chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got a COVID booster shot on Saturday. Sunday night, noticed R side of his chest was red, and sunburned and dose was on the left arm. Looked like a sunburn but was over a covered area of his body, and then next morning, woke up and felt sore under his hair over back of his neck, and wife saw him and asked if he had a birthmark, and was still red. Redness over chest was gone, but redness over the back of the neck is still there, and is feeling better overall. No prior vaccine skin reactions. Had felt mildly feverish day after the shot every time he's had it. No chills, nausea, vomiting. No blistering, skin breaks. No new hair products, change in soaps, detergents. Not itchy, but feels like tired muscle feeling (after working out).
Patient started getting extremely lethargic. He showed signs of pneumonia. On Saturday, November 27, patient had a very painful look and on Sunday he went into a deep sleep. Patient suffered a severe hemorrhaginc stroke. This has been and still is life-threatening. It has caused substantial brain damage. We took him to Hospital and they did not feel that he would make it. He has been at home since then being treated by home care nurses and family. He has ongoing brain injury and numerous physical issues due to the injury. We are not sure if he will  Live or die. He is 100% care constant round the clock struggling for every breath and suffering with pneumonia. Patient has never had an issue like this before in his entire life. He was healthy going into this and the vaccine is the only change that transpired. His very large hematoma's are a direct result of the Pfizer vaccine.
Patient developed symptoms of MISC on 9/3/22; fevers began on 9/5/22 with a Tmax of 39.8 degrees Celsius.  Over the course of illness, symptoms and complications included fevers, shock, sinus tachycardia, hypotension, elevated BNP and NT-proBNP, shortness of breath, chest pain, thrombocytopenia, abdominal pain, vomiting, diarrhea, elevated liver enzymes, elevated bilirubin, rash, mucocutaneous lesions/conjunctivitis, headache, and presyncope. Abnormal labs included elevated fibrinogen, elevated CRP, elevated BNP, elevated NT-proBNP, elevated D-dimer, decreased platelets, and elevated AST. ECHO studies showed left ventricular dysfunction, right ventricular dysfunction, pericardial effusion, pleural effusion, trivial aortic regurgitation, trivial mitral regurgitation, mildly dilated main pulmonary artery, mildly dilated IVC, and physiologic tricuspid regurgitation. Chest x-rays showed atelectasis, pleural effusion, a left basilar opacity, diffuse interstitial opacities, and interstitial edema. Patient was admitted to the hospital on 9/8/22 and treated with low flow nasal cannula, high flow nasal cannula, norepinephrine, epinephrine, IVIG, infliximab x 2, and aspirin; he was discharged on 9/14/22. He was in the PICU 9/8/22 to 9/10/22.
red blotchy rash all over body; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from an other health care professional.  This case involves two patients of unknown demographics who experienced red blotchy rash all over body (rash generalised), while when received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patients received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patients experienced a non-serious red blotchy rash all over body (rash generalised) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  (Other relevant tests included no lab data.)  Final diagnosis was red blotchy rash all over body.   It was not reported if the patients received a corrective treatment.  The patients outcome was not reported for red blotchy rash all over body.  Information on the batch number was requested.  List of documents held by sender: none.
PATIENT REPORTED TODAY 8/24/21 THAT HE HAS EXPERIENCED LOSS OF APPETITE AND REGULAR NAUSEA SINCE VACCINATION ON 8/6/21. PATIENT HAS FELT GENERALLY ILL SINCE VACCINATION AND HAS PREVENTED HIM FROM COMPLETING DAILY WORK/ACTIVITIES.
Received 0.25ml of Bivalent booster instead of 0.5 ml; No Adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) 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)) for COVID-19 vaccination.     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)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event). At the time of the report, UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml).    It was reported as patient received 0.25ml of Bivalent Moderna COVID-19 vaccine instead of 0.5 ml and none of the patients are pregnant. No concomitant  and treatment information were reported by the reporter.   This case was linked to CMOD22-04360 (Linked Report).; Sender's Comments:  CMOD22-04360:CMOD22-04360 cross linked case
LEFT SIDE OF FACE WASSWOLLEN; Headache; Pain; LEFT EYELID  DIAGNOSED WITH BLEPHARITIS; GUM AND TEETH PAIN.; GUM AND TEETH PAIN.; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP6955), in the right arm on 22Mar2021 at 10:30 (at the age 0f 51-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient did not have allergies to medications, food, or other products. The patient did not receive any other medications within 2 weeks of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021 at 18:00, the patient experienced face swelling on left side with headache and pain and also diagnosed with blepharitis in left eyelid. The patient had also experienced swelling in upper eyelid and itchy and also gum and teeth pain. The events resulted in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were taken as result of events which included antibiotics and ointment for both eyes. The clinical outcome of the events left side of face swollen, headache, pain, left eyelid diagnosed with blepharitis, gum and teeth pain was resolving at the time of this report.    No follow-up attempts are needed. No further information is expected.
No additional AE reported.; temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, concomitant therapies and medical history was not provided.  On 03-JAN-2022, the patient was vaccinated with improperly stored hepatitis aAvaccine, inactivated (VAQTA), (once, lot # U024094,was confirmed as formulation vial, expiration date 10-MAY-2023 (route of administration and anatomical location were not reported) for prophylaxis (product storage error). Temperature 35.9 Fahrenheit degrees for 20 minutes on 29-DEC-2021. There was no previous temperature excursions. No additional adverse event was reported (No adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2202USA007167:
severe headache, backache, sore arm,  severe muscle ache, frequent urination, fever 100 deg
Developed temp of 99.9 that increased to 103 by 12/12. Hospitalized them for vomiting and diarrhea.  Home on 12/13 - mom called nurse on 12/15 and 12/19. Patient now has rash MD thinks is related to MMR.  03/05/2007 MR received from hospital for an overnight admit for c/o increased temperature, listlessness, fussiness, and vomiting on and off since vax 4 days ago.  PE: shows listlessness.  Eyes, slighly sunken. Slight rhinorrhea-yellowish discharge.  Tongue-mildly dry.  Temp. = 101.8'F. Otherwise WNL. Admitted for persistant vomiting, fever, and moderate dehydration. No discharge summary written but verbal DX of gastroenteritis given by reporter via TC.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 17Jan2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 06Feb2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 21Oct2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 17May2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "have only 1 kidney" (unspecified if ongoing), notes: have only 1 kidney. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jul2022) Positive; (19Jul2022) Negative; (23Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information :The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.The patient previously received a COVID-19 Vaccine. Patient tested positive on 13Jul2022 and took 5 day course of Paxlovid. Patient tested negative on 19Jul2022. Patient started feeling poorly (chills and headache) and tested positive again on 23Jul.2022 .patients exposure was in different country, but tested positive in another.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information , there is reasonable possibility of causal association between the events Vaccination failure and COVID 19  and the suspect drug BNT162b2 .
COVID vaccine given at noon Abdominal pain started around 3:30pm Nausea and vomiting around 530/6p Went to ED due to unrelenting pain around 9p Diagnosed with appendicitis and went to surgery for appendectomy before 8am the next day
Headache, fatigue, HA, LIGHT SENSITIVITY , EYE BURNING/WARM Narrative:
GOT LITTLE BIT SICK; BIG BRUISE HURTS LIKE HELL; ACHES AND PAINS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: chemotherapy (when she was 21 years old), and concurrent conditions included: bronchitis (from childhood), immunocompromised, traumatic brain injury (brain damage) (The patient is wheel chair bound, had a second delay, sounds like she is interrupting all the time. The processor in her brain doesn't process exactly the way it supposed to every single second, so occasionally could not come out with the right words), and paralysis on right side (sound like she was speaking weird), and other pre-existing medical conditions included: The patient did not have covid-19 and cold after vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 23-SEP-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced got little bit sick, big bruise hurts like hell, and aches and pains. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the got little bit sick, big bruise hurts like hell and aches and pains was not reported. This report was non-serious.
Sudden onset of chills, myalgias, headache, cough, and chest pain throughout the morning. Symptoms worsened throughout the day. Ibuprofen 600mg was taken twice, 5 hours apart, which improved symptoms. I felt feverish, but temperature peaked at 99.9F, although this was after the first course of ibuprofen. The following day, symptoms were significantly improved with some persistent body aches and intermittent chills.
This spontaneous report was received from a physician and refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not provided. On an unknown date in approximately 2012, (reported as "four years ago") the patient was vaccinated with GARDASIL (strength, dosage, frequency, route, lot# and expiration date were not provided). Concomitant therapies were not provided. On an unknown date, the patient was diagnosed with Postural orthostatic tachycardia syndrome (POTS) and she frequently fainted. The outcome of postural orthostatic tachycardia syndrome was unknown. Additional information has been requested.
The patient stated that she has had hearing deterioration in the past "couple of months" and states that her skin burns or hurts. She states that there in no rash or other skin abnormalities associated with the burning or pain. She has consulted her physician but states she is on no therapy. Physician d/c her Crestor but the symptoms still persist.
Swollen and painful lymph node in my left axilla. Went to my OB office and they were able to palpitate it and estimate its size at 1cm. They sent me for a mammogram and ultrasound to be sure it wasn't cancerous. Outcome was inflamed node, most likely from vaccine reaction
This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 85-year-old female patient who received SHINGRIX (batch number ZN22Z, expiry date 2nd February 2021) for prophylaxis. Concurrent medical conditions included diabetes mellitus, hypertension and hypothyroidism. Concomitant products included PNEUMOVAX. On 29th June 2018, the patient received the 1st dose of SHINGRIX. In July 2018, less than a week after receiving SHINGRIX, the patient experienced fatigue, pain, headache, blood glucose fluctuation, shortness of breath, heart rate increased and weakness generalized. The patient was treated with TYLENOL. On an unknown date, the outcome of the fatigue and pain were recovering/resolving and the outcome of the headache, blood glucose fluctuation, shortness of breath and heart rate increased were unknown and the outcome of the weakness generalized was not recovered/not resolved. It was unknown if the reporter considered the fatigue, pain, headache, blood glucose fluctuation, shortness of breath, heart rate increased and weakness generalized to be related to SHINGRIX. Additional details were provided as follows: The patient was generally in good health. The patient was administered initial dose of SHINGRIX in the left arm and on the same day administered PNEUMOVAX in the right arm. The patient developed several reactions after receiving a dose of SHINGRIX and PNEUMOVAX. The healthcare professional (HCP) called to check on the patient 3 days later at which time the patient reported trouble with mobility and pain in the arm which the pneumonia vaccine was administered. The patient was advised to take TYLENOL around the clock at which the symptoms resolved. However, the patient continued to experience symptoms of fatigue, headache and overall achiness. After 2 weeks from the day of administration, the patient reported symptoms remained the same and in addition began to notice fluctuations in her blood glucose levels ranging from 80 to 170, which were previously controlled. The patient followed up with her primary care physician and was found to have shortness of breath and increased heart rate. The patient's physician conducted laboratory test which showed no results that would cause reported symptoms. The patient was also seen by their endocrinologist to test thyroid function and was still awaiting test results from the endocrinologist, however reported symptoms of fatigue and generalized weakness were still ongoing. The HCP reported otherwise, there had been no other changes in the patient's diet or medication regimen that would contribute to these symptoms. No further information was reported regarding the event. Lab Comments: In 2018, the patient had fluctuations in her blood glucose levels ranging from 80s to 170s, which were previously controlled. The laboratory test showed no results should be changed to showed no results which would cause reported symptoms.
Sore arm within 8 hours.  Headache within 24 hours which became increasing severe.  At 32 hours after the vaccine, severe headache, chills, nausea and vomiting.  The headache lasted up to 47 hours after the vaccine and then started to become better.  By noon 48 hours after the vaccine, I felt better but still a little shaky.
Patients wife reported sore and stiff arm with chills. Didn't know if patient had fever. Advised patient to take APAP and if soreness didn't resolve or worsened to call MD.
3/20/23 Pt reported to her day care program on 3/20 that her R delt has been swollen, red + itching  after receiving the vaccine on 3/17 Has H/O mastectomy + only uses R arm for shots
bad nausea; diarrhea; chills; feels very cold; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age (age: 79, unit: unspecified) received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced bad nausea, diarrhea, chills and felt very cold on an unspecified date. Outcome of the events was unknown.  Information on lot/batch number has been requested.
8/3/2000 (14 days post vax) temperature of 101 and body rash. 8/4/2000 rash was pimple like over much of body with patches of red non raised rash over shoulder. Sore throat, eyes itching and light sensitive, muscle aching. Symptoms peaked 8/5/00 and resolved by 8/8/2000. Treatment was Ibuprofen.
3MAY pt recv vax; 4MAY area @ inj site, red, warm-6cm; ice to area, APAP for pain; 5MAY area hot, firm, red 12cm x 7cm; ice to area, APAP, Keflex prescription given;
On day of vaccination throat was closing up for about 40 minutes after vaccine, then was dizzy for several days after.  Stated she didn't feel good.  On 12/4/09 was diagnosed with heart valve damage both mitral and tricuspid and dilated cardiomyopathy.  Was admitted to CCU on 12/10/09 and died. Had H1N1 vaccine on 10/23/09.
arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th February 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient was the caller's wife. The patient received the dose of Shingrix and experienced mild arm soreness.
Approximately 18 hours after the second shot. Pain in left arm was low. motor functions with left arm were good. This was interrupted with an abrupt high fever and numbness in torso and both arms (for about 45-60 minutes). Rapid shallow breathing (for about 15 minutes)  Treatment: Ice pack and time. This was a single occurrence.
Starting at 4:00 am, I had numerous instances of a HR below 40 BPM recorded on my Watch as noted: 3/15/2021 - 3 instances between 4:00 am and 5:35 am;  3/17/2021 - 1 instance at 2:15 am; 3/18/2021 - 1 instance at 4:00 am; 3/19/2021 - 2 instances between 5:40 am and 6:25 am; 3/20/2021 - 4 instances between 4:11 am and 11:28 am;  3/21/2021 - 2 instances between 6:45 am and 2:48 pm; 3/22/2021 - 1 instance at 6:20 am.  No further incidents as of today.  No treatment.
Fever of 104.9 R evening of vax; temp dec w/fever meds; next am temp 104.8 R; taken to MD office while @ MD started chilling had sx; adm to hosp over noc for observation;
Multiple visual hallucinations; Body aches; This is a spontaneous report from a contactable other Health Professional.  A 43-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular at age of 43-years, on 22Apr2021 (Lot number was not reported) as single dose for covid-19 immunisation. Medical history included hyperlipidaemia (HLD) and post-traumatic stress disorder (PTSD). There were other medications in two weeks but unspecified. The patient previously took morphine and experienced allergy. Historical vaccine included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular on 01Apr2021 (Lot number was not reported) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced multiple visual hallucinations and usual body aches occurring evening of vaccine on 22Apr2021, resolved by next day. There was no treatment received for the above events. The patient did not diagnose with COVID-19 prior to vaccination and not test for COVID-19 since the vaccination. Events outcome was recovered on 23Apr2021.  Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported multiple visual hallucinations  and the administration of the suspect, COVID19 vaccine, based on the reasonable temporal association.   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 RA, IEC, as appropriate.
Received the "Fluvirin INJ PF 13-14" last night. 28 hours later I began seeing sparks, and then my vision became cloudy like I'm looking through a foggy mirror. Marked vision trouble. Suddenly hurts very much to read and words are blurry. I feel marked pressure behind my eyes, like a mild headache-almost a low burning feeling. A headache is building in intensity. I don't suffer from headaches and I have had perfect vision my entire life and have never experienced any vision-related events or weaknesses previously in my life. (My vision has been tested and I don't wear or need glasses or contacts.) This is totally unusual and came on absolutely suddenly.I have not seen a doctor yet, and will determine whether this is necessary in the morning, if the issue persists. Too me this is very serious as my vision has been perfect my entire life. No other symptoms so far.
Symptoms appeared roughly 12hrs after the second dose. Chills, slight fever, body aches. Symptoms lasted for less than 24hrs.
When injecting, most of the dose dripped out of the syringe due to either a faulty syringe or the needle not being securely attached. Since most of the dose was lost, pt was given another full dose.