was not provided. Product details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 14-Oct-2003. Dose regimen was 0.5 mL 1 times per day (intranasal). Concomitant therapy: Concomitant therapy included Tavist (clemastine fumarate). Event details: The patient gagged (retching) and some of the Flumist ran out of her nose on 14-Oct-2003. The patient is scheduled for her second dose. No additional information was available at the time of this report.
Persistent arm and shoulder pain.  Cannot lift arm above shoulder without causing pain.  Also painful when laying on the right side.  Symptoms have been present since the day of the vaccine.  Initial arm tenderness at the vaccine site has gone away.
BLED ALL THE WAY DOWN HER ARM; SHOCK DOWN HER ARM; DRUG ADMINISTRATION ERROR; This spontaneous report received from a patient concerned a patient of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: 25-MAY-2021) .5 ml, administered on 09-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced bleeding. On 09-MAR-2021, the subject experienced shock down her arm. On 09-MAR-2021, the subject experienced drug administration error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bleeding, and shock down her arm on 09-MAR-2021, and the outcome of drug administration error was not reported. This report was non-serious.
Pt reported dizziness Vitals: 101/60,72,18, O2 Sat 94% -- > @1824 111/70,75,18, 98% -- > 18:25 101/63,83,18 -- > 18:35 113/77, 70-83,18, 99% Pt given fluids an stated asymptomatic @ 18:25.  Pt stable and released from vaccination site @16:36
very bad sore arm at the injection site. sore throat, diarrhea, fatigue, headache, chill (no fever yet)
I had a high temperature all day, pain throughout my body, a headache that I still have and for a moment I felt pain in my throat but I did not go to the hospital, I am recovering at home.
I had suffered from mild joint pain, and also had occasional stomach issues, especially gas. The severity of these issues went up considerably since the vaccine, and seemed to be made even worse after the booster that I received on 11-22-21.
Within 3 hours of dose #1 administration I had a runny nose, watering eyes, chills and sneezing.  By evening the chills got worse, low-grade fever and fatigue.  Unable to do anything except bundle up and sleep it off.  Still fatigue, chills, runny nose the next day but no fever.  Better by 2nd day after vaccine.
Vomiting & diarrhea started at 12:30 am 9/22/11. Also a nose bleed. Missed 1 day of work.
admitted after throwing up black flecks of suspected blood. He was started on PPI and octreotide.  GI evaluated and elected to hold off on EGD.  Pt doing well.  H&H stable.  No longer having any bloody output from nose or stomach.  Ok to go home today and follow up with PCP in 1 week. He is working towards being on transplant list.   COVID positive but no treatment required on admission
Diarrhea; ill; This non-serious case was reported by a consumer and described the occurrence of diarrhea in a 78-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included atrial fibrillation. Concomitant products included metoprolol, tramadol, rosuvastatin and cyclobenzaprine hydrochloride (Flexeril Tablet (Cyclobenzaprine)).   On 26-OCT-2023, the patient received Shingles vaccine. On 26-OCT-2023, less than a day after receiving Shingles vaccine, the patient experienced diarrhea (Verbatim: Diarrhea) and unwell (Verbatim: ill). The outcome of the diarrhea was resolved and the outcome of the unwell was not reported.   It was unknown if the reporter considered the diarrhea and unwell to be related to Shingles vaccine.     It was unknown if the company considered the diarrhea and unwell to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-OCT-2023 The patient reported that she received the Shingles injection and became very ill after 30 minute shopping. Her daughter brought her home to bed and bathroom where she suffered from diarrhea for several days. The patient  called the pharmacist and told her that they know the side effects included the gastrointestinal issues. The patient was not informed before the procedure.
01/15/22 presents to ED for "shortness of breath". PMHx of "COPD on home oxygen (3-4 L), A-fib (on Eliquis), CAD s/p PCI (last cath May 2021), bioprosthetic aortic valve (2016), HFpEF (EF 65%), complete heart block s/p PPM"
this is one of three pt's who devel severe local rxn;no other info was available @ the time of the call
Patient had received COVID 19 vaccination series of Pzifer 0.3ml on 4/6/2021, 4/27/2021. Additional dose of Moderna 0.5 ml given on 11/6/2021. Patient did not exhibit any clinical symptom, denies complaints after administration of additional dose of Moderna up to time of reporting incident.
Hives, redness, itchy, sore. Spread down arm to elbow.
Information regarding PREVNAR 13 was received from a healthcare professional regarding a 4-year-old female patient who experienced redness, tenderness and soreness at injection site and redness, tenderness and soreness at injection site. The patient received the first dose in Jun-2010. On an unspecified date in Jun-2010, approximately 48 hours post-vaccination, the patient experienced redness, tenderness and soreness at injection site reported as "about the size of a grapefruit or softball". The patient returned to the physician's office where no infection was noted. Treatment was not reported. As of 16-Jun-2010, the patient had recovered. No additional information was available at the time of this report.
Pt recvd vax & exp mild to severe dizziness, malaise, swelling @ inject site, projectile vomiting;
patient stated her arm was stiff, sore, hard, red, and warm to the touch.
6 year old patient received an adult Pfizer bivalent booster instead of the pediatric bivalent booster. The error was not found until admin entered information into the system and the family had already left. Per standing orders the patient sat for 15 minutes to be observed post vaccination and reported no adverse reactions to vaccine. The nurse who vaccinated the child contact the MD and went through the standing orders and error. The nurse called and notified the parents of the inadvertent error. Give reassurance that no adverse clinical sequellae would be likely but any worrisome post-vaccination symptom(s) should be followed up with urgent-immediate medical attention per MD. At that time the parents reported no adverse reactions.
Mother noticed bilateral rash to anterior thighs surrounding injection site with itching 24 hours after receiving injections. Mother stated it has happened the last 2 times patient received vaccines but never reported. TX hydrocortisone/ZYRTEC.