chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a 59 year adult female patient. The patient's pertinent medical history included bronchopneumonia. The pharmacist stated that patient had unspecified reaction to unspecified Non-steroidal anti-inflammatory  drugs on unspecified date. On 09-JUN-2015 the patient was vaccinated with PNEUMOVAX23 lot # K009874, expiration date 19-MAR-2016, 0.5 ml once, intramuscularly. Concomitant therapies included clonazepam, fluconazole, acetaminophen, PERCOCET, prednisone, FLOMAX, ZOFRAN, ZOLOFT, gabapentin, SOMA, budesonide, SYMBICORT and LEVAQUIN. On 10-JUN-2015, the patient experienced nausea, vomiting, diarrhea, fever and injection site soreness. The pharmacist reported that the patient took TYLENOL for the fever and KAOPECTATE for diarrhea. The outcome of the events reported was not recovered/not resolved. The patient sought medical attention by calling pharmacy. No product quality complaint was involved. Additional information has been requested.
Headache, Myalgia & Arthralgia Narrative: 1/20/2021: Injection site: pain-discomfort General symptoms: chills, headache, myalgia, fatigue Symptoms experienced 1/21/2021: Injection site: pain-discomfort (much less than 1/20) General symptoms: headache, fatigue
testing positive for COVID on nasal swab after first dose of COVID vaccine; testing positive for COVID on nasal swab after first dose of COVID vaccine; This is a spontaneous report from a non-contactable pharmacist. A patient of unspecified age and gender received 1st dose of BNT162B2 (reported as COVID 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 experienced testing positive for Covid on nasal swab after first dose of Covid vaccine on an unspecified date with outcome of unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.  Pfizer is a marketing authorization holder of COVID vaccine in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of COVID vaccine has submitted the same report to the regulatory authorities.; Sender's Comments: The reported testing positive for Covid on nasal swab after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.
PATIENT GOT LIGHT HEADED WHILE SITTING THEN FAINTED.  PHARMACIST WAS ABLE TO HELP PATIENT TO FLOOR SO SHE DID NOT FALL.  PATIENT CAME BACK TO IN A FEW SECONDS, WE APPLIED A COOL RAG TO HEAD AND SHE DRANK WATER.  PARAMEDICS CAME AND TOOK BLOOD PRESSURE WHICH WAS LOW.  SHE STAYED UNTIL BLOOD PRESSURE RETURNED TO NORMAL AND HER BOYFRIEND CAME AND DROVE HER HOME
pain in my heart; almost died/almost killed him/her; face turned pale red; loss a lot of weight; heart almost died; right arm still swelled up; lost my breath; it raised my blood pressure; it made me sick; arm feel sore; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunization. Medical history included high blood pressure, high diabetes, and high cholesterol. The patient's concomitant medications were not reported. The patient reported that he/she received the Pfizer shot in (place) on unspecified date. When the patient went back home, his/her face turned pale red and almost died. The patient also experienced loss a lot of weight, heart almost died, and right arm still swelled up on unspecified date. The patient confirmed that he/she didn't receive the booster shot yet as this one almost killed him/her. The patient further stated, "No I almost died, I just can't, I lost my breath, my face was pale red, it raised my blood pressure, and it made me sick. I had pain in my heart, and my arm feel sore". Outcome of the events was unknown.  Information on the lot/batch number has been requested.
COVID-19 Lot# FE3590 Vial PAA165969 Exp 2/22 was placed in the freezer after we received it. it should have been pulled out of the freezer on 10/19/21 at 12:00PM according to the storage guidelines and placed in the refrigerator for 31 days.  Our staff did not pull the vial out of the freezer on this date. The staff noticed the date this morning, November 2, 2021 at 0830.  There were 22 patients who received the COVID vaccination during this time frame. The vials were pulled out of the freezer, thawed, and diluted per instructions during 10/19/21 through November 1, 2021. There are 27 vials that were not used and have been set aside to waste.
Patient felt nauseated after receiving vaccine. Took patient to EMS room for observation during 30 minute wait.
Started out with eyelid not opening all the way and that went away. It started on the right eye and then stayed in the right. Within the last month I am experiencing double vision and shortness of breath. Diagnosed with MG and taking Prednisone.
Achy stiff finger joints (DIP and PIP), feels like arthritis... right hand greater than left. Palm of right hand is tender to palpation. Symptoms started with AM finger joint stiffness a few weeks ago, then progressed and were the worst yesterday 3/3/21 (so 3/3/21 is listed as the start date of symptoms).
I21.4 ACUTE NON ST ELEVATION MI 4/20/2023 HTN (HYPERTENSION) I21.4 ACUTE NON ST ELEVATION MI 4/20/2023 HTN (HYPERTENSION)
A few minutes after the vaccine the patient was feeling weak and her legs "felt funny". Then all her muscles locked up and her head was cocked to the side, eyes were closed, and breathing was shallow. I administered an EpiPen 0.3mg in her thigh while the technician called 911. She was instantly responsive, breathing was normal, and muscles were no longer rigid. She felt weak and nauseous. The EMTs arrived and checked her vitals and for signs of allergic reaction. They saw no rash, swelling, or hives, so they think it was a vagal response. They took her to the hospital for a further check. The father was here and followed her to the hospital. The mother works at the primary care doctor's office and was meeting them
Pfizer-BioNTech COVID-19 Vaccine EUA- Patient received Moderna COVID-19 Vaccine on 1/29/2021. Patient received Pfizer-BioNTech Covid-19 Vaccine on 2/27/2021
Large local reaction left posterior arm, no systemic symptoms. Significant discomfort; indurated, erythematous, warm from shoulder down to almost elbow.   Started Prednisone course PO.
Body aches around 8PM, by 2AM chills fever of 100.5. The next day around 4pm laid down to take a nap woke with a huge lump under my left armpit. Very painful and achy. I have taken ADVIL to help with the swelling and pain. 5 days after shot the lump has gone down but still there. I have also had a lot of chest pain and discomfort with a lot of heart burn.
General soreness and 102-degree fever the following day.  The unexpected event following the injection occurred on 10/25/23 following the 10/22/23 injection.  This was a 10-15-minute manifestation of kaleidoscopic effect and lights at the right periphery of my vision in my right eye, which was diagnosed as an ocular migraine.
unspecified route of administration in the arm left on 29Mar2021 (at the age of 51-year-old), as a single dose for COVID-19 immunisation. Medical history included lupus pernio, hemolytic anemia and autoimmune disorder. Concomitant medications included azathioprine (IMURAN), belimumab (BENLYSTA) and hydroxychloroquine phosphate (PLAQUENIL) on an unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENL202), via an unspecified route of administration in the arm left on 08Mar2021 (at the age of 51-year-old) at 14:00, as a single dose for COVID-19 immunisation. The past drug history included erythromycin and cellcept and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 06:00, the patient experienced entire body - intense itching after, rash left arm, vaccine was injected was swollen, red and was hot. The adverse events had resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the event entire body - intense itching after, rash left arm, vaccine was injected is swollen, red and hot was not recovered.   No follow-up attempts are needed. No further information is expected.
The patient was to get the Moderna Bivalent; instead the Moderna Pediatric age 6-11 was given
Pt presented with shortness of breath, tightness in chest, hypertension, and tachycardia. Vitals presented as BP 181/91 HR 118 SP02 97% when rechecked BP 174/98 HR 106 SP02 100%. Pt transported to ER.
Approx 38min after injection pt c/o feeling lightheaded and that her throat was dry with "a lump."  Rec'd Benadryl 25mg PO at 0754.  Vitals at 0755 160/74, 70, 98% on room air, Vitals at 0800 260/94, 74, 98% on room air.  At 0801 pt c/o having slight difficulty swallowing, denies respiratory complaints.  EMS called.  EMS on scene at 0807.  Pt talking normally with no s/s of distress.  Pt transported to ED with EMS.
1.5 X 2cm red and swollen area at injection site. (per telephone call on 3/12/01)
"Moderna Arm" Swelling and rash developed at injection site area  / Used ice after looking up on internet / Also took generic Benadryl / Some soreness / Faded in 24 hours / Heat seemed to bring it back out the following night
Sore arm since administration 2 months ago. Minimally relieved by NSAIDs/APAP or ice. Bone pain.
RECEIVED IMMU @ 10 A M. ACCORDING TO MOM, APPROX 10 P.M.  BECAME LIMP AND UNRESPONSIVE; ENTIRE BODY TURNED WHITE; TOOOK INFANT TO HOSPITAL; EPISODE LASTED ABOUT 30 MINUTES;THEN SLOWLY RETURNED NORMAL; MOM STATED ER DOCTOR ATTRIBUTED S/S TO IMMUNIZATION.   NO TESTING, LAB, ETC DONE.
Patient presented to clinic on 6/29/12 with swelling and rash to face and neck area. Mom states symptoms began the morning after receiving his vaccines. Mom treated patient with BENADRYL.
Patient had the vaccine on 09/09/14 and stated on 09/12/14 that she developed a rash that looks like measles, and German measles that she had in the past. And she also stated that it was somewhat fading (???) as we were speaking.
Patient developed a bruise from injection site to elbow. Patient's daughter called me to today to inform me about this reaction. She informed me at that time that the patient is on warfarin. Her INR was just checked last week and it was 2.4. I instructed the daughter to have a MD look at the patient's arm to make sure bleeding has stopped. I told her that the bruise should start to clear up on its own but may take some time.
Infection; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (Infection) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.   In January 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In January 2022, the patient experienced INFECTION (Infection). In 2022, INFECTION (Infection) had resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality with Humira for the event INFECTION was not provided. No treatment medication was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Approx. 9-10 days post #2 maderna Vaccine, I broke out in Hives on the back of both upper arms, and entire back,  I work at a dermatology office. One of the Physicians had his M.A. administer a Kenalog inj.- in my Glute. It did not help at all. Was prescribed a cream, triamcinilone, it did not help. I stopped taking ANY and ALL medications and Vitamins as of 2/25/21. It has been over 4 weeks- The hives have now spread to my buttox and down the back of my thighs, The hives are worsening on my back and are moving to the front of my abdomen and on breast. Again my physician gave me a kenalog shot yesterday 3/29/21 5 weeks after the 1st one. I have been on high doses of benadryl and antihistamines. NOTHING is working! I am miserable and now have worry and anxiety.
4/30: "pain radiates down the right arm and shoulder blade x 5 days Pain underneath right shoulder blade  Radiates down right arm  Numbness or tingling  Of right arm and fingers  Patient with decreased strength"  5/2: neck pain x 7 days. Status post fusion surgery in 89 then had right arm and hand issues    Last Sunday 5/2  night pain from verterba arm hand pain with tingle  Similar to prior pain    Was seen in  Urgent care  , referral sent to phys med from  Urgent care  md"  "have been experiencing crippling pain at the c4-c5-c6 range in my neck, the same region that I had a fusion surgery in 1989. The pain is severe, between 9-10 nonstop. This began a few days after receiving my first shot on April 20th.
Nausea,  headache,  weakness, eye pain, nasal discharge, cough
Chills, low fever, achy all over, dizzy, sore at vaccination site, feel nauseated, can't eat. Taking Tylenol; staying in bed or in easy chair. Don't have time for this  --  too much to do.  When will these symptoms go away?
@1219 Pt alerted nurse her throat felt tight while seated. Son translated for patient. No rashes or redness present in the extremities. Alerted NP and EMS for further assessments and assistance.    @1220 NP assessed client and alerted director to call 911. Pt stayed seated. No redness or swelling at injection site or to throat. Reported feeling pressure in chest. Pulse ox placed ? O2 sat 98% pulse 89. EMS in process of obtaining BP ? BP 162/83 pulse of 90.    @1221 Reports feeling heaviness in chest. Pt has eaten and water bottle at hand. Takes medication for cholesterol and HTN with vitamin D supplements. Pt reported that she has not taken meds for a week d/t caring for husband being unwell and forgetting.   @1223 BP 162/84 HR 110. Pt continued seated and reported feeling a little better. Tightness has gotten better. No hx of allergies, no hx of heartburn or GERD, no SOB no dizziness, no pallor, no diaphoresis, denies nausea, denies blurry vision, no faint, no chest pain  @1225 denies tightness or swelling of throat, no closing and able to move and stick tongue out.   @1227 o2 sat 98% BP 162/84 HR 110   @1229 HR 105 BP 155/80 w/ sinus rhythm  @1230 Paramedics arrived. NP endorsed care to paramedic. NP recommended to son that PT visit ER and educated on rebound HTN. Pt refused to be taken to hospital. PT left ambulatory with AMA signed with fire department.
Pt reports via phone: not feeling good the next morning with a temp that runs between 99 and 102 degrees, feeling tired, then at around 2pm feels terrible, have diarrhea, nausea.  Per pt. all of the above symptoms happened the next day after vaccine administered.  The next feeling better but just tired from being sick the day before.
pt recvd vax & w/in 24hrs post vax pt exp numbness on the rt side of face;eye & mouth were sl crooked;sx resolved;
Crying continuously for 1 1/2 hrs. Fever 104(R) tylenol given for fever w/relief.
pt came into the pharmacy today and notified us that she was having pain in her right arm, where the vaccine was given. She said the pain started right after the vaccine administration (on Sunday), and got worse over that day - pt said there was burning and tingling sensation in right arm.  Pt took some anti-inflammatories because the pain was worsening.  As of today, the pain is better, but pt said she still has trouble getting full range of motion in right arm.
Patient had immediate swelling of right arm directly after injection into deltoid. Benadryl given in left deltoid 25mg. Patient observed/vitals taken after 15 minutes. 45 minutes after injection, patient had difficulty breathing. Epi .3ml given SC. Patient continued to be monitored. EMS called. EMS arrived; patient transported to hospital. Follow up - Patient was admitted after presumed heart attack. Released one day later. She was then referred to a cardiologist who did an angiogram of her heart. patient released after procedure and home recovering. She will be back to work in 1 week. Slight memory loss noted as well as weakness. 60 day follow up states pt has recovered. The discharge summary states anaphylactic reaction, chest discomfort, and lab test abnormality. Follow-up with clinet 10/30/03. She has completely recovered from heart attack & anaphylactic symptoms post flu shot 1 year ago. Cardiologist did enzyme test & angiogram post heart attact to verify positively that she had one. Ultrasound test done 1 month post heart was done- She hasn't experienced any cardiac symptoms since. No restricitions on activities - Doctor felt incident was contradicition to future flu vaccination.
Severe dizziness; This is a spontaneous report from a contactable consumer. A 14-year-old female patient (Age at vaccination; 14 Year) received second dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 06Jul2021 at 20:00 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization. Medical history included Tourettes, depression, anxiety and chronic fatigue syndrome all from unknown dates and unknown if ongoing. Concomitant medications included  ibuprofen (IBUPROFEN), duloxetine (DULOXETINE), fluoxetine (FLUOXETINE) and colecalciferol (VIT D [COLECALCIFEROL]) all taken for unspecified indications, start and stop dates were not reported. The patient received first dose of BNT162B2 on 23Jun2021 to right arm at 12pm. The patient experienced severe dizziness on 07Jul2021 18:00 with outcome of not recovered. No treatment was received for the event. Outcome of the event was not recovered.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Menstruated twice in one cycle. Period came one week earlier than supposed to, then continued onto second week it was supposed to occur.
Fever of 102F, headache, welt at injection site, swelling and redness at injection site. Seeking medical treatment at clinic.
I got shingles within 22 hours after vaccination. Doctor confirmed it was shingles the next day. Given an antiviral. Very red rash, left side, same side as vaccination, top of rib cage wrapping all the way around from the middle of my front torso to the middle of my back. Very bright red rash, then developing into itchy scabs after 9 days and weird itching sensation all over the rash like ants crawling under my skin. Low level piercing pain in the rash that makes you cringe.  I'm on day 11 having shingles. Not gone yet still a red rash but the rashes going away and some of the spots have scabbed over but not many. Using an over-the-counter hydrocortisone cream which doesn't seem to help the itching that much.
Woke up on March 24 with markedly increased pain and decreased ROM in operated knee.  Pain level went from previous day, level 1 of 10 during ambulation or PT (no post-op analgesics or antiinflammatory drugs had been taken for several days at that point) to level 7.  In addition, the right (non-operated) knee flared up with persistent pain (pain in that knee previously was only occasional), and arthritic pain in both hands increased.  (I don't normally take analgesics or antiinflammatory drugs for arthritis pain.)  I had also had two days of fatigue following vaccination.  On the day after this increase in pain, I had chills and fever - a low-grade temp of 100 via temporal scanner, on that day only.  PT continued, along with Tylenol and ice for pain.  Elevated pain level persisted for almost three weeks, and didn't begin to decrease at all until about the two-week point - down to a level of about 5.  As of 4/13/21, knee pain and ROM are back to the pre-vaccination post-op level.  Of any note?  After receiving a rubella vaccine twenty years ago - prior to any orthopedic surgeries, but with a history of mild arthritis at that point - I developed hip pain severe enough to require the use of a cane for ?3 weeks or so.  Both hips and one knee were eventually replaced.
pt recvd vax;same day @ 7pm,exp weakness,double vision,palpitations,P=47,BP =173/90 x 30 mins;2 days later exp palpitations & P=40 x 10-15 mins; not subsided;
Within a few minutes of receiving FLUMIST in clinic, patient experienced vomiting and a provoked seizure. Patient was evaluated by a physician afterward. No other treatment of follow-up was needed.
No adverse event; An HCP is reporting an AE on behalf of a patient. The HCP reports that the patient was administered a dose of PNEUMOVAX 23 after it expired. No additional AE details were provided and no additional AE's were reported. No PQC.; This spontaneous report has been received from pharmacist and refers to an identified patient of unknown age and gender.  Information regarding the patient's medical history, concurrent conditions, concomitant therapies, and past drug allergies or drug reactions were not provided.  On 18-JAN-2023, the patient was vaccinated with an expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) syringe injection, 0.5 milliliter (mL) (lot #U018309 confirmed to be valid, expiration date reported and stablished as 08-JAN-2023) administered intramuscularly for prophylaxis (strength was not provided) (expired product administered). No additional adverse event (no adverse event).
This case was reported by a physician via sales rep and described the occurrence of injection site swelling in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site swelling, injection site pain and fever. On an unknown date, the outcome of the injection site swelling, injection site pain and fever were recovered/resolved. It was unknown if the reporter considered the injection site swelling, injection site pain and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced fever, swelling at injection site and general soreness at injection site for 4 to 5 days. The reporter did not agree to follow up from GlaxoSmithKline.