chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm pain from the injection; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a month after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that, over a year ago, the patient reported that, experienced arm soreness after shingrix vaccination. No additional information available. The reporter did not consent to follow up.
patient felt quite sick with definite flu symptoms within 2 days; Initial information received on 06-Dec-2020 regarding an unsolicited valid non-serious case from a non-health care professional via social media.  This case was linked with 2020SA353040 (same reporter)  This case involves a female patient with an unknown age who felt quite sick with definite flu symptoms within 2 days (illness), while being received vaccine influenza vaccine.  Medical history, past medical treatment, vaccination, family history and concomitant medication were not reported.  On an unknown date, the patient received a dose of suspect influenza vaccine (produced by unknown manufacturer) (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patient felt quite sick with definite flu symptoms within 2 days (illness).   No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.
This spontaneous report as received from a nurse practitioner refers to a 53 year old male patient with anemia, appendectomy, benign positional vertigo, congestive heart failure, carpal tunnel syndrome, cataracts, chronic back pain, recent aortic coronary bypass, deaf in left ear, diabetes, end stage renal disease, gastroesophageal reflux disease, gastroparesis, hypertension, neuropathy, sleep apnea, diastolic dysfunction, hyperlipidemia and defibrillator. On 15-NOV-2013 the patient was vaccinated with PNEUMOVAX23 lot # H015749, 0.5 ml, intradermal. Concomitant therapies included amiodarone, HUMALOG, NORVASC, LIPITOR, EPOGEN, PERCOCET, CYMBALTQA, PHOSLO, PROTONIX and ramipril. The patient was supposed to received purified protein derivative (PPD) for tuberculin test but instated received PNEUNOVAX23. Several hours later, on 15-NOV-2013, the patient experienced an injection site reaction of redness, inflammation and pain. The affected area was hot. The nurse practitioner would be prescribing KEFLEX and BENADRYL at the day of reporting (18-NOV-2013). She might order an ultrasound of the patient's arm. On 18-NOV-2013, the patient stated that his arm was improving. The relatedness was not provided. Additional information has been requested.
Patient states she experienced blurred vision, decreased appetite, low blood sugar and a knot under her arms requiring a doctors visit resulting in an ultrasound and antibiotic treatment.
Nodules on legs, arm of injection site, neck and scalp, started 1 week post vaccine and still present on 3/31 when he first saw me for this issue.  Painful and itching, on exam appear to be erythema nodosum
This case was reported by a healthcare professional and described the occurrence of limb swelling in a child (15 months to 5 years) subject of unspecified gender who was vaccinated with INFANRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of INFANRIX at 0.5 ml. Within two days of vaccination with INFANRIX, the subject experienced limb swelling described as doubling or tripling in size. A product complaint was indicated. At the time of reporting the outcome of the events was unspecified. This event occurred in 7 patients. Linked cases include A0746417A, A0746425A, A0746426, A0746428A, A0746429A and A0746430A. Follow-up identified a product complaint number. It was additionally reported that the field rep stated that a nurse reporting the adverse event believed that a quality assurance problem caused the adverse drug effect. No details on the reported event. A quality statement received on 27 November 2008 from GSK Biologicals Quality Assurance and Quality Control stated that, "No deviation that could be linked to the complaint has been highlighted. No incident during distribution and no cold chain deviation that can be linked to the adverse were recorded."
emotional support;  vaque c/o "not feeling right" - mask removed " tickle in throat throat feeling mucousy"  RR 16/min, unlabored, no rash; no dysphagia; no tongue swelling;  drank water; symptom subsided.   waited in observation lot x 15 mins. total.
Patient received her flu shot at the pharmacy and came back a few weeks later to inform staff that she had gotten tendonitis in her shoulder due to improper administration of her flu vaccination. Patient had gone into her doctor who stated it was likely due to improper vaccination technique.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Additional Details: patient reported during the 15 minute waiting period extreme lightheadessness and felt the need to faint. paramedics called, bp was 133/77. patient was responsive and left after examined by paramedics. patient recovered with no residual issues,
Pt. states that after receiving the 2nd dose of Phizer 04/08/2021, started experiencing symptoms immediately of tongue swelling, self-treated with EPI-PEN. Primary visit noted 04/2021 treated with Anti-Viral and steroids. Pt. has recovered with slight weakness and lingering fatigue.
No adverse event; Greater than 35 days between first two doses of the Moderna Covid-19 vaccine; This spontaneous prospective pregnancy case was reported by a patient family member or friend and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between first two doses of the Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 32-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 21-Aug-2022, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In 2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between first two doses of the Moderna Covid-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between first two doses of the Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant medications were not reported.  Treatment medications were not reported. It was reported pharmacist told that it was not true and patient was fully vaccinated and starts a new job on Monday 7NOV2022 where it was fully vaccinated.  Company Comment: This spontaneous case concerns a 32-year-old female patient with no medical history reported, who experienced No adverse event after receiving the second dose of mRNA-1273 vaccine. Inappropriate schedule of product administration was reported in this case as interval between first two doses of the Moderna Covid-19 vaccine is greater than 35 days. Patient was found to be pregnant after the 1st dose of mRNA-1273 vaccine. No details of clinical course, lab reports or treatment received was available in the report. Outcome of events reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-669168 (E2B Linked Report).; Sender's Comments: This spontaneous case concerns a 32-year-old female patient with no medical history reported, who experienced No adverse event after receiving the second dose of mRNA-1273 vaccine. Inappropriate schedule of product administration was reported in this case as interval between first two doses of the Moderna Covid-19 vaccine is greater than 35 days. Patient was found to be pregnant after the 1st dose of mRNA-1273 vaccine. No details of clinical course, lab reports or treatment received was available in the report. Outcome of events reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-669168:dose 1 case
Information has been received from a pharmacist and a pharmacy intern concerning a 41 year old male pt with HIV, bronchitis and on Bactrim therapy for prophylaxis of pneumocystis who on 5/1/02 at 11:00 was vaccinated SC with the 1st dose of pneumococcal vaccine 23 polyvalent (lot 641116/1160L). In approx. 5/02, the pt developed flu-like symptoms described as muscle ache, fever, and weakness. In follow-up, the pharmacy intern described the pt's symptoms as fever/chills, myalgia, arthralgia and malaise. The pharmacist reported that the flu-like symptoms lasted 3 days after administration of the vaccine. The pharmacist also reported that since the vaccination, the pt developed the same flu-like symptoms after every dose of Bactrim, which was taken 3 X weekly. In follow-up, the pharmacy intern reported that the pt has had no previous problems with Bactrim therapy. The outcome of the pt's flu-like symptoms was not known. Unspecified medical attention was sought. No further information is expected.
felt like they were having heart attacks in the middle of the night.; This is a spontaneous report received from a contactable consumer. The consumer reported similar event for two patients, this is the 1st report of 2.  A patient of unspecified age and gender received bnt162b2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The consumer stated she knew 2 other people had the Pfizer vaccine that were having same thing, they all felt like they were having heart attacks in the middle of the night. The outcome of the event was unknown.  Follow-up attempts are completed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021378116 Same reporter/product/event, different patient
Chills, body aches, nausea and 100.5 fever loss of appetite
Patient developed rash; (2) weeks after vaccine. -There is no fever bu patient is crancky. -Macular rash all over trunk.
Cough started the same day of vaccination, productive, 2 weeks; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 11Jul2021 at 11:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any vaccination within four weeks prior to the vaccination.  On 11Jul2021, the patient had cough started the same day of vaccination, which was productive, 2 weeks. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event cough started the same day of vaccination, productive, 2 weeks was not recovered at the time of this report.   The batch/lot number for BNT162b2, was not provided and will be requested during follow up.
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 43-year-old male patient received BNT162b2 (BNT162B2), on 15Aug2021 as dose 1, single (Batch/Lot number: unknown), on 05Sep2021 as dose 2, single (Batch/Lot number: unknown) and on 11Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). Concomitant medication(s) included: CITALOPRAM; TYLENOL; FLONASE [MOMETASONE FUROATE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Paxlovid treatment; (11Aug2022) Positive, notes: My COVID came back four days after I completed the Paxlovid treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient took other medication on 2 weeks, other medications citalopram, Tylenol, Flonase products. Patient Covid came back four days after patient completed the Paxlovid treatment. Adverse event start date 11Aug2022 and recovering. Patient treated Paxlovid start date 02Aug2022 and stop date 07Aug2022 for Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
PATIENT DID NOT HAVE ANY ADVERSE EFFECTS 15 MINUTES POST-VACCINATION.  AFTER LEAVING, PATIENT IMMEDIATELY RETURNED TO THE PHARMACY COMPLAINING OF HEART PALPITATIONS.  AFTER 15 MINUTES, SHE FELT BETTER AND ATTEMPTED TO LEAVE BUT THE HEART PALPITATIONS RETURNED AND 911 WAS IMMEDIATELY CALLED.   PARAMEDICS SOON ARRIVED AND TRANSPORTED THE PATIENT TO THEIR AMBULANCE.
On 10/28/2021 body hurt all over had chills that felt like it was to the bones.  Severe headache dizziness and nausea.  Slept all day. Temperature was 98.8. Left arm pain where injection was. On 10/29/2021 still dizzy and severe headache  still some chills. Pain still where the injection was. Haven't eaten anything yet still very nauseous. Had to call out of work.
administered 1 ml of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (administered 1 ml of the Moderna COVID-19 vaccine) in a 28-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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 milliliter. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (administered 1 ml of the Moderna COVID-19 vaccine). At the time of the report, ACCIDENTAL OVERDOSE (administered 1 ml of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not reported.  Treatment medications was not reported.
nausea,, light headed, fainted, chills, sweats,body aches,
Pfizer vaccine was administered outside of clinic- reported by patient- ? NO LOT NUMBER WERE SUPPLIED -------------------------------------------------------------------------------------------------------------------------  HYPOTENSION 6/2/2021 ASCITES  HYPOTENSION 6/2/2021 ESOPHAGEAL VARICES
BURNING OF THE SKIN; RASH TO THE ANKLES WITH INTERNAL ITCHING THEN PROGRESSIVELY SPREAD TO THE THIGHS, BACK, BILATERAL SIDES AND SHOULDERS, RASH WAS RAISED, WARM, WELTED IN SOME AREAS AND EXTREMELY ITCHY; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 31-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 01-SEP-2021, the patient experienced burning of the skin. On 01-SEP-2021, the patient experienced rash to the ankles with internal itching then progressively spread to the thighs, back, bilateral sides and shoulders, rash was raised, warm, welted in some areas and extremely itchy. Treatment medications (dates unspecified) included: triamcinolone, ibuprofen, diphenhydramine hydrochloride, methylprednisolone, fluticasone propionate, cortisone, and pseudoephedrine hydrochloride. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from rash to the ankles with internal itching then progressively spread to the thighs, back, bilateral sides and shoulders, rash was raised, warm, welted in some areas and extremely itchy, and burning of the skin. This report was non-serious.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 15-Jan-2021. Concurrent medical conditions included Type 2 diabetes mellitus, Hypertension, Hyperlipidemia and Obesity. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ), LOVASTATIN, METFORMIN and VERAPAMIL for an unknown indication.    On 03-Sep-2021 at 11:32 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021 at 11:32 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 03-Sep-2021 at 11:32 AM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, SARS-CoV-2 test: positive (Positive) positive for Rapid Antigen test.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information provided.
FLUZONE was given around 11:15 am 9/21/12 around 3 pm patient reported she felt tightness of her chest, red eyes. Patient came back to store, we gave her 1 cap diphenhydramine 25 mg immediately.
covid symptoms started on 12/28.2021, fever, body aches, night sweats, hacking cough, ticklish throat, headache causing nausea, fatigue ending 8 days later.  wife tested positive for covid, twice, so I didn't bother.
Patient returned to clinic after 30 min, complaining of dizzines, nausea and facial swelling. Assed patients heart and lungs. Breathe sounds clear to ausculation, no diminished breathing, wheezing or rales noted. Flushed face. Blood pressure 138/98, RR 18, oxygen 100%, HR 114. Patient with pervious anxiety about getting flu vaccine as she could not remember if she had inthe past. Discussed with patient to remain calm, no complaints of throat swelling or shortness of breath. Looked for swellingon her facial but could only find mild redness from where she wore the mask on her face. Airway patent, no swlling of throat or tonsils. Had patient sit for 5 mings, gave her water and a sucker as she could not remember the last time she had something to eat or drink, in several hours. After 5 min HR 98, blood pressure 128/82, RR 18, oxygen 100% , airway still patent. Had patient sit in the clinic in a lounged position for another 10 mints. Reviewed side effects of medication, given VIS sheet. Upon leaving the clinic blood pressure 118/72, RR 18, HR 62, oxygen 100 %. Color returned to face and patient reports that she felt much better, able to talk in complete sentence, aireway patent. Reviewed signs and symptoms of an allergic reaction and when to call 911.
This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. The patient's relevant medical history was not reported. On 17-OCT-2014 the patient was vaccinated with M-M-R II (therapy type, route, dose, frequency and lot # were not reported) which underwent an excursion. This is one of several reports received from the same source. Additional information has been requested.
FLUVIRIN W/ THIMERASOL GIVEN TO OB PT. PT NOTIFIED ON 11/5/2009. DENIES ANY ADVERSE EFFECTS. 12/10/09 OB recs received. Pt received vax w/ thimerasol. Normal IUP.
3 x 3" red, swollen, warm arm within 24 hours of getting DTaP and Varivax in that arm. No itching, fever.
Fever over 101, achy all over, headache, chills, soreness at injection site, swollen lymph nodes
Initial report was received from a health care professional on 27 March 2012. An 18-year-old female patient had received a dose two intramuscular injection in the left arm of MENACTRA (lot number not reported) on 22 March 2012 when she was at her primary care physician's office for urinary tract infection (UTI). On the morning of 23 March 2012, the patient experienced a headache and fever. The patient was hospitalized for four days and treated. The patient had a lumbar puncture and the results documented six white blood cells (WBCs) in the fluid, 100% were polymorphonuclear leukocytes (polys), no lymphocytes (lymphs). The patient's gram stain was negative. The patient had a history of H. Pylori and no known allergies. The patient's concomitant medications included LEVORA, BACTRIM, which she started the same day as the vaccination for the UTI, BIAXIN and FLAGYL. It was unknown if the patient had any adverse events to prior vaccinations and received no other vaccines within four weeks of MENACTRA. The patient's outcome was recovered. Documents held by sender: None.
Reports a lump as large as a baseball, red, hot, and painful. Advised pt to see her primary care physician.
About a week after the second injection, I began feeling very fatigued.  I assumed this would go away in a week or so.  It did not.  It has gotten worse.   My GP has suggested it is sleep apnea.  I have had sleep apnea for quite some time and it has never made me feel this way.  I am exhausted, all the time.  I can barely  get through a day.  I can do almost no exercise, climb a couple of flights of stairs, walk a couple of blocks and I need to rest.  Just existing  wears me out..   Initially I thought it was a reaction to the vaccine but after a couple of weeks I began to think it was a heart issue.  So, I had EKG and Echocardiograms done.  They show normal.    I am  not just tired, I am brain fog tired. I am fatigued well past anything I have ever experienced.  I don't know if this is a result of the Vaccine.  That is what I am asking and is there treatment?
5/4/03 showed signs of virus, nasal mucous yellow, cranky. 5/8/03 diagnosed by pediatrician with ear infection at 10:45 appointment rising fever from 101.00 at 9am to 104.8 by 2pm, never has fever with ear infections. 5/11/03 rubella rash and neck lymph nodes swollen, diarrhea, vomiting. 5/12/03 hospital visit for extreme dehydration, IV antibiotic.
PT PRESENTED DIAPHORETIC WITH NAUSEA, NEAR-SYNCOPAL EPISODE O2 SAT - 97 BP - 132/72 RESP. RATE - 18 GCS - 15
12/09/05 IUFD EDC 12/09/05 delivered 12/09/05 at 1629 SVD male 5 lb 14 oz without apgars 0/0