chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was in the health COVID 19 clinic for his 1st dose Pfizer vaccine. Vaccine was administered and patient was sent to the observation area for a 15 minute wait. Upon arrival to the observation area he sat down in a chair and states that he " begin to feel dizzy and then blacked out". Patient was found on the floor by observation nursing staff. He was alert and oriented x4 and vitals were with in normal range. Vitals were as followed: BP 118/74, Heart rate: 79 and regular, 02 98 on room air. Patient was assisted to the emergency pod and he stated that "this happens all the time with needles, and plus I haven't had anything to eat this morning."  Gave the patient crackers and a coke monitored for 35 Minutes.
IPV given right deltoid. Developed 7 cm X 8 cm red hot firm . Left w/dark firm bruise. 7 cm X 8 cm post 7 days.  Malasie, experienced early increase in temperature. Mom reported this day # 7.
Approximately 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion; Poor quality vaccine administered; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Approximately 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Approximately 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Approximately 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Approximately 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    No concomitant medication was provided. Reportedly, the doses were administered before it was known if the vaccine was ok to use after the excursion.  No treatment information was provided.  This case was related to patient number 35 out of 77 patients.    This case was linked to US-MODERNATX, INC.-MOD-2023-696122.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Date of injection - fine. Next morning - shot area red - that afternoon, heavy breathing; 101.8 fever, weakness - (totally different reaction from shot #1 - where I got reappearance of shingles 3 more times in next 3 mo. In my left eye - 3 more times. Part I of SHINGRIX - given Oct. 2018 - same place - from Nov. thru Jan. I contracted shingles.
This is a spontaneous report from a contactable other health professional (patient herself).  A 32-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# El1284), via an unspecified route of administration on 30Dec2020 11:45 in right arm at single dose for COVID-19 immunization. Medical history included COVID from 15May2020 to an unknown end date. Known allergies was no. Other medications in two weeks included pantoprazole, cholecalciferol (VIT D3), ascorbic acid (VIT C), zinc, fish oil, curcuma longa (TURMERIC). The patient experienced mild cold like symptoms (runny nose and sore chest) 3 days after vaccine on 02Jan2021, blood spots on right abdomen, chest 3-4 days after vaccine in Jan2021. Constant headache for a week starting 5 days after vaccine on 04Jan2021 and elevated blood pressure, racing heart, and chest pain 5 days after vaccine on 04Jan2021. All events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included COVID positive on 15May2020. The patient had COVID test of nasal swab post vaccination and result with negative. Outcome of events were unknown. No treatment was received for events.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported bleeding cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Spontaneous hives on face, Associate does have a hx of spontaneous hives and has been seen by allergist. Had an episode in January, February, May and October of spontaneous hives. Hives noted 5.5 after vaccine and about 1.5 hours after taking Advil
Left arm, shoulder, breast area, back were all swollen, red and painful for 8 days. Fatigue and Fever for 24 hours.
blood clots in both legs; swelling in both legs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 15 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Jul2021 14:00 (Lot number: EW0198) at the age of 15 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: THROMBOSIS (caused and prolonged hospitalization, medically significant, life threatening) with onset 05Jul2021 13:00, outcome "recovered with sequelae", described as "blood clots in both legs"; PERIPHERAL SWELLING (hospitalization, life threatening) with onset 05Jul2021 13:00, outcome "recovered with sequelae", described as "swelling in both legs". The patient was hospitalized and prolonged hospitalization for thrombosis (hospitalization duration: 7 day(s)); for peripheral swelling (hospitalization duration: 7 day(s)). The events "blood clots in both legs" and "swelling in both legs" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of thrombosis, peripheral swelling. Clinical course: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No List of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and not tested for COVID-19 since vaccination. Once properly diagnosed after swelling in both legs had to undergo surgery to remove blood clots in both legs just in time before clots moved to his heart or brain. Surgery to rmove blood clots. The patient had no known allergy.
itching sensation and erythema. Treatment administered: Benedryl 50mg at 12:02PM. oxygen at 8L via non-rebreather
instead received Kinrix and Dtap; inadvertently received KINRIX, DOB: 22-OCT-2020; inadvertently received KINRIX; This case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 1-year-old female patient who received DTPa-IPV (Kinrix) (batch number H99J7, expiry date 26th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis and DTPa (DTaP vaccine) (batch number 23T73, expiry date 30th April 2023) for prophylaxis.   On 27th April 2022, the patient received Kinrix, Kinrix Pre-Filled Syringe Device and DTaP vaccine. On 27th April 2022, unknown after receiving Kinrix, Kinrix Pre-Filled Syringe Device and DTaP vaccine, the patient experienced accidental overdose, inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the accidental overdose, inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-Apr-2022 Reporter's comments: This case was reported by the Office Manager for medical office. The patient inadvertently received Kinrix. The patient was to receive IPV and Dtap, but instead received Kinrix and Dtap. The reporter did not have the doses administered or the site of the vaccine. The reporter gave consent for follow-up.  Additional Supportive Information: The patient was to receive IPV and Dtap, but instead received Kinrix and Dtap, which led to Inappropriate age at vaccine administration, wrong vaccine administered and accidental overdose of DTaP component.
This spontaneous report was received from two Licensed Practical Nurses (LPN), referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapy, drug and allergy history were not provided. On an unspecified date in January  2018 after 09-JAN-2018 (which had been previously reported as "between 03-JAN-2018 and 09-JAN-2018"), the patient was vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number M036057 (also reported as "N036057"), expiration date 18-MAY-2019 and ROTATEQ lot number N010709, expiration date 05-DEC-2018; (strength, dose, dose number and administration routes were not provided) for prophylaxis.  The vaccines were exposure to a temperature excursion; the data logger registered a temperature of 48 Fahrenheit (F) for 1 hour and 45 minutes. The previous temperature excursion registered was 35 F for 3 hours. No adverse effects were reported. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1801USA009769:
Patient caregiver called pharmacy explaining patient has left arm reaction (shingrix vaccine was given in this arm) of: orange-sized ball, warm to touch, red and swollen. They stated that the had marked the reaction site the day prior (9/3/2020) to calling pharmacy and the reaction site had grown by 3-4 inches since the mark was placed. Caregiver was instructed to take patient to Urgent Care/ER as soon as possible to be seen for reaction. Phone call was received 9/4/2020 at 10:47am to myself (who doesn't typically work at this facility). I decided to report incident since I was unsure if it could be allergic.
7 days p/vax pt had sore throat & swollen glands in neck 3 days p/sore throat rash appeared all over body; ankle pain started next day fever & chills, joint pain; seen by MD edema; lt knee & leg edema & noted nodules;
After my vaccination on 10/13/2022. I did not have any reaction. On 10/22/2022 I took a COVID-19 test that came back positive. I started to feel my nose becoming more congested. I then contacted my doctor and they did put me on Paxlovid that day. After taking Paxlovid within two days I felt that I no longer had a sore throat or congestion and on Day 3 I tested again and was negative. After that I have been negative since then.  I have been fatigued more than usual since.
Vaccine administered in (L) thigh 9/11/14. Mom reports erythematous, flat rash 5 hours later. This morning woke up with papular rash over right shoulder, scapula, flank. Scattered papules on abdomen and flank. Pruritic. No fever, irritability or change in appetite. No N/V/D.
Patient believes she had an allergic reaction; Hard chest pain; Difficulty breathing; Swollen arm; Itching; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Hard chest pain), DYSPNOEA (Difficulty breathing), PERIPHERAL SWELLING (Swollen arm), PRURITUS (Itching) and HYPERSENSITIVITY (Patient believes she had an allergic reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy.    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced CHEST PAIN (Hard chest pain), DYSPNOEA (Difficulty breathing), PERIPHERAL SWELLING (Swollen arm) and PRURITUS (Itching). On 13-Sep-2021, the patient experienced HYPERSENSITIVITY (Patient believes she had an allergic reaction). At the time of the report, CHEST PAIN (Hard chest pain) and HYPERSENSITIVITY (Patient believes she had an allergic reaction) outcome was unknown, DYSPNOEA (Difficulty breathing) was resolving and PERIPHERAL SWELLING (Swollen arm) and PRURITUS (Itching) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had certain food allergies, but not to medications. No Treatment information was provided. No concomitant information was provided
Started feeling real nauseous and fatigued. Nauseous let up a little after 2 hours. I drank pedialyte at times to stay hydrated. Slept the rest of the night. Woke up at 6:30am on 04/30/2021, still real fatigued and slight nauseous. Slept most of the day. Except to sip pedialyte and eat crackers. Finally feel better on 05/01/2021.
This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patient was vaccinated with ZOSTAVAX (dosing details were not reported) (unspecified lot/expiration date) . No information was provided regarding patient's concomitant medications. The reporter stated that the patient contacted the pharmacy on an unspecified  date and reported that they had "developed an unspecified rash on the left trunk as well as the arm the ZOSTAVAX was given in" the reporter did not know which arm the patient received the ZOSTAVAX in. The pharmacist reported that no treatment was provided at that time for the rash and the pharmacist advised the patient to follow up with their physician. The patient sought medical attention by contacting the pharmacy. The reporter stated that it is not determined if the patient has contacted their physician yet. The outcome of the event was not reported. The reporter did not provide the causality assessment between the event and the suspect therapy. There was no product quality complaint involved. Additional information has been requested.
This spontaneous prospective pregnancy report as received from a other health professional (registered nurse) refers to a female patient of approximately 29 years old age. Current conditions and medical history were reported as none. On 13-SEP-2014, the patient was vaccinated with (Merck) VARIVAX (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. Reporter reported that the patient received (Merck) VARIVAX and later found out she was pregnant. The patient became pregnant with approximated last menstrual period (LMP) of 18-JUL-2014 and estimated date of delivery (EDD) of 24-APR-2015 (calculated as per the gestational age which was reported as 9 weeks and 1 day). Estimated date of conception was 01-AUG-2014. Patient was exposed during first trimester. No lab diagnostics studies performed. No treatment was given. The pregnancy outcome was unknown. Patient sought unspecified medical attention. Product quality complaint was not reported. Additional information has been requested.
I had my first Moderna vaccine on August 13th. On August 21st, I developed a painful, red, swollen nodule about an inch in diameter at the injection site. Fairly deep on palpitation. It also had what looked like tiny red blisters on top. Today, 8-22-21, it is still painful and I have a headache.
SORE ARM; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, the batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers) dose was not reported, administered on 18-MAR-2021 10:30 in right deltoid  for prophylactic vaccination. Non-company suspect drugs included: paracetamol (tablet, oral, batch number was not reported) 500 mg, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On 18-MAR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 18-MAR-2021 22:30. This report was non-serious.
Nausea, headache, weak, lethargy, muscle and joint pain, still occurring 13 days after vaccine (began on day 3-4)
Towards the end of the night I woke up with a sore throat, runny nose, headache and flu like symptoms. I took cough pills to try and sooth my throat but that didn't work. The same day I went to go take a COVID test and it was positive so I quarantined and I was getting worse. I called my doctor and she thought it was a viral affection because I was having lung troubles and she prescribed me some pills (I cant remember the name) and it didn't work. When I went to check my oxygen it was below 80 and I called the ER and my oxygen was below 70 so I stayed in the hospital for 5 days and on oxygen for a month. After I was discharged from the hospital about a few weeks later I started to feel much better. They prescribed me with antibiotics, insulin and other pills and I took those as directed.
This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team, Program ID: Private. The reporter is the patient. A 65-year-old male patient received BNT162b2 (BNT162B2), on 18Aug2021 as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "I have asthma" (unspecified if ongoing); "I have bronchitis" (unspecified if ongoing); "I have COPD" (unspecified if ongoing); "the sickle lung disease" (unspecified if ongoing); "the genetic bone disease" (unspecified if ongoing); "chronic arthritis" (unspecified if ongoing); "chronic spinal cord damage" (unspecified if ongoing); "Osteoporosis head to toe" (unspecified if ongoing); "Rheumatoid arthritis" (unspecified if ongoing); "5 guard region in my leg" (unspecified if ongoing); "two blood clots in my left leg" (unspecified if ongoing); "I collapse lung" (unspecified if ongoing); "COVID collapse my lung and gave me 'actual' blood clot" (unspecified if ongoing); "headache" (unspecified if ongoing); "COVID" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ARTERIOVENOUS MALFORMATION (medically significant), outcome "unknown", described as "like AVM"; THROMBOSIS (medically significant), outcome "unknown", described as "blood clotting"; ILLNESS (non-serious), outcome "unknown", described as "1st shot made him sick and destroyed him"; CHILLS (non-serious), outcome "unknown"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "leg numb/hand numb"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; VOMITING (non-serious), outcome "unknown", described as "throwing up"; MIGRAINE (non-serious), outcome "unknown", described as "severe migraine"; ASTHENIA (non-serious), outcome "unknown", described as "weak". The patient underwent the following laboratory tests and procedures: White blood cell count: 2.3 (Low), notes: he had low white blood cells at 2.3. Therapeutic measures were taken as a result of thrombosis. Clinical course: The first shot made him sick and destroyed him. He mentioned that he was on the blood thinner (Unspecified Medication), no blood thinner because after getting the vaccine, he had blood clotting. When he first got the first shot, it gave him chills, it made his leg numb, it made his hand numb, and it made him dizzy. He was throwing up. He had like AVM, he had severe migraine, and he was very weak. He stayed in bed for 3 days. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-202201166692 same patient/drug, different dose/event.
General Malaise; fatigue; light nausea; light headache; dizziness on and off; blotchy red itchy rash on neck, chest, sides, and back; blotchy red itchy rash on neck, chest, sides, and back; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 25-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on right arm on 29Dec2020 at 01:45 PM at single dose for COVID-19 immunization. The relevant medical history included asthma and COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19?: Yes). Concomitant medications included emtricitabine, tenofovir alafenamide fumarate (DESCOVY), fish oil, vitamin b complex, lisdexamfetamine mesilate (VYVANSE), cetirizine hydrochloride (ZYRTEC), all from Dec2020. The patient experienced general malaise, fatigue, light nausea, light headache, dizziness on and off, several hours later blotchy red itchy rash on neck, chest, sides, and back, lasted for 3-4 hours, all on 29Dec2020 at 07:00 PM. The patient had the most recent COVID-19 vaccine administered at nursing home/senior living facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive treatment for the events. The patient had nasal swab test with unknown results on 30Dec2020. The outcome of the events was recovered with sequel.  Information on the lot/batch number has been requested.
KIDNEY STONE; UNABLE TO URINATE; HEADACHE; This spontaneous report received from a parent (mother) concerning her daughter, a 34 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Janssen series 1) (suspension for injection, route of admin not reported, batch number: 203A21A (also reported as 203AZ1A) expiry: 21-SEP-2021) dose was not reported, 1 total, administered to left arm on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the patient had a headache for about a week. In MAY-2021, the patient experienced kidney problems. She felt really sick one day with headache, stomach ache, back ache, and throwing up. The patient went to the emergency room which revealed a 5 mm kidney stone that was taken out the next day. The patient was hospitalized on an unspecified date. The patient had not urinated on her own since getting the kidney stone out. In OCT-2021 (about a month ago), she started urinating a little on her own. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 15-APR-2021, kidney stone in MAY-2021, and was recovering from unable to urinate. This report was serious (Hospitalization Caused / Prolonged). This case, involving the same patient is linked to 20211144980.; Sender's Comments: V0: 20211145488-covid-19 vaccine ad26.cov2.s- unable to urinate, kidney stone. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).