chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a non-serious spontaneous case, initially received from other health care professional on 15-Nov-2017, concerning a 24-year-old, adult, female patient. It was reported that, the vaccine was not refrigerated in consumer care. Hence, the vaccine was exposed to temperature above 46F for greater than 64 hours likely to be affected. On 15-Nov-2017, the patient was administered with FLUCELVAX QIV that underwent temperature excursion (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported). It was reported that, the patient did not experience any adverse event and there was no information on readministration of vaccine. The reporter assessed the events as non-serious. Follow-up received from other health professional on 11-Jan-2018: The reporter stated that, the vaccine was not refrigerated in consumer care. The patient was administered with vaccine and no adverse effects were reported. There was no information on readministration of vaccine. The narrative was amended accordingly.
6 month well child check received 2 dose of vaccines - Hep B PCV ROTATEQ PENTACEL.
night of taking the vaccine i was up all night from aches and chills  now i am dealing with prolonged headaches, chills, strong aches and nausea, fever  taking tylonel helps with mitigating these side effects,  but when the evening/night comes, the tylonel takes much longer to go in effect (~2 hours tonight, when during the day it was its normal ~30-40 minutes)
pt recvd vax & devel red blotches on torso, head & extremities;
fever fatigue weakness lasted a day, got very ill 1 month later, immobile arms and legs bad balance bad concentration bad vision migraines, shingles
This spontaneous report as received from a pharmacist refers to unspecified patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On an unknown date unspecified patients were vaccinated with improperly stored RECOMBIVAX HB I0X 3DS 00006487300 (dosing details were not reported) (lot # L033343 expiry date 13-SEP-2017, lot # L027733 expiry date: 13-SEP-2017, lot # L044694 expiry date 04-FEB-2018, lot # L040458 expiry date: 04-FEB-2018). No adverse effects were reported. Additional information has been requested.
High fever chills sore throat muscle aches muscle pain in hip right leg hard to bend leg knee pain
My arm was extremely painful and essentially paralyzed. I could not move it more than 1 or 2 inches even when I willed to move it, for 2 days. The pain is still there after 5 days but I am regaining some mobility. Also experienced zero energy and malaise for 3 days. I spoke with the pharmacist and he suggested aspirin or Tylenol, but I had already taken 1 tablet of Ibuprofen.
Heartbeats irregular; I can feel it almost daily specially like in the afternoon time even during late nighttime sometimes a whole day so I just feel bothered I think I never had this feeling this type of like heartbeat.; I can feel strong stronger and weaker and the timing between is the longer it so called of palpitation/can barely feel my heart was beating; This is a spontaneous report from a contactable consumer (patient's spouse). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection) via an unspecified route of administration on 24Apr2021 as unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date in 2021, the patient experienced irregular heartbeats, the reporter also mentioned that the patient can feel it almost daily specially like in the afternoon time even during late night time sometimes a whole day so he just feel bothered he think he never had this feeling this type of like heartbeat. The reporter mentions that the patient can feel strong stronger and weaker and the timing between is the longer it so called of palpitation due to which he can barely feel his heart was beating. The outcome of the events was unknown.  Follow-up attempts not completed. No information about lot/batch number cannot be obtained. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021640418 same reporter/different patient
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because their facility was unable to download the digital data logger, they would need to treat the issue as a temperature excursion. The data logger that caller was unable to download were for the months of Dec-2021, Jan-2022, and Feb-2022. It was also reported that no adverse reactions were reported by patient.  No treatment information was provided.   This case was linked to MOD-2022-501575 (Patient Link).
On 11/8/01, the pt had redness, swelling and warmth in the right upper arm. Saw a doctor in the clinic on 11/8/01 at 14:30 and was prescribed amoxicillin. Stated MD thought it was a local allergic reaction. On 11/9/01, the swelling extended to lower arm. Will call MD.
Patient administered incorrect vaccine during admission at hospital. Received Pfizer vaccine as a 3rd dose/booster but was supposed to receive Moderna Booster 0.25 ml. Patient was monitored inpatient with no signs or symptoms of reaction prior to discharge.
Case number PHEH2013US021134 is an initial spontaneous report from the consumer (patient's mother) received on 08 Oct 2013. This report refers to a 09-year-old male patient. Previous vaccination history included vaccination with unspecified vaccines and were well tolerated. The patient was vaccinated with Flu vaccine (unknown manufacturer, batch number: not reported, so conservatively coded as seasonal influenza vaccine INN) on an unknown date. On an unknown date, after vaccination his arm swelled up, became reddened and painful to touch. The events resolved after 2-3 days. No other information was available.
Throat tightness, difficulty breathing, face swelling, hives, hematoma at injection site. BENADRL and steroids administered.
This case was reported by a nurse and described the occurrence of expired vaccine used in a male patient who received KINRIX (batch number AC20B225BA, expiry date 23rd November 2014). On an unknown date, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional information: patient was inadvertently administered an expired dose of KINRIX.
Chest pain; Tingling Pins and Needles All Over his body/pins and needles all over his skin; This is a spontaneous report from contactable consumer via Medical Information Team. A 76-year-old male patient (Husband) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Not provided), via an unspecified route of administration on 17Feb2021 09:00 (at the age of 76-year-old) in left arm as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 18Feb2021, the patient experienced tingling pins and needles all over his body, pins and needles all over his skin. On an unspecified date, the patient experienced chest pain. Reporter stated that this morning it was only on his left arm where he got his vaccine. February 2021. She explained her husband had "pins and needles all over his skin", and in the morning it was limited to his left arm, where he received the vaccine. She added she experienced "chest pain" the Friday following the injection, which lasted for 4 days. She had a phone consultation with her cardiologist who said it was "fine and muscle pain". She mentioned their second dose was scheduled on 10Mar2021 and asked if they should receive it. She also reported 3 females died post vaccination with the Pfizer-BioNTech COVID-19 vaccine. She explained: one died after the vaccine; the second, in her sixties, died of a heart after the vaccine; and the third, in her fifties, died after experiencing chest pain for 2 weeks post vaccination. She explained she had no additional details on these adverse events. Her husband had pins and needles all over his skin the day after, and it was just in left arm where he had the COVAX. She said he tried to ask the HCP about it, but the HCP would not answer them and told them to call. She had chest pain 4 days after receiving the COVAX and her cardiologist told her it was just muscle pain. She did not have it. Patient was not visited to Emergency Room and physician Office. No vaccine was administered Prior Vaccinations (within 4 weeks). No treatment was given for the events. Outcome of the event chest pain was recovered on an unspecified date, and tingling pins and needles all over his body and pins and needles all over his skin was recovering.  Lot/batch number is not available despite the follow up attempts made. Follow-up attempts are completed. No further information is expected.
Pt was in on Tuesday, 7/16/02, for 4 year old well check and had shots in left and right arms. Left arm became swollen, red and warm to the touch. Pt did not complain of any pain.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On 15-APR-2018, the patient was vaccinated with expired dose of VAQTA (dose, units and frequency not reported) (lot # N005605 and expiration date: 08-APR-2018) intramuscularly (expired product administered). No adverse effect reported. No product quality complaint was involved. This is one of the two reports received from the same reporter. Sender's Comments: US-009507513-1804USA012473.
Several hours after her first Pfizer mRNA vaccine had vomiting X2, H/A, slight rash both arms, face and neck red, very tired and short of breath when climbing stairs; today, better, still remain tired.
Dizzy, shortness of breath, legs are numb within 5 minutes of receiving vaccine, cannot feel feet, whole body tingling, nauseated about 20 minutes after vaccine administration, redness noted in face and at injection site
My first vaccine was: Monday, March 22 My second dose was: Monday, April 19  A blood test at the doctor confirmed we were expecting a baby on: Friday, April 16  2 previous full term deliveries, no other miscarriages  My blood count was lower than expected based off of my last period date (March 3, 2021).  A second blood test was done Thursday, April 29.  An ultrasound was done Monday, May 10 which showed a fetal heartbeat and measurement of 5wks 5days.  A second ultrasound was done Wednesday, May 19 and showed an irregular heartbeat and less growth than was expected by that point.  Bleeding began on Tuesday May 11.  An ultrasound on Wednesday, May 19 showed the baby had stopped growing or moving and no heartbeat was detected.  On Wednesday, May 26 a D&C was performed.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Itch Generalized-Mild, Systemic: Headache-Mild
Day 1:  Vaccine received at 9 AM.  Later that day at 6 PM had fever of 102 and general malaise.  Day 2:  Felt fine until early evening - 6:30 PM had raised temp of 99.7 and nausea.  Day 3:  Again felt fine until early evening - 7:30 PM raised temp 99.5, nausea, sweaty palms.
10/29/2022 my throat began hurting really bad that morning. My eyes were itching really bad. On 11/4/22, I began having a dry cough and I was getting hoarse by the end of the day. 11/5/22 I put allergy eye drops in my eyes, they instantly swelled up with goop coming out. For a week I had a low grade temperature. I waited to go see the doctor until 11/7/22. They did not do an exam and only prescribed a pink eye medicine that I was allergic to. I went to my primary care physician on 11/8/22. My ears were red, not infected, and told me to go back to using my eye drops, MUCINEX, a spray for my nose and CLARITIN. The CLARITIN helps during the day, but after it wears off, all my symptoms return. I am doing better today, it is easier to breathe, my throat hurts a little and my cough is better.
Persistent, low to medium grade throat discomfort starting 2/28 and lasting through the present date  Persistent, low grade to medium grade soreness in right armpit starting 2/28 and lasting through the present date
Had to leave work early a few hours after Shingrix vaccine.  Very weak, slightly nauseous, weird headache, whole body felt dry and achy, had trouble thinking straight.  I was out of work for 5 days.  Mostly slept and very weak with headache.  Injection site was very sore for a week.
Difficulty breathing, itchy irritated skin, red eyes, coughing, blurred vision, fatigue.
Booster shot Covid 19 with lot no: 330308D received 11/30/21 at employee clinic. On December 22,2021 started experience burning on left upper quadrant of tummy  just below the left breast. On Dec.26,2021 rashes appeared on the site. December 30,2021 seen by urgent care still with rashes on left side diagnosed with shingles. Started on Gabapentin, valcyclovir and amitriptylline. Jan29 right eye twitching and burning on right side of cheek, seen by PCP Dr. on Feb2,2022 at 5pm. Started on valcyclovir.
Reported to feel to feel lightheaded and nauseous. The patient was hypotensive but oxygen saturation were good. She was brought to a private patient room and monitored until her vitals improved, she drank water, and stated she felt better. She was then escorted out, no signs of distress.
The pediatric Pfizer 5-11yo 0.2mL vaccine was administered to the patient on Saturday morning, after which he left the pharmacy premises with his brother (who got same vaccine)  and father. About 45 minutes to an hour later, it was realized that he received an undiluted dose. The parents were immediately notified. The only report of side effects came during my follow-up call at 5:30pm that same day. The father reported that one of his sons (did not specify) was feeling sleepy. The parent was told to contact the pharmacy if any concerning ADRs were to arise. As of the time of this report, we have not been contacted.
Severe redness above and below the injection sight. Extreme soreness, heat at the area of redness. Knot under skin at area of redness. Flu-like symptoms including fever.
transferred to hospital on 10/10/2021, Passed away on 10/12/2021 REASON FOR ADMISSION   Stroke    HOSPITAL COURSE Patient is a 79-year-old male admitted to the hospital on 10/10/2021 after he was found to have multiple focal ischemic strokes, mainly a left cerebellar stroke due to left vertebral artery and PICA occlusion.      Past medical history if significant for atrial fibrillation on Xarelto, OSA on CPAP, and diabetes (on metformin).    On 10/4/2021 he developed COVID-19 infection and presented to the ED for evaluation of shortness of breath and weakness.   He was admitted to the medical floor and given supplemental oxygen, remdesivir, and dexamethasone.  Around midnight on 10/10/2021 he became unresponsive and bradycardic with heart rates in the 30s with oxygen desaturation. He was initially placed on BiPAP but required intubation shortly thereafter.   CT/CTA chest was obtained after intubation, negative for acute PE but did show findings consistent with Covid-19 pneumonia.  Around 0200 a head CT was obtained which showed an acute left cerebellar infarct with effacement of the 4th ventricle and hydrocephalus with dilated 3rd ventricle and lateral ventricles.   He was transferred to another hospital on 10/10/2021. Recommended starting barcitinib (JAK inhibitor) for COVID pneumonia. He was started on Lovenox 30 mg subcutaneous b.i.d. for D-dimer greater than 3000.  Lower extremity ultrasound was negative for DVT. Neurology was consulted who recommended a repeat head CT with CTA 12 hours from the initial. CT/CTA at 1500 showed bilateral inferior cerebellar infarcts with an occluded left vertebral artery and left PICA.  There is progressive edema with worse effacement of the 4th ventricle and the prepontine cistern. Given worsening mass effect and brain compression he was transferred to another hospital for management.   His initial neurological exam was poor, although confounded by sedative medications. He was started on mannitol with improvement early in the day on 10/11/2021. Neurosurgery was consulted and evaluated. They discussed neurosurgical options with his family, who conveyed that surgical options would not reverse injury already sustained and therefore not be consistent with his wishes. His neurological exam worsened overnight on 10/11/2021 where he was not following commands in the left hemibody. Despite hydration and careful monitoring he developed acute kidney injury.    Family including wife and three sons were updated via telephone regarding the severity of his strokes. After discussion they agreed that he would not want to live with neurological disability and losing any part of his independence would not be consistent with his wishes. He also had a living will stating that he would not want artifical means prolonging his life if recovery consistent with his wishes was not able to be achieved. Therefore, he was transitioned to comfort care measures after discussion with patients family on 10/12/2021. He passed away peacefully with family at the bedside at 4:44 pm.
Syncope, vomiting, agitation, dizziness 5 min after vaccines.
A report has been received from a Health Professional concerning a 59 year old female patient. The patient's medical history included hypercholesterolemia, hypertension, osteopenia, allergic rhinitis and tobacco abuse. Concomitant medications included lisinopril, simvastatin, alendronate sodium, estrogens conjugated, medrogestone and azelastine hydrochloride. On 19-Feb-2014, the patient received nasal FLUMIST. On 19-Feb-2014, the patient received inadvertently FLUMIST QUADRIVALENT over 49 years of age. The outcome of the event of inadvertently gave FLUMIST QUADRIVALENT to patient over 49 years is unknown. The report was considered to be non-serious by the company physician.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age.  No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a physician office as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2017, the patient was treated for a blistering vesicular outbreak that was diagnosed as a severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
My chronic pain is really bad today. It feels like my normal bad pain only a whole lot worse. I hurt as much as I did 20 years ago before I started with a fentanyl patch. I had to take an extra Tramadol and cyclobenzoprine. It hasn't helped much and I think I'll take another Lyrica and Tramadol this evening.   It's not new pain, just a bad flare like I haven't had in 15 to 20 years. It hurts like before my epidural to deliver my son 10 years ago. It hurts.  Please don't use this as a reason to take my pain medicine. When doctors started tapering or removing our opioids, we have watched chronic pain patients give up and die. Please don't do that to me. I have a 10 year old and he still needs mom. Please? I probably shouldn't have reported this.
Chills, Headache, weakness, unusual tiredness, sleeping 12 hours or more daily, and nausea.  Physician prescribed medication on 09/26/2016.  Improved on 09/28/2016.  Absolutely without doubt this illness was brought on by the injection of the flu vaccination. I was healthy without any symptoms just hours before the injection.