chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore throat; flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and INFLUENZA LIKE ILLNESS (flu like symptoms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat) and INFLUENZA LIKE ILLNESS (flu like symptoms). At the time of the report, OROPHARYNGEAL PAIN (sore throat) and INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications are provided. treatment to the events not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-089560, US-MODERNATX, INC.-MOD-2021-089565 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089560: US-MODERNATX, INC.-MOD-2021-089565:Crossed linked
Within minutes of receiving influenza vaccine pt became flushed c/o difficulty breathing, edema and urticarial s/s face. Epinephrine 1:1000 1.5ml vastus lateralis given. Pt immediately reported decrease SOB, edema. Discharge summary states anaphylaxis. msv Medical records state laryngitis, increased coughing, vomiting. msv
I wanted to report an incident regarding a two-part mixed component vaccine that was not given correctly. After going through inventory, a vial on vaccine Pentacel was missing, I searched for all patients that were given the vaccine with lot# UJ799AA, three patients were a result. One out of the three patients were given only the DTap-IPV component and is missing the HIB
04/18/2022 Vaccination Traveled to the other country 06/05/2022 Started to experience what you thought was extreme allergies.  06/07/2022 COVID-19 POSITIVE home test 06/08/2022 COVID-19 POSITIVE test at Doctor office. Prescribed Plaxovid.  I still have a little bit of drainage and cough but I think it may be a little bit of allergies.
This spontaneous report was received from a physician via a company representative, and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 16-JUL-2014, the patient was vaccinated with an improperly stored dose of GARDASIL, lot # J009788 with expiration date of 17-MAR-2016 (strength, dose and route of administration were not reported). No concomitant medications were reported. No adverse effects and no product quality complaints were involved. On an unknown date, the vaccine was stored at a refrigerator and the longest reported temperature excursion lasted 72 hours, where the lowest recorded temperature was 32 F (0 Celsius degrees). There was also another excursion on an unknown date which lasted 72 hours with a lowest recorded temperature of 34 F (1.111111111 Celsius degrees). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several reports received from the same source. Additional information has been requested.
Three days after second COVID-19 vaccine, patient became lethargic.  Due to advance directive that instructed that no life saving interventions to take place, patient continued to decline and expired on 29 January 2021.
both of her biceps have been hurting; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1,SINGLE), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "both of her biceps have been hurting".  Additional Information: Patient stated that she had second Pfizer vaccine a month ago, last 5 days both biceps have been hurting. She declines to provide any contact information and a report. She wants to know what medications Pfizer recommends to treat her symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Received injection approx 4pm approx 10-15 min after receiving injection I felt heart racing, flushed, shaky.   Sat down and as I've had symptoms of hypersensitivity reactions in the past, I keep prednisone/benadryl/pepcid with me.  Took 50mg benadryl/40mg prednisone/40 mg Pepcid.   4;20pm  B/P 160/100 P 120   feeling very flushed but no hives noted. no SOB or wheezing, still shaky (MD on site noted no issues resp exam) 4:40pm  B/P 140/90 P 100  still feeling shaky but flushed feeling better, no SOB, no wheezing, no hives 5:00pm  feeling much better, shakiness almost resolved, no SOB, no hives, no wheezing.   8:00pm  extra 25mg dose benadryl taken as felt some shakiness return---resolved within 30min and no further issues noted  next day L arm at injection site had approx 10cm area of redness and warmth.  resolved within next 2 days.
Information has been received from a health professional concerning an 18 year old female, with no allergies, who on 17-MAR-2006 was vaccinated with a 0.5 ml subcutaneous dose of Varivax (Lot# 646670/0627R). "Two to three weeks later", in approximately April 2006, the patient broke out with 10 lesions on her scalp and head. She saw her private phyisican and was diagnosed with chickenpox. She was given an antiviral medication, unspecified. Subsequently, the patient recovered. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Nausea in the evening 11/2/15.  11/3/15 muscle/joint stiffness started in back, shoulders, neck, hips, and legs and fatigue started.  Stiffness intensified throughout the week.  Headaches started 11/8/15.  Patient has been seeing massage therapist, chiropractor, and physical therapist for muscle/joint stiffness.
The COVID-19 vaccine administered through vaccine administrator,  University Health, between June 25 and July 30 came from the lot number 039K20A.  It was discovered that this particular lot was beyond its frozen expiration date by five (5) up to forty (40) days. A case was opened with Moderna (Case #: MOD21-126790).  Please refer to this case number if you would like to contact Moderna directly.  Moderna confirmed that the vaccine doses administered maintained the activity necessary to protect against the COVID-19 virus.  Moderna also confirmed there is no danger to anyone's health from receiving a vaccine past its frozen expiration date.  No adverse reactions were identified.
delayed cutaneous hypersensitivity reaction Narrative: onset 7 days post vaccination. duration 5 days
Joints ache, tingling, hot, painful to walk (r/t bones and thighs). Achy when went to bed and woke up with more pain. Tender lymph nodes in groin. Took Advil.
Patient came into vaccine clinic looking for covid vaccine to complete series after receiving first Janssen vaccine on 3/11/2021. Nurse administered moderna dose of 0.5mL to patient?s right deltoid at 10:23am. Nurse told patient a 10-15-minute waiting period after the covid vaccine as per CDC guidelines and patient agreed. After 10-15 minutes patient advised nurse of no ill-being and walked away with no visible signs and symptoms of distress. When reviewing paperwork data entry clerk noticed that instead of a booster dose of 0.25 mL, a full dose of 0.5 mL was administered. Nurse was not able to advise patient of dosage error due to patient leaving. When returned to the office, primary nurse notified and supervisor notified of found error. Protocol orders include notifying patient of error, filling an incident report, and completing a VAERS report. Nurse called Patient at 2:20pm at employment number provided of dosage error, possible adverse reactions, and emergency needs if applicable. Patient given opportunity to ask questions, patient acknowledged and no further questions asked. Nurse gave patient office phone number to contact nurse of any further questions.
Information has been received from an unspecified reporter, concerning a 63 year old female patient. On an unknown date the patient was vaccinated with PNEUMOVAX (dose, lot number, route not reported). On an unknown date the patient stated that the product made her sick. The outcome of the event was unknown. Causality between PNEUMOVAX (manufacturer unknown) and the event was not reported.
Initial information received on 06-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a seven-year-old patient (gender was not reported) who was vaccinated with a 0.5 ml single dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5325BA via intramuscular route in the left deltoid on 24-Mar-2018. The patient had no other vaccinations. It was reported that the patient visited a physician on 24-Mar-2018. It was a case of inappropriate schedule of vaccine administered. It was also a case of inappropriate age at vaccine administration. It is not known whether the patient had any untoward experiences after administration. 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 and Module VI of the 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. List of documents held by sender: none.
Sinus congestion; pains/Body aches; Sore left arm; Low energy; This is a spontaneous report from a contactable other Health Care Professional. A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration in left arm on 05Feb2021 at 12:00 AM (at the age of 71 years old) as single dose for covid-19 immunisation. Medical history included breast cancer, sinusitis, tachycardia, covid-19 from an unknown date and unknown if ongoing. The patient had known allergies to sulfur. Concomitant medication in two weeks included blood pressure, vitamins. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 06Feb2021, patient experienced body aches, pains, sore left arm, low energy, sinus congestion. The patient did not received treatment due to the events. The outcome of events was recovered with lasting effects on Feb2021.  Follow-up (13May2021): Follow-up attempts completed. No further information expected
product was administered to patient post excursion, with no reported adverse event; product storage error temperature too low, with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves an adult patient (gender: unknown) to whom INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] product was administered to patient post excursion and product storage error temperature too low, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE Suspension for injection  (strength: unknown, lot number: UT7683NA; UT7683NA; expiry date: 30-Jun-2023) via unknown route in unknown administration site for prophylactic vaccination and on the same day product was administered to patient post excursion, with no reported adverse event (poor quality product administered) and product storage error temperature too low, with no reported adverse event (product storage error).  It is unknown if the patient experienced any additional symptoms/events. It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available. This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.   Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QIV) was not applicable.  At time of reporting, the outcome was Unknown for both events.  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 the 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.; Sender's Comments:  US-SA-2023SA069712:01495415 US-SA-2023SA069591:01495347
PT WHILE WAITING IN OBSERVATION AREA FOR ALOTTED 30 MINUTES STARTED TO BECOME DIZZY 20 MINUTES AFTER ARRIVAL. VITALS WNL. PT WAS PROVIDED WITH WATER AND CLOSE OBSERVATION. PT REMAINED IN AREA FOR AN ADDITIONAL 30 MINUTES WITH OBSERVING RN; SYMPTOMS RESOLVED. PT WENT HOME
PATIENT NOW DECEASED (11.7.21)  - presented to ED (altered mental status - coded; expired) ED - DX:  acute respiratory failure with hypoxia; COVID-19; respiratory arrest; lactic acidosis Hospitalized (11.1.21 - 11.3.21);  COVID-19 positive (11.1.21);  Fully vaccinated PLUS booster   Date of Admission: 11/1/2021, Hospital Day: 3 Discharge Date: 11/3/2021 PRESENTING PROBLEM: Hypoglycemia [E16.2] Diarrhea, unspecified type [R19.7] Acute hypoxemic respiratory failure due to COVID-19 (HCC) [U07.1, J96.01] Pneumonia due to COVID-19 virus [U07.1, J12.82]   HOSPITAL COURSE: Patient is a 87 y.o. male who presents today with diarrhea . History obtained from medical record and patient. Patient is extremely hard of hearing and severely limiting obtaining history , does not have hearing aids with him . Niece and nephew now on floor however are not informed as to current medical issues. In ed on arrival found to be hypoxic to 87% placed on 3 lnc , cxr findings consistent with covid infection . Tested positive for covind 19 . Blood glucose on arrival found to be 34 , subsequent testin with rather rapid rise with a meal only . He was given decadron in ed .  Hospitalist service consulted for admission further evaluation.  Patient was continued on supplemental oxygen and administered dexamethasone and Remdesivir.  He was weaned to room air with adequate oxygenation.  Patient diarrhea improved likely related to COVID-19.  PT/OT evaluated advised home with assist home health PT/OT.  Case manager was consulted to arrange for outpatient services.  Electrolytes were monitored and repleted throughout the admission.  Patient was symptomatic lead treated with antitussives, antiemetics, analgesics p.r.n. patient clinically improved and hemodynamically stable for discharge.  Discussed plan of care discharge with patient including outpatient follow-up PCP in 7 days.  He will continue 3 additional days of dexamethasone and antitussives.  Patient was advised to follow-up outpatient ENT for evaluation of cochlear implant.  Patient was advised given difficulties with hearing to stop driving until cochlear implant issues addressed. Patient voiced understanding and was agreeable with the plan of care and discharge. CM arranged for patients niece to pick patient up.
In the evening, I was in pain by the elbow and the inside of my arm and it would go down to my hand and it would last from 15 min to 45 min maybe. I thought it was connected to my heart that's why I went to go see the cardiologist. After a month of pain, it gradually got worse. Doctor said he did not think it was the heart and he asked if I had gotten my booster vaccination and I replied yes, he assured that it was not connected to my heart.
Localized reaction at the injection site consisting of pain, swelling, redness and hot to the touch. Symptoms started the evening on the same day patient received vaccine. Despite around the clock Benadryl and ibuprofen administration, redness and swelling continued to spread until patient was seen in office on 7/22/23. At the time of the office visit, swelling and redness had spread throughout 2/3 of patient's upper arm.
My arm swollen up very large and hurts and I have chest pain and was even hospitalized and they saw every thing was clear, Also out of breath and light headed
Pain upon injection at site. Pain continued to get worse. Shoulder pain on day 2 and limited range of motion. No OTC pain meds helped with this pain. I finally made an appt with my Dr. and was seen on 7/23/21. She gave me  a steroid Medrol to take. I finished the medication but it did not help at all.  She ordered a soft tissue ultrasound.  The ultrasound came back an inflamed tendon. She gave me Prednizone and a prescription pain medication. Those did not help. I have a routine appt. On 7/24/21 and will discuss it further. It has now been over 5 months with pain and is very difficult to do normal Activities.
pt recv vax & devel a fever of 104 & pain @ the inj site;d/t  pain pt did not bear weight on lt leg;pt recovered;
Pain and swelling at injection site becoming hot and red at injection site, becoming very swollen in upper arm and some swelling in forearm. Became very hot in upper arm. No fever when taking temperature.   Also some mild headache and mild body aches
Patient stated she felt warmth at the site of injection extending downwards toward her forearm a few hours after injection with no fever, chills, difficulty breathing, hives. What she described was just localized erythema. 24 hour pharmacy instructed her to take ibuprofen and ice pain/swelling. Next morning around noon, she called our store detailing the same information to me about her arm feeling warm and red and that she had no other symptoms. She went to ER next day (08/04/20) around 2pm and saw NP, who stated she might have cellulitis unrelated to the vaccine and administered IV dose of antibiotics and sent oral keflex to be filled to be taken as treatment. I spoke to NP later that evening to inquire in detail to document. He stated the infection was unrelated to the vaccine administration, and patient had an inflammatory reaction causing localized erythema. Per NP, the cellulitis ensuing was from unknown cause (he stated it could've been from anything since a puncture of any sort in the skin can introduce bacteria at any time) - he mentioned patient should make a full recovery. Doctor and myself called patient to give updates and to have her call us if she develops a fever (she has not developed a high temperature reading or any other symptoms besides the warm/red inflamed arm). NP stated he will have her come by the next day to have a check up. I called patient again around 7pm, which husband stated she was doing okay with just the warm/red swollen right arm. Patient's husband will call for any updates. Furthermore, he wanted me to call mfg to see if there was any incidences of contaminated syringes related to the lot number. Mfg was closed at the time - open 08/05/20 9-5pm, which I will call in the morning.
pt recvd vax & 2 wks later exp paralysis on entire lt side; results from MRI suggested MS type demyelination; tested pos on a spinal tap for protein in fluid;
Headache, Myalgia, NauseaVomiting, SORE ARM  Narrative:
Patient presented to the ED and was subsequently hospitalized for paranoia within 6 weeks of receiving COVID vaccination. She is still currently hospitalized.
Lightheadedness, Chest pain, feeling heavy O2: 99% Pulse: 95 BP: 140/90
Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to clinic reporting body aches, heaches, and chills since receiving vaccination five days prior.  No shortness of breath, chest pain, vomiting, or diarrhea. Patient was not in distress or ill-appearing: normal breath sounds (no wheezing, rhonchi, or rales). Five days after clinic visit (ten days after vaccination) patient's wife and daughter reported patient had poor appetite and feeling worse since clinic visit: weakness, pain all over, decreased oral intake, and cough with phlegm. Advised to go to the emergency room immediately. Patient's daughter reported the next day patient admitted to another facility and COVID-19 test was positive.
Patient complained of pain and soreness radiating down her entire arm and into the right side of her chest for 2-3 days.
Information has been received from a physician, via a company representative, and a nurse concerning an 80 year old female, with unknown medical history and unknown drug reactions/allergies, who on 11/15/05 was vaccinated route unknown with a dose of Pneumococcal 23v polysaccharide vaccine (651523/0604R). The next day on 11/16/05, the pt developed swelling, redness, and tenderness to her right upper arm. The nurse confirmed that the pt developed cellulitis. The pt was treated with three doses of cephalexin Keflex and subsequently recovered on an unspecified date. No product quality complaint was involved. The nurse could not provide additional details, However she reported that the office would keep track of additional reactions involving Pneumococcal 23v polysaccharide vaccine. The doctor retrained staff on how to store and administer the vaccine. Additional information has been requested.
Arm soreness/ pain did not go away after 1 week. Arm swollen, weak, difficult to raise arm.
This spontaneous report as received from the mother of the patient refers to her 13 year old son without pertinent medical history and drug reactions/allergies. On 04-OCT-2013, 22-JAN-2014 and on 01-JUL-2014, the patient was vaccinated with a dose of GARDASIL, injection, "1 single shot", intramuscular, respectively. There was no concomitant medication. The reporter stated that "04-OCT-2013, 22-JAN-2014 and on 01-JUL-2014 are the days the patient received GARDASIL and after every dose the patient experienced difficulty breathing, felt faint and his vision was impaired." The reporter also stated that "these reactions did not last very long." The patient didn't seek medical attention. No lab diagnostics studies were performed. No treatment was given to the adverse events. The outcome of the events was recovered. Additional information has been requested.