chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Medium, Additional Details: patient began to feel nauseas and dizzy so laid supine. He described feeling flush. He has a needle phobia so may have been associated with some level of anxiety. The patient kept coughing, denied any throat/breathing trouble but was given benadryl preventatively. patient waited additional time period to recover before leaving the facility
DEATH; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient died. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died due to unknown cause. This report was serious (Death).; Sender's Comments: V0; 20210626664- COVID-19 VACCINE AD26.COV2.S-Death. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Initial case received from a health care professional on 09 October 2012. The male patient, age 60, whose medical history was reported as having received treatment for low testosterone on an unspecified date and no known allergies received a dose of FLUZONE ID intradermally on 05 October 2012 (lot number UT4463AA, expiry 25 March 2013) into the left arm. Within 3 hours of vaccination, the patient developed a fever of 102.5 and redness and soreness at the injection site. The patient was seen by the physician on an unspecified date with redness on entire left arm and anterior chest and a fever. The patient was treated with BENADRYL and antibiotics, details not specified. On the day of the report (09 October 2012), the patient was seen by the physician and was experiencing swollen lips and a feeling of her "throat closing". Concomitant medications and lab results were not reported. No further information was available at the time of report. The patient's outcome was not reported. Documents held by sender: None.
pt stated that after she took the covid vax  her arm was red and hurting very badly.  Later she felt nauseas, had muscle pain and headache.  Temp was 100.4.  She took 2 Tylenol and felt some better.  By 3/17/2021 she began having more muscle pain in her arms and legs and her arm is still very sore.  Pt states she will call her PCP for medical advice.
Congestive Heart Failure; More and more out of breath on any exertion; This case was reported by a consumer and described the occurrence of congestive heart failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included leukemia lymphoblastic acute (found out that she had acute lymphoblastic leukemia in September).   In January 2023, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and acyclovir, the patient experienced congestive heart failure (serious criteria GSK medically significant) and shortness of breath. The patient was treated with acyclovir and dasatinib (Sprycel). On an unknown date, the outcome of the congestive heart failure and shortness of breath were unknown.   It was unknown if the reporter considered the congestive heart failure and shortness of breath to be related to Shingrix.     Additional Information: GSK receipt date: 3-Feb-2023 Reporter's comment: In September, they found out the patient had acute lymphoblastic leukemia. She was treated with a drug called Sprycel which targets the chromosome, and also Acyclovir, an anti-Shingles drug, because people with compromised immune systems could get shingles.  The patient recently she was told that if she got the Shingrix vaccine, and if it worked, she might not have to take Acyclovir. So she took the first vaccine of the pair (Shingrix was given in 2 doses, 2 months apart). The patient also kept on taking Acyclovir. But since the shot, the patient got more and more out of breath on any exertion and now it turns out that she had congestive heart failure.  This could be for any number of reasons, even the Sprycel could contribute to it. In fact the physician thought the reason was probably the Sprycel. However, did notice an interesting thing about congestive heart failure. There are various drugs that made worse and one website says that, 'a number of medications used to treat cancer was associated with potential heart issues. However, the class of drugs of most concern are anthracyclines, which are derived from antibiotics that inhibit DNA and RNA synthesis and prevent cancer cells from growing.' The reporter did not know if Shingrix works on RNA-Acyclovir does and also looking more closely at the website that says this, the mechanism of action did not seem to be relevant. Acyclovir and Sprycel was coded as treatment as per narrative information and off label use was not coded as event as it was confirm from the physician or health care professional whether it was intentionally given or not.
On 08/07/2000 the patient developed an "approximately one to two inch circle at the injection site with red spots in the center, but no blisters. The affected area was also itchy. Additional information has been requested.
I began having symptoms of Adrenal/Addisonian crisis approximately 12 hours after vaccination (extreme cold, violent shivering, shortness of breath, nausea, mental status changes, low blood pressure and rapid heart rate.)  I had to take an immediate dose of steroids  (hydrocortisone) at the time and then increase my usual dose for the following day as well (as I have been instructed by my physicians to do in case of crisis.) No further medical treatment was necessary since I am familiar with "sick-day" self-treatment for adrenal crisis.  This has happened to me once before following COVID-19 vaccination (Pfizer booster) but never from any other routine vaccinations (influenza, pneumococcal, tetanus etc)
Mom called at 9:00am on 08/03/2005 to report that client experienced itching and hives starting about 2 hours after immunizations given on 08/02/2005. Client kept working till evening. States no Meds were given to relieve itching or discomfort mom reports client resting on 08/03/2005. Encouraged mom to take client to own MD.
It is thought to be vaccine-induced myocarditis. Myocardial infarction was ruled out.  Patient does now have a reduced ejection fraction of 45%. Here is the note from the ED today:  "He indicates that he was awakened from sleep with chest pain this morning around 2:50 AM.  He ended up trying to sleep longer to see if it would improve and ended up going to his mother's room.  She recommended that he drink some orange juice and gave him some Tylenol.  He states that the pain continued to increase since that time and he asked her to bring him to the emergency department.  The patient states that the pain is on the left side of his chest radiates to his left shoulder and down his left arm.  He denies that it radiates to his back.  He has had lightheadedness.  He does not feel short of breath.  He does have some pain into his left jaw as well.  He has not had any vomiting.  He denies abdominal pain.  He denies diarrhea.  The patient did receive his second dose of the Moderna vaccine on Friday to his left arm.  He has had fevers over the past 24 hours to 103 at home.  His mother and he indicate that the go away with Tylenol though seem to come back when the Tylenol wears off.  He did complain of some headache, myalgias, malaise and sore throat which she states were all worse when he would have a fever and seemed to dissipate when his fever resolved.  He states he did not and has never had chest pain like this until this morning.  The patient does not have a history of Covid infection.  He is active and has run track in the past.  He has not had any travel.  He denies any pain or swelling to his legs or calves.  He has had no sick contacts.  His mother received her second dose of the vaccine on the same day that he did and has not had any similar symptoms. "
no energy and head aches every sinse second shot; no energy and head aches every sinse second shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Sep2021 14:00 (Lot number: 301308a) at the age of 73 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: 301308a, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 30Aug2021, when the patient was 73 years old, for COVID-19 immunization. The following information was reported: ASTHENIA (non-serious), HEADACHE (non-serious) all with onset 25Sep2021, outcome "not recovered" and all described as "no energy and head aches every sinse second shot". The event "no energy and head aches every sinse second shot" and "no energy and head aches every sinse second shot" was evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of asthenia, headache. No follow-up attempts are possible. No further information is expected.
The night after Moderna's third dose began a low-grade fever of about 100 degrees Fahrenheit, accompanied by headaches, sweating, chills, and coughing.
HAD THE VACCINE ON 5/28/2019 AT 4:20 pm. WOKE UP AT MIDNIGHT, SEVERE PAIN IN LEFT ARM. 5/29/2019 ARM STARTED SWELLING & TURNING RED. PAIN CONTINUED & SWELLING & SEVERE REDNESS FROM THE INJECTION SITE TO ELBOW. THE SITE WAS HOT TO THE TOUCH. IT CLEARED UP IN 5 DAYS REPORTED SITUATION TO DR.
The patient received a pediatric dose of Pfizer in error. They should have gotten the regular dose of Pfizer. The patient's mother was informed of the error as soon as it was discovered. The mother was informed her daughter did not need to repeat the Pfizer dose per CDC guidelines.
This spontaneous report as received form a certified medical assistant refers to five patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. In July 2015, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # K021935, expiration date: 10-NOV-2016), dose and route were not reported. No adverse effects reported. Additional information has been requested.
I got my first Moderna vaccine on  Friday September 24th and felt very ill that night, with profuse sweating. with heart rate of 109 to 113, gait instability but not dizzy, increase somnolence and inability to stay focus. I had a headache on the following day. I felt some what disoriented with generalized body ache. this continued until Friday 10/01/21. Increased heart rate lasted for 2 days. I was unable to function for 1 week.    I got my second dose on Friday 10/22/21 and again felt very ill. Extremely drained of energy with profuse sweating entire body aching, redness and swelling of my left upper arm, severe joint pains with swelling of both shoulders, all joints in my hands, my hips, my knees and both feet, with swelling and redness very much like grossly inflamed bunions. As of today, 10/29/21, I am still having  6/10 bilateral knee pain, swollen joints in both hands, pain in both thumbs, and feet. I am very concerned that the joints in  my thumbs are becoming deformed.  I self medicated with Tylenol arthritis 2tabs twice daily with Meloxicam 15 mg daily. Body Massages two to 3 times daily and lots of vitamin c and good hydration. my pain was reduced by 50 % with the medication. Also Tramadol 50 mg at night as needed. I still have join pains but now able to function.
Covid Vaccine was administered on Left Gluteus (IM) per patient request. Patient requested MSS to administer vaccine on Gluteus due to soreness on arms due to past surgeries.
ITCHY RASH; SWELLING ON FACE; SWELLING ON LEGS; BURNING ON FACE ARM AND LEGS; SORE ARM; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, penicillin allergy, non-smoker, and abstains from alcohol, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 and expiry: UNKNOWN) dose was not reported, administered on 03-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 03-MAR-2021, the subject experienced sore arm. On 13-MAR-2021, the subject experienced itchy rash. On 13-MAR-2021, the subject experienced swelling on face. On 13-MAR-2021, the subject experienced swelling on legs. On 13-MAR-2021, the subject experienced burning on face arm and legs. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning on face arm and legs, and sore arm, and had not recovered from itchy rash, swelling on face, and swelling on legs. This report was non-serious.
The vaccine did not prevent shingles as intended; Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 21-JAN-2009, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown), as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 01-MAY-2015, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as a severe herpetic rash. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Chills, body aches, low fever ~99.5, headache, these lasted for about an hour and mostly went away.  The day after receiving vaccine I had some body aches still and headache
10:00 pt complain of minor swelling in the throat and pain after second dose of covid vaccine. Pt state no allergic reaction with the first dose of Covid vaccine before. This healthcare provider assess pt and no SOB, no swelling of the face, and no sign of distress. VS 98% on room air HR 71. Lung sounds are clear bilaterally and no stridor in the throat. Pt airway patent and clear. Healthcare provider radioed another healthcare provider to asssit. Continue to monitor at this time and have the pt stay an extra 15min.   10:20  Pt state throat swelling has worsen. Healthcare provider assess pt and no SOB, no swelling of the face, and no sign of distress. VS 99% on room air HR 69.  Lung sounds are clear bilaterally and no stridor in the throat. Pt airway patent and clear. Discus with pt to be transfer to onsite urgent care for further evaluation and treatment. Pt agreed to urgent care.   10:21 pt transfer to urgent care with no sign of distress and was accompanied by healthcare provider.
pt recv vax; in may1996 pt exp zoster on sacral area which wrapped around in a band; no further details provided;
Patient became listless, hypotonic, somnolent, minimally responsive (encephalopathy).
Patient listed on questionnaire that this was 4th shot in series.  Their card only had 4 shots on it as well.  Incidentally when I went to put her shot into the electronic charting system it was their 6th shot.  I even asked her prior to injection if they had ever received the Bivalent specifically. There was only 4 wrote on covid card. SHot given believing it was the 5th and last, but impact showed differently even though her card did not reflect that
Post breakfast-got scolded-cried, R eye was red Then got lethargic, eyes half closed and almost fell over. Felt warm called 911-> Pediatric ER. Exam normal. ?Breath holding? just short of a febrile seizure ?stomach cramps (diarrhea on 10/29)
3hrs after the patient's vaccination, she fell to the floor and was unable to get up, noted to have R sided facial droop, inability to speak, R sided weakness.  Found to have a large stroke with left sided M2 MCA clot noted on CT angiogram.
Within hrs., shot site was large, red/pink oval at 4 inches in diameter by 2 inches high.  Lasted 4 days.  In one week, upper arm (site of shot) muscle was throbbing in pain.  Pain so strong patient was unable to use arm for 2 1/2 months.  Now 6 months, after shot, patient occasionally has pain in that upper arm-minor pain. The follow up states, "Dr's nurse said I just had a plain flu shot-not "BCG" type of shot."
Extremely bad headache; 3.5 days of 101F fever; Upset stomach; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Extremely bad headache), PYREXIA (3.5 days of 101F fever) and ABDOMINAL DISCOMFORT (Upset stomach) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (He still has not regained his taste or smell.) in October 2020.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Extremely bad headache), PYREXIA (3.5 days of 101F fever) and ABDOMINAL DISCOMFORT (Upset stomach). At the time of the report, HEADACHE (Extremely bad headache) had not resolved and PYREXIA (3.5 days of 101F fever) and ABDOMINAL DISCOMFORT (Upset stomach) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
4-24-12 - local reaction Rt. upper arm - redness with erythema. 4-25-12 - cellulitis Rt arm inj. site clindamycin started. Went to ER - neck pain - Dx MENACTRA reaction. 4-17-12 Sent to office - allergic reaction - MENACTRA, cellulitis resolved on clinda, BENADRYL, prednisone. 4-28-12 Back pain - difficulty swallowing - sent to ER to R/O Guillain Barre.
Muscle pain, fatigue, headache, shivering, fever, hoarseness and right lower eye lid twitching .  The eye twitching had not gone away yet, other symptoms are fine now, but not the eye twitching.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F(Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the medical assistant regarding an unknown age and gender, patient with no pertinent medical history reported. On 29-NOV-2012 the patient was vaccinated with GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). Concomitant medications included Influenza virus vaccine (manufacturer unknown) administered on 29-NOV-2012 (intramuscular in the right arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Red raised area about 7 inches just below the injection site.  She expressed that she did have her second  pneumonia vaccine 16 days prior to the Moderna vaccine.  UTI in January 2021.
The pt developed a seizure at home on 3/15/01 early in the morning. EMT called, taken to the hospital. The pt experienced another episodes of seizures, was intubated, started on Dilantin IV and transferred to another facility.
Site uncomfortable for week plus one day.  Then hard pain in shoulder and spreading across shoulder, up neck and down  around collar bone.  Went to Dr. and was told it was neuropathy and was prescibed  Prednisone.
Day 1 (1-5-21): sore arm bruise Day 2 (1-6-21): more severe sore arm and bruise Day 3 (1-7-21): sore arm that's getting better. Red, inflamed, hot to touch at injection site. 1in x 2in in size.
With her previous vaccines her arm was a little sore for a couple days but that's it but nothing like this; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 69-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First Dose, Dates Unknown. NDC, Lot, Expiration Unknown.), for Covid-19 Immunization, reaction(s): "With her previous vaccines her arm was a little sore for a couple days but that's it but nothing like this". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "With her previous vaccines her arm was a little sore for a couple days but that's it but nothing like this". Therapeutic measures were not taken as a result of pain in extremity.  Additional Information: It was reported that, husband was calling on behalf of wife, aged 69 received her fourth dose of the Pfizer BioNTech COVID 19 vaccine this past Tuesday. "With her previous vaccines her arm was a little sore for a couple days but that's it but nothing like this". It didn't get all red or swell up. It was sore for a day or two and that was it. It was discolored and it was kind of a large area that got red. It had not gotten better. She did not seem to be running a fever but if she was it would be low grade. He did not know if it was hot to the touch. It looked inflamed and red. He did not think it was a rash. It looked like someone punched her in the arm. The area of inflammation was about the size of his fist. Investigations were reported as No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Tiny vesicle on palate and skin with scattered erythema lesions with tiny and a few less tiny vesicles.
87F with hx of chronic back pain, spinal stenosis, on chronic opioid pain control, macular degeneration with blindness, hypothyroid, HTN, multiple abdominal surgery (5x C-section, partial gastrectomy, Roux en Y), and recent incidental COVID positive test (8/4) who presents to the ED with worsening nausea over last couple of days and constipation for more than a week, despite escalating bowel regimen at home. Pt is still at hospital by 8/18/21 but did not have symptoms for COVID.
Child had allergic reaction two hours after. Immunizations at outside facility. Patient presents to emergency department with hives present on her back, abdomen and legs. She also has facial swelling and wheezing present.