chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Discharge Provider: DO Primary Care Provider at Discharge: NP  Admission Date: 12/17/2022 Discharge Date: 12/31/2022 COVID positive date: 12/17/2022 HOSPITAL COURSE: Patient is a 65-year-old female with history of type 2 diabetes mellitus, hypertension, recent colonoscopy 12/12 who presented to ED on 12/17 after being found on floor by son.  She reportedly had poor oral intake and diarrhea in the preceding days. In ED she was hypothermic and hypotensive with altered mental status. She became increasingly agitated, ultimately requiring intubation. Laboratory studies were significant for profound acidosis (PH 6.7), lactic acid (25), acute renal failure (BUN 56/creat 10.45), leukocytosis (34,000), and she was influenza A positive. CXR showed possible RLL infiltrate. CT angio abdomen showed mild nonspecific pan colitis, vascular exam unremarkable. CT head and c-spine without acute process/fracture. She received bicarb push x 2, hydrocortisone 100 mg, 4L IVF and Tamiflu. She was transferred to ICU in florid shock, requiring up to four vasopressors and bicarb drip. Given Metformin use and severely elevated lactic acid, it was suspected that she was suffering from Metformin toxicity.  She was started on empiric antibiotics, including Cefepime, Flagyl and Vancomycin.  She was also started on Tamiflu.  She was noted to test positive for COVID-19 as well on admission to ICU, in addition to influenza A.  Vascular catheter was placed and continuous renal replacement therapy was started 12/17.  Her acidosis cleared and vasopressors were slowly weaned down. She was able to be weaned off sedation by 12/21, and was extubated on 12/23. Continuous renal replacement therapy was stopped 12/24 and she was transitioned to hemodialysis.   She had a run of hemodialysis on 12/26, but then had progressive improvement in her renal function with increased urine output, such that dialysis was no longer felt to be required.  Vascular catheter was removed on 12/28.   Patient transferred to the hospitalist service 12/25/2022.  She had completed a full course of antibiotics while in the intensive care unit for pneumonia and completed 5-days of Tamiflu therapy for influenza A.  She developed acute worsening in anemia on 12/28, requiring 1 unit packed red blood cells, with hemoglobin stable around 8-8.5 g/dL thereafter.  Her blood sugars remained stable on low dose corrective Humalog, and A1c was normal at 6.0%.   She was felt stable for discharge home on 12/31/22.  She will need follow-up CBC and CMP in 5 days to recheck renal function and hemoglobin.  I am going to keep her off of chlorthalidone, glipizide, Janumet, metformin and losartan at discharge.  She will continue simvastatin and Ozempic.  She should follow-up her PCP in 1 week.  She should establish care with local nephrologist, given high likelihood for ongoing renal dysfunction/CKD in the setting of her severe AKI.
05jun90 pt vax inadvertently;  14Jun90 pt devel fever 101F.  Sx resolved.  As of 02Jul90 pt had exp no other problems.
Fever, redness, edema, cellulitis. Treated with clindamycin, daptomycin, lancing and packing. Symptoms improved in about a week.
Breakthrough case admission after 4 vaccines  Moderna 2/1/21 lot# 015M20A;  Moderna 3/11/21 lot# 030A21A;  Moderna 12/4/21 lot# 012H21B;  Moderna 11/18/22 lot# 014H22A
Patient received second dose 1 day early than recommended. First dose admininstered on 3/25/2021. Second dose due on April 22, 2021.  With 4 days early, would have been on April 18, not April 17.
Left thigh started swelling this AM with redness and hard area noted.  Pt to follow up with MD.
Over the time span of about 6 months (May 2021 to December 2021) she noted worsening fatigue and shortness of breath. She thought this may be due to her hypothyroidism however when she did not improve and presented to the hospital. She was admitted to Hospital from 12/10/21 to 12/14/21. During this time, she had an echo which showed EF of 15-20% and severe heart failure. She received heart transplant on February 5th, 2022, with Dr.  She has since been hospitalized multiple times due to complications relating to heart failure and transplant, immunosuppressant agents.
Date place in refrigerator was 12Nov2021.; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Date place in refrigerator was 12Nov2021.) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date place in refrigerator was 12Nov2021.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Date place in refrigerator was 12Nov2021.) outcome was unknown. Not Provided      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.   Date place in refrigerator was 12Nov2021. Patient did not experience temp excursion and any adverse event
COUGH; BACK PAIN; CHILLS/SHIVERS; HEADACHE IN RIGHT TEMPLE, MALICIOUS HEADACHE; FEVER; LIGHT HEADEDNESS, DIZZINESS; VOMITING; This spontaneous report received from a patient concerned a 45 year old male. 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 not reported,  batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced vomiting. On 12-APR-2021, the subject experienced light headedness, dizziness. On an unspecified date, the subject experienced cough, back pain, chills/shivers, headache in right temple, malicious headache, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F. Treatment medications (dates unspecified) included: oxycodone hydrochloride/paracetamol, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light headedness, dizziness on 12-APR-2021, had not recovered from headache in right temple, malicious headache, and back pain, and the outcome of vomiting, cough, chills/shivers and fever was not reported. This report was non-serious.
Developed 2 hives (about 1/4") on left side of body about 5" below underarm.  H1N1 shot received in left shoulder.  Area is tender to touch.  On 11/29/2009, noticed an area of hives (about 2" x 1") on back of left shoulder.
Information has been received from a licensed practical nurse concerning a 27 year old female patient with no medical history and no drug reactions/allergies who on 10-JUN-2011 was vaccinated with a dose of MMR II (lot number 666510/1624Y, expiry on 19-NOV-2011). There was no concomitant medication. On 11-JUN-2011, after administration of MMR II the patient developed "constriction of the throat". The patient went to the emergency room and was treated with SOLU-MEDROL IV and BENADRYL IV, she was released with a prescription for MEDROL DOSEPAK. There was no diagnostic laboratory test performed. On 17-JUN-2011, the patient recovered from constriction of the throat. Constriction of the throat was considered to be immediately life-threatening and an other important medical event by the licensed practical nurse. A lot check has been initiated. Additional information has been requested.
Staff reported generalized muscle aches and weakness, along with sleepiness. She noted injection site redness. On 1/14/20 at 15:30, her temperature was measured at 100 degrees F. Slightly elevated temp resolved on its own with increased fluids. She rested at home and symptoms resolved.
lt thigh became red & swollen @ inj site starting the morning of 7-9-21;  treated  with cefdinir
CRAMPS; MUSCLE PAIN; CHILLS; WEAKNESS; SINUS PAIN; This spontaneous report received from a patient concerned a 60 year old of unspecified 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 not reported, batch number: 180525, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-MAR-2021, the subject experienced sinus pain. On 19-MAR-2021, the subject experienced weakness. On 19-MAR-2021 01:00, the subject experienced chills. On 20-MAR-2021, the subject experienced cramps. On 20-MAR-2021, the subject experienced muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sinus pain, and weakness on 19-MAR-2021, and chills on 19-MAR-2021 05:00, and had not recovered from cramps, and muscle pain. This report was non-serious.
I had a candida infection in my esophagus that was caused by a steroid inhaler. My GI doctor diagnosed the infection by EGD on February 28, 2023. On March 15, 2023, I had a migraine all day. I felt sick. I went to bed early and woke up late that night. I ate a little bit of food. By midnight, I was vomiting. I had taken the first loading dose of the antifungal medication for the infection that night with dinner. At 02:00 AM, I went to the ER. By 05:00 AM, they told me it was my appendix and that I was going to be having surgery that morning. I had been having severe pain in my lower abdomen in my belly button and below it on the right. By 09:00 AM, I was in surgery. They took out my appendix. A couple of days later, they told me the pathology confirmed Acute Appendicitis. The first couple of days were bad, but I got better. The second week after the surgery, I felt a lot worse. Today marks three weeks since the surgery. This last week I've been dealing with a sharp, stabbing pain in my lower abdomen, and it's not near an incision site.
I had the normal arm soreness experienced by an average flu shot. It started the day after the vaccine and only lasted for 3-4 days. Everything seemed fine. Maybe 2-3 days after completing the smartphone vaccine check-ins my arm felt a little itchy. In the days that followed I had pain in my armpit,  then it streamed down my underarm making it difficult to lift or extend  my arm. As of Saturday, I have a large circular red ring on the outer injection sight portion of my arm as well as redness under my arm.  The pain and itchiness continue. I've only used cool compresses and Advil to treat it thus far. Advil helps with the pain.
with each new vaccine the tinnitus gets a little bit louder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558).  A 68-year-old male patient received BNT162b2 (BNT162B2), on 09Nov2021 as dose 3 (booster), single (Lot number: FF8839), in left arm for covid-19 immunisation. The patient's relevant medical history included: "wears hearing aids" (ongoing), notes: for about 20 years. The patient's medical history, reported also as family history included: "hearing loss" (ongoing), notes: hereditary hearing loss and tinnitus; wears hearing aides and has for about 20 years; "tinnitus; ringing in the ears" (ongoing), notes: hereditary hearing loss and tinnitus; wears hearing aides and has for about 20 years. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EN6206, administered in the left arm), administration date: 10Mar2021, when the patient was 68-year-old, for COVID-19 immunization, reaction(s): "with each new vaccine the tinnitus gets a little bit louder"; BNT162b2 (DOSE 2, SINGLE; Lot number: ER8733, administered in the left arm), administration date: 31Mar2021, for COVID-19 immunization, reaction(s): "with each new vaccine the tinnitus gets a little bit louder". The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "with each new vaccine the tinnitus gets a little bit louder". Therapeutic measures were not taken as a result of tinnitus.  Follow-up (15Aug2023): This is a spontaneous follow-up report received from a same contactable consumer.  Updated Information: reporter details, patient details (identifiers, age, height, weight, race), relevant medical history added, historical vaccine details, suspect vaccine details (vaccination date, lot number, anatomical location), event details (treatment information) and concomitant therapy details.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300276720 same patient/reporter/AE, different vaccine dose;US-PFIZER INC-202300276919 same patient/reporter/AE, different dose;
Soon after the 1st shot I experienced a vaginal discharge and heavy and longer period and my cycle dates changed after being on the same cycle since 2005. Went to the hospital because it was a recurring issue and they could not find anything wrong, no type of infection or STD but I was given an antibiotic shot anyway. When I was checked at the hospital they noticed that I may developed a fibroid so I went for further testing. After I was given an MRI is was discovered that I developed adenomyosis. Never had any of these issues until the vaccine
Swelling and numbness in upper lip and lower left cheek/jaw. Took Tylenol and used icepack to attempt to reduce swelling. Swelling dissipated within 24-hours but some numbness/tingle sensation remained for 48-hours.
Sore throat; Cough; Fever; body ache; sore in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2), administration date 18Aug2021 (Lot number: FC3181) at the age of 47 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 19Aug2021, outcome "not recovered", described as "sore in the arm"; OROPHARYNGEAL PAIN (non-serious) with onset 21Aug2021, outcome "not recovered", described as "Sore throat"; COUGH (non-serious) with onset 21Aug2021, outcome "not recovered", described as "Cough"; PYREXIA (non-serious) with onset 21Aug2021, outcome "not recovered", described as "Fever"; PAIN (non-serious) with onset 21Aug2021, outcome "not recovered", described as "body ache". Therapeutic measures were taken as a result of pain in extremity, oropharyngeal pain, cough, pyrexia, pain.  Additional information: The reporter stated, "Yes, I had the vaccine last Wednesday and it was like the first two days nothing wrong just sore in the arm you know to be expected since Saturday night had been having sore throat, cough and fever and not going away". Reporter stated, "the second one was supposed to be on 08Sep". Reporter confirmed that the start of adverse event was on Saturday evening. When asked about the expiration date, the reporter stated, "It doesn't say that's all they wrote on it they wrote Pfizer and then FC3181 that's it". About treatment, the reporter stated, "I was just been taking Ibuprofen, started on Saturday. I took 400-600 because I had body ache so sometimes I take 3". She stated "probably about twice" as frequency. She was still taking ibuprofen, she stated, "Yes, I took some this morning as I woke up with a fever". No patient history or other products reported. Investigation assessment reported as no.  No follow-up attempts are possible. No further information is expected.
Patient had a vaso vagal event, per the ED notes. Drop in blood pressure and had a fainting spell. Quickly improved after he arrived to the ED
I got a lump in my armpit at the vaccination site a couple of days after I got my second shot of the Pfizer COVID vaccine. A month and a half I started having breast pain on the same side of my body. My doctor found hardened tissue and said it might be the result of the inflammation caused by the vaccine.
I took no medications before the shot. Then, around 7 PM, I had a fever of 100, diarrhea, a terrible headache, and a  very painful arm. I am still running a low-grade fever and I am very tired and no energy.  I am the only one in my family that gets sick. Shot number one I got sick but not that bad and shot number two it was a little worse but this one is much worse.. I know I'll get over it but I am concerned I get so sick and the rest of my family has a slightly sore arm.  Does that mean the shots are not doing me any good?
R09.02 HYPOXIA 3/27/2023 HYPOTHYROIDISM R09.02 HYPOXIA 3/27/2023 WEAKNESS
Sx onset 8/6/22 with generalized weakness and chills. Admitted for observation of symptoms and weakness.
Pt fainted after injection & struck head. Has hx of vasovagal/fainting response to needles she did not disclose beforehand.
This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. An adolescent patient received TRUMENBA on an unknown date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced a seizure following the vaccination and was seen in the emergency room (ER). Clinical outcome of the event was unknown at time of this report. The information on the lot number has been requested.; Sender's Comments: 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, as appropriate. The case will be reassessed if additional information becomes available.
"Flu like symptoms" the day after third dose of  vaccine, including low-grade fever, lasting 1 day. Rash  on day 3 post-vaccine, diagnosed 2 days later as shingles. Currently on anti-viral medication as shingles is running its course.
PENTACEL was administered without reconstituting with the HIB portion of the vaccine, only the DTAP/IPV was administered with no reported adverse event; PENTACEL was administered without reconstituting with the HIB portion of the vaccine, only the DTAP/IPV was administered with no reported adverse event; Initial information received on 13-Dec-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 months old male patient who was diagnosed with pentacel was administered without reconstituting with the hib portion of the vaccine, only the dtap/ipv was administered with no reported adverse event after receiving vaccine diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine at a dose of 0.5 ml (strength, frequency, formulation, route, batch number, expiry date: unknown) via intramuscular route in unknown administration site for Immunization  On 08-Dec-2022 the patient diagnosed with non-serious event of pentacel was administered without reconstituting with the hib portion of the vaccine, only the dtap/ipv was administered with no reported adverse event (Product preparation error,Wrong technique in product usage process) (unknown latency) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both events    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt called 6/28 and reported adverse reaction of facial swelling.  She said her sister first asked her about it 2 days post vaccination.  She claims her face is still swollen 3 weeks post vaccination.  I have not visually seen her so that is the extend of what has been reported.
Patient experienced a rash and urticaria on arms and back after the administration of Pneumovax.  The patient had no other problems prior to this.
Tested NAAT positive for COVID 10/20/21 after being fully vaccinated.
Severe headache chills, body aches, arm pain, Nausea, fainted on standing, dizziness
Information has been received from a registered nurse concerning a female, pediatric patient who was vaccinated with Gardasil (yeast), (lot not reported). Subsequently the patient experienced severe injection site pain. It was reported that the pain was in the muscle and started at the time of injection that the pain was in the muscle and started at the time of injection. The pain lasted for 2 days and then resolved. The patient was treated with warm compresses. The patient sought unspecified medical attention. Additional information has been requested.
Pt recvd vax & reported that following 1st immun, pt had diarrhea (10 episodes/day) lasting 2 days, generalized rash & low grade fever; not seen by MD;
Systemic: Diarrhea-Medium, Systemic: Fever-Medium, Systemic: Vomiting-Medium
¨have a cold¨ with cold symptoms; little cough¨; ¨mucus¨; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (¨have a cold¨ with cold symptoms), COUGH (little cough¨) and SECRETION DISCHARGE (¨mucus¨) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced NASOPHARYNGITIS (¨have a cold¨ with cold symptoms), COUGH (little cough¨) and SECRETION DISCHARGE (¨mucus¨). At the time of the report, NASOPHARYNGITIS (¨have a cold¨ with cold symptoms), COUGH (little cough¨) and SECRETION DISCHARGE (¨mucus¨) 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.
recieved the new shingle vaccine on May 20, 2019 and per pt on May 21, 2019 she noticed a rash on her chest and also rash on left deltoid area where she recieved the vaccination. Per pt the rash on her chest has resolved, she still has a rash on her left deltoid area but to her it looks like it is getting smaller. It itches and slight discomfort if you press on it. No oral lesion, no sob, no wheezing, no fever, no chills. -ice -risk, benefit, options, side effects of empirically treat with antibiotic but pt declined for now, she prefers to just observe it for now, per pt it is getting smaller. -advised pt not to scratch at lesion -pt elects not to get the second shingle vaccine. PER GMC NOTE 05/24/2019
Extensive erythema over anterior R thigh, slight tender & warm. No fever, walking normally.