chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 78 y.o. male with past medical history of uncontrolled diabetes, hypertension and stage IV chronic kidney disease, who presents to the Emergency Department with chief complaint of as mentioned above.  The patient apparently has some cognitive impairment and is not a very good historian.  Thankfully, the patient's primary care physician, Dr, graciously called me prior to admission and sent some records and explained to me this patient has a history of hospital delirium in the past.  Reportedly the patient has been increasingly confused over the last 24 hours so was sent in the emergency room for evaluation from the assisted living center.  In the emergency room, the patient was noted to be febrile, tachycardic and met sepsis criteria.  His x-ray also showed some vague infiltrate in the right lower lobe.  Ultimately the patient test positive for Covid 19 is being admitted for further evaluation and treatment.  He was also found to be in worsening renal failure.  Reportedly the patient received his second COVID-19 vaccination in mid February.   The patient is not a very good historian but is able to tell me he came over from the assisted living center.  He does endorse he has been having diarrhea as of late.  At present he denies shortness of breath fevers but does complain of feeling very hot and wants his fan turned on.
I have been sick; Sore throat; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 15Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 04May2021, outcome "unknown", described as "I have been sick"; OROPHARYNGEAL PAIN (non-serious) with onset 04May2021, outcome "unknown", described as "Sore throat"; FATIGUE (non-serious) with onset 04May2021, outcome "unknown", described as "Fatigue". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: When probed for the concern, consumer stated, "I was originally supposed to get my Pfizer second dose tomorrow (07May2021) but for the past two days I have been sick, I have like a sore throat and fatigue. I got tested got tested today and I was negative for Covid but I was wondering when I should get my second dose. I wasn't sure there like should I be able to take as I am sick now".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I started feeling numbness in my hands and legs.  I had difficult walking.  It happen 3 times.  I wind up falling to the ground.  I was not able to walk any more and was unable to talk correctly.  I am getting physical therapy and speech therapy now.  I still am having trouble walking and talking today.  They said it could be FND.  They said that they did not know what was causing it.  They did a spinal tab, blood work, x-rays, CT scan, and MRI.  They checked me for neuro problems but nothing showed up.
Before pt got her 2nd Covid injection, she did warn me that she might faint.  She said that she is afraid of needles.  I advised to stay seated after the vaccine was given.  After the injection, less than a few minutes, patient did have an episode of syncope.  Mom and brother were there.  I immediately got the EpiPen and told my technician to call 911.  When I got to her, it looked as if she was seizuring for a few seconds, then she came out of it.  I told her that I would give her the epinephrine injection and put she pushed it away and said that she was fine and not needing it.  I asked mom on what they wanted me to do.  She said that she wasn't quite sure.  Patient then slowly became more conscious and was able to talk to me.  I asked her whether she had any difficulty breathing but she said no.  She said that she was just really dizzy.  She was sweating a bit.  She didn't eat or drink anything before coming to the pharmacy.  The injection was given around 12:48pm.  I kept on talking to her to make sure that she was still conscious and not passing out.  Then the EMT came.  They took her blood pressure.  First, it was 90s/60s, then 105/70s (if I am not mistaken).  Per patient, she almost passed out before at Dr. office but ever did.  She didn't with her first Covid vaccine.  Eventually, patient agreed to go to the ER.  I called my coordinator, and informed her of what happened.  I did ask mom whether I could call her to check on her and mom was okay.  However, when I called around 7:20p, and I couldn't reach her.  I left a VM and told them that I will checked back with her on Monday.
Had a little problem breathing; Left arm, where she got the shot, is a lot bigger than her right arm now; Injection arm warm; Injection arm is inflamed; Injection arm hard; Injection arm red; Injection arm swollen; Injection arm sore / hurts; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Had a little problem breathing), INJECTION SITE REACTION (Left arm, where she got the shot, is a lot bigger than her right arm now), VACCINATION SITE WARMTH (Injection arm warm), VACCINATION SITE INFLAMMATION (Injection arm is inflamed) and VACCINATION SITE INDURATION (Injection arm hard) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma, Penicillin allergy, Allergy to antibiotic (Allergy to antibiotics) and Drug allergy (Allergy to Ibuprofen, the patient was hospitalized for taking ibuprofen 3 times).    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced INJECTION SITE REACTION (Left arm, where she got the shot, is a lot bigger than her right arm now), VACCINATION SITE WARMTH (Injection arm warm), VACCINATION SITE INFLAMMATION (Injection arm is inflamed), VACCINATION SITE INDURATION (Injection arm hard), VACCINATION SITE ERYTHEMA (Injection arm red), VACCINATION SITE SWELLING (Injection arm swollen) and VACCINATION SITE PAIN (Injection arm sore / hurts). On an unknown date, the patient experienced DYSPNOEA (Had a little problem breathing). At the time of the report, DYSPNOEA (Had a little problem breathing), INJECTION SITE REACTION (Left arm, where she got the shot, is a lot bigger than her right arm now), VACCINATION SITE WARMTH (Injection arm warm), VACCINATION SITE INFLAMMATION (Injection arm is inflamed), VACCINATION SITE INDURATION (Injection arm hard), VACCINATION SITE ERYTHEMA (Injection arm red), VACCINATION SITE SWELLING (Injection arm swollen) and VACCINATION SITE PAIN (Injection arm sore / hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
PT WTIH RED, WARM, LARGE, HARD, KNOT TO SITE OF ADACEL IMMUNIZATION ON 8-30-06.  PT WAS ADVISED TO USE COOL COMPRESSES AND TAKE MOTRIN FOR PAIN AND CALL OFFICE BACK IF SITE PERSISTS WITH RED, WARM KNOT.
Patient developed a itchy rash on her face, her mouth and cheeks.  Patient was given 25 mg of Diphenhydramine.  Rash and itchiness reduced.
Woke up at 12:35 with severe vertigo. Couldn't even walk for fear of crashing to the floor. Got help to bathroom, and back to bed. Then vomitted.  Cant change position, head spins. Cant lie on back, head spins. Can only lie on side, or sit VERY still.
When patient removed the band-aid, there was a hard spot and some bruising. The next day she noticed a big red area next to the hard spot. She had a headache, fever, rapid pulse and a sore arm. She went to the ER and was given Benadryl and Tylenol. Today she has a low fever. The area is still red but is not as hard anymore.
I experienced a facial herpes outbreak and I took prescription medication for the outbreak and by the time I went to my Dermatologist he didn't see a need for further treatment.
Swelling and numbness of her lips, dry throat, "gritting" feeling in her eyes.  Sx resolved without intervention 6 hours after start.
Patient came to Health Center at 12:06 pm on 1/16/09, 9 days after injections.  Stated "prolonged hard lump on my right arm where I got the pneumonia shot.  Lump is smaller now than it has been.  Edges of lump are itchy. Area is still red. Now I also have a rash, mostly on my chest".  Temp - 98.0 F; Pulse - 72; Resp - 20; B/P - 118/72. 3 cm firm lump at injection site, erythema at site, no drainage. Urticaria chest area only. Patient seen by FNP, for further evaluation and treatment.  Local reaction improving over time. Rash probably not related to adverse reaction, however, included in possible reported symptoms.  Patient agreed to apply heat to area, benedryl PRN, bactrim for delayed reaction if worsening in size, heat, tenderness or redness.  Prescriptions written for prednisone 10 mg: 2 tabs today and tomorrow, then one daily until gone; #10 and bactrim DS 800-160; 1 tab q 12 hours; #20. Follow up PRN.
Initial information received on 12-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves male patient (age 21-22 years) who received 0.5 mL dose of vaccine IMOVAX RABIES lot N1K303M, expiry date- 28-Oct-2019 via unknown route in the right deltoid on 28-Feb-2019 but missed the second dose in series.The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of potential medication error due to missed dose. He received his first immunization on 28-Feb-2019. His second in the series was due 7-Mar-2019, but he did not come in. It was unknown if any adverse event was occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Soreness of right arm 24 hours past adminitration followed by swelling and redness 4 days after administration.
Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 2 weeks old patient for whom FLUZONE QUAD pediatric prefilled syringe was given to a child less than 6 months old was reported, while he/she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On an unknown date, the patient received a 0.25 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via intramuscular route in the thigh nos. Reporter reported that she did not order this vaccine to be given but it was administered by nurse. No side effects noticed yet. This case is actual medication error case due to inappropriate age at vaccine administration. Final diagnosis was FLUZONE QUAD pediatric prefilled syringe was given to a child less than 6 months old. Outcome of the event was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Patent recorded wrong DOB on registration form.  DOB recorded 06/01/2009.  No adverse reaction while in clinic.
I developed Shingles (herpes zoster) approximately 10-12 days after receiving the first  covid-19 vaccine; This is a spontaneous report from a contactable Nurse (Patient). A 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL1284), via an unspecified route of administration, in right arm, on 31Dec2020 at 11:00 as SINGLE DOSE for covid-19 immunisation at Hospital. Age at vaccination was 67 years. The patient's medical history included asthma, osteoporosis. Allergies to medications, food, or other products included NSAIDS allergy. The patient was not pregnant at the time of vaccination. Concomitant medication(s) included fluticasone propionate, salmeterol xinafoate (ADVAIR); montelukast sodium (SINGULAIR); omeprazole (PRILOSEC [OMEPRAZOLE]); ergocalciferol (VIT D); Multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated "I am a healthy active senior citizen. On 12Jan2021 at 04:00 after the first dose of vaccination the patient developed shingles (herpes zoster) approximately 10-12 days after receiving the first covid-19 vaccine. I did not have a weakened or compromised immune system prior to the first covid-19 vaccination." The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283), via an unspecified route of administration, in left arm, on 21Jan2021. The events resulted in doctor or other healthcare professional office/clinic visit/Emergency room/department or urgent care. The patient received treatment included Valacyclovir 1 gm PO three times daily for 7 days. Since the vaccination, the patient hasn't been tested for COVID-19. Outcome of the events was not recovered. The events were considered non-serious by the reporter.   No follow-up attempts are possible. No further information is expected.
PATIENT WAS VACCINATED ON Dose 1 date: hospital 01/06/2021 AND  Dose 2 date: hospital 01/27/2021, AND TESTED POSITIVE TO COVID-19 ON 8/19/21
The vaccine given was an error. vaccine intended was the COVID-19 M-RNA Bivalent by Pfizer.
Patient had allergic reaction to either the influenza or Pneumovax vaccine. Symptoms include, rash/cellulitis, erythema, pain/discomfort at touch, size was about 10-15 cm in diameter.
Nausea, tachycardia and elevated blood pressure.   O2 at 100%, BP at 167/114 pulse 135 patient resolved within 10 minutes
Apneic/bradycardic event starting about 12 hours following immunizations needing positive pressure ventilation and chest compressions.  Following this event she needed increase in respiratory support for about 12 hours continuing for approximately the next 24 hours.
Myalgia, Fever, chills Narrative: Myalgia, fever, chills; recovered in 24 hours
Reacted to the first dose 12 days after the shot, had severe itching, rash on entire upper arm, swelling, redness, red, hot, hard, pain went up into right upper chest (lymph nodes possibly), had a fever and headache for 3 days. Arm issues lasted for 8 days. No sore throat or cough, but unsure if I may have had Covid (did not test at the time). On July 3rd began experiencing neurological issues and low-grade fever for whole month, had fatigue, evaluated for stroke. Saw Nurse Practitioner in urgent care on 19th of July, ordered stat labs and CT of brain, saw doctor the next day on the 20th. Symptoms began to subside for a bit then resurged a bit in early August, then went back to normal.
Given vaccine 05/19/2003: redness, swelling, pain started 05/22/2003.  Still as this date.  06/04/2003, pain, swelling, sore arm (left) up into shoulder.  Up in neck.
Site pain; joint pain in knees, back, and neck; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ek9231), via an unspecified route of administration in the right arm on 20Jan2021 15:15 at a single dose for covid-19 immunization. Medical history included rheumatoid arthritis (RA) and Sjogren's syndrome; both from an unknown date. Concomitant medication included methotrexate, hydroxychloroquine, levothyroxine sodium (SYNTHROID), and folic acid. The patient previously took Codine and experienced allergy. The patient experienced site pain; and joint pain in knees, back, and neck on 21Jan2021 03:00. Outcome of the events was recovering. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The events were assessed as non-serious. No treatment was received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.
AS SOON AS THE PATIENT GOT UP FROM THE SHOT, SHE BRIEFLY FAINTED AND CAME TO IMMEDIATELY,   WE HELPED HER TO A CHAIR AND SHE BRIEFLY FAINTED AGAIN AND IMMEDIATELY CAME TO.
Patient came to the pharmacy and said she feels shaky, jittery, dizzy, has bad headache migraine-like happened 30 minutes after vaccine and pt is still feeling it now. Her arm hurts but not too bad. I asked pt to stay for 10-15 minutes after vaccine to walk around the store to make sure everything is ok and to check back with us, pt did not check back with us yesterday. Recommended pt to go to urgent care and will check on her or she will check with us if there is any issues. Patient will talk to her manager today to see if she can get off work and go to urgent care.
Face swelling,hives,urticaria,dermatographia , urticaria, angioedema, joint pain,can't put anything on my skin without having reaction now,hands and feet swell and are very painful,bottom lip randomly swells,acid reflux,heart burn, and racing heart.
Headache, constant urination, severe fatigue, arms and legs began to feel very heavy. Fever.
PATIENT WAITED 15 MINUTES, AND LEFT THE OBSERVATION AREA.  PATIENT RETURNED TO LET STAFF MEMBERS THAT HE WAS EXPERIENCING ONE SIDED WEAKNESS.  EMTS WERE CALLED, PATIENT WAS PLACED ON A HEART MONITOR. PARAMEDICS UNSURE WHAT WAS GOING ON, EKG NORMAL.  PATIENT WAVED AN AMBULANCE TO GO TO HOSPITAL AND WENT HOME WITH BROTHER
30 minutes after vax felt nauseous, no fever, but symptoms aggravated over time. Then had chills, shakes, shivering and then it stopped at 1 am. Next day felt washed out called pharmacist, had aches all over. Has not felt his "normal dynamic self" since, he is short of breath, but symptoms are improving everyday.
I felt prickly sensation on face. My voice became hoarse after 30 minutes and remained hoarse for about 5 hours.
my lips and tongue started itching and got swollen; my lips and tongue started itching and got swollen; my lips and tongue started itching and got swollen; my lips and tongue started itching and got swollen; itching and got hives; itching and got hives; This is a spontaneous report from a contactable Nurse reported for herself. A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Jan2021 16:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. The patient was not pregnant. Medical history included Asthma, food and environmental allergies, allergy to PCN and Sulfa. Concomitant medications included montelukast sodium (SINGULAIR), bupropion hydrochloride (WELLBUTRIN), escitalopram oxalate (LEXAPRO), loratadine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received her first dose of BNT162B2 on an unknown date for covid-19 immunization. The patient previously took acetylsalicylic acid (ASA), levofloxacin (LEVAQUIN), codeine and azithromycin (ZITHROMAX) and experienced allergy. 8 minutes after the vaccine was given on 22Jan2021 16:08, patient started itching and got hives. She was given Benadryl. About 5 minutes after that on 22Jan2021 16:13, her lips and tongue started itching and got swollen. At that time she was given an injection of Epinephrine and transferred to the Emergency Department. The outcome of the events was recovered on an unknown date in Jan2021.  Information on the lot/batch number has been requested.; Sender's Comments: Pfizer comment: Based on the information currently available, a possible contributory role of the BNT162B2 in the reported events lip and tongue itching and got swollen cannot be excluded in this 56 years old female patient, who with medical history of allergy to food, environment and multiple medications. This impact of this report on the benefit/risk profile of  the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Swelling of the back cheeks of the face. First treated with benadryl and reduced. Then anti inflammatory 7 days. But after 3 weeks I still am unable to chew. The inside of my cheeks are swollen and my teeth no longer meet correctly there is a gap in the front of my teeth when I close my mouth of still 1 cm.
Shortness of breath, trouble breathing, Pt has a HX of Severe Asthma  911 was called and pt was transported to the Hospital
Patient with severly sore arm on same day as injetion. Much improved day after wih ibuprofen and tylenol #3.
102.6 temp; Fatigue; Swollen glands; Slight nausea; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03May2021 at 16:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included omeprazole (PRILOSEC), biotin (MANUFACTURER UNKNOWN), loratadine (CLARITIN) all from an unknown date for an unspecified indication, birth control (MANUFACTURER UNKNOWN) from an unknown date. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Apr2021 at 16:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. 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 04May2021 at 00:00 the patient experienced 102.6 temp, fatigue, swollen glands, slight nausea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events 102.6 temp, fatigue, swollen glands, slight nausea was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Lab data (units for Body temperature "Units: {DF}" removed), event detail (Treatment received updated as No for all events), updated narrative ("The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events." added).
5" diameter hard, red, raised sore spot that was hot to the touch. Symptoms persisted after icing and Tylenol were applied.
pt recvd 2nd dose of vax & w/in 24 hrs exp an acute asthma attack; pts asthma resolved & was not hospitalized; addtl details are being requested;
Soreness, weakness, pain shooting down arm, when picking item up will lose feeling in lower arm and fingers.