chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received the intramuscular seasonal influenza vaccine on 11/10/09. By 14 Nov she c/o lightheadedness, upset stomach, having a 'prickly feeling ' in both legs with a majority in the thighs, intermittent diarrhea, 'heavy legs,' fatigue, some shortness of breath, but no fever. These sxs lasted 2 weeks and then spontaneously resolved. Symptoms: paresthesia, diarrhea, fatigue, malaise <60 days, dyspnea.
Initial and follow up information has been received from a registered nurse and a physician (physician's notes provided), concerning a 50 year old caucasian female with drug hypersensitivity (ciprofloxacin hydrochloride (CIPRO), tramadol hydrochloride (ULTRAM), levofloxacine (LEVAQUIN), moxifloxacin hydrochloride (AVELOX) and norfloxacine (NOROXIN)), asthma, gastrooesophageal reflux disease, hypothyroidism and chronic sinusitis and a history of Hodgkin's disease (in remission), spleen disorder ("post-splenic") and skin cancer (excised in 1984) who on 20-MAR-2008, at 10:21 am, was vaccinated IM into the right deltoid with the fourth dose, 0.5 mL, of pneumococcal 23v polysaccharide vaccine (Lot# 659150/1384U). Concomitant vaccine therapy included a dose in the left upper arm of tetanus toxoid (SP, lot # U1959BB). Other concomitant therapy included tetanus toxoid, levothyroxine Na (SYNTHROID), acetaminophen (+) propoxyphene napsylate (DARVOCET-N), alprazolam (XANAX), testosterone, formoterol fumarate (FORADIL), guaifenesin (MUCINEX), triamcinolone acetonide (NASACORT AQ), prednisone, montelukast sodium (SINGULAIR), carisoprodol (SOMA) and cetirizine hydrochloride (+) pseudoephedrine hydrochloride (ZYRTEC-D). There was no illness at the time of vaccination.The physician indicated that on 20-MAR-2008, the patient's right upper arm was red, hot and tender around the immunization site of the "pneumovax vaccine," and added "there is a 8 x 10 cm area of induration and erythema." On 24-MAR-2008 the patient came into the office with a fever of 10.3.9F, chills, rash at injection site redness and welt that extended from the injection site down towards elbow, stopping about 3 inches above the right elbow. The patient was treated with 1 gram ceftriaxone sodium (ROCEPHIN) injection on 24-MAR-2008, and amoxicillin (+) clavulanate potassium (AUGMENTIN) 875 mg, 1 tablet BID for 10 days was prescribed. The physician advised an ice pack and ibuprofen. At the time of the report, the outcome of the events was unknown. Additional information is not expected.
Redness, swelling, hard and hot to the touch at injection site. Showed up 8 days post vaccination and lasted for a couple of days. Treated with ibuprofen and ice. No medical treatment sought.
Pain in leg, chest pain; Ruled out blood clot in leg; Diagnosed with pericarditis
Initial report received from consumer on 05-Dec-2013. A female patient (age unknown) (medical history and concomitant medications were not reported) received Tetanus toxoid (lot number. expiration date, rout and site unknown) on an unknown date. Patient stated that after getting a tetanus toxoid her ankles swelled then her legs. Outcome of the event was unknown at the time of this report. List of documents held by sender: none.
Within 20-25 minutes after receiving the vaccine I experienced long black lines in the outer corner of my right eye.
FEELING AWFUL; HEADACHE; NAUSEA; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced feeling awful, headache, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling awful, headache and nausea was not reported. This report was non-serious.
Low grade fever on Friday-Saturday temperature higher-went to bed Saturday with headache.  Had migraine Sunday and Monday before stopped eating or ate little since Saturday vomiting since Sunday.  Unable to eat Sunday and Monday no liquids.
Rash localized pain in area of injection Narrative:  Reports awoke day after receiving vaccine with "hot and raised" rash surrounding area of injection. measure 4.5 * 3.5 cm, red, blotchy, slightly itchy rash, skin intact, no other clinical findings with regard to rash. She reports localized tenderness in area of rash.
Patient did not have adverse reaction.  Patient received Pfizer Monovalent vaccine as 4th dose and not Pfizer Bivalent.  At this time have not been able to reach patient to notify her.
Large red swollen area near the site of the shot. It?s a bit itchy and tender and hard and warm. It appeared a few days after the injection.
Approximately one week post vaccination I developed a patch of a hot inflammation and itching spreading down arm from injection site, about 4? x. 7?.  The protrusion was noticed even through sleeve covering.   I applied a poultice for three days when at its worst, day 3, to relieve  irritation and itching (epsom salt, baking powder, water & lemongrass essential oil) which  then slowly subsided after 6 days or so. There continues to be a slight redness and itching.
pt recv vax 10SEP96 & mid-late afternoon noted itchy rash on palmar surface of hands, urticarial rash on volor aspect of both forearms;no resp diff;given DPH;11SEP96 rechecked urticaria have subsided;maculopapular rash;
Pfizer Bivalent Booster dose 0.3ml was administered to five-year-old child, who was to receive first dose Pfizer Pediatric COVID vaccine.  Patient was monitored 15 minutes after administration; no adverse reactions noted.  Medication error not realized until patient had already left the facility.
The vial was exposed to room temperature from 10:28 am on 17-Aug-2022 until 18-Aug-2022 at 12:42 pm; No adverse event; Patient received an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine), PRODUCT STORAGE ERROR (The vial was exposed to room temperature from 10:28 am on 17-Aug-2022 until 18-Aug-2022 at 12:42 pm) and NO ADVERSE EVENT (No adverse event) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053B22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Penicillin allergy.    On 18-Aug-2022 at 12:42 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 18-Aug-2022 at 12:42 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was exposed to room temperature from 10:28 am on 17-Aug-2022 until 18-Aug-2022 at 12:42 pm) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine), PRODUCT STORAGE ERROR (The vial was exposed to room temperature from 10:28 am on 17-Aug-2022 until 18-Aug-2022 at 12:42 pm) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) and PRODUCT STORAGE ERROR (The vial was exposed to room temperature from 10:28 am on 17-Aug-2022 until 18-Aug-2022 at 12:42 pm).    The patient had received first dose and second dose from unknown manufacturer. The Patient was taking other medication. The patient didn't receive other vaccines within 1 month prior to Moderna COVID-19 vaccine. The patient received vaccine after 12 hours in which the vial was open on (17-Aug-2022) at 10:28 am and was administered on 18-Aug-2022 at 12:42 pm. The vial was initially stored in the refrigerator on 11-Aug-2022. The vial stored post puncture at Room Temperature. The vial did not undergo any temperature excursion. The total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) from 10:28 am on 17Aug2022 until 18Aug2022 at 12:42 pm. HCP was not aware patient received an expired vaccine. Patient did not report having side effects. No treatment medication was provided.
Patient was hospitalized with fever, body aches, inability to transfer and SIRS.  Increased liver enzymes as well
Woke up one morning late May with soreness around injection site on my right arm. As symptoms progress, I would get sharp pain, dull achy pain, numbness all down my arm starting from my shoulder. Then it would start to click and pop towards end of June. The sharp pain would take breath away and became more intense as the weeks progressed on. Towards end of June/July, I was noticing I was starting to lose strength and ROM.  End of September / beginning of Oct shoulder froze up.  I was not able to get into the first doctor, partner in my PCP office due to being booked with the current environment  until Aug, he gave me home exercises to strengthen and told me to come back in 6 weeks if I was still having issues. At that time it was Oct and my physical with my PCP. He did few physical tests and exercises, X-ray and said it was frozen. Gave me PT referral that I started that week (2x week). I followed up in November with PCP for status and he did not see any improvement and wanted me to continue PT and come back in Jan. In Jan he sent me to orthopedic surgeon. I saw Dr. as soon as I could get in first thing in Feb. He took x-rays, gave me exam, cortisone injection and sent me to a new PT facility. Started there that week 3x a week until 7/21/22. Dr. had me come back in March to see my progress with PT & injection, he was not too happy and sent me for MRI to see where we could target inflamed area in April. In May, Dr. performed surgery to release the capsule/ inflammation and manually manipulate me while I was under anesthesia.
Right upper thigh lateral central injection site, red, raised 7x3cm, warm, non-tender, itchy.
Information has been received from a licensed practical nurse concerning a female who on 08-JAN-2008 was inadvertently vaccinated with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck). The incident was not due to product confusion. The patient did not experience any known symptoms. No further information was available. Additional information has been requested.
Abdominal cramping and both legs ache down to knees.  A small red, blood-filled, blister appeared on bottom of abdomen. These  symptoms started about a week ago and they are ongoing.
I contracted COVID-19 on 07/15/2022 with symptoms of cough, sneezing, runny nose, congestion, and fatigue. I was not prescribed any medication. I was ill for 4 days before my symptoms began to resolve. I am fully recovered with no lingering symptoms.
pt was recently in hospital with COVID, was dc'd to home with O2 and oral antibiotics; presents back to ED with SOB, O2 sats in 80s on RA; placed on O2 6L via NC (O2 sats now 99% on O2); COVID pneumonia; AKI; pt's condition worsened; transferred to ICU and placed on CPAP; pt became hypotensive requiring vasopressors, and tachypneic; DNI/DNR; pt became bradycardic and passed away in the hospital
Adverse symptoms: Fever, Chills, Body aches, Vomiting, Sweats since 3/5/2022
This spontaneous report was received from a pharmacist, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On 10-APR-2017, the patient was subcutaneously vaccinated with an improperly stored dose of ZOSTAVAX vial 19400 DF reported as plaque forming unit (PFU) (dose and frequency were not reported) lot # M038864 with expiration date of 12-DEC-2017, for prophylaxis. The diluent MRK, lot # M042852 with expiration date of 30-MAY-2019, used to reconstitute the ZOSTAVAX was properly stored.  The temperature excursion of the ZOSTAVAX was 9.5 °F, the temperature excursion time frame was for 12 hours. No previous temperature excursion occurred. No adverse effects were reported. Data logger was involved. There was no product quality complaint (PQC) involved. This is one of two reports received from the same source. Additional information has been requested; Sender's Comments: US-009507513-1704USA005234:
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored VARIVAX dose 1, (dose, lot # and expiry date unknown). On 07-MAR-2012, the patient was vaccinated with improperly stored VARIVAX dose 2 (dose unknown), from lot # 669842/0931AA with expiry date of 13-JUN-2013. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review of records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
Whenever I walk up my stairs now my chest is tight and my heart is beating hard, im unable to catch my breath. this is 1 flight of stairs thats making me feel like i just ran a mile. really anything that gets my heart beating takes 90% faster to make me feel winded and needing time to get my heart to stop beating so fast. i didn't know if this was anxiety at first but it is now clear to me with my apple watch and checking my heart rate that it is indeed beating extremely fast after just minimal physical activity
Engerix-B pediatric dose administered to adult; Engerix-B pediatric dose administered to adult; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 33-year-old female patient who received HBV (Engerix B pediatric) (batch number YM444, expiry date 22nd May 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th October 2022, the patient received Engerix B pediatric 10 ug and Engerix B Pre-Filled Syringe Device. On 9th October 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-OCT-2022 Reporter's Comment: The reporter stated that, an Engerix-B pediatric dose was administered to an adult patient.  The reporter consented to follow up via mail. Additional Supportive Information: The reporter stated that, an Engerix-B pediatric dose was administered to an adult patient, which led to underdose and adult use of a child product. The case had been linked to US2022146235, reported by the same reporter for a different patient.; Sender's Comments:  US-GSK-US2022146235:Same reporter
Narrative: COVID infections following completion of COVID vaccine series 03/04/21 COVID vaccine dose #1 03/25/21 COVID vaccine dose #2 07/29/21 Pt presents to clinic and reports cough and runny nose; advised to exit building and get tested for COVID; COVID POSITIVE 07/30/21 Pt reports cough, fatigue, and runny nose - symptoms started 07/27 08/01/21 Pt reports improving runny nose and cough with the use of honey; reports continued fatigue; rx given for guaifenesin, ascorbic acid, cholecalciferol, zinc 08/02/21 Pt reports muscle pain 08/03/21 Pt reports dry cough, diarrhea, intermittent headache, minor shortness of breath with activity 08/05/21 Pt reports no symptoms
High fever (103+) for about 18 hrs then in the 101s and 100s for s verbal more hours. Extreme headache, body aches and sore arm.
I received my second Moderna booster for COVID-19 on 9/8/2022. On 9/19/2022, I began coughing a lot. I normally cough a lot because of the asthma variant I have, but I was coughing much more than normal. I would get intense coughing fits that would last for a couple of minutes at a time.  I took a home test for COVID-19 on 9/19/2022, and the result was negative.  On 9/20/2022, the coughing increased. I also developed a headache, sneezing, and a very sore throat. I took another home test on 9/20/2022 and got another negative result. I took Tylenol and Mucinex that day; they helped a little, but not much. On 9/21/2022, I was coughing a lot in the early morning hours, so I took another home test. This time, I got a positive result. I began to feel really run down, but I hadn't been able to sleep much on account of the coughing, so that may have had something to do with it. After getting the positive result, I made an telehealth appointment with my doctor.  That morning, the doctor prescribed me Paxlovid and a new inhaler, as my previous prescription for my asthma inhaler had expired. We were on the fence about whether or not I should take Paxlovid, as she questioned whether my asthma put me at a high enough risk to necessitate taking it. We agreed that we would see how I felt during the course of my illness; if I felt any worse,  I would take the Paxlovid. At that point, my symptoms didn't really feel severe; they felt like those of a bad cold. Because of my asthma, I have a tendency to get bronchitis following a cold, so I wanted to also take the necessary steps to prevent bronchitis.  On the evening of 9/22/2022, I started taking the Paxlovid, because I was feeling really run-down and was still coughing a lot. I have family members who had had positive experiences with Paxlovid, so I decided that I had nothing to lose by taking it. On 9/23/2022, I didn't notice much of a change in my symptoms, but by 9/24/2022, the congestion had loosened up and I was having a productive cough. Not only that, but the coughing was now less frequent and less severe. By that evening, I felt much better. On 9/24/2022, I continued to feel better. At the time of this writing, I still have a little bit of a cough, but other than that, I feel fine. I don't need  Tylenol, Mucinex, or my inhaler to manage my symptoms at this point, though I have two more doses of Paxlovid left to take.
This spontaneous report as received from a 26 year old female patient. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 05-JUL-2018, the patient was vaccinated with a first dose GARDASIL subcutaneously (dose, lot# and expiration date were not reported) for prophylaxis. The patient wanted to know if she should repeat the injection due to wrong route of administration.
Severe tenderness/stiffness of arm in which injection was given with redness. Symptoms initially noted by patient later in day after receiving vaccine and progressed into the following day. Exact time of onset unknown. Pt went to physician- he told her to continue OTC NSAID and felt allergic reaction to pneumonia vaccine.
she was anaphylactic / ER Visit Required; difficulty breathing and she was rushed to the hospital / ER Visit Required; swollen arm at the vaccination site; This case was reported by a consumer via call center representative and described the occurrence of anaphylaxis in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced anaphylaxis (serious criteria GSK medically significant), difficulty breathing (serious criteria other: Serious as per reporter) and swelling arm (serious criteria other: Serious as per reporter). The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the anaphylaxis, difficulty breathing and swelling arm were recovered/resolved.   It was unknown if the reporter considered the anaphylaxis, difficulty breathing and swelling arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient's friend. The age at vaccination was not reported. The patient had a swollen arm at the vaccination site and a week later she had difficulty breathing and she was rushed to the hospital.  The patient visited the emergency room. They gave the patient massive amounts of Benadryl and it took a full month for her to fully recover. The reporter did not consent to follow up.
Approximately 12 hours after receiving the vaccine which was administered on January 19, 2020 approximately 1:30 pm,  I developed a fever, severe body aches, along with vomiting and diarrhea.  My resting heart rate was also elevated and my blood pressure was elevated.  I had the vomiting and diarrhea for three days.  i had to take ice baths to reduce my fever as it was 102.5.  My normal body tempurature is 97.1, so it was very high.  I broke the fever on January 22nd and the diarrhead and vomiting abated but still had high blood pressure.
Right after getting the 2 vaccines, the patient fainted and dropped on the floor. She was helped to sit back on the chair by the pharmacist. She requested water. She reported fainting history with being dehydrated and she said she came to get the vaccines right after gym. She didnt drink enough water per self-reporting. She felt fine after 5 minutes. She said the vaccines hurt more than she expected, and her anxiety and nervousness probably contributed to the cause of her fainting she said.
Started itching of scalp, spread to entrie body, palm of hands and sole of foot more intense.  Noticed hives and redness 4-5 hours after receinvg vaccine.
Patient has not had an adverse reaction yet but patient has been given this vaccine 6 times now when he should have only received 2 doses.
having redness and soreness on the arm of the injection site; having redness and soreness on the arm of the injection site; terrible pain, on the night he got the shot, he felt like his arm was coming off; terrible pain, on the night he got the shot, he felt like his arm was coming off; This is a spontaneous report from a contactable nurse. This nurse reported that a male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 09Jul2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Jun2021 as dose 1, single for COVID-19 immunisation. On 09Jul2021, the patient experienced having redness and soreness on the arm of the injection site and terrible pain, on the night he got the shot, he felt like his arm was coming off and the next day he was better. Asking if it will last for more than 3 days. The clinical outcome of events was unknown.  Information about lot and batch number was requested.
Patient Received 1 milliliter instead of 0.5milliliters injected intramuscularly. Patient reported no side effects at the time, left him the store number and my personal cell phone number to call with any adverse reactions to receiving.
4 hours after receiving: chills Over 1 hour of uncontrollable muscle shaking and muscle pain/contractions. Back spasms 3:30am chills and headache  6:30am drenched in sweat 7:30am fatigue and nausea, dizziness 10am diarrhea 11:30am chills 3:15pm excessive sweating Loss of appetite all day Taste buds were off The following day: nausea, arm pain, headache, light headed, fatigue