chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On 22-JUL-2016 the patient was vaccinated with improperly stored PROQUAD (rHA, lot # M011663, expiration date 08-SEP-2017, dose and route were not reported). The vaccine had been stored under temperature of 52.3 degree Fahrenheit for 11 hours. No previous excursions. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.
I had the typical myalgias, headache, nausea, belly pain, and fatigue starting about 16hrs after the vaccine was given.  However, driving home I felt extreme pain, tunnel vision and vagal response before I made it home after trying to walk my dogs at a dog park.  It was about 18 hrs after the vaccine.  I "blacked out" but because i was on an empty road and my car stopped when my foot left the gas pedal.  I was able to escape harm.  I had rolled the windows down thinking I could potentially make it home but then couldn't.  I finally made it home after recovering and slept the rest of the day.  NOT THE RESPONSE from the 2nd injection, which I expected.  My mother did have a vagal response and hit her head and had a TBI from the injury from her second shot.
Pt called the pharmacy, said she felt horrible after the vaccination, mentioning burning in the injection site as well as swollen and pain. Advise pt that this might go away in couple of days will follow up.
45 y/o F with PMHx of vasovagal with seizure c/o not feeling well around 1:14 pm (which was 14 minutes after receiving her second dose of Pfizer vaccine). She began having a tonic-clonic seizure at 1:15 pm lasting around 90 seconds. Patient was post-ictal for approximately 1-2 minutes. When EMS and Clinical Leads were notified, patient was not actively seizing. Patient was not responsive to verbal stimuli while post-ictal. After ~3min pt was able to respond and follow verbal and tactile commands. Pt was c/o feeling tired / nauseous. Pt was AOx3 and able to follow commands.  Patient was assessed by EMS and clin leads, she was placed on a stretcher, attached to monitor, vitals and BGM taken, 18g IV started on right hand and 20g IV access point attained on left hand. 15L NRB O2, 250mL NS bolus, 1L NS bolus   Pt remained stable and transport was called, pt was transferred to hospital for further evaluation/workup. Pt's father accompanied pt to vaccination site and followed EMS to the hospital.   15L NRB O2, 250mL NS bolus, 1L NS bolus, 1L NS bolus started via transport   Denies HA, numbness, weakness, parathesias, tingling, trauma, hitting her head, erythema/induration at injection site, palpitations, chest pain/tightness/heaviness, SOB, dyspnea, wheezing, facial or peripheral edema, cyanosis, hives, pruritis  2nd Pfizer dose administered @13:00pm, symptoms began @13:14pm, seizing began @13:15pm  @1:25pm: HR 80bpm, SpO2: 100% NRB @15L @1:28pm: 3 lead: sinus arrhythmia with notched R waves in leads I, II, III, avR, avL, avF (unspecific QRS abnormality), notched p-waves in all leads, EKG not acutely concerning and patient is not actively infarcting @1:29pm: IV access with 18g  @1:30pm: BGM: 99 @1:31pm: 12 lead @1:37pm: BP: 102/70 (manual large cuff on left arm)  @1:42pm: BP: 80/50 (automatic large cuff on left arm)  Lungs: clear to auscultation b/l, no respiratory distress, no wheezing, no rales  cardiac: normal S1S2, rate, rhythm Eyes: PERRLA Throat: airway patent, no trismus Neuro: AOx3, sensation/motor/strength intact in all 4 extremities, Motor 5/5, DP/PT 2+ B/L
Vaccine leaked out during injection; Vaccine leaked out during injection; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of UNDERDOSE (Vaccine leaked out during injection) and DEVICE CONNECTION ISSUE (Vaccine leaked out during injection) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced UNDERDOSE (Vaccine leaked out during injection) and DEVICE CONNECTION ISSUE (Vaccine leaked out during injection). On 10-Apr-2021, UNDERDOSE (Vaccine leaked out during injection) and DEVICE CONNECTION ISSUE (Vaccine leaked out during injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was not provided.
3 days p/1st HIB vax, pt devel cluster of small, red raised blisters, sl below the site of the inject;
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 46-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The pharmacist called about administration of expired Moderna vaccines tat was given as booster shot to patients around 490 to 500 on the last date 20 -Oct -2021 to 29-Nov-2021. No concomitant medication information was provided.  No treatment medication information was given.
Came into the ER on 2/2 C/O generalized malaise and weakness. Tested positive for covid on 1/24. O2 sat 100%. WBC 14.5. Chest xray worrisome for pneumonia. Creatinine 4.1. Gluc 223. Treating with IV steroids, IV antibiotics, oxygen support by nasal cannula to maintain sat 94%. Started on fluid hydration D/T pt being dedydrated. Creatinine on 2/3 3.5. On discharge creatinine was 2.2. Changed to PO antibiotics and steroids on discharge and follow up with nephrology
PATIENT REPORTED SYSTEMIC RASH ON TRUNK, ARMS, NECK, AND BEHIND HER EARS AFTER RECEIVING BOTH DOSES OF MODERNA COVID-19 VACCINE.
"11p that night I had a 101 -102 temp, chills, headache, hard shakes"
Patient says she had shooting pain when vaccine was administered. She felt it in her neck and back. She still has some residual pain but it is now starting to get better.
Unstable chest pain, short of breath, dizziness, tachycardia Diagnosed with atrial fibrillation TEE found cardiac output lowering with hypertrophy of ventricles Treated with cardizem, metoprolol, atorvastatin, heparin Rate control did not convert rhythm, defibrillator cardioversion was successful Cardiac catheterization appears clear Now treated with metoprolol, xarelto, atorvastatin
Patient given Moderna (underage). Vaccine should have been Pfizer. Patient had no ill or side effects from administration. 2nd dose of Moderna given 5/24/2021.
A report received from a health care professional 11/13/2002, concerning a 62 year old vaccinee who experienced sneezing and malaise 3 hours after receiving Fluvirin on 11/12/2002. On 11/12/2002, the vaccinee experienced sneezing and malaise 3 hours after receiving Fluvirin. The reporter indicated that the vaccinee started sneezing similar to symptoms of an allergic reaction 2 hours after receiving the vaccine. Furthermore, the vaccinee developed a general feeling of malaise that accompanied the sneezing. On 11/13/2002, 24 hours after the onset of the event, the sneezing and malaise spontaneously resolved without treatment. The reporter has assessed the relationship of the vaccine to the event as possible.
Fever, chills, headache, backache, and fatigue that began 14 hours after injection and lasted 24 hours
TIA symptoms - difficulty speaking, reports leaning towards the left side and was dizzy for about 10min.
About 10 days later, I noticed I couldn't taste well. Then, I could only smell if it put it up to my nose. I was also experiencing postnasal drip, nasal congestion and a coated tongue. I went to get checked for COVID, but it was negative. My symptoms lasted for about a month and gradually went away.
Upon vaccination on 6/17/21 had a high heart rate, dizziness, sensory issues with sound and sight, fatigue, chest pains, and general feeling of being unwell. Appeared to recover on days 6/18 and 6/19. Went to work on 6/20 and was very fatigued, confused, felt like I was having a heart attack. Over the few days week back to the hosptial and was concerned about possible blood clots. Could not walk without severe fatigue and pain for more than a block. Felt very sick. My symptoms from 6/20 - 5/31/22 were constantly changing and debilatating. I was forced to reduce my hours at work and took most of my sick days during this time 50 sick days were used. I had terrible insomnia, fatigue, muscle pain, tennitius, neuropathy and feelings of my hand and feet itching & burning.  Severe brain fog to the point I would forget where I was going and what I was doing constantly. At times I felt like my entire body was underwater. Nausea and diagestive issues. Started to have more and more food allergies and could only eat certain things.  I lost around 10 pounds was extremely weak and tired no matter how much rest I recieved.
Pt vaccinated at 3:09 PM on 2/12/19; No S/Sxs until she woke up 2/13/19 at about 9:00 AM. She described her right arm as being sore, hot, swollen and hard. These symptoms were not at the deltoid muscle, but rather lower on the upper arm below the deltoid muscle and above the elbow. Pt showed me her arm on 2/14/19 at 5:00 PM; S/Sxs stated above were still present. Pt stated that it was not as bad as first thing in the AM 2/13/19; PCP prescribed AUGMENTIN 875 one q12h x 7d for these symptoms. Med picked up 2/14/19.
09/23/22 presents as transfer for "acute respiratory hypoxia". ""COVID pneumonia, recently diagnosed with HIV and reportedly also positive for CMV and PCP pneumonia" PMHx of "IVDU (last used approximately 20 years ago) and a recent COVID pneumonia"
Information has been received from a physician concerning an 8 month old patient who received 3 doses, on schedule, of RotaTeq vaccine. It was reported that after completion of the vaccination series the patient developed severe rotavirus lasting for 2 weeks and has recovered. A product quality complaint was not reported. No further information was available. Additional information has been requested.
Extreme vomiting starting at 4:30am following the vaccination, extreme nausea and fever in excess of 102 degrees and up to 104.5 degrees lasting for over 24 hours even while taking Tylenol every 6 hours in an effort to try to. control it. Also experienced extreme diarrhea for 24-36 hours after vaccination with not as extreme diarrhea lasting for two to three days.
96 hours post injection muscle and joint pain.  Injection site pain for 96 hours post injection.  4 days of insomnia.
Sore swollen right arm pit; Sore swollen right arm pit; Dose received: 3; This is a spontaneous report from a non-contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 14Jan2022 (Lot number: FJ5683) at the age of 49 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Breast cancer" (unspecified if ongoing) and "Blood pressure high" (unspecified if ongoing), notes: High blood pressure. Concomitant medications included: LISINOPRIL; ANASTROZOLE; CALCIUM, CLARITON and VITAMIN D3. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: ELA262; Anatomical site: Right arm; Route of administration: Unspecified), administration date: 09Feb2021, when the patient was 48 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: ENG199; Anatomical site: Right arm; Route of administration: Unspecified), administration date: 04Mar2021, when the patient was 48 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 14Jan2022, outcome "unknown", described as "Dose received: 3"; AXILLARY PAIN (non-serious) with onset 16Jan2022, outcome "not recovered", described as "Sore swollen right arm pit"; SWELLING (non-serious) with onset 16Jan2022, outcome "not recovered", described as "Sore swollen right arm pit". Therapeutic measures were not taken as a result of axillary pain and swelling.  Additional information: The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN (experienced pain), PRURITUS (Itchiness) and URTICARIA (Hives) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026BNA) for COVID-19 vaccination. No Medical History information was reported. On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced PAIN (experienced pain), PRURITUS (Itchiness) and URTICARIA (Hives). At the time of the report, PAIN (experienced pain), PRURITUS (Itchiness) and URTICARIA (Hives) outcome was unknown. Not Provided. 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.
Symptoms started around 3-4 hours after vaccine, dizziness with mild vertigo. Led to vomiting due to severe vertigo whenever he moved. Proceeded to vomit uncontrollably for about 12 hours afterwards, tried meclizine and Pepcid to help with no real relief.  Vomiting stopped after that, but still had profound dizziness leading to inability to get up, walk in a straight line or drive. This continued for several days, he went to MD on 9/7 and they did a physical exam and determined that the vertigo was vestibular neuritis due to the immune response he had to the vaccine. Started Medrol dose pak and Valium 2mg on 9/7, feeling minimally better but still unable to move much or drive.
Period started on the 16th. After that my next period was very early. It started 15 days after. The next was 12 days after. Then 16 days. Then 18 days. Then 16 days. The decreased length of time between periods is continuing. Periods at first were much heavier than usual for about 4 cycles. They then became shorter (i used to bleed for 7 days, i now bleed for 4). These things were all very irregular. My period used to be very predictable and consistent.
Patient states developed itching to scalp, then noticed a hive on left side of face.  No shortness of breath, no chest pain, no throat swelling, no difficulty swallowing.  Treated with Benadryl 25mg PO x1 with relief of symptoms.
Noticed that arm where injection was given was itchy & hurt & that's when she noticed a red rash. Went to school nurse & was given an ice pack. Area hot to touch & swollen, so I gave Benadryl @ 4:00 PM & continued ice packs. Painful so gave Tylenol before bed. Then woke up 4/2/11 with a "bullseye" rash, swelling & hard underneath, & still hot to touch. Took to dr's office & was started on Keflex for cellulitis.
Headache severe x2 days Brain fog x 2 days Night sweats night 1  Weak/tired x2 days
10/17/2000 parent called stating Left arm upper red and swollen. Child had no fever, reviewed possible reactions and treatment use of acetaminophen. On 10/18/2000 I called to F/U. Parent not home. Grandparent stated arm still swollen but now down to wrist. Child able to play. Asked if they could bring child not able to do so but will.
Patient stiffened right leg: wouldn't move it for several hours after shot.  Temperature to 102.2, screamed inconsolable most of the night.
FEVER AND CHILLS, ADMITTED TO HOSPITAL ON 19 JUNE 2013 WITH FEVER OF 104.8.
pt recv vax 27FEB97 18 to 20hr later pt devel inc pain & swelling @ site area & numbness from site inc to fingers-up under arm & extending to below lt ear;
Patient states he arm  hurt the evening the vaccine was given and over 1 month later no relief, No redness or swelling, just sore to the touch. Finds relief with NSAIDs
I received the vaccine in my left arm around 11:00 am on June 30, 2021. Tingling/Numbness started in my right arm at approximately 2:00 am July 1, 2021. The tingling/numbness remained in the right arm and traveled into my right leg at approximatey 3:00 pm. Around 12:00 am the tingling and numbness were still in my right arm and leg, and now traveling up my left leg. By 8:00 am the tingling and numbness had subsided.
I suffered a stroke on the 22nd of January 2022. I was hospitalized in high care.
Case number PHEH2015US003154, is an initial spontaneous report from a nurse received on 10 Feb 2015. This report refers to an 11  year old patient of an unknown gender. The patient was vaccinated with MENVEO (batch number: M14071, expiry date: Nov 2015) intramuscularly on 19 Jan 2015. It was reported that the vaccine was frozen with excursion at 0.4 Celsius for 1 hour 16 minutes on 14 Jan 2015, 0.8 C for 36 minutes on 24 Jan 2015 and 0.6 C for 35 minutes on 31 Jan 2015. No adverse event reported following this medication error (incorrect storage of drug).
Information has been received from a physician concerning a 14 year old female who on an unspecified date was vaccinated with a first dose of Gardasil IM. Subsequently, the patient experienced a latent seizure after receiving the first dose of the vaccine. The outcome of the seizure was not reported. Upon internal review, seizure was considered to be an Other Important Medical Event. Additional information has been requested.
Patient 4 hours after vaccines, pt became shaky and felt heart beating rapidly, went to urgent care and blood pressure 250/100 something (doesn't remember bottom number) and Drs couldn't find any reason that it was high, it came down on its own after about an hour without any treatment. No cause was found.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 28-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (Hypertension at start). Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 15-Oct-2020 and the estimated date of delivery was 22-Jul-2021. On 06-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy.  On 03-Apr-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Nov-2020, Pregnancy test: positive (Positive) positive. On an unknown date, Genetic polymorphism: normal (normal) genetic test is normal.. On an unknown date, Ultrasound abdomen: normal (normal) Ultrasoundx2 normal..         Concomitant medication also included pre natal vitamins. Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Reporter contact details were updated, patient demographic detail was added, dose 1 details were updated, dose two details were added.
NUMBNESS; PINS AND NEEDLES IN ARMS; HANDS FEEL PARALYSIS; NECK PAIN; HANDS NOT WORKING WELL/HARD TO GRIP STUFF/HARD TO MAKE A FIST; CAN NOT MOVE FOREARM AND BICEPS WELL/ARM SEIZED UP; ARM PAIN/HANDS ARM HURTING/SORE FOREARM; This spontaneous report received from a patient concerned a 34 year old male with unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was healthy individual. The patient used to work 12 hours a day, would never experience this arm pain before and never had this experience before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 13-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  After eight days of the vaccine (21-DEC-2021) hands and arm of the patient was hurting a lot, patient could not move forearm well and biceps also. Forearm of the patient was super sore right now. It was pretty bad. The patient felt hands paralysis, experienced neck pain, hands not working well, hard to grip stuff, hard to make a fist. On 03-JAN-2022 patient went to primary care physician get a magnetic resonance imaging (result was not reported). On an unspecified date patient experienced numbness, pins and needles in arms and got a professional massage to get pain reduced but that did not help either. On an unspecified date patient visited to emergency room. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the neck pain, hands feel paralysis, arm pain/hands arm hurting/sore forearm, hands not working well/hard to grip stuff/hard to make a fist., can not move forearm and biceps well/arm seized up, numbness and pins and needles in arms was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220123924-COVID-19 VACCINE AD26.COV2.S-hands feel paralysis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
After covid vaccine, allergic reaction, tightness in chest wheezing; After covid vaccine, allergic reaction, tightness in chest wheezing; After covid vaccine, allergic reaction, tightness in chest wheezing; This is a spontaneous report from a contactable Pharmacist (patient) via Pfizer sales representative. A female patient of an unspecified age received BNT162B2 (Covid-19 vaccine), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took flu vaccine for Immunization and experienced this type of reaction, allergic reaction, tightness in chest wheezing. The patient also experienced allergic reaction, tightness in chest wheezing after COVID vaccine, and went to emergency room. Outcome of the events was not reported.  Information on the lot/batch number has been requested.