chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Discharge Physician: DO Primary Care Physician: MD  Date of Admission: 3/25/2023 Discharge Date: 3/26/2023 Room Number:   PRESENTING PROBLEM: Acute febrile illness [R50.9] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a n 86 year old male with history of dementia, CKD, chronic hypotension on midodrine, Type 2 DM, HLD, and chronic DVT on warfarin who presented to ED with weakness, fevers, and cough worsening over the previous 2-3 days. In the ED, The patient tested positive for covid, and UA indicated a possible infection, he was also found to have an elevated lactic acid. Due to the patient's profound weakness, the hospitalist team was consulted for admission. The patient was started on IV Rocephin and received IV fluids. During admission, the patient worked with therapy and felt to be doing much better, they felt he was safe for home with assistance and with home health and PT, the family declines this at this time, but will discuss with the patient's PCP. He remained off oxygen, no issues eating or drinking, his wife felt he was at his baseline. He was transitioned to oral antibiotics, cultures are pending and I instructed the wife I will call if there needs to be a change in antibiotics. She was agreeable to the plan and the patient is medically stable for discharge.   During the ED evaluation and admission, the patient was noted to have mild hypoglycemia, even after meals, his glyberide has been discontinued at this time.   Patient has been out of his midodrine, this has been sent to his pharmacy.   Electrolytes were monitored and repleted PRN throughout the admission. Patient clinically improved and hemodynamically stable for discharge.  Discussed plan of care discharge with patient including outpatient follow-up PCP within 7 days. Patient voiced understanding was agreeable with plan of care discharge.
100.1F low grade fever, muscle soreness, chills, heavy eyes, headache, weakness, sore arm a day after second Pfizer dose. No symptoms after first dose.
Heart failure; Swelling of the soft palate of the throat; This is a spontaneous report from a Contactable Physician via Pfizer sales representative. A 50-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization, influenza vaccine (FLU), via an unspecified route of administration on the same date at an unspecified dose for immunization. The patient's medical history and concomitant medications were not reported.  The patient developed a swelling of the soft palate of the throat. He had heart failure and was taking Lisinopril. He was sent to the Emergency Room where he was given benadryl and the symptoms resolved. The outcome of the event heart failure was resolving and the other event was unknown.; Sender's Comments: The association between the event heart failure with pneumococcal 13-valent conjugate vaccine use can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
12/30/21 Patient states that for the past 2 days he has been experiencing a sore throat which is not significantly changed since it began. Patient has also been experiencing mild hoarseness associated with this or throat but denies congestion, shortness of breath, difficulty breathing, nasal drainage, cough, ear pain, abdominal pain, nausea, vomiting or diarrhea. Patient denies recent fever, chills and overall states that he feels well other than his sore throat. Patient has been fully vaccinated and received a booster for COVID-19. No other complaints today in clinic. Review of Systems  Constitutional: Negative for chills, fatigue and fever.  HENT: Positive for sore throat and voice change. Negative for congestion,
sorness in vaccine arm along with mussle aches. I then experienced not being able to sleep the last 2 nights
Patient received Pfizer COVID vaccine on 3/9/21 and 4/5/21. On 6/15/22, patient admitted to our inpatient facility (med/surg unit) with acute on chronic respiratory failure in setting of COVID 19 infection and COPD exacerbation. As of today (6/17/22), patient is still admitted in the med/surg  unit.
Child was inadvertanty given 12+ dose of Pfizer COVID-19 vaccine as first dose at approx. 2:00pm on 11/30/2021 .  Child waited 15 minutes period after injection with no adverse reactions. Family aware of incident. Educated that recommendation is to get 2nd dose as scheduled in 3wks (10mg dose) . Family will monitor and call with any concerns.
Mom is reporting the School Nurse noticed "hives" today. Pt. has not had any other noted adverse reactions, no new meds, foods, etc.
Body aches and pains; muscle weakness; Muscle pain; Lethargy; Shaky; Severe nausea; Super worse case of flu; This case was reported by a pharmacist via call center representative and described the occurrence of general body pain in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number 5DK5E, expiry date 13th March 2022) for prophylaxis.   On 21st January 2020, the patient received the 1st dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced general body pain, muscle weakness, muscle pain, lethargy, nausea, influenza and tremor. On an unknown date, the outcome of the general body pain, muscle weakness, muscle pain, lethargy and tremor were unknown and the outcome of the nausea and influenza were recovered/resolved.   It was unknown if the reporter considered the general body pain, muscle weakness, muscle pain, lethargy, nausea, influenza and tremor to be related to Shingrix.  Additional details were reported as follows: A pharmacist reported that a the patient experienced body aches and pains, muscle weakness, muscle pain, and lethargy. She also had severe nausea the 1st week after receiving the vaccine.  The patient experienced "super worse case of flu that went on for 1st two weeks after shot" and stated she was "shaky". Consented to follow up.
Injection site pain: Began at 06:00, 11/12/2021, pain 4/10. Continues at the time of this report, 21:20, 11/14/2021, pain 1/10. Redness at injection site, "bull's eye pattern": Began 06:00, 11/12/2021. Resolved without treatment, 11/12/2021, 23:00. Body aches, general: Began at 06:00, 11/12/2021, pain 3/10. Treated with naproxen sodium, OTC, 220 mg, every 12 hours for 48 hours (4 doses).  Resolved at 06:00, 11/14/2021. Muscle/tendon pain, base of skull from occiput to bilateral mandibular joint, bilateral hamstring, pelvic/lumbar area : Began 06:00, 11/12/2021, pain 4/10. Treated with naproxen sodium, OTC, 220 mg, every 12 hours for 48 hours (4 doses).  Resolved at 06:00, 11/14/2021. Intermittent Chills with Intermittent Fever of around 99.8.  Began 11/12/2021, 10:00 am. Resolved 11/13/2021, 21:00. Fatigue. Began at 06:00, 11/12/2021. Bed rest. Resolved at 16:00, 11/14/2021.
Staff member received Covid Vaccination at 0730 after working 3rd shift. Raised hand at 0745 indicating she needed assistance. She complained of heart palpitations, diaphoresis and anxiety. She was taken via wheelchair to the vestibule for monitoring BP 153/97, HR92, Pox 100%. She denied chest pain or difficulty breathing. She stated her throat "felt dry".  Vitals rechecked at 0750: 130/88, HR 85, Pox 97% Staff member stating she felt less anxious, was given water to drink. At 0805 she stated she was recovered. She was stood and vitals checked: 124/84, HR 70, Pox 100%  She was released ambulatory and given a snack for ride home.
Near fainting on 8/23/21 then on 8/24/21 my heart rate was in the 170s when doing simple tasks. I was having drastic increases in heart rate from laying to sitting and sitting to standing (80 when laying and 130 when standing up) To this day I am still dealing with a rapid heart rate, typically in the 130s-150s when walking and doing simple things (no previous medical history or cardiac issues). Chest pain and shortness of breath accompanies the tachycardia.   Extreme fatigue and dizziness accompany the rapid heart rate while exerting and when I have been working all day  As of right now I am taking Metoprolol to try and being down my heart rate (still in the 120's-130's with simple activities) even with an increased dose of Metoprolol
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown date these unspecified patients were vaccinated with improperly stored GARDASIL 9 (lot # 104475 and expiry date 12-MAY-2017)(strength, dosing details, anatomical location were unknown). The vaccine was stored at a temperature of 31.6 degree Fahrenheit for 30 minutes and 55.4 degree Fahrenheit for 30 minutes. No adverse effects were reported. No product quality complaint was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Immediate reaction included diarrhea, blood in diaper and fever. Several weeks later constant, high pitch screaming began and did not cease for months. Extreme change in weight gain (weight percentile went from nearly 50th to 4th.) Extreme change in head size (head circumference went from nearly 50th to 99th).
Patient reports that about 72 hours post-vaccine, she developed sudden blood-dark tinged vomitus, three times, overnight.  Reports no prior episodes, or GI symptoms/prodrome
Red, warm, hard knot at injection site. Site is extremely itchy and sore. Body aches, pains, malaise and headache.
Suffers memory loss, to include short and long term, chronic fatigue, joint brittleness and pain, chronic arthritis.
Felt warm about 3 hours later, dry mouth, then dyspnea, then legs were very sore. Dyspnea has resolved. Legs improved (still sore, but able to walk, but with some difficulty). T-102 at home about 4 hrs post vaccine. Tylenol given. Felt dizzy, but no LOC.   Patient to call with progress report later today.   Patient had same reaction with first dose, sent to ER, unsure of outcome or if reported to VAERS.   Patient only mentioned fever at this visit.  Did not mention any other side effects until after the reactions occurred today.
since receiving the bivalent vaccine, caller experiences tinnitus "a little bit more."; feeling a lose of appetite and he can't eat too much; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558). The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Dec2022 as dose 4 (booster), single (Lot number: GH9693) at the age of 69 years, in right hand for covid-19 immunisation. The patient's relevant medical history included: "tinnitus on his right side" (ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE: 1, lot: ENS318, expiration: Unknown, Route of administration: left hand), administration date: 22Feb2021, when the patient was 67-year-old, for Covid-19 Immunization; BNT162b2 (DOSE: 2, lot: EL9266, NDC: Unknown, expiration: Unknown, route of administration: left hand), administration date: 15Mar2021, when the patient was 67-year-old, for Covid-19 Immunization; BNT162b2 (DOSE: 3 (BOOSTER), lot: FJ8762 , NDC: Unknown, expiration: Unknown, route of administration: right side of hand), administration date: 07Dec2021, when the patient was 68-year-old, for Covid-19 Immunization. The following information was reported: DECREASED APPETITE (non-serious) with onset 27Dec2022, outcome "unknown", described as "feeling a lose of appetite and he can't eat too much"; TINNITUS (non-serious), outcome "not recovered", described as "since receiving the bivalent vaccine, caller experiences tinnitus "a little bit more."". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that, patient was asking if there have been reported side effects for the Pfizer Covid bivalent booster and stated that he "had no problem with the booster before. Patient stated that he experienced tinnitus on his right side prior to receiving any of the Pfizer Covid vaccines, however since receiving the bivalent vaccine, patient experienced tinnitus "a little bit more." Patient also reported that he is "feeling a lose of appetite and he can't eat too much. Caller is asking if tinnitus and loss of appetite is a reported side effect. Patient stated that his doctor says his blood tests are normal. Patient was asking if the vaccine has created these side effects or if something else could be. Patient asked if the loss of appetite is a temporary side effect or a permanent side effect. Patient was worried about the vaccine he took.
Pt recvd 3 doses of Engerix-B & did not respond; will revax;
Itchy ,flaky , burning sensation , hyperpigmentation  Eyelids are dark/black due to skin damage now   It's been 1year and a month now I'm waiting to see a dermatologist on November 11th I been dealing with a issue I have no idea how to treat it's stressful some days my eye lids are so raw it just hurts and nothing I can do about it
Status epilepticus within 24 hrs of vaccines, coma 5 days, second episode of status epilepticus regressed to infantile state. Has fine motor skill impairment, speech delayed, he had to learn to walk again, was toilet trained. Per review of discharge summary on 7/28/05, additional symptoms included anoxic brain injury, nonpruritic rash, apnea, unable to talk, anemia, agitation, mild R eye ptosis, and poor visual tracking.
rash at the injection site, that is swollen, sore and warm to the touch, 5cm in diameter; rash at the injection site, that is swollen, sore and warm to the touch, 5cm in diameter; rash at the injection site, that is swollen, sore and warm to the touch, 5cm in diameter; a little bit of soreness on her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (rash at the injection site, that is swollen, sore and warm to the touch, 5cm in diameter), VACCINATION SITE RASH (rash at the injection site, that is swollen, sore and warm to the touch, 5cm in diameter), VACCINATION SITE PAIN (a little bit of soreness on her arm) and VACCINATION SITE SWELLING (rash at the injection site, that is swollen, sore and warm to the touch, 5cm in diameter) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ATENOLOL and OXYBUTYNIN for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE PAIN (a little bit of soreness on her arm). On 19-Feb-2021, the patient experienced VACCINATION SITE WARMTH (rash at the injection site, that is swollen, sore and warm to the touch, 5cm in diameter), VACCINATION SITE RASH (rash at the injection site, that is swollen, sore and warm to the touch, 5cm in diameter) and VACCINATION SITE SWELLING (rash at the injection site, that is swollen, sore and warm to the touch, 5cm in diameter). At the time of the report, VACCINATION SITE WARMTH (rash at the injection site, that is swollen, sore and warm to the touch, 5cm in diameter), VACCINATION SITE RASH (rash at the injection site, that is swollen, sore and warm to the touch, 5cm in diameter), VACCINATION SITE PAIN (a little bit of soreness on her arm) and VACCINATION SITE SWELLING (rash at the injection site, that is swollen, sore and warm to the touch, 5cm in diameter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment information  provided
Pt received flu shot on 10/26/12. Broke out with hives on 10/28/12. Hives were on legs & all over torso by 10/29/12. Her primary care MD told her to take BENADRYL 50mg every 4 hours. Seemed to help. Left eye was swollen.
Patient returned to clinic after leaving clinic at 1105 for c/o upper back and shoulder "itching"  VS monitored, negative for s/s of anaphylaxis  Benadryl given, monitored patient x >30 minutes  discharged in stable condition, symptoms resolved  recommended close f/u with PCP and seek emergency attention for s/s of anaphylaxis or complications
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On 18-MAY-2016, the patient was vaccinated with improperly stored dose of MMR II 0.5 ml injection, lot# L027432, expiration date 22-JUL-2017 (route and site of administration were not reported). According to the reporter, the vaccine was stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also at a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes. No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
I know four people who had a stroke; This is a spontaneous report from a contactable consumer or other non hcp. This is for 4 of 4 reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, i know four people who had a stroke on an unspecified date. The outcome for the event was unknown.  The lot number for the vaccine, was not provided and will be requested during follow up.
Necklace pain; Knees inflamed; Pain getting worse; Pain in his knees; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Necklace pain), ARTHRITIS (Knees inflamed), ARTHRALGIA (Pain getting worse) and ARTHRALGIA (Pain in his knees) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In December 2020, the patient experienced NECK PAIN (Necklace pain), ARTHRITIS (Knees inflamed), ARTHRALGIA (Pain getting worse) and ARTHRALGIA (Pain in his knees). At the time of the report, NECK PAIN (Necklace pain), ARTHRITIS (Knees inflamed), ARTHRALGIA (Pain getting worse) and ARTHRALGIA (Pain in his knees) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment for the events was given as pills for pain.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Severe throbbing upper arm and shoulder pain for 7 days. Dull to moderate ache continuing to present day with off and on again sharp pain that interferes with everyday activity and sleeping at night.
On 6/1/00, the pt was hospitalized for seizures and otitis media. An EEG was performed and the results were not provided. The pt was hospitalized again on 6/4/00 and was diagnosed with epilepsy. He was treated with Phenobarbital and had partially recovered. It was reported that the investigator and medical monitor agreed that the "epilepsy, otitis media and congenital abnormality were not reasonably related to Prevnar administration", however the relationship to varicella virus vaccine, MMR was unknown. Upon medical review, seizures were considered to be an "other important medical event". Additional information has been requested.
Initial report was received 15 August 2011 from a health care professional. A 15-year-old female patient had received a first dose intramuscular right deltoid injection of MENACTRA, lot number U3780AA, and a first dose intramuscular right deltoid injection of VAQTA (manufacturer Merck), lot number 0627AA, and a first dose intramuscular left deltoid injection of GARDASIL (manufacturer Merck), lot number 0636AA, and a second dose subcutaneous left deltoid injection of VARIVAX (manufacturer Merck), lot number 1704Z on 01 August 2011. One to two days later, the patient complained of pain and difficulty walking in both legs which lasted approximately three days. These symptoms resolved (date not reported) and did not require a doctor's visit. On 12 August 2011, the patient was seen by her physician with complaints of a sore throat and she was subsequently diagnosed with acute pharyngitis. The patient denied any concurrent illness or pre-existing medical conditions and she had not been taking any concomitant medications. It was unknown if the patient experienced any adverse events following prior vaccinations. Outcome for the event of pharyngitis was unknown at the time of the report. Documents held by sender: None.
OBSTRUCTIVE SLEEP APNEA 4/21/2023 CERVICAL RADICULOPATHY ALLERGIC REACTION, INIT 4/28/2023 CERVICAL RADICULOPATHY
low fever, achy wrist, legs, back, exhaustion, lasting 48 hours intensively, then recurred on and off for 4-5 more days
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 27-FEB-2017, the patient inadvertently administered an expired M-M-R II dose (dose and frequency: 0.5ml, "once", lot # L001336, expiry date: 13-JAN-2017) subcutaneously for prophylaxis. No adverse effect was noted. Additional information has been requested.
Ache and discomfort in right shoulder, neck, and upper back accompanied with extreme swelling of right axilla that is sensitive to palpation.  Extreme fatigue was also noted for 2 days following vaccination.  Treatment included alternating doses of Tylenol 500mg and Advil 400mg, heat compress, and lymph massage.  Swelling and other symptoms resolved 48hrs after they began.
11MAR93 w/fever, cough, flu-like sx; seen by MD collapsed & taken to hosp; presented typical septic process of meningococcal, pneumococcal or H. flu; was 5 wks pregnant spontaneously aborted; went into renal failure; COD DIC;
mom states pt cried unconsolably for 3 hrs the evening of 12OCT94 p/receiving vax; parents did not contact clinic or MD re event;
Patient was short of breath, dizzy & had cold sweats initially. Became incoherent for brief period of time. Epinephrine was administered at 16:20 to patients right leg.
It was a sleepless night with a fever below a 100. It seemed like a high fever to me. I got up the next day and was able to do my normal activity. It was fully done after that one night. I was diagnosed with Enzyme the 2nd or 3rd week of October. I used steroid cream for the Enzyme, and it has gone away, but the hives from dose 2 are still visible. I don't see the same spotting. It didn't seem like they worked initially it is much reduced, but it seems like there's swelling and my skin is lose and saggy.