chrisvoncsefalvay/vaers-outcomes huggingface dataset:
48 yo Caucasian male developed acute pain in bilateral inguinal areas on July 16, 2003, with pain along the length of his right lower extremity. He also had subjective weakness of right lower extremity, and subjectively altered sensation medial right thigh.  He was found to have tender lymphadenopathy (or tenderness without discernible adenopathy in the case of one axilla) in bilateral inguinal and axillary areas. He was admitted to the hospital (7/16 to 7/22) because of the severity of pain, and for diagnostic evaluation. Nodes were said to be "pea" to "acorn" size at that time. No constitutional symptoms were noted at that time.  Neurology and infectious disease consulted on his case. Despite multiple tests no explanation was found for his symptoms, which improved significantly in hospital.  He did well after discharge and returned to work, with apparent diminution of enlarged nodes. Symptoms increased again in August, and he was again hospitalized from 8/15-8/19. He reported about a week of feeling "run-down and achy"  He has apparently been requiring narcotics for analgesia since then, and has not returned to work as a security guard.  He recently went to the University of Iowa for another infectious disease consultation.   The vaccinee is convinced that his symptoms are related to his smallpox vaccination.  Current medications:  Topamax 100 bid (for chronic headaches) Fiorcet prn pain  Allergies: tetanus and beestings  PMH: history of smoke inhalation with ? h/o cardiac arrest vs MI, ? anoxic brain injury. Has memory deficits and chronic headaches. PSH knee arthroscopy, lumbar laminectomy, surgical repair of shrapnel injuries Bilat calves.  Extensive past travel history, none recent. History of some unprotected sexual encounters. Lymph node biopsy (July) showed follicular hyperplasia. Recent neg labs include HIV, tularemia, Lyme, CSD, Ehrlichia, CMV, Monoscreen, C-RP (less than 0.3) ESR (10), blood cultures (2),  AFB stains of lymph node, fungal and bacterial cultures of lymph node biopsy specimen (grew coagulase negative Staph aureus felt to be contaminant), ANA, Brucella,   WBCs normal eg 10.1, with unremarkable differential. Had 5.2% eosinophils in July on a single draw, but subsequently about 3%. Hgb 14.7 to 13.5., 258,000. CPK 66.  Lumbosacral MRI normal post-surgical changes. Brain MR 7/16 showed "vascular flow void in left vertebral and basilar arteries". CT scan chest to pelvis normal except one group of fairly small retroperitoneal nodes as noted above. The 60 day follow up received on 11/26/03 states the pt was ultimately diagnosed with lymphoma. Consensus of treating physicians is that lymphoma is not related to smallpox vaccination administered about 4 months before symptom onset. This has been discussed with CDC staff on smallpox detail. I have not been able to obtain pathology report.
(L) arm red, swelling. BENADRYL, AMOX 250/5.
Brain Fog along with feeling faint, nausea, hot, clammy, fatigue. July 2021 and would occur 2-3 times per week lasting for few seconds to few minutes. The Brain Fog has remained all day constant with no relief.  Very strong back of the head headache came on after each episode.  Sleep was interrupted and  often difficult to maintain straight length of deep sleep. In August 2021 contacted doctor and they said to go to ER as the spells were getting stronger and they were thinking heart issue.  EKG showed no issues. The symptoms seemed to become little less frequent through early September then got more so into October.  Memory and confusion became very problematic, would talk about events that were over 20 years old like they happened more recently.  Neighbor stated I had told him I was feeling dizzy from going out the night before with friends, when in fact I don't drink and was not out at all.  11/25/21  had first "seizure type" activity where would just freeze and not be responsive to others around me with no recollection of the events at all. 6 total of these types of seizure activity in one day. went to ER and they prescribed Kepra and kept over night for testing. Since home have not had any more seizures just short term memory and issues still with getting continued sleep on daily basis.
big bruise the size of a Nickle above where they got the needle, still gets the bruises; gets bruises on her arm,legs, knees, various places; start off pink or red and then get brown, sometimes they come in brown; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (big bruise the size of a Nickle above where they got the needle, still gets the bruises), CONTUSION (gets bruises on her arm,legs, knees, various places) and SKIN DISCOLOURATION (start off pink or red and then get brown, sometimes they come in brown) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Jansen (First dose). Past adverse reactions to the above products included No adverse event with Jansen. Concurrent medical conditions included Blood pressure high.    On 12-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced VACCINATION SITE BRUISING (big bruise the size of a Nickle above where they got the needle, still gets the bruises), CONTUSION (gets bruises on her arm,legs, knees, various places) and SKIN DISCOLOURATION (start off pink or red and then get brown, sometimes they come in brown). At the time of the report, VACCINATION SITE BRUISING (big bruise the size of a Nickle above where they got the needle, still gets the bruises) and CONTUSION (gets bruises on her arm,legs, knees, various places) had not resolved and SKIN DISCOLOURATION (start off pink or red and then get brown, sometimes they come in brown) outcome was unknown. Patient concomitant medications include high blood pressure medications before getting the vaccines. Patient did not taken any medications for reaction and declined for date of birth. No treatment medications were reported.
Patient received second dose of the Moderna Covid-19 Vaccine past the expiration date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received second dose of the Moderna Covid-19 Vaccine past the expiration date.) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received second dose of the Moderna Covid-19 Vaccine past the expiration date.). On 07-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Patient received second dose of the Moderna Covid-19 Vaccine past the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter reported that Moderna Covid-19 vials were moved from the freezer to the fridge on 06May2021. The 30 day expiration date was on 05Jun2021.   No concomitant medication details were provided.  No treatment medication details were provided.
Twitching in both legs, (calves, thighs, quads) beginning approx 3 weeks after second done.  Seems to be worsening /progressing.  The twitching is now preventing restful sleep.  Present all the time now.  Causing anxiety.   Leading to tense muscles and fatigue.
arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No medical history reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm soreness). At the time of the report, PAIN IN EXTREMITY (arm soreness) outcome was unknown. Not Provided   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    No relevant concomitant medications were reported.  No treatment information was provided.
A nurse reported the occurrence of an injection site reaction in a 4-year-old male who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Infanrix) for prophylaxis. The pt had no relevant medical history, concurrent conditions or concurrent medications. On 04/29/2002 the pt received his 5th injection of Infanrix (lot DTPA 546A2). On 05/01/2002, he developed an injection site reaction characterized by redness, swelling, warmth and welts "the size of golf balls". The pt was seen by a physician. The reporter stated that the injection site reaction was related to Infanrix administration. As of 10/08/2002 the injection site reaction had resolved.
generally not feeling well; fever close to 101.0 degrees; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MALAISE (generally not feeling well) and PYREXIA (fever close to 101.0 degrees) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concomitant products included LOSARTAN, VENLAFAXINE and LEVOTHYROXINE for an unknown indication.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced MALAISE (generally not feeling well) and PYREXIA (fever close to 101.0 degrees). At the time of the report, MALAISE (generally not feeling well) and PYREXIA (fever close to 101.0 degrees) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information included advil with acetaminophen (ibuprofen/acetaminophen combo) - unknown dose as needed for elevated body temperature (one dose taken as of time of call).Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable.
1/6/20 Call from patient, she is now away for approx. 1 month received vaccine 1/3/20. States 6" area of redness and hardness, started Friday night patient states better now. She states today having trouble lifting left arm. Advised seek care today.
Sudden onset rigorous chills, fever 101.5 F., sweats, and headache.
Information has been received from a nurse referring to 3 unspecified patients. On 18-AUG-2015 the patients were vaccinated with improperly stored PROQUAD (Merck) (lot # L002419, expiration date 23-JUL-2016) (lot # L013545, expiration date 17-OCT-2016). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
pt recv vax 22AUG95 & 6JAN97 pt devel a mild case of atypical chickenpox;the rash consisted of less than 50 lesions & was not itchy;
Patient had symptoms of dizziness with near syncope, sensation of throat constriction with tightness at the base of his neck.  This was then accompanied by chest pain and tightness.
This spontaneous report as received from a certified medical assistant refers to multiple patients of unknown age and gender. The patient's medical histories, concurrent conditions and concomitant medications were not reported. On an unknown date the doses of RECOMBIVAX HB (lot # K008334 with expiry date 09-JUN-2016 and lot # K016005 with expiry date 27-AUG-2016) were administered post excursion to those multiple patients. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
PATIENT OBSERVED TO HAVE POSSIBLE SEIZURE ACTIVITY IN CHAIR. PATIENT BROUGHT TO THE FLOOR AND LASTED ABOUT 1 MINUTE. PATIENT HAD CONTRACTED ARMS, HUNCHED OVER, PALE, DIAPHORETIC, AND VERBALLY UNRESPONSIVE. 911 DISPATCHED AND ARRIVED WITHIN FEW MINUTES. PATIENT DID NOT RECALL EVENT ONCE VITALS STABILIZED AND WAS TRANSPORTED TO NEAREST HOSPITAL.
Fever of 103, fatigue, urinary, frequency, body aches x48 hours after vaccine
Severe and at time debilitating insomnia: significant delayed sleep onset latency (2+hrs), nighttime awakening, and inability to return to sleep (3-4hrs to fall back to sleep). Contributing to profound lethargy and exhaustion.
Pt received varicella vaccine. Pt sitting on Dads lab when Nurse walked out of room. Dad came out of room stating patient passed out and hit head on counter then floor. Patient placed on table. Pt examined by CRNP. B/P WNL. Pulse ox 99%. Pt left office in stable condition after waiting 20 mins and being examined by CRNP.
Rt arm began to inflame w/i a few hrs & was warm, & sore. Began feeling wrist soreness approx 4 hrs after shot. Pain was stronger as time went on & began feeling tingling sensation in fingers. The next morning, pt had pain & numbness in fingers.
Blurred vision, muscle pain, stomach cramps and diarrhea. Last for weeks. I took Airborne and vitamins. I missed one day from work. I refrain from exercising I was too weak.
itchy; on second case give the shot anyway; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pruritus in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included shingles.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pruritus (Verbatim: itchy) and off label use in unapproved indication (Verbatim: on second case give the shot anyway). The outcome of the pruritus was not resolved and the outcome of the off label use in unapproved indication was unknown.   It was unknown if the reporter considered the pruritus to be related to Shingles vaccine.     It was unknown if the company considered the pruritus to be related to Shingles vaccine.   Additional Information: GSK receipt date: 18-MAR-2023 The case was received from the patient interactive digital media. The patient was on his/her second case of that horrible mess.  The physician said that he was going to give him/her the shot anyway.  The patient stated that physician was not sure it would take.  The patient got it and it took.  The patient still get really itchy that felt like those shingles from time to time, but not a full case of that stuff.  The patient thanked goodness. The follow-up could not be possible as no contact details were available.
Burning sensation in throat; coughing, face flushed; seen @ 100 in ER @ hosp; t98.3, P107, R24, BP 133/79 episode reportedly lasted 30min;
About 40 hours after vaccine, our son noticed red, raised, circular bumps on the toes of his left foot. They were irritated but not terribly painful, They were not itchy. Later that evening, the same red bumps appeared on the toes of his right foot. The following day there were red, raised circular bumps on the fingers of his right hand as well. At that point the left toe bumps had started to fade. It is now 5 days post vaccine and the marks are almost completely faded from both fingers and toes.
Administered only the diluent; Administered only the diluent; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 51-year-old male patient who received Herpes zoster (Shingrix) (batch number 5392T, expiry date 31st August 2023) for prophylaxis.   On 4th January 2023, the patient received the 1st dose of Shingrix. On 4th January 2023, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK Receipt Date: 20-JAN-2023 Reporter's Comment: The registered nurse called to inquire that how to proceed and should the dose been repeated. The nurse reported that the patient was inadvertently administered the Shingrix diluent (AS01b) only without the lyophilized component. The reporter did not consent to follow up. Additional Supportive Information: The patients received Shingrix vaccines with only the diluent component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
HOARSNESS OF VOICE; COUGH CAME BACK; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (HOARSNESS OF VOICE) and COUGH (COUGH CAME BACK) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CF. In October 2021, the patient experienced COUGH (COUGH CAME BACK). On an unknown date, the patient experienced DYSPHONIA (HOARSNESS OF VOICE). At the time of the report, DYSPHONIA (HOARSNESS OF VOICE) and COUGH (COUGH CAME BACK) was resolving.            No relevant concomitant medications were reported.   The reporter's causality for the events of HOARSNESS OF VOICE and COUGH CAME BACK with HUMIRA(ADALIMUMAB) was no reasonable possibility.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
She got her flu vaccine yesterday. Then she devloped a rash, she states it is really itchy. She states it is in her scalp down her face and now on her butt. She took benedryl last night that didn't help. No difficulty breathing or swallowing. No throat swelling. Has had the flu shot before, without reaction. She has several red spots on her Right hip area that burn; the rest of the spots on her scalp, face and legs only itch. Works in the NICU. Patient got her flu vaccine yesterday afternoon and then developed a rash that is very itchy, on her scalp, face, neck and now his bottom.
Loss of speech, loss of social interaction, loss of eye contact, severe eating problems, irritability, sound and light sensitive, sleep disorder; all of which appeared within one week of administered vaccine. The 60 day follow-up states lack of speech, lack of social skills, chronic diarrhea and inability to digest.
Redness, swelling, warmth to touch, and  itching at injection site.  Swelling and redness are 7.5 cm x 6 cm on the left upper arm. This has been present since 01/05/2021 and has mildly increased in size since onset.
This case was reported by a medical assistant and described  the occurrence of swelling at the injection site in a pt who received Infanrix. On an unknown date, the pt received Infanrix (lot DTPA612A9). At an unknown time, the pt experienced "severe" swelling at the injection site. The event resolved. The medical assistant considered the events were probably related to vaccination with Infanrix. The medical assistant also stated that "one additional, unidentified pt experienced swelling at the injection site".
Narrative: COVID infection following COVID vaccine series 01/05, Pfizer, dose #1 01/27 , Pfizer, dose #2 09/20 COVID swab, result: detected 09/20 pt cc: exposure: unknown
Both elbows painful, tender to palpation, red, rashy areas over both ante? areas left knee tender.
Redness and swelling around DTaP injection site.  Patient on ZYRTEC will add BENADRYL. Site marked with ink pen to see if still reacting.
My son was born the due date was July 18th so he was late, and he was 10lbs 0oz. My son was born and it was a really long and complicated birth along with a complicated pregnancy. I developed gestational diabetes when I was pregnant as well. I had along labor over 33 hours- I also had a post-partum hemorrhage I lost 2.5 liters of blood and needed a blood transfusion; I also went septic. About six weeks later I had a gallbladder attack, but I thought I was a heart attack based on the pain. I went to the ER because of this, and I was sent home with meds but was back two days later, I was then admitted on September 12th and had my gallbladder taken out.
Starting approximately one week after the first dose of vaccine, my mother began suffering what she describes as "episodes" of chest pain, neck pain (front and back), pain going down her arms, pain up into her jaw that are very sudden onset and cause her to have to lay down and rest until the episode is over.  Timing of these episodes are random, but seem to occur when she first gets up in the morning or after she takes a shower or has been active.  They lasts between 3 and 7 minutes and then completely resolve.  She has never had any similar symptoms.  She reports that these episodes occur between 4-6 times during the course of 24 hours.
On 11/10/2021 I started having discharge,  pain, and lumps in both breasts. I went to hospital and after testing was told I have cancer.  On Monday the 15th of November I have another appointment for follow-up.
2 hours after vaccination: diarrhea began followed by vomiting, fever, dehydration, abdominal cramping, extreme lethargy, limpness, irritability, runny nose, cough. Is still continuing 6 days later although symptoms have improved somewhat.  Diagnosis from doctor was viral and treat with pain reliever and fluids.
fevers, chills, sweats, headache, low-grade fever with T-max at 100.4°. continues to have symptoms at clinic visit 13 days post 3rd dose/booster.
R deltoid area w redness, soreness, swelling tender to touch. pt felt body aches and fatigue. Tx w Keflex for possible cellulitis
approx 10-12 hrs after vax,developed red, pruitic palms of hands, and feet. subsequently, had pruritic all over body rash. on exam, rash was suspicious for erythema multiforme, but more consistant with viral cause.
severe erythema & edema of lt arm extending from shoulder to elbow, circumferentially; arm is warm & moderately tender; rxn noted w/in 24 hr of vax;
Within one hour of vaccination I experience jaw tightening & throat constriction. I treated with Benadryl x 2 PO and took a nap. For the next 3 days I had diarrhea.