chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756487, A0756489 - A0756562A. The CRC provided lot number AFLUA3208A to regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (FLUA320 and AFLUA320BA): AFLUCA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and FLUA350B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Consulted with the local Health Dept. and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Local Healthcare is working on a compliance improvement plan and has been reinstated vaccination privileges.
injection site pain, tiredness, headache, muscle pain, chills, fever, nausea, diarrhea, vomiting
Debilitating and immobilizing menstrual cramps and a high volume of large red/purple menstrual clots. I received the vaccine on the 23rd and felt ill for two days with fever peaking around 102 degrees, aches, sweats and fatigue. On the 25th I started my menstrual cycle. My typical bleed is a regular cycle length, average volume of red blood, and no cramping and no clotting. On the 25th I was brought to tears the pain from cramps was so intense. I passed about a dozen clots varying in size from about the size of a dime to that of a quarter and an overall larger volume of blood. Since the vaccination I?ve also experienced light pressure in the lymph system on the left side of my body.
4/21: Felt "explosion in head," lightheaded, poor focus, vision off, felt like concussion, fatigue, "my computer short circuit", spinning, dizzy, anxiety, "eyes darting", racing thoughts at night while trying to sleep. 4/26: light sensitivity, new onset sciatica, hypersensitivity, inability to focus, spinning. 2nd phase: right posterior occipital pain (neuralgia). 3rd phase: moving eyes, felt crunching noise. Vertigo treated with vestibular therapy. Anxiety/insomnia treated with Xanax.
Information has been received from a nurse practitioner concerning a 25 year old female who on 20-OCT-2008 was vaccinated with the first dose of GARDASIL. The second dose of GARDASIL was given on 04-FEB-2009. The third dose of GARDASIL was given on 16-APR-2009. On 21-APR-2009, the patient was seen by a provider because she presented with a generalized rash. She was treated with (ZYRTEC) and (CALRITIN). At the time of reporting, the outcome was unknown. No further information is available.
No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion.; This spontaneous report was received from a healthcare professional concerning a 16-months-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On 20-DEC-2022, the patient was vaccinated with the third dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular injection, administered intramuscularly in left thigh, lot # W006596, expiration date 11-OCT-2024, for prophylaxis (dose was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Data logger was involved.  No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA009943:
Patient stated that he is experiencing pain in his left arm. He states the pain began after the immunization and he is still experiencing discomfort. Referred patient to his family physician if the pain continued.
approximately 1.5 hours after vaccine pt's mom called stating she had a fever and headache, and this morning she called to inform us headache was gone but that she had a rash from head to toe.
NONE. Covid  19 Vaccine expired 11.22.2022 Given 12/10/2022
This spontaneous prospective pregnancy report was received from a registered nurse and refers to a female patient of unknown age. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 29-NOV-2016, the patient was vaccinated with a dose of M-M-R II, lot number reported as M011666, expiration date 08-MAR-2016, (dose, route and anatomical location were not reported) for prophylaxis. There was no concomitant medication reported. On the same date after administration, the patient notified the nurse that she was 16-17 weeks pregnant. The last menstrual period was on 03-AUG-2016 and the exposure was at the second trimester. No adverse effect was reported. At the time of the report, the pregnancy outcome was pending and the fetal outcome was unknown. Additional information has been requested.
patient developed  gradually progressive dyspnea.  had a near syncopal event.  found to have pulmonary embolism (moderate clot burden) with evidence of R heart strain and was hospitalized for monitoring.    she is recovering and on anticoagulation.  negative thrombotic risk panel.
Within 12 hours after vaccination, I became hot and sweating with pain all over my body.  I went to bed at 7 pm and stayed in bed until noon the next day.  The pain and sweats were 90% gone by that time.     Total  hours in pain+ was about 12 hours.
This spontaneous report was received from an other health professional referring to an adolescent patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported. On 30-MAY-2017, the patient was vaccinated with first dose of GARDASIL 9, lot # N000326 and expiration date: 14-OCT-2019, intramuscularly for prophylaxis at 13 years of age (strength, dose, unit and anatomical location were not reported). On 17-APR-2019, the patient was vaccinated with second dose of GARDASIL 9, lot # R004689 and expiration date: 29-NOV-2020, intramuscularly for prophylaxis at 15 years of age (strength, dose, unit and anatomical location were not reported) (inappropriate schedule of product administration) (onset date: 31-MAY-2018). No adverse effects were reported. No product quality complaint (PQC) was involved.
TIA: loss of balance, blurred vision, slurred speech, unable to speak, nonsensical words once I could speak, headache, confusion
The pt experienced severe, constant muscle and joint pain, headaches, hot hands, hot feet. 60 Day FU states still has pain in muscles and joints, weird rashes.
1/26/16 - evening (R) upper arm, red, warm, tight. Denies fever or pain. Called office AM of 1/27/16. Advised MOTRIN, compress, monitor. 1/25/16 spoke with dad - area is smaller, better overall.
P/receiving Influenza vax, pt devel sores in mouth & itchy, red hard raised somewhat painful skin eruptions on shoulders; The eruptions were the size of a fifty cent piece; @ time of vax pt had earache (lt ear); Seen by MD;
Pain/rash/hives around injection site. Administered diphenhydramine 50 mg PO.
Constant ringing in ears that started less than 24 hrs after receiving vaccine and is still occuring
8hrs post vax had mass bruises all over back of leg-gave Pred & APAP; 3NOV Restoril; 4NOV lorazepam;
PATIENT REPORTED FLUSHING/ARRHYTMIA. BP 170/70. MONITORED PATIENT, RECHECK OF BP AT 15 MIN. INTERAVALS. SECOND BP 160/70, 3RD READ 154/64, FINAL BP 150/70. PATIENT REPORTED HEADACHE, LEFT FACILITY, WILL CONTACT PCP/CARDIOLOGIST.
In March after the vaccine, I had flu symptoms, joint pains and low grade fever. Which went off the next day. It started as congestion on 30Aug2021, I have general not feeling well, sinus pain, fever, cough, headache, fatigue, aches, lost of taste and smell and chills. Did tele doctor and went to ER on 13 Sep2021, because I was having chest pressure and difficult to breathe.
Eye was quivering and trembling for a short while; This spontaneous case was reported by a consumer and describes the occurrence of EYE MOVEMENT DISORDER (Eye was quivering and trembling for a short while) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Nerve damage (left nerve damage). Concomitant products included VITAMIN B NOS (B-COMPLEX [VITAMIN B NOS]) and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced EYE MOVEMENT DISORDER (Eye was quivering and trembling for a short while). At the time of the report, EYE MOVEMENT DISORDER (Eye was quivering and trembling for a short while) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also include hair, skin, nails vitamins Treatment details not provided.     Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: TCR was received the details was for second dose outcome has been resolved and requested no further follow up On 27-May-2021: Event outcome updated.; Sender's Comments:  MODERNATX, INC.-MOD-2021-060506:2nd dose
Severe flu symptoms, body aches low fever, fainted after getting out of bed; required 18 stitches.
FELT SYMPTOMS FOR COVID/ Suspected COVID-19; SORE ARM ON SECOND SHOT OF COVID VACCINE/ Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (FELT SYMPTOMS FOR COVID/ Suspected COVID-19) and VACCINATION SITE PAIN (SORE ARM ON SECOND SHOT OF COVID VACCINE/ Vaccination site pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 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 started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In March 2021, the patient experienced VACCINATION SITE PAIN (SORE ARM ON SECOND SHOT OF COVID VACCINE/ Vaccination site pain). On 04-Oct-2021, the patient experienced SUSPECTED COVID-19 (FELT SYMPTOMS FOR COVID/ Suspected COVID-19). At the time of the report, SUSPECTED COVID-19 (FELT SYMPTOMS FOR COVID/ Suspected COVID-19) and VACCINATION SITE PAIN (SORE ARM ON SECOND SHOT OF COVID VACCINE/ Vaccination site pain) had resolved.            Relevant concomitant medications were not reported.  In Mar-2021, the patient experienced sore arm on second shot of COVID-19 vaccine. On 04-Oct-2021, the patient experienced felt symptoms for COVID-19.  On an unknown date SARS-COV-2 test was performed but the result was not provided.  Treatment information was not provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Body odor seems very strong and bad smelling. This has continued to occur for a month now and I am not pregnant nor more stressed. My diet has not changed.  I'm not sure it's the vaccine but I have no other explanation.
Developed intense pain in the right deltoid to the point cannot move the shoulder much.  Pain extends to the scapula and down the arm.  Some numbness down the arm and into hand as well.
under the age of 65 were administered FLUZONE HD QIV instead of the FLUZONE QIV with no adverse event; under the age of 65 were administered FLUZONE HD QIV instead of the FLUZONE QIV with no adverse event; Initial information received on 26-Oct-2022 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case is linked to cases 2022SA446068(CLUSTER), 2022SA447057(CLUSTER), 2022SA447385(CLUSTER), 2022SA447853(CLUSTER), 2022SA448075(CLUSTER), 2022SA446195(CLUSTER), 2022SA447822(CLUSTER), 2022SA448121(CLUSTER) and 2022SA447057(CLUSTER).  This case involves a 59 years old female patient who was under the age of 65 were administered influenza quadrival A-B high dose HV vaccine [fluzone high-dose quadrivalent] instead of the fluzone QIV with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 18-Oct-2022, the patient received suspect influenza quadrival A-B high dose HV vaccine at a dose of 0.7 ml (lot UT7729CA, expiry date: 30-Jun-2023) via intramuscular route in the left deltoid for immunisation.  On 18-Oct-2022 the patient developed a non-serious under the age of 65 were administered fluzone hd qiv instead of the fluzone qiv with no adverse event (wrong product administered, product administered to patient of inappropriate age, latency: same day).  Action taken: Not applicable.  Outcome: Unknown for both the events.   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 the 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.
Pressure on chest, rapid heartbeat, dizziness, chills, arm soreness, difficulty breathing lasting 12 hrs after shot until 4 days later
Intense pain at injection sight beginning same day lasting 48 hours Exhaustion, chills, headache, diarrhea, nausea, starting same day and lasting 24 hours   Headache and diarrhea intermittent for the following week
After my second vaccination I began to have coughing, phlegm that was a white pigment, and body aches. I then went to the local urgent care to seek some medical attention, and was given a prescription injection for my bronchitis. I was then given a prescription for Azithromycin and a Nebulizer. It lasted for two weeks and then symptoms began to fade away.
After Moderna injection #1:  Facial flushing, horseness, face and throat swelling, trouble swallowing, slight asthma. Treated with Benadryl injection.  Next day:  Petechiae on face, face swelling, slight arm soreness, some dizziness, chills, body aches, sinus congestion, cough.
having problems with her left eye twisting; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced having problems with her left eye twisting. The outcome of event was unknown.   The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.
bruise at injection site.; This case was reported by a pharmacist via call center representative and described the occurrence of injection site bruising in an unspecified number of patients who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   In 2018, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced injection site bruising. On an unknown date, the outcome of the injection site bruising was unknown.   It was unknown if the reporter considered the injection site bruising to be related to Boostrix.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The several family members were received Boostrix and experienced a 2 cm small bruise at injection site. This case was linked with case US2020182601 and US2020182599 as reported by same reporter. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020182601:same reporter US-GLAXOSMITHKLINE-US2020182599:same reporter
Sudden partial deafness in right ear.  Referred to ENT.  Audiology indicated major loss of low frequency hearing in right ear.  Doctor prescribed steroid taper (12 day) with possible minor improvement.  ENT doctor offered a steroid injection into ear but thought that too much time had passed for it to be effective.
After 2 days I had face swelling. I used steroids to treat. I still have pain in my injection site 13 days later. There's a dull achy pain, as well, in my left back shoulder.
MULTIPLE SCLEROSIS FLARE UP; This spontaneous report received from a patient concerned white, not hispanic or latino male of an unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included multiple sclerosis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: unknown) dose was not reported, 1 total, administered on 12-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 15-JUN-2021, the patient experienced multiple sclerosis flare up symptoms including difficulty walking and moving the right leg specifically, patient experienced numbness about 50 percent numbness in both legs and had visited physician's office. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from multiple sclerosis flare up. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:-20210608685-covid-19 vaccine ad26.cov2.s-Multiple sclerosis flare up. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: MEDICAL HISTORY
Aching in arm spreading to neck region. Continues to have neck pain on 12/8/2010.
The next day after I took the vaccine, I was fine that day, but that night I broke out in hives, all over my body. Mostly on my legs and thighs, and some on my chest and back. Next week, I broke out all the way up to my chin in hives. Very itchy. Dr. did a biopsy and it showed that it was hives. Another symptom I had was cold symptoms, I reported it to my general practitioner. He suggested I took a Covid Test, and the covid test was negative.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FJ4991), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course : treatment start date: 19May2022, treatment stop date:24May2022.  No follow-up attempts are possible. No further information is expected.
I had a bladder infection in December 2020.  I saw my urologist, who prescribed an antibiotic on 12/11/2020.  Then I had my first two rounds of COVID 19 vaccine on 2/3/2021 and 03/03/2021.  I had a followup appointment with Dr. on 03/08/2021.  I had developed tinnitus by then.  I asked Dr. if the antibiotic he had prescribed if tinnitus could be a side affect.  He said no.  Continuing to suffer with tinnitus, on July 28 and October 4, I saw a otolaryngologist.
Individual symptomatic with fatigue, chills, congestion, nausea, upset stomach, and "tickle" in her throat since 12/16/21. Test Covid positive on 12/17/21. Still symptomatic. Advised her to isolate for 10 days away from family in separate rooms and to update mgmt. She will callback on 12/26/21 for follow up. She participated in study and would like antibody testing.
Treatment of COVID-19; Treatment of COVID-19; 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 37-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 09Dec2021 as dose 3 (booster), single (Lot number: F58757) at the age of 35 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 28Sep2023 to 02Oct2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300316023 same reporter/patient, different drug/AE;
Headache, fever, chills, vomiting and nausea lasting 4 days requiring medical attention., acute sense of smell causing continued nausea, sweat that smelled like pool chlorine, rash on chest, extreme sensitivity to sound, feeling woozy and not quite balanced when walking, blurry eyes and extreme fatigue.