chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine was cold, and customer put away vaccine as normal not knowing too long in transit which was given to a patient, with no AE; Vaccine was cold, and customer put away vaccine as normal not knowing too long in transit which was given to a patient, with no AE; Initial information received on 06-Oct-2020 regarding an unsolicited valid non-serious case received from the other health care professional.  This case involves a patient of an unknown age and gender who received INFLUENZA VACCINE which was cold, and customer put away vaccine as normal not knowing it would take too long in transit (batch number and expiry date not reported) via unknown route in unknown administration site on an unknown date for prophylactic vaccination (product storage error and product distribution issue).  The patient had no medical history, concomitant disease or risk factor.  The patient's medical treatments, vaccinations, concomitant medications and family history were not provided.  It was an actual medication error due to incorrect product storage and product shipment delay (latency: same day).  Reported Adverse Event Information: Vaccine belonged to the Saturday shipment and arrived on Tuesday. Reporter referred the consumer to contact medical affairs a second time. The first time she did not receive a very warm welcome or much of a response to help navigate the issue. It is unknown if patient's physician provided consent to be contacted. It is unknown if the patient experienced any additional symptoms/ events. There were no lab data/results available.  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. 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.
Patient was so dizzy that he was having trouble talking.  His words were slurred and slow.  Patient had started to become dizzy about 30 minutes after getting the vaccine.  It continued to get worse. He ate to see if that would help.  He then began having trouble speaking.
Patient received vaccination 8/27/14 (6:54 pm). She began feeling nauseous on 8/28/14 (approx 1 pm) and vomited at around 1:30 pm and again at 4 pm. She ran a low grade temperature. She took TYLENOL 8/29/14 at 10 am and again 2 pm (because low grade temp came back). She is taking ginger ale to replenish fluids (Gator Ade/water/tea).
Received Varicella vaccine 8/29/13, then on 9/4/13 developed fever/illness symptoms, then on 9/9/13 developed chicken pox. Had generalized rash which started in the thigh where administration occured and spread to adbomen, upper extremities, and face. PCR test from a vesicular swab specimen taken on 9/9/13 was positive.
RN administered an undiluted Pfizer Booster Shot to the patient.  Patient was observed post booster administration without any reaction.  Spoke with the patient today and claimed that he felt fine and no adverse reaction over the weekend.
Information has been received through the Merck pregnancy registry from a 35 year old female, with no medical history and no allergies, who was vaccinated with a first and second dose of Varivax on 21-FEB-2006 and 21-MAR-2006, respectively. There was no concomitant medication. It was noted that the patient had pregnancy tests on each of the days that she was vaccinated and both of the pregnancy tests were positive. "One day after the second vaccination with Varivax," on 22-FEB-2006, the patient developed a red lump at the injection site, that went away within one week, and was considered to be recovered on 28-MAR-2006. It was reported that a pregnancy test done on 06-APR-2006 was positive. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested. 02/11/2010 No further information is available.
Presented to ED 1/12 with primary complaint of Fatigue starting that AM. Being treated for Stage IV Sacral Decubitus Ulcer w/ possible osteomyelitis, Still admitted
5 minutes after vaccine patient complained of dizziness and became diaphoretic, pale, and clammy. BP 74/48, HR 42 bpm, O2 92%. Water and snacks were given. At 10 minutes post vaccine HR was 52 bpm and O2 was 96%, patient is alert. At 15 minutes post vaccine BP was 90/50, O2 99%, HR 86 bpm and very talkative, states he is feeling better.
I had heart pain I could barely breath and also I felt pain in liver. As well as typical symptoms such high fever
Headache, feeling faint, shortness of breath 1:45 PM. Red face that turned into hives on both cheeks 2:00 PM.  Symptoms faded to just headache and hives by 3:00 PM.  Seen by Dr. at 3:30.  Told to take Benadryl to alleviate symptoms and watch for any further signs of distress.
The patient had a seizure on the Friday after getting the vaccine. Patient had a seizure w/u-extension, LP/UDS. Patient had CT scan and EEG. The EEG showed diffuse encephalopathy.
Light rash appearing at the site if the injection.  There is mild discomfort due to itching.  Appears to have a small lump in the area.
This spontaneous report was received from a healthcare worker concerning unspecified patients of unknown age and gender. The reporter stated that on unspecified dates, since 11-MAY-2015, unspecified patients have been administered doses of improperly stored VAQTA (dose, frequency and route of administration not reported) (lot # H021243, expiration date 25-SEP-2015) exposed to temperatures outside of the recommended range. No adverse experience has been reported. This is one of several reports received from the same source. Additional information has been requested.
8 days post vax, the pt experienced edema and erythema of the entire upper arm which quickly resolved with antibiotics and Benadryl.
Acid reflux - (Omeprazole);Pain lower back (Naproxen & Flexeril);Medicine adm by VA Fatigue;Energy loss
Patient complained of right elbow pain, swelling, and stiffness 12-16 has after Anthrax vaccination to right VE.  Patient has no erythema/edema.  Treated with NSAD, and jobs of light duty.
3year-old male patient received on 5/11/2021 a Kinrix vaccine by error; 3year-old male patient received on 5/11/2021 a Kinrix vaccine by error; received 2 Pediarix vaccines on 11/16/2018 (first dose) and on 7/19/2019 (second dose).; This case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 3-year-old male patient who received DTPa-IPV (Kinrix) (batch number D24G7, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pediarix (received 1st dose on 16th November 2018).   On 11th May 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 19th July 2019, the patient received Pediarix. On an unknown date, the patient started Pediarix Pre-Filled Syringe Device. In July 2019, not applicable after receiving Kinrix and Kinrix Pre-Filled Syringe Device and unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. In May 2021, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered, inappropriate age at vaccine administration and drug dose administration interval too long were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported for Pediarix. Pharmacy director reported that the patient received Kinrix vaccine by error instead of Pediarix, which led to  wrong vaccine administered, inappropriate age at vaccine administration. The patient had received 2 Pediarix vaccine first dose and second dose was received at an interval longer than recommended, which led to lengthening of vaccination schedule. The reporter consented to follow up by fax. Kinrix expiration date was not available at the moment of the call.
1:00 PM client started to have itchy eyes and throat felt scatchy. 5:00 PM Headache started 6:30 PM Eyes swelling, throat swelling, nausea took over the counter meds 6:45 Taken to ED by family members for treatment due to difficulty breathing, with IV started, meds unknown. Kept for observation until 2 AM.  Returned to work this morning without residual effects.
Nausea, Headache, Fever. Dizziness, Rapid Heartbeat.  Myocarditis. Lowered Brain Function.
Vaccination site pain; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (soreness of arm) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 046A21A) for COVID-19 vaccination.     Concomitant products included RITUXIMAB (RITUXAN) for MS, DEXTROMETHORPHAN HYDROBROMIDE, QUINIDINE SULFATE (NUEDEXTA [DEXTROMETHORPHAN HYDROBROMIDE;QUINIDINE SULFATE]) for Pseudobulbar affect, MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2. On 23-Mar-2021, the patient experienced MYALGIA (soreness of arm). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency and IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, MYALGIA (soreness of arm) outcome was unknown.        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 did not allow further contact
Minutes after administering the HPV vaccine to the patient, patient presented involuntary body movements, nausea, dizziness, pain on the left arm and sleepiness.
4 days after my second shot I have developed a large itchy rash on my arm at the injection site. And also a smaller itchy red patch on another portion of the arm. It?s uncomfortable but not serious. It was / is about 6 inches in diameter almost perfectly round circle. It is bumpy and red and itchy and I treated it with Benadryl and taking Aleve. But it continues, the Benadryl really doesn?t seem to be helping with the itchiness but it has made the redness and the swelling go down.
Stroke on 8-1-2021.  Patient never had any prior symptoms leading to this.  Patient worked out 5 days/week his entire life.  They administered TPA and results look good.  Found AFib.  Administered blood thinner, Eliquis for the rest of life.  We can't prove this is caused by the vaccine, but enough people that know the patient and his habits believe this to be the cause because he was in such perfect health prior.  I am filling this out as I have questions myself as I think it is possible.
3 hrs p/vax felt cold had chills, felt tired; fever of 103; felt dizzy & had no appetite; called MD; duration 36 hrs
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult female patient who received SHINGRIX (batch number H547E, expiry date 22nd February 2021) for prophylaxis. The patient's past medical history included shingles (reoccurring). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional (HCP) reported that a patient received their initial dose of SHINGRIX and developed shingles thereafter. No further details were reported regarding the event.
INJECTION SITE REDNESS; SEEING SWIMMERS IN BOTH THE EYES; INJECTION SITE LUMP GETTING BIGGER (SINCE THE DAY PATIENT GOT VACCINE, SIZE OF HALF A DOLLAR AND GETTING BIGGER); STABBING PAIN/HURTS BAD AND TENDER AT THE SITE OF VACCINATION; This spontaneous report received from a patient 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, and batch number were not reported) dose was not reported, administered on 2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the patient experienced seeing swimmers in both the eyes, injection site lump getting bigger (since the day patient got vaccine, size of half a dollar and getting bigger), and stabbing pain/hurts bad and tender at the site of vaccination. On 2022, the patient experienced injection site redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stabbing pain/hurts bad and tender at the site of vaccination, injection site lump getting bigger (since the day patient got vaccine, size of half a dollar and getting bigger), and injection site redness, and the outcome of seeing swimmers in both the eyes was not reported. This report was non-serious.
Bell's palsy predniSONE 20MG  vaiACYclovir HCL 1GM Artifitial Tears Erythomycin
Pfizer-BioNTech COVID-19 Vaccine: I had painful axillary lymphadenopathy, chills, fever over 102.5, piercing headache, dizziness and vertigo with change in position, severe fatigue, sore throat, generalized muscle aches the following day (1/20) after I received the vaccine. It took hours just to get out of bed this morning, I felt so unwell.  I took 1000 mg of tylenol before bed on the day I received the vaccine (1/19), but I still woke up with fever. I continued to take 1000 mg throughout the day every 6 hours, which did help. Most symptoms resolved by 1/21 but I continue with fatigue and painful left axillary lymphadenopathy. The node is still really swollen and tender.
Contracted covid even though has received Bivalent vaccine; Contracted covid even though has received Bivalent vaccine; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history (No pMH). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Contracted covid even though has received Bivalent vaccine".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.
Pt received dose #1 of the Moderna vaccine today. Within minutes of sitting in observation the pt c/o experiencing burning in her ears and feeling "weird." EMS called and pt evaluated by paramedic. Pt then c/o tingling in throat. Pt transported to ED.
Hands, bilaterally erythematous and hot to touch.   One-25 mg Benadryl was given at 2:25.
Delay of menstrual period by 6 weeks, when menstruation returned it was heavy prolonged bleeding. This happened with the initial vaccines and again with the booster I got 11/23/21.  The bleeding was heavier and more prolonged with the booster. Two cycles of heavy, prolonged bleeding until I used birth control to stop the bleeding.  The bleeding became bad enough to soak through a pad, two layers of clothing, a towel and a blanket.  After 6 weeks of birth control cycle went back to normal.  In 16 years of menstruating (8 off birth control and 8 on birth control) I had never experienced heavy or prolonged bleeding. Only after delayed cycles directly after the original set of vaccines and then with the booster shot.
Left deltoid with erythema and warmth 4cm; mild edema. No treatment prescribed.
loud ringing in both ears; left arm sore at the injection site and down the elbow; Initial information was received on 08-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case involves a 74 year old female patient who had a loud ringing in both ears (tinnitus) and left arm was sore at the injection site and down the elbow (vaccination site pain), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 29-Sep-2020, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number not reported) once via unknown route in unknown administration site for prophylactic vaccination.  On 29-Sep-2020, the patient developed a non-serious loud ringing in both ears (tinnitus) and left arm was sore at the injection site and down the elbow (vaccination site pain) within 2 hours following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.   She and her husband received the fluzone high dose vaccine at the local pharmacy. Her husband did not have a reaction and they have not had one in the past. The ringing in her ears did not stop.   No laboratory data was provided.  The patient did nothing to treat herself  At the time of reporting, the outcome of event vaccination site pain was unknown while the event tinnitus was not recovered.  There will be no information available on the batch number for this case.
Dizziness (24 hours after shot), achy body (followed 1-2 hours after dizziness), no fever but felt feverish. All symptoms except a little lingering dizziness dissipated within 5-7 hours. History of vertigo.
pt recvd vax & eyes became constantly irritated & had erythema; pt exp a herpes zoster like dry & scaly rash around eyes; also pt naturally wavy hair straightened;
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 4:56 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Nov-2021 at 4:56 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided by the reporter.  The information about allergies, acute illnesses, chronic or long standing health conditions, information about other medications (prescription, OTC, dietary supplements or herbal remedies) at the time of vaccination or at time of reporting were unknown.  The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial was initially stored in refrigerator on 19-Nov-2021 and was moved from freezer to refrigerator on same day, it was a day when the Moderna COVID-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator or maintained at room temperature. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported.  Treatment medication was not provided.   This case was linked to MOD-2021-402935 (Patient Link).
Event started with chills and fever, progressed to nausea, loss of appetite, and exhaustion. I slept for 11 hours and woke with a headache and brain fog. Appetite did not return until early afternoon. Continue to be tired on 2nd day.
04/29/2022 vaccination 05/18/2022 Started to experience a flare-up with allergies and asthma. Proceeded to get worse. I cough daily, almost every minute. I would time in between coughs.   06/06/2022 Saw GP. They put me on steroids and antibiotics; erythromycin, rescue inhaler, and a prescription cough pearls.  *If I don't talk, I don't cough. My cough is now every 5 minutes. Mucous is in my cough.
5/6/05 HBV and Menactra were administered. 5/11/05 bronchitis, treated with Biaxin/Albuterol and Prednisone; 5/14/05 Diarrhea, vomiting; 5/15/05 generalized seizure, ER, Dx: viral meningitis. Pt 15 yo child was seen in our office on 5/6/05 for well visit. He was given HBV and Menactra. No calls received from parents regarding any side effects. On 5/11/05 child was seen for cough, wheezing. He was diagnosed bronchitis/RAD, started on Biaxin XC, Albuterol Inhaler and Prednisone for 5 days. As per mom, he developed vomiting and diarrhea on 5/14/05. On 5/15/05 he developed generalized seizure. No h/o high fever or stiff neck or rash. Child was taken to nearest hospital by ambulance. CBC, Lumbar puncture, blood and urine culture, drug screen, Ct scan brain were done. Child was started on Ceftriaxone, Dexamethasone, Vancomycin and transferred to another hospital. He was admitted because of change in mental status. He was also started on Acyclovir. EEG NL, Neuro was consulted, child was discharged on no medication. All antibiotics were discontinued because cultures and PCR (CSF) negative in deciding for herpes simplex. the final diagnosis was viral meningitis and seizure. Please see enclosed lab results.
SYPMTOM ONSET 8-9-21 FEVER MUSCLE ACHES SORE THROAT RUNNY NOSE FATIGUE COUGH SHORTNESS OF BREATH NAUSEA DIARRHEA STILL
The patient reports fever, chills, body aches, diarrhea, left axillary lymph node enlargement, and left breast tenderness following first dose of Pfizer vaccine. Constitutional symptoms lasted less than 1 week and were managed conservatively.  The left axillary lymph node and left breast remained painful and enlarged for approximately 1 month.