chrisvoncsefalvay/vaers-outcomes huggingface dataset:
diminished use of my left thumb in picking pills off counter and tying my shoelaces; tingly feeling in my left palm and thumb; discomfort/ache in my left hand; aching in my left hand, wave like impact/ pain (not ache) in my left mid finger; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249 and expiration date not provided), via an unspecified route of administration in the left arm on 17Jan2021 16:00 at a single dose for COVID-19 immunization. Medical history included High cholesterol and bypass surgery. Concomitant medications included metoprolol, famotidine, ezetimibe, and atorvastatin. The patient had no known allergies. The patient did not receive any other vaccine in 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had his first COVID vaccine shot on 17Jan2021 16:00. On 17Jan2021 22:00, the patient had an onset of aching in his left hand, wave like impact. The ache became more intense, and then receded, then more intense, then receded, etc. That night, 18Jan2021, he woke up at 03:30 with a pain (not ache) in my left mid finger. Then 30 min later, it receded and he fell back asleep. On Monday, 18Jan2021, he woke up with discomfort/ache in his left hand. It disappeared by mid afternoon of 18Jan2021. On Tuesday, 19Jan2021 02:00, he woke up with pain in his mid finger left hand which again receded and he went back to sleep. On Thursday, 21Jan2021, he noted a diminished use of his left thumb in picking pills off counter and tying his shoelaces. He can replicate the tingly feeling in his left palm and thumb by inverting his hands and stretching them away from him. The events resulted in Doctor or other healthcare professional office/clinic visit. It was unknown if treatment was given in response to the events. The outcome of the events pain in extremity was recovered on 19Jan2021 and limb discomfort was recovered on 18Jan2021 while the outcome of the rest of the events was not recovered. The patient has not been tested for COVID post vaccination.
started running temp 103 on 19APR96;@ approx 1AM 20APE96 pt suffered a sz & was taken to hosp ER had been given APAP or motrin & wrapped in cool wet towels prior to ER visit;
General malaise; nausea, headache, dizziness, and fever started the evening of the shot.  This continued through the next day at various levels and the fever subsided at some point.  I have continued to feel somewhat lethargic and tired and the dizziness though mild is still present on day 5.
Patient started reporting tingling in her hands about 10 minutes after the vaccine was administered. The tingling spread to her face and then her throat within minutes. Because the patient was reporting abnormal feeling her throat, an EpiPen was administered. She had relief within a minute. The ambulance arrived within 10 minutes and the patient was stable. She was checked out by the EMT's and was taken to the hospital for further evaluation.
Information has been received from a health professional concerning an 8 year old male who in 1999 was vaccinated with varicella virus vaccine live (Oka/Merck). On 05-APR-2007 the patient experienced a mild breakthrough case of the chicken pox. The patient had less than 50 lesions and had no fever. The patient's chicken pox persisted. Medical attention was sought. Follow up information has been received from the physician concerning an eight year old boy who on 13-SEP-1999 was vaccinated with varicella virus vaccine live (Oka/Merck). On 02-APR-2007 the patient developed varicella exanthens status post immunization. The patient was instructed to use AVEENO and CLARITIN for the itch. It was reported the patient recovered. Additional information has been requested.
MOC describes cont crying since 12 on 30JAN to date of call 3FEB; unconsolable, sleeps fitfully, jerks awake; MOC took child to MD 1FEB95 for re-check; URI d/t cold; 7FEB95 pt dx BOM;
Felt nauseous. Sore throat. Next day throat was swollen. Went to doctor. Back of throat swollen. Possible bacterial. Strep test - neg. Followed by chills/fever and continued extremely sore throat. Doctor prescribed Antibiotics in case.
The 14 year old child was given 1st dose of the Moderna vaccine due to the parent completing the immunization consent form incorrectly. His birth date was written as 2002, when in actuality he was born in 2006. No symptoms or adverse events reported. No treatment needed.
My face is tingling.; This is a spontaneous report from a contactable consumer or other non healthcare professional.  A 31-year-old non -pregnant female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, formulation: solution for injection, Batch/Lot Number: EM9809), via an unspecified route of administration, administered in Left arm on 19Feb2021 at 18:45 (31-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. Medical history included depression, anxiety and Known allergies to Paxil, Levaquin , codeine and penicillin. Concomitant medication(s) included ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported; sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported and Women's multivitamin. The patient did not have covid prior to the vaccination and post vaccination. The patient experienced face tingling on 20Feb2021 at 04:30 Am. No treatment received for the event. The outcome of the event was not resolved.  Follow-up attempts completed. No further information expected.
Extreme soreness at injection site.  Major muscle soreness.  Vomiting.  Fatigue.  Allover achiness.
Redness and swelling of left upper arm for 48 hrs. Tender to palpate, bruise at site.
Patient stated she had a rash (redness), swelling, and warmth around injection site. I explained this was a histamine reaction and to take benadryl for a few days to resolve and if it does not resolve to contact the pharmacy again.
Patient reports she received 2nd dose Moderna vaccine Lot 039K20A on 01/26/2021. Shortly following the  injection Patient developed SOB. Staff at vaccine clinic administered epi pen. Patient was transferred to ED.  Evaluated and released following inhaler administration.
Breakthrough case admission after 4 vaccines Moderna 1/12/21 Lot# 012L20A;  Moderna 2/18/21 Lot# 006M20A'  Moderna 2/10/22 Lot# 028K21A;  Moderna 6/30/22 Lot# 017B22A
Father had stroke a few hours after receiving moderna vaccine. Was taken to hospital after becoming confused, disoriented, and constantly repeating last words said to him and it was confirmed at the hospital a stroke had occurred
Patient admitted to hospital on 8/10 with acute respiratory failure. Symptoms started 8/4. Respiratory status worsened and transferred to ICU on 8/15. Patient passed away on  8/17/21.
did not feel dizzy, she could not walk straight or "elegantly"), TENSION (the next day she was completely wired for a 24-36hr period), MIGRAINE (She took a nap and woke up with a migrane) and COUGH (cough) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included LANSOPRAZOLE and LEVOTHYROXINE for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced DRY THROAT (2 minutes later her throat went completely dry she did not feel that she could not breathe, she was able to drink water), GAIT INABILITY (she started to walk, and even though she did not feel dizzy, she could not walk straight or "elegantly") and NAUSEA (The first 10 minutes felt mild nauseosness). On 16-Jan-2021, the patient experienced TENSION (the next day she was completely wired for a 24-36hr period). On 17-Jan-2021, the patient experienced MIGRAINE (She took a nap and woke up with a migrane) and VOMITING (Ended up vomiting). On an unknown date, the patient experienced COUGH (cough). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Sleep problem, at an unspecified dose and frequency. On 15-Jan-2021, NAUSEA (The first 10 minutes felt mild nauseosness) had resolved. On 17-Jan-2021, TENSION (the next day she was completely wired for a 24-36hr period), MIGRAINE (She took a nap and woke up with a migrane) and VOMITING (Ended up vomiting) had resolved. At the time of the report, DRY THROAT (2 minutes later her throat went completely dry she did not feel that she could not breathe, she was able to drink water) and GAIT INABILITY (she started to walk, and even though she did not feel dizzy, she could not walk straight or "elegantly") was resolving and COUGH (cough) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 (High) 99 degree Fahrenheit.         Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-219219, MOD-2021-219219 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Jun-2021: Added event, lab data and dosage information.
Several days after the  J&J Vaccine I had a rash on my face and my lips became very swollen and turned a blueish gray color. Under my top lip there were several large dark red marks that were tender and swollen.
Information was viewed on the internet concerning a 14-year-old female patient, who on an unspecified date was vaccinated with a dose (s) of GARDASIL. It was reported that the patient has been "suffering since September 2008, she is now in her third hospital". It was also reported that she "has nearly died from this vaccine. She can not eat anything, her digestive system and intestines have shut down, she had the numbness in her legs and the horrible pain. She has nearly lost her entire freshman year of high school, her mother has not been able to work since September". No further information is expected.
Child received MMR#2 and DTAP #5 approximately 11:30 am, left the office, mom and child had lunch with dad.  Approximately 12:15pm, mom noticed hives, child complained of itching.  School nurse gave Benadryl then child had difficulty breathing.  Epi pcn administered and 911 called.
This spontaneous report received from a patient concerned a 58-year-old Not Hispanic/Latino and white female. The patient's height, and weight were not reported. The patient's concurrent conditions included: enterocytes cystitis (captured: cystitis), bad bladder (captured: bladder disorder), bees sting allergy, wasp sting allergy, and sulfa allergy. The patient previously received covid-19 vaccine vaccination (unspecified manufacturer) (suspension for injection, route of admin not reported, batch number: unknown expiry: unknown) dose was not reported, 1 total, administered on unspecified date for prophylactic vaccination (Dose number in series 1). It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine. On 05-DEC-2021, the patient received covid-19 vaccine (suspension for injection, route of admin not reported, lot number: 1855191, expiry: Unknown) dose was not reported,1 total administered to left arm for prophylactic vaccination (Dose number in series 2). No concomitant medications were reported. On 06-DEC-2021 (reported as Monday), the patient woke up on morning really sick and complained of delirium (serious event), dizziness, chest feeling heavy, felt like the worst flu, feeling weak, fever, body aches, headache, "so sick this time", and Fever 102 (dose number in series 2). Laboratory data included: Fever (captured as body temperature) 102 F. On 09-DEC-2021, the patient experienced sores in mouth (dose number in series 2). Laboratory data included: Fever (captured as body temperature) 99.5- 99.8 F (reported as "normally 97.9F). The patient also stated no fever for 3 days as of now and asked for advice on what to do regarding AE (adverse event). The action taken with covid-19 vaccine was not applicable. The outcome of fever 102 was recovered (also reported as not recovered but stated to be recovered by the patient). The outcomes of the following events were not reported/unknown: headache, delirium, weakness, dizziness, body aches, feels like the worst flu, so sick this time, and chest feeling heavy. The outcome of sores in mouth was not recovered. The patient had not recovered from delirium, dizziness, sores in mouth, and feels like the worst flu, and the outcome of sick and chest feeling heavy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211222712-COVID-19 VACCINE Delirium. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns an 84 year old patient. Weight: not provided; height: Not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 13-Sep-2016, the patient received AFLURIA. Dose regimen: not reported, route of administration: not reported. Batch number: WT53706. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 13-Sep-2016, doses were administered. Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered in the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions form 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016.
Had a low grade fever (100.5) and was not acting himself.  Crying almost all the time, wouldn't eat, and had a hard time sleeping.  Only wanted to be held-did not want to walk around and play like he normally does.
Within 90 min of receiving the vaccine patient developed myalgias, lassitude and a fever with a temperature max of 104F within 24 hrs. Her fever persisted (101-102 degrees F) and was associated with dark urine, nausea ans a sense of being off balance for 4.5 days.
I immediately felt dizzy, and there was ringing in my ears, I felt faint. I also felt shakey.  I have had these symptoms for 12 days, unchanged. I cannot work because of these symptoms. I have been to urgent care and have had lab work and an EKG
Per reporter: "I received the COVID vaccine on 12/29/2020 (first dose). The first couple days I had a really sore left arm, but didn?t feel any ?side effects? until about Wednesday, 1/6 (about a week later). I remember waking up to a sore left side of my upper body. The left side of my neck, chest, arm, and lymph node (under my left arm) felt weird. It was until about Saturday night, 1/9, that I felt my left under arm lymph node noticeably swollen. I had a bad headache and loss of energy, and overall feeling unwell. No fever or night sweats to report. I was absent from work on 1/11 and 1/12, as a result.  1/13 was my first day back and feel better. The swollen left lymph node is no longer present, but still slightly tired. I did not seek Medical Care for my symptoms.
C/O dizziness, then eyes rolled back and forth. Then fell down and passed out x 15 minutes.
Ringing in both ears more noticeable at times than others, beginning approximately 1-2 weeks after first varicella vaccine dose. Second varicella vaccine dose given 4/20/2020, same lot#.
"Rash" red area, swelling, hot to touch. Patient experienced pain in left arm.
Pt received flu shot on 11/11/03 in AM. The next day felt "bad". After 24 [hours] developed fever up to 104 degrees F., chills, cough, headache and started having (unreadable) local reaction. Left gluteal area with localized redness. Went to ER. Found to have CXR abnormality and given Zithromax for apparent pneumonia and sent home. Pt has been having fever for 2 days and came to my office 4 days after a flu shot. She had no fever, her physical exam was remarkable for wheezing (she is chronic COPD pt) and localized redness (measuring 16 x 10cm in the left gluteal region where flu shot was administered. Pt was given Avelox 400, po for 5 more days and Bartoban cream to apply on a red skin area. Pt is now recovering well (no fever, localized redness disappearing as of 11/18/03).
She got her vaccine, went to Store and had the vaccine, the shot wasn't painful at all, and felt that it went well . She was OK the rest of the day until late evening when she normally starts to get ready for bed, and she started shivering.  Her teeth were shattering, she was freezing, and her husband kept piling on her blankets.  She did have a fever that was low at 100._.   She walks around the house with a walker as she has a bad back, and bad knees, and was using the walker and made it to the bathroom and started getting back out and right before she got to her chair her legs were so weak that they gave out.  She fell on the floor, and he had to call 911 to help get her up.  This is also the same thing that happened last year when she took her vaccine.  She is still weak and can barely stand up, and is now using a wheelchair to navigate around the house.    She has not called her doctor.  Every day she gets a tiny bit better where she can stand up long enough to get from her wheelchair to her lift chair and back.  She is not running any fever at this time, just the weakness that she is having.    When she had this last year it took several days for the symptoms to get better.  She states she will not go through this again and will not take another COVID vaccine.
This case was reported by a healthcare professional and described the occurrence of skin sensitive at injection site in a 11-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline) and PENTACEL (Non-GSK). On 4 August 2014, the subject received 1st dose of BOOSTRIX (.5 ml) and received erroneously an unspecified dose of PENTACEL by mistake of human error. On 4 August 2014, less than one day after vaccination with BOOSTRIX and PENTACEL, the subject experienced increasing of sensitivity at injection site and accidental overdose. At the time of reporting, the outcome of the event was unspecified.
MOM STATES CHILD WENT HOME, PLAYED FOR SEVERAL HOURS, ATE DINNER, FATHER BATHED CHILD THEN SHE WAS PUT TO BED. HER YOUNGER WOKE HER UP SO MOM MOVED HER TO MOM'S BED. SHE FELL ASLEEP AT 11:10PM AS STATED MOM AND STARTED HAVING SHAKING ALL OVER HER BODY LIKE A IF IT WAS A SEIZURE. MOM CALL 911. GRABBED CHILD IN HER ARMS, WENT OUTSIDE TO WAIT FOR AMBULANCE. SHE HAD VOMITED SOME CLEAR FLUID WHILE WAITING ON AMBULANCE. THEN ONCE MORE. AMBULANCE TOOK CHILD TOMEDICAL CENTER. MOM STATED THEY WERE BACK HOME THIS MORNING AROUND 6AM OR LITTLE AFTER. CHILD IS HER NORMAL ACTING SELF AT THIS TIME OF CALL (10AM), MOM STATED THAT CHILD HAS APPOINTMENT FOR CHILD TO HAVE CAT SCAN, MRI AND BRAIN STUDIES. CHILD STILL NO FEVER. CHILD IS ONLY ON PROBIOTIC AS FAR AS MEDS. MOM ALSO STATED THAT SHE WAS TOLD BY MEDICAL CENTER THAT THE SEIZURE WAS PROBABLY CAUSE BY HER GETTING THE LIVE INTRANASAL VACCINE.
Patient has been feeling shortness of breath with a productive cough, fatigue, malaise, and generalized body aches for about 3 weeks (beginning mid August?). She presented to the hospital on 9/7/21 and tested positive for COVID.
covid-19; covid-19; diarrhea; throwing up; nausea; depleted of potassium; diagnosed with a UTI; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "covid-19"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; VOMITING (non-serious), outcome "unknown", described as "throwing up"; NAUSEA (non-serious), outcome "unknown"; BLOOD POTASSIUM DECREASED (non-serious), outcome "unknown", described as "depleted of potassium"; URINARY TRACT INFECTION (non-serious), outcome "unknown", described as "diagnosed with a UTI". The events "depleted of potassium" and "diagnosed with a uti" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood potassium: depleted of potassium, notes: she was not admitted just walked in and was told that her body was being depleted of potassium and she also was diagnosed with a UTI which she states happens to her all the time and she sees a urologist and a specialist for that.  Additional information: Caller states she had diarrhea. Caller clarifies that she received a call asking about an adverse event she experienced to the Covid vaccine and states that it was a week after that she went to the hospital, had diarrhea for two weeks from Covid, not the vaccine, states the Covid gave her bad diarrhea and throwing up and nausea. States she had to go into the hospital, she was not admitted just walked in and was told that her body was being depleted of potassium and she also was diagnosed with a UTI which she states happens to her all the time and she sees a urologist and a specialist for that. States she had not been on Paxlovid for a week or two and then went to the hospital. Caller was unable to clarify details. Caller was noticeably frustrated and hard to re direct during call. Caller declines to provide any other contact information, states that she does not want there to be any reports of her having an adverse event because she states she did not have an adverse event to any medication. Caller would like someone to follow up to confirm that she stated she did not have an adverse event reported. States that the lady she spoke with from Pfizer before may have thought she said it was from the product. Caller does not provide any reference numbers.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
syncope; POTS; dizziness; headache; This spontaneous report was received from a lawyer regarding a case in litigation concerning a 15-year-old female patient (pt). Information on the pt's concurrent conditions, medical history or concomitant therapy was not reported. On an unknown date, the pt was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. Following vaccination, in 2012, the pt experienced Postural orthostatic tachycardia syndrome (POTS), syncope, dizziness, and headache. The outcome of all the events was not provided. The reporter stated that the events were deemed or should had been deemed causally related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) vaccination. This is one of multiple cases from the same reporter.  Upon internal review, Syncope was considered a medically significant event.; Sender's Comments:  US-009507513-2301USA006946: