chrisvoncsefalvay/vaers-outcomes huggingface dataset:
indication=Treatment of COVID-19; indication=Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single Vaccine administration time=12:00 AM (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing). Other medications in two weeks: No. Known allergies: No. Other medical history: high blood pressure. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test positive: Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective. Adverse event start date: 09May2022 at 12:00 AM. Adverse event: Patient did great while on paxlovid. felt like patient was not sick at all. on day 7 from positive test, 2 days after finishing paxlovid. Patient got incredibly sick with covid. elevated heart rate and congestion. Patient was now day 24 and patient still have nasal congestion and elevated heart rate. Anti-viral details: Product= Covid-19 treatment Brand= Pfizer Treatment start date= 02May2022 Treatment stop date=06May2022 Indication= Treatment of Covid-19. Adverse event stop date: May2022. No treatment for adverse events.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Low grade temp for 48 hrs with muscle aches and sore arm. 48 hrs after vaccine 2 blotchy pale  red spots appeared near vaccine injection site. As of 11/8/2021 the spots are still visible. The spots are flat and there were never any welts. it is not painful or itchy, just visible.
Muscular pain from the Soles of feet, to both thighs, upper back/shoulders, back of head.
2 year old patient mistakenly received a MENQUADFI vaccine instead of the intended PREVNAR 13 vaccine with no reported adverse event; Initial information received on 22-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 years old male patient who had mistakenly received a MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] vaccine instead of the intended PREVNAR 13 vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) and HIB VACCINE CONJ (TET TOX) (ACT-HIB) for prophylactic vaccination.  On 22-Sep-2022 the patient developed a non-serious event of 2 year old patient had mistakenly received a MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] vaccine (dose: 0.5ml, batch number: U7294AC and expiry date: 24-May-2023, route, administration site was unknown for Immunization ) instead of the intended PREVNAR 13 vaccine with no reported adverse event (wrong product administered) (Latency: same day). Nurse asked if a follow up dose at age 11 or 12 of MENQUADFI was recommended.  Action taken : not applicable.  Outcome: Unknown  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 guidelines. 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.
12/18 1st vaccination 12/27 COVID + 1/10 2nd vaccination  Later that evening, I had tightness on R side chest. Rapid HR. Pulse 144. Lasted 3-4 minutes. Called 911. HR had gone back down to 78, normal BP, normal EKG. Tachycardia  1/11 lymph nodes swollen under armpit on R side. Sore arm.  Had another episode 2 days later; Tachycardia.  Went to Dr 1/13/2021. Full work up.  Started on BP medicine.
Information has been received from a physician concerning a female patient who was vaccinated with GARDASIL. The patient received the first dose of GARDASIL and a week and half later she was scheduled to have heart surgery due to a hole in a heart that patient already had. Then after surgery the patient started to experience illness on a mitochondrial level. The physician stated that the patient was hospitalized due to surgery but did not specify how long the patient was in the hospital. Illness on a mitochondrial level was considered to be immediately life-threatening and disabling. At the time of this report, the patient was recovering. No further information is available.
Sore arm at 8 hours after Big welt in inside elbow of same arm (left) at 9 hours Tight and significant numbness in fight leg and foot at 12 hours 99.1 fever at 18 -22 hours after Body aches and fatigue 18-24 hours
pt recvd vax; 30 min to 1 hr p/ vax, pt exp difficulty breathing; numbness & upper body tingling; went to er & was given meds; saw pmd 1nov94 due to "feeling strange"; advised to cont meds x 2 more days & avoid another flu vax;
pt vaxed on 26AUG92 afternoon w/DTP/OPV/HIB; had sore leg @ site of DTP inject, up most of noc crying but not unconsolably & not high pitched; could not walk for 1 1/2 days p/that; lt thigh was not very swollen or reddened @ inject site;
Case number PHEH2013US008933 is an initial spontaneous report received from a nurse on 17 Apr 2013. This report refers to a male patient. His medical history and concomitant medications were not reported. It was reported that on an unspecified date he was vaccinated with 0.5 ml MENVEO (batch number: M11081, expiry date: Apr 2014) intramuscularly and did not receive MenA lyophilized conjugate. No adverse reactions were reported. No further information was provided.
Moderna COVID-19 Vaccine EUA dose given 67 days after BUD for refrigeration
I was administered the flu vaccine at walk in flu clinic time and immediately felt pain and stiffness in my upper arm after shot was given.  I could barely use my upper arm for many months and still have residual soreness in my upper arm.  I believe the vaccine was administered improperly.  I am hoping that is the case as I need to get another flu vaccine soon.  I hope it was not the fluid itself.
Patient received Moderna vaccine for first 2 shots, received incorrect booster for 3rd shot - Janssen in error.
I started with a raspy voice on December 24, 2022, I tested positive for COVID-19 on December 25, 2022. I went to urgent care. They prescribed PAXLOVID. I started taking it the same day. It gave me diarrhea. I had the sore throat on December 25 and 26, 2022. I was very tired for a few days. I had a slight cough. On December 31, 2022, I tested negative for COVID-19. I also tested negative for COVID-19 on January 2, 2023. Now, I feel fine.
TOOK ONE DOSE OF UNREFRIGERATED VIVOTIF; This spontaneous case report (PVX2019-2650) was received from a pharmacist on 24-Oct-2019. It described a female consumer who "took one dose of unrefrigerated Vivotif" (PT: Product storage error), while being on Vivotif for typhoid prophylaxis.  Case report: The consumer took a dose of Vivotif on 24-Oct-2019 which had been left at room temperature for two months.  Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported event was unknown.   Company's Comment: The causality of the event "took one dose of unrefrigerated Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took one dose of unrefrigerated Vivotif" was considered as not applicable.
Non immunocompromised patient has received 2 booster doses; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Non immunocompromised patient has received 2 booster doses) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus.   In October 2021, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced EXTRA DOSE ADMINISTERED (Non immunocompromised patient has received 2 booster doses). At the time of the report, EXTRA DOSE ADMINISTERED (Non immunocompromised patient has received 2 booster doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. No treatment medication was reported by reporter.
Patient had a pneumococcal and influenza vaccine placed in his left arm, 3 days ago, April 13, 2021. His initial reaction, was pain that developed hours after the injection, with subsequent erythema on left arm. The patient developed erythema around the left injection site, cough and headache. Symptoms are improving, but patient will let us know if his symptoms do not improve or worsen next week.
BILATERAL WHEEZES SHIVERING FLUCTUATING OXYGEN SATURATION SKIN FLUSH
Uppper arm starting swelling up about 8 hours after vaccination. Red, painful to the touch.
Narrative: Patient received two doses of Pfizer vaccine in March 2021. The patient tested positive for COVID 19 on 19 Oct 21 and was hospitalized with fever, chills, sweats, weakness, diarrhea, and COVID pneumonia. The patient was treated and discharged in stable condition on 23 Oct 21. Reported per EUA.
Client presented  receive Pfizer Booster .Client stated she has a history of fainting with vaccines. She declined to sit in zero gravity chair for vaccination and reported to Vaccinator that ?it hasn't happened with other vaccines in a while. I should be ok?.  Client was at vaccination table and received Pfizer COVID vaccine Booster. While still in chair client fell on floor face forward. Client had loss of responsiveness for about 30 seconds. Client was moved over on her back and legs were elevated by  RN .. Client was AAOx3. Client was speaking normally and denied dizziness, or blurriness, no double vision. Client was sweating, and no pallor was observed on face, arms or neck. Vitals taken by RN at 1225 Vitals . Client stated she felt better and didn't feel like she was going to faint again. Client stated she had a mild headache pain scale 1/10 on the left side of where she bumped her head. Client had a scrape on left upper side of eye with mild bleeding. Scrape was cleaned and covered by RN. Client was informed that EMS were going to be called due to bumping her head. Client verbalized understanding. EMS was activated .. Client denies being on blood thinners.  No other medical history was reported. Client was advised  to follow up with her Primary care provider and seek emergency care for any other symptoms.
pt devel chickenpox on 1AUG97 which was 9 days post vax of 2yr old son;;pt presented to MD office w/approx 10 pox on face, torso, & breast;
pain in the right leg; muscle pain in the lower back region; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the right leg) and MYALGIA (muscle pain in the lower back region) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in the right leg) and MYALGIA (muscle pain in the lower back region). At the time of the report, PAIN IN EXTREMITY (pain in the right leg) and MYALGIA (muscle pain in the lower back region) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication information was reported.
Patient currently inpatient admission at (1) day. COVID 19 bronchopneumonia; Generalized weakness/lethargy/fatigue. Patient vaccinated x2 with Pfizer; Patient does not qualify for Remdesivir/Decadron as not hypoxic and minimal CXR findings; Symptom onset 12/4/21. Continue severe respiratory precautions; Supportive care: CXR showing mild L bronchopneumonia. Received Azithromycine/Rocephin in ER. Will check procalcitonin and if elevated, will continue. Otherwise, in setting of no fever/elevation in WBC, suspect due to COVID infection. PT/OT; Acute on chronic hyponatremia; Patient has h/o hypervolemic hyponatremia; At this time, suspect hypovolemia due to dehydration/diarrhea. Daughter has been holding Torsemide for last 2 days given decreased PO intake. Continue to hold Torsemide and received 1L IVF in ER. Repeat CMP in AM. Diarrhea - likely due to COVID infection; No abdominal pain, leukocytosis; Continue supportive care. Received 1L IVF in ER. Mg level pending; Chronic diastolic CHF: Hold Torsemide and KCL for now. As patient is having diarrhea and decreased PO intake, no fluid restriction ordered at present but may need to add once PO intake increases. PAF: Continue Cardizem CD 180 and Eliquis. HTN; Continue Norvasc 5, Cardizem CD 180, and hydralazine 50 TID. Pituitary microadenoma; Continue Cortef. If patient has any signs of hypotension, will order stress dose. DVT PPX - on Eliquis. Code status - NO CPR, ok for intubation for respiratory failure. Patient is a 87 year old female with history of diastolic CHF, chronic hyponatremia, HTN, PAF, CAD, mitral stenosis, pituitary macroadenoma, carotid stenosis, OA who presented to the ER with increasing weakness, cough, and lethargy. Patient's daughter who lives with and cares for patient was diagnosed with COVID over 2 weeks ago and had mild symptoms (vaccinated). She reports patient on Saturday (12/4) developed cough, increasing fatigue, and diarrhea. She continued to have symptoms and today was falling asleep mid-sentence and lethargic so was brought to the ER. There she tested positive for COVID. Patient is vaccinated for COVID (Pfizer) and was due to for her booster. She admits to cough and mild SOB with exertion. No fevers/chills. + nonproductive cough. Continues to have some diarrhea, 2-3 BMs per day. Patient's daughter has held her Torsemide the last 2 days as she had decreased PO intake. In the ER, patient was not hypoxic. CXR showed mild bronchopneumonia, primarily involving the L lung. She was given 1L IVF and admitted under observation for continued monitoring.
This spontaneous report was received from a pharmacist regarding a 59-year-old female patient. The current conditions of the patient included high blood pressure and high cholesterol. The patient had no drug allergies. On 18-NOV-2015, the patient was vaccinated with ZOSTAVAX (lot number # L024998 Expiry date: 06-OCT-2016) (strength and dosing regimen was unknown), via subcutaneous route. Concomitant therapies included PLAVIX and aspirin (manufacturer unknown) and some unspecified medication for high blood pressure. On 18-NOV-2015, in the evening time, after the patient was vaccinated with ZOSTAVAX, experienced a large, red, sore area around the injection site with a nod in it. On 23-NOV-2015, the patient visited the pharmacy and reported that the nod or the hematoma has disappeared, however, the site was still large (the size of her lower arm), red and black and sore and was also described the site as "black and blue" and the size of an orange. The patient was advised and encouraged to follow up with her primary health care physician. The outcome of the event "a large, red, sore area around the injection site" was reported as not recovered however the outcome for the event "the injection site with a nod" was reported as recovered. The relatedness of the events with ZOSTAVAX was unknown. No product quality complaint was reported. Additional information has been requested.
Tenderness in Lt deltoid x 2 wks nausea/vomiting/dizziness x 2 wks (intermittent) Tx-Meclizine/Valium 1/3 testing @ medical center.
This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 35-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline) during pregnancy. The subject's medical history included no previous pregnancies. The subject was not using contraception. On 9 October 2012 the subject received a dose of FLULAVAL (.5 ml, intramuscular, right deltoid) and experienced vaccine exposure during the first trimester of pregnancy. The gestational age at the time of vaccination was reported as "about 3 weeks." The date of last menstrual period was not reported. The estimated date of delivery was reported as the "beginning of June 2013." At the time of reporting, the pregnancy was ongoing. The subject did not experience any adverse events from receiving the vaccine FLULAVAL. Follow up was received from the nurse reporter on 26 March 2013. The nurse documented for this conception, the method of conception was normal and no in-vitro fertilization was used. This pregnancy was with one fetus. Concurrent medications included Calcium with vitamin D, VITAFOL ONE, Ferrous fumarate and PPD. The date of last menstrual period was reported as 20 August 2012 and the estimated date of delivery was reported as 4 June 2013. At the time of reporting, the subject was at 7 and a half months pregnant and there had been no problems. Follow up was received from the consumer (subject) on 17 September 2013. The information received was not medically confirmed. The subject documented that the conception was not by normal method; however, also documented that in-vitro fertilization was not received. Concurrent medications included: prenatal vitamin, insulin LANTUS (from "20 weeks until delivery"), and insulin HUMALOG (from "20 weeks until delivery"). Concurrent medical conditions included: gestational diabetes from "20 weeks until delivery." The consumer did not consider this event to be serious. On an unknown date, after an unknown number of weeks gestation, the subject gave birth to a female live infant with no apparent congenital anomaly. The delivery method and infant weight were not reported. The consumer did not consider events in the infant to be serious; however, there were no events reported. Follow up was received from a healthcare professional on 18 October 2013. The healthcare professional reported that in October 2012, 3 weeks after vaccination (at approximately 6 weeks gestation) with FLULAVAL, the subject experienced flu like symptoms. The outcome was reported as improved and possibly related to FLULAVAL per the reporter. The healthcare professional did not consider the events to be serious. On 6 June 2013, after 40 weeks gestation, the subject gave birth to a full-term female live infant with no congenital anomaly. The infant as delivered by normal vaginal delivery and weighed 3.5 kilograms and was 19 inches long. The APGAR score at 1 minute and 5 minutes were 10.
pt recv vax & devel an inj site rxn w/soreness & redness;the rxn persisted 3wk post vax;
Shot given about 12:30pm. AT 16:30 started to have sweaty palms, chet tightness, lightheaded-went to urgent care at 17:30. EKG-labs done all neg. Has strong maternal hx CAD with mother having MI at 15 y/o and three inches dead CAD. No meds or tx given in ER. MD felt panic atttack. Pt admitted having stress-two toddlers, in-laws in town, delivery person felt her reaction not from the flu shot.
Pt. had bilateral lower extremity pain and weakness; he also had abdominal pain and low back pain. Tmax 103 degrees.   10/28/09:  Hospital Record and Discharge Summary received for Dates of Service 10/25/09 to 10/27/09.  Final DX:  Ataxia, Bilateral lower extremity weakness and pain, Abdominal pain, rule out Guillain-Barre Syndrome.   Assessment:  Presented to the ED with fever of 103, chills, recent HA's, pain and weakness in the bilateral LE's, pain in the abdomen on the left and pain in the low back on the left.  Also, one episode of nausea and vomiting as well as cough and headache.  Decreased patellar reflex and difficulty walking.  Patient discharged to home to follow up in 5 days.  10/29/09:  Vaccine record received.  No lot number included.
pt recvd vax; grand mal sz,brief 2-3 mins duration, about 8 hrs after vax;18 hrs after vax had another sz > 1 hr;
This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information was provided. No treatment medication were provided. Reporter did not allow further contact.
The certified immunizing pharmacy technician removed the needle from  the patient's arm before administrating the entire dose. She then activated the safety mechanism on the syringe and expelled the rest of the dose. The patient did not receive a full dose, but said she received more than half of the 0.3ml.
I woke shaking violently I was extremely cold with chills coming and going, my heart was racing and I felt as if I were in a dream. I could not quite grasp reality. I do not take any drugs. (Of any kind) I was was sweating a great deal and it required me to change clothes and to get out of the bed. My wife gave me a Tylenol because my shoulder was very sore and painful.  My wife said there was an order ?musky? she could smell  which I suppose was from my sweating. I don?t have a musky odor ever.  You can call me if you wish to discuss this further. I have only had a shot once or twice before.   It is called Inactivated Influenza Vaccine Recombinant on the paper I was given
gotten sick as a dog; Initial information received on 19-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involves patient (unknown demographics) who gotten sick as a dog (illness), while she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer and lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious gotten sick as a dog (illness ) unknown latency following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for illness.  There will be no information available on the batch number for this case.