chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever Blister on her Lip; Left Arm 10/10 Pain, can't lift her arm up, has to use her right arm to lift her left arm up; Left Arm 10/10 Pain, can't lift her arm up, has to use her right arm to lift her left arm up; This is a spontaneous report from a contactable consumer or other non HCP (Patient). A 54-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6204), dose 1 via an unspecified route of administration, administered in Arm Left on 20Mar2021 09:15 (at the age of 54-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient had no medical history and no family medical history relevant to AE. The patient's concomitant medications were not reported. The patient had no other Products. The patient had no history of previous immunization with the Pfizer vaccine. The patient had no additional vaccines administered on same date of the Pfizer suspect. The patient had no prior Vaccinations (within 4 weeks). The patient had no adverse events (AE) following prior vaccinations. Caller states her injection was done on 20Mar2021, but she didn't have any problems until 28Mar2021. On 28Mar2021 (Time of Onset (24-hour clock): P.M. when went to bed that night, 20:00-21:00), stated it was at the point now that she can't lift up her left arm. States where she got her injection, it was not red and not swollen but the inside of her arm was where the pain in coming from. Stated on a scale of 0-10, her pain was a 10. States it was to the point where she can't lift her arm. She stated she has had no fever, no coughing, just a lot of problems with her left arm. States she contacted her physician, but he didn't offer anything, and he said to still get the second injection on 14Apr2021. She stated if it was still hurting, she was not going to get the second injection. Caller asks if Pfizer has any suggestions for her. Stated she hasn't talked to anyone about this because a lot of her friends don't want to get the injection anyway and she has to be careful what she says around people. Caller states she was a Medical Assistant. Caller states she contacted her doctor on 07Apr2021, but he didn't recommend anything just that she should get the second injection. States she came home to get in touch hoping to find someone that could offer her something for pain for her to get better before the second injection. States there was no way she was letting them stick her in her right arm. Clarifies she has to pick up, using her right arm, she has to pick up her left arm to move it. Caller states she developed a fever blister on 08Apr2021, and she doesn't know if it was coming from the pain, but she doesn't get fever blisters. States it was on her lip. The adverse events not required visit to emergency room. The patient did not visit the physician office but called the doctor. She was treated with alcohol, warm cloth, witch hazel, Icy Hot. The patient had no relevant tests. The outcome of the event fever blister on her lip was unknown and outcome of the other events was not recovered.   No follow-up attempts are possible. No further information is expected.
BURNING SENSATION DOWN THE INSIDE OF ARM/ BURNING IN UPPER BODY; BURNING IN TONGUE; WEAKNESS IN CHEST; HEART PALPITATIONS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, and batch number were 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 subject experienced burning sensation down the inside of arm/ burning in upper body, burning in tongue, weakness in chest, and heart palpitations. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the burning sensation down the inside of arm/ burning in upper body, weakness in chest, burning in tongue and heart palpitations was not reported. This report was non-serious.
Patient received his Kinrix and Proquad in his left thigh on 12/27/19.  Patient came in with his father on 12/30/19 due to redness and swelling of his left thigh.  He denied pain, had no limp, no fever and the swelling was improved since 12/29/19.  I measured the red area to be 16 cm down his thigh by 23 cm across.  It was slightly warm to the touch but non-tender and pt was using his legs fully, squatting spontaneously during the visit.  He had a very small, mobile non-tender lymph node in left inguinal area.  No streaking.  Discussed with patient's father that sometimes we see a localized skin reaction related to the diptheria in the vaccine.  Recommend continue Benadryl for 48 hours and warm compresses.  If fever, pain, not walking normally, return to clinic to consider giving antibiotics.   Since he is doing better with Benadryl, we chose to not start antibiotics today.
SEVERE BLOOD CLOT IN EYE; SLEEPING DIFFICULTY; LOT OF MUCUS; SEVERE RASH ON NECK WHICH WENT DOWN THE ARMS TO THE ELBOW/RASH ON BACK AND PART OF THE HEAD; This spontaneous report received from a patient concerned a 7 decade old female of unspecified race and ethnicity. 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 (dose number in series: 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient developed a severe blood clot in the eye and a severe rash on the neck which went down the arms to the elbow. The patient had visited the dermatologist and had started to get better. The rash had lasted for several months. The patient also had difficulty sleeping (dose number in series: 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe blood clot in her eye, severe rash on neck which went down the arms to the elbow/rash on back and part of the head, and sleeping difficulty was not reported. On 10-NOV-2021, the patient received booster of non-company suspect vaccine MRNA 1273 (dose number in series: 2) (form of admin, and route of admin, were not reported, batch number: 033F21A expiry: UNKNOWN) dose was not reported, administered to the left arm shoulder deltoid muscle for prophylactic vaccination. On an unspecified date, following vaccination with MRNA 1273, the patient developed a rash on the back, neck and part of the head. The patient had seen the doctor for the rash and was prescribed with cortisone tablets, antihistamine, ointments and liquids to put on the rash. The patient was also prescribed with clobetasol propionate (Clobetasol 0.05%). The patient also noticed a lot of mucus after the booster vaccine and stated that the rash was not as severe as it was after the covid-19 vaccine ad26.cov2.s. (Dose number in series: 2). The outcome of the lot of mucus was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220152554 COVID-19 VACCINE AD26.COV2.S- severe blood clot in her eye. 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).
Redness in her arm from where she wad given the shot (deltoid) down to her elbow. Also experiencing warmth in the affected arm but no pain.
Approximately a month after vaccine, patient noticed a large red area on upper right arm, which then developed into a darkened and thickend area, approx 3cm x 3cm a few days later.
Pt recvd measles vax 27DEC90; On 4JAN91 pt devel malaise, h/a, & photophobia; On 5JAN91 pt c/o neck stiffness; next day pt devel t99-100; On 7JAN91 temp inc to 103 & devel a generalized rash on chest; Pt taken to ER w/rash & fever;
The patient states that first dose , she got very sleepy after 5 minutes getting the dose. She states she get tremors from an eye drop she doesn't know the name of.  Patient states that she has no seizures, and her dr cant explain tremors from eye drop. On the second dose , patient got tremors after 5 minutes, the tremor was a bit severe, patient got sleepy and her neighbor states that's what happened last time , in terms of sleepiness but not tremors. Then patient was back to normal . talking normally
PATIENT STATES SHE WAS VOMITING AND SEVERE DIARRHEA.
event: Stroke 3.5 weeks after shot.. affected complete left side of my body,  arm  limited dexterity, also left leg  is the same way.  I'm impaired for the rest of my life..
mom first noted small red bump 17MAR98 & put cortisone lotion w/alovera;pt c/o area itching, rash enlarged per mom-circular bruise noted 1 1/2 x 1 1/6 w/3 red bumps in center skin dry;T98.3;20MAR98 rash on lt deltoid pt moving arm w/o diff;
Child is 12 y/o and rec'd a lesser Pfizer dose; a Pfizer dose of 0.2 mL which is given for 5-11 y/o's.   There was no adverse outcome.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2 NOS), on 05Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Erythromicin, reaction(s): "Drug Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from  06Aug2023 to 11Aug2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Presented to ER on 11/27/21 and admitted. This is an elderly 82-year-old Caucasian gentleman with history of dementia,  prior history of CVA as well as CKD stage 4, who was brought to the local  emergency room at Hospital with a fever of 101.6,  complaining of generalized malaise.  Also he was found to be COVID positive  and chest x-ray was showing questionable left lower lobe pneumonia.  Also his  lactic acid was slightly high at 2.8; repeat one being 2.1.  The patient does  have a history of BPH.  They placed a Foley catheter in him and the patient  was supposed to go to Clinic, but as per the family's request, they  called another location.  When I spoke to the ER doctor, the patient had not gotten any  treatment, no Decadron, no remdesivir, and since his onset of symptoms is  relatively new and he is hypoxemic requiring 3 L of oxygen, he was deemed to  be a candidate for both remdesivir and Decadron, which was then requested to  be started over there.  When I saw the patient, he is pleasantly confused.  He  is oriented times 2, knows his name, knows that he is at this hospital.  His  vital signs are relatively stable.  He is saturating well on 3 L nasal  cannula.  He will be admitted as an inpatient to our COVID-19 floor. Patient was weaned of oxygen, was afebrile. Prior to discharge patient continued to feel better. Discharged on 11/29/21
Flu Symptoms   Clinical Support 8/6/2021 Urgent Care Medication Infusion  Reason for Visit Progress Notes (Registered Nurse) ? ? Encounter Date: 8/6/2021 ? ? Signed    1300 Patient arrived for MAB infusion. SOB after walking to exam room. Pulse ox 88% on RA. Encourged to cough and deep breathe. Move pulse ox to another finger.    1305 pulse ox 85% RA patient states he is SOB.    1308 O2 2L NC applied   1311 Pulse ox 90% on 2L NC   1314 Pulse ox 90-91% on 2L. Less labored breathing. Patient states he is fine if he is just sitting but becomes SOB with any exertion.    1319 Asked patient to lean forward to listen to lungs, started coughing and pulse ox dropped to 89%.    1323 Patient stated he noticed significant labor breathing after showering this am that did resolve after resting. He then became SOB anytime he was out of his chair moving about.    1332 Pulse ox 91%. Patient states he is starting to feel a little better. Removed O2 to see if patient can maintain pulse ox of 90% or better. Explain to patient that if pulse ox drops we will not be able to administer the medication. Patient verbalized understanding.    1338 Pulse ox dropped to 89% on RA. O2 @ 2L NC reapplied.    1345 Pulse ox up to 92-93% on 2L NC. Dicussed the need for the ED. Patient would does not want to go by ambulance. His wife is at home and he has the car.    Patient declined ambulance. Removed O2. Patient discharged and instructed to go to ED.    1356 Report given to ED  ED to Hosp-Admission Discharged 8/6/2021 - 8/17/2021 (11 days) Hospital 1.  Acute hypoxic respiratory failure present on admission secondary to COVID-19 pneumonia in a morbidly obese patient.  I will start him on O2 protocol nebulization treatments. 2.  COVID-19 pneumonia chest x-ray reviewed we will start the patient on remdesivir IV steroids nebulization treatment O2 protocol. 3.  Diarrhea with severe dehydration dry oral mucosa we will start him on normal saline at 100 mL/h diarrhea most likely from COVID-19 GI symptoms. 4.  Acute on chronic renal injury present on admission underlying CKD stage III.  Secondary to diarrhea and poor oral intake I will hold lisinopril and Lasix.  We will start him on normal saline at 100 mL/h repeat BMP in the morning. 5.  Hypertension benign fairly controlled we will keep a close eye on his blood pressure we will continue the Coreg but will hold lisinopril because of acute on chronic renal injury and dehydration. 6.  Morbid obesity with body mass index 50.92 patient's counseling done in detail. 7.  DVT prophylaxis moderate risk subcutaneous heparin bilateral compression devices. 8.  Advanced care planning discussion he is full code.   Patient will be admitted to intermediate care under hospitalist service medical management was discussed with the patient and his wife in detail at the bedside.   Chief Complaint Patient presents with ? Hypoxia
pt recvd vax & later febrile; projectile vomiting; lethargic-unresponsive & staring;  episode lasted 30-60mins; pt limp, would not support head; appeared tired;
After 1st shot Just a sore arm. The 2nd shot, 12 hours later, woke up with severe fever, chills, tachycardia, and heart beating uncomfortably hard. Severe headache, eyes twitching, and restless, I felt like my system was being fried. Lasted 16 hours and treated with 400mg ibuprofen every 4 hours which helped a little.  However, 2 nights later, woke up sweating, with tachycardia, and chills. As well as last night for a pattern of every other night. Also, irregular feelings in my chest occur randomly now. Extremely scary and upsetting that I was healthy and now feel like something isn't right. One day I'm fine, the next I'm not.
Previously well 19 y/o who on 29 Sep; presented with acute chest pain and shortness of breath x 24 hours that started with exertion. Pain worse with exertion and lying down and better with rest and leaning forward, w/o dyspnea, lightheadedness, or history of trauma. No cardiac risk factors. Also has a rash on trunk (probably NVP or heat rash). CP described as sharp, worse with inspiration. Located over center chest with left more prominent than right. Difficult to breath when chest pain severe. Robust take of smallpox vaccination site on RUE.
Talked w/ client on Thursday May 24th around 1:30. She said her (L) arm, crown of her head, and (L) leg swelled the day after receiving MCV4. Note: Pt. also complained of gastric upset following Hep A injection on 5-15-12.
Sore Arm to the touch and when moving; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm to the touch and when moving) and CHILLS (Chills) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer in 2018. Concurrent medical conditions included Neuropathy. Concomitant products included PREGABALIN for Neuropathy, DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL EXTRA) for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced CHILLS (Chills). On 26-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm to the touch and when moving). On 19-Mar-2021, CHILLS (Chills) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore Arm to the touch and when moving) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medication also included muscle relaxer. Treatment information was not provided. Patient said she is feeling better now and has nothing else to report and that her symptoms cleared up quickly.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow-up information received on 13 MAY 2021 and does not contain any new information.
I had nausea and dizziness the following day after the vaccine. I passed out from it.
Red swollen lump that started same day of vaccine and is still there. Larger and hot to the touch. Fatigue and exhaustion. Body aches. Headache.
The injection site has been sore all day (03/18/2021). It hurts to lift my arm. I also have developed a slight rash on my face.
I spiked a pretty high fever over 101 degrees accompanied by chills. The spot on my left arm swelled up to the size of an orange and was burning hot and very panful and red. The fever lasted for a day or 2 and the issues with my arm lingered for 2 weeks.  I was given a prescription for a steroid cream (Triamcinolone .1%) which helped with the swelling and burning within a few days. I was also prescribed an oral steroid that I did not use.  I was advised by my doctor to take it easy, rest and drink plenty of fluids and to let the vaccine run it's course.  Additionally I contracted COVID -19 at the beginning of August. The person I contracted it from tested positive for the virus on July 30th 2021.  I then tested positive on Aug 2nd 2021.  I started feeling sick Sunday afternoon. My temperature stayed around 100 degrees. I have a lot of congestion, extreme fatigue and I have lost my sense of smell.  My doctor feels I may have contracted the virus and developed a sinus infection at the same time. I am on antibiotics (Cefdinir 300mg) which I started on Aug 2nd. An X-Ray was completed and concerns were raised about my heart though my lungs look fine.
After administration of GARDASIL vaccine patient felt like she was going to pass out.  Her blood pressure dropped to 90/52 and pulse dropped to 48.  Layed patient down, given a drink of soda.  Rechecked patient after 10 minutes and she felt better.  Blood pressure rechecked and returned to normal.  Patient released.
LITTLE SORE ARM; This spontaneous report received from a patient via a company representative concerned a patient. 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced little sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of little sore arm was not reported. This report was non-serious.
This case was reported by a consumer via sales rep and described the occurrence of itching both hands in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced itching both hands. On an unknown date, the outcome of the itching both hands was unknown. It was unknown if the reporter considered the itching both hands to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. The reporter indicated that the pharmacist told him that patient experienced the same side effect. (itching on the top and bottom of both hands.) This case was linked with case US2018178360, reported by the same reporter.
A spontaneous report has been received from a Health Professional concerning a patient of unknown age and gender, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent started on an unknown date. In November 2014, the patient was inadvertently administered FLUMIST quadrivalent. The outcome of the event of inadvertently administered FLUMIST quadrivalent to 7 children under 2 years of age is unknown. The report was considered to be non-serious by the reporter.
Had a flu shot on 8/20 at 3:40 pm, 102.6 Fever at 8:30 pm on 8/20/2016 until 6:00 PM on 8/21/2016.
Fever 102 11/29/97 - fussy & lethargic.  Rt thigh red & swollen & warm to touch at injection site.
PROQUAD and KINRIX administered to patient on 7/25/18 at 9:30am after his routine well child exam. Mother then brought him to school. Mother received a call from the school nurse around 2pm letting her know patient had developed an itchy rash under each armpit. Mother picked patient up from school and brought him home. She reports the rash was on his trunk at this time. Through the evening mother administered BENADRYL every 6 hours. At 8am patient was in the office for an evaluation. Diffuse generalized hives noted throughout his body including his face. No facial swelling, cough or wheeze noted. Rash very itchy. CLARITIN administered in the office with moderate effect. Prednisone (15mg/5ml) 5ml PO BID x 5 days was prescribed.
today he woke up very cold; shaking; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING COLD (today he woke up very cold) and TREMOR (shaking) in a male 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. In January 2022, the patient experienced FEELING COLD (today he woke up very cold) and TREMOR (shaking). At the time of the report, FEELING COLD (today he woke up very cold) and TREMOR (shaking) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.
This non serious case was received 11 March 2009 from VAERS (reference number 249662) via a search of QScan database. A 38 year old female patient received FLUZONE SV '2005-'2006 USP (lot number U1830AA) intramuscularly on 21 December 2005. Four hours post vaccination, the patient experienced a foreign body sensation in her throat and a dry cough. Six hours post vaccination she experienced fatigue, a low grade fever (temperature was not taken), uncontrollable chills/rigors, muscle aches throughout the entire body, and "injected eyes bloodshot". Seven hours post vaccination, the patient was treated with ADVIL 400mg. The patient had an improvement in her symptoms two hours after taking ADVIL. The patient had further improvement except for tiredness eight hours after taking ADVIL. The patient was reported recovered.