chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist and refers to a 13 year old patient. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not provided. On 30-JUN-2017, the patient was vaccinated with a first dose of GARDASIL 9 1 dose, intramuscular (lot number and expiration date were not provided), for prophylaxis. The patient was going to be administrated the second dose of GARDASIL 9 on 04-MAY-2018. No adverse effects was reported.
10/29/03 Pt stated that the night 10/27/03 after shot right arm began to ache and swell. Next morning arm was hurting worse and swollen more. Area red and swollen above elbow and below elbow, warm to touch. Instructed to keep warm towels on arm and keep taking Motrin. Understanding to RTC or ER if condition gets worse.
08/24/22 presents to EC ED for "Fall/COVID". PMHx of "HTN, breast Ca, diverticular bleed, dementia"
PT C/O anxiety approximately 20 mins s/p injection.  EMS spoke with PT, symptoms have resolved per PT - refused additional intervention, signed EMS release and departed facility in no obvious distress at 1320.
50 year old patient received 2 doses of Gardasil; This spontaneous report was received from a pharmacist referring a 50-year-old patient's gender not reported. No information was provided regarding the patient's medical history, concurrent conditions, or concomitant medications.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) dose 2 for prophylaxis (dose, route of administration, lot number, and expiration date were not reported).  The pharmacist mentioned that they discovered that the patient was 50 years old until after the second dose was administered. No additional adverse event was reported.
rash; itchy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 11Feb2021 (Lot number: EM9809) at the age of 74 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Auto immune" (unspecified if ongoing); "Convulsions many years ago" (unspecified if ongoing). Concomitant medication(s) included: PHENYTOIN taken for seizure, start date: 1970 (ongoing); DILANTIN taken for seizure, start date: 1970 (ongoing); VIT D; VIT E; FOLIC ACID; PRESERVISION; CRANBERRY. Vaccination history included: Bnt162b2 (Lot/Batch number: EL8982, Route of administration: Intramuscular, Time (24hr): PM, Anatomical location: Left arm, Dose no: 1), administration date: 21Jan2021, when the patient was 74 years old, for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset 2021, outcome "unknown", described as "rash"; PRURITUS (non-serious) with onset 2021, outcome "unknown", described as "itchy".  Comments/Narrative: Relevant test was none. Specific relevant test for thromboembolic events with thrombocytopenia was none About a month after second shot, patient experienced outing a rash. They itchy like crazy- feels like a red ant stinging. None had ever going away- just get more, That pop up like a little purple. And then looked like large ringworm. Absolutely horrible- I had a case of covid prior to my shots and it were nothing but a runny nose, I have them everywhere but on my face I cannot find a thing that helps! It is measurable.  Follow-up attempts are completed. No further information is expected.
Seen in ER around 1530, on 1/26/2021 after receiving second Covid Pfizer vaccination. Complained of Diffuse Headache with Left Shoulder Pain/numbness and verbalized lethargy, after receiving second dose Covid Pfizer vaccination. E Treated with Diphenhydramine Hcl 25 mg and Prochlorperazine Edisylate 5 mg and was discharged to home on stable condition.
SKIN ITCHINESS OF FACE, SCALP, EYES; VERY SLIGHT PUFFINESS OF UPPER CHEEKS AT BOTH SIDES OF NOSE; This spontaneous report received from a patient concerned a 66 year old male. The patient's weight was not reported and height was 185.42 centimeters. The patient's concurrent conditions included HIV, alcoholic, and non-smoker, and other pre-existing medical conditions included patient had no known allergies and no known history of drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 at left arm for prophylactic vaccination. Concomitant medications included bictegravir sodium/emtricitabine/tenofovir alafenamide fumarate for HIV.  On 15-MAR-2021, the subject experienced skin itchiness of face, scalp, eyes. On 15-MAR-2021, the subject experienced very slight puffiness of upper cheeks at both sides of nose. The patient was treated with antihistamines for itching.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from skin itchiness of face, scalp, eyes, and very slight puffiness of upper cheeks at both sides of nose. This report was non-serious.
Patient, with both doses of the series, encountered a fever greater than 100 F, chills all over, and aches around the body. The symptoms lasted for less than a day and then went away.
Hives day 6-8 after MMR. Symptom treatment with antihistamines.
Drug ineffective; Symptom rebound and positive rapid test; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 30Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Insomnia" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered", described as "Symptom rebound and positive rapid test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Treatment of COVID-19; (25Jun2022) positive, notes: Symptom rebound and positive rapid test 5 days after ending treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Diarrhea, nausea & vomiting, low grade temp (100), HA, body aches, fatigue x 24 hours
Hives; This is a spontaneous case received from a contactable consumer (patient). A 50-years-old female patient BNT162B2 received (Pfizer-BioNTech COVID-19 VACCINE, Solution for injection, Lot number was not reported) 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 received COVID-19 Vaccine first dose last week and was scheduled to receive the second dose on 24Feb2021. On unspecified date patient experienced Hives. Patient was scheduled to take Xolair for her hives and was asking should postpone or change the schedule. The outcome of event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Patient reported "mild chest tightness" 2 hours after receiving vaccine, which subsided over the next 4 hours. Six hours after receiving vaccine, patient reports "mild difficulty swallowing" with blotchy red rash scattered across the face and upper body.  Patient made her personal physician aware; was instructed to report her experience to facility that administered the vaccine.
6 hrs post 2nd vaccine, fever, chills, head ache came on, over next 6 hrs got progressively worse, some delirium, weakness, fatigue, balance issues, pressure  behind eyes, loss of appetite , very sore arm, lack of ability to process thoughts.  Today is day 9 with continued symptoms but not as severe as yesterday.     Note: After first vaccine, had worst flu symptoms ever experiences and the arm stayed sore a full week.
Info has been received from a health professional concerning a 13 year old white female, with no medical history and no allergies, who on 4/20/05, was vaccinated with a 1st dose of varicella virus vaccine live (Lot # "0859P") (also reported as Lot # "08594"). There was no illness at the time of vaccination and no adverse events following prior vaccination. On 5/6/05, the pt experienced chickenpox breakthrough, during a middle school breakout, described as a mild generalized rash with a few mild scattered lesions, 20 bumps, with no fever. There was no treatment. It was noted that the pt had no complications. It was reported that the pt recovered without hospitalization. Unspecified medical attention was sought. No product quality complaint was involved. No other info was provided. Additional info is not expected.
Chills, affected muscles...very weak, dead weight  tired could not stand up, fell on floor while in bathroom, called paramedics ...weakness and stability  for several  days
Chest and neck pain, shortness of breath, slight nausea, hot flashes Chest pain was from myopericarditis- inflammation of heart
onset of chest pain after initial injection which resolved prior to disposition home with mother.  Denied any other symptoms.
Sore arm; Minor body aches after first vaccine; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and MYALGIA (Minor body aches after first vaccine) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Sudafed allergy (tachycardia)). Concomitant products included NADOLOL for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and MYALGIA (Minor body aches after first vaccine). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) and MYALGIA (Minor body aches after first vaccine) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient had shivering and body aches with 2nd shingles vaccine.   This case was linked to MOD-2022-658188 (Patient Link).
hot to the touch; rash on the injection site; redness that is the size of a softball; sore arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE RASH (rash on the injection site), VACCINATION SITE ERYTHEMA (redness that is the size of a softball) and VACCINATION SITE PAIN (sore arm) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-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 WARMTH (hot to the touch), VACCINATION SITE RASH (rash on the injection site), VACCINATION SITE ERYTHEMA (redness that is the size of a softball) and VACCINATION SITE PAIN (sore arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE (BENADRYL ITCH STOPPING CREAM) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE RASH (rash on the injection site), VACCINATION SITE ERYTHEMA (redness that is the size of a softball) and VACCINATION SITE PAIN (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.
2:44p Stated felt dizzy, feet elevated, ice pack to neck and forehead, BP 151/99, HR 60, repeat  six minutes later 152/94, and he stated he is not hypertensive. Within ten minutes stated was feeling fine, no longer dizzy. After about 15 minutes more he left the area.
Pt reported dizziness at 1210. Patient vitals were taken: BP 160/80 mmHg, HR 80 bpm, and SpO2 97%. Patient reported history of high blood pressure and hypothyroidism (currently taking medication for only hypothyroidism). Patient given pretzels and water.  Patient advised to wait for further observation. Pt reassessed at 1236. Vitals were BP 170/75, HR 78 bpm, and SpO2 98%. Pt reported feeling much better. At 1237, pt left facility to self with unlabored respirations  and steady gait.
was vaccinated for shingles, still got them/ Suspect vaccination failure; shingles; very painful!; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 23-September-2022 Reporter's comment:  This case was reported by patient via interactive digital media. The patient was vaccinated with Shingles vaccine and still got shingles without the outbreak. Still very painful. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles was not provided. The follow up would not possible as no contact details were available.
Information has been received from a physician, via a company representative, concerning a "teenaged" female patient, who on unspecified date was vaccinated with the first dose of Gardasil (Lot # not provided). Concomitant therapy included MENACTRA. Subsequently, after receiving the first dose of Gardasil, the patient developed hives, that "were most severe on the injection site arm." The physician confirmed that the patient had recovered from the hives (duration and date not provided). The patient sought unspecified medical attention. The physician reported that three additional teenaged female patient's also developed hives after vaccination with the first dose of Gardasil (lot # not provided (WAES 0707USA00837, 0707USA01120, and 0707USA01121). Additional information has been requested.
He had a high fever of 103 for 3 days, and then it finally went down. We gave him TYLENOL and MOTRIN. We took him to the doctor, and they prescribed penicillin. The tested him for Strep throat and he tested positive.
Redness and itching at injection site.  Small red bumps formed.  The bumps have since gone away.  There is a slight redness left on her arm.
On May 26, 1999 the patient noticed a moist sore on the corner of her mouth and two crusty sores between the corner of mouth and her nose. On May 29, 1999 she noticed a small, opened blister on the back of her leg and a few fluid red spots on the left side of her face in patch formation. On May 31, 1999 her facial rash started moving down her jaw line and back to her physician and treated with antibiotics, phisodex scrub, a soaking solution, and a dermatology salve. The MD felt that the pt's condition was not chickenpox as the rash was not symmetrical and she was dx with blistering impetigo. By the middle of July 1999, the pt's rash had completely resolved.
patient inadvertently received FLUZONE HIGH-DOSE QUADRIVALENT instead of the pneumonia vaccine with no adverse event; patient has already received a high-dose flu vaccine this season with no AE reported; Initial information received on 08-Nov-2021 regarding an unsolicited valid non-serious case from another health professional via Medical Information (Reference number- 00847913).   This case involves Elderly and unknown gender who was by mistake given dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE instead of pneumococcal vaccination (extra dose administered and wrong product administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 08-Nov-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ745AC and expiry date: 30-Jun-2022, Frequency once) (Suspension for injection) via intramuscular route in the right deltoid for prophylactic vaccination.  It was an actual medication error case due to extra dose administered and Wrong vaccine administered (latency on same day).  At the time of reporting, no adverse event was reported.  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.
My watch went off and said that I had atrial fibrillation. I took my blood pressure and it said that I had irregular heart beat. I went to the ER. They confirmed that I had atrial fibrillation. They did EKG. Then, next day they did a cardioversion that took it away until Dec 24th. Then, it came back and is still ongoing as of today. I get lightheaded because of my heart complication. My doctor has been trying to treat it with medicine. I seen my cardiologist on March 16th. They changed my medicine for me to try for 3 months. Then, they are going to do another cardioversion.
Patient received shot approximate 9:55am within the hour became sluggish, nauseated, vomited once. At approximately 230pm parent states family had had stomach virus in home within the last 72 hours.
This case was reported by a pharmacist and describe the occurrence of allergic reaction in a subject of unspecified age and gender who was vaccinated with Fluarix for prophylaxis. The subject's medical history included allergy to antibiotic. The subject had received influenza virus vaccine in previous years with no subsequent adverse events. On an unspecified date in 2006, on or before 14 November 2006, the subject received unspecified dose of Fluarix. On an unspecified date in 2006, on or before 14 November 2006, less than one year after vaccination with Fluarix, the subject experienced allergic reaction and hive. The subject was seen in an emergency room. The outcome of the events was not reported.
Rash around injection site small red papules. Does seem to itch. Appeared 2 days after shot. There (seen) 5 hours after shot. Gave BENADRYL orally and triamcinolone topically.
This case was reported by a medical assistant and described the occurrence of swollen leg in a 5 year old male subject who was vaccinated with Infanrix for prophylaxis. On 10 April 2006, the subject received 5th dose of Infanrix in the right thigh (lot AC14008AA) for prophylaxis. On 10 April 2006, the subject also received inactivated Ipol in the left thigh and MMR II in the left arm. On 11 April 2006, one day after vaccination with Infanrix, the subject experienced injection site swelling, injection site induration, and swelling, "past the knee." The subject was seen at a physician's office. The injection site swelling and injection site induration resolved on 11 April 2006. The medical assistant considered the events to possibly be related to vaccination with Infanrix.
This spontaneous report as received from a certified medical assistant refers to unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with an improperly stored doses of RECOMBIVAX HB (dose, route, lot number and expiry date were not reported). No adverse effects reported. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information has been requested.
Moderna COVID-19 VACCINE EUA  Pain at site of injection within an hour of injection.  Body and muscle aches, fatigue, fever, nausea 12 hours after injection. Took 1 dose ibuprofen and 1 dose acetaminophen. Lasted for 12 hours.
2 pediatric patients came to pharmacy to receive their second dose of a COVID vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (2 pediatric patients came to pharmacy to receive their second dose of a COVID vaccine) in an adolescent patient of an unknown 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 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (2 pediatric patients came to pharmacy to receive their second dose of a COVID vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (2 pediatric patients came to pharmacy to receive their second dose of a COVID vaccine) had resolved.            No concomitant medication reported.   No treatment information was provided.
Pt reports feeling like it was hard to swallow. Pt was given 50 mg Benadryl IM at the vaccination site and continued to be monitor  afterwards. Pt reports that after about 15-30 mins, it start to feel difficult to swallow again. Pt was advised to come to the emergency room. Upon arrival, pt was given medication via IV of 25 mg of benadryl, 125 mg of solumedrol, and 20 mg of pepcid and monitored for further worsening of symptoms
Seen in office 06/09/2021 by Dr Extensive urticaria rash, tight throat beginning 36-48 hours after second dose of Pfizer COVID vaccine. Claritin 10mg 2 po qday for 7 days, continue Nexium, Benadryl prn.
Moderna Covid -19 Vaccine EUA I started to experience  pain going down my right arm and two days after my vaccine a patch of herpes blister appeared on my right palm.
Patient reported hives 7 minutes after injection under direct observation to bilateral upper extremities. Patient denied itching, shortness of breath, hoarseness, throat tightness, altered tongue sensations, fatigue, dizziness, lightheadedness, or any other associated symptoms at that time. Patient given 4mg of dexamethasone immediately following reaction and observed for an additional 30 minutes. Patient reported no acute distress and hives were localized with some shrinking in size. Patient released at 310 in no acute distress with medication sent to pharmacy. Medications that were sent are medrol dose pack and hydroxyzine 25mg to take TID. Patient also given information regarding reaction and Moderna fact sheet. Patient ambulated to car without assistance to return home with instructions to report to nearest ER should any symptoms worsen or new symptoms present.
This spontaneous report as received from a Doctor of pharmacy refers to a patient of unknown age and gender. On 25-NOV-2015, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # K000326 exp date 27-FEB-2015) (dose and route not reported). No adverse effects were reported. Additional information has been requested.