chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever onset day after second vaccine dose, associated with gross hematuria, proteinuria and rhabdomyolysis (metabolic crisis due to Very long chain acyl carnitine dehydrogenase deficiency VLCAD).  Admitted to the Hospital on 6/12 with hypertension and elevated creatinine.  Renal biopsy c/w IgA nephropathy.  She was discharged on 6/23 on prednisone 60 mg daily with plan for slow taper.  Acute kidney injury, proteinuria, rhabdomyolysis and hypertension improved at discharge.  She had 2 additional admissions for elevated CK on 6/29 and 7/6.  CK improved with IV hydration and glucose, and both admissions were <48 hours. Of note, patient had transient episode of gross hematuria in 1/21.  Creatinine normal,  BP normal.  Proteinuria and hematuria resolved spontaneously on repeat testing of urine 3 weeks later. Also of note, patient had multiple episodes of rhabdomyolysis as young child due to VLCAD, with most recent episode in 2016.  Trigger was viral illness or fasting.  Previous episodes had higher max CK >20,000, no prior history of acute kidney injury during these episodes.
Seen in clinic on 7/13/01 and dx'd with varicella. Scalp, face, anterior and posterior trunk with diffuse maculopapular pinkish lesions.
Pt was given 1mL dose instead of 0.5mL dose; no signs/symptoms at this time
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 14-MAY-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB, lot # N022167, expiration date: 08-FEB-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA001505; US-009507513-1806USA009026; US-009507513-1806USA009027; US-009507513-1806USA009028; US-009507513-1806USA009029; US-009507513-1806USA009030; US-009507513-1806USA009031; US-009507513-1806USA009032; US-009507513-1806USA009033; US-009507513-1806USA009034; US-009507513-1806USA009035; US-009507513-1806USA009036; US-009507513-1806USA009037; US-009507513-1806USA009038; US-009507513-1806USA009039; US-009507513-1806USA009040; US-009507513-1806USA009041; US-009507513-1806USA009043; US-009507513-1806USA009044; US-009507513-1806USA009045; US-009507513-1806USA009046; US-009507513-1806USA009047; US-009507513-1806USA009048; US-009507513-1806USA009049; US-009507513-1806USA009050; US-009507513-1806USA009051; US-009507513-1806USA009052; US-009507513-1806USA009053; US-009507513-1806USA009054; US-009507513-1806USA009055; US-009507513-1806USA009056.
vaccination failure; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Lot number: ch9899), in left arm, on 06Jan2021 as dose 2, single (Lot number: ek9231), in left arm and on 23Aug2021 as dose 3 (booster), singl (Lot number: fd8448) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 26Jan2022 as dose 4 (booster), single (Lot number: 022j21a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "htn" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE, start date: 03Jan2022, stop date: 11Jul2022; WEGOVY, start date: 19Jan2022. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received paxlovid on 11Jul2022 to 15Jul2022 for Covid 19 treatment. The patient received other medication in past 2 weeks. The patient had no allergy.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Vaccination failure and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Fever, swelling and redness from shoulder to elbow with a hard mass in bicep accompanied by pain and limited range of motion, the swelling and redness extended on day 3 to below the elbow. On day 3 was told to apply ice every hour for 20 minutes and to keep arm elevated, and to take Benadryl. As of today 7/16/18 the swelling, redness and pain are still present but to a much smaller degree. Range of motion is restored and hard mass is decreasing.
Information has been received from an office nurse concerning a female who on an unknown date, was vaccinated with the third dose of GARDASIL (lot# not reported). Subsequently the patient was diagnosed with Guillain Barre by a neurologist. Upon internal review, Guillain Barre was considered to be an other important medical event. In follow-up, the nurse revealed that the approximately 22 year old patient received two doses of GARDASIL on 18-JUL-2007 (lot# 658100/0525U) and 20-DEC-2007 (lot# 659439/1267U). Additional information has been requested.  8/26/09  MR rec'd for DOS  5/6-12/2008 with D/C DX:  Guillain-Barre Syndome, s/p 5 days of IVIG.  ADHD.  Pt initially presented to ER with 9 day hx of ascending numbness and weakness to the level of the abdomen. 2 prior ER visits, but presented again with chest pressure, decreased strength, difficulty walking, and worry re: condition. PE (+) for decreased strength and sensation. DTRs trace or absent. Admitted for IVIG.  Pt had autonomic instability with tachycardia and HTN, insomnia, H/A and constipation, somewhat improved by d/c.  Transferred for rehab 5/12/08 ICD9-357.0, 787.20, 349.0,314.01,  9/4/09 Hospital records received DOS 5/23/08 to 6/9/08. Assessment: Guillain-Barre' Syndrome Previous hospital stay complicated by respiratory distress / insufficiency. Transferred and placed on respiratory support (BiPAP). 7 days of plasmapheresis. Dysphagia, PEG tube. Difficulty activating facial muscles. Decreased muscle strength. Deep tendon reflexes absent lower extremities, trace in upper extremities. Anemia. Headache. Discharge to rehabilitation.
Pain at injection site, fever, body aches, lethargic,  nausea, fatigue immediately after shot, lasted 5 days. About a day later I developed a pain in my left lower back. This continued for over a week. I then had severe back and back pain so bad that I went to the emergency room. Sent home after a battery of tests. Symptoms persisted about a week and a half later I developed debilitating nausea and vomiting. Went back to the emergency room diagnosed with vertigo. I am now seeing an ENT and physical therapist for treatment.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # M037651, expiration date 28-AUG-2018 (dose and route of administration were not reported) reconstituted with sterile diluent (manufacturer unknown). There was no adverse effect reported. Administered doses of vaccines experienced many temperature excursions from -8.1 to -4.9 degrees Celsius for 24 minutes to 1 hour 52 minutes. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA013057:
Sitting in general observation area, began screaming and holding his head with clenched arms and hands.  1000 became rigid, suspect seizure, EMT reports syncopal episode. Assisted per EMT to w/c and taken to private observation area. BP 84/52 HR 54 O2 96% on room air. Color pale. EMT remains present. Offered patient water. Patient oriented x 3, Educated on taking next vaccine while lying down. Sister states patient has history of passing out while donating blood. Patient has needle phobia 1011 patient eating cookies and drinking water without difficulty. PB 105/79 HR 80 O2 98%. Denies dizziness, lightheadedness, Denies headache.  1015. STood at w/c - no dizziness. Patient states he feels well enough to leave, gait steady, ambulated to POV
C/o redness/pain at site of immunization on (R) thigh. 6 x 3 cm size. Provided Keflex/complesser. F/u PRN.
Body chills. Fever (102.6),severe headache, bodyache, stomach ache, loss of stamina and apetite. No medications taken
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not reported. The patient's concomitant medications included sterile diluent. On 20-FEB-2018, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX 19400 plaque forming units (PFU), lot # M042851 with expiration date 18-FEB-2018, for prophylaxis (route of administration was not provided). No adverse effects were reported.
10-15 minutes post vax, the pt became pale, weak, warm, dizzy, and diaphoretic. One hour later the pt continued to feel dizzy, weak, warm, and painful at injection site with a sense of numbness and inability to move arm. Taken to ER for continued evaluation and dx with anxiety reaction.
ED visit for lumbar disc herniation - treated and released. Hospital admission for acute diverticulities. She received 5-day course of prednisone 40 mg daily without improvement in symptoms.  On 12/28 she received gabapentin and muscle relaxant without benefit.  She reported her symptoms are worse supine.  On the date of admission she had a CT scan of her abdomen and pelvis that showed some mild diverticulitis changes in the rectosigmoid region.  She was started on ciprofloxacin and metronidazole. Antibiotics were changed to augmentin to complete a 7 day course. Inflammatory markers improved w/ abx, but pain did not change significantly. Repeat CT abdomen showed persistent diverticulitis, w/o abscess.  Left low back pain persisted- she was sent home on celecoxib and oxycodone. Spine referral made. ED visits and hospital admission within 6 weeks of receiving the COVID vaccine.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 13-SEP-2013 the patient was vaccinated with an expired dose of MMR II (lot number # 1293AA, expiration date 09-AUG-2013) 0.5 ml, subcutaneously. No adverse effect was reported. The outcome of vaccination with expire dose of MMR II was unknown. Additional information has been requested.
Myalgia, Fever, pain in injection site; body aches; chills Narrative:
Information has been received from a physician and a registered nurse concerning a 30 month old male with reactive airway disease, chronic sinusitis, other respiratory conditions, immune problems and low immunoglobulin G (IgG) (patient noted to be sick all of his life) who on 4/29/04 was vaccinated IM in the left deltoid with a dose of pneumococcal 23v polysaccharide vaccine (lot # 646712/1179N). There were no other vaccinations administered on that day. Other concomitant therapy included R2D, fluticasone propionate, mometasone furoate, levalbuterol HCl and clindamycin. The physician reported that on 4/30/04, the patient developed arm tenderness and was shrieking in pain. Ice and diphenhydramine HCl were recommended as treatment. On 5/1/04, the patient developed a fever, vomiting, and his arm was swollen. On that same day, the patient was seen in the ER. On 5/2/04, the patient was again seen in the ER. On 5/3/04, the patient was hospitalized for three days as his arm was red, hot and swollen in addition to the arm tenderness, fever, and vomiting. In May 2004, the patient recovered from his events and was scheduled for a follow up visit with his physician. The physician also reported that two other patient developed non-serious adverse events after being vaccinated with pneumococcal 23v polysaccharide vaccine. Additional information has been requested.  Follow UP: The physician also reported that two other patients developed non-serious adverse events after being vaccinated with pneumococcal 23v polysaccharide vaccine (WAES $s 0405USA01170 AND 0405USA01171). Additional information is not expected.  Follow up on 09/09/04 states: "There were no relevant diagnostic tests or lab tests performed.  The reporter considered the pt's experience to be an other important medical event (OMIC).  Additional information is not expected."
The night after receiving the vaccine, I had a fever but it went away shortly. 3 days later I developed "COVID arm" where it was extremely red and swollen around the injection site. I had swollen lymph nodes under the arm, on top of the shoulder, in the collar bone area and my groin (all on the right side of my body). Also, one night, I felt I had chest pains on the right side and shortness of breath but it only lasted that night and went away. It took awhile for the COVID arm to go away but I am unsure of how long it took. They gave me solumedrol and prednisone when I went to see the PCP about the COVID arm and other symptoms, which I reacted poorly too. It made all of my symptoms worse and I ended up having a racing heart rate. I ended up going into the clinic and they gave me IV fluids. I did feel better after this but it took awhile for me to feel normal.
Fever 102. Pain in left arm, shoulder, back and chest. Pain under left breast when taking a deep breath.
I had sore throat, chill, and coughing. I then got body ache, slight fever, and headache. I was also fatigue. These symptoms are still ongoing. The fever lasted for only a day. On Jan 20th, I was tested positive for Covid-19.
Apparent Hematuria (pink-red urine) approximately 6 hours after administration of 3 vaccines.  Continued through the evening, tea-colored urine in morning and then cleared. No other symptoms noted. NOrmal UA at the exam earlier in the day.
Approximately 1 hour after administration of flu vaccine patient developed itching, swelling, pain, erythema in the right arm.  Also developed body aches and chills.
pt recvd Typhoid vax & devel fever the following day & an illness described as lethargy for 3 days;
CHEST PAIN; DIZZINESS; SHORTNESS OF BREATH; SHE WAS UNABLE TO MOVE FOR WHOLE DAY; CRAWL TO THE BATHROOM; CHILLS; HEADACHE; FATIGUE; BURNING ARM; BODY ACHE; CHEST TIGHTNESS; LEFT ARM PAIN; LEFT SIDE OF BODY OUT OF IT; This spontaneous report received from a patient concerned a 27 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1806025, expiry: UNKNOWN) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced left side of body out of it. On 15-MAY-2021, the subject experienced chest tightness. On 15-MAY-2021, the subject experienced left arm pain. On 15-MAY-2021, the subject experienced burning arm. On 15-MAY-2021, the subject experienced body ache. On 16-MAY-2021, the subject experienced she was unable to move for whole day. On 16-MAY-2021, the subject experienced crawl to the bathroom. On 16-MAY-2021, the subject experienced chills. On 16-MAY-2021, the subject experienced headache. On 16-MAY-2021, the subject experienced fatigue. On 18-MAY-2021, the subject experienced chest pain. On 18-MAY-2021, the subject experienced dizziness. On 18-MAY-2021, the subject experienced shortness of breath. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from she was unable to move for whole day, was recovering from crawl to the bathroom, had not recovered from fatigue, burning arm, headache, dizziness, shortness of breath, chills, left arm pain, and chest pain, and the outcome of left side of body out of it, chest tightness and body ache was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Pt had redness, swelling, and warmth on right arm from shoulder to elbow. Pt also had two blisters that had popped on right arm. Pt using Benadryl and Tylenol for treatment.
31Jan91 slept throught night & was doing well. @ 630 am 1Feb91 went into convulsions that lasted more than 1 hr. @ 720 am he arrived @ hospital & had T 101.9, mom had given only 1 dose of Tylenol. Transported to Hlth Ctr via helicopter.
SOB, tightness in throat, nausea and vomiting, abdominal cramping
Saw my PCP on 6/6/22 and he sent me for a ultrasound on 6/9/22 thinking it was a lipoma on my calf and the results came back that it may be a Baker's cyst that drained into my leg.  I went to my orthopedic doctor and they wanted to do a guided ultrasound aspiration but my PCP wanted a CT scan and it came back inconclusive but they ruled out cyst but have not made a final determination.  My knee doctor says he doesn't want surgery but still wants to do a guided aspiration.  I am suppose to see a surgeon but I don't want to be operated on and it still cramps up and I didn't have this before my vaccination.
Patient who was supposed to receive MMRII and VARIVAX, but received a full dose of VARIVAX and half a dose of PROQUAD.; Patient who was supposed to receive MMRII and VARIVAX, but received a full dose of VARIVAX and half a dose of PROQUAD.; Patient who was supposed to receive MMRII and VARIVAX, but received a full dose of VARIVAX and half a dose of PROQUAD.; This spontaneous report has been received form a prescriber nurse, regarding a 14-month-old patient of unknow gender. The patient's pertinent medical history, current conditions, previous drugs reactions or allergies and concomitant medications were not reported.  On 25-APR-2022, the patient was supposed to receive a dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (Oka/Merck) (VARIVAX). Instead, the patient received a full dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) and half a dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) as prophylaxis (strength, dose, route of administration, anatomical location, lot number or expiration date were not reported) (wrong product administered) (incorrect dose administered) (product use issue).
Janssen COVID-19 Vaccine EUA Side Effects: - Nausea - Head ache - Body aches - Chills - Very sore arm
Pt received Gardasil HPV vaccine #1 on 4/4/07. On 4/6/07 pt awoke with raised welts (hives) on arms, Right leg, and had swelling of the toes (bilateral). This lasted for 1 week.
Patient was given Pneumovax 12-16-2008 with localized reactions to right arm. Arm was swollen right deltoid site of injection exendsdistally to upper elbow measures 2X3 inches at injection site 4X4.5 inches to area above elbow
Received vaccines on 10/2/00. Mother noticed left thigh was red and swollen on 10/3/00. She comes to our office on 10/4/00 with a 7cm X 4cm area of mild erythema and induration. Instructed to monitor. On 10/6/00, redness was gone.
3/7/05 lethargy, 3/8/05 temp 105 irritability began, 3/9/05 Temp 105, Irritability continued, 3/10/05 temp 101.8, office visit, Pt improving.
This spontaneous case was reported by a consumer and describes the occurrence of SINUS HEADACHE (extremely bad sinus headache) and HEADACHE (headache) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SINUS HEADACHE (extremely bad sinus headache) and HEADACHE (headache). At the time of the report, SINUS HEADACHE (extremely bad sinus headache) and HEADACHE (headache) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported. No treatment reported. Reporter did not allow further contact.
difficulty breathing which requires inhaler; dose received: 3; cough which makes sleeping difficult; cough which makes sleeping difficult; some congestion; swollen glands; extreme fatigue; fever; chills; muscle aches; still not well, three days later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Nov2021 15:00 (Batch/Lot number: unknown) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "various foods" (unspecified if ongoing); "molds" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXIN; VITAMIN D NOS; MELOXICAM. Past drug history included: Aspirin, reaction(s): "Drug allergy"; Thimerosal, reaction(s): "Drug allergy"; Prednisone, reaction(s): "Drug allergy". Vaccination history included: Bnt162b2 (Dose Number: 2, Location of injection: Right Arm, Vaccine Administration Time: 03:15 PM), administration date: 20Mar2021, when the patient was 61 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Location of injection: Right Arm, Vaccine Administration Time: 09:30 AM), administration date: 27Feb2021, for Covid-19 Immunization. The following information was reported: DYSPNOEA (non-serious) with onset 20Nov2021, outcome "not recovered", described as "difficulty breathing which requires inhaler"; IMMUNISATION (non-serious) with onset 20Nov2021, outcome "unknown", described as "dose received: 3"; COUGH (non-serious), INSOMNIA (non-serious) all with onset 20Nov2021, outcome "not recovered" and all described as "cough which makes sleeping difficult"; NASAL CONGESTION (non-serious) with onset 20Nov2021, outcome "not recovered", described as "some congestion"; LYMPHADENOPATHY (non-serious) with onset 20Nov2021, outcome "not recovered", described as "swollen glands"; FATIGUE (non-serious) with onset 20Nov2021, outcome "not recovered", described as "extreme fatigue"; PYREXIA (non-serious) with onset 20Nov2021, outcome "not recovered", described as "fever"; CHILLS (non-serious) with onset 20Nov2021, outcome "not recovered", described as "chills"; MYALGIA (non-serious) with onset 20Nov2021, outcome "not recovered", described as "muscle aches"; MALAISE (non-serious) with onset 20Nov2021, outcome "not recovered", described as "still not well, three days later". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Nov2021) pending, notes: Nasal Swab. Therapeutic measures were not taken as a result of dyspnoea, cough, nasal congestion, lymphadenopathy, fatigue, pyrexia, chills, myalgia, malaise, insomnia.  The lot number for bnt162b2 was not provided and will be requested during follow up.