chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient should have received Shingrix not Varicella. Advised by Team to vaccinate with Shingrix in 8 weeks then repeat in 2 to 6 months
Trouble with muscles in arm in vicinity of injection site, spasmatic. Notified my PCP in December. Currently undergoing physical therapy.
large blood clot in right leg/groin, xarelto po, consult hematologist and vascular surgeon, still waiting for treatment to resolve blood clot
ringing ears; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of TINNITUS (ringing ears) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 008B212A) for COVID-19 vaccination.     The patient's past medical history included Diabetes (Insulin). Concomitant products included INSULIN BOVINE (INSULIN 2) for Diabetes.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 28-Feb-2021, the patient experienced TINNITUS (ringing ears). At the time of the report, TINNITUS (ringing ears) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 23-May-2021: Patients demographics updated, AE outcome, batch number of the doses updated
Migraine began 15 minutes after shot and lasted 24 hours. Shaking, chills, extreme body aches and fever of 101.5 with Tylenol occurred 16 hours after injection. Cough, chest tightness, had to leave work. Extreme exhaustion, mental fog, diaphoresis, blurry vision, dizziness, swollen lymph nodes,  extreme pain I the injected arm, sore throat. Had to leave work and take Tylenol and Motrin to get fever down and pain under control.  The next morning work up with continued sweating and mild headache.
Red rectangle around injection site; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE ERYTHEMA (Red rectangle around injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (Red rectangle around injection site). At the time of the report, INJECTION SITE ERYTHEMA (Red rectangle around injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information in response to events was not provided.
Pt received vaccine on 04/01/2021. Began to have rash on 04/03/2021. Rash is described as reddened, close in proximity and extreme itching from base of neck and into hairline at base of neck. Also back and abdomen and from shoulders to elbows. Areas are hot to touch. Also has low grade fever around 99.0. Note light cough in am that she reports is normal for her and nurse notes SOB upon answering phone. Seen by MD on 04/06/2021 after phone call to nurse. Has MD follow up planned. COVID test was done
within 5 minutes of getting vaccine, patient complained of generalized itching and feeling of fullness in throat; was given 50mg diphenhydramine IM and within 5 minutes symptoms had resolved
Large red welt to R deltoid where 1/2 of the dose was given. Warm to the touch. Welt approximately diameter of golf ball. Instructed to take BENADRYL. Provider advised steroids by mouth; and antihistamine. Advised pt. apply ice to area. Advised urgent care if needed.
Nausea; Diarrhea; This spontaneous case was received on 22-Sep-2022 from other healthcare professional (nurse) (reference number: SEQW22-03395) and concerned a patient of unspecified age and gender.  The patient's medical history and concomitant medications were not reported. It was reported that some of patients were diabetic, however, it was not specified whether this patient was diabetic.   On 20-Sep-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration and anatomical location: not reported) for active immunization of persons 65 years of age and older against influenza caused by influenza virus subtypes A and B contained in the vaccine. The batch number reported was 346341, and expiration date 28-Apr-2023. The reporter stated that the vaccination went normal as always.   On 21-Sep-2022, during the night, 18 to 24 hours after receiving Fluad Quadrivalent, the patient developed nausea and diarrhea. The patient was given 7up and acid as treatment. Also, couple of patients did receive anti-diarrhea pills.  On the same day, the patient recovered from the events. The patient no longer had these symptoms.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  This case is linked with the cases 202204733, 202204734, 202204735, 202204736, 202204737, 202204739, and 202204740 (the same reporter).  Company comment: The events of nausea and diarrhea are assessed as possibly related to Fluad Quadrivalent due to plausible temporal relationship.; Sender's Comments: The events of nausea and diarrhea are assessed as possibly related to Fluad Quadrivalent due to plausible temporal relationship.
2 linear hematomas 2 inches long each run horizontally along outer aspect of upper (L) arm/shoulder, deltoid area.
This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 24-NOV_2015, the patient was vaccinated with improperly stored ROTATEQ oral liquid, lot # L008574, expiration date 22-NOV-2016, (dose and dose number were unspecified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Approximately 24 hours after the 2nd dose of Pfizer BioNTech Covid vaccination I experienced a temperature of 100.1, headache, body aches, night sweats, and fatigue. After 12 hours all symptoms subsided except for the headache which persisted for another 24 hours.
My wife got the shot then got the shingles / Suspected vaccination failure; My wife got the shot then got the shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient was reporter's wife. The age at vaccination was not reported. The reporter mentioned that, the patient got the shot then she got the shingles no lie. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible, as no contact details were available.
He had fever; Tired; arm soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 2nd), for Covid-19 immunization; Bnt162b2 (Dose: 1st), for Covid-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "He had fever"; FATIGUE (non-serious), outcome "unknown", described as "Tired"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness".  Additional information: Optional Information:Tired and arm soreness after receiving the booster shot. Event took place after use of product.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No additional AEs or PQC reported.; Caller reported expired dose of PROQUAD was administered.; This spontaneous report was received from a registered nurse referring to a patient of unspecified age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 23-JUN-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant Human albumin (rHA), 0.5 ml (route reported as intramuscularly [IM] subcutaneously [SQ] [conflicting information]), lot # T034827 and expiration date 11-APR-2022 (expired product administered), as prophylaxis. No additional adverse events (AEs) or product quality complaint (PQC) reported.
Erythema, pain shot site.  Extending an area of 8 inches.  Also had tinuitus and fatigue.
Fever of 99 degrees, shortness of breath, aching of joints and muscles, full body weakness, throbbing of arm from shoulder to elbow where shot was given. Had vaccine approximately at noon- symptoms started about 5pm/much worse by 7 pm. Saw physician following day-no treatment.
large amount of swelling under rt arm;swelling cont down childs rt side to waist;difficult for pt to put arm against body;mom gave APAP & DPH;same sx on #3 DTP;
RED KNOT AT SITE OF INJECTION SIZE OF GOLF BALL HOT & PAINFUL TO TOUCH.  PATIENT WILL CONTACT PRIMARY PHYSICIAN.
Pfizer dose #2 yesterday 5/6/21 and had a local rash at injection site. today reporting  generalized rash "little spots all over," itchy on arms, feet and back. denies any respiratory symptoms or facial swelling.
Pt devel myoclonic episodes; Seen in ER; fainted x 2, one day following MMR booster; observed in Hosp x 40 hrs; No specific treatment;
Pain/ soreness to the touch; Itches at injection site; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain/ soreness to the touch), VACCINATION SITE PRURITUS (Itches at injection site) and VACCINATION SITE RASH (Rash) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Heart failure. Concomitant products included WARFARIN, RAMIPRIL, TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF), CARVEDILOL and FINASTERIDE for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN (Pain/ soreness to the touch), VACCINATION SITE PRURITUS (Itches at injection site) and VACCINATION SITE RASH (Rash). At the time of the report, PAIN (Pain/ soreness to the touch), VACCINATION SITE PRURITUS (Itches at injection site) and VACCINATION SITE RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications provided   This case was linked to MOD-2021-021854 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Follow-up information received on 27-APR-2021 contains no new information
tenderness at the site of injection; itching; hives; rash that covered my entire abdomen, my back, legs, arms, and neck; This is a spontaneous report from a contactable consumer (Patient herself). A 62-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6203), via an unspecified route of administration, administered in Arm Left on 27Feb2021 at 10:45 (at the age of 62-years-old) as single dose for covid-19 immunisation. Medical history included hypertension, tooth infection and had hives a few times in her life. She has had hives before and had allergic reactions twice in her life. One time she had no idea why and the other time was after cutting grass. Concomitant medications included amoxicillin and hydrochlorothiazide, losartan potassium (LOSARTAN HYDROCHLOROTHIAZIDE ACTAVIS). She had a flu shot probably three months ago and she had shingles vaccination six months ago. She did not have any prior vaccination within 4 weeks. Patient reported that she had the first COVID19 Vaccination. Everything was fine. She didn't have any reaction except tenderness at the sight. Nothing bothersome. She waited 15 to 30 minutes after the vaccine and no adverse reaction. She was not sure if the reaction could happen later. At 4:00 AM Sunday she started to get hives They woke her up because they were itchy. She took two Benadryl and they went away. She woke up Monday morning exhausted because she had taken Benadryl. Yesterday afternoon the hives came back again. Benadryl dissipated the hives. Last night about 1:00AM she had a rash that covered the entire abdomen and partial back. She had spots on her arms and neck. When it happened the first time she thought who knows. Now she has gotten them three times. Today at noon she got them again under her breast, waist, neck, and abdomen. She knows not to wear anything too restrictive or tight. She questioned if Pfizer heard of people having a reaction several days later. She feels terrible. She knows four people that have had the vaccination and no one has had a reaction. Everything she reads says hives happen right after the reaction. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
pt was vaccinated at work with her 2nd dose on 1/20/21 and began having symptoms on 1/22.   pt presented to my office on 1/25/21 she had confusion, memory loss, labial bp, relative hypotension, bradycardia, severe fatigue, muscle pain and weakness, barely able to rise from a chair or walk, also reported HA, diarrhea, hiccups,decreased O2 sat to a low of 91%-her baseline is 98-100%, she developed a rash after her appointment with me.
In the end of Jan2022 I developed on my left hand a lesion that looks like Zoster; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Dec2021 15:00 (Lot number: FD0809) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "I had chicken pox as a child" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6199, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), administration date: 26Mar2021, when the patient was 57 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6198,, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 05Mar2021, when the patient was 57 years old, for COVID-19 Immunization. The following information was reported: HERPES ZOSTER (non-serious) with onset 24Jan2022, outcome "not recovered", described as "In the end of Jan2022 I developed on my left hand a lesion that looks like Zoster". It was unknown if therapeutic measures were taken as a result of herpes zoster.  Additional information: Patient had PFE booster on 22Dec2021 (left arm) and in the end of Jan2022  developed on my left hand a lesion that looks like Zoster (I had chicken pox as a child), which doesn't go away. Patient had no other vaccine in four weeks. Patient had not no covid prior vaccination  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 26-SEP-2013 the patient was mistakenly vaccinated with VARIVAX (Merck) (dose, route and lot# not provided) instead of ZOSTAVAX. No adverse effects were reported. Additional information has been requested.
Haemophilus type B septicemia, meningitis. Hx of febrile seizures.
Received vaccinations 9/10/19. On ~9/12/19 started losing her balance "walking like a drunkard" as per mother. falling, staggering. resolved slowly over the next 2 weeks. was only seen at PCP's office 9/25/19 when history was told. at that point she's almost totally resolved, so monitoring was recommended.
Severe pain in left arm the night of injection (9/21/22). Used ice packs throughout the night to ease pain. Had telephone appointment visit with Dr. to discuss continued pain in arm and shoulder. I indicated to Dr. the ful injection was quite high on my arm and the person injecting the vaccine apologized that the vaccine was going in so slowly. Dr. recommended Physical Therapy and prescribed Meloxicam. I had two PT visits, exercises focused on shoulder. Pain increased. I stopped PT and pain lessened. Lifted something on Thanksgiving and pain increased. Wen back to PT, did more exercises and pain became very severe. Have stopped PT again, slight improvement. Prescription for Melocicam is finished. I continue to have limited range of motion. I wake frequently during the night because of the pain. I spend several minuetes moving my arm up and down and around to stretch the muscle or tendon to make the arm feel better. There really isn't any shoulder pain to speak of, it is in my upper arm. I return to PT on Friday December 16 to discuss possible alternatives to the past exercises. Dr. has suggested considering a steroid shoulder injection. Without knowing where the pain is or coming from, I hesitat to do that. Would that heal or hide the pain?
no adverse event reporte - however, patient received both doses of vaccine at the age of 17 when it is only approved for 18 and over.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Jan2021 as dose 1, single (Lot number: EK4176), in right arm, on 30Jan2021 as dose 2, single (Lot number: EL9262), in right arm and on 29Sep2021 as dose 3 (booster), single (Lot number: 301308A) at the age of 58 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Benadryl, reaction(s): "Known allergies: Benadryl". The following information was reported: SUSPECTED COVID-19 (medically significant) with onset 30Apr2022, outcome "unknown", DRUG INEFFECTIVE (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: (30Apr2022) Postive, notes: I tested positive. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Rebound COVID symptoms after taking the full course of Paxlovid.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.
This case involves a female patient  of unknown age who was vaccinated with already expired INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (batch number and expiration date were not reported) via unknown route in unknown administration site for prophylactic vaccination on an unknown date in 2021, as well as reported that it was left from the 2019-2020 season (expired product administered). The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. It was a case of actual medication error due to expired vaccine used (same day latency). Patient did not provide any AE (adverse event) details. Also reported that MIS (Medical Information System) discussed expired vaccine, overdose, adverse events per PI (present illness) and interactions. Physician was asked about spacing before re-vaccination, side effects, and whether acetaminophen or benadryll would help with the side effects. Physician was impatient with transfer, and irate. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will be no information on the batch number for this case.
Significant redness around the vaccines sites with positive erythema/edema in lower legs and feet. These symptoms resolved and petechial developed below the knees only.  Pt was admitted for a complete sepsis workup.  Pt was febrile on day one of admission but remained afebrile afterwards.  All cultures and Lumbar puncture were negative at 48 hrs.  Pt was discharged and followed up with PCM.  Pt's mom was advised one vaccine at a time unless otherwise indicated or recommended.
in addition to above, pt had the  following diagnosis: portal HTN, abnormal blood chem, essential tremor, depressive disorder, abnormal glucose tolerance test, hyperlipidemia, hypothyroidism, insomnia, localized osteoarthrosis, calculus of kidney, pancytopenia, odule on liver, hepatocellular CA, hyotension, hypovolemia, hepatorenal syndrome   additional meds: zoloft, aldactone, thiamine,demadex, ultram, kenalog, vitamins, bactroban ung
Patient received GARDSIL 8/24/09 and returned to clinic 9/8/09 and had positive urine pregnancy test.  No testing done 8/24/09.  LMP 7/24/09. No physical adverse reaction/symptoms.
HEADACHE, SHIVERS, FEVER, MUSCLE ACHES, PAIN AT INJECTION SITE
7/22 - 7/25: 85-year-old patient presented with upper respiratory symptoms. Diagnosed with COVID-19. No respiratory compromise. Mild cough and rhinorrhea, no SOB. He is vaccinated. Currently receiving Remdesivir. On admission it was noted he had a significant drop in Hb. Educated son on home care services upon discharge from the hospital. Son politely declined.
This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 12-AUG-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (dose and route were not reported, lot # L003774, expiration date 04-FEB-2017). There was no adverse effect reported. Additional information has been requested.
Itchy at injection site. Hard and swollen. Painful to the touch. Red rash.