chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received  1.0 ml  of Fluzone Quadrivalenton, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA297927, 2019SA317307, 2019SA317358, 2019SA317359, 2019SA317360, 2019SA317361, 2019SA317362, 2019SA317363, 2019SA317365, 2019SA317366, 2019SA317367, 2019SA317368, 2019SA317369, 2019SA317370, 2019SA317371, 2019SA317372, 2019SA317373, 2019SA317374, 2019SA317375, 2019SA317376 (same reporter).  This case involves a 56  years old patient (gender not reported) who received a 1.0 ml of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [Fluzone Quadrivalent] (lot UJ223AB, expiry date not reported) via unknown route in unknown administration site (side reported as left) on 22-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of overdose.   At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Severe body ache / hands and feets are stinging; Her feets are red; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Severe body ache / hands and feets are stinging) and ERYTHEMA (Her feets are red) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No prior medical history was reported).    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PAIN (Severe body ache / hands and feets are stinging) and ERYTHEMA (Her feets are red). At the time of the report, PAIN (Severe body ache / hands and feets are stinging) and ERYTHEMA (Her feets are red) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable.
negative antibody test; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and ANTIBODY TEST NEGATIVE (negative antibody test) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 043L20A) for COVID-19 vaccination.     Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 01-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 12-Jan-2021, the patient experienced ANTIBODY TEST NEGATIVE (negative antibody test). At the time of the report, PAIN IN EXTREMITY (sore arm) and ANTIBODY TEST NEGATIVE (negative antibody test) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Antibody test: negative (Negative) Negative. On 25-Jan-2021, Antibody test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications Eliquis, blood pressure medication. Treatment medication was not provided.   This case was linked to MOD21-14815, MOD21-04383, MOD21-14815 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD21-14815: MOD21-04383: MOD21-14815:
Systemic: Dizziness / Lightheadness-Medium, Additional Details: Pt. experienced dizziness a few minutes after receiving her shingrix injection. She put her head between her knees and rested for several minutes. I checked on her several times. She did not want emergency called. Her husband came to get her about 20 minutes later. I called her at home a couple hours later, and she reported feeling fine.
5 hours later developed cough, wheezing, lightheadedness, "ringing in head" but not tinnitus
1st shot on 08/16/2021 noticed leg joints at knees extremely achy.
Fever, Fatigue, Chills, Cough and Redness and swelling at injection site (irregular shaped growing redness) Fatigue started within 12 hours, lasted 4 full days. Cough started on day 3 to day 5.  Fever Day 2-4. Tested for COVID infection on day 3- Negative result. Missed work on Day 2, Worked partial days on days 3-4 from home (not normal arrangement). Redness at injection site is still occurring today (6weeks later) although there is no swelling or soreness anymore. Redness was about 2inches x 4inches and swelling was about the same and only 1 inch deep. I called and my doctor did not wish to see me unless symptoms persisted 7 days or swollen arm more than 2 weeks or significantly impacting life. Neither were happening. My employer allowed me to return to campus after my negative test.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 20-OCT-2012 21:04, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
I still ended up contracting Covid after being fully vaccinated.  Weakness, tired, stuffy nose, total loss of taste and smell
Fainted minutes after receiving vaccines. Monitored in office and felt better after a few minutes.
STARTED ITCHING, RED, SWOLLEN, HARD 3 IN X 2 IN AREA. SYMPTOMS HAVE DISIPATED BUT STILL HAS SOME REDDNESS ON THIS DATE. REPORTED TO HEALTH DEPARTMENT 2/4/2021 DURING VACCINE VISIT TODAY.
Woke up in AM (1/19/11) with right arm red, swollen and warm to the touch.
On 3/6/00, the pt received vax. On 3/9 at 8:15 PM received a phone call stating the pt experienced a high pitched crying that was inconsolable for 4 hours. Seen at the office on 3/10/00 with questionable immunization reaction. Mom states crying unlike before or after incident.
Patient said she felt a little woozy when she saw her daughter get her vaccine. She gets it every year without issues. I told her did she feel. Okay to get it or does she want to wait and she said she was fine. After she got it she said she felt like she was going to Throwup. She was shaking and broke Out in rash on her face and neck. I have her two Benadryl and orange juice and elevated her legs. She felt better. I took her blood Pressure it wS 170-100 ans she went to the emergency room.
Excessive swelling & redness on arm of injection reported to pharmacy 2 days after immunization. Patient went to walk-in clinic 9/5/12 and was started on antibiotics.
Hospitalized 1/14/22-1/17/22 for pericarditis with pericardial effusion without tamponade (evaluated by cardiology). Patient was initiated on colchicine and steroids with improvement in chest pain.  Re-admit on 1/28/22 for chest pain and possible exacerbation of pericarditis.
The patient experienced a 5 1/2" x 4 1/2" area of erythema and edema around and below the injection site with a tender node of the left axilla.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a patient who received SHINGRIX (batch number 5Z5LX, expiry date 30th January 2020). On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain and needle issue. On an unknown date, the outcome of the injection site pain and needle issue were unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional information was received were as follows: The age at vaccination was not reported. The health care professional reported that a lot of resistance when administering the SHINGRIX vaccine and a lot of pain with the injection. Additional information was received as follows: The health care professional reported that the needle was becoming dull from the stoppers of the vials when reconstitution and drawing up the SHINGRIX dose. The HCP believes the dull needle before injection the next patient and this has resolved the issue. The HCP decided to change needle before injecting the next patient and this has resolved the issue. The HCP did not have any patient information available but had this issue with 3 prior patients.
Chills, Rigors, extreme sensation of being very cold with intense lethargy,   Low grade fever 100.3degrees po.   The reactivity was intense enough to be described as incapacitating for a period of approximately 10 hrs
increased fatiguability; This is a spontaneous report received from contactable reporter(s) (Physician and Consumer or other non HCP) for a Pfizer sponsored program (054550). The reporter is the patient.  A 77 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 16Jan2021 (Batch/Lot number: unknown) at the age of 77 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Low Amount of Calcium in the Blood" (unspecified if ongoing); "Major Depressive Disorder" (unspecified if ongoing); "EDEMA" (unspecified if ongoing); "joint supplementation" (unspecified if ongoing); "vitamin supplementation" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL 8 HR ARTHRITIS PAIN; ASPIRIN [ACETYLSALICYLIC ACID]; LIPITOR [ATORVASTATIN]; B-COMPLEX [VITAMIN B COMPLEX]; BACITRACIN; CALCIUM CARBONATE AND VITAMIN D taken for blood calcium decreased; CALCIUM MAGNESIUM [CALCIUM;MAGNESIUM]; CHOLECALCIFEROL; PROLIA; CYMBALTA; LASIX [FUROSEMIDE] taken for oedema; NEURONTIN; GLUCOSAMINE & CHONDROITIN COMPLEX taken for supplementation therapy; LECITHIN taken for vitamin supplementation; SYNTHROID; ZESTRIL; MAGNESIUM CHLORIDE; MELATONIN; TOPROL XL; REMERON; LESCOL; CYMBALTA taken for major depression. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "increased fatiguability". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient got her Covid vaccine 16Jan2021 and due second dose on 24Feb2021. Vaccination Facility Type was unknown. Vaccination facility type was unknown. Vaccine Administered at military facility was not reported. No prior Vaccinations within 4 Weeks. It was reported that Increased fatiguability Trying to switch to CYP2C9 agent: Fluvastatin = Lescol.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
My face was red and prickly after getting the vaccine and I'm still trying to keep my face dry with cool packs but it's still really red. It is still ongoing.
Pale and light headed. Given water, ice pack for neck.  Rested and monitored for 30 minutes and left walking and without symptoms.
ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE PULMONARY EMBOLISM 2/17/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
11-20-07 13 y/o female was given Fluarix 0.5 ml IM in (R) arm lot AFLUA282DA Exp 6/30/08. This vaccine is not approved for children < 19 yrs old. No adverse event reported from parent
Patient had a cellulitis type reaction to the vaccine. I've seen this happen with several patients getting Fluad versus the regular Fluzone HD vaccine. He got the vaccine back in September 2020. The cellulitis has resolved since then but the patient states that he can still feel like there is something in his arm (pain, etc.)
had the vaccine and have shingles/suspected vaccination failure; shingles at the moment /Just one spot; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 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 was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 2-June-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient  had the vaccine and had shingles at the time of reporting. The patient had just one spot. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles was not provided.
Patient presenting to the hospital with worsening central chest pain. Found to have elevated troponin and EKG showing diffuse ST elevations and PR depression. Symptoms began ~3 days after vaccination .
No additional AE details are available; Caller states they had a patient who was inadvertently administered PROQUAD and VARIVAX today. No additional AE details are available. No PQC reported.  VARIVAX T032932 9/28/2022 0.5ml PROQUAD U009262 9/19/2022 0.5ml; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On 31-MAY-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 ml, lot number T032932, expiration date reported as  28-SEP-2022, administered for prophylaxis (strength, and route of administration were not provided); and  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 0.5 ml, lot #number 009262, expiration date: reported as 19-SEP-2022, administered for prophylaxis (strength, and route of administration were not provided) (inappropriate schedule of vaccine administered). No additional adverse event reported.
Per MD note: "18-yr-old with Type 1 VWD received Hepatitis B reimmunization dose #3 of second series. Upon leaving clinic and reaching elevator stated he had deltoid and finger numbness. On questioning stated he had experienced immediate paresthesiae with sensation of a "furry caterpillar crawling from deltoid down arm". Numbness of dorsal surface of four fingers excluding thumb, also reported increased warmth in right hand compared to left. Objectively there was no significant bleeding at injection site. There was hyperemeia of the affected distal upper limb. Motor examination was completely normal." Given Benadryl 25mg po, observed in clinic. Injection site was 9 cm from acromion and in appropriate location with 1 inch needle. Upper arm circumferences was equal at 33cm. Eventual discharge from clinic around 5.50 pm."
Fever of 106F; Admitted to hospital for observation; Appears fine now; No hx of allergies; 3rd DTP; No family hx available;
LOW BLOOD SUGAR; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) 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 an unspecified date, the subject experienced low blood sugar. Laboratory data (dates unspecified) included: Blood test (NR: not provided) low blood sugar reading was 86. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low blood sugar. This report was non-serious.
This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On an unspecified date in 2016 (reported as "on or after 03-MAR-2016"), the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # M002252 with expiry date: 28-FEB-2017, orally; strength, dose and site of administration were unspecified). The administered vaccine underwent the temperature excursion at 8.3 degrees Celsius for 19 minutes. There was no previous temperature excursion. It was a case of a "data logger". No concomitant medications were reported. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Expired Twinrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) (batch number unknown, expiry date August 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix 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: 20-FEB-2023 Reporter's comment: The information about patient and vaccine was asked but declined. The reporter consented to follow up via email. Additional supportive information: The patient was administered an expired dose of Twinrix, which led to expired vaccine used.
About 12 hours after receiving the shot patient started having flu like symptoms, starting with a dry cough, chills and fever.  The symptoms considerably worsened over the course of the following weeks, the cough becoming so intense patient had trouble sleeping at night or functioning during the day.  Tiredness was also a symptom, causing patient to spend 2 to 3 weeks with hardly any physical activity.  Went to a Doctors assistant after a week of this and said it was a shot reaction & viral. Gave an antibiotic to prevent a secondary infection, but it did no good.  Now, a month later patient still has horrible coughing spells.
Malaise, general ill feeling, aching, runny noise, cough, fever around 101, cough, redness and lumpy arm, described as "felt like real pneumonia infection". Took ASA for fever but did nothing so switched to Ibu but still did little. Took Benadryl on 10/27 and it helped with redness on arm.
tenderness @ site w/in first 2-3 days;9 days post vax: redness, swelling from shoulder to elbow;pain lt shoulder, lt elbow;12 days post vax: arm cont to swell & states worse than yesterday;recommended MD eval;
Extremely significant  swelling under left eye and left cheek  from dermal filler received months ago. The product most recently used was Volure. Voluma was used in the past. Swelling only occurred on one side..
This spontaneous report was received from a physician via a company representative concerning a 52 year old female patient. The patient's pertinent medical history and concurrent conditions were not provided. On 23-JUL-2015, the patient was vaccinated with a dose of ZOSTAVAX(Lot# not provided), 1 single shot, subcutaneous. On 24-JUL-2015, the patient experienced swelling in the upper left arm. The upper left arm was red and hot to the touch. The physician reported that the adverse reactions resolved themselves in approximately August 2015 (reported as in approximately 10 days from 24-JUL-2015). There was no treatment given for the patient's adverse events. The patient did not seek medical attention. Additional information is not expected as the reporter did not wish further contact.
10/20/2021: Series 3/Booster. 1st sympt: fatigue in late afternoon; 2nd sympt: very sore injection site. 10/21/2021: extreme chills/uncontrollable shaking; severe muscular pains in back and hip; Tylenol/H2O 10/22/2021: finally slept and ate; woke completely drenched; no more symptoms. I am single/divorced/mother/grandmother, live in a retirement village apartment and am physically active but 5'4''/200lb. With degrees from four different universities in music/counseling/special education, my medical experience is only as a surgical patient every four years beginning in 1944 when I survived the polio pandemic but began losing tonsils/appendix/uterous/both breasts and then began acquiring plates/screws and a new knee.
Sore left upper arm by 5pm, 3-13-21. Very tired, muscular aches whole body, chills/feverish, headache overnight to present, nausea. abdominal cramping and diarrhea x 2 days. Feels like 'the flu'.
Patient with 2 COVID vaccines who admitted with COVID detected PCR.  Provider d/c note:  "Reason for Admission:  66-year-old male with a past medical history of CKD, OSA, GERD, DM2, hypertension, morbid obesity admitted with weakness, found to have bacteremia and COVID.   Brief Summary of Hospital Stay:  The patient was found to have MSSA bacteremia, source unclear.  Blood cultures did clear after 2 and half days.  The case was discussed with ID, who had some concern for prostatitis.  They recommended a TTE, followed by discharge with linezolid until October 8th.  The TTE was not concerning.  The hospital has agreed to pay for this medication for the patient.   The patient received supportive care for his COVID infection.  His weakness and symptoms have resolved.  He had an acute kidney injury which is now improving.  A1c was 8.7 indicating poor control.  Will defer this management to PCP."
Child received vaccine on 1/28/02. Parent covered vaccine site with a bandage for 2 weeks due to "had a few chickenpox at the site". Mother states did not change bandage every day and the bandage got wet. Mother called on 2/11/02 and stated that the site was bout the size of a quarter, red and slight raised. Didn't hurt child. Called mother back on 2/12/02 and she states it is a much smaller red area and less red area.
11 days s/p vax c/o lt arm soreness w/inc in erythema & warmth over past 24hr;area approx 5mm w/various stages of bruising;below area arm warm, erythema, nontender & no swollen to approx 3 1/2-4cm;dx bacterial infect;
Within 1 hr stuffy nose, edema of eyelids and marked edema of loose skin of shaft of penis, Benadryl.