chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After booster, Left and Right Ear began to swell up and I couldn't hear out of them. It was as if something popped in my ear and there was sharp pain the went into my jaw and I couldn't hear out of one ear and then the other ear and it would go back and forth. I went to the ER due to these symptoms and they looked at my ears and saw that they were inflamed and they seemed to just dismiss my problems. This continued for about a month and it took awhile for it to go down and even now my left ear is feeling like fluid is pooling and only on my left ear. So far, I can hear people however sometimes there is a constant random muffling of my hearing paired with my fluid buildup. I have been feeling issues with my memory retention.
8 days after I received the vaccine I notice my arm was itching where I received the injection.  There was a circular area of small whelps there.  The area is still sore to the touch and red.
Awoke 11/13/09 Bell's Palsy left side - went to urgent care - Rx-steroids, Valtrex, Neurontin. Still on Neurontin. Previously has had episode of Bell's Palsy 4 times.
Tested positive for covid; Tested positive for covid; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: en6208), as dose 2, single (Lot number: ew0161) and on 20Dec2021 as dose 3 (booster), single (Lot number: fl3197) at the age of 51 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SERTRALINE. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20May2022, outcome "recovering" and all described as "Tested positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20May2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received treatment with paxlovid for treatment of COVID-19. Treatment start date: 20May2022. Treatment stop date: 25May2022.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
vaccine at 11:30 am on 12/18/20  and after 15 mins she felt the room started to spin, dizzy and tunnel vision.  nausea and dry heaves also  2-3 mins after.  persistent dizziness.  pruritic rash and was taken to the ER by wheel chair. About an hour after the vaccine, she felt something in the back of her throat, speech ok, able to swallow.  No sob. She was treated with benadryl, pepcid, zofran and fluid.  She felt very hot and shaking. In the ER, she noticed that the rash had progressed to her back.  Notes chest redness, back with erythematous, raised pruritic bumps on back and arm (smaller size of dime)  Within 4 hours of treatment, she had improved.  That night at 2am she had a rash -not as pruritic.  She took more benadryl.  No rash after. No new meds, no nsaids.  She has never had any medical problems or rashes before.      Her symptoms are concerning for anaphylaxis but it is reassuring that her vitals were ok and that she did not progress and improved with benadryl and pepcid - advised to not get 2nd vaccine dose - will plan on skin testing her in the future
Red, swollen itch bump about 3 inches across at injection site. Had this for two days after shot it went away. Reappeared 8 days later and lasted for about 2-3 days before fading.
Rash on top of both hands, extending to a couple fingers.; Itchy rash; This is a spontaneous report from a contactable Consumer. This 47-Year-old Female Consumer (patient) reported. A 47-year-old non-pregnant female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EL9263), dose 1 via an unspecified route of administration, administered in Arm Left on 04Feb2021 16:45 (at the age of 47-years-old) as a single dose for covid-19 immunization. Medical history included none. Concomitant medication(s) in two weeks included zinc; elderberry [sambucus nigra] (ELDERBERRY [SAMBUCUS NIGRA]); curcuma longa (TURMERIC [CURCUMA LONGA]); vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]). The patient did not have any allergies. The patient had no other vaccine within four weeks. 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 06Feb2021, the patient experienced rash on top of both hands, extending to a couple fingers. After 1st dose, about 2 days after the vaccine, the rash showed up on top of both hands. it's raised bumps, some larger, and all itchy. It lasted about a week. The patient did not receive any treatment. Outcome of the event was not recovered, at the time of this report. No follow-up attempts are possible. No further information is expected.
DECEDENT WAS NOTED TO BE COUGHING FOLLOWING THE ADMINISTERING OF THE VACCINE. FAMILY INTERVIEWED COULD NOT RECALL WHETHER THE DECEDENT WAS COUGHING PRIOR TO RECEIVING THE VACCINE.
itchy rash on her legs and stomach; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash on her legs and stomach) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (itchy rash on her legs and stomach). At the time of the report, RASH PRURITIC (itchy rash on her legs and stomach) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported she had events two days after the getting the Booster Moderna. No concomitant products were reported. No treatment information was reported by the reporter.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in an unspecified number of adult patients who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site swelling and injection site erythema were unknown. It was unknown if the reporter considered the injection site pain, injection site swelling and injection site erythema to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per vaccine indication. The healthcare professional (HCP) stated that, many of her patients complained of injection site reactions, such as pain, redness and swelling after the administration of Shingrix vaccine.
Severe pain, severe chills, sweats, nausea, hand swollen, remains swollen today 12/16/2014 large knot, small knot still remains. Flu like symptoms.
PAIN IN ARM; FLU LIKE SYMPTOMS; This spontaneous report received from a patient via a company representative 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) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The Company was unable to perform follow-up to request batch number. On an unspecified date, the subject experienced pain in arm, and flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in arm and flu like symptoms was not reported. This report was non-serious.
Fatigue and nausea starting the evening of 11/27/18 and continuing until now (11/29/18) although these symptoms are slowly decreasing. Chills on 11/27/18 around 11pm, then I awoke in the middle of the night very sweaty. Unsure if I had a fever as I did not take my temperature. I felt as if I had the flu, felt somewhat better in the morning and did not have a fever.  The injection site and surrounding area was very sore but pain is steadily decreasing.
DTaP given 3/29/04. Today (4/1/04) arm swollen, pink, elbow- shoulder, questionable itchy; min pain. T 100.5. Questionable hyperimmune response vs infection.
Bubbled up at time of injection, knot-hot to touch that afternoon, knot got bigger (2 inches by 1 3/4 inches) sore. Used Ice Pack, Benadryl, Ibuprofen, Tylenol. Some improvement- rx given for antibiotic.
Arm very sore and painful - within a few hours, red, hot, swollen, sore to touch - sore even when not touched. The redness is subsiding - it is almost 2 weeks - not yet completely gone.
Patient was unfortunately given an expired ActHIB vaccine, No Ae; Initial information received on 31-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves patient who was vaccinated with expired vaccine HIB (PRP/T) VACCINE [ACT-HIB] on an unknown date for prophylactic vaccination. The lot number: not reported and expiry date: 05-Dec-2019.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to Expired vaccine used.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
16 days after getting vaccination, I developed severe allergic reaction with hives, swollen areas on the body including facial droop with numbness. Was prescribed medication and with prednisone, after 3 days was finally able to get the hives under control.
1/14/21-Vaccinne 1/16/21- broke out in small bumps that  are very itchy everywhere. Like hives, but not blotchy. Like goosebumps everywhere. A bumpy itchy rash.  1/18/21- headache and sore throat 1/18/21-  went to after hours clinic for Covid/29 test. Negative 1/19/21- went to after hours clinic for sore throat. Possibly Strep B.  But definitely Strep. Started antibiotics.
I received the vaccine 01/16/2021. Two week later I gotten a red slightly swollen arm and contacted my GP. Was told this was normal. Lasted about two weeks.
The minute sh e gave it to me, I got hot - within 5 seconds. I let her know and she gave me water. I got a little cold and then I got really dizzy. Got light headed. Blood Pressure - sky high; Started throwing up immediately. I had chills; fever 102.3 - all in a matter of twenty minutes from taking shot. They took me to the ER and was there all day Saturday and Sunday morning for observation (wasn't admitted officially) and I was able to go home. I had had COVID in the past  - April 19, 2020 and so they thought that's why I had a reaction to the shot. After three days, I felt fine. My arm was still hurting but I was fine. I missed work for those three days. I had developed a cough (within  a couple hours of the vaccine) and it went to a dry cough three or four hours after the shot. ; fever; chills -felt like I had when I had COVID. They told that since the vaccine had potassium in it - that my body went into shock because my body was so low in potassium.
Patient came in for first covid vaccine and about 10 minutes after receiving the vaccine started sweating, lightheaded, dizzy, low blood pressure. Patient remained for about an hour and then felt well enough to leave.
This spontaneous prospective pregnancy report as received from a female consumer of unknown age referring to herself. ON 13-DEC-2013 the patient was vaccinated with GARDASIL (dosage regimen, lot# and expiry date unspecified). Concomitant medications were not reported. The consumer reported that she might have become pregnant on 22-DEC-2013 or 23-DEC-2013 with last menstrual period of approximately 08-DEC-2013 and estimated date of delivery of approximately 14-SEP-2014. Trimester of exposure was first trimester. The pregnancy outcome was pending. Additional information has been requested.
My arm was extremely sore and red with a large bump..it then get better starting January 13 2021 I noticed the bump and red spot coming back it is now very large and swollen itchy and sore i have a headache and am very fatigue a week after
It was reported that a female in her twenties, received Fluzone WV '99-'00 on 10/4/99. About 4 hours, post vax, the pt experienced "weakness, headache, fever and general malaise". This is 1 of 3 similar cases by the same reporter: U199900891 through U19900893. No further information is available at this time. When additional information was provided, it was reported that this pt also experienced nausea, vomiting and diarrhea. The pt took Tylenol. The pt also reported a slight swelling and a "lid" erythema about 4cm in diameter at the site of the injection. The pt is 1 of identical twins with nearly identical reactions.
pt recvd vax; 6pm,eyes rolled  back for 2 mins; non responsive to movement; very limp all eve;to sleep about 10pm;improved next am;back to nl on 2nd day;
Tightness in my chest; It is hard to breath/ Have an Asthma feeling; Congestion in chest; Left arm pain; Coughing; Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), RHINORRHOEA (Runny nose), CHEST DISCOMFORT (Tightness in my chest), DYSPNOEA (It is hard to breath/ Have an Asthma feeling) and NASAL CONGESTION (Congestion in chest) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 01-Jan-2021.    On 25-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced COUGH (Coughing), RHINORRHOEA (Runny nose) and VACCINATION SITE PAIN (Left arm pain). On 27-Aug-2021, the patient experienced CHEST DISCOMFORT (Tightness in my chest), DYSPNOEA (It is hard to breath/ Have an Asthma feeling) and NASAL CONGESTION (Congestion in chest). At the time of the report, COUGH (Coughing), CHEST DISCOMFORT (Tightness in my chest), DYSPNOEA (It is hard to breath/ Have an Asthma feeling) and NASAL CONGESTION (Congestion in chest) had not resolved and RHINORRHOEA (Runny nose) and VACCINATION SITE PAIN (Left arm pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment medications were provided.  The patient contacted vaccination provider and was told that if the symptoms got worse, than the patient should go to the emergency room.
Reaction noticed within one hour of administration - scratchy throat.  Next few hours developed body aches, eyelid swelling, upper lip swelling.  N/V developed 12 hours after vaccination.  Reported to this provider 15 hours post vaccination.  Contacted his personal MD - refused emergency department treatment.  Encouraged 50mg Benadryl P.O. and 650mg acetaminophen P.O.
Injection administered 2/25/08 at Safeway pharmacy.  Patient states fine first week.  Second week rash on upper chest; she treated with Lidx cream.  Now has "rash" on right temple by eye and has "crawling" sensation under skin on face.  No pain experienced.
patient felt lightheaded and dizzy 10 min after receiving his first covid vaccination, patient did not have full syncopal episode, vital signs remained stable, patient improved after  juice and crackers given to patient
back ache; sweating; headache; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 31 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 07Jan2021 17:21 (Lot number: EK9231) at the age of 31 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Iron deficiency anemia", start date: 03Sep2020 (ongoing); "CIN 2", start date: 29Sep2020 (unspecified if ongoing); "HPV +", start date: 29Sep2020 (unspecified if ongoing); "Leep procedure", start date: 07Oct2020 (unspecified if ongoing); "Irregular menstruation", start date: 01Jan2015 (ongoing); "COVID", start date: 28May2020 (unspecified if ongoing), notes: Symptomatic 01Apr2020; "COVID-19 PCR", start date: 03Oct2020 (unspecified if ongoing), notes: Not detect negative, Asymptomatic, pre-procedure; "antibody", start date: 28Sep2020 (unspecified if ongoing), notes: Result: Positive, Units: Negative; "Low vitamin D" (ongoing). Concomitant medication(s) included: VITAMIN D [VITAMIN D NOS] taken for vitamin d decreased, start date: 01Jan2006 (ongoing); FERROUS SULFATE taken for iron deficiency anaemia, start date: 23Oct2020 (ongoing); SPRINTEC taken for menstruation irregular, start date: 01Jan2016 (ongoing). Vaccination history included: Bnt162b2 (1st dose, Lot Number: EH9899, Expiration Date: 01Mar2021, Time:16:46, Route: Intramuscular, Anatomical site: Left deltoid), administration date: 17Dec2020, when the patient was 31 years old, for covid-19 immunisation, reaction(s): "left arm soreness x36h". The following information was reported: HEADACHE (non-serious) with onset 07Jan2021 22:00, outcome "recovered", described as "headache"; BACK PAIN (non-serious) with onset 08Jan2021 07:00, outcome "recovered", described as "back ache"; HYPERHIDROSIS (non-serious) with onset 08Jan2021 07:00, outcome "recovered", described as "sweating". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, back pain, hyperhidrosis.  Additional information: Patient received ibuprofen as a result of events reported. Reporter considered that BNt162b2 had a casual effect to the adverse event reported.  No follow-up attempts are needed. No further information is expected.
This case was reported by a physician via sales rep and described the occurrence of rash in a 11-year-old female patient who received CERVARIX. In November 2016, the patient received the 1st dose of CERVARIX. In December 2016, 30 days after receiving CERVARIX, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved. It was unknown if the reporter considered the rash to be related to CERVARIX. Additional details were provided as follows: The patient got a CERVARIX vaccine. Approximately 1 month later, the patient developed rash. The patient was still having this symptom as it was able to see in her last medical appointment. The patient was being treated.
right sudden sensorineural hearing loss; tinnitus; vertigo; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. The patient's medical history, concurrent conditions, and concomitant medications were not provided. On or around 26-OCT-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine adult health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (dose, route of administration, site of administration and lot # were not provided). Shortly after receiving the vaccine, the patient suffered dizziness, hearing loss, ringing in the ears and nausea. The patient was diagnosed with right sudden sensorineural hearing loss, tinnitus and vertigo. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the vaccination, he suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the vaccine, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered not recovered. The lawyer felt the events were related to zoster vaccine live (ZOSTAVAX).  The events were considered to be disabling. Upon internal review, the event of right sudden sensorineural hearing loss was determined to be medically significant.
Subsequent to receiving one dose of varicella virus vaccine live the pt was diagnosed with chickenpox that consisted to 102 lesions. Follow up information indicated that the pt was seen by a dermatologist who determined the pt had urticaria and not chickenpox.
This spontaneous report as received from a healthcare worker (certified medical assistant) refers to a 21 year old female patient with codeine allergy. the patient's medical history included positive PPD skin test (Tuberculin test), chicken pox and negative titers for varicella. On 04-MAR-2014 the patient was vaccinated with VARIVAX (Merck) (lot # reported as J013507, exp 31-OCT-2015) dose and route not reported). There was no concomitant therapy. The healthcare worker reported on an unspecified date in March 2014 the patient developed a vesicular rash after being vaccinated with VARIVAX (Merck). The reporter stated the patient received vaccinated with VARIVAX (Merck) because she was showing negative titers for varicella despite having had the chicken pox and the patient needed clearance for nursing school. the outcome of vesicular rash was reported as recovering. The patient sought medical attention by office visit. it was reported there was no lab diagnostics studies performed. Additional information has been requested.
Vomiting multiple times, loss of color, low-grade fever, loss of appetite, lethargic.
Fever, chills, body aches, fatigue, head ache all have subsided as of 02/11/2022 sore & swollen lymph node under left armpit still persisting as of 02/11/2022
I am reporting this because I am enrolled a program, and my reaction to the vaccine (Moderna shot #1) occurred *after* the seven days of monitoring. I no longer have a way to report my reaction to the vaccine: the text messages asking me to report in have stopped, and when I tried to use the most recent link texted to me,  it said I'd completed my reporting so there was no way for me to continue. But there is no question that I am having a reaction at the exact place I received the shot. I have a blotchy, red, rash at that area on my left arm. It is itchy and uncomfortable, and has actually been getting worse over the past two days. It now measures about 3"x4". I did not notice a rash here during the seven day  monitoring period after receiving the vaccine. My arm ached for a couple days after the injection, then it went away, and now it is a bit achy again.
pt stated that she developed a rash on the left torso and back which turned into blisters.  She had a virtual appt on 2/18/2021.  Pt was diagnosed w/ Shingles.  She was prescribed Valacyclovir.  Pt is to take the 7 day RX along w/ Tylenol or Advil for pain.
Headache, Myalgia, Fever, UrticariaPruritus, NauseaVomiting, temp 101.0 then 99.5 Chills Narrative: