chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Route was intended to be IM.  Upon assessment by this RN, injection was given below deltoid.  Employee (patient) reports needle had been inserted one half or less by staff member, then injected.  Appears to have been administered SQ.  Employee (patient) reports swelling, pruritis,  and erythema to injection site.  Reported to this RN 12/11/2019 at 0930.  Denies any worsening of symptoms since increased erythema early this morning.
parent falsified date of birth on registration form to appear that child was 12 years old. as of this time, no known adverse event occurred.
Approximately one hour after the vaccine was administered, patient went home from work ill. His skin became very dry, and a large rash with large red blisters/welts with clear liquid presented itself. Evidence of rash is still present today.
Pt presented with SOB and leg swelling and found to have RLE DVT. He was admitted and started on anticoagulation
My son experienced severe bruising about one week later after receiving his Pfizer vaccine. My son right arm was very sore as well. He also had little bumps, petichae all over his body.  He still has the bruising and he had a sore, scab where he fell down before the vaccine and he could not stop the bleeding at the site. I took him to ER, performed a complete blood work and platelet count. On 06-22-2021, his platelet count had dropped to 15,000.  The ER did not admit him and we had to go back to the ER last Thursday 06-24-2021 and his platelet count 13,000.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Mvp" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Rash - started with large spot (looked like a burn) on back of right shoulder near the neck, within 2 weeks several other spots developed on chest, within 4 weeks spots covered much of chest, abdomen and back and spread to arms and legs but concentrated on back and abdomen. Spread is continuing (as of 5/29/2021) but initial spots are receding. Doctor diagnosed as Pityriasis rosea and should clear in 2-3 months. Triamcinolone Acetonid Ointment 0.1% and Betamethasone Dipropionate Ointment 0.05% prescribed to aid in healing.
Day of shot, about an hour later: Slight tingling in cheeks/sinus area, slight numbness in lips. Brain fog. Numbness/tingling in fingers of injection arm. Mild pain/tightness in chest above right breast.  Day after shot: Red rash at injection site; worsened within 5 hours, arm soreness worsened as well.
Experienced Pruritus, redness, skin irritation, hives on bilateral arms, chest, hands Treated with Diphenhydramine 12.5 mg IV, Pepcid 20 mg IV, SoluMedrol 125 mg IV, Normal Saline x 1000 ml
Patient reported to her previously scheduled dr appointment for an ear ache even though symptoms had cleared. At her appointment which was two days following her vaccination her blood pressure was found to be 173/126. Her previous high for bp was 115/78. She had an EKG which was normal and had labs preformed for troponin both of which appeared  normal. She was treated in the ER for hypertensive crisis.
This spontaneous report received from an office manager who is also a medical assistant refers to a 74 years old female patient. The patient was inadvertently vaccinated with a dose of GARDASIL on 03-AUG-2012. No symptoms reported. This is one of two reports received from the same source. Additional information has been requested.
received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired vaccine) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Dec-2021 at 3:39 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 17-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired vaccine). On 17-Dec-2021, EXPIRED PRODUCT ADMINISTERED (received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not reported.  Treatment medications was not reported.  Vaccine expiration date was 24 Oct 2021.   Most recent FOLLOW-UP information incorporated above includes: On 17-Dec-2021: Follow up document received included  ID confirmed and document contains Non-significant information.
Patient is a 77 y.o. male with PMHx of GERD, DM with neuropathy, afib, BPH, bipolar, depression, dementia, septic left prostehtic knee who presented to ED last night following progressively worsening symptoms of fatigue and SOB.  Pt reports 4 days ago noticing his LE becoming edematous.  Hx of diabetic neuropathy to LE causing pain.  Edema progressed into thighs over next 2-3 days with worsening fatigue.  Began feeling palpitations.  Yesterday began developing orthopnea that was worsening and presented to ED.  Found to have mildly elevated BNP, CXR c/w edema, and atrial fibrillation with RVR and rate into 130s.  He was admitted for treatment.  Has been started on cardizem.
Developed severe petechiae on hands within 30 minutes following vaccination.  Developed headache and muscle pain within 6 hours following vaccination.
Approximately 24 hours post immunization, swelling, fever, redness measuring 4-6" across injection site extreme pain at site (RA). Full body fever and sweat/chills the night before presented to immunization for follow up.
seasonal allergies - takes zyrtec & metoprolol;   HX: anxiety, tightness to forehead / sinusis.
No adverse effects reported; was vaccinated with an improperly stored PROQUAD; This spontaneous report was received from a medical assistant, regarding an 8 year old female patient. The patient's illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were not reported. Concomitant medications included "FW".  On 20-SEP-2019, the patient was vaccinated with an improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) intramuscularly (IM), (dose, dose number and location of administration were not reported) (lot # S012472, expiration date 20-OCT-2020), for prophylaxis. The patient was vaccinated at a private doctor's office hospital and the vaccine was purchased with public funds.  The vaccine was exposed to a temperature of 25.61 degree Celsius from 19-AUG-2019 to 02-OCT-2019 as recorded by a digital data logger. There were no previous temperature excursions, however on an unknown date, the vaccine was exposed to a temperature from 9 to 25 degree Celsius (25.4 degree Celsius) for a time frame of 8290 hours and 30 minutes as recorded by a digital data logger. No adverse effects were reported.   This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1910USA012352: US-009507513-1910USA007637: US-009507513-1910USA012351: US-009507513-1910USA012240: US-009507513-1910USA012349: US-009507513-1910USA012360: US-009507513-1910USA012356: US-009507513-1910USA012355: US-009507513-1910USA012357: US-009507513-1910USA012350: US-009507513-1910USA012353: US-009507513-1910USA012354: US-009507513-1910USA012358: US-009507513-1910USA012359:
This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (vaccine given 6 days post expiry) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 046C21A) for COVID-19 immunization. No medical history reported. On Dec 30, 2020, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 12, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 12, 2021, patient administered expired product (vaccine given 6 days post expiry). On Nov 12, 2021, administered expired product (vaccine given 6 days post expiry) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. This case was linked to MOD-2021-395985 (patient link).
This case was reported via a literature article regarding a case in litigation. The parents of a child diagnosed with an autism-related condition had evidence of developmental problems in time to meet the Vaccine Act's three year statute of limitations, Vaccine Court special master ruled in a decision released on May 5th. The special master said that the petitioner's (patient's parents) expert was correct to criticize the government's "myopic focus" on the patient's speech delay as the event triggering the Vaccine Act's three year statute of limitations given that there was no speech regression. However, the special matter could not agree with him that no other symptoms were present to signal onset of PPD NOS, he said that the patient's trouble, from early as his four month visit, in meeting developmental milestones in more than one category could be seen as a developmental delay that was pervasive in its reach. Moreover, in a phone call made in October 2004, the patient's mother communicated to a physician about behaviors that the patient was exhibiting which led the physician to suspect autism. The thorough evaluation on 08-OCT-2004, demonstrated that the patient's symptoms were certainly not limited to speech delay: It was repeated throughout the histories given to evaluators by the patient's mother, that the patient had begun to have more frequent temper tantrums, and that even though she "was not that worried" about the speech delay, she was concerned about behavioral problems that had arisen (temper tantrums). The special master acknowledged "obtuse and bedeviling" language in the controlling case, which defined the vaccine Act's specification of the first symptom or manifestation of onset as the first event objectively recognizable as a sign of a vaccine injury by the medical profession at large. The patient's parents had argued that, given autism is not recognized by the medical profession as a vaccine injury, the statute, should be more liberally construed. That line of argument was rejected. The crucial date was 09-OCT-2004, three years before his parents, filed their short form autism petition. According to the special master, the patient, 7 years old at the time of this report, received DTAP; poliovirus vaccine inactivated (unspecified); MMR II; Hib conj vaccine (unspecified carrier) (manufacturer unspecified); hepatitis B virus vaccine rHBsAg (manufacturer unspecified); varicella virus vaccine live (Merck) (manufacturer unspecified) and pneumococcal 23v polysaccharide vaccine (manufacturer unspecified) in several doses, between 09-DEC-2002 and 16-APR-2004, when he was approximately 18 months old. The patient parent's representatives were provided. Upon internal review autism was considered another important medical event. No further information is available.
Eight hours after injection arm became very sore and four to five hours later became sick vomiting all night...no fever or chills.  The following day was very tired. By evening back to normal
allergic reaction; hives and itching in the administration site; hives and itching in the administration site; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient asked for information if she should be administrated with the second dose of the Pfizer's COVID-19 vaccine if she developed side an allergic reaction to the first dose of the vaccine. The patient reported that after the first dose of the Pfizer's COVID-19 vaccine she had hives and itching in the administration site on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Arm swollen, red, painful down arm. Had MRI, no blood clot. On antibiotics.
About a week after vaccination I noticed fingernail changes in 3 nails where the nail was starting to turn white/detaching from the nail bed.  The skin on my left pinky finger also turned rough and slightly red.  This slowly spread and is now affecting all but one of my fingernails   Fingernails are about halfway detached.   3 doctors were not sure and one prescribed clobetasol liquid.  Slight improvement on the pinky finger skin but returned when stopped.  Dermatologist at local dermatology office On 10/27/21 diagnosed me with psoriasis of the nails.  And has now suggested prescription Taltz. Which I have yet to start.
DUE TO A CLERICAL ERROR, PATIENT RECEIVED DOSES OF SEASONAL INFLUENZA, IPV, HEPATITIS A,  HEPATITIS B, DTAP & POLIO 15 DAYS AFTER RECEIVING THE SAME VACCINES AT ANOTHER CLINIC
Headache, severe bodyaches, chills/leg shaking violently because I am so cold, unclear thinking, pain and swelling and injection site.  The most severe symptoms so far set in at 3 AM and I won?t be able to work tomorrow.  This is much more intense than COVID-19 was. I don?t plan to get vaccinated again if this is what I have to go through every time.
Information has been received from a published article, title as stated above. This literature case was initially reported on 29-MAR-2010. This article concerned 32 patient's (8 male and 24 female) aged between one to 57 years (mean age of patients was 29 years). The patients received a RECOMBIVAX HB, manufacturer, batch number, route and site not reported, on unreported dates. This report concerns patient #11 of 32, a 11 year old male. On an unreported date between 1982 and 2009, one to fifteen days post vaccination, the patient experienced uveitis (mean time to onset of three days). The uveitis was reported to occur after the first vaccination in 15 patients, after the second vaccination in three patients and after the third vaccination in three patients. The duration of the uveitis was not reported for nine patients. One patient had recurrent uveitis after the first and second doses of vaccine. One patient had recurrent uveitis after both the second and third doses. Patient outcome had not been reported. An 11 year old male on an unspecified date was vaccinated with his second dose of RECOMBIVAX HB (lot number, route and site not reported). There was no concomitant medication. Two days after vaccination, the patient developed uveitis. At the time of the report, the patient's outcome was not reported. The authors stated the RECOMBIVAX HB may have a possible association with the development of uveitis in some patients. Immune complex deposition and adjuvant effects are potential pathogenic mechanisms. Uveitis was considered to be an other important medical event. Other business partner numbers include E2010-02312. Additional information has been requested. The article also discussed the experience of an additional 31 patients while on therapy with RECOMBIVAX HB (WAES #1004USA01716, WAES # 1004USA02327 to WAES # 1004USA02335, WAES # 1004USA02337 to WAES # 1004USA02357). A copy of the published article is attached as further documentation of the patient's experience.
I received my 2nd booster shot on 06/04/22. I was positive for shingles on 07/01/2022.  06/29/2022 on Wednesday evening  I had rash on my back and nerve pain. My doctor prescribed me an anti viral medication for 10 days. I still have rash on my back and nerve pain at night but i am recovering from it.
Developed psoriasis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2021 as dose 2, single (Lot number: ER6207) at the age of 50 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Lamisil, reaction(s): "known allergies Lamisil", notes: known allergies Lamisil. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: ER6207, Location of injection: Arm Left), administration date: 21Mar2021, when the patient was 50-year-old, for Covid-19 immunization. The following information was reported: PSORIASIS (non-serious) with onset 25Apr2021, outcome "not recovered", described as "Developed psoriasis". The event "developed psoriasis" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of psoriasis.  Addition information: Other vaccine in four weeks was none. Other vaccine in two weeks was none. Covid prior vaccination was none. AE treatment was received included Tropical Medicine. The patietn recieved the first dose of BNT162B2 (Lot Number: ER8734 as reported) on 21Mar2021 on the left arm for COVID-19 immunization.
Tired; legs and arms felt sore; mild headache; fever 101.1; chills; This is a spontaneous report from a contactable pharmacist (patient). A 43-year-old female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand=Pfizer, lot number=EK9231) on 10Jan2021 03:30 PM (vaccine location=Left arm, dose number=2) at single dose via unknown route of administration for unknown indication. Medical history was not reported. Concomitant medications included ibuprofen (MOTRIN); vitamins NOS (MVI); calcium carbonate, colecalciferol (OSCAL D); vitamin c. Historical vaccine included patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand=Pfizer, lot number=Ek5730), on 19Dec2020 03:15 PM, (vaccine location=Left arm, dose number=1) via unknown route of administration at single dose for unknown indication. There were unknown allergies. Patient did not receive other vaccine in four weeks. Patient did not have covid prior vaccination and did not have covid tested post vaccination. Patient experienced Tired, legs and arms felt sore, mild headache, fever 101.1, chills on 11Jan2021 01:30 PM. Patient did not receive any treatment. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Narrative: Pt is a 81 y/o male with a PMH of CAD, HTN, and HLD. Pt was administered the first dose of Pfizer COVID-19 3/26/21. Pt never followed up for the 2nd dose. Pt expired 5/26/21. Cause of death unknown
Patient suffered a seizure approximately one hour after immunizations were given. Patient was evaluated in emergency dept. and discharged after 5 hours of monitoring post seizure activity.
Pt vaccinated with MMR experienced skin cold, sweaty, thirsty, weak, BP 80/60, pulse 56; Rx Benadryl.
pt recv vax 22JAN97 & 48hr p/vax pt devel a hard & distended abd, discomfort when sitting down, & tenderness in the liver area;
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 21Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 30Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 09May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history or no known allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Negative; (Dec2022) Negative; (Dec2022) Negative; (Dec2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 for which included PF-07321332, ritonavir (PAXLOVID) 17Dec2022 to 21Dec2022. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Gout flare up in  Thumb. Never had Gout there before but do have take medicine to control gout. Alopurinol daily.  Took extra gout medicine and pain subsiding. Still swollen and tender at this time.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 16-JAN-2014, the patient was inoculated at a clinic with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. Zoster vaccine live (ZOSTAVAX) did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 13-JUN-2016, the patient was treated by a physician for a severe vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed tramadol, valacyclovir, and oxycodone-acetaminophen for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. The outcome of the events is unknown. Additional information has been requested.
Lack of appetite and then wouldn't drink anything. Then starting around 7:00 AM I was awaken to my son vomiting, then diarrhea, lying around the house not wanting to do anything, not wanting to eat or drink. Today on 6/24/13 he still has the diarrhea, not wanting to eat, or drink. This is what happens when he gets shots. Also we have 8 kids and none of them are sick.