chrisvoncsefalvay/vaers-outcomes huggingface dataset:
it was also drying out her eyes; I still Have mouth swelling; I had swelling in my face / I had swelling in my lower jaw / I had swelling in my cheeks; I also had swelling in my upper lip; This spontaneous case was reported by a consumer and describes the occurrence of MOUTH SWELLING (I still Have mouth swelling), SWELLING FACE (I had swelling in my face / I had swelling in my lower jaw / I had swelling in my cheeks), LIP SWELLING (I also had swelling in my upper lip) and DRY EYE (it was also drying out her eyes) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 026L20A) for COVID-19 vaccination.     The patient's past medical history included Dermal filler injection (The patient got fillers in her face, lower jaw and cheeks) on 17-Feb-2021 and Dermal filler injection (The patient got fillers in her upper lip well over one year prior) in 2020.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced SWELLING FACE (I had swelling in my face / I had swelling in my lower jaw / I had swelling in my cheeks) and LIP SWELLING (I also had swelling in my upper lip). On 20-Aug-2021, the patient experienced MOUTH SWELLING (I still Have mouth swelling). On an unknown date, the patient experienced DRY EYE (it was also drying out her eyes). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Adverse event, at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form. At the time of the report, MOUTH SWELLING (I still Have mouth swelling) had not resolved and SWELLING FACE (I had swelling in my face / I had swelling in my lower jaw / I had swelling in my cheeks), LIP SWELLING (I also had swelling in my upper lip) and DRY EYE (it was also drying out her eyes) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.
On 10/2/08 client received her 1st flu shot.  30-45 min after shot, felt a sensation at injection site & then began coughing with phlegm production. Unable to stop coughing.  Took Claritin, resolved X 1 hr, cough came back w/some difficult breathing.  Allergist & PCP sent her to ER where she was given IV Benadryl coughing & phlegm stopped.  Went home, coughing began again at 9 pm that night, took Claritin.  Coughing began again in the am, took Benadryl and Pepcid Q 6 hours though the weekend.  Monday morning took Claritin, ok until 3 pm, then had difficulty breathing, increased HR, faintness, took Claritin & Pepcid, still felt dizzy/faint -30 min later- PCP & Allergist again sent her to urgent care.  Finally allergist advised regular dosage of Claritin or Zyrtec.  Has been ok X 2-3 days at time of this report.  10/13/2008
Had a bruise for about 3 weeks after immunization. Continued to have pain, and hurts to lay on arm. When deltoid muscle is tightened, patient is in pain.
No adverse event; Nurse is calling to report that patient received expired vaccine on 12-JUN-2023; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Nurse is calling to report that patient received expired vaccine on 12-JUN-2023) and NO ADVERSE EVENT (No adverse event) in a 6-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jun-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Nurse is calling to report that patient received expired vaccine on 12-JUN-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Nurse is calling to report that patient received expired vaccine on 12-JUN-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Nurse is calling to report that patient received expired vaccine on 12-JUN-2023).    No concomitant information was reported. Suspect product dosage text was reported as unknown. The 2.5ml vial was initially stored in refrigerator on 09-Jun-2023 and did not underwent temperature excursions.  This case is reported for 6 month old baby. No treatment information was provided.
Initial information received on 05-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves an unknown age female patient who received vaccine FLUZONE HIGH DOSE (lot number not reported) via sublingual route in unknown administration site on an unknown date. The patient's past vaccination(s) included FLUZONE HIGH-DOSE sublingually for the past 3 years. The patient's past medical history, medical treatment(s) and family history were not provided. The patient has ongoing illness of MS. It was a case of actual medication error due to wrong route of product administration. It was reported that the patient has MS and cannot take any shots (IM). At the doctor's office they squirt the liquid under her tongue have her hold it there for a couple of minutes then swallow the liquid. It was reported that the patient never had any adverse event. 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. List of documents held by sender: none.
Injection sight had remained tender and warm since vaccination on 12-31. After scratching lightly on 1-9 noticed significant increase in heat, redness, itching and swelling. By 1-11 had formed a firm lump slightly larger than a tennis ball  - approximately 4 inches in diameter that was hot to the touch, tender and angry red with a purple center. On Tues 1-12 I contacted the local health dept who advised cold compresses and benadryl and if it did not started to shrink to see my pcp. On Wednesday 1 -13 2 more significant misshapen lumps had formed, 1 towards the inside of my arm and another towards the other. The irritation, swelling and redness had also spread while the color was no longer so angry. Due to that on Thursday 1-14 I saw my PCP who diagnosed cellulitis.  I was prescribed 2000mg of amoxicillin a day for 7 days and a 5 day course of prednisone 20mg.
Fever of 102.0 Heaviness in my chest Aches/ sore Redness at injection sight
A heavy head, neck hurts, needing to hold the back of her head, headache,  diarrhea, fatigue
Very swollen leg, from upper thigh down to her knee, softball sized, hot to the touch.  Skin became hard and red, very itchy. Took her to urgent care, doctor verified it was a large site reaction. Treated with Motrin and antihistamines.
Rash on chest - Benadryl. Sore arm. Possible fever.
Site: Bruising at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Within 2weeks major dev of juvenile dermatomyositis with muscle wasting and weakness. Developed Von Willebrand's disease. Among other symptoms of a autoimmune crisis.
Information has been received from a physician concerning a female patient who was vaccinated with a first dose of Gardasil. Subsequently, the patient experienced chest pains and shortness of breath. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Shortly after getting the vaccine, patient got lightheaded and fell to the ground hitting her head on the door. After about 30 seconds or so she came to and asked what had happened. We called 911 and got an ice pack for the patient's head. Paramedics came within 5-10 mins.
Pt presents ambulatory post influenza vaccine 30-35 minutes. C/o numbness right upper extremity and tingling right wrist. Shot administered in right upper arm. Pt provided Ketorolac 10mg po for pain.
Within an hour following vaccinations, right eye appeared red on the inside white part of the eye. Patient reported feeling a little pressure below the eye. Patient was told to monitor, and go to urgent care if it gets worse.
This spontaneous report was received from a physician refers to a 13 year old male patient. The patient had no pertinent medical history and no known drug reactions or allergies. On 21-MAR-2002, the patient was vaccinated with the first dose of VARIVAX (Merck), 0.5 ml, subcutaneous, lot # reported as 1552L (which is not valid for VARIVAX), expiration date August 2004 or lot # 1249L, expiration date March 2003. On 04-MAY-2009, the patient was vaccinated with the second dose of VARIVAX (Merck), 0.5 ml, subcutaneous, lot # 0097Y, expiration date 16-JAN-2011. There was no concomitant medication. On 28-FEB-2015, the patient experienced rash vesicular which started as left flank and back pain and then the rash actually developed on 03-MAR-2015 according to the patient. On 05-MAR-2015, the patient was seen in the physician office due to developing a shingles like rash on the left hip and thigh laterally. Acyclovir was given as treatment. There were no laboratory diagnostics studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.
36 hours after receiving immunizations, patient developed a fever. Seizures ensued and patient was taken to the emergency room. Child is now afebrile.
diagnosed with covid19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (diagnosed with covid19) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (diagnosed with covid19). At the time of the report, COVID-19 (diagnosed with covid19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test positive: Diagnosed with covid19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No relevant concomitant medications were reported No treatment information was provided.
Patient was offered covid booster vaccine by provider patient misunderstood and states she had received primary series when she had not.  Error was not caught until booster was administered.
This spontaneous report as received from a health care worker refers to unspecified number of patients of unknown age and unknown gender. The unspecified patients pertinent medical history was not reported. On an unknown date, the unspecified number of patients were vaccinated with PNEUMOVAX 23 (dose, frequency and lot # were not reported) which was improperly stored. No adverse events were reported. No product quality complaint was reported for PNEUMOVAX 23. This case is linked to case # 1501USA006479 (same reporter link). Additional information has been requested.
Adverse event #1: extremely heavy menstrual bleeding, started first period after receiving second dose of pfizer approximately 3/13/2021 resulting in anemia Treatment: DNC and blood transfusion  Outcome: DNC stopped bleeding, blood transfusion and additional vitamin intact has helped anemia  Adverse event #1: rashes after receiving second dose of pfizer approximately several days later Treatment: prescription cream  Outcome: still have rashes and itching on back, under arms, and on ankles
no adverse effects were reported in the patient; the patient received a dose of MMR II via the intramuscular route; This non-valid spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information concerning the patient's pertinent medical history, concurrent conditions, concomitant medications or allergies provided.  On 04-MAY-2019, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) therapy type rHA(lot # R031679, expiration date: 01-NOV-2020, intramuscularly(Inappropriate route of administration))(exact dose was not provided) for prophylaxis. No adverse effects were reported.  This case is non-valid due to lack of patient identifiers.
On 09/23/2005 at 1500 began shaking all over with chills, and headache, cried with pain, stated hurt all over, no local redness or warmth, afebrile, denied nausea, vomiting or diarrhea, stated spent two days in bed. Since 09/25/2005 continues to feel weak, and had no appetite, but is better.
Patient received vaccine at approx. 8:05pm. Around 8:20pm he presented at the pharmacy in distress, with a headache, trouble breathing and feeling as though he could not swallow.  I had him sit down and relax for a few minutes, he had some sips of water, and I took his BP which was 221/130 HR81.  Advised him to seek emergency services.  Patient was coherent and responsive the entire time, he stated an allergy to benadryl and did not require the use of Epipen.  He felt that he wanted to go sit in his truck and relax, his wife was present as well, I checked on him at 8:30pm and he was doing much better, he still felt that he had "cotton mouth" could not swallow well but denied trouble breathing.
Patient requested COVID booster during office visit.  Patient had COVID in October.  Per provider, patient was past their quarantine window & asymptomatic at visit.  Provider asked what the patient was treated with, patient told provider that they were treated with antibiotics and steroids.  Patient completed questionnaire for COVID vaccine & circled "No" on the question about receiving monoclonal antibodies.  Patient received 0.25mL booster per protocol.  Patient called later that day after leaving office, verified patient per name & DOB, patient stated that she forgot that she had received monoclonal antibodies and she was concerned since she received the COVID booster.  Patient also received the flu shot on the same day.  Patient has not developed any signs nor symptoms; spoke with patient today and patient states that she felt fine.  CDC has been reached out to for guidance on the situation.
Pt fainted after receiving vaccines, approximately 15" after vaccines.  Pt did not hit head;  No seizure noted.  Pt. recovered with fluids (juice + water) and sat in a chair till stable.
LEFT LEG RED  WARM AND SWOLLEN SPREAD ON THE THIGH 4 FINGERS WIDTH  SPOKE TO MOTHER ON 02/04/2022 AND PATIENT LEG HAS IMPROVED WITH WARM PACKS
First time receiving influenza vaccine of any type.  Child felt a little confused 5 minutes after receiving dose.  In school classroom, could not process math problems easily.  Child felt dizzy walking to school clinic.  Checks were flushed and rosy.  Breathing and pulse were normal, no fever (98.7 F).  Flushing continued for at least 25 minutes.
Developed a metallic taste in mouth four days after injection. Symptom was present for 48 hours before resolving for 24 hours, but then returned again for at least 48 hours (symptom currently present). 50% improved from yesterday.
April 14:  First COVID dose; Upon receiving the shot, my face got hot and flushed.  I felt strange in the head like brain fog, not sharp. This lasted a few hours.  My arm was sore and I experienced fatigue, but all of that seemed relatively normal.  Soreness went away over the next couple of days. April 21:  Day 8; This evening I started feeling a tightness in my chest that felt like what I imagine heartburn feels like, as if something was stuck deep in my esophagus and every time it squeezed I felt pain.  It was painful to take a big breath, I got painful hiccups frequently but not long lasting, and occasional painful twinges like a quick squeeze. April 22:  Day 9; I woke up with a really sore front of the neck, like I had frontal whiplash.  It was painful to move too much, to cough, sneeze, swallow, hiccup. Also got a sensation off and on in my left arm like it was buzzing with alcohol, and occasional twinges of pain or a general light ache. Still had the chest tightness, off and on.  Some days it would last a full day, others it seemed to just act up lightly a few times throughout the day. These symptoms went away by April 24 or 25. April 28:  Day 15 Woke up throughout the night with a severely itchy inner ear (left ear -- same side as injection site). Also the left side of my neck was very itchy and swollen up by my jaw.  Swollen lymph node as well.  The neck muscles on the left side were also sore. My head felt hot to the touch, as if it had a rash. My chest starting hurting again like before, but not as badly (hiccups, big breaths were painful and restricted).  Got the left arm twinges, too, but not as bad. The itchy inner ear lasted two full days, waking me up throughout the night two nights in a row. April 30:  Day 17; I went to urgent care and got an EKG, chest x-ray, and blood tests done.  All results were normal.  The doctor said my ear was red inside and that it must be an ear infection (caused by unknown reasons).  There was no visible rash on the outside (no shingles present).  She prescribed antibiotics, which I planned to fill, but the next day the itching was gone on its own, so I did not take the antibiotics. She had no thoughts on explanation for the other symptoms. May 5:  Day 22; Chest tightness is back, with hiccups.  Front of neck is a little sore, but not as bad as before.  My headache got much worse. May 6:  Day 23; Woke up with a cold (I think):  headache still really bad, sore throat, hot feeling in my head, a little congested, and a little bit of a runny nose.  Stayed home from work, feeling sick.  Still have the chest tightness throughout the day.
Patient was nervous about getting vaccine. Discussed safety profile of vaccine and that many people are tolerating very well. Patient seemed much better after discussion and was ready to get vaccine.  Gave injection and he was doing fine and went to sit down for 30 minutes as recommended. After giving next vaccine about 15 minutes later patient apparently tried to come across waiting room to speak to me and started to fall. Next patient was leaving room and caught patient, preventing injury and called for help.  Multiple staff responded.  Patient reported dizziness and seeing colors.  Was breathing fast but not having any swelling or trouble breathing. Was able to stand after a minute and was taken to clinic that is right next to pharmacy for evaluation. Patient was evaluated and left within the next hour doing well.  Spoke to patient in the afternoon and reports recovering well, has a headache that he thinks is stress related.  Counseled to continue to monitor and seek medical attention if any worsening of symptoms.
Days 1 and 2 after - severe headache. Resolved after 2 days. On day 8 woke with migrane headache that included room spinning, dizziness and nausea. Took an imitrex 50 MG then another 2 hours later.; Days 1 and 2 after - severe headache. Resolved after 2 days. On day 8 woke with migrane headache that included room spinning, dizziness and nausea. Took an imitrex 50 MG then another 2 hours later.; Days 1 and 2 after - severe headache. Resolved after 2 days. On day 8 woke with migrane headache that included room spinning, dizziness and nausea. Took an imitrex 50 MG then another 2 hours later.; Days 1 and 2 after - severe headache. Resolved after 2 days. On day 8 woke with migrane headache that included room spinning, dizziness and nausea. Took an imitrex 50 MG then another 2 hours later.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 09Apr2021 08:30 (Batch/Lot number: unknown) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Have previously had shingles" (unspecified if ongoing); "get occasional migraine" (unspecified if ongoing); "known allergies: Sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: TESTOSTERONE; BIJUVA. Past drug history included: Cephalosporins, reaction(s): "Known allergies: Cephalasporin", notes: Cephalasporin. The following information was reported: HEADACHE (non-serious), MIGRAINE (non-serious), DIZZINESS (non-serious), NAUSEA (non-serious) all with onset 17Apr2021 06:30, outcome "not recovered" and all described as "Days 1 and 2 after - severe headache. Resolved after 2 days. On day 8 woke with migrane headache that included room spinning, dizziness and nausea. Took an imitrex 50 MG then another 2 hours later.". Therapeutic measures were taken as a result of headache, migraine, dizziness, nausea.  Additional information: Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines in fourweeks. Patient did not visit emergency room and physician office visit for the events. Patient did not have covid prior vaccination and Patient do not have covid tested post vaccination  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax 24JAN89 & approx 12 days following vax pt devel a rash & an arthritis-type reaction;
patient was given 1ml dose in one setting instead of .5ML; A spontaneous report was received from a physician concerning a patient who experienced accidental overdose (patient was given 1ml dose in one setting instead of .5ML).    The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.   On 10 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 030M30A) intramuscularly for prophylaxis of COVID-19 infection.   On 10 Feb 2021, the patient was given 1 mL dose in one setting instead of .5 mL. Treatment information was not provided.    Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event patient was given 1ml dose in one setting instead of .5ML was unknown.; Reporter's Comments: This report refers to a case of accidental overdose for mRNA-1273.  There were no reported adverse events associated with this case.
Numbness in left side of the body after few hours of getting the vaccine. This only lasted for a few hours. After few hours and to this day, only the left side of the face feels kind of numb at times. Not every day. Haven't received any medical treatment for this.
On 19Mar21 at 8:30 am EST noticed A burning sensation  and small rash on the left side of neck. On same day in the evening noticed left supraclavicular  LN the size of a walnut. The node is not painful or sensitive to the touch and is currently ongoing. Have no other symptoms except pain at the injection site the second day after the vaccine administration.
Rash and itching to chest, Periorbital and facial edema and rash. Onset aprox 36 hours post vaccination of dose 2 Treated with Prednisone 60mg and antihistamines in outpatient setting.