chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 83 y.o. female with history of fib, HFpEF, CAD s/p CABG, COPD, OSA, HTN, HLD, DM2, presented to the hospital with dyspnea found to have hypoxia .   Acute on chronic respiratory failure with hypoxia Normally requiring only 2L nocturnal. Initially presenting with hypoxia requiring 3 L. Etiology secondary to COVID. Treating as per below. CT reviewed and without edema or fluid level. Wean O2 as tolerated. 2/1: Currently stable on room air.  Stable for discharge and to complete course of dexamethasone.   Covid-19 Virus Infection Date of onset of symptoms: 1/28/2023 Symptoms present on admission: Cough, nausea, dyspnea Date of covid positive test: 1/30/2023 Vaccination status: vaccinated Imaging: CXR, CT PE Oxygen requirements on admission: 3 L Current oxygen requirements: Room air Medical therapy: steroids.  Holding remdesivir against AKI. Consultants following: N/A Anticipated special isolation end date: 2/8/2023 2/1: Clinically stable on room air, discharge to complete 10-day course of dexamethasone.   Chronic HFpEF Recent admitted to other hospital from 1/18 through 1/22/2023. Diarrhea significantly at that time. Euvolemic on this admission. Most recent echo 3/2022 with EF 63%, RV systolic function mildly reduced  Holding lisinopril and Lasix against AKI. Resume home metoprolol and sotalol. Follows with Dr. as outpatient We will follow clinically.  2/1: Remains euvolemic, and the patient has significant decompensation admission earlier in the month we will cut Lasix down to 40 mg twice daily.   AKI On recent admission Lasix was augmented to 80 mg twice daily. Holding as creatinine has risen to 1.50. 2/1: Continues to improve to 1.47. With history of HFpEF we will cut Lasix down to 40 mg twice daily upon discharge.  To follow-up with cardiology as outpatient. Repeat labs in 1 week.   Abnormal TSH TSH 4.34, recheck normal   Atrial fibrillation EKG with sinus rhythm Continue home metoprolol, apixaban  Sotalol on hold until reevaluation by cardiology.   Chronic normocytic anemia Baseline hemoglobin 9?10 At baseline
Extreme nausea afternoon of shot 103 degrees fever that evening took TYLENOL and MOTRIN fever down to 100 degrees in AM then normal that afternoon.
Pt received ZOSTAVAX vaccine on 3-4-08. Pt came into office on 8-11-08 with rash painful, erythematous, vesicular eruptions. This is in follow-up to report(s) previously submitted on 9/24/2008. Information has been received from a licensed practical nurse concerning a 63 year old female with arthritis, bronchitis, blood pressure high, cardiac disorder, sinusitis, hay fever, bad knee, penicillin allergy, codeine allergy, drug hypersensitivity and sulfonamide allergy and a history of measles, mumps, chickenpox, infectious mononucleosis, hives, cancer, back discomfort, anaemia, ulcer, haemorrhoids, bladder infection and hernia who on 04-MAR-2008 was vaccinated subcutaneously into the left deltoid with a 0.65 ml dose of ZOSTAVAX (Merck) (lot no. 659759/1873U). Concomitant therapy included alendronate sodium, ZANTAC, INDERAL, nortriptyline, cabbage palm, ZYRTEC, WELLBUTRIN XL, DIOVAN HCT, fluticasone furoate, metformin, KLOR-CON, DYAZIDE, simvastatin (manufacturer unknown), metoprolol, diltiazem HCL, CECLOR, diltiazem HCL, doxycycline, NITROLINGUAL and "other medications". On 07-AUG-2007 the patient was diagnosed with shingles. The patient had rash on upper left leg which was painful and blistering redness. The patient had no other symptoms. The patient was treated with TYLENOL. On 11-AUG-2008 the patient was in office with draining lesions located on left upper thigh. The physical examination was done. Blood pressure was 108/64. Pulse was 66. Respiratory rate was 18. Body temperature was 97.1 F. There was no abnormal discovery with the patient. The patient was well health and well nourish. Heart was regular rate and rhythm. Lungs were clear to auscultation and no wheeze. There were multiple patches of painful, erythematous; vesicular erythema within the L2 dermatome of the left leg. It was diagnosed that the rash was probably shingles infection. The patient was treated with VALTREX 1000 mg, three times per day for 7 days; triamcinolone cream 1%, VICODIN, 1-2 tablets, four times per day as needed for pain. The patient would be followed up in 2 weeks. At the time of this report, the patient's shingles persisted. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain. The sample of the lesion was collected on 14-AUG-2008. The sample was taken from a vesicle (lesion) (site not provided). On 20-AUG-2008 lab results reported the PCR results for the specimen from the vesicle lesion identified the presence of WT VZV. No further information is available.
I've had TYPE 1 Diabetes since 1982 and other autoimmune conditions including Hashimotos.  This was my 5th Covid related vaccination.  The first vaccination I noticed a similar reaction as this most recent dose.  It may be coincidence but about 12-36 hours after the injection, I got extreme fatigue, malaise, mild fever and body aches.  Then felt completely fine after that time frame each time.  I expected that.  What I did not expect, but did notice was a consistent trend in lower blood sugars.  I have a continuous glucose monitor and an insulin pump.  A few days to a few weeks after each vaccine, I noticed a decreased need in insulin (increased insulin sensitivity).  I had more low blood sugars that seemed to come on faster and be more severe.  The shift in blood sugar seemed to last for a few weeks.  It may be complete coincidence, but after 40 years with TID and close monitoring, this seemed much more obvious each time.  This last time, A few weeks after the Covid Vaccine, I got the Quadrivalent Flu Vaccine.  The low blood sugars continued.  I am wondering if it is an immune response that increases insulin sensitivity.  I feel that it was significant and repeated enough to notice and report this VAERS.  I hope that eventually a study is noted and data is reported so others can be alerted if there is a correlation.  Thank you.
This case was reported by a healthcare professional and described the occurrence of shortness of breath in an elderly subject of unspecified gender who was vaccinated with Flulaval for prophylaxis. Concurrent medications were not specified. On an unspecified date (15 November 2007 or later) the subject received 1st dose of Flulaval (unknown) with expiration date March 2008. In November 2007, at an unspecified time after vaccination with Flulaval, the subject experienced shortness of breath, fever, weakness and vomiting. The reaction was classified as systemic. The healthcare professional considered the events were disabling. The reporter suspected a safety and quality issue (product complaint) with the vaccine. At the time of reporting the outcome of the events was unspecified. It was indicated that these events occurred with multiple subjects. Nine specified at the time of the report. It was noted that 2 or 3 subjects had to be treated in the emergency room for these events. Most of the subject recovered from the events after 2 to 4 days. Some subjects had not yet recovered at the time of reporting. Specifics on each individual subject were not provided.
ACUTE RESPIRATORY FAILURE 5/1/2023 ALLERGIC ASTHMA, UNSPECIFIED, W ACUTE EXACERBATION ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/1/2023 ALLERGIC ASTHMA, UNSPECIFIED, W ACUTE EXACERBATION HYPOXIA 4/30/2023 ALLERGIC ASTHMA, UNSPECIFIED, W ACUTE EXACERBATION
Tired, dizzy, vomiting through out the night and morning, diarrhea throughout the night and morning. Still monitoring him.
cold sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2), administration date 28Mar2021 (Lot number: ER8130) at the age of 39 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ORAL HERPES (non-serious) with onset Mar2021, outcome "unknown", described as "cold sore". Therapeutic measures were taken as a result of oral herpes.  Additional information: Product: PFIZER-BIONTECH COVID-19 VACCINE. The patient was a 39-year-old female who received the first dose of the Pfizer Covid 19 vaccine yesterday. Afterward, she felt a cold sore coming on and took a dose of valacyclovir. She asked if this is a problem.  No follow-up attempts are possible. No further information is expected.
patient got the covid vaccine shot ,sitting down waiting  for 15 mins, patient got up and walked to consultant window, was asking for bathroom and same time he fainted on the floor, his face was looking pale , sweaty. After few minute, patient said he is ok and sat on the floor. we offered him water and had him sit on the chair, he said no need to call 911 because he said he was feeling ok. When pharmacist asked him did he eat breakfast before coming over here, he said he did not has breakfast and drink ,little nervous with needle.
Previous to  Pfizer vaccines I had chronic tinnitus with mild symptoms. I'm a retired dentist. I wasn't aware of any changes in my tinnitus after the 1st vaccine. But after the 2nd vaccine I noticed a definite profound increase in my tinnitus. It is now on the verge of being debilitating in nature. It is now  pulsating and much louder, very difficult to ignore even during day time activities. Before my tinnitus was bilaterally equal, now I would say my right ear is louder than my left. But both are louder than before. Today marks about 50 days since 2nd vaccine, and I think its actually getting progressively worse! Hopefully this is not permanent.
This case was reported by a nurse and described the occurrence of incorrect storage of drug  in several patients who received FLUARIX Quadrivalent 2013-2014 season.  On an unknown date, the patient received FLUARIX Quadrivalent 2013-2014 season at an unknown dose. On an unknown date, an unknown time after receiving FLUARIX Quadrivalent 2013-2014 season, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional  information: Per the nurse, FLUARIX QIX was stored at 30.6 degrees F and administered to several patients in torsed.
Flushing, diaphoresis, severe pain to injection site, fatigue, diarrhea. Symptoms lasted <24 hours. Still has diarrhea.
Anaphylactic reaction approximately 25-30 min after injection of vaccine Itching as swelling of lips, tongue Administered 50mg oral Benadryl Administered 0.3mg epinephrine via Epipen Reaction subsided in 5-1 min. Observed 2 hours post with no change
This spontaneous report was received from a nurse practitioner regarding an unknown age patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unknown date, the patient initiated the GARDASIL 9 for prophylaxis, intramuscular route (dose, strength, frequency, lot# and expiration date were not reported) series after age 26. No adverse effects were reported. No product quality complain was present.
Pt admitted to Hospital for issues other than +Covid. Fatigue, exhaustion, and loss of appetite. Intermittent nausea w/out vomiting.
Pt received both injections as listed below. Pt states started to feel soreness only when sleeping on sides at injection sites approx. 1 week later. Soreness continues until pt reported reaction to pharmacy on 12/10. RPh followed up with pt on 01/01/14 - he states lifting weights x past 1 week improved soreness but still sore. Pt states will continue exercise x 1-2 more weeks, if soreness persists will contact PCP to be evaluated. Also, (L) deltoid more painful than (R) deltoid. No visible or palpable changes/abnormalities at either site.
after receiving their vaccine, they have contracted the Covid-19 infection; after receiving their vaccine, they have contracted the Covid-19 infection; This is a spontaneous report from a contactable pharmacist.  A patient of unspecified age and gender received first dose BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. After receiving their vaccine, the patient experienced contracted with the covid-19 infection an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: they have contracted the covid-19 infection. Caller wanted to know whether they get the 2nd dose of the vaccine? How long should they wait before getting it and is there a recommended interval? Can they get the vaccine if they still have symptoms? Outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (COMIRNATY) on an unspecified date, and contracted COVID on an unspecified date.  No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.  Further information like COVID infection date needed for a full meaningful medical assessment.
Got the J&J on March 9th.  Had severe cramp/knot in my left leg starting the 19th.  Lasted through the 29th and right leg got it the 24th through 30th.  I attributed it to pushing too hard at the gym.  When they didn't go away after heat/cold/rolling/hot tub I did worry about clots, but not due to vaccine.  Was going to call Dr but they went away.
6 minutes post vaccination patient reports feeling "wonky" and similar to reaction she has had after Xolair injection(s). Pt has own epi pen and was assisted to couch, feet elevated.  Pt denies respiratory distress, no urticaria or angioedema.   Pts vitals taken while recumbent on couch:  O2 98%, HR 76, BP 160/100.  Offered water, juice, crackers. Pt remained resting on couch; at 14:40 reports nausea and patient agrees to 12.5 mg IM diphenhydramine in opposite arm of vaccination.  Pt remained resting on couch denies respiratory distress and no other s/s of anaphylaxis noted.  Pt vitals taken several times while on couch ranging from 130/90 - 158/100, OZ 98% and HR 72-76.   Pt remained resting on couch without further symptom progression  until family member arrives to transport home 85 min post vaccination.
Approximately at 2am on 2/12/2021 the patient woke up with intense full body body aches.  Patient went back to sleep.  At 7am, patient had fever of 99.8, felt hot, and had 9/10 full body body aches, worse in the trunk of body, as well as in the left arm at site of injection. Fever lasted until 4pm. Accompanied by general malaise, sweating, a one-hour period of chills and fever, no appetite and fatigue.  At 4 pm the same day, fever finally broke and patient experienced no body ache except for arm.  On 2/15/2021, the patient experienced extreme allergies with symptoms such as sneezing, itchy eyes, itchy nose, blowing nose, which lasted two days.  Severe allergies lasted two weeks.
This spontaneous report was received from a pharmacist and refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unspecified date, the patient was vaccinated subcutaneously with the first dose of ZOSTAVAX injection (dose, lot # and expiration date were not reported). On 07-OCT-2016, the patient was vaccinated subcutaneously with the second dose of ZOSTAVAX injection (dose, lot number and expiration date were not reported). No adverse effects were reported. There was no product quality complain involved.  Additional information has been requested.
Information has been received from a physician concerning an 8 year old male with no past medical history and no known allergies who on 10/15/1996 was vaccinated subcutaneously with a 0.5ml dose of varicella virus vaccine live (Oka/Merck) (Lot# 617911/0778D).  Subsequently the child was exposed at school, and developed chickenpox.  The number of lesions was unknown.  At the physician's office on 04/14/2004, the patient was given acyclovir.  Unspecified medical attention was sought.  There was no product quality complaint.  The reporter also mentioned another child who received varicella virus vaccine live (Oka/Merck) and developed an adverse experience.  Additional information has been requested.
Report  fatigue fever and chills started the next day. Also report bleeding at the injection site immediately vaccine was given stated, "gauze was saturated with blood" Treatment: Tylenol and Ice, Outcome: No bleeding occurred the next day.  Does not interfere with ADLs.
pt rcvd vax; t 101; pt screamed frequently, crying, slept 1 & 1/2 hrs over 24 hr period; sz like activity; pt taken to ER; dx as reaction to DTP; MD instructed cont use of apap & observation at home;
Chills immediately and continued 2 days later; muscle aches, joint pain and headache started day after. Current right hip joint pain and HA(3 days after 2nd dose)
Headache, arm swollen and in pain, extremely tired, naseua,for 2 and half days following shot
pt recvd MMR #2 17AUG92; seen by MD on 25AUG92 for c/o malaise, joint pain, skin rash; diarrhea, dec appetite, tired; given meds;
My adult son is getting me grain s after getting your booster shot/ Migraine headache; the pain of the headache; stated that now he is in a lot of pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the parent.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 21Jul2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 56 years for covid-19 immunisation. The patient's relevant medical history included: "mentally challenged (Medical condition)" (unspecified if ongoing). Concomitant medication(s) included: FLUOXETINE. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 Immunization. The following information was reported: MIGRAINE (non-serious) with onset 2022, outcome "unknown", described as "My adult son is getting me grain s after getting your booster shot/ Migraine headache"; PAIN (non-serious) with onset 2022, outcome "unknown", described as "stated that now he is in a lot of pain"; HEADACHE (non-serious) with onset 2022, outcome "unknown", described as "the pain of the headache". The events "my adult son is getting me grain s after getting your booster shot/ migraine headache" and "the pain of the headache" required emergency room visit. Therapeutic measures were taken as a result of headache.  Additional information: it was reported that he was at the emergency room twice and they definitely said it was from the shot. The patient was taking a very small amount of blood thinner.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
initially he said welts occurred on first day of vaccination.  on questioning, learned hives started on abdomen0700 to 0800 the day after the first dose of the Moderna vaccination for COVID-19 prevention. 2 days later hive on lip.  then subsequent days progressively worse urticaria with back, neck, arm, leg, feet, ankles affected.  Rashes, welts he says covered 50 to 60 % body.
Pain at injection site; arm continued to be sore all week and became red and swollen, according to the patient.  Now one week later she is c/o flu-like symptoms with fever but not actually measured.
in bed the whole day; pain all over her body; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of BED REST (in bed the whole day), MYALGIA (pain all over her body) and FATIGUE (flet tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BED REST (in bed the whole day), MYALGIA (pain all over her body) and FATIGUE (flet tired). At the time of the report, BED REST (in bed the whole day), MYALGIA (pain all over her body) and FATIGUE (flet tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Pt lost consciousness & had an apparent sz immediately p/receiving Typhoid vax; Vax administered IM rather than SQ; pt on oral meds for convuls disorder;
Patient received vaccine and about 10 minutes after administration experienced syncope. She recovered well within the following 30 minutes and her husband took her home after the fire department monitored her.
This spontaneous report was received from a physician refers to unspecified number of patients of an unknown age. The patients' concurrent conditions, medical history and concomitant medications were not reported. The physician stated that the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # L025738, expiry date 14-AUG-2017) (34 F for 4 hours) between 24-DEC-2015 and 12-JAN-2016. No adverse events were reported. This is one of the several reports receive from the same reporter. Additional information has been requested.
Itchy and redness about 2 inches below injection site started 1 hour after injections were given. Redness continued to worsen as time went by, swelling, warm to touch.
Patient was administered both improperly stored ROTATEQ, improperly stored VAXELIS; Improperly Stored; This non-serious spontaneous safety report with reference number 02125902 was received by a partner on 10-MAR-2022 and forwarded to Agency on 15-MAR-2022 from a health care professional.  The causal relationship between Vaxelis and the reported event Patient was administered both improperly stored ROTATEQ, improperly stored VAXELIS; Improperly Stored is assessed as not applicable due to the nature of the event.  Further information is expected.
Case number PHEH2016US031011, is an initial spontaneous report received from a nurse on 24 Nov 2016. This report refers to a 91 year old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1620501 and expiry date: Jun 2017) at a dose of 0.5 intramuscularly on 17 Nov 2016 and on 23 Nov 2016. The nurse stated that, no adverse effects were noted after this maladministration.
Developed hives on thighs, ankles, elbows 11/05/09. Itching, red, looked like mosquito bites. Had dizziness night before, could hardly stand up. Took BENADRYL several times and it helped. Rash finally gone around 11/17/09. Never had a fever. Dizziness did not recur. No N+V, no headache complaints.
No additional adverse effect reported; patient received improperly stored PROQUAD on 5/5/2020; This spontaneous report was received from an administrator and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 05-MAY-2020, the patient was vaccinated with dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD)injection (lot # S006019 was an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD); strength, route of administration and dose were not reported) reconstituted in properly stored sterile diluent, for prophylaxis.  On an unknown date, the dose of the vaccine was exposed to temperature excursion at 10.4 Fahrenheit degrees (F) for 15 minutes. There was previous temperature excursion at 11.1 F for 15 minutes. The call was due to digital data logger. No additional adverse effect were reported.