chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 29-OCT-2011, the patient was vaccinated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 15-JUN-2015, the patient was treated for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), on 15Jan2021 as dose 1, single (Batch/Lot number: unknown), on 12Feb2021 as dose 2, single (Batch/Lot number: unknown), on 03Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 30Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant) with onset Jun2022, outcome "unknown", COVID-19 (medically significant) with onset Jun2022, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) positive, notes: positive COVID test for the week up to this point. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. Four days after completing the course of Paxlovid, patient started sneezing and by the next day patient had bad head cold symptoms. Patient only prescription medication was atorvastatin which he stopped taking while on Paxlovid. Events were not getting much better since 17Jun2022 but it was not worse so the patient hopes it goes away in the next days. Patient found in the internet that it seems like this may be a symptom of rebound effect of Paxlovid since patient has been isolating due to the positive COVID test for the week up to this point. The patient had penicillin allergy.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Exposed to someone who was positive on a Tuesday. Started having severe coughing and a lot of phlegm. By Thursday it was worse- I was coughing up blood. I thought it was just a cold but I tested positive for COVID on Thursday night. Saturday I was trying to get the MAB therapy but was unable to get the treatment.
Lightheaded; sinus discomfort; This is a spontaneous report from a contactable consumer reporting for himself. A 75-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number Ek9231/expiration date: not provided), via an unspecified route of administration, on 06Jan2021 at 10:00 AM (at the age of 75 years old) as a single dose in the arm for COVID-19 vaccination. Relevant medical history included prostate cancer and rheumatoid arthritis. The patient has a known allergy to sulphar. Prior to the vaccination, the patient was diagnosed with COVID-19, on an unspecified date. Concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06Jan2021, at 04:00 PM, the patient was lightheaded the first day with some sinus discomfort. The patient did not receive any treatment for these events. The outcome of the events lightheaded and sinus discomfort was recovering. Since the vaccination, the patient had not been tested for COVID-19.
Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and administered on 08-Jun-2022; Dose administered post the expiration or beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) and PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and administered on 08-Jun-2022) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003K21-2A and 034F21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 08-Jun-2022 at 10:25 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 08-Jun-2022 at 10:25 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and administered on 08-Jun-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) and PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and administered on 08-Jun-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and administered on 08-Jun-2022).    No concomitant medications information was reported.  Vaccines expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and administered on 08-Jun-2022.  The event did not cause the patient to seek medical care. There was not any other potential causes and  it was unknown if the patient experienced a similar event in the past.  It was unknown if patient was allergic to medications, food, and other products. It was unknown if the patient had ever been diagnosed with/ tested positive for COVID-19. Acute illnesses at the time of vaccination and up to one month before were unknown. Chronic or long-standing health conditions were unknown.  No treatment medications were provided.   This case was linked to MOD-2022-598063 (Patient Link).
20 min after injection; nausea & dizzy, lasted 30 hrs. Had dry heaves 1 hr. At injection, sore arm, some numbness in arm, cramping in hand, lasted 24 hrs. Had small knot where shot was given. Gone by 2/28/00. (1/28?).
Kindergarten shots were given on 4/26/04. Tuesday her left thigh was sore. That evening the leg was red and swollen. On 4/28 am the leg was much more red and swollen (on the left thigh) The area affected measured 17x12 cm. That leg had DTaP and IPV (her brother also developed a reaction. Treated with Augmentin and Benadryl
Client had first Pfizer injection on 3/24/2021. The client presented to the emergency department on 4/27 with a fever, generalized weakness, body aches, headache and right flank pain. She had lithotripsy and a right ureteral stent replacement the day before, 4/26. She is on ciprofloxacin. Urine Analysis was consistent with a UTI. Most recent positive urine culture grew out multidrug-resistant Klebsiella. The patient will be admitted to the hospital service for further evaluation and treatment.
48 hours after receiving vaccine, I woke up/washed my face, realized my left cheek was both swollen and sore. Felt like it was bruised. It didn't look swollen in the mirror, but I could see it was swollen in my peripheral view.  I had fillers in that area (on both sides) June 1, 2020. The swelling/soreness gradually went away over the next 2 days.
got Hiberix reconstituted with sterile water; got Hiberix reconstituted with sterile water; This case was reported by a other health professional via sales rep and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination were not reported. The reporter reported that one of their nurses found just the diluent vial for Hiberix without the powder vial in their fridge, and the only other vaccine they kept in that fridge was from Merck. So the reporter thought one of their patient's got Hiberix reconstituted with a Merck sterile water diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administration.  The reporter ran a report and they know that it was one of 8 patients who possibly received Hiberix mixed with the wrong diluent.  These patients were all in valid age groups for receiving Hiberix and they haven't had any reported side effects from the patients since receiving their Hiberix dose.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR243498:Same reporter
6 days after injection, left supraclavicular lymph node swelling and tenderness and axillary tenderness and swelling
AFTER GETTING HIS 1ST DOSE OF MODERNA VACCINE, PATIENT SAT IN THE OBSERVING AREA. AND WITHIN 2 MINUTES OF RECEIVING THE VACCINE, PATIENT HAD A SEIZURE LIKE SYMPTOMS FOR 1-2 SECONDS AND HE FELL OFF THE CHAIR.  HIS MOTHER WAS THERE TO CATCH HIM.  I CAME RUNNING OUT TO ASSIST.  HE REGAINED CONSCIOUSNESS ALMOST IMMEDIATELY AND REMEMBERED EVERYTHING THAT HAPPENED.  BUT HE TOLD ME THAT HE FELT VERY DIZZY.  I HAD HIM LAY DOWN ON HIS SIDE.  HE WAS ALSO SWEATY.  HE LAY ON THE FLOOR FOR THE NEXT 10 MINUTES, DURING THAT WHOLE TIME HE WAS ALERT AND AWAKE.  ONCE HE FELT BETTER AFTER  10 MINUTES LATER, HIS MOTHER TOOK HIM HOME.  WE DIDNOT HAVE TO CALL AN AMBULANCE FOR HIM.
Severe vertigo  Chiropractic care Symptoms temporarily alleviated. Return of milder symptoms 2nd week of July. (Dizziness, brain fog)
Soreness,  redness,  itching to injection site  Severe headache  Nausea,  vomiting and diarrhea  Symptom last  about 24 hours.
About an hour after the vaccines, she started jerking her arms and legs, and her eyes became glassy, then her body went stiff and her eyes rolled up. This lasted about a minute or two. She barely ate or slept the next weeks, and screamed like she was in pain for hours at a time.
site is about 3" round; It's also hot and warm to touch; hardness; site went red; swollen arm, a couple inches in diameter; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE INFLAMMATION (site is about 3" round), VACCINATION SITE WARMTH (It's also hot and warm to touch), VACCINATION SITE INDURATION (hardness), VACCINATION SITE SWELLING (swollen arm, a couple inches in diameter) and VACCINATION SITE ERYTHEMA (site went red) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE SWELLING (swollen arm, a couple inches in diameter). On an unknown date, the patient experienced VACCINATION SITE INFLAMMATION (site is about 3" round), VACCINATION SITE WARMTH (It's also hot and warm to touch), VACCINATION SITE INDURATION (hardness) and VACCINATION SITE ERYTHEMA (site went red). At the time of the report, VACCINATION SITE INFLAMMATION (site is about 3" round), VACCINATION SITE WARMTH (It's also hot and warm to touch), VACCINATION SITE INDURATION (hardness), VACCINATION SITE SWELLING (swollen arm, a couple inches in diameter) and VACCINATION SITE ERYTHEMA (site went red) outcome was unknown.        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.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Allergic reaction. Itching. Redness all over and joint/ muscle pain. I have been advised by vaccine provider to just take benedryl .  and contact vaers. Going on 72 hours since received shot
Asa result of dizziness the patient fell unwitnessed. Resident was sent to the ER with low O2 Saturation <90
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving covid vaccination. She died on 2/26/2022
Patient received 0.3 ml of undiluted Pediatric Pfizer Bivalent vaccine, we he was to receive adult Pfizer Bivalent, no adverse reaction reported
My shot was in the morning, early evening the injection side started to itch, it was very warm. The aching from the site spread down my arm and worked around to my underarm. Today it's still very warm. The dark pink color around the site is now about 4"x5". The aching has gone down underneath my armpit. My range of motion with that arm is limited. I can't raise it above my head.
26AUG93 20 mm area of inflammation; 31AUG93 30 x 35mm area of inflammation, nodular formations under skin;
Red raised hives to lower extremities.  Pt given steroids and Benadryl.  Physician diagnosed it as Serum Sickness.
Breakthrough COVID-19 case with  Muscle or body aches,  Cough (new onset or worsening of chronic cough),  Nausea or vomiting, Abdominal pain. Patient presented with nausea and vomiting of 2 days duration.  She developed generalized abdominal pain nausea loss of appetite and vomiting of ingested material since 2 days back.  She denies fever but has been having cough. She has chronic respiratory failure she is on 4 L of oxygen at home and has not noticed any change in shortness of breath denies any palpitation or chest pain. She states she is fully vaccinated against COVID-19. She continues to take her insulin and her last dose was this morning. Her last dialysis was on Saturday. Investigations in the ED revealed hyperglycemia with blood glucose level of 1296, sodium level of 117 and potassium level of 5.7. Bicarb level was 13 and anion gap was 22. WBC count was within normal range.  Chest x-ray showed bilateral opacities suggestive of volume overload vers
Minor pericarditis for several months.  Had to go to urgent care and then to ER to make sure it wasn't myocarditis. Symptoms tapered but possibly still persistent after 5 months.
Numbing of left arm around injection site, stiffness for 2-3 days. Itchy but did not scratch area. After 3 days or so swelling and stiffness gone. A week later very mild scarring/scabby near injection sight. Still visible as of 6/10/21 3:10pm.
Headache; This spontaneous case was reported by a physician and describes the occurrence of HEADACHE (Headache) in a 40-year-old female patient 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) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Redness, inflammation at the site of injection of about 2-3 inches in diameter.
After receiving the H1N1 vaccination in his Left deltoid, the student reported that his left hand was cold and his arm felt tingly and weak.  His grip strength was decreased in his left hand.  Pulses were equal bilaterally and his blood pressure was not significantly different in the 2 arms.
Pt had a recent traumatic left subdural hematoma.  Pt admitted for acute on chronic left traumatic subdural hematoma that is worsening.  Pt was tested for COVID and was positive, but asymptomatic.
arrhythmia; pain in my chest, in my heart; pain in my chest, in my heart; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9262) via an unspecified route of administration into the right arm on 11Feb2021 as single dose for COVID-19 immunisation. Medical history included glaucoma, diabetes, hypertension, cholesterol, diuresis, bone disorder, pain, back surgery and replaced right knee. Concomitant medications included atorvastatin (ATORVASTATIN) taken for cholesterol, furosemide (FUROSEMIDE) taken for diuresis, alendronate sodium (ALENDRONIC) taken for bone disorder, latanoprost (LATANOPROST) taken for glaucoma, sitagliptin (JANUVIA) taken for an unspecified indication, potassium (POTASSIUM) taken for an unspecified indication and celecoxib (CELECOXIB) taken for pain. On 11Feb2021, patient felt pain in her chest and in her heart. Patient underwent electrocardiogram (ECG) on 11Feb2021 and was told that she had arrhythmia. Patient was brought to the emergency room and was treated with Aspirin. Outcome of events was unknown.
pt recv vax 26AUG96 & 29AUG96 pt exp pharyngitis;this adverse event resolved on 10SEP96 & exp a full body rash; ER or MD visit was required;rash was treated unsuccessfully w/topical hydrocortisone but resolved spontaneously 5 days later;
Information has been received from a registered nurse concerning a female who on 06-JAN-2007 was vaccinated with a first dose of Gardasil (yeast) (0.5 ml), intramuscularly. On 06-JAN-2007 the patient had a lump at injection site. It was reported that one month later the patient still had lump at injection site. Unspecified medical assistant was sought. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 3/14/2007. The physician felt that the adverse event occurred due to "placement" versus the GARDASIL. The physician also mentioned to the nurse that the vaccine might have been administered "too far over on the leg". In follow-up, the registered nurse reported that the physician decided that the vaccine was given in an incorrect site in the thigh and confirmed that it was an administration error rather than a vaccine adverse event. Additional information is not expected.
At 8pm that same day of 11/06/2021 at 8pm, I got a pain in my left arm, it's been moving to my shoulder to my neck and arm. It makes it hard to chew to and I've had a horrible headache. I've been taking Tylenol and ibuprofen, about two or three times a day, depending on how bad the pain is.  I don't have insurance at the time, so I haven't seen a doctor. If it gets any worse, I'll go to an emergency room.
Information has been received from a pharmacist concerning an adult patient, who on an unspecified date, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) instead of a dose of zoster vaccine live (Oka/Merck) (MSD). Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
It started with chills around 4:00 PM. I became progressively more ill within the next few hours. By 6:00 PM I had severe chills, a fever of 102, muscle aches, loss of appetite due to nausea. At 4:00 AM I was awakened by a raging headache. The fever had subsided. My left arm (injection site) is quite sore. 24 hours after injection it remains sore, limiting mobility.
My mild-moderate hearing loss has IMPROVED! The tinnitus has changed timbre and does not overpower regular sound as much.
Feb 4th there were two red lumps that appeared  around  4p.m.  under the vaccination site on the left arm.  I did take a picture.    They continued to get larger, so  I took 100 mg of Benadryl that night.  The next morning both lumps were considerably smaller and not  as hot to the touch.  The following morning both areas were less warm to the touch and had reduced in size.  There was a minor rash. By 5:00 p.m. Feb 5th the two areas are considerably smaller and not as red.
I had a runny nose, a little bit of a cough, sneezing, low grade headache, my sinuses were congested and I had sinus pressure. I took a home COVID-19 test and it came back positive so I called my PCP who I was unable to talk to at that time. So I called  telehealth COVID-19, after we discussed my symptoms they called in a prescription of Paxlovid  I just took my last dose today, I am feeling better just a little tired with a bit of a runny nose.
This was my second dose - within 14 hours I experienced fever, body aches and headaches which lasted about 24 hours.  My menstrual period started  earlier than expected this month (LMP 2/1/21, vaccine 2/7/21 and menstrual period 2/22/21) I am always regular - never early or late and wonder if this is a side effect of the vaccine.
At 1400 I began to feel tightness in my chest. Tried to rest and woke up at 1430 with worsening symptoms. My throat was scratchy, very hoarse voice, felt like I had to try really hard to talk. Breathing was difficult, felt like I had something in my throat, but j did not feel my airway was compromised. I was able to talk it was just difficult and I sounded hoarse. Began to cough. Very dizzy. Took 25mg Benadryl. Did not improve, but did not get worse. Decided to go to the doctor and get some steroids. Got an IM injection of dexamethasone and methylprednisone. My voice was less hoarse and easier to breath within 3 hours.
Immediate chest tightness. 10 minutes in severe burning at on upper arm and pain. At same time entire stomach area, abdomen began with  intense itching. No hives, swelling or redness. Tachycardia present 139. sPO2 97, respiration?s 22.  Stayed in observation for 30 minutes, when  outside and in car left eyelid itching and now swollen.  When home Dyspnea began and itching and prickling sensation began systemically all over body. Took 25 mg. Diphenhydramine and  20 mg. Famotidine.  20 minutes later worse and now upper lip swollen and numb, facial puffiness, nose extremely swollen and red, neck swollen and upper chest red. Got Epi Pen and drove 25 minutes to ED. No issues with breathing, or swelling of throat, tongue or uvula.  BP 151/91, HR 112, respiration?s 18 at triage taken into ED and given 60 mg. po of Prednisone observed 4 hours. At 2 hours symptoms began to return to baseline, tachycardia resolved now 87. Discharged with 50 mg. Prednisone daily for 4 days, Diphenhydramine 50 mg. q6h for 13 doses and Famotidine 20 mg. bid x3 days. Referred to immunologist.,