chrisvoncsefalvay/vaers-outcomes huggingface dataset:
red puffy itchy rash, at injection site, spreading onto the back and down the arm.  initial rash stared 5 days after injection and continually spreading  since.  -Diphenhydramine HCI 25mg 2 tablets every 6 hour to help with itching and swelling.
Swelling, redness, hardness, and itching at injection site. Headache, fatigue. S/sx have persisted for a 10 days thus far.
Large urticaria over back, abdomen, and face.  Covering >70% of trunk, began two days after vaccination (<48 hours)
After both shots had issues with eyes focusing; Intermittent dizziness; This is a spontaneous report from a contactable nurse, the patient. A 45-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 13Aug2021 at 11:00 (at the age of 45-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3F83) via an unspecified route of administration in the left arm on 14Sep2021 at 11:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis (MS) and attention deficit disorder (ADD). 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 vaccination. Concomitant medications included natalizumab (TYSABRI), methylphenidate hydrochloride (CONCERTA), vitamin d nos (VITAMIN D), levocetirizine dihydrochloride (XYZAL) and fluticasone propionate (FLONASE); all taken for unknown indications from unknown dates and unknown if ongoing.  On an unknown date in 2021, after both the shots, the patient had issues with her eyes focusing and intermittent dizziness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the events after both shots had issues with eyes focusing and intermittent dizziness was not resolved at the time of the report.
At 9:30 that evening I started throwing up, terrible chills I couldn?t get warm even under my electric blanket and featherbed, my muscles were spasming, my joints hurt like never before with stabbing pains,  the headache was worse than the worst migraine I ever had, it hurts to open my eyelids even in the dark , I literally thought I was dying from the 2nd shot.
This spontaneous report was received from a medical assistant referring to a 29 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 17-MAY-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB with lot # reported as M046376 and expiration date 04-NOV-2018 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved. This is one of several reports received from the same reporter. Lot number M046376 is an invalid lot number for hepatitis b vaccine (recombinant). Follow up information was received on 18-SEP-2017 from the medical assistant, concerning RECOMBIVAX HB with lot # reported as M046376. On 11-MAY-2017 at 12:24, the time in the range 32°Fahrenheit (°F) to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On the same day at 21:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 8. On 12-MAY-2017 at 03:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 5. On 13-MAY-2017 at 05:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 26. On 14-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 2 hours from 16:24 to 18:24, number of cycles 21. On the same day at 20:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On 15-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 3 hours from 01:24 to 04:24, number of cycles 4. On the same day at 12:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 7. It has been determined that case # 1710USA009239 was created with the wrong Aware date as 02-OCT-2017 which is previous of the correct Aware date 18-SEP-2017. Therefore, case # 1710USA009239 is being deleted from our files and the case is consolidated into case # 1711USA004090 with the correct Aware Date 18-SEP-2017.; Sender's Comments:  US-009507513-1708USA011654:
Shingles 5/12/2021 noted burning sensation on lower right back.  5/13/2021 small blister formed on lower right back at site of burning sensation.  5/13/2021 sought medical care.  Diagnosed with shingles and prescribed Valacyclovir (Valtrex).  Shingles progressed and cleared in appox. 2 weeks.
Arm soreness; This is a spontaneous report received from a Pfizer-sponsored program . A non-contactable female consumer reported for herself that she received first dose of BNT162B2(BNT162B2,Pfizer COVID-19 vaccine,formulation solution for injection,Lot number/Expiration date:unknown) via an unspecified route of administration on unspecified date and time as a single dose for COVID-19 vaccination. Patient medical history and concomitant medications were not reported. On unspecified date, the patient experienced Arm soreness after taking the 1st dose of the Covid-19 vaccine. The outcome of the event was unknown.  No follow-up attempts are possible, Information about batch/lot number cannot be obtained. No further information is expected.
Information has been received from a medical assistant concerning an 11 month old patient who on 30-AUG-2010 receive the third 2ml dose of ROTATEQ, oral. It was unspecified if the patient sought medical attention. No adverse effect was reported. Additional information has been requested.
This study case was received from the investigator in a trial on 06 June 2011. A 20 year-old male subject with no significant medical history was found to have an unspecified disease of the pericardium and a non-specific myocarditis 27 and 19 days respectively after he had received an injection of ACAM2000 (lot number, route and site of administration not reported), ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) and Japanese Encephalitis-IM (manufacturer, lot number, route and site of administration not reported) on 27 January 2011. Relevant laboratory data included: an abnormal Troponin I result with the highest recorded value of 01.54, a normal Echocardiogram and the ECG result was not available. Treatment were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Took vaccine 1/20/2010 at 12:00 (noon). Severe lower (lumbar/sacral) back pain started 1/21/2010 at 8:00 AM. Barely able to walk to bathroom and living room. Used cane for stability. Used heating pad. Able to walk better 1/25/2010. Took EXCEDRIN PM at HS. Was able to walk fairly pain free for first time 2/3/2010.
The day after the vaccine I got a rash on my rib cage. Over the next two days it spread to my whole back from my wait to neck to my head. It also spread to my belly and down my arms and then down my legs. It was very itchy and slightly raised. I treated it with over-the-counter anti-itch cream. I went to the doctor yesterday; I saw the PA. The only change in my life has been the vaccine. She concluded it could be from the vaccine. She prescribed prednisone 6-day treatment. She also mentioned to do an AVENO anti-itch cream. I am still itching but it seems to be getting better. I have not stopped doing my daily activities. I have been taking cool showers to help.
This report, as received from a physician via a field representative, regards an unspecified number of patients (no demographic details were provided). No medical history was reported. It was reported that a healthcare clinic stored PROQUAD (Merck) for three weeks in the refrigerator instead of in the freezer. An unspecified number of anonymous patients may have received the improperly stored PROQUAD (Merck), but whether any patients received it was not confirmed. No further information was provided. Additional information has been requested.
Administered vaccine, bled slightly, wiped with alcohol-small, marble sized hematoma formed immediately before applying band aid. Placed ice pack immediately, patients.
Narrative: COVID infection following COVID vaccine series 02/19, Pfizer, dose #1 03/12, Pfizer, dose #2 10/01, Pfizer, dose #3 08/16 pt cc: cough, headache, rhinorrhea, sore throat, exposure: daughter 08/ 20 COVID swab, result: detected
Flare-ups of eczema; This is a spontaneous report based on the information received by Pfizer from another company. A contactable pharmacist reported for patient. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and Expiry date was not reported) dose 2 via an unspecified route of administration on an unspecified date in Apr2021, as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient took previously BNT162B2, Dose 1, (Lot number and Expiry date was not reported) for COVID-19 Immunization. 2nd dose was about 3-4 weeks ago, on an unspecified date in 2021 patient has been having some flare-ups of eczema over past few weeks. However, he was working in a construction site in hot, sunny and dirty conditions. Pharmacist advised that they had a handful of patients report that 1-2 months after their 2nd dose of COVID Vaccines, their symptoms have flared up like the medication was no longer working (eczema, hives). In theory, the vaccines ramp up the immune system to build up protection against COVID. However, these COVID Vaccines seem to be pretty responsive which may be causing the immune system to really ramp up and causing flare-ups of the symptoms we are trying control with the meds. In theory, if this is what is happening, once the immune system calms back down, the med should be able to control the symptoms again. In general, for vaccines, the immune system is responsive for about 2-4 weeks. However, it seems like it may be longer for the COVID Vaccines. Pharmacist has had a couple patients report this to them about 1-4 months after the 2nd round of vaccine. So, if symptoms do not improve about 2 months after 2nd dose, follow up with md to see what he/she thinks. The outcome of the event was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
NO ADVERSE EVENT.  DOSE OF MODERNA WAS GIVEN.  WHEN VACCINE WAS ENTERED INTO MN IMMUNIZATION DATABASE, IT SHOWED PATIENT HAD RECEIVED THE 2 DOSE MODERNA SERIES FEB, MARCH 2021.  DOSE GIVEN 5/7/21 WOULD BE 3RD DOSE IN SERIES.
Primary bacteremia, complications resulted in heart failure. (Note: Patient was on 60 mg prednisone every other day for kidney problems.)
Approximately 2-3 days after first vaccination I had started to have frequent urination, uncontrollable thirst, headaches, trouble sleeping. Before second vaccination on 21 January 2003,I had notified Chief at Clinic that I was having these symptoms, and I had asked him if the anthrax vaccine could possibly cause these symptoms. He stated no, but it sounded like I may have diabetes. He suggested I make an appointment to be seen. After the second vaccination I started to have blurred vision,and noticed considerable weight loss within the past two weeks. The first vaccination was on the 6th of January,and the second on the 21st of January. I was seen on the 23rd of January by Maj. He notified me that my Blood Glucose Level was considerably high, and I needed to be sent to a hospital right away. I was then driven by my squad leader to hospital where I was taken to the emergency room for evaluation and treatment. I was then admitted to the hospital from the 23rd of January until the 27th of January. I met with numerous doctors,and diabetic educationers. I was released with a P3 profile,and instructed to come back to see my doctor Dr. approximately two weeks later. Currently I am on Gluboride, Pioglitizone, metphormine, lisinopril, and NPH(Insulin).
J&J vaccinated @1030 today. HA, chills, fever and bodyache started @1600. Took tylenol 325mg po x4. Denies difficult breathing, chest pain or cough. History:  pt here for fever of 104F at home since 1600.  Had J&J COVID vaccine in the morning today.  Has body ache, headache, light sensitivity, slight nausea.  Denies any symptoms before vaccine and denies vomit/diarrhea, rash, cough, runny nose, ear pain, recent illness/injury, recent sick contact, recent procedure, prior co-morbidities.  Took 4 tylenol pills at around 1830.  Ibuprofen or NSAIDs make pt's throat swell up.
felt painful, hot, and burning like a spider bite; felt painful, hot, and burning like a spider bite; Pain in right side of back, shoulder blade; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04May2021 10:40 (Lot number: EW0161, Expiration Date: 31Jul2021) at the age of 77 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hives" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious) with onset 15May2021, outcome "recovering", described as "Pain in right side of back, shoulder blade"; FEELING HOT (non-serious), SKIN BURNING SENSATION (non-serious), outcome "unknown" and all described as "felt painful, hot, and burning like a spider bite".  Additional information: Caller states that on 15May2021 he was working in his yard and had a terrible pain pop up in the right side of his back, shoulder blade. States he thought he  had been bitted by a spider because it felt painful, hot, and burning like a spider bite. Caller states he went inside and had his wife look at the area and there was nothing there; it was perfectly normal looking. States that it has continued to hurt. The pain comes and goes but it is in the exact same area. States he feels it to some degree all the time, like if it was a muscle  problem. Says he doesn't know if this is something that has been experienced with the Covid Vaccine.Caller denies any medications, medical conditions, labs, testing, or treatments relevant to these events. Caller states that he actually does not take any medications.many years ago when he was in the Air Force they received multiple vaccines in each arm, each day. He states the vaccines were administered with an air gun that cut him.  No follow-up attempts are possible. No further information is expected.
sore arm; nausea; slight fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), NAUSEA (nausea) and PYREXIA (slight fever) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis and Dry eye syndrome.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (sore arm), NAUSEA (nausea) and PYREXIA (slight fever). In February 2021, PAIN IN EXTREMITY (sore arm), NAUSEA (nausea) and PYREXIA (slight fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.
06/16/2022 in the middle of the night it started off with cold symptoms, headache, stuffy and runny nose. On 6/17/2022 I got worse with headache, vomiting, diarrhea for a couple of days, low energy and no appetite. I tested positive for COVID. I called my physician and started PAXLOVID. I got better every few hours. I had my first negative test on 6/23/2022. On 6/27/2022 I began having symptoms again. I took another COVID test, and it was positive. I tested negative on July 1,2022 and July 3, 2022. Today, my cough is mostly gone, my runny nose is gone, but I continue to get fatigued easily.
PT RECEIVED MENACTRA ON 8/12/08. SEEN IN CLINIC ON 8/13/08 C/O SEVERE HA 8/12/08 AT NIGHT, TIRED, CHILLS, NECK PAIN. MD EVALUATED, NOTED POSITIVE NECK SPASM, BUT NO RIGIDITY, NORMAL GAIT, NO FOCAL NEURO SIGNS. RXED SUPPORTIVE CARE FOR NECK SPASM-ICE/HEAT PACKS AND MOTRIN PRN, TO RETURN TO CLINIC FOR WORSENING SYMPTOMS.
Patient was Covid +  on 10/29/2021. Patient received Moderna with 1st dose on 01/13/2021 and 2nd dose 02/10/2021. Patient was on inpatient unit at time of testing positive. Patient was admitted to unit on 08/07/2021 Per IM Progress Note: Assessment/Plan  - Acute COVID-19 upper respiratory infection - Bipolar mixed disorder, with initial severe psychosis  - Borderline personality  - Cognitive impairment  - Tobacco use/dependence   ?Patient attests that she was vaccinated with both vaccinations in the outpatient setting, she is minimally symptomatic, would maintain isolation protocol in patient's room, could consider quarantining appropriate patients together for company/someone to talk to as doors should remain closed while there are COVID negative patients on the unit ?Symptomatic care alone as patient is without any signs of respiratory failure ?Periodically check O2 sats at least 3 times daily at the beginning and end of day team and prior to sleeping hours ?Observe off IV steroids not indicated at this point time given minimal symptoms, no need for remdesivir or Actemra ?Could consider periodically checking inflammatory markers, though at this time they do not seem of benefit ?Add DVT prophylaxis given the fact that patient is confined to one room only ?Continue supportive care, MVI, zinc, vit c, melatonin  Subjective  Patient seen and examined, in follow-up for recent COVID-19 test positive.  Complaining of upper respiratory symptoms with cough nasal discharge, otherwise has no complaints, when she wants to get up and walk outside of her room.  She denies any fevers, chills, chest pain, shortness of breath, nausea, vomiting, diarrhea.  She is tolerating p.o. intake.
This spontaneous report was received from a nurse refers to a patient of unknown gender and age. Information regarding patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unspecified date in March 2016 (reported as about a week ago), the patient was inadvertently vaccinated with an expired dose of VARIVAX (lot # K002928, expiry date: 26-FEB-2016) (expired product administered). No adverse effects were reported. Additional information has been requested.
Sudden hair loss(telogen effluvium): beginning 2-3 days after 2nd dose of vaccine, continuing to current date (11/24/21)
Patient- Has a mast cell disorder and can react sometimes to meds etc. At the end of 30 minutes, the patient started to get a raised red bump on leg. The Patient took 50 mg diphenhydramine and headed to Dr Office.  Physician was waiting, as patient had prearranged.
Pt received vaccine on 2-9, 2-10 started with pain & swelling at site, fever & chills, weakness. Pt in office 2-11-11, PCP evaluated, saw redness at site, edema, warmth to touch. Pt prescribed antibiotic.
The evening of vaccination at 9:30 I started having chills and shaking, I started throwing up really bad, I was in bed for like 31 hours and have had diarrhea.
Patient was told to wait for 30 minutes due to history of anaphylaxis. After sitting for several minutes patient developed tightness in her throat. Was given 50mg diphenhydramine PO. Patient was still having tightness in throat and was given 50mg diphenhydramine IM in her left arm. Within several minutes of IM admin, patients symptoms began to resolve. Patient was stable and left in the care of several nurses at the facility.
myalgias, sharp left sided chest pain, shortness of breath.  Chest pain is worse with deep breathing.  Patient is treated with normal saline fluids.
sore neck, fatigue, arm cellulitis at injection site,  headache. Tylenol taken
Inconsolable crying X 48 hrs after shots. Tried Tylenol and behavior interventions without success. Resolved spontaneously.
3mL 23Gx1 inch syringes used to administer Moderna COVID-19 vaccine treatment under Emergency Use Authorization(EUA): I would like to make two product complaints about these syringes. 1. We have consistently only been able to withdraw 9 doses from the Moderna COVID-19 vial when using these syringes. This device appears to have a very large "dead space" as the safety shield is a separate piece which is leur-locked between the syringe and the needle. This large space is likely the cause of the lost vaccine liquid. 2. We had an incident today where the vaccinator injected Moderna COVID-vaccine into the above patient. Upon withdrawing the syringe from the patient's arm, the syringe and safety shield disconnected from the needle and the needle and needle hub remained in the patient's arm, requiring the vaccinator to use his hand to withdraw the needle. The patient did not notice the device malfunction. The removed needle was examined to be intact and was discarded into the sharps container. Patient tolerated the vaccination without other incident. There was no harm to the patient. Syringe REF # 4236, Lot # 4014236, manufacture date 2020-09-23, ex 2025-09-23, GTIN 20351688048827
11/23/22 Reports she presented to occupational health for the varicella and Hep B vaccinations  After, she developed hives x 2 days Felt her throat and tongue swelling for a couple of hours after the incident/ subsided with a couple of doses of Benadryl 75 mg  Had a large red area on her arm where she received the vaccine, this has since decreased in size but is still present
This spontaneous report was received from a pharmacist refers to a "few" unspecified patients of unknown age and genders. The patient's concurrent conditions and medical history were not provided. On unspecified dates, the patients were vaccinated with an unspecified dose of ZOSTAVAX, injection, (dose, route of administration, anatomical location, lot number and expiration date were not reported). There were not concomitant medications provided. On unspecified dates, the patients developed injection site erythema reported as redness at the injection site. The outcome of injection site erythema was not reported. The reporter did not assess the relatedness of injection site erythema with ZOSTAVAX. This is one of several reports received from the same reporter. Additional information has been requested.
Developed a red, bumpy, itchy, rash within hours after receiving inactive H1N1 flu vaccine. The following day it covered most of the client's body. The rash completely resolved on the 4th day after vaccination. The client was given Benadryl by parent.
Noticeable increase in menstrual cycle- bleeding increased 6-7 hours post injection, and was accompanied by very large clots. (Not normal )  This lasted two days.  Intense chills/shivering. Night sweats, nausea.  This was the night of the injection.  Headache. Everyday since  injection.  Throbbing in left temple.   Muscular pain, left deltoid. This has increased since day of injection.   Redness, swelling, pain  at injection site that has intensified since injection. (No other indicators of it being an infection. Not warm to touch, no oozing or bleeding or any type of fluid.)   Left  forearm  muscle pain, left wrist pain- almost like a dull ache going down arm.
On 4/24/09, Pt came in for #2 GARDASIL. Pt had no adverse reaction to #1 dose. Pt had a vasovagal episode immediately after vaccine given. Pt had appropriate recovery time after event.