chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional adverse effect reported; on 3/4/2020, a patient received a second dose of GARDASIL 9 that was later then the recommended dosing interval per PI.; This spontaneous report was received from a registered nurse referring to a 12-year-old patient of unknown gender. The patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not reported.  On 06-DEC-2018 and 04-MAR-2020, the patient was vaccinated with first and second respectively of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) by intramuscular route as prophylaxis (concentration was not reported, lot number and expiration date were unknown by the reporter) (inappropriate schedule of product administration). No additional adverse effect reported.
Myalgia; Chills; Nausea; Joint pain; Headache; Fatigue; This is a spontaneous report from a non-contactable pharmacist (patient herself). A 29-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date not reported), via an unspecified route of administration in the right arm on 06Jan2021 18:15 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. The patient previously took first dose of bnt162b2 (lot number: EL0140, expiry date not reported) in the right arm on 18Dec2020 at single dose for COVID-19 immunisation. On 07Jan2021 at 02:00, the patient experienced myalgia, chills, nausea, joint pain, headache and fatigue. No therapeutic measure was taken as a result of the events. Clinical outcome of the events was recovered on 08Jan2021 at 02:00.  No follow-up attempts are possible. No further information is expected.
Starting the next day when I woke up around 1am, I had a massive headache, fever (101.6), severe chills, body aches and my joints hurt. I tried to "chill out" until first thing in the am. I called my doctor asap to see if there was anything else I could take other than Tylenol, but there wasn't. I felt like I had COVID again, but was able to breath. The severe chills/shaking was so bad that I couldn't do anything. The shaking lasted for about 2 days. The chills and fever lasted for about 8 days (low grade: 99-100), but the body aches and the headache lasted for 11 days. I visited my cardiologist later on, and they determined my heart rhythm had changed about 4 days after the vaccine. I have a pacemaker/defibrillator with a home monitor which tracked the change.
C/o facial fullness, jaw/facial heaviness, dizziness, and slight speech slurring 5 mins after vaccine. No CP, SOB, dyspnea, blurry vision, HA, redness, swelling, rash noted. A&O x 4, able to speak full sentences. VS stable: 88. 97%, 144/86, BS: 116. EKG: NSR. Neuro exam normal, muscle strength intact, facial symmetry, no facial droop noted. Advised pt to transport to hospital but pt refused transport. Observed for total 45 mins.
Patient developed a shingles-like rash on his upper right arm (injection was in left arm) approximately 3 days after getting his 2nd Shingrix dose.  He reports the rash was not painful and did not itch.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 25-AUG-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength: 0.5ml, lot # K005957, expiration date 08-MAR-2015, route unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 1728 hours with lowest recorded temperature of 20 Fahrenheit degree. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Headache, Myalgia, Fever, fatigue, headache, nose bleeds Narrative:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Lot number: ER8733), in left arm, on 21Apr2021 as dose 2, single (Lot number: EW0161), in left arm, on 09Dec2021 as dose 3 (booster), single (Lot number: 3300ba), in left arm and on 27Jun2022 at 13:15 as dose 4 (booster), single (Lot number: FN2908) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "copd" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing), notes: hypothyroid; "Gerd" (unspecified if ongoing); "IBS-D" (unspecified if ongoing), notes: IBS-D; "Osteoarthritis" (unspecified if ongoing); "Elhers Danlos Syndrome" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "PTSD" (unspecified if ongoing), notes: PTSD. The patient's concomitant medications were not reported. Past drug history included: Vicodin, reaction(s): "known allergies: vicodin", notes: known allergies: vicodin; Codeine, reaction(s): "known allergies: codeine", notes: known allergies: codeine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It is unknown whether other medication was received in 2 weeks. Patient received treatment for COVID-19 with Paxlovid from 06Dec2022 to 11Dec2022.
Pt. received a Janssen vaccine on 9/11/2021. Received a second Janssen vaccine on 9/29/2021.
Lousy and in pain in my body. I had a weird pain in my shoulder, I was tired, and my hand was swollen for a month. I went to the doctor, and he ran a test and just gave me an injection.
small raised erythema papular over ankles, wrists & knees; pruritus; erythema @ site of inject rt thigh;
flu symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (flu symptoms) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced INFLUENZA (flu symptoms). On 05-Mar-2021, INFLUENZA (flu symptoms) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient reported no concomitant or regular medications. No treatment medications were reported.   This case was linked to MOD-2022-552549 (Patient Link).   Reporter did not allow further contact
pt recvd vax; devel inject site rxn characterized by induration & erythema; also exp malaise & n;
15 minutes after immunization the patient became dizzy, hot and sweaty, fell down. the patient then began to vomit. the patient then sat down and drank water for about 30 minutes and felt better. the patient did not have any problems breathing. After filling out a report the patient then left with a caregiver.
extreme fatigue; tired; A spontaneous report was received from a consumer concerning a 68-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events extreme fatigue, tired.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 024M20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events extreme fatigue, tired.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events, extreme fatigue, tired was unknown.
Red rash over neck and upper chest with welt-like bumps and intense itching/burning started 8/16/18. Initially treated at home with 1% hydrocortisone and BENADRYL 25-50 mg for approximately one and a half weeks - not effective.  Seen at clinic - provider indicated uncertainty regarding cause and prescribed the following: triple antibiotic - 1% silver sulfadiazine cream - 1% clotrimazole cream (mixed together and applied to affected area twice daily and at bedtime) as well as valacyclovir 1gm TID. No improvement was noted - burning and itching became unbearable. Went to Emergency Department on 9/7/18 and was advised to discontinue previous treatments.  Diagnosis was contact dermatitis of neck and face - was prescribed 40mg of prednisone x 12 days with a 6-day taper. Symptoms improved, but have returned with completion of steroid course.
This spontaneous report as received from a healthcare worker refers to two patients of unknown gender and age. On an unknown date, the patients were vaccinated with PNEUMOVAX23 injection (dose, dose number, lot/batch number, expiration date were not reported). On an unknown date, the patients developed cellulitis at the injection site after receiving PNEUMOVAX23. No product quality complaint (PQC) involved. The outcome of cellulitis at the injection site was unknown. The relatedness between the event and PNEUMOVAX23 was not reported. This is one of the several reports from the same source. Additional information has been requested.
Fever, malaise, fatigue, moderate headache beginning 02/14/2003 at noon at lasting through 02/16/2003.  Fever reached 104 degrees F 02/14/2003.  Took Tylenol and Motrin with some relief.
29NOV pt recv vax & 3DEC lt perinial pain;4DEC lt knee, lt heel pain rx'd w/APAP, Ibuprofen;6DEC resolved;exp radiculopathy , inflammation of the nerves, diffuse over the body;
Treatment of COVID-19/ Experiencing COVID rebound; Treatment of COVID-19/ Experiencing COVID rebound; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 29Sep2021 as dose 3 (booster), single (Lot number: EW0168) 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: "Hypertension" (unspecified if ongoing); "hypertriglyceremia" (unspecified if ongoing); "mitral valve prolapse" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; FENOFIBRATE; ASPIRINE; VITAMIN D [ERGOCALCIFEROL]; ATENOLOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19/ Experiencing COVID rebound". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Jul2022) Positive, notes: First tested positive for COVID on 07Jul2022 by PCR test; (17Jul2022) Negative, notes: Tested negative by COVID 19 antigen rapid test on 17Jul2022; (20Jul2022) Positive, notes: tested positive with the test on 20Jul and on 21Jul2022; (21Jul2022) Positive, notes: tested positive with the test on 20Jul and on 21Jul2022. Therapeutic measures were taken as a result of drug ineffective and covid-19, included Paxlovid, Treatment start date: 07Jul2022, Treatment stop date: 12Jul2022.  No follow-up attempts are possible. No further information is expected.
Vax administered 12/30/02. C/o soreness at site on 1/2/03. Developed rash on 1/15/03. Seen and treated by a family MD then referred to dermatologist, who Dx'd as reaction to MMR.
Information has been received from a RN concerning her son who in July or August of 2000 was vaccinated with varicella virus vaccine live. On 15Apr04 the pt developed shingles, which spread down his inner thigh. Medical attention was sought. The physician prescribed an antihistamine, would let it run its course. No product quality complaint was involved. There were also three other cases reported (WAES0404USA01771, 0404USA01828, and 0404USA01829). Additional information has been requested.  Additional information received. The patient's age and date of birth have been added.
immun given 17NOV97 afternoon & 3AM devel hives & intense itching lt arm where recv inj;no other sx;hives left arm only lasted 24-36hr;
Initial information received on 11-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves 14 months old female patient who was vaccinated with a 0.5 ml instead of 0.25ml dose of FLUZONE QUADRIVALENT (batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was reported that the patient was given 0.5ml of FLUZONE QUADRIVALENT instead of 0.25ml for her first vaccine of the 2 part series. It was an actual medication error due to overdose. No information about any adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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. List of documents held by sender: none.
This spontaneous report was received from a physician referring to a female patient of unknown age. Patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot #, expiry date and route of administration not reported). Other co-suspect or concomitant medications were not reported. On an unknown date, the patient developed fever tightening of her chest injection site pain and swelling. The physician said the patient possibly received a previous dose of PNEUMOVAX 23 less than 5 years ago but the physician was not sure. The outcome of chest discomfort, injection site swelling, injection site pain and pyrexia was unknown. It was reported that the patient called the physician's office. Additional information has been requested.
Sore arm; This spontaneous report has been received from a consumer via Pfizer, regarding to herself, a 49-years-old female patient. The patient's pertinent medical history included asthma, gastroesophageal reflux disease (GERD), aneurysm and irritable bowel syndrome as current condition, concomitant medications included omeprazole and amitriptyline. The patient's previous drug reactions or allergies were not reported.  On an unspecified date, the patient was vaccinated with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) subcutaneous injection, BCG vaccine (BCG VACCINE) powder for injection (reported as TB vaccine), Hepatitis A Vaccine, Inactivated (VAQTA) intramuscular injection (reported as Hepatitis A vaccine), Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) intramuscular injection (reported as Hepatitis B vaccine), a tetanus vaccine (unspecified), flue vaccine (unspecified) and a polio vaccine (unspecified) all as prophylaxis (strengths, doses, schemes, routes and anatomical locations of administration, lot numbers and expiration dates were not reported).  On an unspecified date, the patient experienced sore arm (Pain in extremity), which was reported as being a result of these previously mentioned vaccines. The outcome of Pain in extremity was not reported.   The causal relationship between Pain in extremity and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), BCG vaccine (BCG VACCINE), Hepatitis A Vaccine, Inactivated (VAQTA), Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB), tetanus vaccine (unspecified), flue vaccine (unspecified) and a polio vaccine (unspecified) was not provided.
tested positive for secondary immune deficiencies after completing the series of 3 Pfizer COVID vaccines.; This is a spontaneous report received from non-contactable reporter(s) (Nurse) from a sales representative.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), for COVID-19 immunization; Bnt162b2 (Dose: 02), for COVID-19 immunization. The following information was reported: SECONDARY IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "tested positive for secondary immune deficiencies after completing the series of 3 Pfizer COVID vaccines.". The patient underwent the following laboratory tests and procedures: secondary immune deficiencies/secondary immune: Positive, notes: 3 patients have tested positive for secondary immune deficiencies. Therapeutic measures were taken as a result of secondary immunodeficiency.  Additional information: 3 patients have tested positive for secondary immune deficiencies after completing the series of 3 Pfizer COVID vaccines. All have been diagnosed and started on IVIG. Patients were not treated with any biologics prior to testing positive for secondary immune deficiency.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the limited information provided, the Company (Pfizer) cannot completely excluded that the suspect medication may have contributed to the reported event secondary immune deficiencies  in this patient. Additional information regarding onset dates of drug administration/ events, relevant medical history, underlying conditions, concomitant medications will aid in the comprehensive assessment of the case. This impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300061072 same reporter/drug/event, diff patients;US-PFIZER INC-202300141698 same reporter/drug/event, diff patients;
Fever of 102.6, chills, dizziness, headache, fatigue. Still have low-grade fever and it is now Apr. 25th - shot was on Apr. 22. Hoping fever is gone for good.  Had COVID on Jan 17 - 30 so I waited to get vaccinated since I had antibodies.  This was my first shot. I felt like I had the virus all over again for about the first 24 hours.  Now it is milder fever (99-100) and just fatigue and still some dizziness.
Shortly after receiving the vaccine I developed a worsening and constant "hissing" and "ringing" in my ears that has not gone away since.   This has been categorized by my ENT as tinnitus. This had happened intermittently for many years prior but became constant and unrelenting following the two doses of the Moderna vaccine.
Serious palpitations; Lower number of blood pressure was high; Lower heart rate; Muscle ache; Headache; This spontaneous case was reported by a nurse and describes the occurrence of PALPITATIONS (Serious palpitations), HYPERTENSION (Lower number of blood pressure was high), HEART RATE DECREASED (Lower heart rate), MYALGIA (Muscle ache) and HEADACHE (Headache) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Sep-2021, the patient experienced PALPITATIONS (Serious palpitations), HYPERTENSION (Lower number of blood pressure was high), HEART RATE DECREASED (Lower heart rate), MYALGIA (Muscle ache) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PALPITATIONS (Serious palpitations), HYPERTENSION (Lower number of blood pressure was high), HEART RATE DECREASED (Lower heart rate), MYALGIA (Muscle ache) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Sep-2021, Blood pressure measurement: high (High) lower number of blood pressure was high.. On 30-Sep-2021, Heart rate: 56 (Low) lower heart rate (56 bpm) for 2 weeks..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the patient had serious palpitations, lower number of blood pressure was high, headache, muscle ache, and lower heart rate (56 bpm) for 2 weeks. The headache and muscle ache were coming and going. And all the symptoms started together the next day after first shot. No Concomitant medications were reported.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
A few days after vaccination, I had a major allergy attack, which was highly unusual.  I hadn't had a single allergy attack for the previous 15 years (after I moved to another city).  Before that time (15 years prior), I experienced many major allergy episodes over the span of 25 years.