chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling and moderate soreness/pain in lymph nodes in left armpit and left side of chest under left arm, minor swelling and pain at injection site on left arm. Symptoms did not begin until the morning after (approx 12 hours) receiving the booster but seem to be worsening as of second morning following booster. Seem to have minor pain and tingling sensation down the left arm into left hand/fingers as well. Treated with ibuprofen for pain.
Fever + 2 degrees above my normal 98, lasting 48 hours. Site of injection extremely red and swollen, itchy, painful. 6" long by 3" wide, lasting 5 days.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2009, the patient was inoculated with the ZOSTAVAX vaccine at a physician office as recommended for routine adult health maintenance for the long term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 25-NOV-2015, the patient was treated by a physician for the onset of a vesicular rash, which was diagnosed as severe herpes zoster. The patient was prescribed VALTREX for management of his painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
After being injected child instantly fell asleep, slept for 24 hours straight. Redness around injection site and tender. By the next morning his skin broke out in a red itchy rash. He now has eczema. Break outs include itching non stop even when skin is broken open and bleeding.
Box 17 - Shingrix   1st dose - 3/2019. Exact date unknown. Adverse event began the following day. 100 fever for two days. Chills.  2nd dose - 02/12/2020. Adverse event began 2/13/2020  Three inch circumference redness and swelling, hard knot and soreness at injection site. Lasted 6 days. Injection site is not pink, but not as hard. No plans to seek medical attention.   Box - Flu vaccine
I react to the Covid shots; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (I react to the Covid shots) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for COVID-19 immunization.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (I react to the Covid shots). At the time of the report, IMMUNISATION REACTION (I react to the Covid shots) outcome was unknown.     Concomitant medication was not provided. Patient reacted to both COVID shots, i.e., both Pfizer and Moderna.  Treatment information was not reported.   Reporter did not allow further contact.
Per web report received from hospital. Patient with no significant past medical history, presented to the ED via ambulance for evaluation of altered mental status. The patient was somewhat of a poor historian. She was oriented to person and place. She recalled she went to a store for shopping. Patient did not know what happened next.  She stated she was feeling fine and did not want to stay in the hospital.  She was unsure why she is currently in the ED. Patient denied any headache, fever, or chills.  Denied any chest pain, palpitations, nausea, vomiting, abdominal pain, diarrhea, or dysuria. Per ED documentation, patient was found with altered mental status in shopping center parking lot. Patient was brought via EMS to hospital for further evaluation. Record noted that patient's diagnosis of altered mental status/acute metabolic encephalopathy of unclear etiology. Hospital notes stated this could be related to COVID-19 infection.  CT scan of the head was negative for any acute intracranial process.  No focal signs of acute stroke.  COVID treatment was instituted, and the patient was monitored for changes in mentation. Hospital note stated primary diagnosis of COVID-19 infection, symptomatic. Not hypoxemic. Chest x-ray showed mild right upper lobe pneumonitis.  Note stated Labs showed lymphopenia and laboratory orders for inflammatory markers ordered. Patient was started on Decadron 6 mg daily due to symptoms and monitor.  Oxygen supplementation was ordered p.r.n.  Speech evaluation was ordered due to concern for aspiration. Additional diagnosis of hypothyroidism, untreated.  Hospital not stated that it is unclear if this is contributing to her altered mental status.  The patient was started on Synthroid. Hospital notes stated addition diagnosis of Bacteriuria, due to probable acute urinary tract infection present on admission.  Patient was started on IV Ceftriaxone and follow up on urine culture ordered. Additionally, patient had a normal anion gap metabolic acidosis, hypokalemia, Hypomagnesemia, of which supplemental potassium and magnesium and IV fluids for hydration and acute kidney injury were given and BMP monitored. Hospital note stated abnormal LFTs. LFTs on admission with slightly elevated AST; could be from COVID 19 infection. Patient was monitored for deep venous thrombosis and was put on prophylaxis Heparin. Additional note stated the patient declined and patient transferred to Hospice and died on 1/10/2022 from complications of acute on chronic respiratory failure and covid pneumonia at 12:02 with family present.
When injecting needle, vaccine spilled out of syringe so patient did not receive dose.  I injected another full dose in the other arm.
the patient did not experience any symptoms; the patient, who is 2 months old, was administered one dose each of MMR II and VARIVAX.; the patient, who is 2 months old, was administered one dose each of MMR II and VARIVAX.; This spontaneous report was received from a registered nurse, referring to a 2-month-old patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies were not reported, and concomitant medications included hib conj vaccine (ompc)(PEDVAXHIB), pneumococcal 13v conj vaccine (crm197)(PCV 13), rotavirus g1 p1 vaccine live (89-12)(ROTARIX) and hepatitis a virus vaccine inactivated (HAVRIX).      On 04-DEC-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (rHA) the first dose, administered subcutaneously as prophylaxis (anatomical location, lot number S005248 has been verified to be a valid, expiration date not reported but validated as 20-FEB-2021) and varicella virus vaccine live (oka/merck)(VARIVAX) the first dose, administered subcutaneously (anatomical location, lot number S021320 has been verified to be a valid, expiration date not reported but validated as 09-JUL-2021) (product administered to patient of inappropriate age and inappropriate schedule of vaccine administered).   The patient did not experienced any symptoms.
On Jan. 19th, 2021, right arm suddenly became sore again at injection site. This was 1 week after vaccine injection. Next day, upper right arm was red, rashy, tender to touch and hot to touch. Red area on arm spread during the day.  No fever. Called my Doctor and went in for check. Suspected blood clot, but ultrasound was negative.  Suspected  Cellulitis. RX given for Keflex 5 day regimen.  Symptoms ceased on Jan. 23rd, 2021.
The patient has not received their 2nd dose Patient is at day 71; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (The patient has not received their 2nd dose Patient is at day 71) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (The patient has not received their 2nd dose Patient is at day 71). At the time of the report, PRODUCT DOSE OMISSION ISSUE (The patient has not received their 2nd dose Patient is at day 71) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication history not provided. Treatment information was unknown.
His blood pressure dropped to around 100; His temperature was down to 91°F; His entire left side of his body was numb/left feet/middle 3 toes remain numb currently; Started to break out in a profuse cold sweat; he was cold; Fatigued; This is a spontaneous report from a contactable consumer. A 72-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 13Mar2021 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin from an unknown date. Concomitant medications were not reported. The reporter stated her partner received his first dose of BNT162B2 on 13Mar2021 and immediately after started to break out in a profuse cold sweat, his blood pressure dropped to 100, which was very low for him, and his entire left side of his body was numb. The reporter stated the numbness had mostly improved and only his left foot/middle three toes remained numb "currently." She reported his temperature was down to 91 degrees Fahrenheit when his temperature was checked to go into work. She reported he was cold and fatigued for two weeks after the vaccine. The reporter was concerned his symptoms had lasted that long and was seeking more information on this. She also stated that her partner was allergic to penicillin and she had read that people with this allergy should not receive anything with "PEG," thus he might have had this reported side effect due to his penicillin allergy. The clinical outcomes of his blood pressure dropped to around 100, his temperature was down to 91 degrees Fahrenheit, profuse cold sweat, he was cold, and fatigued were unknown; the outcome of his entire left side of his body was numb/left feet middle three toes remain numb was not recovered.
I developed Bronchitis after the vaccine was administered, I noticed that I have been sick more often this year since taking the vaccines, I saw Dr. diagnosed with Bronchitis, I then saw different doctors ordered a CT Scan to further investigate my lungs for the 10th of November. Extreme fatigue, whenever I walk around I become more fatigued than ever before, shaking chills, sweating, no real fevers, headaches which lasted for weeks. Levaquin was prescribed to help symptoms. I saw a Immunologist and a Pulmonologist
felt lightheaded; Pinched nerve; Numbness on face; Tingling sensation on face; The left side of the face was burning; Left side of the arm was burning; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (felt lightheaded), NERVE COMPRESSION (Pinched nerve), PARAESTHESIA (Numbness on face), PARAESTHESIA (Tingling sensation on face) and BURNING SENSATION (The left side of the face was burning) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included IBUPROFEN (ADVIL 12 HOUR) and PARACETAMOL (TYLENOL) for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced DIZZINESS (felt lightheaded), NERVE COMPRESSION (Pinched nerve), PARAESTHESIA (Numbness on face), PARAESTHESIA (Tingling sensation on face), BURNING SENSATION (The left side of the face was burning) and BURNING SENSATION (Left side of the arm was burning). At the time of the report, DIZZINESS (felt lightheaded), NERVE COMPRESSION (Pinched nerve), PARAESTHESIA (Numbness on face), PARAESTHESIA (Tingling sensation on face), BURNING SENSATION (The left side of the face was burning) and BURNING SENSATION (Left side of the arm was burning) had resolved.            Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not Applicable.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up was received included AE outcome reported: Events have resolved
My son acted whinier than normal the evening of his vaccine.  The following morning around 9:30, he dry heaved and said he was very tired and had body aches.  The whole day following the vaccine, he complained of body aches, ran a fever (101.8 was the highest) and took a very long nap (very out of character.  He had no appetite and is normally a very big eater.  Two days after the vaccine, he was back to normal.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 12-JUL-2016, the patient was vaccinated inadvertently with an expired PNEUMOVAX 23 (lot # L002310 with expiration date 08-JUL-2016; dose and route were not reported). No adverse effect was reported. Additional information has been requested.
Passed out; felt dizy; hit my head and injured my ankle; fallen; hit my head and injured my ankle; This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number was not reported) via an unspecified route of administration, administered in Arm Right at the age of 26-year-old, on 12Apr2021 10:30, as SINGLE DOSE for covid-19 immunisation.  Medical history was not reported. The patient's concomitant medications were not reported. The patient did not receive vaccine in four weeks nor was the patient tested for COVID post vaccination. On 12Apr2021 at 11:00, the patient felt dizzy and then the patient passed out. When the patient woke 3 minutes later, he had fallen and hit his head and injured his ankle. The patient was taken by the ambulance to the local ER and was released later that day as his vitals had returned to normal. Therapeutic measures taken in response to the events included IV fluids. They advised that the patient reach out to see if he can receive my second shot on 03May202. Outcome of the events was recovering at the time of the report.  Information about lot/batch number has been requested.
Shoulder pain begin after the injection and persisted for 2 days. Then shoulder mobility began to decrease and pain returned. I was then diagnosed with frozen shoulder and underwent months of physical therapy and 3 steroid injections. Then I had to get an MRI and shoulder surgery to repair the shoulder and and undergoing recovery now. I had no previous injuries to that shoulder and am right-handed so there's no other way to explain the onset of frozen shoulder and subsequent related woes.
There was a hard raised lump at the injection site with inflammation and soreness at the injection site.  The next day,  the soreness has gone away,  but a one inch circle around the injection site it black & blue.  Also,  there is a very definite 3/4 inch square around the injection site that is slightly recesses.  There is still a hard spot on the day after the injection at the injection site, but the swelling has gone down.
She thought maybe she has a sinus infection; She has been feeling sick; Has Covid and she received both the Pfizer vaccines; Has Covid and she received both the Pfizer vaccines; This is a spontaneous report from a non-contactable consumer (patients parent) via Pfizer Sales Representative. A 23-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 2 via an unspecified route of administration on 01May2021 (at the age of 23-years-old) (Batch/Lot Number: EW0153; Expiration Date: Jul2021) as DOSE 2, SINGLE for prevention for Covid 19. The patient medical history was not reported. There were no concomitant medications. The patient previously took bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration on 10Apr2021 (Batch/Lot Number: ER8730) as DOSE 1, SINGLE for covid-19 immunisation. The patient parent (Pfizer Sales Representative) stated his daughter received her vaccine on 10Apr2021 and 01May2021 but through Pfizer. Today, she just texted that she has Covid. Reporter was not a health care professional he was just sales representative. Reporter further stated, do you need the final result to the report, she just sent me her report that says she is positive? The patient was taking, the doctor just put her on an antibiotic be-cause she thought maybe she had a sinus infection on an unspecified date. She al-so had been feeling sick on an unspecified date. So, she was taking an antibiotic that was Amoxicillin (Intent: Treatment). The patient underwent lab test, which was  nasal swab, it was collected on 27Jul2021 at 11:09:57. Collected 27Jul2021, received 28Jul2021 and Released 28Jul2021 at 11:43 pm, they are not 'Time' (not clear). Her report that says she was positive on 28Jul2021. The patient had no prior vaccination within 4 weeks. The outcome of all events was unknown.  Follow-Up (03Aug2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Patient received booster dose at 3:07-3:08 PM on 2/03/2021.  Patient had no issues with first shot (even commented that she didn't have a sore arm with the first shot).  At approximately 3:19 patient stated that she was having extreme itching  around the injection site and down her arm.  I asked her if she was having any trouble breathing or itching of the throat and she said no.  Approximately 1 minute later she stated that her throat felt like it was tightening up.  At that point, 0.3 mg of epinephrine was administered into her right mid outer thigh and emergency personnel were dispatched.  First repsonders arrived 5 minutes later and the ambulance/EMTs arrived.  Patient's pulse ox never dropped below 98% and she was transported to a local hospital.. She was discharged a couple of hours later and came back by the pharmacy to let us know that she was ok.  She stated that she had received 1 more dose of epi, corticosteroid, and antihistamines in the hospital.
Client had flu symptoms approximately 2 weeks after the Flu Mist administration, and has continued with these to the present.  Is being treated by the primary physican with Tamiflu.
my arm is hurting; cause his neck to hurt. It is hurting.; might have slept wrong; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age (reported as 66 [units unspecified]) received his first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he got the first dose of the vaccine yesterday and his arm was hurting and wondering if it could cause his neck to hurt. It is hurting. He might have slept wrong. The outcome of the events was unknown.  The following information on the batch/lot number has been requested.
Patient was given a (0.25ml) dose instead of (0.5ml) dose.
Extremely fatigued. Slept sixteen hours on Fri day/Saturday. Woke up for three hours, and slept four hours. Woke up again, staying up for five hours, and slept another seventeen hours. After only two hours, I was fatigued once more. I feel too nauseous to eat, and am shaking as if I'm cold.
Information has been received from a nurse concerning a 17 year old female, who, on an unspecified date, was vaccinated intramuscularly with a dose of Gardasil. Subsequently, on an unspecified date the patient developed a low grade fever after being vaccinated. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information is not expected.
Patient received a JEV, Ixiaro, vaccine of 0.5ml to R-deltoid IM due to the fact he will be flying next week. Patient received JEV#1, JEVax, on 13FEB06 and JEV#2, JEVax, on 27FEB06.  There is no other documentation of completing JEV#3. Patient has had no adverse reaction from JEV - Ixiaro vaccine to date. A comment/question via email was sent to HC this PM explaining the above and asking if patient needs to receive another JEV vaccine of Ixiaro in 28 days. This is being submitted in VAERS as an FYI/tracking purpose.
Fever for 2 days ranging from 101-102.5 F. Patient was given childrens Tylenol to minimize the fever. Pateint was sluggish and had a low appetitie on day 10/3.   A rash of small red bumps appeared on skin on 10/5.
accidentally given a 5 year old child with no adverse event; Initial information received on 05-Nov-2022 regarding an unsolicited valid non-serious case received from a pharmacist via e-mail.  This case involves a 5 year old patient of an unknown gender who was accidentally given INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] with no 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 0.7 ml of suspect of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ925AA, expiry date: 30-June-2023, formulation, and strength not reported) via unknown route in unknown administration site for prophylactic vaccination and accidentally given a 5 year old child with no adverse event (product administered to patient of inappropriate age) (unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.   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.
Cellulitis of the arm, red with warm to touch, put on Keflex per ED.