chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt recvd vax on 30APR92 & w/in 15 mins exp a tightness in throat which gradually spread over the next several hrs to involve neck, jaw & chest; also lightheadedness w/poss hypotension, chest muscle soreness;
Rash 17 days post SPV. Developed papules distant from site near elbow. Lesions red, raised and scaly. C/o itch. No drainage. Site irritation from dressing. Treated with steroids for 5 days with improvement. Also with one lesion on opposite arm, near anthrax vaccination site. Pt otherwise well. Symptoms: RASH&OTH NONSPEC SKIN ERUPTION(R21).
3 weeks after booster, difficulty breathing, went to hospital ER,  admitted with COVID19. developed vision problems in left eye, which has advanced to aprox 75% of vision loss.  Focus problems between eyes.  Opthalmalogist said my eyes are OK, but suspected brain stroke  effecting optic nerves.  Problem getting worse since release from hospital.  Why did CDC, or Pfizer not warn anyone about injuries?????????????????????????????
Information has been received from a physician concerning an 8 month old male who on an unspecified date in 2007 developed chickenpox after being exposed to another child who was vaccinated with varicella virus vaccine live (Oka/Merck), on 21-APR-1999 and subsequently developed shingles. It was noted that the patient had not been vaccinated with varicella virus vaccine live (Oka/Merck). No further information was provided. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source.
Spongiotic Dermatitis; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 23Mar2021 as dose 2, single (Lot number: EP6955) at the age of 61 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EN6199; Location of injection: Arm Right), administration date: 02Mar2021, when the patient was 61-year-old, for COVID-19 immunization. The following information was reported: ECZEMA (non-serious) with onset 01Apr2021, outcome "recovering", described as "Spongiotic Dermatitis". The event "spongiotic dermatitis" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of eczema.  Additional information: Patient also received dose 3 (lit number: 33030BD) on 02Dec2021 in right arm.  No follow-up attempts are possible. No further information is expected.
Pains in right leg  after first dose  Pains at ankles in both legs after first dose  Headache after second dose of vaccine only  Chills after first dose only  Swollen under left arm and is still painful -second dose  Chest pains left side - after second dose Upper back pain comes and goes -after second dose
Patient, called to report an adverse reaction to one of her immunizations given at a Pharmacy sponsored immunization clinic at her place of buisness. She stated the immunizations were given on Thursday, 11/7/2019, and she thought she was given HepA and tetanus in one arm and pnuemonia and flu in the other arm. Patient reported feeling pain worsening throughout the day/evening to the extent that she left work early. She stated that she had fever/chills and was achy the entire evening, all day Friday and when she woke today feeling the same way, she felt she should report it. She said the arm that she thought the pneumonia vaccine was given was swollen, and warm to the touch under the area where the vaccine was injected.
Sudden extreme chills lasting ~4 hours followed by ~101-F fever lasting for ~16 hours.  Generalized fatigue with episodes of dizziness continued for ~3 days.  Reduced fitness for walking more than 15-minute intervals for ~1 week.
This spontaneous report was received from a certified medical assistant regarding an unspecified number of patients of unknown age and gender. Information on the concurrent conditions and medical history of the patients were not reported. On an unknown date, the patients were vaccinated with unspecified doses of improperly stored GARDASIL immunization series of lot # K011562, expiry date 08-APR-2017 and lot #K008931, expiry date 04-MAR-2017 (dose #, units, frequency, route and anatomical location were not specified). Concomitant medication were not reported. There were no adverse effects reported. There was no Product Quality Complaint (PQC) involved. Temperature and time frame to which the product was exposed was 33 degree Fahrenheit for 72 hours. Temperature and time frame to which the product was exposed previously: 34 degree Fahrenheit for 72 hours and 47 degree Fahrenheit for 12 hours. This is one of several reports received from the same reporter. Additional information has been requested.
I have a red circle below my injection site that is sore and tender.  It is also very warm and itchy.  All I have tried so far is hydrocortisone cream.
After administration of vaccine, we were notified by Agency that the vaccine had experienced a temperature monitoring event outside of our facility.  Patient was notified of CDC guidelines that recommend revaccination.  Patient came in 10/24/2022 for revacination.
Menveo administered to patient. Only one vial or partial dose used and diluted with a generic diluent. Two vials needed for administration are not attached from the manufacturer.
One week after receiving Moderna booster dose (Dose 1 and 2 were Moderna) pt began to experience itching and dermatographic urticaria.  Reports "Moderna arm" after 1st Moderna injection in March 2021 unrelieved by zyrtec
Vaccine induced eruption (mild) after recommended varicella vaccine. One lesion on left arm, right leg, left neck, 3 mm and minor itch.
Hair loss - smaller pieces sticking up. Thinner hair - sx started at the end of Dec. 2012.
Chemo fog (brain fog) months later; Headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Chemo fog (brain fog) months later) and HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Chemo fog (brain fog) months later) and HEADACHE (Headache). At the time of the report, FEELING ABNORMAL (Chemo fog (brain fog) months later) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported. The treatment information was not provided.    This case was linked to MOD-2021-295786 (Patient Link).
pt recvd vax;7 days later exp macular rash arms,hands swollen bluish orange; pt seen by MD; pt indicated that dph resolves "it" temporarily;events have not resolved;
Passed away a few days ago; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, unknown manufacturer), for COVID-19 Immunization. The following information was reported: DEATH (death, medically significant) with onset Aug2023, outcome "fatal", described as "Passed away a few days ago". The patient date of death was Aug2023. The reported cause of death was unknown. It was not reported if an autopsy was performed. Caller on behalf of his father, who passed away a few days ago (Aug2023). He wanted to report an adverse reaction to the Pfizer-BioNTech COVID-19 Vaccine.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: Passed away a few days ago
Discharge Provider:  MD Primary Care Provider:  DO Admission Date: 4/14/2023 Discharge Date:  04/16/2023  PRESENTING PROBLEM: Hyponatremia  Chronic obstructive pulmonary disease with (acute) exacerbation (HCC)  Acute on chronic respiratory failure with hypoxia and hypercapnia (HCC)    HOSPITAL COURSE: Patient is a 70-year-old male with past medical history of chronic obstructive pulmonary disease requiring 2-4 L nasal cannula at his baseline, alcohol abuse, hypertension and obstructive sleep apnea who presented to the hospital for shortness of breath.  Symptoms had been progressively worsening over the prior 2-3 days with no improvement with nebulizer treatments and inhalers.  As result patient came to the ER.  In the ER patient was hypoxic and required non-rebreather that was escalated to BiPAP.  Patient had mild leukocytosis and was found to be acidotic with CO2 retention.  Sodium was also decreased at 122. X-ray did not show any signs or concerns for pneumonia.  Additionally patient was COVID positive which was later found on admission.  Patient was started on Solu-Medrol, doxycycline and admitted for chronic obstructive pulmonary disease exacerbation.  Patient was able to quickly wean off of this went back to his baseline 2-4 L. sodium gradually improved.  No signs of alcohol withdrawal during admission.  Patient is stable breathing at baseline on discharge.  Will be discharged home with remaining course of steroids and antibiotics.  Encouraged to follow up with PCP within 2-5 days for repeat blood draw to evaluate status of hyponatremia.  Will also be discharged home with salt tablets.
difficult breathing; heart pumping going fast; Fever; dizziness; when I stand up, I get dizzy; Weak; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization; Bnt162b2 (Dose : 2), for COVID-19 Immunization. The following information was reported: DYSPNOEA (non-serious), outcome "unknown", described as "difficult breathing"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "heart pumping going fast"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; DIZZINESS POSTURAL (non-serious), outcome "unknown", described as "dizziness; when I stand up, I get dizzy"; ASTHENIA (non-serious), outcome "unknown", described as "Weak".  Additional information: The reporter got the booster shot (Pfizer COVID-19) on Friday and was having some symptoms like difficult breathing, heart pumping, going fast, again there as and weak and fever. The reporter does not know if all that was normal or should reporter go to the doctor. The reporter was having dizziness, when stood up, and get dizzy. Regarding lot, the reporter stated the card was in the wallet and wallet was downstairs and reporter told that am not going to do it right now but will call and do it later.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt was 17 years old at time of first Moderna injection. Moderna is indicated for ages 18 and over.
Cellulitis to right thigh due to vaccine. Antibiotics, Benadryl, and instructions to ice was given.
Day 3- Light Fatigue- Slight Swelling and Tenderness inArmpit (Lymph Node) of Injection Arm;Day 4- Slight but Easing Swelling andTenderness in Armpit (Lymph Node)of Injection Arm.; Day 3- Light Fatigue- Slight Swelling and Tenderness inArmpit (Lymph Node) of Injection Arm;Day 4- Slight but Easing Swelling andTenderness in Armpit (Lymph Node)of Injection Arm.; Day After- Medium to Heavy Fatigue- Mild Body Aches- Soreness at Injection Point;Day 2- Medium Fatigue- Soreness at Injection Point;Day 3- Light Fatigue- Slight Swelling and Tenderness inArmpit (Lymph Node) of Injection Arm;; Day After- Medium to Heavy Fatigue- Mild Body Aches- Soreness at Injection Point;; Day After- Medium to Heavy Fatigue- Mild Body Aches- Soreness at Injection Point;Day 2- Medium Fatigue- Soreness at Injection Point;; This is a spontaneous report from a non-contactable consumer, the patient. A 52-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11May2021 at 13:15 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient previously took Penicillin and experienced Penicillin allergy. Concomitant medications taken within two weeks of vaccination included ibuprofen (MANUFACTURER UNKNOWN) and vitamin d nos (VITAMIN D) both from unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12May2021, day after vaccination, the patient experienced medium to heavy fatigue, mild body aches and soreness at injection point; on 13May2021, day two medium fatigue and soreness at injection point; on 14May2021, day three light fatigue, slight swelling and tenderness in armpit (lymph node) of injection arm; on 15May2021, day 4 slight but easing swelling and tenderness in armpit (lymph node) of injection arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the event mild body ache was resolved on 12May2021; soreness at injection point was resolved on 13May2021; day after vaccination medium to heavy fatigue, day two medium fatigue, day three light fatigue was resolved on 14May2021 and of swelling and tenderness in armpit (lymph node) of injection arm was resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Rash started 7 days after injection on torso with just a few bumps, went to Family Dr on 1 Oct after it had become widespread on torso on 1 Oct.  DX with unspecified dermatitis.   Prescribed Predisone (2 week dosage) which really cleared up rash.   Once steroids were complete on 14 Oct,  rash came back with a vengeance and covered torso, neck, and face.  Itching, redness, and very dry bumps.  Went to dermatologist on1 Nov and DX was pityriasis roses.  Prescribed lotion and acyclovir.  Rash was not completely gone until  the end of December
Fever >102, vomiting, swelling, redness, pain, edema & decreased mobility of left upper extremity. Rx - ZOFRAN, Pedialyte, analgesics & rest.
Sore arm, pain and after 6 days development a full case of shingles, with rash on the left hand side of my back, which continue across my left hand side onto my left breast.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021 at 9:24 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Feb-2021 at 9:24 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 71.53   Concomitant products were not provided.  On 28-Feb-2021 Excursion time was reported at 09 am and 1 pm with temperature as 27 and 26 degrees Fahrenheit respectively, total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-feb-2021, vial was moved to clinic on 27-feb-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
I received my vaccine at 8:31AM and stayed at the site until 9:01.  As we were driving home about 9:20 i started coughing and feeling a tickling feeling in my throat.  I coughed for about 1-2 minutes.  on my way to CVS i developed some small rash bumps on my left forearm.  I took two CVS brand (Benadryl) and it went away.  I felt sleeping which i think was due to the Benadryl.
Pt felt like she was going to vomit 2 mins after administration, then fainted as being assisted to gurney to lie down.
This spontaneous report was received from a medical assistant referring to a 17 year old female patient. The patient had none pertinent medical history nor drug reactions/allergies. Concomitant therapies included MENVEO (also reported as "Concomitant Medication: no"). On 06-APR-2017. the patient was vaccinated with the first dose of GARDASIL 9 (lot # M041212, expiration date 21-JUN-2019) in the left arm, for prophylaxis (dose and route of administration were not reported). On 06-APR-2017 as well, the patient's left entire arm became swollen, red, itchy and painful. It was reported that the patient's mother took her to an urgent care facility on 07-APR-2017 and she started treatment with prednisone (manufacturer unknown) 20 mg for 10 days. Her left arm was better after treatment and the adverse effects resolved on an unspecified date in 2017. No laboratory diagnostics studies were performed. The medical assistant also reported that the patient had also been administered MENVEO to the right arm and no adverse effects occurred to that arm. Causality relationship between the events and GARDASIL 9 vaccination was not reported. No product quality complaint was involved. Additional information has been requested.
Client requested shingrix vaccine. Stated has never had shingrix vaccine in the past. Vaccine given.  Nurse printed document to give to client, and noticed client has already received two previous doses of shingrix. Client made aware.
Extreme fatigue, feeling cold, headache, total body muscle aches, extreme pain in all my joints. Started the evening I received the shot. I stayed home from work for 2 days and slept most of the time. Took ibuprofen for the pain. Pain left after 2 days, fatigue has lasted a few more days.
pt recv vax 1NOV97 & 4NOV had osteoarthritic pain in lower back;took lodine & applied topical pain buster;that noc pt awoke w/itchy rash described as red measles;next day MD prescribed pred;pt eye & throat burning;splotchy appearance;
sore arm, lethargy. Severe eye swelling the day after injection.  rash on face.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2021 at 11:00 as dose 1, single (Lot number: ER8727), in left arm, on 09Apr2021 at 10:00 as dose 2, single (Lot number: ER8735), in left arm and on 13Dec2021 at 09:00 as dose 3 (booster), single (Lot number: 331308A) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "overweight" (unspecified if ongoing); "known allergies: Sulfas" (unspecified if ongoing), notes: known allergies: Sulfas. Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course information: On 27May2022 the patient had cramping in her stomach, on 28May2022 she had aches and chills and on 29May2022, she had body aches as no chills and headache  No follow-up attempts are possible. No further information is expected.
Left thigh with significant swelling, erythema and warmth, nontender, no fever. Treatment with Benadryl prn and cold compresses.
Signs/symptoms of community acquired pneumonia. COVID negative. Bacterial pneumonia based on chest x-ray.
A couple of days after the vaccine, her arm turned red around the injection spot, got hard, now redness has spread more on the arm down to the elbow and almost all the way around the arm, does have some welts on the red area, is a bit swollen, itchy and a little painful at the injection site.
COVID -19 BREAKTHROUGH CASE THAT EXPIRED FOUR MONTHS AFTER COMPLETING COVID VACCINATION SERIES.
Fever, extreme fatigue, chills, shortness of breath, diarrhea, congestion, runny eyes, headache x 1 week
Hot soreness surging through shoulder and down arm, pain in joint. Took some Tylenol throughout the rest of day. Next day, and every day since, there is pain in shoulder joint, painful to lift or rotate arm at shoulder.
Headache/Neck & lower back pain since 1/15/21,  Fever/chills:1/13/2021-1/15/2021, Infected Bartholin Cyst- 1/14-1/21. Localized erythema/itching below injection site:1/20/21-1/27/21. Left neck-lymph node swelling & pain radiating to left ear-1/20-1/22. Baker's cyst Left knee 2/1/21-current.
On a walk, legs, torso, and buttocks became unbearably itchy. It was about a mile walk and occurred about halfway through, upon arriving home, my entire body was red, skin was bumpy and swollen, and itchy was increasing. It started around 2:50pm and I took an extra dose of Cetirizine 10mg at 3:15pm.
Self reported vaccinated pregnant pt admitted in labor and tested positive for covid infection. No information on vaccine type, location, date, etc.
Swelling of arm, throbbing pain, can not move arm even 4 days later, after shot.