chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Right upper arm began hurting last PM, noticed it was red and swollen this AM. Reddened, swollen, hot area inside right upper arm.  11/06/2003: patient was called and is improving.
Pt received PNEUMOVAX in (R) deltoid on 7/1. Developed redness at shoulder to mid upper arm. C/o pain/weakness for 3 days. Improved by Monday 7/7. Redness almost completely gone.
Chief Complaint...Tingling of back and sides of tongue which began at 5:08.  5:10:  REPORTS STARTING TO DISSIPATE 5:17  MOSTLY RESOLVED (TINGLINING).  LEFT CLINIC.  WAS EDUCATED ON CALLING 911 IF SYMPTOMS WORSEN OR ADDITIONAL SYMPTOMS APPEAR.  ENCOURAGED TO REPORT THROUGH V-SAFE  5/3/2021...Follow up call placed with no return call or text/message .
82-year-old female with past medical history of vitamin D deficiency depression, iron deficiency anemia insulin dependent diabetes mellitus peripheral neuropathy, hypertension, hyperlipidemia, recent fall presented to the emergency room on 06/23/2021  7/19/2021 tested positive 07/21/2021 patient discharged. 82-year-old female with past medical history of vitamin D deficiency depression, iron deficiency anemia insulin dependent diabetes mellitus peripheral neuropathy, hypertension, hyperlipidemia, recent fall presented to the emergency room on 06/23/2021 sustaining left-sided rib fractures, recent robotic low anterior resection of rectosigmoid polyp , pending pathology to rule out cancer presenting today with shortness of breath and cough.  Patient reports she noted slight cough last night.  This she some shortness of breath.  She has health aide who listened to her lungs and told her she had a rattle on the right side to into the emergency department.  Patient came in to get evaluated and noted to have COVID-19 pneumonia.  Patient is saturating well on room air.
Patient was given vaccine.  Patient was talking , coherent as i was giving it.  Right after the bandaid was put on his arm, his head went back up against wall and his arms went stiff.  I yelled out "call 911".  One of the store managers who was working the drive thru immediately got on phone and called 911.  Patient's mom was right there, she was holding his head and saying his name, his eyes seemed to roll up into head, and remained open, but he was unaware of his surroundings and what was happening.  I had the epinephrine in my hands, but then he regained his composure and seemed to come to.  Paramedics arrived, tested all his vitals; heartbeat, blood sugar, blood pressure.  All were normal.  Patient sat for a while with his mom, then left with her saying he was feeling fine. Paramedics suggested he go to a walk in clinic or emergency room to get checked out further.
Patient received Pfizer BioNTech Covid -19 vaccine Monovalent 0.3mL and should of received Bivalent Covid -19 Vaccine 0.3mL
About 9.5 hours after the injection, I started feeling a bit shaky. Seemed to be on left side of chest. Shakiness got stronger and stronger, spread across chest and into head.  By 10 hours after injections, hands were shaking, voice, was shaking, teeth chattering.  The worst lasted about 20 minutes, and then started to subside in reverse order ending on left side of chest. By 90  minutes after initiation, all shaking was gone.  During the worst of it, I could sometimes control the shaking briefly with slow breathing. But then shaking would return.  Fitful sleep through the night. Aches and low fever next day.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 49-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant product were reported Pharmacist stated that the vaccines was stored in freezer and placed out one to two vials and place in fridge each day as needed Pharmacist reported administration of expired vaccine were given as booster shot to patients around 490 to 500 people on the date last 20-Oct-2021 to 29-Nov-2021. No treatment medication was provided
Near syncopal episode Diaphoretic, lightheaded, pale, nausea, abdominal pain Onset approx 09:45 am , IV fluids administered, IV Ephedrine administered, EKG, telemetry monitor Taken to ER ,
dizziness; diarrhea; generalized aches; This is a spontaneous report from a contactable consumer A 91-years-old female received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jan2021 dose 1 at SINGLE DOSE for covid-19 immunisation. Facility type vaccine: Nursing Home. Medical history included cardiac assistance device user, hyperthyroidism, hypertension, blood cholesterol increased, macular degeneration, glaucoma, osteoporosis. Concomitant medication included calcium (CALCIUM), flecainide (FLECAINIDE), chondroitin sulfate, glucosamine sulfate (OSTEOFLEX [CHONDROITIN SULFATE;GLUCOSAMINE SULFATE]), vitamin d (VITAMIN D) , meclizine [meclozine] (MECLIZINE [MECLOZINE]). The patient experienced dizziness on 16Jan2021 20:00 with outcome of not recovered, diarrhea on 16Jan2021 20:00 with outcome of not recovered, generalized aches on 16Jan2021 20:00 with outcome of not recovered. The action taken was not applicable. Information on the lot/batch number has been requested.
Pt reported to have rash, hives on her back, size of rash/hive is approximately 12 inches in length. Patient contacted her primary care physician and was advised to take Benadryl and Aspirin as soon as possible. Rash/hives went away within several hours.
Patient reports a blotchy rash that extends down from the injection site to her elbow (left arm). It is not itchy, but red and hot to the touch. She also received Fluad vaccine in the same arm, but she has taken Fluad before with no reaction. She received Spikevax at the same time in the right arm.  She received the vaccine on 10/10, and the side effects started on 10/11/23, about 24 hours later.  The rash is still present at this time, 10/12/23 at 3pm.
pain,swelling, & redness to right arm began on 10/21/09. No fever, numbness, or tingleing to right arm. Patient placed ice to right arm; no medicines were given for symptom relief.
Initial information received on 14-Feb-2019 regarding an unsolicited valid non-serious case received from a other health professional by phone. This case involves a 17 months old female patient who was vaccinated with 0.5 ml once second dose of ACT-HIB (Batch number: UI822AAA and expiry date: 05-Jan-2019, route and site of administration were not reported) on 07-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were reported as none. It was a case of actual medication error due to expired vaccine used. No symptoms were reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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 the sender: none.
I don't know if this is relevant, but I'm reporting it anyway. A few minutes I had a "rush," sensation similar to when I had allergy injections,  which my allergist explained was most likely due to a sudden release of histamines, and I felt like I might have been get flush. I got the attention of one of the nurses, and she took my BP and pulse and said things looked okay. The "rush" last maybe four minutes, and dissipated. I stayed an extra few minutes at hospital and then left, feeling ok. No other "events" in the 26 hours since the injection.  The nurse said she's heard of other people experiencing that. Is it something to worry about? Have other people reported the same experience?  I'll be sure to mention this experience to the nurse who gives me the second injection on Tuesday, February 23, at hospital.
9SEP fever started 10PM day of vax, 104 climbing;10SEP 105+ was seen in hosp MD prescribed APAP to alternate w/Ibuprofen;blood work done;11SEP fever <100 feeling better, wanting to eat;
any:    Dizziness, Phlebitis, Fever, SkinRash, Rash,   1st dose-pm 7th day arm became red, swollen, itchy. 2nd dose site redness, swelling, itching, HA, muscle pains fatigue, nausea, cough swollen glands. Update 4/26/2021: L wrist pain onset in February, dizzy spells, loss of balance, onset March.   Narrative:
This case was reported by a consumer and described the occurrence of autism in a child male subject who was vaccinated with Dtpa (manufacturer unspecified).  A physician or other health care professional has not verified this report.  The subject received concurrent vaccinations that were not specified.  On an unspecified date the subject received unspecified dose of Dtpa (unknown).  At an unspecified time after vaccination with Dtpa, the subject was diagnosed with autism.  This case was assessed as medically serious by GSK.  At the time of reporting the outcome of the event was unspecified.  It was reported that this event occurred in five of the consumers children, three boys and two girls.  Case A0725679A serves as the master case and the other case numbers are A0725685A, A0725686A, A0725687A and A0725688A.
admitted to the hospital and taken to the operating room and underwent a(n) Laparoscopic Appendectomy.  The patient tolerated the procedure(s) well and was transferred to the ward post operatively.  Post operative course was unremarkable. Patient discharge to home. Hospital admission within 6 weeks of receiving the COVID vaccine.
Pt was given dose number 3, covid-19 bivalent booster Pfizer 5-11. Dosage was 0.2ml but vial was not diluted first with 1.3 of diluent prior to withdraw of 0.2 dosage. Patients mom was notified via phone by RN of potential adverse events such as local reactions due to higher dose, no repeat booster dose needed.
Treatment of COVID-19; Treatment of COVID-19; interchange of vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 28 years for covid-19 immunization; BNT162b2 (BNT162B2), on 01Dec2021 as dose 3 (booster), single (Lot number: PF8841) for covid-19 immunization; elasomeran (MODERNA COVID-19 VACCINE), on 29Mar2021 as dose 1, single (Lot number: 021B21A) and on 26Apr2021 as dose 2, single (Lot number: 048B21A) for covid-19 immunization. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ampicillin, reaction(s): "Known allergies: ampicillin". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Dec2021, outcome "unknown", described as "interchange of vaccine"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: positive COVID test on day 8 of isolation; positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from registered nurse refers to a 9 month old paitent of unknown gender. On 29-OCT-2014 the patient was vaccinated with a dose of M-M- R II (dose, route of administration, lot number and expiration date were not reported). On 06-NOV-2014 the patient was vaccinated with a dose of VARIVAX (Merck) (dose, route of administration, lot number and expiration date were not reported). The nurse stated that the patient received M-M-R II and VARIVAX (Merck) "too close together". No adverse effects reported. Additional information is not expected, because the reporter didn't wish to be contacted.
Immediately after administration of vaccine, pt was at first flushed in the face then became pale. Complained of ringing in the ears, nausea and dizziness. Ice pack placed to back of neck and legs were elevated. Pt asked for water to drink. At 10 minutes into episode pt stated she was feeling better but drained. At 16:45, pt said she was fine and was able to leave the clinic.
Breakthrough varicella with >200-300 lesions, no fever.  Vaccinated as a single dose on 10/28/1997.  Presently ongoing.  Culture results pending, but dermatologist fairly certain it is smallpox breakthrough.
This spontaneous report was received from a medical assistant and refers to a 9 week old patient of unknown gender. No information about the patient's medical history and concurrent conditions was provided. On 26-OCT-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # M044397 with an expiration date in 20-JUN-2018), for prophylaxis, reconstituted with properly stored sterile diluent (manufacturer unknown), that underwent a temperature excursion from 9 degrees Celsius to 25 degrees Celsius during 20 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1801USA001565: US-009507513-1801USA001566: US-009507513-1801USA001568: US-009507513-1801USA001569: US-009507513-1801USA001570: US-009507513-1801USA001571: US-009507513-1801USA001572: US-009507513-1712USA003377.
For the first 24 hours I had no symptoms other than arm pain. For the next 6 days experienced debilitating headaches, which led to nausea (because they were so severe). Elevated blood pressure also coupled with headaches.  I initially took Ibuprofen (which helped somewhat), whereas Tylenol did nothing. I also have a flexible ice pack that I placed over my head. That also helped a little. I went to the doctor on March 17th, but he was dismissive of the headaches being related to the vaccine. I have since been referred to  a neurologist (April 1st appointment).
Itching and hard area at MMR injection site progressing to warmth at site on 8/21/13.
Information has been received from a medical assistant concerning a 45 year old female patient who on 11-OCT-2006 was vaccinated with a dose of Pneumovax 23 (lot #651319/1007P). Concomitant therapy included Fluvirin (unspecified), administered at the same visit in separate arms (separate sites). On approximately 11-OCT-2006 the patient developed a reaction in arm where the Pneumovax 23 vaccine was administered that ranged from redness to blotchiness to pain; and visited the hospital for flu like symptoms (diarrhea and dizziness), but was not admitted. Subsequently, the patient was feeling better. The medical assistant requested a lot check. No product quality complaint was involved. The reporter indicated there were 4 other patients who developed similar reactions after receiving Pneumovax 23 vaccine (lot #651319/1007P). Follow up information has been received from the Certified Medical Assistant concerning the black patient with hypertension, high cholesterol, asthma, and an allergy to codeine who at 4:15 p.m. on 12-OCT-2006 was vaccinated IM in left deltoid with a dose of Pneumovax 23 vaccine (lot #651319/1007P). At 4:17 p.m. she was vaccinated in the right deltoid with a dose of Fluvirin. At 7:00 p.m. the patient went to the ER approximately 3 hours after the injection. She was dizzy, sick, reaction in arm, flu-like symptoms, did not feel well. She recovered from the above symptoms on 16-OCT-2006. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information is not expected.
Pain, redness Left arm axilla to elbow proximally - with redness, warmth - approx (L) 6 in (W) 3 in,  increasing in size appears as cellulitis, Advised f/u with ED if symptoms increase.
Leg hard to walk - soreness; inject site OK; warm off/on did not take temp; 20AUG leg is fine was walking ok by afternoon;
Patient states felt dizzy after vaccinations given, patient was reclined and lost consciousness for approx 45 sec, weak and dizzy upon awakening, c/o heaviness feeling in extremities, assessed by EMS personel, f/u of pt been taken by mother to urgent care facility to be assessed.
Information has been received from a consumer concerning her 19 year old daughter who on approximately 13-AUG-2008, "two weeks ago", was vaccinated with the second 0.5 ml dose of GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). On approximately 20-AUG-2008, "last week", the patient developed a rash over her body and it had become itchy and painful. At the time of this report, the patient's symptoms persisted. The patient sought unspecified medical attention. Additional information has been requested.
Day 1 -slight soreness in arm Day 2- couldn't raise arm more than half way, low grade temperature, body aches, band of pressure around head.   Day 3 - No issues at all Day 4- Developed an ear ache (Pain/Pressure) in area under left ear and I still have it as of 4/15/21
PLAN & IMPLEMENTATION:   Reasoned Conclusion: Nursing diagnosis: Non-urgent symptoms of vaccine . Nursing Interventions: Home care advice given - see care advice and patient instructions.  EVALUATION:  Patient states agrees with plan of care.  ASSESSMENT FINDINGS:   Caller is: Patient.  Current Symptom(s): (include Onset, Duration, Character, Progression, etc) Started this morning Localized welt/lump at injection site Warm to the touch Erythema at injection site Received 1st injection of Moderna COVID19 vaccine  Denies:  Pain Drainage Itching   Home care prior to call:  benedryl . Home care was somewhat effective..  Pertinent History: Recent medical care: received Moderna Covid19 vaccine on 1/20/21  Pertinent Medications:  None
Saturday, December 11th, 2021 patient begin to exhibit symptoms of loss of appetite and lock jaw. Sunday, December 12th, 2021 patient woke up with a face swollen on left side and complaints of a soft bump underneath ear. The facial swelling was from the left side of ear and extended a little pass jaw area. Face was slightly warm. Patient's pediatrician's office was called, symptoms were given and they thought it was a dental issue. Monday, December 12th, 2021 patient's mom made an appointment with dentist. Dentist completed an xray and through evaluation of the mouth. Dentist placed patient on an antibiotic. No injuries to mouth or teeth but facial swelling on left side. Dentist referred to pediatric dentist. Patient visited pediatric dentist, Tuesday, December 13th, 2021. He noted that there was facial swelling and no injuries to mouth or teeth. He referred patient to an oral surgeon. Patient's mom contacted pediatrician. Had an appointment with pediatrician, Wednesday, December 15th, 2021. He noted mild facial swelling. Completed blood work and ordered a facial ultrasound of left side of face. Ultrasound reading was that patient has swollen lymph nodes and parotitis.
p/vax pt was breaking out in hives;mom picked child up & called MD office;advised to give child allergy med & bath;child seen by MD 5/6/99 MD felt was adverse rxn-child to have allergy tests;
Patient noted to have slight swelling and redness to left upper arm 8-22-08 per mom's report. Was seen by Dr. on 8-23-08 and given omnicef with little improvement. Mom then took him to ER where he was seen by Dr. due to no improvement. Child noted to have blister to injection site, with redness and swelling to upper arm. Was given rocephin injection in ER and TMC ointment to apply to area. Into Health Department on 8-25-08, blister noted to be open and draining, swelling to arm improved from pictures mom had taken in ER.
After 1st vaccine dose: - Severe pain, swelling, itching and heat at injection site (left arm) - Headaches - Injection site pain continued for 3+ weeks - After week 3 started to have trouble walking and keeping my balance  After 2nd vaccine dose: - Severe pain and swelling, intense itching  at injection site (right arm) - Severe Headaches - Developed large hives on torso with intense itching which lasted for months (eased up toward end of August, 2021) - Walking became impossible, legs continuously shaking with no sense of balance. - Could not walk without using  walls, counters and/or cane to steady myself.  Been to may doctors before i was properly diagnosed (the reason I am just filing now). Scheduled for physical therapy as treatment. Still not walking properly an as of this filing continue to have buzzing, pins & needles and muscle  twitching in my legs.
p/vax pt began to feel nauseated 7 heaved 20min, chills, fever, vomit, diarrhea, aches, pain, hallucinations, T103;spoke to MD by phone;
This spontaneous report was received from a nurse regarding unspecified patients of unknown age and gender. Information regarding the patients' pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unspecified dates, the patients were vaccinated with unspecified doses of improperly stored ROTATEQ (lot/batch# 1035510 with an expiry date 13-MAY-2017 and dosing details not known). No adverse reactions reported. There was no product quality complaint (PQC) involved. Lot number 1035510 is an invalid lot number for rotavirus vaccine, live, oral, pentavalent. This is one of the four reports received from the same reporter. Additional information has been requested.
1) Patient developed much worsening alopecia areata that went from 2 small spots on scalp to 75% of scalp hair loss within 2 months post-vaccination 2) Patient developed shortness of breath and tightness in chest within a few hours post-vaccination which persisted till this day (unresolved currently 3/9/23). Pulmonary Function Test in January 2023 revealed possible inflammation around lungs with diffusion defect.
SkinRash Tingling in the arm Narrative:  Patient sent to ED for further observation. BP at 1100: 143/90; HR88. BP at 1115 130/87, HR 87