chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 68 y.o. male with a PMHx of uncontrolled T2DM, hypothyroidism, dyslipidemia and obesity who presented for a chief complaint of generalized weakness and altered mentation. Acute evaluation positive for COVID diagnosis with concurrent volume overload, noting 3+ pitting edema during examination. Thus, diuresis was initiated with gradual reduction in swelling and satisfactory urine output by daily monitoring. The onset of COVID symptoms within a 1 week period warranted further intervention by way of Infectious Disease management, to regulate Remdesivir and Tocilizumab dosing. Pt's hospitalization was complicated by a slow reduction in oxygen requirements despite diuretic management, suspected secondary to fluid retention in the setting of suspected cardiac contribution, as well as active pulmonary infection from a viral nidus. Echocardiogram ruled out any acute, left-sided dysfunction. Continued evaluated was able to demonstrate an improvement in strength by PT and OT evaluations. Once improving substantially enough to maintain his SpO2 off of supportive therapy, Pt was determined appropriate for hospital discharge with close outpatient follow-up. Recommendations for close outpatient follow-up were discussed as listed, as well as the importance of continued medication management.    Discharge diagnoses   Acute respiratory failure with hypoxia - improving  Acute COVID infection  Volume overload, present on arrival - improving  Pulmonary artery dilatation of 3.2 cm, present on arrival  Generalized weakness - improved Acute metabolic encephalopathy - resolved  Elevated transaminase levels, present on arrival - improving  Cholelithiasis  NAFLD Normocytic anemia, present on arrival    Chronic Problems:   Diabetes mellitus type 2 with non-proliferative diabetic retinopathy Hypothyroidism  Dyslipidemia  Obesity Class III
Had injection on 10/15/07, noticed increased redness and swelling on 10/16/07, site was sore and warm.  On 10/18/07, pt was sent to med ctr physician Dr and he provided her with a prescription of Keflex, which seemed to take care of the problem.
Vaginal Itch, severe; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient (not pregnant) receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm, second dose on 26Feb2021 12:00 (at the age of 73 years old) (Lot Number: EN6205), third dose on 08Oct2021 16:15 (at the age of 74 years old) (Lot Number: FH8020), at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. No other vaccine in four weeks. The patient previously received the first dose of BNT162B2 (Lot no: Pfizer EL9264) on 05Feb2021 12:15 (at the age of 73 years old) in left arm for covid 19 immunization. The patient experienced vaginal itch, severe on 10Mar2021 12:00. Clinical course: Vaginal itch, severe, started after receiving intials shots. She believed it was side effect from Covid shots. She can confirm it was since her booster shot was 2 weeks ago and the itch is back with a vengence. Event resulted in doctor or other healthcare professional office/clinic visit. Treatment received included: ointment, helps relieve itch, but still there. No covid prior vaccination. No covid tested post vaccination. The outcome of the event was not recovered.
urticarial-papular rash of chest, back & extremities 12 days p/vax;
3 days post vaccine, patient developed progressive DOE.  Ultimately dx with microagiopathic hemolytic anemia and severe pulmonary HTN thought to be pre- and post capillary.  TTP ruled out with normal ADAMTS 13, attempted IV vasodilation but ultimately died.
Per the decedent's wife, he received the COVID-19 shot and his flu shot at the same appointment at about 1200hrs on 12/06/22. The COVID-19 shot was Moderna Bovalent and the clinical site was a local pharmacy.  After the shot, his wife states that the decedent had no complaints. Patients wife last saw the decedent at about 0000hrs on 12/07/22. Wife states that the decedent had no complaints at that time, and that his arm was feeling normal. His wife states that she woke up with AM to find the decedent in significant respiratory distress. the wife called 911 for assistance. The local Fire Department responded and found the pt to be agonal breathing. Professional Medical Team arrived and noted that the, now deceased, had agonal res
Hypotonic, unresponsive episode, immediately, post vax, lasting an estimated 40 minutes. Possible tonic/clonic seizures, 1 day after vaccines, estimated duration of about 7 minutes. Both were witnessed only by family.
Information has been received from a physician concerning a 4 y/o male pt with eczema and no known drug allergies who on 05May2000 was vaccinated SC in the left thigh with a first dose of varicella virus vaccine live. Concomitant vaccination the same day included a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) given SC in the right thigh. Other comcomitant therapy included pimcrolimus (ELIDEL) as needed for eczema. There was no illness at the time of vaccination. On 03Jul2003 the pt experienced varicella. The physician reported the pt was seen in the office on 09Jul2003 for an itchy rash that started on the face then lower extremities, upper extremities and lower back. More than 150 lesion were noted with less on the trunk. It was noted that the patient was treated with hydroxyzine hydrochloride (ATARAX). Subsequently the patient recovered. There was no product quality complaint involved. No further information is expected.
Pt complained of fast HR 15 mins after receiving vaccine, she was assessed by NP and EMT. Her was 168/117 with automatic cuff, 162/110 manually, HR - 75 O2 sat 100 on RA, normal sinus rhythm on monitor. She denies past medical history of HTN or any other.
Spreading redness to the injection site.  Tenderness and warmth to touch.  In clinic redness is 7 x 10 cm.
I injected the PNEUMOVAX23 first, once I injected the FlLUZONE into her arm it swoll up and was red. It was a little smaller then a dime. Over the weekend the patient became weak and had a temperature. She is now feeling much better (3 days later).
1 hr after vaccine (received DT) pt developed fatigue, SOB but no wheezing and achy. Today 11/10/04 developed headache, temp to 100 briefly responded to Tylenol, some nausea. (ADR vs viral illness? unclear)
given a dose of Engerix-B though the doctor had ordered HPV vaccine.; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 36-year-old female patient who received HBV (Engerix B) (batch number 74EM4, expiry date 20th December 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th March 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 11th March 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient was inadvertently given a dose of Engerix-B though the doctor had ordered a dose of the HPV vaccine, which led to wrong vaccine administered. The reporter reported that it was unknown which site the dose had been administered in; as of the time of reporting the Medical Assistant who administered the dose had not documented site of administration. The reporter consented to follow up.
Error occurred when administering a dose of Pfizer Bivalent vaccine. Clinic staff did not dilute vaccine vial prior to administration and so patient received concentrated vaccine. Estimated dose administered ~28 mcg rather than intended 10 mcg.  Unable to reach family x 4 to report error. No known reactions.
No additional AEs.; HCP called in to report a temperature excursion and also reported that the vaccine, GARDASIL 9 was administered.; This spontaneous report was received from a Licensed Practical Nurse regarding a patient of an unspecified age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 29-JUL-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #1780876, expiration date: 09-NOV-2023, (dosage regimen, strength, route of administration, and anatomical location were not provided) as prophylaxis, which underwent a temperature excursion (Product storage error). No additional adverse events (AEs) were reported.
Patient developed skin rash/itching 2 days after Zoster vaccine administration. 2/16 Rash described as macular/papular on left ear and left upper arm (administration site). Left face around mouth swollen. Treated with oral diphenhydramine and topical hydrocortisone cream on 2/16/10.
Received the immunization @8:00 PM on 1/25/2021. On 1/26/2021, woke @07:00 feeling chilly, dizzy and headache behind my eyes. My energy level was very low too. Took my temperature @ 09:00 and it was 101.1. I took Aspiring @325 mg every 4-6 hours plus used cold wet cloths to calm my fever down. I was not able to walk or drive a car with confidence. Also, I had painful sensation with lights on. No appetite--Did not eat anything until 1/27/2021 in the afternoon. On 1/27/2021, my hunger came back and fever down to normal. I was able to drink juices and eat some soup. Today, I had some breakfast of Tofu and scrambled eggs. But still feel a bit "floaty."
TO PREFACE - I RECEIVED A POSITIVE COVID TEST IN LATE JULY OF 2021. This is my experience with both doses of the Pfizer vaccine after having recovered from COVID-19, but I will only report the side effects from the second dose. Arm pain around injection site began immediately, and though it has lessened, as of 9/5/2021 at 4:03 PM there is still some soreness. Muscle pain spanning from mid thigh to just above the ankles began the evening of 9/2/2021 and lasted until the morning of 9/4/2021. Around this time, I developed a headache and brain fog, neither of which have I recovered from yet.  On the morning of 9/3/2021, I woke up with a fever of 104 degrees Fahrenheit, which I was able to get under control over the course of six hours with the help of approx. 400mg Advil.
Site: Pain at Injection Site-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Weakness-Severe, Additional Details: numbness and weakness in the entire arm. to the tips of the fingers. hard for patient to pick up anything. Injection site was correct
Developed flu like symptoms and also causing adverse effect of pneumonia shot. Right arm pain, loss range of motion, red welts, swelling lasting entire weekend. Texted allergist and Hospitalist with pics, and paged PCP.
Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster).    Concomitant product use was not provided by the reporter.  It was reported that 100 patients were administered an invalid dose of Moderna COVID-19 bivalent booster. The nurse had no standing order other than what they had for second booster, when administering bivalent boosters, so they assumed same dose as second booster and administered 0.25mL to uncompromised adults.  This case was for one of the patient among the 100 patients who were administered an invalid dose of Moderna COVID-19 bivalent booster.   It was reported that CDC had recommended to revaccinate the patients with full dose of 0.5mL.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-646512 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646512:Master case
Information has been received from a registered nurse concerning a 45 year old white female medical assistant with a history of thyroid dysfunction and no known drug allergies who on 06/01/2001 at 16:00 was vaccinated with the right beceps with a first dose of hep b vaccine recombinant. There were no illnesses at the time of vaccination. On 06/02/2001, the pt developed hive-like rash on her groin, trunk and inner thigh. The pt also experienced flu-like symptoms with headache and had intense itching. The pt sought unspecified medical attention. The pt was given Benadryl and pt recovered from the experience. It was reported that the vaccine was improperly stored. For a month, the refrigerator was being unplugged for a few hours or days each time prior to administration of the vaccine. The attending physician was not sure if the symptoms were from the vaccine or the improper temperature excursions. No further info is avaialble.
neck spasms; diarrhea; the urge to go to the bathroom all day long; a bloating abdomen with a lot of gas; a bloating abdomen with a lot of gas; feeling severe muscle pain in the stomach; This is a spontaneous report from a contactable consumer. This 78-year-old female consumer (patient) reported.   A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 05Feb2021 (at the age of 78-years-old) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient called to report her symptoms after the administration of the second dose of the Pfizer's COVID-19 vaccine. On 06Feb2021, the patient started having neck spasms, diarrhoea, and the urge to go to the bathroom all day long, also a bloating abdomen with a lot of gas, feeling severe muscle pain in the stomach. She stated her symptoms were not putting her on risk based on the information that she received about the vaccine when it was administered to her. Outcome of the events was unknown.   Information on the lot/batch number has been requested.   Follow-up attempts are completed. No further information is expected.
Case of a male (unk age), experienced increased aggressiveness post administration of the 2nd dosing of the Anthrax vaccine on 24Mar00 (lot FAV047). On 01Mar00, the pt was administered his initial dose of the Anthrax vaccine. No medical history, treatment,  concomitant therapy or pt recovery status was indicated. Additional information will be provided, as it becomes available. Reported on: 09Feb01.
Arm pain, diagnosed with arm injury due to injection, visited DR. given Ibuprofen Rx and physical therapy.
A non-serious spontaneous report of administration of FLUMIST to a pregnant woman was received from a non-health professional concerning a 22-year-old female. Neither her relevant medical history, concomitant medications nor obstetrical history had been reported for the patient. On 30-Nov-2011, FLUMIST was administered to the pregnant patient. Her last menstrual period was on 19-Sep-2011 and had gestation period of eight weeks when FLUMIST was administered. The patient's estimated date of delivery was on 25-Jun-2012. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments are not applicable and the event was considered resolved. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during the pregnancy.
Pt. had vaccine administered and then had a fingerstick lipid and hemoglobin drawn. Within 10 minutes of completing these 2 tests, the pt. became vasovagal, light headed, dizzy and diaphoretic. Pt. was lied down on exam table, legs raised, ice pack to neck pt. was mildly bradycardia ~ HR 50. After 16 minutes pt. was able to sit up, drink juice, eat animal crackers, felt better. 911 was called EMT's assessed heart rate/rhythm - all WNL. Patient was able to walk out of building on his own after ~ 15 minutes. Parent/pt. refused transport to ER felt not needed.
Symptoms began 2-3 weeks after 2nd Pfizer dose Symptoms have been varies but continue to date (08-15-2021) without relief and/or diagnosis NONE of the following symptoms were ever experienced by the patient prior to the vaccine Symptoms include numbness in arms and hands / parasthesia, sharp jabbing pains in head (scalp) that come and go, neuropathy pain in feet and hands,  occasional presyncope, occasional episodes of extreme fatigue/suppressed senses, chest pain, peeling skin on hands and feet, occasional pain behind eye (mainly left eye)
Hives - flat red on left upper arm, measures 3x4cm at 2x2.5 cm. No swelling noted. No respiratory distress/sx (Arm hurt day of injection - slowly getting better).
VACCINE GIVEN AND WITHIN 1 MIN FELT NAUSEOUS AND HEAD WENT BACK UNCONSCIOUS. AMONIA IHALENT USED. AWAKENED. ASSISTED TO WHEEL CHAIR. CONTINUE TO MONITOR. FLUIDS AND CRACKERS GIVEN. BP 84/50-100 SPO2 93%. MONITORED X 30MINUTES. 12:07PM FEELING BETTER. DRINKING FLUIDS. 12:18PM EATING AND DRINKING. BP 94/60 P108. COLOR PINK. TAKEN BY W/C TO DOOR. HOME ADDITIONAL BOTTLE OF WATER GIVEN. NO N/V.
Pt received shot and, after about 20 min began complaining of dizziness and headache. VS: BP 230/90, P 58, O2 98% RA. Pt states that her BP normally runs around 130/80 for which she takes losartan at night. Last dose was last night. Pt requested EMS evaluation. EMS called and came to evaluate pt. Hospitalization offered. Dr. notified. Pt declined hospitalization. Per RN, EMS rechecked BP and it was 180/90. Per RN, pt signed AMA form with EMS. RN called pt?s PCP (with pt?s permission) to notify them of her BP. PCP scheduled a follow up appt for pt for 3/24/21. PCP also told RN that they will call patient at home tonight to make BP medication adjustment for tonight?s dose. Pt?s son-in-law came to pick up pt so pt did not have to drive. Pt remained A&O x4 and fully conscious. No breathing difficulties. Skin warm and dry. RN
UNSPECIFIED ADVERSE EVENT/REACTION; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; OFF LABEL USE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: yeast allergy, and vinegar allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, and dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced unspecified adverse event/reaction, inappropriate schedule of vaccine administered, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the unspecified adverse event/reaction, inappropriate schedule of vaccine administered and off label use was not reported. This report was non-serious.
Pt states on 7/11/00 at 03:15 AM, she had vomiting and diarrhea which lasted until 06:15 AM. She was concerned it was from Hep-B vaccine she received on 7/10/00.
tunnel vision; Muscle fatigue; joint pain; This is a spontaneous report from a contactable other healthcare professional (HCP) communicated to a Pfizer colleague. A 38-years-old female patient (not pregnant) received her first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on right arm on 04Jan2021 at single dose for covid-19 immunisation.  Medical history was None.  The patient's concomitant medications were not reported.  On 04Jan2021 the patient experienced tunnel vision, muscle fatigue, joint pain. No treatment was received for the events.  The outcome of the events was not resolved.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect BNT162B2 in triggering the onset of tunnel vision cannot be 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.
insomnia; This is a spontaneous report received from a non-contactable reporter (consumer) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) 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: INSOMNIA (non-serious), outcome "unknown", described as "insomnia".   Additional information: The patient wanted to know if a side effect of the Pfizer BioNTech Covid vaccine was insomnia. He is not sure when it started, may have started around the time of the first vaccine.  He can go to bed at 11pm or midnight and then wake up at 3am-4am and toss and turn for a few hours. He said his doctor knows nothing on the topic.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.