chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Discharge Provider: MD Primary Care Provider: MD Admission Date: 9/7/2022 Discharge Date: Sep 11, 2022  PRESENTING PROBLEM: Weakness generalized [R53.1] Generalized weakness [R53.1]   HOSPITAL COURSE: 89 y.o. with a PMH of carotid occlusive disease, coronary artery disease, type 2 diabetes with diabetic peripheral neuropathy, essential hypertension, history of renal artery stenosis, history of retinal vein occlusion the right eye, dyslipidemia, prostate cancer and lupus.  He presents in the emergency department on 9/8 with progressive generalized weakness over the past several months, which became much worse over the 24-48 hours prior to presentation.  He was noted to have hypertensive urgency with elevated troponins.  Cardiology did evaluate him and did not think that this represented an acute coronary syndrome.  He was assessed by Physical and Occupational therapy and his weakness did improve.  His blood pressure remained quite elevated so his meds were titrated.  His systolic blood pressure ranged from 130 to 150s at discharge.   After discussion and in light of risk factors for progression to severe disease, paxlovid was prescribed for covid 19.
VACCINE EXPIRED ON 2/19/2019 AND IT WAS ADMINISTERED TODAY. NO S/S OCCURED OR HAVE OCCURED SINCE TIME OF VACCINE ADMINISTRATION.
This spontaneous report as received from a Registered Nurse refers to a multiple unspecified patient's of unknown age and gender, who on unspecified dates were vaccinated with a dose of PROQUAD (Merck) (dose, indication, route, site of administration and lot # were not reported), that might have been subjected to significant light exposure. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Moderna COVID-19 Vaccine EUA Large red, itchy patch on shoulder where injection was given, about 3 inches by 3 inches First appeared this morning, two weeks after injection
Hospitalization for decubitus ulcer (tested positive for COVID-19 on day of admission)on dates 8/2/2023- 8/10/2023.  Treated with dexamethasone, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Patient stated started as sore at injection site on day of injection and continued for 2 days. Soreness then moved to elbow on 4th day  and turned red. A dark ring developed around the elbow on the fifth day. Still hurts a little, but getting better per the patient.
2 weeks after my second dose of my vaccine I started to have chest pains, that would get really bad but than go away, than after a week I started to get shorten breathing and the chest pains would come and go every other day. I went in October 31st when the chest pain got worse to hospital in town, they told me they couldn't see anything. The chest pains would still come and go every other day or every other 2 days. Until January 25th I woke up and this time the pain didn't go away it got 3x worse and I went into the urgent care and I was having a heart attack, I was told that one of my valves are narrowed.
Note- did not eat breakfast 1. Symptoms: difficulty breathing, fats heart beat, dizziness, extremely weak, sweaty palms, shaking 2. With in 5 minutes of injection (reaction occurred) 3. Sat with legs up and drank juice/ ate crackers. took apprx. 10 hours (began to feel better apprx. 09:00 pm Went home rested had lots of fluids.
Muscular and joint aches and pain, fever 101.5, chills, frequent urination
very debilitated; Pain is also going up her neck; vaccine site would swell, de-swell and swell again; pain was more intense/has not been to work; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (very debilitated), NECK PAIN (Pain is also going up her neck), VACCINATION SITE SWELLING (vaccine site would swell, de-swell and swell again) and VACCINATION SITE PAIN (pain was more intense/has not been to work) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced ASTHENIA (very debilitated), NECK PAIN (Pain is also going up her neck), VACCINATION SITE SWELLING (vaccine site would swell, de-swell and swell again) and VACCINATION SITE PAIN (pain was more intense/has not been to work). At the time of the report, ASTHENIA (very debilitated), NECK PAIN (Pain is also going up her neck), VACCINATION SITE SWELLING (vaccine site would swell, de-swell and swell again) and VACCINATION SITE PAIN (pain was more intense/has not been to work) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. No relevant concomitant medications reported.  No treatment information was provided.    This case was linked to MOD-2021-027254 (Patient Link).
An irregular shaped Blister at site of vaccination was noticed a day after the first vaccine dose, and which then burst producing clear liquid with open skin when the bandage was removed. It healed later with a scar.
11/12/16 while traveling sudden onset (L) and (R) UE paralysis. W/U at Med Ctr c/w Transverse myelitis w/1 mo. R/O of other causes (MS, infec, NMO, Autoimmunity, etc) 1-mo rehab w/partial paralysis.
Information has been received concerning a pt with bronchitis and sinusitis at the time of vaccination. On 06/12/00 he was vaccinated with the first dose of varicella vaccine. On 06/23/00 the pt developed a fever, rash, and maculopapaular lesions. The pt sought unspecified medical treatment and the physician noted consistent with varicella. On 07/07/00 the pt recovered.
. MAY HAVE BEEN ADMINISTERED WITH WRONG DILUENT. WILL NEED TO BE RE-DOSED
is paralysed; This serious case was reported by a consumer via interactive digital media and described the occurrence of paralysis in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced paralysis (Verbatim: is paralysed) (serious criteria GSK medically significant). The outcome of the paralysis was not reported.   It was unknown if the reporter considered the paralysis to be related to Shingles vaccine.   It was unknown if the company considered the paralysis to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient's parent via interactive digital media. The reporter would never get this shingles vaccine. The reporter stated that adverse reactions were severe.  The patient was paralyzed and he/she blamed the shingles vaccine. The follow up would not possible as no contact details were available.
fever 103.6R 5-6hrs p/vax;treated w/Anti-pyretics
This spontaneous report received from a physician referred to two patients of unknown age and gender. The patients' pertinent medical history, concomitant medication and drug allergies/ reactions were not reported. On an unknown date, the patients were vaccinated with improperly stored VARIVAX (dose, strength, route were not reported, Lot number: M006726, Expiry date: 08-Feb-2018. No adverse symptoms were reported. Additional information has been requested.
A week later, started having sleep difficulty, sleeping from 8-9 hours a day to 2 hours. Has had sleeping problems for about 3 1/2 weeks. 1/2 week later welts started moving on right side from arm to abdominal area, right leg. Have been sleeping on back side, very unusual, usually sleeps on right side. Was snoring and woke himself up. Started using homeopathic remedy for welts, improved after a few days. Sleeping patterns have changed so had to double dose of trazodone. Patient delivers pizza so was very sleepy driving since couldn't sleep normally. Also having problems with alpha interferon PEGASYS therapy. Also had problems with skin healing. Grabbed shovel which created red lines, veins, on hand. Lately have been doing body cleanse and taking Golden Seal root tablets. In terms of sleep had to increase dose of trazodone to be able to sleep.
Chills, temperature 103.6, nausea, chest pain, vomiting progressively (temperature went below normal after vomiting) for 15 hours total. Left arm still red, swollen and hot.
After giving injection, I realized I gave patient an expired vaccine that occurred this morning around 11 am. The expiration date on the HPV was 06/03/2019. Patient was contacted and notified.
MMR given IM instead of SC. Review of CDC/info indicated no need to repeat dose, valid dose.
Vaginal bleeding that started 1 day after receiving first dose; ultimately diagnosed with endometrial/uterine cancer
Administration Error. Patient had her first Monovalent Moderna dose on 7/14/22, and never had 2nd dose completed. Today (10/31/22) bivalent Moderna dose was given in error as her 2nd dose.
Patient did not eat prior to vaccination.  Felt anxious about vaccine. Felt weak and lightheaded. Patient was brought to ER for monitoring and assessment.  Was released back to work without treatment required after a few hours.
Pt. is 27 yo presenting with substernal, pressing chest pain radiating to L axilla and back, worse with running and associated with shortness of breath.  Also worse with deep breathing, post eating, and worse at night (laying on the bed).  Some subjective F/C but non-febrile in clinic.  EKG abnormalities noted in clinic.  Pt. sent to the ER for further lab/work-up and referred to Cardiology with concern for pericarditis.   Symptoms began 1wk s/p 1st vaccination, peaked at 2wk post, and then improved.  After 2nd vaccination Pt. noted worse symptoms and SOB with CP during morning run with unit.  Pt. presented to the clinic the following day.
This spontaneous report as received from a physician via a company representative, refers to a 13 year old male patient. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On 10-APR-2015, the patient was vaccinated with the first dose of GARDASIL (which had a lot # of K006960; however, dose, route of administration and expiration date were not reported). Subsequently, on 10-APR-2015, the patient was vaccinated with the second dose of GARDASIL (which had a lot # of K006960; however, dose, route of administration and expiration date were not reported). No concomitant therapies were reported. Thirty minutes after getting vaccinated with the second dose, the patient developed hives on an unspecified area of the body. Therefore, he sought medical attention by visiting the physician and was given BENADRYL for the treatment of the adverse event. It was to be noted that no product quality complaint was involved. The hives reportedly lasted a few weeks, following which they resolved on an unspecified date in 2015. The reporter provided no causal relationship between the event and the vaccination with GARDASIL. Additional information has been requested.
At 10:45 AM patient began to exhibit the following symptoms: dizziness, faintness, paleness, weakness, loss of color, diaphoresis, and tingling in the hands. Cold pack was placed on patient's forehead as well behind the neck. Patient's legs were elevated. Vitals were as follows: BP = 132/90, pulse = 58, & temp = 95.3F. Paramedics arrived at 10:55 AM vitals were: BP= 153/95, Pulse = 60, pulse ox: 99%. Blood glucose done by paramedics = 105 mg/dL. Patient declined transport to ER with paramedics at that time. Patient stated she was "starting to feel better" RN continued to monitor patient at facility another 15 minutes. Patient instructed to self-monitor for the next 48 hours for any of the signs or symptoms that occurred above and to immediately go to urgent care/ER if symptoms resumed again. Patient agreed to instruction and verbalized understanding. Patient left facility in stable condition, alert, and oriented.
Beginning 6 hours after shot I had chills and shaking for 6 hours. Then fever of 102 for the next 6 hours then ok.  I took ibuprofen for the fever.
This initial spontaneous case, received from pharmacist on 19-Oct-2017, concerning a 28-year-old, adult, female patient. This refers to 02 out of 04 reports. The patient had no relevant medical history. The patient's concomitant medication included unspecified birth control medication. On 04-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, batch number: 195126, expiry date: Apr-2018 and anatomical location: not reported). After the administration of the vaccine, it was reported that, the patient's period was late by 13 days. The patient underwent a pregnancy test which was negative. No treatment was taken for the event. The reporter considered the causality as related. The reporter assessed the event as non-serious. Follow-up report received on 27-Oct-2017: The patient's period was late by 13 days. It was reported that, the patient underwent a pregnancy test which was negative. Amended narrative accordingly.
4 inch round circle around injection site with hard white center and black and purple in the middle of white.  Began running yellow clear liquid night of 11/7/13.
The unblinded injector inadvertently went into the wrong exam room and then further failed to ask the patient to confirm name; Injection site tenderness; This is a spontaneous report from a contactable physician. This is a report based on information received by Pfizer from LLP-Biontech SE [Other Case identifier(s): US-BNTAG-1581 (BNTAG), license party for Comirnaty].  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INJECTION SITE PAIN (non-serious) with onset 17Nov2021, outcome "recovered" (17Nov2021), described as "Injection site tenderness".  Additional information:  On 17Nov2021, a dose was drawn up by the pharmacist for a subject in study BNT162-17. The unblinded injector inadvertently went into the wrong exam room and then further failed to ask the patient to confirm name and DOB per site process. The dose of BNT162b2 was then administered to a non-study patient, not in the study. (The patient was on site for a Covid-19 vaccine booster dose). The patient that was not trial participant was observed post dose and had been followed up via phone calls for monitoring of any symptoms. The originally intended trial participant received the correct dose according to randomization assignment. The patient that inadvertently had received study medication/vaccine with phone calls and the non-study patient has had only an expected post injection site tenderness. At time of reporting, the events have resolved with date of 17Nov2021. No further information was available at that time. Additional information had been requested.  Reporter comment: The reporting physician considers the event to be non-serious. The company agrees to the physician's assessment. Hence, the case was assessed as unexpected on case level. The reporting physician assessed the event as related to treatment with BNT162b2. The sponsor agreed to the investigator's assessment as injection site pain was expected for parent vaccine BNT162b2 (Comirnaty). Medication error was not considered an adverse drug reaction in this case, as only consequences of medication error are considered to be adverse drug reactions. Therefore, seriousness, expectedness and causality are assessed as not applicable.  The benefit-risk profile of BNT162b2was not affected by this event and no change in the reference safety information was required at that time.  Causality Assessments: Drug: COMIRNATY Injection site tenderness, Medication error Per Reporter: Possible Per Company (BioNTech SE): Possible. Bnt162b2 (COMIRNATY) is under agreement with Biontech.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient called and said she felt weak,  her temp was 99.1, she was going from having chills to being hot,  and it hurt to touch  her body.  I instructed the patient to call  the CDC hot line at 1-800-232-4636
sudden onset nausea, mild fever (100.5), exhaustion. required 15 hours sleep, chills began 1 hour later. all considered mild but wanted to report for tracking.
Shortness of breath. Originally admitted November 19, 2021 and discharged November 23, 2021. Now being readmitted December 3, 2021.
fever, sweats, muscle aches and head ache came on during the evening within first 24 hours.  Felt very much like the flu like symptoms I experience with first exposure to COVID virus in December.
right side of her face was swollen/cheek were swollen; eye swelling; right arm was hurting; right eye was watery; Headache; This is a spontaneous report from a contactable consumer (patient's child). A 93-year-old female patient received the first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration, administered in Arm Left on Feb2021 (at the age of 93 years old) (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. 5 days after receiving the Covid-19 Vaccine, patient had a headache over the weekend and took acetaminophen (TYLENOL). Patient didn't have anything else beside the headache. On 22Feb2021, patient woke up and the right side of her face was swollen. The patient's right eye and cheek were swollen, and her right arm was hurting. The reporter clarified that the patient's right eye was watery, as well, and the patient got her Covid-19 Vaccine in her left arm. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On day 1  significant fatigue; I now have Chronic fatigue going on 7 weeks. On Day 3, I developed ear fullness with stabbing pains (in both ears); I am also reporting this because this has  become a chronic issue. I continue to experience ear fullness and pain daily.  On December 23, 2021 labs showed a positive ANA. I had a negative ANA prior to vaccination.
Tdap Vaccine given 8/23/06 10AM. Fever started approx. 11 hours after injection (9PM), along with severe headache, stomach ache, achy body. By AM child was running 103 degree fever, vomiting, stomach and head aches, running nose, cough. Symptoms continued for 48hours to present (Sunday evening 6:46 pm). Injection site is very red, swollen and sensitive to touch.
Post vax, the pt took Tylenol but subsequently developed an achy, high fever. This is one of three pts from this facility who had an adverse experience following receipt of vax.
I been having long congestion with some difficulty of breathing. I've also experienced a low-grade fever, body aches, and headaches. I tested positive in April for COVID-19. My doctor did prescribe me PAXLOVID and that did help me. I ended up testing positive for COVID-19 on 4/14 with congestion and difficulty breathing.
I noticed that the left side of my face was feeling numb while I was working mid afternoon on Tuesday, March 16.  The feeling was similar to a novacaine shot that a dentist would give for a cavity.  This feeling has been continuous for 3 day and I noticed my left upper lip was feeling numb to the touch as well.  The heaviness is felt in the  cheekbone area, the area below my left nostril, and down to my jaw on the left side of my face.
Fainted; did not fall or sustain any injury. Awoke within less than a minute and felt fine. Observed closely for 30 minutes after.
I experienced a breakthrough case of COVID-19 with shortness of breath, fever, body aches, cough, lack of appetite and diarrhea.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD subcutaneously, lot # N020615, expiration date 22-JAN-2019, albumin status rHA; and lot # N010246, expiration date 25-SEP-2018; (dose was not reported) for prophylaxis; administered along with a properly stored sterile diluent, subcutaneously, lot # L028663, expiration date 29-MAR-2018 (dose was not reported) for prophylaxis. It was reported that the vaccine was exposed to temperature of -9 degrees Celsius to 8 degrees Celsius, for a time frame of 4 hours and 4 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received form the same reporter (MARRS # 1712USA008050, 1712USA008779, 1712USA008780, 1712USA008781, 1712USA008782, 1712USA008783, 1712USA008785, 1712USA008786, 1712USA008787.). Sender's Comments: US-009507513-1712USA008050.
Patient admitted to hospital 12/9/5 with an acute, rapidly ascending motor weakness diagnosed as Guillain-Barre, for which he received a 5 day course of IVIG followed by inpatient rehab (ongoing at the time of this report).  The patient had no URI or GI symtoms or sick contacts in the preceeding 4 weeks (he did have his usual chronic smoker's cough but no acute change in sputum).  The patient's symtoms began on 12/8/5; he had received the flu vaccine at work on 12/6/5.  The patient had received flu vaccines at this same place of work over the last 12 years without any remembered ill effect. Medical records state paresthesia. msv
Shortness of breath, headache, tired feeling, hoarseness; states took ibuprofen and it helped some.  Told to called doctor on 5-20-13.
sharp pain (cramping) back, chest & stomach as of 830AM 13NOV94;
Upon patient leaving clinic, noted that expiration date on IPV vaccine was 1/23/11 and date was 1/28/11.  Date was checked prior to administering and written down but thought to expire in January the following year.  Representative from state vaccine program called.  Told that child needs to be re-vaccinated.  Grandparent called 1/31/11 for follow-up and child is doing well.  Notified that vaccine would have to be given again, and grandparent is agreeable to re-administering vaccine at next visit.
Mother reported patient was abnormal looking and unresponsive.  911 called and CPR administered by EMTs.  Patient arrived to ER, CPR still in progress, 4 doses epinephrine administered with no change.  Patient declared dead at 6:28 AM (20 hours post vaccine administration).
got sick; chills; couldn't eat; This is a spontaneous report received from a contactable consumer (patient). A 68-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (reported as pneumonia shot, unspecified trade name) at a single dose, influenza vaccine (reported as "regular flu vaccine", unspecified trade name) at an unspecified dose and influenza vaccine (reported as "flu vaccine for senior citizen", unspecified trade name) at an unspecified dose all via an unspecified route of administration on an unspecified date in 2019 immunization. The patient's medical history and concomitant medications were not reported. In 2019 she got 2 flu vaccines at the same time, the regular flu and the one for senior citizens, and also the pneumonia shot. So she got 3 vaccines at once. She has no product names, NDC, Lot, or Expiry for those products. Afterward she got sick and was in bed with chills and everything, she couldn't eat and was sick for the day. It was explained that she was at work but left for the day. This only lasted for the one day and she was fine and back to work the next day. Outcome of events was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.