chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient was administered with DAPTACEL instead of Tdap with no reported adverse event; 37 YEARS OLD patient was administered with DAPTACEL instead of Tdap with no adverse event; Initial information received on 24-Aug-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 37-year-old male patient who was administered with diphtheria-15/ tetanus/ 5 AC pertussis vaccine [Daptacel] instead of Tdap (diphtheria, tetanus and acellular pertussis vaccine) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 18-Aug-2023, 37-year-old patient received unknown dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine, suspension for injection (batch number: C6013AA; expiry date: 05-Jun-2024) via unknown route in unknown administration site for Immunization instead of diphtheria, tetanus and acellular pertussis vaccine produced by unknown manufacturer (unknown formulation, batch number, expiry date) with no reported adverse event (wrong product administered) (product administered to patient of inappropriate age) (same day latency).   Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.   No additional information at the time of the report.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I am reporting my COVID 19 symptoms that I tested positive on 04/25/2022. My symptom are mild. I have sinus congestion, headache, had to urine a lot, occasionally cough and fever for the first day.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Metastatic breast cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset May2022, outcome "unknown", COVID-19 (medically significant) with onset May2022, outcome "not recovered" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Seriousness criteria-Results in death was reported as no. Seriousness criteria-Life threatening was reported as no. Seriousness criteria-Caused/prolonged hospitalization was reported as no. Seriousness criteria-Disabling/Incapacitating was reported as no. Seriousness criteria-Congenital anomaly/birth defect was reported as no. Did you/the patient previously receive a COVID-19 Vaccine was reported as yes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
patient did not experience any adverse reactions; administration of PROQUAD to patient who was only intended to receive VARIVAX; This spontaneous report was received from a certified medical assistant concerning a 16-year-old female patient. The patient's medical history, concurrent conditions, and concomitant medication were not provided. On an unspecified date, she completed a 2-dose schedule of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II).   On 04-AUG-2022, the patient was supposed to receive a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX), but instead she was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) for prophylaxis (dose, route of administration, injection anatomical location, lot # and expiration date were not reported) (Wrong product administered). The patient did not experience any adverse reactions (No adverse event).
Patient developed tingling in back of throat and back of tongue. No swelling, vomiting, trouble breathing, hives. Symptoms lasted about 1 hour, did not get progressively worse and seemed to resolve within 1-2 hours. No medication, treatment or intervention was needed.
An 87 yo patient was given two doses of FLUZONE- HIGH DOSE. One on 9/3/14 and one one 12/10/14.
Patient began to develop neurological symptoms approximately 10 months after receiving Zostavax. In May 2008 she was diagnosed with Amyotrophic Lateral Sclerosis. 7/14/08-records received-4/1/08-seen for C/O low back pain since 2004, increasing in severity and intensity over past 6 months since 9/07. Left lower extremity numbness, foot drop involving left ankle and foot for past 3 months. Feel weak. Numbness in toes. Blurred vision, unsteady, tingling. 6/30/08-DX with ALS.
72-year-old male who presents emergency room complaining increased shortness of breath.  He also has had increasing cough.  He reports that his symptoms started yesterday afternoon.  Patient states he has not had any fever at home.  He did have a temperature of 99.6° on presentation to the emergency room.  Patient has a history of severe COPD and is on 4 liters/minute of oxygen continuous at home.  His pulse ox on presentation to the emergency room was 87% and his oxygen was increased to 6 L. patient takes an aspirin daily 81 mg.  He also is on prednisone 20 mg daily and states that he has been on this for the past 6 weeks.  His pulmonologist is Dr.  He also is followed by Dr. Cardiology.  Will his chest x-ray tonight shows some by basilar stranding but overall does not appear much different than his previous chest x-rays.  The patient has had his initial COVID shots and has had 2 boosters.  He reports that he when out to eat at a restaurant approximately 1 week ago.  His COVID swab tonight is positive.  I have been asked to admit the patient due to an increased oxygen requirement.  On the patient is a retired respiratory therapist who worked at this facility.  PT IS CURRENTLY INPATIENT.
SARS-COV-2 (COVID-19) - PFIZER (12 years or older) 10/25/2021  no lot # documented presents with a fever and cough.has body aches and more fatiguedz, cough is somewhat worse but continues to be dry and nonproductive
Approximately 24 hours after receiving the vaccine. his left arm pit was sore. He woke up the next morning with a softball size lump under his left arm.  Took some Tylenol and applied ice to the lump.
Erythema multiforme (minor) developed the night after vaccines given, persist today. No other complications.
COVID-19 Lot # FE3590 Vial PAA165969 Exp 2/22 was placed in the freezer after we received it. It should have been pulled out of the freezer on 10/19/21 at 12:00PM according to the storage guidelines and placed in the refrigerator or 31 days.  Our staff did not pull the vial out of the freezer on this date. The staff noticed the date this morning, November 2, 2021 at 0830.  There were 22 patients who received the COVID vaccination during this time frame. The vials were pulled out of the freezer, thawed, and diluted per instructions during 10/19/21 through November 1, 2021. There are 27 vials that were not used and have been set aside to waste.
Pt came into office this morning for second GARDASIL injection. Pt now c/o HA, nausea, and dizziness.
Rash on forehead, Neck, Chest. Itching on forehead. General Fatigue. Low grade fever (99).
Vertigo; she fell; On first day she was about to faint, second day she was about to faint again; Pain went away; The initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 07Jul2021, this case now contains all required information to be considered valid.  This is a spontaneous report from contactable consumers from a Pfizer-sponsored program. A 96-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration on 22Jan2021 (at the age of 96-years-old) at dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 22Jan2021, on the first day, the patient was about to faint and on the second day, she was about to faint again; then on 26Jan2021, the patient fell. On 29Jan2021, they took the patient to an urgent care. CT of lumbar spine and pelvis performed on 04Feb2021 and thoracic spine and upper middle back scan performed on 10Feb2021 showed that nothing was broken. Therapeutic measures were taken as a result of the events. The patient had to have a caregiver because of her fall. Her second dose was due on 24Feb2021 and the reporter wanted to know if the patient should get it despite her current situation. On 13Mar2021, the patient started feeling better and the pain, which started from an unspecified date in 2021, went away. The event fall required emergency room visit but did not require hospital admission. The last week of Jun2021, the patient started having vertigo. The outcome of the event vertigo was unknown, recovered on 13Mar2021 for pain, and recovered on an unspecified date in 2021 for all other events.
pt was admitted to hospital from 1/4/22 - 1/11/22 with AHRF secondary to COVID pneumonia; treated with dexamethasone; acute on chronic kidney disease stage 4; pt was dc'd to home; per the death certificate, pt had a condition contributing to death of coronavirus and died at home
Arm pain for 2 days, head ache next morning for 2 hours, stomach ache at lunch lasted 2 hours, At 6 pm at night my temp went to 100.1 and the thighs of my legs felt like lead and was hard to walk lasted several hours. the lead legs have returned several times a week  through present 04/27/2021
My father had a reaction soon after the first dose in which he vomited violently. The vomiting continued over the next several months but less frequent along with dizziness and fatigue. On April 10 he was admitted to the emergency room with low hemoglobin numbers. Things quickly escalated from there. He was admitted to the ICU and diagnosed with autoimmune hemolytic anemia. After a month in the ICU, over 60 blood transfusions, 20 dialysis, multiple pharmaceutical treatments and a splenectomy, my father died on May 13.
sore left arm for a few days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm for a few days) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 019A21A) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery (quadruple bypass heart surgery,lost a lot of weight (57 lbs.) after the heart surgery) in April 2021. Concurrent medical conditions included Diabetes.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore left arm for a few days). At the time of the report, PAIN IN EXTREMITY (sore left arm for a few days) had resolved.            The caller stated that he felt like superman after receiving first and second doses.  In Apr 2021, patient experienced pain throughout his body and went to hospital and had a quadruple bypass heart surgery. Patient reported that he is having occasional feeling of fainting since the heart surgery and lost a lot of weights(57 lbs.)  Concomitant medications included prescribed medications for heart and diabetics.  Patient did not have any known drug or food allergies.  Treatment details were not provided.   This case was linked to MOD-2021-395844, MOD-2021-396362 (Patient Link).
Lt deltoid has large blister with multiple smaller blisters and erythematous area around blisters
Arm pain, rash (2 inch), fatigue, joint pain (shoulder on that arm)
ERYTHEMA AND SWELLING AROUND INJECTION SITE, SUBJECTIVE FEVER/CHILLS.
Elevated blood pressure. Doctor changed medicine to Lisinopril-Hydrochlorothiazide on  5/5/2021.
This spontaneous reprot as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ, orally, lot # K020181, expiration date 24-JUN-2015 (strength and dose were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as there was no consent to contact any physician.
12:00pm - immunization  6:00pm - aching in arm 8:00pm - fever and body aches, improved with Tylenol Next morning (12/21/2021) - all over body aches, felt feverish, took 1000 mg of Tylenol every 4 hours with some improvement 7pm - fever of 102.5 F with chills lasting about 2 hrs. Later I woke up covered with sweat.  Next morning (12/22/2021) - currently, low fever (99.4), body aches in arms and torso, severe headache.   The above reflects my CURRENT symptoms.
pt recv vax & 5 min p/vax site area became swollen & red;approx 3/4 in size;cold compress applied, DPH;no SOB, no wheezing;
I began developing idiopathic uritcaria with raised wheals across my entire body on September 20, 2022. I saw my dermatologist on September 30, 2022 who diagnosed me with dermatographia and recommended starting Allegra 180 mg and Zyrtec 10 mg daily with triamcinolone PRN. I have had little to no relief of itching with these medications. I continue to have severe reactions to pressure and scratching. I had no adverse effects from the prior 3 Moderna vaccines I received. I have not had recent increase in NSAIDs, increase in caffeine intake, or increase in stress.
Day 2 after injection right eye lid in right corner became painful and watery like a stye.  That night it woke me up through the night. It continued to get worse throughout the 3rd day after shot. That night it was crusted over and swollen over the entire lid.  Still painful, watery and inflamed
Severe neck pain - approximately 3 days  Joint pain - approximately 1 week headache - approximately 3 days
PT received his 2nd vax, anthrax vax on 3/1/03. He received it in right arm. On 3/2/03 he started to develop fatigue and the start of localized reaction to right arm. On 3/3/03 - he states that his right arm at the inject site was the size of a soft ball - red inflamed and tender and also itches. He states he felt very fatigued. He spent the next 2 days in bed resting. He did take some Tylenol and Motrin for right arm discomfort. He did contact the clinic and was informed to take oral Benadryl and warm moist heat pack. He did do that warm moist heat which took down the swelling. At this point in time, he states he 100% no fatigue his arm is not swollen, he does have a small induration at the inject site approx 1.5 - 2 cm x 10 cm. No erythema - minimal tenderness, no rated with palpation.
Breakthrough COVID-19 Case:  I started to have a slight bout of nausea, headache that was concentrated on the back of my head. I just remember feeling off. I did not take anything. My husband tested positive 2 days earlier so I decided to do a home rapid test and it came back positive 06/10/2022. I called my primary care physician to request the antiviral. I was given Paxlovid which I am still taking. I do experience a raw feeling in the back of my nasal passage. My symptoms are not too bad.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site tenderness in a 68-year-old female patient who received SHINGRIX for prophylaxis. On 10th September 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site tenderness. On an unknown date, the outcome of the injection site tenderness was recovered/resolved. It was unknown if the reporter considered the injection site tenderness to be related to SHINGRIX. Additional details were provided as follows: The reporter indicated that she has a consumer that received dose of the SHINGRIX vaccine and stated that the consumer indicated that the only adverse event she experienced was tenderness at the injection site. Did not consent to follow up. The field representative was unable to provide any additional information. This case linked with case US2019052087 and US2019GSK054969, reported by same reporter for the same patient.
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Contacted Covid; Contacted Covid; This is a spontaneous report from support programme Via a contactable consumer (Patient). A 57-year-old female consumer (patient) received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/ Lot number: Not reported) dose 2, Via an unspecified route of administration on Apr2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the Pfizer vaccine in April, both does. The patient now contacted Covid (SARS-CoV-2 test: positive) and vaccination failure occurred in Sep2021. He truly believes with getting vaccine, it kept her out of the hospital and even death. The outcome of the events were unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Pt was inadvertently given a booster dosing for their first moderna vaccination. After which, a second dosing  of 2.5ccs was given into the same arm to equate to a 5cc total dosing for their first shot.
This spontaneous report was received from a registered nurse referring to multiple unspecified number of patients of unknown age and gender. Pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB, lot # K021444 with expiration date 17-SEP-2016 and lot # K024552 with expiration date 22-OCT-2016, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effect were reported. This is one of the several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 60 year old female patient. On 23-JUL-2013 the patient was vaccinated with one dose of ZOSTAVAX (lot # J000434, expiration date 10-APR-2015) 0.65ml, subcutaneous. The patient was allergy to cephalosporin. There was no concomitant medication and no medical history. On an unknown date in July 2013 (a couple days after vaccination) the patient developed a rash and "what looks like shingles". The patient saw physician on 27-JUL-2013, and was prescribed unspecified antiviral medication. The reporter did not know whether the patient was diagnosed with shingles or if the rash is still present. Additional information has been requested.
Narrative: COVID infection following COVID vaccine series 05/03, Pfizer, dose #1 05/24, Pfizer, dose #2 05/27 CXR result: Essentially normal. 07/13 NASO PCR result: RSV detected 08/24 pt cc: No symptoms exposure: unknown 08/24 COVID swab, result: detected
Injection site area is a few inches out like a "balloon shape" ; rash; redness in the injection site; itching around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching around the injection site), RASH (rash), VACCINATION SITE ERYTHEMA (redness in the injection site) and VACCINATION SITE SWELLING (injection site area is a few inches out like a "balloon shape") in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itching around the injection site). On 11-Jan-2021, the patient experienced RASH (rash) and VACCINATION SITE ERYTHEMA (redness in the injection site). On 27-Jan-2021, the patient experienced VACCINATION SITE SWELLING (injection site area is a few inches out like a "balloon shape"). At the time of the report, VACCINATION SITE PRURITUS (itching around the injection site), RASH (rash), VACCINATION SITE ERYTHEMA (redness in the injection site) and VACCINATION SITE SWELLING (injection site area is a few inches out like a "balloon shape") had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Swelling and redness at the site of injection with severe pain. Difficulty in moving the arm.  This lasted for 14 days. Fever between 100 to 102 F lasting for 10 days. Symptoms started on the night of injection of vaccine
Received unstable vaccines after a temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 65-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 05-JAN-2023, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incorrect storage of drug (Verbatim: Received unstable vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 14-APR-2023 The patient who received unstable shingles vaccines after a temperature excursion. The reporter stated that all the vaccines were administered, lot numbers, administration dates and patient involved. The reporter provided the consent for a follow up via email by safety team. The patient who received unstable shingles vaccines after a temperature excursion, which led to incorrect storage of vaccine. This was 1 of 3linked  cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter