chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received 4 year old vaccines on 8/15/2023. On 8/16/23 mother reported red swollen arm on left side where dtap/ipv was given. Also patches of rash on left arm, one by shoulder, one by elbow, and two on forearm. I recommended mom to apply cool compresses to the red swollen area on the upper arm. I also recommended her to report to the primary dr. I would follow-up with mother in a few days. As of today mother reported patient still has some patches that look like a scar, red and patchy, but looks better then first day. Mother followed-up with doctor and he recommeneded keeping an eye on areas of rash and it was caused by the vaccines.
Cough, chills without fever, redness around site 1.5 inches across, nausea, headache
This spontaneous report was received from a physician refers to a patient of an unknown age. The patient's medical history and concomitant medications were not reported.  On an unknown date the patient received a dose of PROQUAD and then received a dose of VARIVAX (Dose, frequency, route and lot# were unknown) for prophylaxis instead of PREVNAR 13 (Wrong drug administered). It was unknown if VARIVAX was administered in error due to product confusion.
extreme fatigue; malaise/feel sick; the bottoms of my feet hurt so it's hard to walk; the bottoms of my feet hurt so it's hard to walk; This is a spontaneous report from a contactable other hcp (Patient). A 49-year-old female patient received bnt162b2 (Pfizer), dose 1 via an unspecified route of administration, administered in Arm Right on 26Mar2021 13:15 (Lot Number: er8733) as single dose for covid-19 immunisation at the age of 49-year-old. The patient was not pregnant at time of vaccination. Medical history included herniated disc (l5-s1) and back pain from an unknown date. No known allergies. The patient's concomitant medications were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient experienced extreme fatigue and malaise/feel sick, the bottoms of feet hurt so it's hard to walk on 28Mar2021 with outcome of not recovered. The events were considered serious as disability. The events resulted in Doctor or other healthcare professional office/clinic visit.  The clinical course was reported as follows: I am having extreme fatigue and malaise. Prior to receiving the vaccine I had NO health issue other than back pain, but now I have extreme fatigue, the bottoms of my feet hurt so it's hard to walk, (and I'm fit) and I feel sick ALL OF THE TIME.  Follow up needed, further information has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on temporal relationship. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Headache, Myalgia, Arthralgia, Fever, Chills, Tiredness Narrative:
Accidentally given nasal mist H1N1, and is pregnant. Left clinic with no complaints. T/C x 2 - no answer.
tooth extraction that became infected; whole left side face is swollen; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH INFECTION (tooth extraction that became infected) and SWELLING FACE (whole left side face is swollen) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 039A21A) for COVID-19 vaccination.     The patient's past medical history included Oral surgery (Oral surgery after first dose of vaccine). Concomitant products included METRONIDAZOLE (FLAGYL 250) and CLINDAMYCIN for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced TOOTH INFECTION (tooth extraction that became infected) and SWELLING FACE (whole left side face is swollen). At the time of the report, TOOTH INFECTION (tooth extraction that became infected) and SWELLING FACE (whole left side face is swollen) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No treatment information was provided    This case was linked to MOD-2021-126496, MOD-2021-126496 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: VAERS
Breakthrough case admission after three vaccines MOderna 2/1/21Lot031L20A;  Moderna 3/29/21 LOt# 007B21A;  Pfizer 1/5/22 Lot#FF2593
Moderna COVID 19 Vaccine EUA: 3 of 4 vials used to administer booster doses were punctured 21 times, instead of the max limit of 20. Vaccine storage, handling and draw were all performed with integrity. Vaccine was stored between 2 degree C and 8 degrees C until time of draw. Each vial was drawn with sequential punctures, and batched for administration. Syringes and vials were inspected prior to moving to administration table. No defect identified. Each of 3 vials where 21st dose was extracted, has all 21 doses extracted within 15-20 min.  It is not known if any patient received any of the 3 "21st' doses". 29 Patients were identified as receiving a booster dose from one of the 3 vials, where a 21st dose was drawn. However, we are not able to verify if any of these 3 "21st" doses were in fact administered.
Crazy itchiness yesterday on arm (left arm, where vaccine was given), and back. Red circular rash on left arm, still itchy on my back. Foregoing treatment today (I have a high-deductible health plan, so would end up paying full price to see my PCP),  am monitoring, itching.
PATEINT RECEIVED BOTH DOSES OF MODERNA AND GOT INFECTED WITH COVID-19 VIRUS MORE THAN 14 DAYS AFTER COMPLETING THE SERIES.
31DEC93 3 hrs p/inject achey esp in joints that same evening sx worse inc chills & achiness; felt poor over the weekend; sx pretty much gone by 3JAN94; c/o heavy red rash & diarrhea;
Patient received a dose of Pfizer COVID-19 Vaccine Pediatric formulation (5-11yr) that may have been reconstituted with a single use vial of 0.9% NS that was entered into multiple times to reconstitute other vials of Pfizer vaccine. Staff did not realize the 10mL vial was for single use only (to take out 1.3mL then discard). Each time the vial was used it was swabbed with alcohol and a new syringe was used to enter the vial then to add the diluent to the Pfizer vaccine for reconstitution. The 10mL, 0.9% NS vial was disposed of at the end of each day. The patient did not experience any adverse reaction. At the recommendation of Pfizer and the CDC, due to lack of stability data, it was advised to revaccinate the patient.
found dead; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (found dead) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetic.    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)) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported. It was reported that patient got the booster shot found dead morning.  Company comment: This spontaneous case concerns a male patient of unspecified age with no reported medical history, who experienced the fatal unexpected serious (Death) event of Death that occurred on unspecified day after receiving a dose of mRNA-1273 bivalentBA4/5 vaccine in the COVID-19 vaccination series. It was reported that patient got the booster shot found dead morning. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.   No information on detailed clinical course, concomitant medication and treatment of the event was available in the report. The benefit-risk relationship of mRNA-1273 bivalentBA4/5 is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient of unspecified age with no reported medical history, who experienced the fatal unexpected serious (Death) event of Death that occurred on unspecified day after receiving a dose of mRNA-1273 bivalentBA4/5 vaccine in the COVID-19 vaccination series. It was reported that patient got the booster shot found dead morning. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.   No information on detailed clinical course, concomitant medication and treatment of the event was available in the report. The benefit-risk relationship of mRNA-1273 bivalentBA4/5 is not affected by this report.; Reported Cause(s) of Death: unknown cause of death
4 days after second dose Dizziness nausea diagnosed with vertigo seen in ER; 4 days after second dose Dizziness nausea diagnosed with vertigo seen in ER; 4 days after second dose Dizziness nausea diagnosed with vertigo seen in ER; This is a spontaneous report from a contactable nurse (reporting for herself). A 35-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EL3302), at age 35 years, via an unspecified route of administration on the left arm, second dose on 29Jan2021, at single dose, for COVID-19 immunization. Medical history included breast feeding from an unknown date and unknown if ongoing, and COVID-19 on unspecified dates diagnosed prior to vaccination. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. The patient's concomitant medications were not reported. The patient previously took BNT162B2 on 08Jan2021 at age 35 years for COVID-19 immunization. On 02Feb2021, 4 days after the second dose, the patient experienced dizziness, nausea and was diagnosed with vertigo when seen in ER. The adverse event resulted in emergency room/department or urgent care visit. Treatment received for the adverse event includes IV fluids and meclizine.  Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was at a hospital. The outcome of the event was recovering/resolving. Case was reported as non-serious.
Information has been received from a physician via a company representative, concerning a 16 year old female who on approximately 02-Dec-2006 was vaccinated IM in the left arm with Gardasil. After receiving the injection, the patient went to school and later during the day, she got very dizzy "that she almost passed out.". She also developed a red rash and bumps all over the site of the left arm where the dose was administered and had to go home. Subsequently, the patient recovered. The patient sought unspecified medical attention. Additional information has been requested. This is in follow-up to report(s) previously submitted on 3/14/2007.  Initial and follow up information has been received from a physician, concerning a 16 year old female patient who at 3:15 pm on 29-NOV-2006 (previously reported as approximately 02-DEC-2006) was vaccinated with 0.5ml, IM in the right deltoid (previously reported as left arm), with the first dose of GARDASIL (lot # 653736/0868F).  There was no known illness at the time of vaccination.  After receiving the injection, the patient went to school and later during the day, she got very dizzy and "felt like passing out."  She also developed a red rash and bumps all over the site of the left arm where the dose was administered and had to go home.  Follow up information from the physician added that on approximately 30-NOV-2006, the patient also experienced a light edema and itching.  The patient was treated with (ZITHROMAX Z-PAK), and subsequently recovered (date not specified).  No further information is available.
This spontaneous report was received from a nurse concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 26-MAR-2018, the patient was vaccinated with M-M-R II lot # M011667 with expiration date of 08-MAR-2018, for prophylaxis (dose, route of administration and anatomical location were not reported). No adverse effects were reported.
Began experiencing vertigo early this afternoon.  I've had it worse but haven't had it at all for years.
Information has been received from a registered nurse referring to 7 unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were unknown. On unspecified dates, the patients were vaccinated with improperly stored PEDVAXHIB (dose and route unknown, lot # M027883, expiration date: 15-APR-2019). No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.
ACUTE HYPOXEMIC RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE AND CHRONIC POSTTRAUMATIC RESPIRATORY FAILURE, UNSPECIFIED TYPE
Symptoms- light headed, stomach cramping  Vitla signs- BP- 160/90, P- 98, 02 sat- 98 Pt was discharged by physcian, Pt stated that she feels fine and less anxious.
REDNESS NOT REALLY LIKE LAST TIME, SLIGHTLY SMALLER; LITTLE BIT PAIN UNDER THE ARMPIT; REDNESS; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (REDNESS), ERYTHEMA (REDNESS NOT REALLY LIKE LAST TIME, SLIGHTLY SMALLER) and AXILLARY PAIN (LITTLE BIT PAIN UNDER THE ARMPIT) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3001177) for COVID-19 vaccination.     Concomitant products included CANDESARTAN for Hypertension, CEFUROXIME (FURIX [CEFUROXIME]) for Leg edema, OMEPRAZOL [OMEPRAZOLE] for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced ERYTHEMA (REDNESS). On 29-Mar-2021, the patient experienced AXILLARY PAIN (LITTLE BIT PAIN UNDER THE ARMPIT). On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ERYTHEMA (REDNESS NOT REALLY LIKE LAST TIME, SLIGHTLY SMALLER). The patient was treated with PARACETAMOL (ALVEDON) on 29-Mar-2021 at a dose of UNK, bid. On 29-Mar-2021, AXILLARY PAIN (LITTLE BIT PAIN UNDER THE ARMPIT) had resolved. At the time of the report, ERYTHEMA (REDNESS) had resolved and ERYTHEMA (REDNESS NOT REALLY LIKE LAST TIME, SLIGHTLY SMALLER) had not resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
7 days after injection, the area around the site became very red and kind of hard - I googled it and it looked just like what is being called Covid Arm
3 inch in diameter red welt appears at place of injection. Getting bigger every day. Warm to the touch. Aching arm.
The doctor inadvertently gave a dose to an 8 month old who never had any dose before this.; This spontaneous report as received from an office manager concerning to an 8-month-old male patient.      The patient's concurrent conditions, medical history, previous drug reactions, allergies and concomitant therapies were not provided.  On 12-JUL-2019, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (strength, dose and frequency were not reported), lot # R021650 and expiration date 27-MAY-2020, for prophylaxis. The patient had never received a rotavirus vaccine, live, oral, pentavalent (ROTATEQ) before this dose. The patient's mother was made aware that if she noticed diarrhea or vomitng, to take the child to the emergency room.
Swollen area Right thigh 1 x 1.5 cm red area > left thigh 1 x 1.5 cm sl. pink. Temp 101. TYLENOL TID & ZYRTEC 3 ml BID x 3-4 days.
After waiting in the Pharmacy waiting area for 15 minutes, the patient went to his car.  Then his wife called to notify us that he was experiencing leg numbness and vomiting.  Wife then promptly called 911.  Wife later reported that patient had blacked out and was with EMS.
1/4- Injection - Lt deltoid 1/5- Fever 100.9, Severe Body Aches, Fatigue 8AM 8AM 1/6- Mild bodyaches, large swelling lymph nodes LT Axilla 9AM 1/7- Lt axilla Lymph nodes swelling + pain (size of baseball) slight red 8AM Saw Dr Mild swelling of Lt Axilla Lymph node No redness
Tired; At his injection site, he felt numbness; Swollen arm around injection site; Feels weird; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 19 year-old male patient received bnt162b2 (BNT162B2, Solution for injection), administration date 11Mar2021 09:06 (Lot number: EN6207, Expiration Date: 31Jul2021) at the age of 19 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Autism Spectrum" (ongoing), notes: Diagnosed at 5 Years of Age; "Asperger's Disorder" (ongoing), notes: Diagnosed at 5 Years of Age; "Heavy metal toxicity" (unspecified if ongoing), notes: He had heavy metal toxicity at 5 years old because he had 3 vaccines on the same day; "Thimerosal Poisoning" (unspecified if ongoing). The patient took concomitant medications included Carlson Cod Liver Oil, Floradix Epresat Liquid Multi Vitamin, D3, Eye liquid vitamin. The following information was reported: FATIGUE (non-serious) with onset 11Mar2021 09:06, outcome "recovering", described as "Tired"; INJECTION SITE HYPOAESTHESIA (non-serious) with onset 11Mar2021 09:06, outcome "recovered" (11Mar2021), described as "At his injection site, he felt numbness"; INJECTION SITE SWELLING (non-serious) with onset 11Mar2021 09:06, outcome "recovered" (11Mar2021), described as "Swollen arm around injection site"; FEELING ABNORMAL (non-serious) with onset 11Mar2021, outcome "unknown", described as "Feels weird". Therapeutic measures were taken as a result of injection site swelling.  No follow-up attempts are possible. No further information is expected.
When I had my yearly labs done I had A1C 11.6 which almost put me and a diabetic coma. I was put on Metformin twice a day 500mg.
After 2 shots, plus 2 boosters I noticed I had become increasingly breathless,  left arm still sore,  increasing fatigue each time...strange pains in left breast...so bad that I had mammogram, all clear.  Tingle in back of neck, down shoulders, gasping for breath ...went to ER....heart tests done...heart OK....lungs showed small nodule but sounded clear....VERY slowly feeling better.
cluster headaches every day since approximately one week after shot.This is four months straight of daily cluster headaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Feb2021 12:15 (Batch/Lot number: unknown) at the age of 56 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "history of cluster headaches every few years .They usually last for about a week", start date: 1986 (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single, location : arm Left, Lot: Obscured by other product labelling), administration date: 08Jan2021, when the patient was 55 years old, for COVID-19 immunization. The following information was reported: CLUSTER HEADACHE (non-serious) with onset 15Feb2021 12:00, outcome "not recovered", described as "cluster headaches every day since approximately one week after shot.This is four months straight of daily cluster headaches". Therapeutic measures were taken as a result of cluster headache.  Additional information: Patient didnot receive any other vaccine in four weeks and didnot received any other medications in two weeks. Patient had no Covid, prior vaccination and had not been covid tested, post vaccination. Treatment medication included sumatrin.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
made me sicker than a dog for a week; Initial information received on 03-Dec-2020 regarding an unsolicited valid non-serious case from a patient via social media.  This case involves an adult patient of an unknown gender who was sicker than a dog for a week (illness), while the patient received influenza vaccine.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  No concomitant medication was reported.    On an unknown date in 2018 (reported as 2 years ago), the patient received a dose of suspect influenza vaccine (produced by unknown manufacturer) (with an unknown route, frequency, strength, lot number and expiry date) for prophylactic vaccination.  On an unknown date (latency unknown) after starting the suspect vaccine therapy, sicker than a dog for a week (illness) and stated that no more for the patient.  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.  No further relevant information was reported.
Chicken pox from shingrix vaccine; Red itchy bumps like chicken pox; Red itchy bumps like chicken pox; Red itchy bumps like chicken pox; Chills; Fever; General malaise; This case was reported by a consumer via call center representative and described the occurrence of chickenpox in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included MODERNA (COVID-19 VACCINE MODERNA) for covid-19 prophylaxis.   The patient's past medical history included chickenpox (The patient had the chicken pox when she was a kid).   On 3rd January 2022, the patient received Shingrix and COVID-19 VACCINE MODERNA. In January 2022, less than a week after receiving Shingrix and COVID-19 VACCINE MODERNA, the patient experienced chickenpox, itchy rash, varicella-like rash, red rash, chills, fever and general malaise. On an unknown date, the outcome of the chickenpox, itchy rash, varicella-like rash and red rash were not recovered/not resolved and the outcome of the chills, fever and general malaise were recovered/resolved.   It was unknown if the reporter considered the chickenpox, itchy rash, varicella-like rash, red rash, chills, fever and general malaise to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The patient also got the moderna booster at the same time that she got the Shingrix. The patient had chills, fever, general malaise for two days after vaccination, but now she was noticing red itchy bumps like chicken pox on torso. The patient had chicken pox from Shingrix vaccine. In January 2022, chills, fever and general malaise were resolved. The patient asked if Shingrix could cause chicken pox. The patient asked if she was contagious. It was unknown if the reporter considered the chills, fever, general malaise, itchy rash and chickenpox to be related to Covid-19 Vaccine Moderna.