chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received booster dose. No concomitant medications were reported. The vial was initially stored in the refrigerator on 04-Nov-2021. Dates of administration of vaccine Some were on 05-Nov-2021 and the other doses on 12-Nov-2021. The vial did not undergone any temperature excursions. HCP stated, no adverse event occurred as a result of this misadministration, patients were monitored. No treatment medications were reported.
Extreme hyper behavior unable to sleep - awake til 3-4 am. "Wired", running around "like crazy". Usually sleeps large pt of day because of sz + meds.
Rash under both breasts; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received BNT162B2 (Pfizer COVID-19 Vaccine), via an unspecified route of administration on 13Feb2021 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. This patient got the shot of Pfizer COVID-19 vaccine last Saturday, 13Feb2021. Last night, 17Feb2021, she noticed she had a rash under both breasts. She asked for recommendations on treating the rash, like if she should get something like Benzidine. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
concern on the effect of the Steroid injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "receives steroid injections for her knee and foot" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: POTENTIATING DRUG INTERACTION (non-serious), outcome "unknown", described as "concern on the effect of the Steroid injection".  Additional information: Caller stated that she receives steroid injections for her knee and foot. and has received the Pfizer Covid 19 vaccine 1st dose and is scheduled to receive the second dose on 12Apr2021. In speaking to her HCP there is concern on the effect of the Steroid injection which the caller does not know the name to on the vaccine and would she need a booster. Disclaimer provided: There is no information in the Pfizer Covid 19 vaccine Prescribing Information about a potential interaction or administration with (drug name or drug class or food in question). Please consult with your doctor or pharmacist for further guidance and ensure that your health care providers know all the medications, including over-the-counter (OTC) products, that you are taking, have recently taken or are planning to take. Caller stated that she receives steroid injections for her knee and foot. and has received the Pfizer Covid 19 vaccine 1st dose and is scheduled to receive the second dose on 12Apr2021. In speaking to her HCP there is concern on the effect of the Steroid injection which the caller does not know the name to on the vaccine and would she need a booster. If you receive one dose of the Pfizer-BioNTech COVID-19 Vaccine, you should receive a second dose of this same vaccine 3 weeks later to complete the vaccination series. The Regulatory Authority has provided interim considerations for use of Pfizer-BioNTech COVID-19 Vaccine.  These interim clinical considerations from Regulatory Authority note the following But if it is not possible to give the second dose at 3-weeks, it may be given up to 6 weeks (42 days) after the first dose. Please speak to your healthcare provider on this topic.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
"Hives on body - from right wrist along length of right arm, on right side of trunk to belly button", itchiness for two to three days; also felt exhausted for two days, and on 5/2/11 had a fever of 101 or 102 degrees.
30min p/vax pt became lightheaded, nausea/vomiting severe;dizzy;
joint pain, fatigue & rash feet, dyspnea hosp FEB93 to MAR93;
rt arm shot area grew red hot, swelled devel a hard area approx 12cm wide/diam w/in a 4hr time period, nausea, h/a, fever, chills, pain @ base of neck, malaise, t102
J&J Dose 1 6/2/21 (lot NA) J&J Dose 2 11/22/21 (lot NA) COVID Positive 1/19/22  1/26/22: This is a 33-year-old male with history of obesity and no other significant past medical history who presented to the emergency department with worsening dyspnea and cough.  Patient tested positive for COVID-19 on 01/19/2022. Patient was seen in the emergency department on 01/22/2022 for shortness of breath but did not require oxygen was sent home on oral azithromycin course which he finished today with no relief of symptoms. He states that he has worsening dyspnea, cough, fever, chills, body aches and slight diarrhea. He states that his wife and daughter test is positive for COVID-19 but have mild symptoms.   In the emergency department, patient was found to be hypoxic and was put on 3 L of O2 via nasal cannula. Labs showed an ALT of 109, AST of 93, WBC count of 4.5, D-dimer of 1.42. CT angiography of the chest with contrast was negative for pulmonary embolism but it showed severe bilateral pulmonary infiltrates. Patient was given nebulizer treatment, IV fluids and a dose of IV Decadron, Zofran, azithromycin and Rocephin.  1/30/22: Patient is a 33-year-old male who was admitted to the hospital with chief complaint of COVID-19 pneumonia and resultant hypoxia from COVID pneumonia.  Patient was treated with IV remdesivir IV Decadron along with vitamin-C zinc and vitamin-D.  Patient was also treated with IV antibiotics for possibility of pneumonia.  Blood cultures were negative.  Patient was weaned to room air on 01/30/2022.  An oxygen walk test was conducted for the patient and was determined that the patient does not require any oxygen upon ambulation or upon rest.  Patient was discharged home with prednisone taper.  Patient can resume work on February 7, 2022. Patient was also instructed to follow-up with his PCP in 1 week time and repeat CMP.  Patient was discharged from the hospital in a stable medical condition on 01/30/2022.
Pt recvd vax on 22JUN92 & exp h/a, nausea, & dizziness; pt recvd 2nd dose vax & sx did not recur; No further details were provided;
Woke up to severe itching located at hands and feet. Hives began to develop and facial swelling began. Labored breathing shortly after. Treatment at the ER was epi shot, plus several others.
Strong headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Strong headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2021, the patient experienced HEADACHE (Strong headache). At the time of the report, HEADACHE (Strong headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported by the reporter. Treatment included 800 mg of Tylenol.
"COVID  ARM" I have experienced a large rash that grew larger on days 2 and 3. The rash is hot to the touch, and painful. Rash appeared on day 11 after receiving the vaccine.
Inadvertently administered Proquad instead of MMR II; No additional adverse event; A 45 Years-old patient received Proquad; This spontaneous report was received from a nurse referring to a 45 years old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On an unknown date the 45-year-old patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), 0.5 milliliter (strength, vaccination scheme, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis, instead of Measles, mumps, and rubella virus vaccine live (M-M-R II) (wrong vaccine administered and product use issue). No additional side effects or product quality complaints were reported (no adverse event).
patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received dose from vials beyond 30-day use by date) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received dose from vials beyond 30-day use by date). On 15-Jul-2021, EXPIRED PRODUCT ADMINISTERED (patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information were reported by the reporter  The date of refrigeration was 7 May 2021.   This case was linked to MOD-2021-363730 (Patient Link).
underlying mild shoulder pain started Oct 2020. Moderna COVID19 Vax 1st dose 2/16/21. 2 wks later awoke with severe pain in RT shoulder (opposite arm of injection) and new burning nerve-like pain. After  a few weeks, pain started to decrease. Weakness noticed 1-2 wks after onset of pain. Significant weakness seen at office visit 3/25/2021.
Patient states he now experiences impaired wound healing now that he's gotten his Moderna Vaccinations.
Patient fainted in the chair and appeared to be having a seizure. An Epipen was administered during the reaction and paramedics were called. The patient refused medical treatment from the paramedics and called her parents to come pick her up.
Confusion, headache, numbness/weakness of left side.  c/o extreme headache
6 days after the vaccination my arm got terribly sore and a little itchy - very similar to what happened the first couple of days after the vaccine.  However, on day 8 I woke with hives all over my back, around my waist to the front, on top of both of my feet and in spotty locations on arms and legs.  Today, I still have no relief.
Approx 15 minutes after administration, pt returned to office. Child crying, flushed, urticaria all over body, increased heart rate and respiratory rate, no wheezing. Benadryl 0.4ml (20mg) administered deep IM. Urticaria then improved, child alert, not crying, playing. No SOB or wheezing. Symptoms to watch for discussed with mother.
This case was reported by a pharmacist via call center representative and described the occurrence of dizziness in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, several hours after receiving SHINGRIX, the patient experienced dizziness and fall. On an unknown date, the outcome of the dizziness and fall were unknown. It was unknown if the reporter considered the dizziness and fall to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The health care professional reported that the patient experienced severe dizziness hours after receiving a dose of the SHINGRIX vaccine. This dizziness caused the patient to fall. The health care professional did not have vaccine or patient details because this patient was given the vaccine at a different location. The health care professional did not believe that the patient had any medical treatment or emergency room visit.
Information has been received from a physician concerning his 22 year old daughter with no medical history and/or drug reactions/allergies who on during the week of 22-NOV-2007 was vaccinated IM with the third dose of Gardasil (lot # not reported).  Dates of previous doses were not reported.  There was no concomitant medication.  "After administration of the third dose of the vaccine, the patient's arm became red and swollen.  Her arm improved after 3 days.  The patient's status was reported as recovered.  No laboratory diagnostic tests were performed.  There was no product complaint involved.  Additional information has been requested.
This spontaneous report was received from a nurse practitioner concerning a female patient of unknown age. The patient's pertinent medical history and concurrent conditions were not provided. "About three years ago" in approximately 2013, the patient was vaccinated with the second dose of GARDASIL (dose, route and lot # not provided). No information was provided regarding first dose in the series. The nurse practitioner stated that at the time of the report on 07-APR-2016, the patient was in the office to receive the third dose in the series. It was reported that the patient would be administered GARDASIL 9 (dose, route and lot # not provided). Concomitant therapies were not provided. No adverse effects were reported. Additional information has been requested.
The right side under my armpit hurts and I now have a rash at the injection site. This happened 7 days after my first shot.
Per patient, it was Influenza vaccine administered at Pharmacy. Per patient, she does not have the vaccine information including lot number and administrator. Patient states vaccine was given in left upper arm, about 1 finger breath below shoulder. At night she started developing sharp shooting pain on the under side of her left upper arm, since then the pain has radiated to her elbow and forearm. Denies any numbness or tingling. Full range of motion in arm.
This 17 month old female consumer received 0.5mL of PCV 13 (pneumococcal vaccine) on 20Jul2010 for a routine vaccination at a local health center. On 22Jul2010, a red rash with firm papules, that appeared like vesicles, but firm to touch were noted on the patient's left thigh. The patient's relevant medical history includes no previous allergic reaction to the pneumococcal vaccine. The patient's relevant concomitant medications and past drug history are unknown. The patient was treated with Benadryl. No additional drugs were started because of her rash. No additional laboratory testing was required. The outcome of the patient's rash is unknown.
Upper lip swelling and itching, I gave patient BENADRYL. Swelling decreased after 2 doses but not gone completely. Parent took him to a clinic just to be safe. Updated pending.
Exactly 10 days later I was in the ER with heart failure.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 16Jan2021 as dose 1, single (Lot number: EL8982) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: OMEPRAZOLE; ALOPURINOL; CALCIUM and daily vitamin (as reported). The following information was reported: CARDIAC FAILURE (hospitalization, disability, medically significant) with onset 26Jan2021 at 12:00, outcome "not recovered", described as "Exactly 10 days later I was in the ER with heart failure.". The patient was hospitalized for cardiac failure (hospitalization duration: 3 day(s)). The event "exactly 10 days later i was in the er with heart failure." required emergency room visit. The patient underwent the following laboratory tests and procedures: Test: (unspecified date) Unknown results; SARS-CoV-2 test: (23Nov2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of cardiac failure.  Clinical course: the patient took his first dose of the Pfizer Covid Vaccine on 16Jan2021. Exactly 10 days later he was in the ER with heart failure. He never had any heart issues whatsoever in his entire life up to that point. He was active duty for 25 years and with an agency for almost 20 years after that. He had a physical every year without fail and his heart was always perfect until the reported first shot. Was three days in the hospital and then had a pacemaker and Difibulator put in, in Aug2021. Patient was also on heart meds for the rest of his life (as stated).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300247071 Same reporter/patient, same drug/different dose, different AEs;US-PFIZER INC-202300247072 Same reporter/patient, same drug/different dose, different AEs;
The evening of the vaccination the patient developed a rash on left deltoid described as the size of the hand, tried naproxen and heating pad with no alleviation. The next morning the patient said the rash was very tender to the touch and the arm was very sore described as could not lift her arm. As well as the patient had a lump under the skin at the site of injection.  Currently recommending antihistamines for allergic reaction as well as continuing naproxen for pain relief.
At first I had some smooth reddish purple spots in my groin area. Then I had some hive-looking spots on my abdomen; last night 4/17/21 they clustered around my groin and I had a few spots on my left calve. I also felt some muscle pain in my left thigh.
Patient administered vaccine on 29-Apr-2022, which was expired on 17-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 29-Apr-2022, which was expired on 17-Apr-2022) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 29-Apr-2022, which was expired on 17-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 29-Apr-2022, which was expired on 17-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient received the booster dose of Moderna vaccine (Expiry date: 17-Apr-2022). The vial was initially stored in the refrigerator on 29-Apr-2022. Vial did not undergo any temperature excursions.  No treatment medications were reported.
pt recv vax;apap given;pt crying incessantly since am;leg slightly red&sl edema at site;child screaming;to MD who stated rxn probably to inject;apap given every 3 hrs;pt slept well at noc;MD stated it was adverse rxn to inject,not vax;
Acute Headache: Unusual for patient. This happened for an hour and occurred several hours after. Fingers tingled: Within an hour after.
21 year old male presented with tonic-clonic seizures approximately 10 minutes after receiving first dose of Pfizer vaccine, lasting approximately 3-5 seconds as reported by staff. Patient was assisted to ground by patient?s father. Patient regains consciousness, alert and oriented x4; denies headache, neck pain, back pain, and recalls events prior to seizure episode. Patient admits to having history of seizures 12 years ago, does not take medications. Exam and vital signs performed post seizure. EMS arrived on scene approximately 13:21, transfer of care initiated.
ALLERGIC REACTION; chills; TACHYCARDIA; TINGLING; This case was reported by a consumer via other manufacturer and described the occurrence of allergic reaction in a female patient who received HBV (Engerix B) for prophylaxis.   Concurrent medical conditions included lymphatic disorder (problem in the leg) and drug allergy (Ibuprofen or an inactive ingredients in the Ibuprofen).   On an unknown date, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced allergic reaction, chills, tachycardia and tingling. On an unknown date, the outcome of the allergic reaction, chills, tachycardia and tingling were unknown.   It was unknown if the reporter considered the allergic reaction, chills, tachycardia and tingling to be related to Engerix B.  Additional details were reported as follows: This case was reported by patient for herself. The age at vaccination was not reported. The patient experienced severe allergic reaction to the hepatitis B vaccine specifically Engerix B. The allergic reaction was further described as tachycardia, chills and tingling. The patient reported this information prior to receiving Pfizer Covid 19 Vaccine. The reporter refused to provide an address.
Due to a miscommunication on my part, the MA was instructed to administer an adult flu vaccine instead of a Program vaccine (I thought that once the patient was over the age of 18, we could give the adult vaccine). Patient tolerated it well and had no reaction of any sort. Parent was with them during the administration.
L tinnitus and diminished hearing, patient does not recall specifically, but states this happened approximately 6 days after 2nd dose.
muscle pain; bone pain; tiredness; chills; joint pain; injection site pain; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN6201 and expiry date not reported), via an unspecified route of administration, administered in Arm Right, on 01Mar2021 16:00 (at the age of 47-year-old), as dose 1, single, for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. The patient had no medical history, no known allergies, and no concomitant medications. Patient did not receive any other vaccine in four weeks. Patient was not diagnosed with COVID prior vaccination. Patient was not tested for COVID post vaccination. The patient experienced muscle pain, bone pain, tiredness, chills, joint pain, and injection site pain on 02Mar2021 11:00. Patient received no treatment for the events. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Information has been received from a registered pharmacist concerning a 67 year old female patient who on 19-APR-2009 was vaccinated with ZOSTAVAX (Merck) (lot # 663333/1555X) SQ. At time of reporting the patient had tingling, itching and a small blister that is trying to form. The patient had a case of shingles on an unspecified date of the buttocks. The shingles had all cleared up and pain subsided for one month prior to the patient receiving ZOSTAVAX (Merck). The patient called the registered pharmacist on 24-APR-2009 to inquire if the shingles could reoccur on the same location as the previous shingles episode. The patient was not experiencing pain. The patient had a visit to physician for medical attention. The physician prescribed Acyclovir (manufacturer unspecified) 400mg 3 times daily for 5 days. The patient's tingling and itching and a small blister that is trying to form persisted. Additional information has been requested.