chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures)    Patient admitted with hypoxic respiratory failure related to COVID 19. She was also treated for possible bacterial coinfection. Noted also to have acute anemia thought likely due to supratherapeutic INR (on chronic warfarin therapy for afib and mechanical aortic valve replacement). She has a history of GI bleed, though this was not worked up as possible cause during this admission as her hgb stabilized without intervention, and INR is a known cause of anemia. Hgb monitored during hospitalization, she did not require transfusion.    Patient completed course of remdesivir,steroids, and a course of cefepime for possible CAP coinfection. Eventually weaned off of HFNC to nasal cannula. She was still very dyspneic with minimal exertion. Therapy teams recommended SNF for rehab; patient initially hesitant and wanting to go home, but did accept this as short term rehab. In the past few days she has continued to show marked improvement, I expect her to recover well from this. She is motivated to do well in therapy with the goal of home independently (lives with her son, though she has previously managed all her ADLs).    CKD3A with acute kidney injury noted, AKIN stage 1; resolved prior to discharge.
The patient had a syncope episode on 11/9/21 and fell. She was brought to the hospital and tested positive for COVID.
This spontaneous report from a contactable physician through a Pfizer Sales Representative. A patient of unknown gender and age received PREVNAR-13 single dose, unknown route for immunization on unknown date. Relevant medical history and relevant concomitant medications were unknown. Vaccines given on the same day was unknown. Vaccines taken within the last four weeks were unknown. On 06Sep2013 the patient experienced swelling on the arm and pain in the arm. Relevant lab data was unknown. At the time of the report clinical outcome of above mentioned events was unknown. Follow-up (01NOV2013): Follow-up attempts completed. No further information expected.
After receiving vaccine, I felt fine, then at 9pm that night, I started having chills, and being lethargic along with headache and nausea. By Sunday Morning, I had all those sypmtoms all day long, with back vomiting and fever. Today, I feel better, just still feverish and still upset stomach. I will not be going to work today.
No adverse reaction noted with patient; Temperature excursion in freezer, was instructed vaccines were okay to use; This spontaneous report was received from a certified medical assistant, concerning a 4 years with 2 months old male patient.  The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 18-AUG-2020, the patient was vaccinated with second dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (strength, dose or anatomical location were not reported) with lot # reported as T007359 with expiration date on 29-AUG-2021, administered subcutaneously, for prophylaxis, at a public clinic, with public funds, by a trained operator. It was reported that there was nothing wrong with the vaccine which was used according to the instruction leaflet; however, it underwent a temperature excursion in the freezer before administration and the vaccine provider was instructed that the vaccine was okay to use (product storage error). No digital Data logger was involved. No adverse reaction was noted in the patient.  Lot number T007359 is an invalid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA001768:
Patient seen Dr. and he put the green flag out signaling there is a nurse task needing done. I looked into patient's chart and there were two standing orders, one for a influenza vaccine and one for a steroid injection. I prepared the paperwork and injections. After I administered the injections I went to chart and noticed to the far right of the influenza vaccine order it said it was ordered by another LPN in 2020. I notified patient immediately and she said she had already had the flu vaccine in September 21. Patient verbally understood. I notified my supervisor and provider the next morning.
27 patients were scheduled for the day and provider did not have a nurse or medical assistant, to help with any tasks or check-in. several patients were siblings needing different vials of Pfizer, which required different dilution amounts. Small (1ml) syringes were on the counter, and provider accidentally drew up the wrong dilution amount and diluted the vials with 0.22 mL of NS instead of 2.2 mL. the does given was still 0.2mL.   outcome: he had a minor fever and pain at the injection site.
Fever, chills, nausea, body aches, headache, sore and swollen armpit, sore swollen warm to the touch injection site, fatigue
Pt came to clinic on 11/15/02 at 4:25pm reporting that she received a pneumonia and flu shot on 11/11/02 at this clinic: pt c/o of redness, swelling in left tricep following these shots.
Severe joint pain with extreme fatigue.   Pain all over my body.  Blurred vision, back of head hurt constant aching.   I walked a lot for exercise I no longer could continue walking 2 to 3 miles a day.  Made appoint with GP doctor.
nausea, vomiting and diarrhea, left arm pain at site of injection, headache
I developed intraparotid lymph node swelling. One lymph node measured 9mm and another 7mm
Vaccination given in the A.M. The patient woke up at 7 P.M. with full body hives. The mother states he has some swelling of the mouth and congestion.
Developed severe nausea for several days, hospitalized for dehydration. Lost 7 pounds. 4 y/o sister was sick as well a week earlier but only for part of a day. Still has runny nose.
Refrigeration excursions identified/vaccines have undergone several temperature excursions; No adverse event; patient was administered vaccine which had undergone several temperature excursions; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 36-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Sep-2022 at 1:34 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 23-Sep-2022 at 1:34 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions).    No concomitant drug information was provided.  Patient had received previous 3 doses of vaccine, intramuscular with anatomical site as deltoid. Dose 4 anatomical site was also reported as deltoid.   It was unknown if the patient had ever tested positive or been diagnosed with COVID-19.  The vial(s) moved from freezer to refrigerator on 07-Sep-2022.   It was reported that the vaccines had undergone several temperature excursions in Aug 2022.   Refrigeration excursions were identified, state vaccine was housed in the units. There were excursions noted. Manufactures were notified and the state department was made aware of the situation. No adverse reactions were reported for any of the patients at the time of the report.  No treatment information was provided.
Urticaria began roughly four days after receiving Pfizer covid vaccine.  Begining on upper arms around 6pm on August 6th, 2021. Took Banophen before going to bed. Woke up around noon on August 7th 2021, hives have spread, covering hands, arms, torso (front, back and, sides), legs, and tops of feet. Angioedema of lips observed as well, beginning around 2pm August 7th 2021.
On March 10th: - Patient woke up with swelling on the lower right side of her lip. - Usual foods eaten that morning: mashed potatoes, milk, cream of wheat - Throughout the day, patient notes she was not feeling well. At 6 PM, she developed rashes on her hip, groin, and abdomen. At 7 PM, she took diphenhydramine 25 mg. By then, her mouth was swollen. Her tongue also started to swell. At 9:30 PM, she had increase itching, burning sensation, and hives worsened. Developed a large rash on her butt. At 10 pm, took a second diphenhydramine; notes she had tongue swelling voice changes (gravel-like quality), and bilateral facial swelling. She was also breathing rapidly. Went into the ER, was checked in after ~3 minutes. She was administered epinephrine IM, IV diphenhydramine, solumedrol 125 mg, and IV famotidine. Patient was also intubated for respiratory distress and airway swelling, and admitted to the ICU. Was intubated until the afternoon of the following day.
Pt vaccinated with Engerix-B according to 0,6 months schedule.About one month following the 3rd dose test indicated a low titer. Reporter states pt did not have any adverse rxn following inject.
1 day p/vax pt exp severe flu like sx for next 6-7 days;pt notice rise in home monitored blood sugar level >300 to 400;pt exp swelling in both great toes;saw MD & determined to have bone disease;toes damaged & gangrene;great toes amputated;
Patient was given a monovalent booster instead of a bivalent dose. Attempted to contact patient to advise of immunization error. Left voice message requesting a call back.
Nurse reconstituted Pediatric Pfizer with 1.8 ml diluent then administered to a 17-year-old leading to a very low  dose.
Swelling of the shoulder started the evening of the day after vaccination (10/10/23). The patient went to ortho on 10/12/23 and had 3 vials of fluid drained from her bursa sac of her left shoulder. Then made a repeat trip on 10/13/23 where another 3 vials were drained from the same shoulder. A steroid injection to the shoulder was also administered at the 10/13/23 visit. A followup visit on 10/19/23 was also performed. The patient says that there is some lingering discomfort of her left shoulder.
Blood pressure went from normal 135/65 to 180/100 within two hours; Headache; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Mar2021 15:30 (at the age of 57years) as unknown, single for Covid-19 immunization. Medical history included acid reflux after gallbladder removal, hypertension, and allergy to Strawberries; all from an unknown date and unknown if ongoing. Concomitant medications included lisinopril (LISINOPRIL) and omeprazole (OMEPRAZOLE), both taken for an unspecified indication, start and stop date were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced blood pressure went from normal 135/65 to 180/100 within two hours (as reported) and headache on 17Mar2021 23:00. The patient has not been tested for COVID-19 since the vaccination. It was unknown if the patient was treated for the events. The outcome of events was not recovered.  Information on the lot/ batch number has been requested.
Day after vaccine child had generalized scarletina body rash with confluent 2 cm area left lower thigh and 1 cm confluent right thigh rash that started the evening she recieved the vaccinations listed below.
generalized pruiritic raised rash to arms, back, abd, and legs accompanied by neck/back/shoulder/knee/head pain
Previously potty-trained toddler became incontinent for 3 days following administration of the vaccine. Daycare teachers also commented on this, without any knowledge of the vaccine having been given. Eventually potty-training habits returned. Also child fell asleep unusually quickly (less than 5 minutes), and she was less talkative for about a week following administration of the vaccine.
Information has been received from a registered nurse referring to a 21 year old female patient. On unspecified dates, the patient was vaccinated with unspecified number of doses of RECOMBIVAX HB (route, lot# and dose were unknown). The patient sought medical attention by an unspecified means. The result of a Hepatitis B titer on an unspecified date was no immunity to Hepatitis B. On 29-JUN-2015, the patient was vaccinated with another RECOMBIVAX HB (route, lot# and dose were unknown) as the treatment. The outcome of the event was unknown. The relationship of the event and RECOMBIVAX HB was not reported. Additional information has been requested.
After injection had L arm pain, the following day (12/17) pain continued . 12/18  onset of  fever max temp 38,  chills, fatigue, muscle pain and nausea. Treated with Tylenol for symptom relief. Symptoms continue and worsened 12/19 and 12/20. 12/20 underwent video clinician visit for symptoms and inability to return to work for continued symptoms 4 days after vaccination, last day of fever.  12/21 covid and flu swab negative symptoms all continued fatigue very evident going to and from swab exam. 12/22 morning near syncope while getting ready for day,  tachycardia, underwent ED eval was given fluids and labs drawn and discharged home with improvement in tachycardia and lightheaded/dizziness with fluids, another covid swab was negative along with negative RVP. Continued to have fatigue 12/22 evening.
Within hour: nasal drip, sore throat, developed into coughing, heavy mucus (yellow/green). Very ill for two weeks. Bed rest and fluids. Gradually symptoms tapered off. 10/6/2011 still have some mucus.
Patient was inadvertently given an MMRV vaccine that had previously expired about 2 weeks prior to the date of vaccination. Clinic personnel did not observe any adverse events immediately after vaccine administration, and we did not receive a call from the patient's family following the vaccination regarding any adverse reactions.
Information has been received from a pharmacist concerning a 62 year old female patient with no pertinent medical history and no drug reactions/allergies, who on 25-JAN-2011 was subcutaneously vaccinated with a 0.65ml dose of ZOSTAVAX (Merck) (lot # 669189/1389Z). There was no concomitant medication. On 26-JAN-2011 the patient experienced injection site reaction after receiving ZOSTAVAX (Merck). The patient had 3 inch diameter of swollen area which was very red, hot and hard. No lab diagnostics studies were performed. The patient called the pharmacist for medical attention. The patient was treated with ibuprofen and cold compress. At the time of the report, the patient had not recovered. Additional information has been requested.
Injection site was so painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site was so painful) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection site was so painful). At the time of the report, VACCINATION SITE PAIN (Injection site was so painful) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       High Blood Pressure Med was given as concomitant medication.  No treatment information was provided.   This case was linked to MOD-2021-275274 (Patient Link).
Received my second shot of the vaccine and my armpit is swollen; Pain in my neck and it ran down my arm; Stiff neck; Pain in my neck and it ran down my arm; This is a spontaneous report from a contactable consumer (patient).  A 67-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9262; Expiration Date: 31May2021) as dose 1, single for covid-19 immunisation and co-suspect reported as Ibuprofen (MOTRIN [IBUPROFEN]), route of administration, start and stop date, (Batch/lot number and dose were not reported). The patient medical history and concomitant medications were not reported. The patient had swelling in the armpit and it happened probably within like 10 to 15 minutes after she got the vaccine and it was only one not on both armpits it was just one armpit. On an unspecified date, the patient had pain in her neck and it ran down her arm and experienced stiff neck. The patient want to know if she can take Motrin that will make this swelling go away. The patient was asking how long it will last or what she can do about it. The clinical outcome for events was unknown.
This spontaneous report was received from a nurse practitioner concerning a female patient of unknown age. On an unknown date (several years ago), the patient was vaccinated with the first two doses of GARDASIL (lot number, expiry date, dose and route unspecified), intramuscularly as per the labeled vaccination schedule. The patient was not administered the third dose of GARDASIL until recently (09-APR-2013). No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
This spontaneous report as received from a registered nurse via company representative refers to a non-pregnant female patient of unknown age. On an unknown date the patient was vaccinated with a dose of GARDASIL intramuscularly (dose, lot# and expiration date were not provided). Then, on an unkonwn date the patient felt faint. No treatment was given for the event. No laboratory diagnostic was performed. The patient recovered on an unspecified date. Relatedness between the event and GARDASIL was not provided. Additional information has been requested.
COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 79-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. ASKU and ASKU) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 immunization: spikevax (dose 1) and spikevax (dose 2); for Drug use for unknown indication: FLU I. Past adverse reactions to the above products included No adverse event with FLU I, spikevax and spikevax. Concurrent medical conditions included Overweight.   In September 2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In May 2023, received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2022, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. On 05-Dec-2022, COVID-19 (COVID-19) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The patient already received 2 doses of Moderna COVID-19 Vaccine (did not remember dates but he thought it might be 6 months apart. The patient got COVID-19, the patient had mild symptoms, starting with sore throat and decided to get tested, then the patient was treated with Paxlovid and the disease got resolved.
Tight wheezing lungs, headache, overall lethargy like a mild illness.  Will never take this again.
Between that evening and the next morning I Cold, flu like symptoms, chills and not feeling good. In November is when I went to see my Doctor due to the symptoms wouldn't go away and this cough. On 12/22/2021 at 11AM I went to my doctor because this cough was brought to my attention,  He checked me for fever and this is only in the area. I had a chest X-ray and labs, 12/23/2021 I went for my Chests X-Ray and results showed that I had damaged in my lungs,  12/29/2021 I went and had the echo, 01/03/2022 I had my second shot of my shingles, On the 4th of January 2022 I went to see Dr. at 03:00PM allergist to check on my Asthma. 01/18/2022 I had labs done and I have an appointment on 02/16/2022 because she wants to make sure my lungs are kind of back to normal.
The patient was experiencing headaches 1 week ago. She also had aphasia later in the week. She went to an outside hospital on 3/24/2021 and was found to have intraparenchymal hemorrhage in addition to venous sinus thrombosis. She is being treated for the venous sinus thrombosis with heparin.
posterior occipital adenopathy, fever, myalgias (severe), morbulliform rash;
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 08-AUG-2016, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as shingles. The patient has been prescribed NORCO and valacyclovir for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome is unknown. Additional information has been requested.
This medically confirmed spontaneous report (initial receipt: 28-Sep-2012) concerns a female patient. Between 24-Sep-2012 and 27-Sep-2012 (exact date of vaccination was unspecified) the patient received AFLURIA (batch number: P58306) injection. Following vaccination, the patient developed injection site reactions. The reaction was described as being localised at the injection site 3 inches in diameter, red, hot and hard to the touch. The patient sought medical attention. The event outcome was recovering.