chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles; leg Pain/ pains on the left side of his thigh and leg and back area; Sore; pains on the left side of his thigh and leg and back area; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) (batch number 9277N, expiry date 27th June 2021) for prophylaxis.   On 9th February 2019, the patient received the 1st dose of Shingrix. On an unknown date, 30 days after receiving Shingrix, the patient experienced shingles, leg pain, pain and back pain. The patient was treated with antivirals for systemic use (nos) (Antiretrovirals (Nos)). On an unknown date, the outcome of the shingles, leg pain, pain and back pain were unknown.   It was unknown if the reporter considered the shingles, leg pain, pain and back pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter states that a patient received the 1st dose of Shingrix and developed symptoms about a month later that included pains on the left side of his thigh and leg, and back area. The patient also developed a sore and non-severe pain in association with the sore. The physician diagnosed the patient with shingles and started him on started him on antiretrovirals.  The reporter declined to leave additional patient demographics.
thrombocytopenia noted on 7/20/21. No previously low platelets.
pt recv vax 28MAR96 & 1wk later exp neck pain & fever;pt seen by MD & was treated w/ATb;
About 30 to 45 minutes after the shot I got a metallic taste in my mouth. It is intermittent and seems to be happening less almost 24 hours after the shot. About 16 hours after the shot, I noticed my right cheek tingling and seeming somewhat numb. It is a continuous feeling; however very minor in nature. I have no difficulty using my facial muscles in any normal everyday activities like chewing or smiling. The feeling is very similar to what I have had felt after putting on a topical anesthetic gel on my internal mouth tissues or a few hours after I had been numbed for a dental procedure. I have moments of dizziness as well, but this is something I have dealt with before the Moderna shot. My left arm is sore and I am taking ibuprofen for this.
This spontaneous report was received from a pharmacist concerning a patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 04-APR-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX 19400 plaque forming units, lot # M037013, expiration date: 22-NOV-2017, as prophylaxis (Dose and route were not reported), which experienced a temperature excursion of 15 to 46 Fahrenheit degrees for 12 hours. There were no previous temperature excursions and a digital data logger was involved. No adverse effects were reported. The patient's concomitant medications included sterile diluent. This is one of 4 reports received from the same reporter. Sender's Comments: US-009507513-1707USA009283: US-009507513-1707USA009292: US-009507513-1707USA009293.
Vaccine administered 5/6/22 @ 12:23pm, Mother reports at approx 10:30pm the patient experienced a fever, shaking, and "pain throughout entire body, stronger than any pain she had ever experienced".  The fever subsided after 24 hours however the body pain continued for 3 days. The mother did not report to our office until 5/17/2022. Mother did report she spoke to her neighbor who was is a Doctor.
Local cellulitis; local allergic reaction to DTaP. Pt given Benadryl and Rocephin inject with Keflex tocon.
Nausea, vomiting, abdominal pain, red chest, facial swelling,
7MAY91 given APAP this repeated in 4hrs; c/o h/a & temp when APAP wears off; vomited & ele temp, local rxn @ site of inject;
RECTAL BLEEDING AND EASILY BRUISING NOTED IN THE LAST 2 DAYS
Dentist used lidocaine 2% with epi injection to numb so she can do a deep cleaning. Pt was very nervous. She was fine when getting injection but  15 min later when SRP almost done, pt complained that she had the chest pain. The procedure had been terminated right away at 9:46am and the code blue had been activated. I stayed with the pt the whole time in the room to make sure she was fine untilThe Medical staffs came and took over right after the code blue, about 2min. Pt had been checked and took care by medical staffs and she was transferred to MD side for EKG. HX: she has the pacemaker and had covid vaccine 3 days ago.
Redness at injection site, swelling, hot at injection site Narrative:  Referred to primary care doctor
about 18 hours after getting the most recent spikevax vaccine I got a bad headache.  I get migraines routinely but this felt different than a migraine and was not accompanies by aura or light/sound sensitivity.  It lasted for about 24 hours and then I felt better.
Fatigue; 2-3 weeks of persistent headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and HEADACHE (2-3 weeks of persistent headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 012A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN XL) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (2-3 weeks of persistent headache). On an unknown date, the patient experienced FATIGUE (Fatigue). The patient was treated with IBUPROFEN for Persistent headache, at an unspecified dose and frequency. In April 2021, HEADACHE (2-3 weeks of persistent headache) had resolved. At the time of the report, FATIGUE (Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication included the patient took ibuprofen 2 or 3 times but it did not help relieve the symptoms.   This case was linked to MOD-2021-409890 (Patient Link).
Within 24 hours of injection pt reports that left ankle became erythematous and swollen and painful. Pt requested an appointment, but was not seen for some time. When seen pt was diagnosed with an abscess in the left lower lateral leg/ankle which was I&D'd and the patient was treated with PO Abx and received daily wound packing. Unfortunately this abscess continued to occur and pt had this area opened and packed with PO and IV abx 3 times over the last 7 months. It was suspected initially that this abscess was possibly involving the historical hardware from ORIF approx 18 years prior (pt had never had infection in this area prior to this event s/p vaccination).
pt recvd 1 dose of Engerix-B vax & about 24 hrs p/inject eyelids were swollen lavender on top; outside corners of eye were red; face & neck-red, blotchy, itchy & stinging; itching gone when diprolene ointment applied;
pt recvd vax & devel fever w/ t 101.6 -> 103.6;
Administration of vaccine past published expiry; The vaccine were thawed on the day of administration and administration was spread out throughout the end of March to the beginning of April; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) and PRODUCT STORAGE ERROR (The vaccine were thawed on the day of administration and administration was spread out throughout the end of March to the beginning of April) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) and PRODUCT STORAGE ERROR (The vaccine were thawed on the day of administration and administration was spread out throughout the end of March to the beginning of April). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) and PRODUCT STORAGE ERROR (The vaccine were thawed on the day of administration and administration was spread out throughout the end of March to the beginning of April) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  Vaccines were administered to 19 patients on 29-Mar-2022, 30-Mar-2022, 31-Mar-2022, 01-Apr-2022 and 04-Apr-2022. Reportedly, 19 doses or Vials were initially stored in the refrigerator on 01-Apr-2022 and thawed on the day of use. The Vials did not undergo any temperature excursions. The doses were administered after 30-day Use By Date and after manufacturer date of expiry.  Treatment details were not reported by the reporter.
Vaccine leaked out; A spontaneous report was received from a physician assistant concerning an unknown age male patient who was going to receive Moderna's COVID-19 vaccine (mRNA-1273) and when the syringe dislodged and fell to the floor, a lot of the vaccine leaked out (Incorrect dose administered).   The patient's medical history was not reported. Relevant concomitant medications were not reported.   On 19 Mar 2021, the patient was going to receive their first of two planned doses of mRNA-1273 (lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 19 Mar 2021, the patient was receiving the vaccine, when the syringe dislodged and fell to the floor, a lot of the vaccine leaked out (small puddle) not able to really estimate how much of the vaccine was lost. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, vaccine leaked out was considered as resolved on 19 Mar 2021.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273 with no associated AEs.
Patient received first vaccination on 11/09/2009 and second on 12/02/2009.
Treatment of COVID-19; Treatment of COVID-19; Dose 1  Pfizer,  Dose 2 and 3 Moderna Dose 4 Unk; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Lot number: 1802070) at the age of 32 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 23Oct2021 as dose 2, single (Lot number: 046C21A), in right arm and on 17May2022 as dose 3 (booster), single (Lot number: 059M21A), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 27Sep2022 as dose 4 (booster), single (Lot number: A57164B), in right arm for covid-19 immunisation. The patient's relevant medical history included: "high BP" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Oct2021, outcome "unknown", described as "Dose 1  Pfizer,  Dose 2 and 3 Moderna Dose 4 Unk"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.
This spontaneous report was received from a pharmacist referring to a 26 year old male patient. The patient's historical drugs included a dose of MMRII when he was a child (dates unspecified). On an unspecified date in November 2015, the patient was vaccinated with a booster dose of M-M-R II (HSA) injection (dose, route, anatomical location and lot # were unspecified). There was no concomitant medication described. On an unknown date, the pharmacist noted that the patient had titers drawn for measles, mumps and rubella at four and six weeks after the administration of M-M-R II, and the titers were undetectable. No product quality issue was informed. At the time of this report, the outcome of undetectable titers was unknown. The relatedness between the event and suspect therapy was not provided. Additional information has been requested.
Broke out in hives suddenly all over body. Antihistamines improved symptoms, but dermatographia remained. Still taking Zyrtec daily six weeks later to curb symptoms.
Dizziness, itching feeling face, ears, legs, and buttock no rash this far.
Pfizer Dose 1 2/8/21 (EL1283) Pfizer Dose 2 3/2/21 (EN6200) Pfizer Dose 3 10/25/21 (FF2593) COVID Positive 2/17/21  2/19/22: Patient is 84-year-old male with past medical history of coronary artery disease status post triple bypass surgery, hypertension, dyslipidemia, CKD stage 3 and tobacco abuse.  Presented to the emergency room with a complaint of generalized weakness and fall. Patient was at the emergency room 2 days ago with a complaint of upper respiratory symptoms including sore throat, congestion, cough productive of sputum. Patient tested positive for COVID-19 despite being fully vaccinated and boosted. Patient was sent home with COVID-19 safe at home program. Since then, he has been having progressively worsening generalized weakness. He also reported exertional dyspnea. He also reported cough productive of scanty sputum, fever and shortness of breath. No chest pain or palpitations. He reported decreased appetite nausea but no vomiting. No urinary symptoms. No headache, blurring of vision or extremity weakness. Patient is a former smoker. He drinks alcohol occasionally. Earlier today, while he was trying to get up from recliner chair, he lost his balance and fell down on his left knee.  No report of head injury. No loss of consciousness. This prompted patient to come to the emergency room again today.  Upon evaluation at the emergency room, he was febrile with temperature of 101.1° F. He was maintaining saturation of 85% on room air. He was requiring 3 L of oxygen to maintain saturation.  Blood pressure was on the lower side with systolic blood pressure in the 90s but fluid responsive. Significant lab findings are creatinine of 1.46 higher than his baseline, lactic acid of 2.1 and proBNP of 892. Troponin was at 0.03. D-dimer was elevated at 2.33. CT chest with IV contrast was negative for pulmonary embolism but it revealed scattered bilateral areas of airspace disease likely representing multilobar pneumonia versus viral pneumonitis.  At the emergency room, patient received Levaquin 750 mg IV stat, and DuoNeb nebulization. He also received IV fluid per sepsis protocol  2/23/22: 84-year-old male with coronary artery disease status post CABG x3, hypertension, hyperlipidemia CKD stage 3 and tobacco abuse presented with cough, exertional dyspnea and generalized weakness, tested positive for COVID-19 on 02/17/22.  Patient admitted for acute hypoxic respiratory failure secondary to COVID-19 with superimposed bacterial pnd4reumonia.  On dexamethasone, ceftriaxone and azithromycin.  Did not receive remdesivir due to CKD and bradycardia.  Patient's symptoms resolved, weaned off oxygen to room air.  It has elevated blood pressure due to anxiety and steroids, amlodipine increased to 10 mg and continued on losartan.  Patient advised to monitor his blood pressure at home.  Therapy recommendation is for home with home health and was provided a walker as well. Patient discharged home.
A lot of body aches? neck , back, legs  & arm & underarm & a feeling of being tired, heaviness ir sluggish.
Swelling of right foot big toe joint and ankle. Subsequent swelling of right knee. Orthopedic doctor gave shot of novocaine and cortisone in right knee. Knee swelling went down after 3 days. Foot problems continued. Gout was suspected. Primary care doctor ordered blo0d tests. Gout was confirmed.
Case number PHEH2014US024363, is an initial spontaneous report received from a nurse on 02 Dec 2014 and with follow-up from a nurse received on 19 Jan 2015. This report refers to an 81 years old female patient. Her medical history and concomitant medications were not reported. She had tolerated vaccines (no further details provided) well in the past. She was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) into right deltoid intramuscularly at a dose of 0.5 ml on 07 Nov 2014. Nurse reported that PFS of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration. Follow-up from a nurse received on 19 Jan 2015: Site of vaccination (right deltoid) and other clinically relevant information on previous vaccinations in the narrative was updated.
This spontaneous report as received from a registered nurse refers to a currently 35 year old male patient with no drug reactions/allergies or pertinent medical history. The nurse stated that the patient was vaccinated with 6 doses of RECOMBIVAX HB (Lot# and route not reported) on an unknown date and had negative titers for immunity. The patient sought medical attention by an office visit. No treatment was given. At the time of reporting, the patient had not recovered from negative titers for immunity. Additional information has been requested.
Expired Havrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a female patient who received HAV (Havrix) (batch number 7ya99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th October 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 7th October 2022, unknown after receiving Havrix and Havrix 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 Information: GSK Receipt Date: 10-OCT-2022 Reporter's Comment: The reporter reported that the patient received expired dose of Havrix vaccine. No adverse event was reported. The reporter did not provide patient's identifiers. The reporter did consent to follow up. Additional supportive information: The patient received a Havrix which was already expired, which led to expired vaccine used.
Per the patient report, she experienced ongoing pain with limited range of motion after one week of receiving the flu vaccination at her employment through a work clinic. Patient reported pain was worse at night.
Pt received Hep-B about 08:30 or 08:45. He had not eaten breakfast. He declined offer of juice and crackers. Parent stated she would get him something to eat as they left the building. Child cooperative but apprehensive. Elementary school called about 12:30 and stated child had flushed, red cheeks, temperature of 99.4F. He became "limp" and complained of a sore throat. Parent came for child. States child fell asleep and needed 2 people to help with coat. Advised parent to check with MD or ER. On 2/28/01, parent reports child responded and improved after taking Tylenol yesterday afternoon. Did not seek medical evaluation. Child is in school this morning. Parent feels child possibly had a reaction to the Hep-B vaccine. She also noted his sister has been ill.
PATIENT'S MOTHER CALLED APPROXIMATELY 24 HOURS AFTER VACCINATION TO REPORT LARGE PORTION OF HIS UPPER ARM WAS RED AND SLIGHTLY WARM TO THE TOUCH; THE PATIENT ASKED IF HE COULD TAKE OFF HIS BAND-AID AND THAT IS WHEN SHE NOTICED THE REDNESS/SWELLING. IT IS NOT KNOWN HOW SOON AFTER THE VACCINATION THAT THE REACTION OCCURRED.
Pt recvd 3 doses of Engerix-B vax & did not seroconvert; Booster doses were administered; no tx was given;
Felt hot in the face then I started having difficulty breathing then my hands and feet started tingling. When I stood up my legs felt very weak.
No adverse event; Patient administered with doses of 0.25 mL instead of 0.50 mL of  bivalent booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient administered with doses of 0.25 mL instead of 0.50 mL of  bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 61-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2022, 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 21-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient administered with doses of 0.25 mL instead of 0.50 mL of  bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient administered with doses of 0.25 mL instead of 0.50 mL of  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 administered with doses of 0.25 mL instead of 0.50 mL of  bivalent booster).    Concomitant medications details were not reported by the reporter.  No AEs were reported.  Treatment details was not reported by the reporter.   This case was linked to MODERNATX, INC.-MOD-2022-662391, MODERNATX, INC.-MOD-2022-662390, MODERNATX, INC.-MOD-2022-662385 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-662390:same reporter MODERNATX, INC.-MOD-2022-662391:same reporter MODERNATX, INC.-MOD-2022-662385:same reporter
swelling, pain, redness, itching @ inj site;9OCT pain in back & shoulder & difficult to raise arm;13OCT shooting pain down arm to fingers & numbness;tx w/APAP, amoxicillin, then keflex, medrol;
Patient noticed a red, splotchy, rash on the back of her neck and upper back, extending to posterior R shoulder. She discovered it when she rubbed the back of her neck and felt a "sand-paper like"  texture to her skin. She noticed this at about 48 hours post-vaccine, and she went to the school nurse at the school where she is employed for an assessment. She denies having any other symptoms since the injection on 2/24/21. She denied itch but then reported itchiness after "thinking about it too much". She was advised to notify her PCP and took Benadryl once she got home around 2:45 PM. She also applied hydrocortisone cream and noticed a decrease in erythema. The sandpaper texture was also moderately relieved. Her injection was in the opposite arm, the L arm. She has no known history of allergies or reactions to vaccines or injectables. She did not have any recent changes in soaps, laundry products, or personal hygiene products. This nurse spoke with the patient at 4:40 PM on 2/24/21 and at this time the Benadryl was still in her system, but she felt it was helping to alleviate the size and extent of the rash which was originally  2 adjacent splotchy areas of about 2.5 inches in area. The patient had not yet notified her PCP and was again encouraged to do so.