chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My symptoms felt like they started in the left side of my neck. I had a severe sore throat and aches, but I never ran a fever. The sore throat moved up into my teeth. Then, it moved to my eyes. A week later, I went to the doctor. They tested me for COVID-19 and Flu. Both results were negative. She have me FLONASE and told me to do a nasal flush. She also prescribed a mouthwash that they called magic mouthwash and benzonatate. I alternated TYLENOL and ibuprofen.
Pt received vaccine in left deltoid. In evening/night on same day, pt went to ER with c/o numbness, swelling, pain in her left arm and unable to use her left arm. Pt had nausea & unable to sleep.
This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with improperly storage RECOMBIVAX HB, lot number as reported M020929, expiration date 11-AUG-2018, lot number L048236, expiration date 31-MAR-2018, lot number M037248, expiration date 21-FEB-2019, lot number M018625, expiration date 11-AUG-2018, (strength, dose, dose number, route and  anatomical location were not reported), for prophylaxis. The temperature excursion was reported below 32 Fahrenheit degrees (0 Celsius degrees), time frame of 25 hours 5 minutes. The vaccines did not experience any previous temperature excursion. Digital data logger was involved. No product quality complain was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA007383: US-009507513-1702USA007382: US-009507513-1702USA007380: US-009507513-1702USA002897:
The pt received vax on 4/4/00. The pt experienced pains in muscles, joints, and chills. No temp was taken, but pt felt feverish. Pt had an appointment on 4/5/00 complaining of same symptoms, additionally a complaint of a lump under right arm which was not present on exam. Advised to take Tylenol, rest, fluids. On 4/6/00, the pt called the MD again, she continued to have aches, pain at site. Advised to take Motrin. On 4/7/00, pt much better, very little redness or pain.
loss his sense of smell; Pains; fever; body ache; loss of appetite; felt awful,; cold sweats; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (loss of appetite), FEELING ABNORMAL (felt awful,), COLD SWEAT (cold sweats), ANOSMIA (loss his sense of smell) and PAIN (Pains) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.     On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced DECREASED APPETITE (loss of appetite), FEELING ABNORMAL (felt awful,), COLD SWEAT (cold sweats), PAIN (Pains), PYREXIA (fever) and MYALGIA (body ache). On 26-Apr-2021, the patient experienced ANOSMIA (loss his sense of smell). The patient was treated with PARACETAMOL (TYLENOL) from 23-Apr-2021 to 24-Apr-2021 at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (loss of appetite), FEELING ABNORMAL (felt awful,), COLD SWEAT (cold sweats), ANOSMIA (loss his sense of smell), PAIN (Pains), PYREXIA (fever) and MYALGIA (body ache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant details were provided
pt complained of getting dizzy and having trouble seeing when talked to him after. patient had parent with him (father) pt was nervous. got vaccine and left room. father said he looked very pale and then pt sat down and started to throw up. patient wasn't hospitalized. mild redness at injection site. left the premises after 15 to 02 minutes feeling fine.
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 53-year-old male patient received BNT162b2 (BNT162B2), on 27Dec2021 as dose 3, (booster) single (Lot number: 33036bd) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Iga nephropathy" (unspecified if ongoing); "essential thrombocytopenia" (unspecified if ongoing); "Gout" (unspecified if ongoing); "hypertension" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL SUCCINATE, start date: 04Oct2021; ALLOPURINOL; ECOTRIN; VITAMIN D3; GUAIFENESIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: COVID-19: (unspecified date) positive, notes: Treatment of COVID-19; (27Jul2022) positive, notes: Verified Covid positive with test 2 days later. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: If vaccine received: Yes. Other medication in 2 weeks: Yes. Patient received Paxlovid from 20Jul2022 to 25Jul2022 for Covid 19 treatment. Patient received her medication in 2weeks product: Farxiga (lot no Pa0051) from 01Mar2022. On 04Oct2021 Metoprolol succ er 25 mg tab, Allopurinol 300 mg tablet, Asprin 325mg, Ecotrin, Vitamin D3 50 mcg, Guaifenesin 400 mg. Acetaminophen 500mg, on 22Jul2022, started Diphenhydramine HCL 25mg, 22Jul2022, Pseudoephedrine HCL 30mg. Covid symptoms returned 3 days after last dose of Paxlovid. Verified Covid positive with test 2 days later. Eevnt onset is 28Jul2022 at 03:00 PM and no treatment and no known allergy reported.
pt recvd vax;12 hrs later, exp raised red area below inject site which was hot & painful;neck,jaw,upper back pain lasting about 48 hrs;
itchiness on the injection site; a small rash was noticed on the injection site area; A spontaneous report was received from a (Reporter like HCP or Consumer) concerning a 55-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced, itchiness on the injection site(Injection site itching) and a small rash was noticed on the injection site area (Injection site rash).  No medical history was reported. Concomitant medications reported included,Synthroid, Bystolic, vitamins B12-C-B3 and stomach medications.  On 09-Feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch No:031L20A) through an unknown route of administration, on the right arm for prophylaxis of COVID-19 infection.  On 16-Feb-2021, the patient experienced events, itchiness on the injection site(Injection site itching) and a small rash was noticed on the injection site area (Injection site rash).  No Laboratory details were provided.  No Treatment information was reported.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events reported, itchiness on the injection site(Injection site itching) and a small rash was noticed on the injection site area (Injection site rash) was considered unknown.
13OCT95 reports t100.6, BP 160/101, P91, R20 advised to take APAP; no problems breathing, no hives, no body aches;1hr later t102.4 went as high as 103; arm red, warm to touch, w/swelling of a couple inches @ inj site;
thigh red, hot and swollen and itchy (20x14cm area) given Benadryl 25mg IM, Zyrtec 5mg and ice pack in office.
pt recv vax 22DEC93 & pt was given 10 mcg instead of 5mcg;22DEC93 following vax pt exp aching arm;no further details were provided;
A 7 year old patient was administered Flublok, no AE; Initial information was received on 04-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.   This case involves a 7 year old male patient who was administered INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age).  Medical history, past medical treatment, vaccination and family history were not provided.  The patient did not receive any concomitant vaccines.   On 01-Sep-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2003, expiry date: 19-May-2021) once via unknown route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate age at vaccine administration (latency same day).  Reporter wanted information regarding this occurrence due vaccine not being approved for this age  At the time of report, 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 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.
Chest tightening (Major), Left shoulder muscular spasms that moved up to MAJOR muscle spasms on left side of neck, moved to upper back, and over to right muscle in neck (major), fog Also had MAJOR Head ringing, light headed vertigo (I can't even describe) I felt like everyone was yelling and my head was in a fog.
Reappearing rashes in different areas of the body that are itchy, burning sensation, raised and come and go. Rashes started about a week after the Moderna booster shot.
Pt. started vomiting after vaccines. Vomited several times then was shaking, no apnea. Recovered quickly. Later that evening increased vomiting and was admitted to local hospital.
queasy; headache; chills; vomiting; fatigue; muscle pain in her legs; muscle pain in her hips; joint pains; sweats; dry cough; temperature was between 96-97 F; soreness at the injection site; "it started hitting her harder"; pain from arm to neck and base of head; This spontaneous case was reported by a patient and describes the occurrence of PAIN ("it started hitting her harder"), PAIN IN EXTREMITY (pain from arm to neck and base of head), BODY TEMPERATURE INCREASED (temperature was between 96-97 F), HYPERHIDROSIS (sweats) and COUGH (dry cough) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included OMEPRAZOLE for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PAIN ("it started hitting her harder"), PAIN IN EXTREMITY (pain from arm to neck and base of head) and VACCINATION SITE PAIN (soreness at the injection site). On 04-Mar-2021, the patient experienced BODY TEMPERATURE INCREASED (temperature was between 96-97 F), HYPERHIDROSIS (sweats), COUGH (dry cough), NAUSEA (queasy), HEADACHE (headache), CHILLS (chills), VOMITING (vomiting), FATIGUE (fatigue), MYALGIA (muscle pain in her legs), MYALGIA (muscle pain in her hips) and ARTHRALGIA (joint pains). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN ("it started hitting her harder"), PAIN IN EXTREMITY (pain from arm to neck and base of head), BODY TEMPERATURE INCREASED (temperature was between 96-97 F), HYPERHIDROSIS (sweats), COUGH (dry cough), VACCINATION SITE PAIN (soreness at the injection site), NAUSEA (queasy), HEADACHE (headache), CHILLS (chills), VOMITING (vomiting), FATIGUE (fatigue), MYALGIA (muscle pain in her legs), MYALGIA (muscle pain in her hips) and ARTHRALGIA (joint pains) outcome was unknown.            This case was linked to MOD-2021-035984 (Patient Link).
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. The patient started the GARDASIL (lot#, dose and route not provided) series "over 2 years ago" (in approximately 2013) and had not received the third dose yet. Patient was in the office (on 18-AUG-2015) to receive the third dose (inappropriate schedule of drug administration). No adverse effects reported. It was also reported that the patient sought for medical attention. The outcome of the event was not reported. Additional information has been requested.
This spontaneous report as received from a nurse, via other company (Pfizer # 2015293822) refers to a patient of unknown age. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. On an unspecified date, the patient experienced her entire arm painful and swollen. The outcome of the events was unknown. The reporter's causality for the events was not provided. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2022 at 11:00 as dose 4 (booster), single (Lot number: FP4554) at the age of 61 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Reactive airway disorder" (unspecified if ongoing); "deleterious BRCA2 mutation" (unspecified if ongoing); "breast cancer survivor" (unspecified if ongoing); "food allergy" (unspecified if ongoing), notes: citrus, cantaloupe and honeydew melons, apricots. The patient's concomitant medications were not reported. Past drug history included: Septra, reaction(s): "drug allergy"; Doxycycline, reaction(s): "drug allergy"; Fosamax, reaction(s): "drug allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jun2022) positive, notes: Tested positive on Abbott rapid antigen test on Day 12; (Jun2022) Positive, notes: Original course was positive testing Day 1-Day 4; (Jun2022) negative, notes: with Day 5 testing negatively. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not received other medication in 2weeks. Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 01Jun2022, Treatment stop date: 05Jun2022. Adverse event: Tested positive on Abbott rapid antigen test on Day 12. Original course was positive testing Day 1-Day 4, with Day 5 testing negatively. The Known allergies: Septra, doxycycline, Fosamax; food. Allergies are citrus, cantaloupe and honeydew melons, apricots. The other medical history: Reactive airway disorder; deleterious BRCA2 mutation and breast cancer survivor.  No follow-up attempts possible. No further information expected.
She was vaccinated 12/23. Initially she had some soreness,  nausea, diarrhea, extreme fatigue, but no fever. Two days later, she developed a diffuse erythematous rash on her bilateral arms, chest and neck with sharply delineated white patches. She also describes that her hands were purple, almost cyanotic appearing. The rash was not itchy or painful and lasted about 6 hours before going away completely.
Had vaccine 8/10/15. Rash on back 8/11/15 resolved within one day. Had fever 102, cranky, decreased appetite and activity on 8/17/15. No further fever but not crawling, eating or talking like usual since then.  Maculopapular pink rash developed over trunk and extremities on 8/20/15. Seen in walk in clinic. Treated with BENADRYL. Seen by me 8/21. Alert and nontoxic. Normal neuromuscular exam, pink maculopapular rash c/w viral exanthema.
The morning after receiving the booster shot I felt quite a bit of soreness at the injection site and began felling tightness in my upper chest along with a runny nose.  Over the next two weeks it developed into what I believe was an upper respiratory infection with a productive cough and runny nose. I saw my local physician who ordered a covid test and upon learning it was negative saw me in his office. He indicated my lungs were clear of infection.
Nurse was supposed to vaccinate the patient with Adacel, however vaccinated them with Daptacel instead in error with no A/E; Inappropriate age at vaccine administration with no A/E; Initial information was received on 16-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via phone call (under Medical Information Inquiry Number: 00773248).  This case is linked to cluster cases 2021SA310131and 2021SA311632.  This case involves a 66-years old female patient who received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].(wrong product administered and product administered to patient of inappropriate age).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.    On 10-Aug-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number: C5687AA and expiry date 09-Dec -2021 via intramuscular route in the deltoid for prophylactic vaccination.  It was an actual medication error due to Wrong vaccine administered and inappropriate age at vaccine administration (same day latency).  It was reported "Director of Quality stated that a nurse was supposed to vaccinate three patients with Adacel, however vaccinated them with Daptacel instead in error. The caller asked if the patient's should be injected with Adacel now, or if the Daptacel was sufficient. The caller stated that this occurred because the Daptacel and Adacel sound the same. No additional Adverse events  were reported as a result of this.Patient two Pasteur adverse event reporting refunds/credits would not be issued due to adverse events."  At the time of reporting, no adverse event 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.
1. Extreme fatigue on day following both 1st & 2nd COVID-19 vaccination 2. tinnitus started about 5 days following 2nd COVID-19 vaccination and has not stopped since.  Worse at night.  I did experience tinnitus on rare occasions prior to COVID-19 vaccination.
This spontaneous report has been received from a pharmacist, concerning a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were unknown by reporter. On an unknown date, the patient was vaccinated with the second dose of VARIVAX (frequency, route, lot number and expiration date were not provided) for prophylaxis. On an unknown date, the reporter stated that the patient received a mutated VARIVAX for the second dose and got very sick. The outcome of got very sick was unknown and the causal relationship between the adverse event and the therapy was not assessed. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1805USA005879:
Pt. given varicella in back of Rt. arm. Next morning noted red and itching. Only hurt when scratched or rubbed to relieve itch. No fever. No breathing prob. Advised to take BENADRYL. Can use cold moist to relieve sx - anti itch cream. Feb 8th at 4pm 40 mm x 50 mm red, warm to touch.
pain, swelling at the site, low grade fever,nausea,diarrhea, sore joints, body aches, and tiredness.
Immediately upon receiving Varicella 0.5ml sub cut to Rt. leg, pt. developed hives above inj. site.
Patient taken to the Emergency Department following first dose. He felt like his heart was racing and his hands and feet tingling. Was given benadryl in the ED and advised to discuss second dose with his primary care provider. He has a history of allergies to shellfish and possibly other allergens.
Information has been received from a pharmacist concerning a 65 year old female with penicillin allergy and a history of thyroid cancer 30 years ago who on 20-APR-2007 was vaccinated SC with a 0.65 ml dose of Zostavax (Merck) (Lot # 656413/1477F). Concomitant therapy included levothyroxin. On 21-APR-2007 the patient developed redness, itching and warmth at injection site. At the time of report patient had not recovered. No diagnostic laboratory test were performed. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.  Additional infromation has been received from the pharmacist who reported that the patient had recovered.  No further information is expected.
This spontaneous report as received from a physician via a company representative refers to a female patient in her 20's. On an unknown date, the patient was vaccinated with GARDASIL injection, first dose (dose, frequency and lot number were not reported). The patient who received the first dose of GARDASIL and developed rash all over her body. The patient mentioned this incident to this physician "in passing during an annual exam". No treatment was given. The patient did not receive medical attention. The patient's outcome was unknown. Additional information is not expected.
swollen . sore arm, elevated temp, 2 degrees above normal,  weak, ache all over, feet burnt and itched (not normal)  today, 13th, temp is down, arm is better, still sore , weak, but not the ache all over as bad, feet not burning, now today diarrhea, but at 11;30 getting better,  eyes have been more sensitive and blurry than normal and still are.
Throbbing pain at injection site that spread to shoulder, neck and upper back. 24 hours after injection my entire left side hurt including my ribs.  By day 2, the pain was localized to arm, shoulder and neck. Pain has been ongoing for 8 days.