chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Covid Breakthrough; Covid Breakthrough;   This is a solicited report received from a contactable consumer (patient) based on information received by Pfizer from a company (Mfr. Control No. :21K-163-4058551-00). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Tozinameran), intramuscular on 20Mar2021 at the age of 44-year-old (Batch/Lot number was not reported) as dose 2, single, intramuscular on 27Feb2021 at the age of 44-year-old (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in Pre filled pen), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for moderate to severe ulcerative colitis.   The patient's medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a Covid -19 Vaccine Trial. The patient experienced covid breakthrough on Aug2021 with outcome of not recovered.  The action taken in response to the event for bnt162b2 was not applicable, for adalimumab was unknown. Primary reporter did not have the lot number information, because the information was not accessible to the physician at his/her clinical setting. Covid Breakthrough reported as non-serious. Causality for Humira (Adalimumab): The reporter's causality for the event of Covid Breakthrough was not provided, for Pfizer Biontech Covid-19 Vaccine (Tozinameran) was Possible.  The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events COVID-19 and Drug ineffective cannot be totally excluded.The case will be reassessed if additional information becomes available
This spontaneous report was received from a registered nurse and refers to a 13 year old male patient with no concomitant medication, no pertinent medical history and no drug allergies. On 08-NOV-2017, the patient was vaccinated with a dose of GARDASIL 9 lot # M032650 with expiration date of 31-MAR-2019, intramuscularly, for prophylaxis.  Other suspect therapies included MENACTRA and ADACEL administered on the same date. On 27-NOV-2017, the patient experienced injection site pain with a knot under the skin and no redness, no swelling and no warmth to touch, she was afebrile and treatment of ice and ibuprofen (unspecified manufacturer) was performed on 27-NOV-2017 which provided some relief "but the knot under the skin still remained."  It was reported that the patient did not have significant disability, did not need hospitalization and the events were not life threatening events. The outcome of injection site nodule and injection site pain was reported as not recovered/not resolved. The causality between injection site nodule and injection site pain with the suspect therapy was not reported.
diffused, erythematous macules on anterior/posterior thorax, appear bloating to touch; localized swelling to inj site;
Urticaria = Legs and arms. No other symptoms. Occurred after shot. Disappeared after Benadryl.
After an hour of receiving vaccination I began to have a headache. I began to feel fatigue and overall malaise. That night I experienced chills, fever, body aches and felt terrible. My left arm was very sore.  The next day I experienced fatigue, body aches and headaches throughout the next few days.
A few years post vax, this pt developed "modified chickenpox consisting of greater than fifty lesions all over the body." Medical attention was sought.
Excessive somnolence for 24 hrs p/1st DTP; had to be waken throughtout day for feeds; resolved by 48 hrs;
NONE COVID-19 VACCINE EXPIRED 11/22/2022 GIVEN 01/06/2023
immediately upon receiving the Covid Pfizer vaccine, there was an immediate rush of sensation up my left arm and into my left jaw. i started to have tingling and loss of sensation to the left side of my face that extended from the left lower eyelid to 4 cm down the left side of jaw, midline to trachea, midline to left nare and radiating to the mid inner left ear canal. I had a burning sensation in the inner left ear canal as well as the left lower lid. Spoke with Dr and was placed on Prednisone 60mg po daily x 10 days with a taper and Valacyclovir 1gm po bid x 10 days.  The degree of parenthesis as of 1-22-21 is improved to now encompass from the edge of left nare to the outer canthus of left eye, into the edge of the left ear canal and the edge of the jaw.
pt recv vax 8JAN96 & SEP96 pt was exposed to chicken;2wk later on 7OCT96 pt devel very mild chickenpox w/20 spots on torso;
Pt had MENACTRA and PNEUMOVAX administered here 9/10/08 (Flu shot given by another Dr). Had splenectomy 9/26/08. While in hospital patient experienced arm paralysis. Also received Hep B at health clinic. 12/1/08-records received for DOS 9/24-9/30/08-DC DX: Thrombocytopenia. Splenomegaly. Myelofibrosis. Admitted due to enlarged spleen, thrombocytopenia caused by myelofibrosis syndrome diagnosed July 2008. Splenectomy. Received influenzae vaccination pre operatively, pneumonia vaccination and meningitis vaccination. Ventilator for atelectasis. Developed right sided weakness in arm after surgery weakness. Similar weakness as part of multiple sclerosis diagnosed 10 years ago. Impression: could have an exacerbation of previously weak point that can happen after stressful circumstances such as surgery or new multiple sclerosis plaque
Pt. presented 24 hours after receiving PPSV23, with severe pain in the axilla, radiating down the R flank. Tingling sensation in the fingers, pain with ROM. Site of injection did not appear erythemic, swollen, or bruised. Axilla was exquisitely painful, but no lymphadenopathy appreciated. passive ROM painful and limiting. CMS intact, extremity is warm. Pt. was given 25 mg Benadryl, ibuprophen 600 mg TID. Advised to ice area and return for worsening or new symptoms.
patient had a high fever; Trouble sleeping; patient was fussy; patient had diarrhea; This spontaneous report was received from a nurse and refers to a 6-month-old male patient. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.    On 19-SEP-2023 at around 11:30 a.m., the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # X008011, expiration date: 25-SEP-2024; pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) lot #X019110, expiration date: 30-AUG-2025; diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) lot # U7446AA, expiration date: 25-JUN-2025; and with influenza vaccine (FLUZONE), lot #UT8040LA, expiration date: 30-JUN-2024, (strength, route of administration, anatomical location not provided for any vaccine) all as prophylaxis.    On the same date, the patient experienced high fever, trouble sleeping (poor quality sleep), being fussy (irritability) and had diarrhea. I was reported that within the 6 hours of receiving vaccination, his body temperature was 102.6 Fahrenheit (F). On 20-SEP-2023, Body temperature was 102.9 F, and on 21-SEP-2023, body temperature was 99 F. All these temperatures were taken by the patient's mother. On 22-SEP-2023, he was seen in the office, and he had still fever with a temperature not over 100.4 F. At the reporting time, the outcome of all the events was unknown, but the patient was fine.   Causality assessment between fever, trouble sleeping, fussy, diarrhea and all the suspected vaccines was not reported.
Brief seizure-5-7 second with subsequent sleep x 1 hour and some lethargy x 1-2 hours. No sequelae observed on exam 5-3.
redness down her arm; reaction of swelling at injection site; Menactra was administered to a patient via subcutaneous route rather than intramuscular; Initial information received on 10-Jul-2020 regarding an unsolicited valid non-serious case from a physician assistant.  This case involves a 22 years old female patient who developed redness down her arm (erythema) and reaction of swelling at injection site (vaccination site swelling), while she received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  Medical history, medical treatment, vaccination and family history were not provided. No concomitant received by the patient.   On 07-Jul-2020, the patient received a dose 0.5 mL of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number: LU6365AA and expiration date: 24-Sep-2020) via subcutaneous route in the left arm as prophylactic vaccination. It was reported that the patient had booster then received this dose.  On an unknown date, the patient developed a non-serious redness down her arm (erythema) and  reaction of swelling at injection site (vaccination site swelling), couple of days later following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  It was also a case of medication error due to inappropriate route of vaccination as the vaccine menactra was administered to a patient subcutaneously rather than intramuscular ( PT: incorrect route of product administration) on 07-Jul-2020.  No laboratory data reported.  Final diagnosis was erythema and vaccination site swelling.  The patient was treated with hydrocortisone cream and benadryl on an unknown date.  The outcome was of events was not 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 Directive and Module VI of the 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.
Day after: ached in every joint, bad headache, fatigued, temperature of about 100. Two days after: fatigued and bad headache. Then, Just after midnight on the 3rd day I went into atrial fibrillation (I have a Kardia Mobil  unit that can detect heart arrhythmias). I had two more readings of afib over the next hour or so and then fell asleep reading.  When I awoke  a couple of hrs. later had a "normal" reading but, after falling back asleep, I awoke about 9 am and had a reading of "normal sinus rhythm with premature ventricular contractions (pvc)".  I have been having either pvc's or "sinus rhythm with supraventricular ectopy" readings on and off daily ever since (two and a half weeks).  I contacted my cardiologist and he said continue on the same medications as see what happens.  I have an appointment on June 14 to discuss this.  Could it be related to this second booster?
This spontaneous report as received from a consumer (the patient's spouse) refers to a 79 year old male patient with high blood pressure. The patient did not have any drug reaction allergies. On approximately 14-APR-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported) (dose and route not reported, in the left arm). Concomitant therapy included lovastatin (manufacturer unknown) and metoprolol. On 14-MAY-2013, the patient developed shingles after receiving ZOSTAVAX. Laboratory diagnostic studies were not performed. The patient went to the dermatologist and was treated with valacyclovir. At the time of the report the patient's outcome was not recovered. Additional information has been requested.
Patient came in for shingrix but was administered Moserna. Patinet had already finished the Pfizer series several months ago.
Elevated liver enzymes, 2 days after immunization. Incidental finding when elevated for another problem 12/17/17. Report enzymes on 12/20/17 significantly improved.
patient was administered Menactra at age 11 years and then 10 months later; Initial information received on 21-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA240611 and 2019SA236741 (same reporter).   This case involves an 11 years old patient who received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and reported that patient was administered Menactra at age 11 years and then 10 months later.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  In October 2018, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to extra dose administered.  It was unknown whether the patient had any adverse reactions.  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 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.  Information on the batch number was requested.  List of documents held by sender: none.
3/28/2023 I tested negative with an at home COVID test. I was coughing that night and did not sleep well. On 3/29/23 I had a positive at home COVID test. The next 2 days I was tired. I continued with a persistent cough and felt sluggish. I started taking MUCINEX, TYLENOL, ADVIL and cough drops. On 3/30/23 I started PAXLOVID prescribed by my daughter, an APN. I called the doctor and he said to stay on the PAXLOVID. I did not have any other symptoms. I had very minor diarrhea and was sweaty a couple of times. My head cleared up and my brain has been working pretty well. I still have a cough and will sometimes cough until I almost throw up.
Low grade fever (100), chills, slight sore throat, mild headache, eyes burning, lassitude, lack of appetite
Information has been received from a physician and his 73 year old white female pt who on 4/19/02 was vaccinated IM with a 0.5cc dose of pneumococcal vaccine 23 polyvalent (lot 641130/1161L). Concomitant therapy included atorvastatin calcium (Lipitor) (20mg X 1 daily); lisinopril (reported as Prinivil and Zestril (20mg 1 daily), metoprolol succinate (Toprol XL Tablets) (25mg 1 daily); aspirin and amlodipine besylate (Norvasc) (5mg 1 daily). On approx. 4/21/02 (also reported as 4/22/02 and 4/26/02), the pt developed welts and "terrible itching" all over her body. Medical attention was sought and the physician confirmed urticaria and pruritus. The experience was treated with prednisone (5mg "as directed"); cetirizine hydrochloride (Zyrtec) (10mg 1 daily); halobetasol propionate (Ultravate Cream) ("as directed") and permethrin (Elimite Cream) ("as directed"). At the time of report, the experience was still being treated and the pt had not recovered. Additional information is not expected.
Pt expressed that she began having symptoms including fever (unknown actual temp.), chills, dizziness, and joint and muscle aches that peaked four days after vaccination.  On Sunday Nov. 2nd she saw large red spots on her right arm and decided to be seen at urgent care.  Dr. prescribed a course of antiobiotics...pt thought to be cephalexin.
Admits to fever of 101'F, chills, sluggish, headache, and body aches. Denies rash and difficulty breathing.
About 3 minutes after receiving flu shot, pt passed out in chair, moved pt to floor, pt regained consciousness, moved to a sitting position after a few mins, moved into chair and passed out again - 911 arrived seconds later and took pt to E.R.
No Adverse event; patient received 0.25 instead of 0.5 of the Moderna Bivalent vaccine/accidental under dose of the Moderna Bivalent booster; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (patient received 0.25 instead of 0.5 of the Moderna Bivalent vaccine/accidental under dose of the Moderna Bivalent booster) and NO ADVERSE EVENT (No Adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (patient received 0.25 instead of 0.5 of the Moderna Bivalent vaccine/accidental under dose of the Moderna Bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (patient received 0.25 instead of 0.5 of the Moderna Bivalent vaccine/accidental under dose of the Moderna Bivalent booster) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (patient received 0.25 instead of 0.5 of the Moderna Bivalent vaccine/accidental under dose of the Moderna Bivalent booster).    No concomitant medication details was reported.  It was reported that the patient received 0.25 instead of 0.5 in the beginning of the month or last month. Patient was over 18 years old and should have received the 0.5 dose.  No treatment medication details was reported.
This spontaneous report was received from a physician referring to a patient of unknown gender and age. The patient's concurrent conditions and medical history were not reported. On 24-JUL-2018, the patient was vaccinated with an expired dose of M-M-R II (dose, route and anatomical location were not provided) (lot # N001490, expiration date: 12-JUL-2018) for prophylaxis. The physician reported that the sterile diluent used to reconstitute the M-M-R II was not expired. No adverse effects were reported.
I received my initial 2 vaccines in March 2021 (Pfizer) and did not have any adverse events. However, after I received my COVID booster (Moderna) on 1/6/2022 and experienced a significant reaction from it including; high fever (101.4F), excessive joint pain, swollen lymph nodes in left armpit, malaise, mental confusion, migraine headache, irritability, significant soreness/ tenderness at injection sight.
left hand increased numbness above baseline/right foot increased numbness above baseline; arm pit blotch; red and sore streaks on arm; red four inch blotch at injection site, red and sore streaks on arm; arm pit soreness; achiness; tiredness; very mild headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH MACULAR (arm pit blotch), HYPOAESTHESIA (left hand increased numbness above baseline/right foot increased numbness above baseline), PAIN (achiness), FATIGUE (tiredness) and HEADACHE (very mild headache) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune disorder and Neuromuscular disorder NOS.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 05-Mar-2021, the patient experienced PAIN (achiness), FATIGUE (tiredness) and HEADACHE (very mild headache). On 07-Mar-2021, the patient experienced INJECTION SITE PAIN (red and sore streaks on arm), VACCINATION SITE ERYTHEMA (red four inch blotch at injection site, red and sore streaks on arm) and AXILLARY PAIN (arm pit soreness). On 08-Mar-2021, the patient experienced RASH MACULAR (arm pit blotch). On an unknown date, the patient experienced HYPOAESTHESIA (left hand increased numbness above baseline/right foot increased numbness above baseline). At the time of the report, RASH MACULAR (arm pit blotch), HYPOAESTHESIA (left hand increased numbness above baseline/right foot increased numbness above baseline), PAIN (achiness), FATIGUE (tiredness), HEADACHE (very mild headache), INJECTION SITE PAIN (red and sore streaks on arm), VACCINATION SITE ERYTHEMA (red four inch blotch at injection site, red and sore streaks on arm) and AXILLARY PAIN (arm pit soreness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Five minutes after immunization, patient experienced headache, lightheadedness, dizziness, with temperature of 98.8.  Patient provided ice pack, water, and was put in trendeleburg position.  Symptoms resolved, and patient was discharged home after 18 minutes.
Information has been received from a Merck pregnancy registry for Gardasil via a nurse practitioner concerning a 17 year old female with a history of 1 pregnancy and 1 live birth with drug reactions/allergies reported as none known who on 08-MAY-2007 was vaccinated with the first dose of Gardasil (lot #656372/0243U), 0.5 ml, IM in the left deltoid. On the same day, the patient received concomitant therapy which included HAVRIX in the right deltoid, Dtap in the right arm and Varivax in the right tricep. On 21-MAY-2007, the patient came to the office since she missed her period. A urine pregnancy test was performed with results positive for pregnancy. The patient's last menstrual period (LMP) was 17-APR-2007 and expected delivery date was 22-JAN-2008. The nurse practitioner stated that the patient initially thought that she may want to obtain an abortion, but she changed her mind. This was the second pregnancy for the patient who had a 9 month old daughter. Follow-up information has been received from the nurse practitioner who reported that the patient elected to terminate the pregnancy at 12 weeks gestation. The patient's decision was not related to any medical reason. Elected to terminate the pregnancy was considered to be an other important medical event. Additional information is not expected.
Severe bone and muscle pain; Sore Arm; Fever of 102 Degrees; Nausea; Headache; Severe bone and muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Severe bone and muscle pain), PAIN IN EXTREMITY (Sore Arm), PYREXIA (Fever of 102 Degrees), NAUSEA (Nausea) and HEADACHE (Headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.    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 BONE PAIN (Severe bone and muscle pain), PAIN IN EXTREMITY (Sore Arm), PYREXIA (Fever of 102 Degrees), NAUSEA (Nausea), HEADACHE (Headache) and MYALGIA (Severe bone and muscle pain). At the time of the report, BONE PAIN (Severe bone and muscle pain), PAIN IN EXTREMITY (Sore Arm), PYREXIA (Fever of 102 Degrees), NAUSEA (Nausea), HEADACHE (Headache) and MYALGIA (Severe bone and muscle pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) Fever 102 degrees.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No medical history information was reported.  No treatment information was reported.