chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning her 17 year old daughter with sulfa/sulfites allergy and a history of reactive lymph node in her neck, who on 23-NOV-2010 was vaccinated with the first dose of GARDASIL (lot number not provided) and on approximately 08-MAR-2011 was vaccinated with the second 0.5ml dose of GARDASIL (lot# 1560Z). Concomitant therapy included ADDERALL TABLETS. The consumer mentioned that the patient did not have a reaction after receiving her first dose of GARDASIL. The consumer reported that her daughter received her second dose and had an allergic reaction. It was reported that 24 hours later, the patient began to have hives on her torso and on her cheeks. The consumer also reported that 48 hour later they had the hives somewhat under control with BENADRYL but all the patient's limbs swelled up. The consumer stated that they had received a steroid packet from the doctor that they had not used yet. The consumer also stated that the patient's swelling had started to go down. It was reported that on an unspecified date the patient visited the doctor. No lab diagnostic studies were performed. At the time of the report the patient was recovering. Additional information has been requested.
Patient was given Pfizer 5 to 11 year old vaccine instead of adult vaccine.  Vaccine was diluted as if it were adult vaccine and 0.3ml administered.
pt recv vax 17JAN97 & it was reported that about 48 hr later the inj site was red (about 5 inches), warm & very hard;
Pt presented to pharmacy on 10/08/2015 with right deltoid soreness, but was more concerned about subcutaneous bruising.   It appeared purple and yellow and pt was concerned because it appeared to be "spreading".  She reported that bruising began to appear on Sunday 10/04/2015.
expired dose administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to patient) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered to patient). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired dose administered to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.  Some patients had reported of experiencing flu-like symptoms after receiving the vaccine but the reporter did not have details on that.
sore arm; some tiredness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) and FATIGUE (some tiredness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis rheumatoid. Concomitant products included METHOTREXATE SODIUM (METHOTREXATE ACCORD) for Arthritis rheumatoid.    On 30-Jan-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 VACCINATION SITE PAIN (sore arm) and FATIGUE (some tiredness). At the time of the report, VACCINATION SITE PAIN (sore arm) and FATIGUE (some tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
the refrigerator that held the shingrix vaccine for the second dose was open for less than an hour and that her second shingrix dose's efficacy may be affected; This case was reported by a consumer via call center representative and described the occurrence of wrong technique in drug usage process in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   In October 2022, the patient received the 2nd dose of Shingrix. In October 2022, unknown after receiving Shingrix, the patient experienced wrong technique in drug usage process. On an unknown date, the outcome of the wrong technique in drug usage process was unknown.   Additional Information: GSK receipt date: 28-NOV-2022 Reporters comment: The reporter was the patient and she reported that she received both the doses of shingrix vaccine . The patient stated that last friday(three day before the day of reporting)that means 25th Nov 2022 the pharmacist called and stated that the refrigerator that held the shingrix vaccine for the second dose was opened for less than an hour and that her second shingrix dose's efficacy might be affected. No further information was able to be collected from patient The reporter did not consent to follow-up. Additional Supportive information: The refrigerator that held the shingrix vaccine for the second dose was opened for less than an hour and that her second shingrix dose which led to wrong technique in drug usage process .
mom reports p/vax 11DEC96 on 15DEC96 pt stiffened body & stared several times;also occurred on 16DEC96;saw MD 17DEC96;also called ER 16DEC96;no meds given;
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.  The vaccine was manufactured on 09 Mar 2021. Delivered at vaccination center on 30 Sep 2021. Patient did not experience adverse event.
no adverse event, moderna  confirmed 216K22A was viable until 2/21/23 despite beyond use date of 1/22/23
red rash right below the injection site about the size of a silver dollar; Red rash itches like crazy; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (red rash right below the injection site about the size of a silver dollar) and INJECTION SITE PRURITUS (Red rash itches like crazy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 06-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced INJECTION SITE RASH (red rash right below the injection site about the size of a silver dollar) and INJECTION SITE PRURITUS (Red rash itches like crazy). At the time of the report, INJECTION SITE RASH (red rash right below the injection site about the size of a silver dollar) and INJECTION SITE PRURITUS (Red rash itches like crazy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       no concomitant medication provided no treatment provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt reported that she had a Pfizer vaccine on 2/7 at 10am and went home and experienced chest pain at  1pm that lasted for only a few seconds. Pt also experienced a mild SOB while walking in the hallway. Mild SOB was only lasted for a few secs (prior to chest pain). Pt stopped and rested and Pt felt fine afterwards.  Chest pain Hx: Upon assessment, Pt also reported that pt experienced chest pain x1 (6 months ago) which also lasted for a few seconds. But, pt never reported this to pt's physician.   Other Sxs: Symptoms: Headache.  Onset: 2/8 AM. Pt took Tylenol 1000mg this 9am. Pt states she usually takes QAM for her arthritis. Effect: "It did not help." Pt denies any change in vision, blurry vision, double vision. Denies NV. Pt denies any chest pain or SOB today. Pt was able to speak clearly in full sentences. Pt was able to do ADLs without this morning. Pt stated, " I am able to carry on all my chores without difficulties. Other than headache I feel completely fine." No distress noted that needed an emergent care.   Recommendation -Pt denies any significant related symptoms such as ?worst headache of life? or changes in vision, speech, or coordination, or nausea/vomiting.  -Instructed to take analgesics such as Acetaminophen after 4-6 hrs (Adult dose: DO NOT EXCEED 4,000mg per day unless directed by the doctor) according to package instructions provided there are no contraindications. -Advised to rest and increase water intake.   Education:  -If pt experiences any chest pain, SOB, visual changes, change in mental status, N/V or ?worst headache of life?, pt was advised to go the nearest  ED.  -If headache is severe, focal, progressive or persists > 1 day: Pt was advised to reach out  to PCP same day.???If PCP is not available should seek care at Urgent Care.   Pt verbalized understanding and agreed with the plan.
Vaccine was given vaccine, as soon as needle was ejected from arm, patient fainted. He was unconscious for about 30 seconds and then became conscious. Provider came over to assess patient and determined he was fine. Patient sat for 10 minutes to continue monitoring. Pt stated he felt fine, and mom took him home. She was instructed to call our office if any other reactions occurred at home.
HepB vaccine dated 6/16/16 exp. given to pt on 6/16/15. No adverse reactions reported to supervisor. State DOH contacted. CDC Info contacted. To repeat dose at next visit (3 mths).
Information has been received from a physician concerning a 71 year old white male, a full length TED stockings wearer, weight 161.51lb, with deep vein thrombosis, allergies to Sulfa (cause hives), HYTRIN (cause rapid pulse rate), ACE inhibitor, CARDURA (increase heart rate) and anything containing HCL (raise blood pressure and cause jumpy) and a history of pulmonary embolism and shingles 12 years ago and no illness at the time of vaccination, who at 13:27 on 14-JUL-2008 was vaccinated with one dose ZOSTAVAX (lot#: 659672/0294X) 0.65mL SQ in the left arm. Concomitant therapy included CRESTOR, LOVENOX, meclizine, warfarin, VIAGRA, LOPID, DEBROX, PHENERGAN, CITRUCEL and lorazepam. One week prior to receiving ZOSTAVAX, the patient was taking COUMADIN for deep vein thrombosis. Subsequently, on 14-JUL-2008 the patient experienced pain at the right hip area, which was the same area where the patient experienced shingles prior to receiving the vaccine. The pain gradually moved down to the leg and by the next day the pain was present in the right foot. Within an hour of vaccination the patient also felt a strange taste in his mouth. On 17-JUL-2008, the patient saw the physician. His blood pressure was 138/74 mmhg, pulse: 80 bpm, T: 98.1F. The exam demonstrated the patient appeared healthy and well developed. His weight was stable. He can communicate normally. He had myalgia and the exam was normal. His right hip range of motion was normal. The patient was diagnosed with myalgia and myositis. The reporting physician considered the adverse events were most likely due to overexertion, however, doubt related to the vaccine. As of 17-JUL-2008, the patient adverse events persisted. The physician prescribed CELEBREX for the pain. Additional information is not expected.
Pt called in on 11/08/2004 states 2 hrs after shots were given. She had redness, some swelling and pain at the site but had pain from her R ear to R breast. Pt unable to come to clinic due to transportation. Advised her to take Tylenol or Ibuprofen. Is taking Advil every 6 hrs, no fever. On 11/9/04 slightly better, but still painful, using cold pack to site.
onset itching and rash on face and upper chest with headache for 3 days. Rash on face and neck
Information has been received from a physician concerning a 36 month old patient who on an unspecified date, when he/she was an infant, received the full 3 doses 2ml regimen for ROTATEQ. The nurses in the pediatric department of the office advised that the patient reported intussusception at the 3 years of age. The patient sought medical attention and was referred out to another physician from their primary doctor. At the time of the report the patient outcome was unknown. Upon internal review, intussusception was considered to be an other important medical event. This is one of several reports from the same source. Additional information has been requested.
there are a lot of days I have to push myself through the day; I just very weak; This is a spontaneous report from a contactable consumer (patient) via medical information team. A male patient of an unspecified age received bnt162b2 (COMIRNATY, Solution for injection) via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient asked about the data on the long-term side effects to the vaccine. He is asking because he stated that was a very active person and after the vaccine there are some days, he felt good and there are "a lot" of days I have to push myself through the day. He had advised to take iron pills, which he confirms he took. He says today he woke up feeling "fine" and "a few hours ago I just very weak." His symptoms began back in Mar after he received the vaccines a few weeks later. The patient stated he wanted to know if there is any data on an effect it will have on a person who has had postpartum depression. He also stated that he has 2 other daughters that have not received the vaccine and he is trying to convince them to get vaccinated. He stated that they have seen on TV/news or told by a friend that after the vaccine they are losing their hair, and this is a big thing for his daughter, and she will not get the vaccine because of this. He stated that the daughters have also been told, despite the short 7-8 months the vaccine has been out he states, that teenagers are saying from the 12+ age group that they are not able to have children after the vaccine. He also stated that he is fully vaccinated since Mar. He questions why they want "us to get the booster vaccine. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Patient complained of arm soreness and tingling the next day, took OTC meds and got better. # days later on 2/16 patient said symptoms were no better and went to ER with arm tingling/numbness, and arm pain. Was given meds and discharged.
101 Fever on 3/19, 3/20, 3/21 afternoon only 3/22 rash on face
None.  Patient was supposed to get a Pneumovax vaccination and received a Menveo vaccination instead.  I caught this when I was doing inventory and notified the provider.  The provider asked for me to call and explain to the patient what happened and see if he would return to the clinic to get the correct immunization Pneumovax.  I called and left a message for the patient to return my call.
Patient says swelling of face and tongue occurred 3 weeks after shot and has continued off and on up to the present. He has taken steroids, allergy meds, and PEPCID and no success of it going away.
Fever first afternoon and through night, next day extreme fatique, diarrhea, then projectile vomiting once.  After vomiting, about 28 hours after injection, I felt fine. Everything was then normal but I felt miserable up until then.
Axillar pain after second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (Axillar pain after second dose) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient experienced AXILLARY PAIN (Axillar pain after second dose). At the time of the report, AXILLARY PAIN (Axillar pain after second dose) outcome was unknown.            No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.
Arm Hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Hurting) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm Hurting). At the time of the report, PAIN IN EXTREMITY (Arm Hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment drugs were reported.   Reporter did not allow further contact
Left Arm sore and ache  (  on a scale of 1-10  it is a 6)   day 2 it got worse Day 3 persistent
ER visit 11/25/19 left shoulder pain radiating to neck four hours after Shingrix vaccine. Office visit 11/29/19 redness, swelling left arm treated with Keflex 500mg for cellulitis. Office visit 12/3/19 follow up on cellulitis.
DTaP given to left thigh on 9/30/03; reaction started approx 8 hours after injection. Swelling to entire thigh from knee to hip. On 10/2/03 circumference of left thigh a 35cm, right thigh 21cm. Mild erythema. Not warm to touch, afebrile, weight bearing. Tx with Motrin and close observation. Looks like an exaggerated local reaction.
Pt recvd Hep B vax on 12MAR92 & exp h/a; 16MAR92 devel rash;
Sore arm, 6;30pm 10/1/21,  Nausea, 10:00pm 10/1/21,  body aches 10:00pm  Took 1.5 aspirin 10:00pm 10/1/21.   Chills 9:30am 10/2/21, Fatigue 10/2/21 9:30am,  took 1 Advil 10:00am 10/2/21 for deep body aches.  chills 2:00pm 10/2/21,  fever  of 102.7 6:00pm. took 2 aspirin for fever, considered ER decided to wait.  checked fever every hour.  fever remained between 100 and 102.3 until 10:00pm.  Deep fatigue and body aches 10/2/21 and 10/3/21, with on off chills then fever of 100.5 along with vision focusing issues and headaches.    10/4/21 and 10/5/21  a bit better with a lessening of all symptoms but all still present.  10/6/21 still fatigued with chills then slight fever and on and off headaches and vision issues.
This spontaneous report as received from a Medical Assistant referring to an unknown number of patients of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. It was reported that on an unknown date, the patients may have received an unknown number of doses of VARIVAX strength, dose and route of administration were not provided (Lot # M035141 with expiration date of 03-AUG-2018) for prophylaxis. The doses of the vaccine were following a temperature excursion of 14-46 degrees Fahrenheit for 63 hours. No adverse effects were reported in any patients. No product quality complaint was involved. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA002892:
Small erythematous papules spreading up arms, trunk, abdomen and over back during exam. Up neck--no pustules yet.
Pt reports pain at injection site and following bone downward.  Pain began 2 days after vaccine administered.  Pain is continuous if not on NSAIDS.  On NSAIDS, pain appears when patient lifts right arm.  Spoke with patient via phone today and recommended that he follow up with his physician for evaluation.  He will follow up with me regarding physician diagnosis.
Immediate aches on left side of neck, quickly spreading to the whole body. Since then, whole-body aches, sore throat, severe lethargy, sleepiness, quickly exhausted, odd feelings in the heart, nauseousness, deep chills.
On 01/31/2021 client noticed a red rash on arm much like the rash she has had in the past to some medications - took Benadryl On 2/5/2021 client had itching, swollen, red, raised area around injection site, continues today
Approximately 18 hours after receiving vaccine(Monday,04/05/2021,9:30AM) I began running a fever.  The fever continue to rise/fall through the day.  It was accompanied by chills and an all over body ache.  My hands and feet were cold. There was some slight dizziness, along with a headache.  This continued all day. Overnight, The temp continued to rise and chills got worse.  The fever finally broke around noon on Tuesday, 4/06/2021.  All other symptoms were gone by that evening.   I did not experience any difficulty breathing. No swelling of face or throat.  I did not get any sort of rash.  The dizziness was mild and the weakness was on par with a mild case of the flu.
Red rash on arm below vaccination site on outside of arm on bicep and tricep. It did not itch
This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose of VARIVAX, dose, route and frequency unknown for prophylaxis. On 18-MAY-2012, the patient was vaccinated with improperly stored VARIVAX lot # 671861/1907AA dose number 2. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Patient called the office stating she wasn't supposed to receive the MMR vaccine because it's a live virus and she gives herself Dupixent injections. She stated she did not have any reactions to the vaccination and was encouraged to call the office if symptoms did develop.