chrisvoncsefalvay/vaers-outcomes huggingface dataset:
an expired TENIVAC was administered (with no reported adverse event); Initial information was received on 02-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 29 years old female patient who experienced an expired tenivac was administered (with no reported adverse event) while receiving vaccine diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 02-Feb-2023, the patient received a Dose 1 dose of 0.5 ml suspect diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT lot U6831AA of expiry date 08-Oct-2022 via intramuscular route in the deltoid not otherwise specified for Immunization.  On 02-Feb-2023 the patient developed a non-serious event of an expired tenivac was administered (with no reported adverse event) (expired product administered) following the administration of diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (an expired Tenivac was administered (with no reported adverse event)).  At time of reporting, the outcome was Not Recovered for the event an expired tenivac was administered (with no reported adverse event).   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.
Swollen left axillary area (lymphadenopathy); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 at 15:00 as dose number unknown (booster), single (Lot number: GH9694) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "If covid prior vaccination: Yes" (unspecified if ongoing). Concomitant medication(s) included: TOPAMAX; ACYCLOVIR [ACICLOVIR SODIUM]; SEASONALE. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 21Sep2022 at 16:00, outcome "unknown", described as "Swollen left axillary area (lymphadenopathy)". It was unknown if therapeutic measures were taken as a result of lymphadenopathy. Additional information: Patient was not tested for covid post vaccination. No vaccines in four weeks. Patient received vaccine at pharmacy or drug store.  Follow-up attempts are completed. No further information is expected.
Left eyelid swelling and conjunctival redness/eye pruritis.  Benadryl given.  No wheeze/sob/emesis/hives/normal BP.
Pt received 6 mth vaccines on Saturday 12/09/2008 and developed fever with GI Sx within 24 hrs.  Seen in ED early Saturday am returned to office today.  On 12/9 visit-fever 101, still vomiting with diarrhea, decrease in appetite.  No sign of local erythema, edema, warmth at injection sites.
Systemic: Cardiac Disorder (diagnosed by MD)-Mild, Systemic: Dizziness / Lightheadness-Mild, Additional Details: Pt felt lightheaded and dizzy after second dose. EKG taken by EMT from RI DMAT team and he was irregularly irregular. In atrial fibrillation. He said he had been diagnosed with it a long time ago and his MD had shocked him back to normal sinus rhythym. After 10 minutes pt anxiety went down and pt was in normal sinus rhythym when EKG re taken.
bronchitis; expired vaccine administered; This case was reported by a consumer via call center representative and described the occurrence of bronchitis in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number N17058, expiry date unknown) for prophylaxis.   On 20th May 2019, the patient received Menveo. On 20th May 2019, unknown after receiving Menveo, the patient experienced expired vaccine used. On 21st May 2019, the patient experienced bronchitis. On an unknown date, the outcome of the bronchitis was not recovered/not resolved and the outcome of the expired vaccine used was unknown.   It was unknown if the reporter considered the bronchitis to be related to Menveo.  Additional details were provided as follows: The reporter stated that the patient received an expired dose of Menveo on left arm. On unknown date, the patient developed symptoms of bronchitis. The bronchitis was ongoing with no improvement at time of reporting. The reporter did not had the expiry date, but provided the lot number. The reporter was consented to follow up.
Information has been received from a female consumer with a thyroid problem who was vaccinated with her 1st dose of GARDASIL (lot# not provided). Concomitant therapy included YASMIN BAYER and SYNTHROID. Subsequently the patient experienced abdominal problems after receiving her first vaccination. It was reported that the patient was treated with a course of antibiotics for 3 weeks and had some unspecified test done. Additional information has been requested.
Feet swelling; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Feet swelling) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product VENETOCLAX (VENCLEXTA) for Chronic lymphocytic leukemia.    No Medical History information was reported.   In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, the patient started VENETOCLAX (VENCLEXTA) (unknown route) 100 milligram four times per day. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced PERIPHERAL SWELLING (Feet swelling). At the time of the report, PERIPHERAL SWELLING (Feet swelling) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: Counts had gone from 133 to 4,000.         IT was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant medications were reported. No treatment medications were reported.  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.
Narrative: 93 year old male, received first dose of COVID-19 vaccine (Moderna) on 1/23/21. Reported on 2/19/2021 that he tested COVID positive after roommate tested COVID positive. Called to reschedule second dose of vaccine. Admitted to ED 2/23/21 due to difficulty tolerating foods and drinks over the previous week, loss of taste and smell with intermittent dry coughs. O2 sat 91% on room air, 97% on 2L. 3/3/21, medicine reports patient desat with NRB and 3L NC. Code blue called 3/7/21, patient expired at 07:41.
Left arm swollen, hard knot, fever, bruise, red ring around injection site, sore to touch.
involentary muscle spasm/jolt on left side of the body that is getting worse, fever, headache, rash on left arm. involentary muscle spasm/jolt on left side of the body remains but all other syptoms went away
Left arm swollen and red, warm to touch. Dx'd with cellulitis. Treated with Augmentin. Vaccine given on 9/18/1995.
Patient received 1st Dose Covid 19 vaccine Janssen Lot # 1805018.   04/01/2021 patient returned  to  Vaccine clinic 04/22/2021 received a 2nd dose of Pfizer Lot # ER8731.
made her deaf; fever; scared to get the shot because of my reactions before to other vaccines / after the vaccine she had an allergic reaction (rahses); This spontaneous report was received from an 56-year-old female consumer reporting on herself.      On an unknown date, when she was born, she was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(MEASLES, MUMPS, AND RUBELLA (WISTAR RA 27-3) VIRUS VACC, LIVE) (dosage regimen, route of administration, lot number and expiration date were not reported) for prophylaxis.         On an unknown date, after the vaccine, the patient experienced an allergic reaction-rashes (dermatitis allergic), fever of 105 (units not provided) (pyrexia) and made her deaf (deafness)   The outcome of deafness, dermatitis allergic and pyrexia, as well as the causal relationship with the vaccination were not reported.  Upon internal review, the event of deafness was considered medically significant
5 to 10 hours later aching arm at injection area, following day tired and needed 2 hours napping , chills come and go, headache comes and goes, flushing of face for  several days
Profound muscular aches to arms, back & legs started 12 hours after the vaccine. Profound fatigue where I was in bed the entire day after the shot. Nauseated and could not eat the next day . Could not walk without profound pain in all the muscles . This all resolved 36 hours after the vaccine .
Several days after vaccination his left arm turned red. He was taken to the hospital where he was evaluated and admitted with a diagnosis of left axillary vein thrombosis. A chest X-ray was taken and he presented bibasilar atelectasis and pneumonia with pleural effusions.
Extreme fatigue  Muscle/bone aches Swollen lymph nodes  Mild fever
While administering the Rotateq the patient's eyes rolled to back of head and he went limp.  Oxygen was given immediately.  This was before any injected vaccines.  He recovered within 10 minutes.
This initial spontaneous case, was received on 15-Nov-2017, from a consumer, concerning a 30-year-old adult female pregnant patient. The patient had a history of previous pregnancy (single). The patient's current condition included thalassemia minor. The concomitant medications included, prenatal vitamins and iron. The last menstrual period was reported as an unspecified date in Mar-2017. On 20-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left side (as reported), batch number, expiry date: not reported) (explicitly coded as vaccine exposure during pregnancy). The estimated due date (EDD) was reported as 27-Dec-2017. The reporter assessed the event as non-serious.
Cough Aggravated; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough Aggravated) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cough and Acute sinusitis (since 40 years).    On 28-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced COUGH (Cough Aggravated). At the time of the report, COUGH (Cough Aggravated) outcome was unknown.            Concomitant medication information was not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: follow-up received on 30-Jun-2021 contains NNI
Constant fatigue starting upon date of vaccination.  Have not fully recovered, was not aware of vaccine related condition until recently.  Assumed normal condition. I feel tired and tend to need a lot of sleep. I am able to average about 3 days of work per week before the fatigue forces me to rest.
Spotting outside of my menstrual period. Light spotting since 5/19/21
Mom reports 2-3 days p/DTP/OPV/MMR/HIB given on 18JUL91 pt had temp of 104.8, puffy face, both legs swollen & generalized rash all over his body; Pt taken to Hosp & spent 36 hrs there was admitted; fever brought under control & d/c to home;
Patient has a squishy lump on right shoulder above clavicle.  Looks to be swollen lymp node. Patient described as squishy. Says it hurts. She has taken Ibuprofen.  Arm is unremarkable with no redness.  Patient is calling her primary care md.
Patient with history of allergy to azithromycin and sulfa drugs.  Experienced lightheadedness, dizzy, and faint with passing out after 10minutes of receiving vaccination.  Nurse Lead and observer present.  Patient had VSS: HR 80 120/Palp, SaO2 97% on RA CBG: 105. Assess by EMS on duty.  Symptoms improving after placed on gurney and water provided.  Pt reports not having had eaten before being vaccinated today. Water given and patient continued to be observed for a total of 45 minutes.  Pt discharged home with her ride with VSS: b/p 120/90, HR 84, Skin: PWD, SaO2 96% on RA.
COVID-19 breakthrough infection. Pt received Pfizer on 3/23/21 and 4/13/21.
Migraine; Sore arm on the left side the first shot; This is a spontaneous report from a contactable consumer (patient). A 56-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration in Arm Left on an unspecified date in Apr2021 14:00 (Batch/Lot Number: EW0158, Expiry date: unknown) as 0.3 ML single for covid-19 immunization. Medical history and past drugs reported as no. Concomitant medications included lisinopril, omeprazole, fluticasone propionate (FLONASE ALLERGY RELIEF) and loratadine taken for an unspecified indication, start and stop dates were not reported. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient had been tested for COVID-19 was mentioned as no. The patient received any other vaccines within 4 weeks prior to the COVID vaccine as no. After first shot in Apr2021, the patient had very bad migraine a mile sore arm on the left side resulted in doctor or other healthcare professional office/clinic visit. The unspecified medication was giving help some with the pain. The outcome of events was not recovered.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected
Hives all over body except face and back, for 2 days; 1 day after shot. Also, diarrhea for 2 days.
Patient was given 2nd dose of Moderna after stating he had received his 1st dose more than one month ago. It was later discovered he had received his 1st dose 21 days ago which is not within the recommended time frame.
Flu like symptoms Major chills could not get warm Fatigue had to leave work No fever Headache Resolved by 11:00am 01/22/2020 No adverse events with first dose
Initial report received from a patient on 08-November-2013. A 55-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE ID (Lot number unknown) via intradermal route at right arm between elbow and shoulder on 06-November-2013. On 07-November-2013, the patient experienced a red mark at the injection site about the size of 3 1/2 dollars between the elbow and the top of the arm not the deltoid where the muscle is. She also has pain under the right arm. Corrective treatment was not reported. At the time of this report the outcome of events was unknown. Documents held by sender: none.
Patient immediately experienced nausea, became pale, and started sweating. Patient stated they had not had anything to eat and was nervous about the vaccine. After 30 minutes, water, and a snack, the patient was ok and able to leave with spouse driving.
Chest pains, pounding skipping heart beats started 2 weeks after shot and lasted three weeks before resolving.
Child with no personal or family history of seizures, previously healthy, had 1st time febrile seizure 1 day after receiving FLUMIST, seizure was borderline atypical.
Hives (painful, itchy, red); Hives (painful, itchy, red); Hives (painful, itchy, red); body aches; hives all over the body; wheezing; fever; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives all over the body), WHEEZING (wheezing), PAIN (Hives (painful, itchy, red) ), ERYTHEMA (Hives (painful, itchy, red) ) and PRURITUS (Hives (painful, itchy, red)) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In September 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced WHEEZING (wheezing). In September 2021, the patient experienced PYREXIA (fever). On an unknown date, the patient experienced URTICARIA (hives all over the body), PAIN (Hives (painful, itchy, red) ), ERYTHEMA (Hives (painful, itchy, red) ), PRURITUS (Hives (painful, itchy, red)) and MYALGIA (body aches). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse reaction, at an unspecified dose and frequency and EPINEPHRINE for Adverse reaction, at an unspecified dose and frequency. At the time of the report, URTICARIA (hives all over the body), WHEEZING (wheezing), PAIN (Hives (painful, itchy, red) ), ERYTHEMA (Hives (painful, itchy, red) ), PRURITUS (Hives (painful, itchy, red)), MYALGIA (body aches) and PYREXIA (fever) outcome was unknown.            No Concomitant medications were reported.   This case was linked to MOD-2021-317635, MOD-2021-317634 (Patient Link).
patient was here for a flu shot and was given the COVID (moderna) shot by mistake. Patient didn't  have any rxn at the time but did go to an urgent care later in the week. Outcome is unknown
Beginning ~4  h after injection: mild arm ache at injection site ; beginning ~12 h after injection: insomnia, moderate fatigue/malaise, muscle aches (particularly back/hips, which is unusual), low grade fever, mild nausea, loss of appetite, continual thirst, mild stuffy nose, increase in mild asthma symptoms previously controlled by medication, ache in left armpit possibly associated with lymph node; almost all symptoms resolved by 24 h after onset except residual mild arm/armpit aches and slight swelling of a lymph node at the left collarbone.
Pt developed a fever up to 103 and parent states she almost had a seizure. Pt was taken to the ER and was advised that it could be from the vax. Parent also advised to treat with Motrin between doses of Tylenol. Fever lasted for 2 days and then resolved.
The next day (10/13/21) reported significant left upper arm/shoulder pain, limited range of motion. Seen in clinic 10/15/21, supportive care advised over next few days. Due to persistence, imaging obtained. Xray 10/19/21 without bony abnormalities. Ultrasound 10/20/21 showed "IMPRESSION: Left shoulder fluid collection suspicious for bursitis.  No evidence of hemorrhage or infection at this time." Referred to physical therapy and steroid taper prescribed(10/22/21).
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 06-NOV-2012 at 12:48, 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.
C/O constant mild pressure to chest. EKG done at pt with labs, echo done, 24 hr observation for telemetry.
when I get second dose of it, it is almost all completely fallen out; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Lot number: GE1990) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot: FP7136, received the first dose on 14Apr), for COVID-19 immunization, reaction(s): "I started losing my hairs". The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "when I get second dose of it, it is almost all completely fallen out".  Additional information: Reporter was calling about the Covid Vaccine. She received the first dose on 14Apr, within 2 days she started losing her hairs and when she got second dose of it, it is almost all completely fallen out and right about quarter to a 3rd of hairs that was it. The reporter stated that it increased the hair loss, and she had lost about almost well over half the 3 quarters of her hair from this. She has not changed any products that she used prior to this and like she said, it started falling out about 2 days after receiving first Covid shot. She reported, this is the huge hair loss. Patient was asking does Pfizer do anything to reimburse because now the patient has to go to the Physician now. The patient stated, "Yes, I just said Is Pfizer is going to reimburse for anything that it is going to take from me to grow this hair back. Where there be hormone therapy or whatever because I have a doctor's appointment to go to. It is that bad."
Muscle aches, nauseated, BP over 160/?, headache, finger doesn't bend, and pt has been in bed since Friday. Pt is going to see MD today (Monday).
PT REPORTED PAIN, TINGLING, NUMBNESS FROM LEFT SHOULDER TO TIPS OF FINGERS OF LEFT HAND. STARTED 3/8/2021 AND LASTED FOR ABOUT 30 HOURS.  SYMPTOMS RESOLVED BY ITSELF WITHOUT TREATMENT. SYMPTOMS RE-OCCURED ON 3/22 AND LASTED FOR 24HRS, THEN RESOLVED AGAIN BY ITSELF. PT SAID SHE DIDN'T EXPERIENCE ANY RASH OR SWELLING AT THE INJECTION SITE.
Covid monitoring documentation. PT admitted 12/10/21 documented to have positive covid. PT received Moderna 03/16/21 Lot 006B21A for dose 1. Dose 2 was Moderna given on 04/13/21 Lot 036B21A.
Patient experienced arm swelling and rash 6 days after the vaccine. She went to urgent care and was advised to go to the emergency room. At the emergency room, she told she had a staff infection and was prescribed two antibiotics. her condition has resolved.
3/8/2021 Experienced Amaurosis Fugax, over 50% of sight impacted in left eye for 6+ hours. Saw Optometrist on 3/9.  Dr diagnosed the Amaurosis Fugax and referred me to GP / Cardiology to investigate TIA. 3/25 debilitating headache.  Sent from Urgent Care to E.R. with elevated blood pressure and excessive headache pain
Patient states rash with small blisters appeared bilaterally from elbow to wrist, some itchiness. Saw something on TV and called 10/2/12, may have been yard work, pt not sure.
Pt slept more after immunization for next 24 hrs. Pt seen 1 day later with normal exam.
Swollen arm at injection site, unable to lift using injected arm.  Pt began with flu like symptoms and was down in bed for 2-3 days.  Fatigue, lethargy, body aches.
Drastically elevated liver enzymes (AST and ALT) as of September 28, 2021.  Trying to determine the cause.