chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COPD exacerbation (CMS/HCC)  COVID-19  Multifocal pneumonia  ED Discharged  3/14/2021 (2 hours) Hospital ED MD Last attending ? Treatment team COPD exacerbation (CMS/HCC) +2 more Clinical impression Shortness of Breath Chief complaint ED Provider Notes MD (Resident) ? ? Emergency Medicine Cosigned by: MD at 3/16/2021  2:06 PM Expand AllCollapse All        ED RESIDENT NOTE                Chief Complaint      Chief Complaint Patient presents with ? Shortness of Breath        History of Present Illness   Patient is a 64 y.o. yo female presenting to the ED with shortness of breath.  Patient has history of COPD and asthma.  She uses inhaler daily and also uses nebulizer as needed.  She got her first Covid vaccine on March 1.  Approximately 6 days later she spent a significant amount of time around her son-in-law who unknowingly at that time had Covid.  She presents today with worsening shortness of breath, nighttime chills, productive cough.  She also feels that she has been wheezing and using her inhaler recently.  She is concerned that she potentially has Covid and that she may have a more severe version because she got the vaccine and was exposed to someone at the same time.  She endorses some vague right-sided chest pain that is only present while coughing.  Patient is Spanish-speaking only so translator is used for history gathering.        Medical Decision Making     Patient presents emergency department complaints of shortness of breath.  Recently got first vaccine for Covid but shortly thereafter was exposed someone with Covid.  Has been coughing, having nighttime chills, and chest pain with coughing.   Bedside exam reveals stable vital signs other than tachypnea.  Pulmonary exam does reveal diffuse rhonchi and wheezings.  Heart is regular.  Abdominal exam is benign.   We will get CBC, BMP.  Check chest x-ray and EKG.  Will give patient DuoNeb and steroids.  Will check a Covid swab.  I think patient is likely suffering from COPD/asthma exacerbation versus pneumonia.  Potentially triggered by Covid.  She currently is not hypoxic.  Anticipate breathing treatments, reevaluation, and likely discharge home.  Low suspicion at this time for cardiac process given that her pain is only present whenever coughing and she has significant findings on pulmonary exam.
Information has been received from a nurse concerning a 78 year old female who on 10-AUG-2009 was vaccinated with PNEUMOVAX 23 (LOT # 661527/0112Y). On 11-AUG-2009 the patient experienced back pain and an injection site reaction and pain in her arm where the vaccine was given. The outcome of the events persisted. The patient called the physician's office and was planning to come in to be seen. Follow-up information has been received from a registered nurse via medical records who reported that the patient was a retired female patient with hypertension, hypothyroidism, osteoporosis, gastroesophageal reflux disease (GERD), cholesterol levels raised and penicillin allergy. There was no illness at the time of vaccination. Concomitant therapy included SYNTHROID, PREVACID, CRESTRO, calcium (unspecified) and vitamin D (unspecified), losartan potassium-HCTZ (MSD), FISH OIL, aspirin, BONIVA and CENTRUM SILVER. ON 10-AUG-2009, the patient also experienced generalized myalgias, elevated temperature and localized edema at her injection site. The physician considered that the patient experienced PNEUMOVAX 23 allergy. The patient was told to use warm moist compress to injection site, increase fluids and have a rest. No lab diagnostic studies were performed. Subsequently, the patient recovered from these events on 13-AUG-2009. Additional information is not expected.
Adverse effects noticed:  Crippling Migrane headache (9/10), high fever (101-102?F), neck stiffness (7/10), nausea  (6/10), joint and muscle pain (8/10),  malaise (7/10), and considerable fatigue (8/10)  Treatment used: Over the counter medications (acetaminophen, small doses of caffeine, heat applications (submerged in high temperature bath, and used a heating pad set to high every 30 minutes), rest, fluids, and non-solid foods (soup, mashed potatoes)  Outcome: symptoms started rapidly 8 hours after vaccine, dampened after 32 hours, and disappeared after 53 hours from the vaccine.
SWELLING, REDNESS, AND FIRMNESS OF 1 CM AT BOTH INJECTION SITES ON LEFT LEG X 1 DAY
Patient nausea\vomiting and lightheadedness after vaccine. Given Zofran 4mg PO. Patient asymptomatic after about 10 minutes. Able to discharge home.
Patient was admitted to hospital 8/28/03 - 9/20/03 for sinusitis, sagittal sinus thrombosis and right frontal cerebral hematoma with infarct with symptoms of fever, headache and emesis starting 5 days prior to admission. Temporally related to Td immunization. Required oriniectomy and partial right frontal lobectomy.
CHILLS; FEVER; HEADACHE; NAUSEA; 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 was not reported, administered on 05-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced chills. On MAY-2021, the subject experienced fever. On MAY-2021, the subject experienced headache. On MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever, and the outcome of headache and nausea was not reported. This report was non-serious.
Information has been received on 6/4/02 from a physician concerning a male child who was vaccinated with a dose of MMR (second generation). Subsequently, the patient had a severe anaphylactic reaction, almost to the point of intubation. The physician reported that the reaction was probably caused by neomycin or gelatin but is not sure. The patient sought unspecified medical attention. Upon internal review, severe anaphylactic reaction was considered to be an other important medical event (OMIC). Additional information has been requested.
Hand, wrist, and forearm numbness upon waking up daily in both arms. Taking more than an hour to return to normal.
1st Pfizer vaccine given Feb 4th;  2nd Vaccine received 9:30 a.m. March 25;   Side effect 1:  Never having had nose bleeds I had 8 minor nosebleeds after the 1st vaccine. (chalked it up to "ND dry air).  March 24 at 1;30a.m. I awoke to a nose bleed my husband and I could not stop; went to ER and a catheter was placed in my nose  after an hour after they could not get it stopped. Catheter was removed next day.  Blood pressure 184/96 unusual for me range 120/80.  Side effect 2:  10 days after the 2nd vaccine I noticed loss of hearing in my right ear.  That has persisted but I have not taken any action on it.  My head is tender and I feel more "off balance than normal".  Not sure if this coincidence or side effect.
A grand mal seizure within 24 hours of shot. A warm reddened, sore area the size of a coffee cup still occuring 3 days later.
Chills, body aches, fatigue, diarrhea,  and caused menstrual bleeding to occur
Patient received flu shot. She got up and watch mother receive hers. Her and her mom walked out of pharmacy. Rph noticed they sat back down. Rph went to them. Daughter was hot and sweaty. She looked pale. She threw up in waste basket. Mother said she looked pale. Patient received flu shot around 12:00 pm. She got up. Her mother received hers. She watched mom get her flu shot immediately after hers. Her and her mom walked out of pharmacy. I (the Rph) noticed them sit back down. I went to them. Mom said daughter felt dizzy and was sweaty and pale. Daughter look pale and was "pasty". Daughter felt nauseous. Mom gave her a waste basket and she threw up. I felt her skin and it was cool and pasty. Injection site looked normal. After about 10-15 mins. daughter looked like she got her color back. I observed her until she felt better. Mom was confident she was ok and walked out with her. I called mom 2 hours later and daughter went to work and felt back to normal and ate something when she got home.
Fever 103 and above for 3 days. Patient was inconsolable and severely cranky, fussy, and not himself until fever broke.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 41-year-old female patient who received BOOSTRIX (batch number FB942, expiry date 3rd December 2017). On 11th April 2016, the patient received BOOSTRIX (intramuscular) .5 ml. On 11th April 2016, less than a day after receiving BOOSTRIX, the patient experienced injection site pain. On 13th April 2016, the patient experienced injection site nodule, injection site lymphadenopathy, injection site inflammation, injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site pain, injection site nodule, injection site lymphadenopathy, injection site inflammation, injection site erythema and injection site swelling were not recovered/not resolved. The reporter considered the injection site pain, injection site nodule, injection site lymphadenopathy, injection site inflammation, injection site erythema and injection site swelling to be possibly related to BOOSTRIX. Additional details provided were as follows: The case was not previously reported to anyone. On 11th April 2016 at 19:00, the patient received BOOSTRIX in left deltoid and on the same day, the patient's arm became painful, which had continued since that day. On 14th April 2016, 2 days after vaccination, the patient had redness and swelling at injection site. She also noticed that the lymph node under her left arm was swollen, there was a raised nodule, a red circle and very red inflammation (approximately 2.5 inches in diameter) at the injection site. The injection site was painful to touch, but was not interfering with normal daily activities. The reporter inquired about having any recommendations. The call was transferred to Medical Information System. This case was identified as duplicate of US2016054163. Case US2016054163 was deleted and all the future correspondence will be added in the present case which stands as case record for this patient.
Reported by father:  headache, screaming, fever (100.8).  Son has never been sick.  ER doctor gave some pills and said it was "the shot".  Dad gave Motrin next am for "fever".  Father did not return calls:  upset due to mandatory Tdap; blames this vaccination/side effects.
Sudden onset severe fever/chills, "shaking" woke pt from sleep.  Developed redness & swelling R arm to elbow & up to neck, wheezy breathing & throat swelling.  Took Tylenol.  Office exam 11/19/07-residual redness R upper arm.  Recovering as of 11/19/07
A mother reported that her 9 year old son received doses of Prevnar and Hep-A vaccines on 6/2/00. In 10/00, she noticed that her son was losing weight. By 1/01, her son had lost 10 lbs. He was subsequently, seen by his pediatrician. On 3/16/01, her son received a second dose of Prevnar. At that time he had developed bulging eyes, weight loss with increased appetite and had lost 14 lbs. In 5/01, her son was dx'd with Graves disease. The reporter noted that she requested the pediatrician to report this event; however, he declined since "he felt that it (Graves disease) had nothing to do with the vaccine". No further information was available at the date of the report. Follow-up info received from the child's pediatrician on 10/08/2001 stated that on 03/16/2001, the child received prevnar and Hep a vaccines. "It is my medical opinion that his shots on 03/16/2001 did not cause or contribute to his graves disease." Follow-up info changed suspect vaccine to Pnu-Imune 23.
Mouth sores. Started on right side and has gotten larger in last day. Several Other smaller ones appeared
you can get shingles even when vacinated I have had this experience/suspected vaccination failure; shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The reported stated that you could get shingles even when vaccinated. The reporter had this experience and it sure was not fun.  The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown at the time of reporting.
Patient stated that her arm was sore as of 6/16/21.  This soreness has lasted longer than 2 months now with no resolution.
Patient called today; 10/19/15 and said she got little bruises and redness around the injection site about 1 inch per patient. No other system - no itch, no fever, no pain. I suggested if patient doesn't feel it is getting better, she can see doctor or if any sore, take TYLENOL.
Pt was administered a Moderna vaccine booster dose of 0.25ml after the vial had been opened > 12 hours. Vial had been opened approx. 24 hours but remained in avg temperature of 4-5 degrees Celsius. No adverse reaction noted.
I received my vaccine on 12/23/20. My arm was a little sore for a couple of days and the injection site bruised a little. Seven days after the vaccine (12/30/20) I noticed my arm was itching just below the injection site. I now have a small, red, swollen square at/just below the injection site. It is about 2x2 inches in size. Warm to the touch.  It is not interfering with my daily activities, but is noticeable.
at 10:30 am on 2/11/2021, I started feeling a tingling sensation throughout my body, followed within 30 minutes by muscular pain.  At noon, chills sat in and I took my temperature.  It was 99.5.  I sat by the fire, in sweatpants and sweatshirt covered with two afghans and still cold.  If I tried to move, it hurt.  About 2 pm, a headache arrived.  Finally went to sleep at 10 pm.  Awoke at 5:30 am today, 2/12/2021 and chills and headache were gone.  Only minor muscular achiness remained and temp back to 97.6. (my normal temp).  Now it is 1:20 pm CST and the muscular achiness is gone also.  I feel normal again.
TDAP- given left arm - not sure what vaccine it was - was given at work place. Hep B- given right arm no adverse reactions. Swelling, redness, baseball size bump, - very painful....could barely lift arm -  the day after 9/6/17 had chills, painful, body aches, like a truck ran me over..... 10 days later I still have a dime size bump at injection site. Went to primary care at work clinic - she marked it...to make sure redness didn't get any bigger....and told to put ice on it.
Patient began stating that she felt dizzy and nauseated within a minute of getting the Pfizer vaccine. She asked to go to the bathroom to pee. Was accompanied to the bathroom. Struggled to get out of the bathroom as she was feeling so lightheaded. Was helped to a chair where she stated she felt like she was having a hard time swallowing. Was given some water. No evidence of stridor, LCTA. She explained to me while she was sitting that she has been having intermittent allergic reactions to something and last night had to take some benadryl for that. She asked if she could get some benadryl. She was given some and within a minute stated she felt fine. After waiting an additional 5 minutes she was allowed to stand and was accompanied as she walked around the clinic without further complaint.
Patient received pfizer vaccine on 2/2/21 and 3/2/21. Presented to ER on 7/10/22. COVID positive on 7/5/22. presented to the ED with weakness and cough on 7/11/22.  While in the ED, patient's saturation dropped to 80% and she required 4 L nasal cannula. Patient COVID symptoms started on 07/03/2022 and patient went to her primary care physician on 07/05/2022 and tested positive. She had been taking steroids and cough medications at home with no improvement.  While in the ED, Potassium was initially 5.8; repeat potassium 3.4, Magnesium was 1.5 and BNP was 130.  CT angio chest showed Cardiomegaly, raising question of a dilated cardiomyopathy and Pulmonary hypertension. Findings also suggestive of chronic and/or acute bronchitis with mucous plugging and bibasilar atelectasis   Pt admitted with acute hypoxia with COVID-19 pneumonia.  She has now been weaned off of oxygen.  She has been treated with Remdesivir, Antibiotics and steroids in house.  Pt weaned off of oxygen for more than 24 hours and doing well without desaturation even after exertion.  Vitals are stable.  Will discharge home at this time as pt is off of oxygen and vitals and labs are stable.  Pt was able to walk around the room this afternoon and complete ADLs without any problems.  Pt to complete course of antibiotics and steroid.  She is to have labs repeated prior to next appointment.  Pt to follow up with PCP in the next 3-5 days. Discharged on 7/14/22
22MAR95 4Pm h/a w/lightning sharp pain flu-like ache; 23MAR95 530 started heavy vaginal bleeding (10 days before menstrual period) w/heavy large clots; went to ER;
WITHIN APPROXIMATELY FIVE HOURS OF RECEIVING FLUZONE HD QUADRIVALENT VACCINE, SINGLE DOSE SYRINGE, IM TO LEFT DELTOID ON 10/09/2023 AT 8:07AM AT THE DOCTOR'S OFFICE, PT'S HUSBAND NOTICED PT WAS DEMONSTRATING PERSONALITY CHANGES AND HAVING FULL BODY TREMORS. WITHIN MINUTES FROM THIS FINDING, PT BECAME APHASIC, CONFUSED AND DIAPHORETIC. SHE EXPERIENCED LOSS OF BLADDER CONTROL, MUSCULAR RIGIDITY AND GENERALIZED WEAKNESS.  FAMILY MEMBERS ADMINISTERED CHEWABLE ASPIRIN 81MG X 3 PO TO PT THEN TRANSPORTED HER BY PERSONAL VEHICLE TO ER. PT WAS ADMITTED TO THE HOSPITAL ON 10/09/2023 AT 7:39PM. HER TREATMENT INCLUDED IV ANTIBIOTICS, ROCEPHIN & VANCOMYCIN, IV ANTIVIRAL, ACYCLOVIR, ANTIPYRETICS,  IV FLUIDS, NS AT 75MLS PER HOUR, AND PT/OT/ST.
Pt reported swollen red tender hot at injection site...pt self medicated with Benadryl....event was over by Monday morning...pt had also received pneumonia in other are with no ill effects.
1/21/21 received first Moderna vaccine, no long standing adverse side effects. Received second Moderna vaccine 2/17/21. no adverse side effects. Received Moderna booster 09/01/2021 and around. 2 months afterwards suddenly developed Hypertension. With medication was controlled on dosages of medications taken. Received Moderna 4th shot  or second booster Mat 18,2022 and on June 15th Hypertension not controlled anymore and needed increased dosage of meds. After my first booster hypertension started but became controlled with meds but after second booster, the hypertension increased again. There was no change in anything else in my life except the booster shot given. I discussed this my cardiologist and he agreed that.
Patient received 2nd dose of Moderna COVID-19 vaccine in clinic today.  A couple of minutes after receiving vaccine, patient reports throat itchy and causing her to cough a lot.  At 9:45am, BP 159/115, O2 sats=99%, HR=70.  Benadryl 25 mg PO (instead of 50 mg accepted by patient due to concerns of drowsiness) and Famotidine 20 mg PO administered at 9:47am.  Patient reports eyes are a little watery.    At 10:00am, O2 sats = 100%  HR=77  BP 143/79.  Patient reports no change to her "scratchy" throat.  Is not drowsy from 1st dose of Benadryl.  Patient accepted additional Benadryl 25 mg PO dose at 10:03am.  Patient clinically stable.  Patient released from clinic at 10:10am.
About one month after receiving first dose I noticed that it had been several weeks that I had not been getting a full night's sleep.  Looking back I estimate it started the same week I received the first dose.  Normally I can sleep 7-8 hours each night but from January on I rarely was able to sleep more than 3-4 hours at a time and woke up once or twice at night.  Most nights I can fall asleep quickly.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa antibiotics" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive, notes: confirmed by positive home antigen test; (Dec2022) Negative, notes: I tested negative on home antigen test; (Dec2022) Positive, notes: had a bright red positive antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient does not have other medical history. Treatment received with Paxlovid from 09Dec2022 to 14Dec2022 for covid-19. Rebound Covid - patient tested negative on home antigen test on Day 6 after first infection confirmed by positive home antigen test. By Day 9 patient had a headache and was feeling nasal congestion again and tested and had a bright red positive antigen test. Her current symptoms at Day 11 after first infection are nasal discharge and congestion, sneezing, itchy eyes, fatigue, some dizziness.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No additional AEs; Improperly stored vaccine was administered; This spontaneous report was received from a nurse referring to a patient of unspecified age and gender. Information regarding the patient's medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.   On 18-AUG-2022, the patient was administered an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (dose, route of administration, and anatomical site of vaccination were not reported; lot number 1775811 has been verified to be valid, expiration date reported and established as 07-DEC-2023) (product storage error). No additional adverse event was reported (no adverse event).   This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2208USA008089: US-009507513-2208USA008439: