chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a patient of unknown gender, age range reported as 16 (units not reported). On 04-NOV-2014, the patient was vaccinated with a dose of (oka/Merck) VARIVAX lot number K005180, expiration date 10-APR-2016 (dose, dose number, route and frequency were not reported) which was improperly stored. No adverse effects were reported. The patient did not seek medical attention. No product quality complaint (PQC) involved. The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
pt recvd vax 20JUL92 had very small knot in neck 3 wks prior to MMR; p/shot knot became bigger, about the size of a marble (28JUL92); @ the same time another knot appeared above the 1st knot; aching in neck, shoulder lt arm; also fever, ras
On 16 Dec at approx: 1300 hr, pt presented to clinic, requesting Pneumococcal vaccine. Vaccine administered in upper left deltoid region. Her arm began to become stiff prior to leaving facility. At approx: 1830, after undressing, she noticed the swollen injection site. Site was reddened, firm and painful to touch. Self medicated at 2200 hr with two Motrin 400 mg ea. Site was still swollen this morning. This morning she experienced dizziness, fast heartbeat. At 11:30, swelling progress below the elbow. Presented to clinic and assessed as: a moderate reaction to vaccine.
Redness and swollen. Rx. 1.) Prednisone (15/5) 5 mL PO QID x 5 days. 2.) Omnicef (200/5) 2 mL PO BID x 7 days.
Arm very, very sore even 48 hours later; Red, hard, sore injection site; Fatigue; Muscle aches.
mom states 1hr p/vax last time pt started crying & cired > then 3hr inconsolable;pt had shrill cry;pt was taken to see MD later than evening;pt wouldn't take formula for hr;
Information has been received from a nurse concerning one of two sisters (another sister's adverse event captured in WAES1105USA04011) who was vaccinated with GARDASIL. The nurse reported two sisters who wanted to be vaccinated simultaneously. She recollected that she and another nurses at both of the sisters on the same table, administered each sister a shot of GARDASIL at the same time, and she reported that both sisters lost consciousness at the same time. She reported that she and the other nurse held both of the sisters up to keep them from falling off the table, since they could not lay them down on the same table. She stated that this occurrence was over a year ago which was in approximately 2010, and that both sisters were "fine with no residual effects." Neither of the girls was injured in any way, but she state that she would never do that again. It was unknown if the patient sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Patient moaned, fell backwards onto exam table, her body and arms jerked severel times, she was incontinent of urine.  Then she opened her eyes. C/O dizziness and headache for the next 20 minutes. Tx - cold cloth.
Destroyed bicep tendon and cuff, 2 surgeries; Destroyed bicep tendon and cuff, 2 surgeries; 2 Shingrix destroyed biceps tendon and cuff; This case was reported by a other health professional via other manufacturer and described the occurrence of rotator cuff injury in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, TOZINAMERAN (COVID 19 VACCINE PFIZER) for prophylaxis, TOZINAMERAN (COVID 19 VACCINE PFIZER) for prophylaxis, TOZINAMERAN (COVID 19 VACCINE PFIZER) for prophylaxis and TOZINAMERAN (COVID 19 VACCINE PFIZER) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix, the 1st dose of Shingrix, the 4th dose of COVID 19 VACCINE PFIZER, the 3rd dose of COVID 19 VACCINE PFIZER, the 2nd dose of COVID 19 VACCINE PFIZER and the 1st dose of COVID 19 VACCINE PFIZER. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced rotator cuff injury, tendon injury and vaccine administered at inappropriate site. On an unknown date, the outcome of the rotator cuff injury, tendon injury and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the rotator cuff injury and tendon injury to be related to Shingrix and Shingrix.     Additional Information:  Receipt Date: 18-NOV-2022 Reporter's Comment: The reporter stated that she had a patient who was also a physical therapist who received the Pfizer BioNTech Covid19 vaccine adult bivalent booster and it was administered in the quadricep muscle and received it yesterday and wanted to report some side effects.  The patient had her a lot of information for the side effects she reported and stated the patient got the vaccine in her quadricep and she did this because she has had two surgeries in the past three months on her right shoulder and because she had four covid vaccines already in the right shoulder and two Shingrix vaccines in the same right shoulder. The reporter stated it had just destroyed her bicep tendon and cuff and the injection site where she got the vaccine yesterday, it was sore to the touch, and sore when she walks. The patient had swelling distal to the injection site and stated overall she was having a lot of pain, soreness and swelling. The full report details not able to be obtained due to caller disconnected the line prior to transfer. It was unknown if the reporter considered the rotator cuff injury and tendon injury to be related to Covid-19 vaccine.  Additional Supportive Information: The patient received Shingrix on her right shoulder, which led to vaccine administered at inappropriate site.
(08-15-07 - 08-21-07 symptoms) Awoke with 3cm area right palm small poison-ivy looking area and large hive-looking raised irregular area near right ear and eye corner, day later 2 small red sores at right wrist, next day small hive left side of face just like right side, next day, 5-6 sores in breast cleavage mostly right few left. Next day small itchy area right ankle. Mostly right side some eruption left Varicella-like reaction.
This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown gender and age. On an unknown date, the patients were vaccinated with doses of ROTATEQ suspension, oral (lot/batch number, expiration date, dose, dose number and indication not provided) that were improperly stored. No adverse effects were reported. This case is one of several reports from the same reporter. Additional information has been reported.
pt call hospital call center reporting redness on his injection site since the day after his Jyunneos vaccintion.  Pt has had some more redness durign the call. Pt advised to monitor and to follow-up with PCP or if needed to evaluated earlier to go to UC/ED.
Patient had pre-existing medical issues kidney transplant (2017), so he was not a candidate for an experimental vaccine.  Anemia worsened, infection, high blood pressure, respiratory issues, inflammation and worsening kidney function
Patient reported swollen, redness, and warmth on her arm the day after vaccine. Possible fever, but never confirmed it with a thermometer. The second day the swelling had gone done but still red. Patient iced the area, which seemed to help.
Headache; vascular rash on toes; This is a spontaneous report from a contactable consumer (patient). A 63 year-old female patient received first dose of BNT162B2 (lot number: 3246), via an unspecified route of administration on 16Jan2021 14:30 at single dose in the left arm for COVID-19 immunization. Medical history included chronic lymphocytic leukaemia from an unknown date. The patient has no known allergies. Concomitant medication included metformin extended release. On 16Jan2021, the patient experienced headache and vascular rash on toes. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient received any treatment for the events. The patient underwent lab tests and procedures which included PCR and nasal swab: both unknown results on 20Jan2021. The outcome of the events was not recovered.
6/19/15 office visit notes: History: The symptoms are reported as being moderate. The symptoms occur daily. He states the symptoms are acute and are of new onset. Here with swelling to right deltoid after having immunization on Wednesday (17th). Has not had fever. Has pain and swelling, with pink area and warm to site. Has diarrhea since then. Has not tried anything for pain. Assessment/Plan: Swelling of arm. Ice to warm, raised area on the right upper arm.  10-15 minutes of ice them remove. Ibuprofen for pain Return as needed. Swelling should reduce over the next 48 hours. 6/22/15 at 9:47 am.  I called patient via interpreter. He said onset of symptoms was almost immediate. Arm became uncomfortable to move. Arm is much better now. Last dose of ibuprofen was last night, doesn't need today. Can move arm freely without pain. Swelling almost all gone, some firmness in the center. Still some tenderness when push on area.  To return call if symptoms get worse.
pt recvd Engerix-B & devel abdominal cramping lasting 2 days;
administration of an expired dose of Infanrix/  given on 03Jun2021/ expired/ on 30May2021; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa (Infanrix) (batch number J947T, expiry date 30th May 2021) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd June 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 3rd June 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 received the Infanrix vaccine which was expired 4 days prior to the date of vaccination, which led to expired vaccine used.  The reporter declined follow up but did provide the vaccination and patient details.
PT REPORTED ON 1/26/2018 OF PAIN IN LEFT ARM RADIATING TO LEFT UPPER CHEST. SAYS IT GOES AWAY AND COMES BACK, NO PHYSICAL SIGNS OF BRUISING OR REDNESS. PT SAYS SHE WILL CONTINUE TO MONITOR AND SEE DOCTOR IF IT DOESN'T GO AWAY.
This case was reported by a healthcare professional (a nurse, also the subject) and described the occurrence of injection site pain in a 57-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included FOSAMAX. Medical history was significant for sulfa allergy, prevention of bone density disease and also in 2003 had a diagnosis of frozen shoulder. On the afternoon of 21 October 2010 the subject received a dose of FLULAVAL at 0.5 ml in the left arm. At an unspecified time following administration of FLULAVAL the subject experienced consistent injection site pain, pain in left shoulder joint, back pain and muscle pain in left shoulder. The pain was described as achy and sometimes sharp in nature. It was noted that the pain gets worse at night. The healthcare professional considered the events were disabling. The subject had an appointment to see her physician. At the time of reporting the events were unresolved. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL.
Hospitalized;  COVID-19 positive (9.1.21);  fully vaccinated  Admission Date: 9/1/2021 Discharge Date: 9/4/2021 DETAILS OF HOSPITAL STAY PRESENTING PROBLEM: Hypoxia [R09.02] Hypotension, unspecified hypotension type [I95.9] Pneumonia due to COVID-19 virus [U07.1, J12.82] COVID-19 [U07.1]   HOSPITAL COURSE: 83-year-old male with a history of chronic atrial fibrillation scheduled for DC cardioversion, nonischemic cardiomyopathy, hypertension, that is stylus CHF, pacemaker who was admitted for weakness, fatigue and has a positive COVID-19 test.  He denies any shortness of breath or any respiratory complaints.  As part of his workup he has blood cultures growing out 2/2 g negative rods.  He was admitted to the hospitalist service and treated for Gram-negative bacteremia/sepsis secondary to pyelonephritis and COVID-19.  He was only briefly on supplemental oxygen was rapidly weaned to room air.  Blood cultures grew pansensitive E coli.  He was continued on ceftriaxone 2 g daily.  He was briefly placed on vasopressor therapy initially and this was rapidly weaned off.  Patient did make significant improvement clinically.  His home medications including anticoagulation (apixaban) for atrial fibrillation were continued.  The patient was hemodynamically stable and afebrile for greater than 24 hours prior to discharge.  His symptoms completely resolved.  He was discharged on 09/04/2021 to continue his home medications.  He was prescribed ciprofloxacin 500 mg 2 times a day for 7 days for treatment of E coli bacteremia secondary to pyelonephritis.  He will follow-up with his primary care physician and cardiologist upon discharge.
I got COVID symptoms on May 16, 2022 and tested positive the next day. I received my second booster (4th overall COVID shot) on April 7, 2022. I don't believe the shot had anything to do with the symptoms I got one month later.
Vial was beyond use date. Vial should have been removed from freezer on 7/1/2021 and placed in refrigerator.  Vial was removed from freezer on 7/5/2021.
On 8/20/2002 presented to health center with c/o itch x 2 days. Vesicles on arms and trunk large vesicles and pain at injection site.
Pt reported localized swelling and redness at injection site on 09/16/21. Arm was marked to monitor for increasing redness. On 09/17/21  redness had continued to spread and pt also reported nausea, dizziness and shaking. Advised pt to take benadryl 50 mg  every 4 to 6 hours. Pt reported improvement of side  nausea/dizziness/and shaking and redness at injection site had gone down. Advised patient that if she had any worsening of symptoms to seek further care
This spontaneous report was received from a nurse refers to unspecified multiple patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VAQTA which had lot # L043209, expiry date: 17-SEP-2017 and lot # M003011, expiry date: 15-NOV-2017 (route, dose and anatomical place of vaccination were not provided). The vaccines were exposed to temperature of 74 degree Fahrenheit for 10 hours. The temperature excursion was detected by a data logger. No adverse effects were reported. At the time of this report, the vaccines were back in range. No product quality complaint (PQC) involved and no further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE ERYTHEMA (Red injection site) and RASH (Developed a rash on her legs) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), FAMOTIDINE and TRAZODONE for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy injection site). 28-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red injection site) and RASH (Developed a rash on her legs). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE ERYTHEMA (Red injection site) and RASH (Developed a rash on her legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications Crestor, Protonix, Famotidine, Trazodone.
She added the bottoms of her feet feel fiery and dry; I can't stay up too long; She has chills, feeling tired, itching, hands are feeling numb and on fire, and no appetite since receiving her second dose.; She has chills, feeling tired, itching, hands are feeling numb and on fire, and no appetite since receiving her second dose; She has chills, feeling tired, itching, hands are feeling numb and on fire, and no appetite since receiving her second dose; She has chills, feeling tired, itching, hands are feeling numb and on fire, and no appetite since receiving her second dose; She has chills, feeling tired, itching, hands are feeling numb and on fire, and no appetite since receiving her second dose; She has chills, feeling tired, itching, hands are feeling numb and on fire, and no appetite since receiving her second dose; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EP6955) via an unspecified route of administration on 26Mar2021 as dose 2, single for covid-19 immunisation. Medical history included She had an allergy to Penicillin. She was having the same symptoms as if she was reacting to Penicillin, She had gained some weight. The patient's concomitant medications takes medications every day, details not provided. Previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot no.: EN6206) at left arm on 05Mar2021 as dose 1, single for covid-19 immunisation. The patient experienced chills, feeling tired, itching, hands are feeling numb and on fire, and no appetite since receiving her second dose on 26Mar2021. She added the bottoms of her feet feel fiery and dry, I can't stay up too long on an unspecified date. Patient did not any AE(s) require a visit to:  emergency room, physician office. The outcome of the event for dry skin and feeling abnormal was unknown and rest all were not recovered.  No follow-up attempts are needed. No further information is expected.
Patient pulled out trach (witnessed by family members), unable to replace trach, trach site began gushing blood, patient coded.  Temperature in ER was 36.9 at the time of arrival at 8:22 p.m.  Pronounced dead at 8:47 p.m.
Anaphylactic reactions; Within 5 minutes could not breath; Heart was racing; A spontaneous report was received from a consumer concerning a 28-yearsold female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced within five minutes could not breath/ dyspnea, heart was racing/ palpitations, and anaphylactic reaction.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 13 Feb 2021, five minutes prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch Number: 16M20A0) intramuscularly for prophylaxis of COVID-19 infection.  On 13 Feb 2021, the patient experienced within 5 minutes could not breathe, heart was racing, and anaphylactic reaction.  The patient was seen in the emergency room for treatment. The event anaphylactic reactions was considered as Medically significant.  Treatment for the event included oxygen, prednisone, cetirizine hydrochloride, diphenhydramine and two doses of epinephrine.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.   The outcome of the events, could not breathe and heart racing, was resolved on 13 Feb 2021. The outcome of the event anaphylactic reaction was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
pt recvd vax & Rt Leg became red & swollen; t 104;mom gave apap q 4 hrs since vax given; to er; tests reveal no illness, mom repts pt cried & cried eve of vax;
Information has been received from a 61 year old female consumer with sulfonamide allergy and allergy to beef and green peppers who on 08-AUG-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). There was no concomitant medication. On 09-AUG-2008, "one day after" vaccination, the patient experienced an intense heavy pain at injection site including redness. The patient was also experiencing flu like feeling, headache and pain in her neck and arm. At the time of this report, the patient's symptoms persisted. The patient did not seek medical attention. Additional information has been requested.
This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 34, via an unspecified route of administration, on Apr 14, 2021, at 10:00, single dose, for COVID-19 immunisation. Medical history: none. The patient did not receive any other medications within two weeks of vaccination. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient does not have any allergies to medications, food or other products. On Apr 15, 2021, patient experienced pain in lymph node under armpit. Therapeutic measures were not taken as a result of the event. The outcome of pain in lymph node under armpit: not recovered (at the time of this report). No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.
Woke up with extreme discomfort and stiffness throughout my body. Was unable to fully move left side. Felt around where near the most pain and discovered a knot on the left collarbone. ER doctor conducted a site check and stated that my left supraclavicular node was swollen and that it would disappear within a few days. As of May 13, 2021 it is still physically there.
Hair falling out; Lost 40 lbs; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair falling out) and WEIGHT DECREASED (Lost 40 lbs) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALOPECIA (Hair falling out) and WEIGHT DECREASED (Lost 40 lbs). At the time of the report, ALOPECIA (Hair falling out) and WEIGHT DECREASED (Lost 40 lbs) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.  patient gender was not specified.