chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant concerning an 18 months old female who on 15-APR-2009 was vaccinated subcutaneously with a 0.5mL dose of VARIVAX (Merck) (LOT# 662577/0047Y). Ten days after vaccination, on 25-APR-2009, the patient experienced injection site redness and swelling, her arm was immediately red and stayed red, then turned black. She required an emergency room visit and was put on antibiotics. She did not have any streaking and was not admitted. It was also reported that the patient was recovered. A lot check has been initiated. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. (Complaint ID # 154667). Follow-up information has been received from a medical assistant who reported that the patient with possible diaper rash at time of vaccination and no known drug allergy, no known birth defect or medication conditions who on 15-APR-2009 at 10:30 was vaccinated subcutaneously with the first dose of VARIVAX (Merck) (LOT# 662577/0047Y) in right thigh. Concomitant therapy included MOTRIN and SEPTRA. On 15-APR-2009 (previous reported as 25-APR-2009) the site of shot was discolored, hot to touch and swollen shortly after shot was given. The patient developed a fever (>/=100 F) on Sunday 26-APR-2009, but was in great pain starting on Friday 24-APR-2009. Patient received antibiotic KEFLEX in emergency room and responded well to this treatment. The patient was recovered on 27-APR-2009. This is one of several reports received from the same source. No further information is available.
COVID-19; COVID-19; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4197629-00 (AbbVie).  A 32 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 15Apr2021 (Batch/Lot number: unknown) at the age of 32 years as dose 2, single and intramuscular, administration date 25Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 01Dec2021, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset 01Dec2021, outcome "not recovered" and all described as "COVID-19". The action taken for upadacitinib was unknown.  Additional information: No relevant medical history. No known allergies. Action taken with covid vaccine was drug discontinued, causality as per reporter (Vaccine) was probable.  The reporter considered "covid-19" related to bnt162b2.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of Suspected COVID-19  and Drug Ineffective
This spontaneous report was received from a nurse refers to unspecified number of patients of unknown demography. Concurrent conditions and medical history were not reported. On an unknown date, the unspecified number of patients were vaccinated with GARDASIL (dosage regimen, lot # and expiry date were not reported) that was stored improperly. No adverse effects reported. No further information was provided. This case is one of the several reports from same reporter. Additional information has been requested.
Could not sleep on back as shoulder would go to sleep and tingling would creep down my arm to the elbow. Had to sleep on my side. Shoulder would also go to sleep when doing things such as driving. 2 months later shoulder became sore. 4 months later shoulder and arm still goes to sleep, but is much better. Soreness has gone away. I was a perfectly healthy and sports active individual prior to taking the vaccination.
Liquid dripping down arm  and pant leg wet; Liquid dripping down arm  and pant leg wet; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Liquid dripping down arm  and pant leg wet) and SYRINGE ISSUE (Liquid dripping down arm  and pant leg wet) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced UNDERDOSE (Liquid dripping down arm  and pant leg wet) and SYRINGE ISSUE (Liquid dripping down arm  and pant leg wet). At the time of the report, UNDERDOSE (Liquid dripping down arm  and pant leg wet) and SYRINGE ISSUE (Liquid dripping down arm  and pant leg wet) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Reporter's Comments: This report refers to a case of Underdose and Syringe Issue, for mRNA-1273, lot # unknown, with no associated AEs.
17 year old patient received the vaccine; A spontaneous report was received from a healthcare professional concerning a 17 year old patient of unknown gender who was administered the mRNA-1273 vaccine at an inappropriate age.    The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.    On 22-FEB-2021, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.    The patient was 17 years old and not the appropriate age of 18 to receive the vaccine.  Treatment information was not provided/unknown.    Action taken with mRNA-1273 in response to the event(s) was not provided.  The event, product administered to patient of inappropriate age, was considered recovered.; Reporter's Comments: This case concerns a 17-year-old patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age without any associated adverse events.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; BRAIN FOG; EAR ACHE; SINUS CONGESTION; FEVER; NAUSEA; SINUS PAIN; BOWELS ARE "FLOATING"; HEADACHE; MALAISE; This spontaneous report received from a patient concerned a 65 year old female. The patient's weight was 146 pounds, and height was 63.5 inches. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: 20-JUN-2021) dose was not reported, 1 total administered on 31-MAR-2021 around10:45 for prophylactic vaccination on left deltoid. No concomitant medications were reported.  On 31-MAR-2021, 5 hours after vaccination patient got sick and did not reported this because it got better after couple of days. She experienced fever, malaise, nausea, headache, sinus pain and bowels movement were floating. Patient recovered in 3 days and was doing fine till 06-JUN-2021. On 06-JUN-2021 patient started really feeling bad. Patient's all joints, head and everything was hurting. On same day patient experienced fever, headache, chills, nausea, joint pain, brain fog, body aches, sore throat, ear ache, sinus pain, sinus congestion, productive cough (phlegm), and shortness of breath.  Patient's shortness of breath was not severe enough to go to emergency room. Patient experienced shortness of breath while talking and walking up the stairs. ON 08-JUN-2021 Patient experienced sharp pain in random body places and loss of taste and smell. Patient got herself tested on 08-JUN-2021, with an antigen test (nasal swab), and it was positive(confirmed clinical vaccination failure). It was reported that turned positive quickly without waiting. On an unspecified date, the patient experienced breakthrough infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ear ache, and sinus pain on JUN-2021, fever, and nausea on 02-APR-2021, and malaise, and headache on 03-APR-2021, had not recovered from bowels are "floating", confirmed covid-19 infection, brain fog, and sinus congestion, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).  The suspected product quality complaint has been confirmed to be not voided based on the evaluation/investigation performed.; Sender's Comments: V0: 20210627726- covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
face Acne/ooszing acne on my face; This case was reported by a consumer via call center representative and described the occurrence of acne in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced acne. On an unknown date, the outcome of the acne was unknown.   It was unknown if the reporter considered the acne to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had acne on face and three months later still struggling with oozing acne on face.  The patient supposed to get 2nd dose at time of reporting. The reporter asked was shot 2 like shot 1 or was it weaker. The reporter asked was acne a symptom of Shingles.
3 days p/vax pt c/o redness, swollen arm, & rash down lt arm;reported on 12NOV96-stated no rash anywhere else;reported confusion along w/above sx;
PATIENT DEVELOPED FEVER TO 102F, MYALGIAS, CHILLS AND ARM SWELLING AND SORENESS, BEGINNING DAY OF VACCINE (GIVEN SUBCUTANEOUSLY IN RIGHT ARM).  PATIENT IS DIABETIC, AND HAD SIGNIFICANT HYPERGLYCEMIA WITH ILLNESS.  PATIENT WAS SEEN 2 DAYS AFTER VACCINE, AND HAD LARGE, RED, ERYTHEMATOUS INJECTION SITE, FEVER, AND LEUKOCYTOSIS.  CLINICAL IMPRESSION IS CELLULITIS.
titers tested low for mumps and varicella; a 41-year-old female patient was given PROQUAD; This spontaneous report was received from a registered nurse concerning a 41-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 18-DEC-2013, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #J003705, expiration date: 27-MAR-2015 (strength, and route of administration were not provided); and  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) subcutaneous injection, lot #J002502, expiration date: 28-FEB-2015 (strength, and route of administration were not provided), both administered as prophylaxis.  On 14-DEC-2022, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) subcutaneous injection, 0.5 milliliter, lot #W012741, expiration date: 16-OCT-2023, administered as prophylaxis (strength, and route of administration were not provided) (Product administered to patient of inappropriate age), because her recent titers tested low for mumps and varicella (Viral titre decreased). The patient needed to make sure her immunizations were up to date for upcoming nursing school, which is why they drew the titers. The outcome of the event of viral titre decreased was not reported.   The causal relationship between the event of viral titre decreased and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), varicella virus vaccine live (oka/merck) (VARIVAX), or  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) was not reported.
Admitted for cdiff colitis and COVID infection. Vaccinated x3. Treated with Rocehpin, flagyl, oral vanc. Improved and discharged.
Patient states hives started on 01/08/10 on right arm (indicating deltoid area) and spread to chest area. Pt presented 011310 w/ .5 cm hives unraised covering Rt shoulder/deltoid area and anterior Rt and lt chest c/o itch and had treated w/alcohol causing skin dryness. Referred to doctor and seen 011310. Pt states doctor does not know if vaccine caused this, but suspicious that it started in Rt deltoid or could be dry skin. Rx: ZYRTEC 10 mg #30 1 prn  pruritis.
Vaccine ineffective (Lack of Efficacy); Vaccine ineffective (Lack of Efficacy); This is a spontaneous report from a contactable consumer (patient). A male patient of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included ocrelizumab (OCREVUS). On unknown date, it was reported that patient experienced: Vaccine ineffective (Lack of Efficacy). The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Received flu shot and five days later had to go to doctors office where I was diagnosed with Bells Palsy. Gave me anti-inflammatories and steroids to help correct. Symptoms lasted 12 days, with a total of 3 office visits.
Information has been received from a registered nurse concerning a 65 year old female with penicillin, codeine, sulfa, DARVON, DEMEROL, morphine, ezetimibe, simvastatin allergies and a history of thyroidism who on 30-SEP-2008 was vaccinated with PNEUMOVAX vaccine IM (lot # 658496/1225U) 0.5 ml and FLUZONE on the same arm. Other concomitant therapy included, SYNTHROID, aspirin, calcium (unspecified) and vitamins (unspecified). On 04-OCT-2008 the patient developed hives. The itchy welts were on the neck, breast, and stomach. The patient had shortness of breath and felt heaviness of chest while sleeping that week. She was given ZYRTEC and was seen on 06-OCT-2008. On an unspecified date the patient recovered from hives, shortness of breath and felt heaviness of chest. This is one of several reports from the same source. Additional information has been requested.
-Felt like his throat was swelling, was drooling. Like when he had allergic reaction to food -seafood. Self-resolved in 15-20 min without treatment.
Expired drug given ( Expiration 6/7/23, given 6/12/23)
Pt developed pain, swelling, erythema at vaccine site 1 day after injection. He had headaches and subjective fevers for 2 days after. On exams, afebrile, normal neuro exam. 11 x 12cm area induration, erythema, warmth and tenderness at injection site.
the patient called the next day complaining of rash at the injection site and around her neck.  The patient was instructed to contact her primary doctor or go to an urgent care to have the rash evaluated since it was migrated to her neck.  The patient was called two days later on monday, and she claimed that she did not take anything or applied anything to the rash but that it was resolving.  The pharmacy still encouraged her to make an appointment with her doctor, which she did for two days later.  She was contacted again two days later after her doctor visit and the patient claimed her rash had resolved; therefore, she did not tell her doctor about the rash after her vaccine.
FEELING WARM; MAJOR SHAKING; CHILLS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.   No concomitant medications were reported. On 14-MAR-2021, the subject experienced feeling warm. On 14-MAR-2021, the subject experienced major shaking. On 14-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, major shaking and feeling warm was not reported. This report was non-serious.
Information has been received from a physician concerning a patient who was vaccinated with Gardasil.  Subsequently the patient experienced swelling, rash and hives.  The patient's outcome was not reported.  Additional information has been requested.
PATIENT CALLED DAY AFTER RECEIVING FLU SHOT. STATED SHE WAS HAVING INTENSE PAIN IN HER ARM AND CANNOT MOVE IT. SHE STATES IT DOESN'T FEEL BRUISED, BUT MORE LIKE A PINCHED NERVE. I SUGGESTED A HEATING PAD, APAP, IBU TO TRY TO LOOSEN IT UP. STATES SHE HAS BEEN DOING THAT ALREADY WITH NO IMPROVEMENT. I REFERED HER TO CALL HER PROVIDER FOR FURTHER EVALUATION.
This spontaneous report was received from a nurse concerning to a 5 months old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 22-JUN-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # K023534, expiration date: 22-MAY-2016) (strength and dose were unspecified), the route was defaulted to oral. No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a registered nurse concerning a female patient who in April 2007, was vaccinated with a dose of VARIVAX (Merck) (Lot # 645579/0440N) and developed a chicken pox rash as per the father's report.  The registered nurse reported the patient had not been by the physician and no follow up appointment is scheduled.  At the time of reporting the patient was recovering from "chicken pox rash".  The registered nurse mentioned that the patient received MMRII + VARIVAX (Merck) (Lot # 656941/0227U) on 15-AUG-2003 without any incidence.  It was reported that the patient sought for medical attention by a phone call.  Additional information has been requested.
first 2 shots had very minor side effects only pain on the administration site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Mar2021 (Lot number: EWS318) as dose 1, single and intramuscular, administered in arm left, administration date 23Mar2021 (Lot number: EWS318) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "environmental allergies" (unspecified if ongoing); "known allergies:Only penicillin" (unspecified if ongoing); "Allergies" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST SODIUM taken for asthma (ongoing); LEVOCETRIZINE HYDROCHLORIDE taken for hypersensitivity (ongoing); ADVAIR taken for asthma (ongoing); SPIRIVA taken for asthma (ongoing); NASONEX taken for hypersensitivity (ongoing). The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "first 2 shots had very minor side effects only pain on the administration site".  No follow-up attempts are possible. No further information is expected.
This medically confirmed literature report (initial receipt 22-Jul-2014) concerns a 59-year-old female. On an unknown date, the patient received Influenza flu vaccine, manufacturer and batch number not provided). On an unknown date, two days following influenza vaccination, the patient developed left upper arm and neck pain. The patient presented at the clinic 1 week following the vaccination and was examined for complaints of worsening left upper arm and neck pain. On the physical examination, there was tenderness and a palpable 3 cm/3 cm non-fluctuant soft tissue mass at the injection site within the left upper extremity. Otherwise, the musculoskeletal exam was non-contributory. CBC and ESR were normal on laboratory assessment. BMI was recorded as 37.2 kg/m2. MRI of the shoulder was performed 20 days after the vaccine injection. The MRI demonstrated a minimal increased T2-weighted signal in left deltoid muscle and subcutaneous fat tissue, which might suggest focal inflammatory changes. The MR imaging showed minimal infiltrative edema within the subcutaneous fat and striations within the deltoid muscle. There was no evidence of a dominant mass or abscess/hematoma on MR images. Neither bone marrow signal changes nor bursitis were found. The subcutaneous fat thickness was 2.1 cm measured on the oblique coronal T1-weighted MR images. The MR imaging showed absence of bursal fluid and rotator cuff tear, however, the soft tissue signal showed subcutaneous edema. The bone marrow signal was normal. Laboratory testing did not support any infectious etiology. The patient was not actively anti-coagulated. The patient had full range of motion. Her white blood cell count and erythrocyte sedimentation rate were normal. The patient was treated conservatively with non-steroidal anti-inflammatory drugs and demonstrated complete resolution of symptoms at 33 days post-vaccination. Outcome was reported as recovered. Author's comments: Shoulder injury related to vaccine administration presents with persisting and severe shoulder pain may relate to deltoid bursitis, tendonitis, rotator cuff tear, frozen shoulder, impingement syndrome, adhesive capsulitis and shoulder bursitis. Localised intrasubstance oedema like signal in deltoid muscle is most common finding.
Pain at injection site (day 2 only ) Fatigue  (day 2 only ) Chills  (day 2 only ) Nausea  (day 2 only ) Feaver  (day 2 only ) Swollen lymph nodes (day 8 - present)
This literature marketed report was received from the authors of a published literature article, refers to a 50-year-old female patient whose immune evaluation was consistent with Common variable immunodeficiency (CVID). On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacture unknown) (strength, dose and route were unspecified). The patient had poor antibody responses to polysaccharide antigens after both a pneumococcal vaccine and its conjugated version (No therapeutic response) and was diagnosed with CVID in 2014. The patient had the following lab tests: Serum IgA was 54 mg/dL, Serum IgG was 551 mg/dL, Serum IgM was 113 mg/dL; S. pneumo Serotype 1 (1) Pre-Titers was 1.1, Post-Titers was 1.2;S. pneumo Serotype 3 (3) Pre-Titers was 0.9, Post-Titers was 0.6; S. pneumo Serotype 4 (4) Pre-Titers was 0.4, Post-Titers was less than 0.3;S. pneumo Serotype 5 (5) Pre-Titers was 10.9, Post-Titers was 6.1; S. pneumo Serotype 8 (8) Pre-Titers was 7.4, Post-Titers was 7.2;S. pneumo Serotype 9 (9N) Pre-Titers was 2.2, Post-Titers was 1.8; S. pneumo Serotype 12 (12F) Pre-Titers was 0.4, Post-Titers was 0.4; S. pneumo Serotype 14 (14) Pre-Titers was 0.6, Post-Titers was 0.6;S. pneumo Serotype 19 (19F) Pre-Titers was 2.8, Post-Titers was 2.6;S. pneumo Serotype 23 (23F) Pre-Titers was 3.3, Post-Titers was 3.2; S. pneumo Serotype 26 (6B) Pre-Titers was 2.1, Post-Titers was 1.8;S. pneumo Serotype 51 (7F) Pre-Titers was 17.9, Post-Titers was 11.3;S. pneumo Serotype 56 (18C)  Pre-Titers was 10.5, Post-Titers was 5.3;S. pneumo Serotype 68 (9V)  Pre-Titers was 35.7, Post-Titers was 35.2. She was started on intravenous immunoglobulin at 400 mg/kg monthly. The outcome of the event was unknown.