chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have PCP (Pneumocystis jirovecii pneumonia); drastic saliva alteration; Fluid imbalance (all body fluids affected); Mucosal disorder (heavy mucosa); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19", start date: Nov2020 (unspecified if ongoing), notes: Contracted COVID-19 in Nov2020. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunisation. The following information was reported: PNEUMOCYSTIS JIROVECII PNEUMONIA (medically significant), outcome "unknown", described as "I have PCP (Pneumocystis jirovecii pneumonia)"; SALIVA ALTERED (non-serious), outcome "unknown", described as "drastic saliva alteration"; FLUID IMBALANCE (non-serious), outcome "unknown", described as "Fluid imbalance (all body fluids affected)"; MUCOSAL DISORDER (non-serious), outcome "unknown", described as "Mucosal disorder (heavy mucosa)". The events "i have pcp (pneumocystis jirovecii pneumonia)", "drastic saliva alteration", "fluid imbalance (all body fluids affected)" and "mucosal disorder (heavy mucosa)" required physician office visit. The patient underwent the following laboratory tests and procedures: over 100 tests: Negative, notes: have had over 100 tests performed with negative results over the past 15 months. Clinical course: Patient had severe adverse reactions to Pfizer COVID Vaccine and wanted vaccine reversal antidote.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Covid-19; Bad Cough; Pneaumonia; Headache; Fever; A spontaneous report was received from a  consumer concerning an  70 -year old,  male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and    experienced  headache, Fever, Tested positive for covid-19, admitted to hospital, had pneumonia and covid-19, Bad cough, Received only first dose of moderna covid-19 vaccine.  The patient's medical history, was not provided by the reporter, included no known allergies,  Concomitant medications reported were Blood pressure medication, Cholesterol medication, Blood thinner medication.  On  07 Jan  2021prior to the onset of the symptoms, the patient received their first  of two planned doses of mRNA-1273 (Batch number 012L20A) unknown route  for prophylaxis of COVID-19 infection.   On 08 Jan  2021, patient experienced headache and fever. On 16-Jan-2021 he tested positive for covid-19 on same date he was admitted to a hospital where he spent 7 days in ICU, had a bad cough, Pneumonia and covid and spent one month in hospital and he discharged from hospital on 15-feb-2021. The serious events Tested positive for covid-19, pneumonia, are hospitalized and medically significant.  Treatment information  provided was 10 doses of Remdesivir, oxygen, Breathing treatment, Dexamethasone injections a couple of times a day.  Action taken with mRNA-1273 in response to the events  was not provided.   The outcome of the events  headache and fever were resolved on 15 Jan 2021, covid-19, pneumonia, admitted to hospital were resolved on 15-feb-2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
After hot bath following day -R thigh red, welted, tender approx 2" round circle - lasted 2 wks. No treatment
No adverse event; bivalent more than 12 hours after the initial vial puncture.vial was first punctured on 24OCT2022 and administration of vaccine on 25OCT2022; Vaccine administered more than 12 hours after the initial vial puncture.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (bivalent more than 12 hours after the initial vial puncture.vial was first punctured on 24OCT2022 and administration of vaccine on 25OCT2022), PRODUCT STORAGE ERROR (Vaccine administered more than 12 hours after the initial vial puncture.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 25-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (bivalent more than 12 hours after the initial vial puncture.vial was first punctured on 24OCT2022 and administration of vaccine on 25OCT2022), PRODUCT STORAGE ERROR (Vaccine administered more than 12 hours after the initial vial puncture.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (bivalent more than 12 hours after the initial vial puncture.vial was first punctured on 24OCT2022 and administration of vaccine on 25OCT2022), PRODUCT STORAGE ERROR (Vaccine administered more than 12 hours after the initial vial puncture.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (bivalent more than 12 hours after the initial vial puncture.vial was first punctured on 24OCT2022 and administration of vaccine on 25OCT2022) and PRODUCT STORAGE ERROR (Vaccine administered more than 12 hours after the initial vial puncture.).    No concomitant medication details was reported. Individual vails was used and vail size was 2.5ml. On 21-OCT-2022 the vial was initially stored in the refrigerator. The vial was first punctured on 24-OCT-2022 8-9AM. Total amount of time the vial was exposed to room temperature range was 20 minutes approximately. The vial did not undergone any temperature excursions. No treatment medication details was reported.
Received DTaP #5, IPV #4, MMR #2 on 11/17/04. Parent states child had fever that same night (parent with thermometer) around 2 AM of 11/18/04. In morning, child had nausea and vomiting; was given Children's Bayer ASA for fever. Seen here with 101.4 fever. Seen by doctor on 11/18/04.
Patient was to the clinic for STD testing. Pt was stuck x 3 to obtain blood for the testing, Hepatitis A vaccine was given then the ROCEPHIN injection was given. After the patient was sitting down and stated I don't feel so well, patient passed out for about 5 seconds. Once patient came to, patient stated he had only drank one cup of coffee this AM. Patient was given water and peanut butter crackers. Sat for about 10 more minutes then completed the taking the medication as was ordered (azithromycin). Stated he felt fine. Just should have eaten before he came.
Paresthesia  within a minute, but only in right fingers at first.  Then within the hour the left fingers had the effect.  This sensation went on and off for about 5 days and after the first day began to include both feet.  After a week it seemed to resolve, however, at the 2 weeks and 1 day point, paresthesia returned stronger, in both hands and forearms, both feet and lower leg starting at around 12:30pm on 4/7/21.   It continues at this writing which is 9:00pm on 4/7/21.  The sensation is more severe than the first week and not intermittent this time.
Vomiting; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and VOMITING (Vomiting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.     On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced DIARRHOEA (Diarrhea). On 25-Feb-2021, the patient experienced VOMITING (Vomiting). At the time of the report, DIARRHOEA (Diarrhea) and VOMITING (Vomiting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Feb-2021 and was forwarded to Moderna on 25-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and VOMITING (Vomiting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.     On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced DIARRHOEA (Diarrhea). On 25-Feb-2021, the patient experienced VOMITING (Vomiting). At the time of the report, DIARRHOEA (Diarrhea) and VOMITING (Vomiting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Broke into cold sweats when I went to the bathroom. Went back and sat in the chair and blacked out. Eyes rolled into the back of my head. Stiffened up and rolled out of the chair. Then I slowly came out of the black out.
Initial information received on 20-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves 77-year-old male patient who was vaccinated with a dose of FLUZONE HIGH DOSE (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 an actual medication error due to underdose and syringe leak. It was reported that more than half through the injection when she noticed fluid leaking from the hub down the patient's arm. It was unknown if patient had adverse event. 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 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. List of documents held by sender: none.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. Initial information was processed along with the additional information received on 29-DEC-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Janssen dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported,1 total, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The patient received additional non-company suspect vaccine included: BNT 162 (dose number in series 2) (form of admin, route of admin, and batch number were not reported) dose was not reported, administered on DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-DEC-2021, the patient experienced mild congestion. She stated the symptom was only upper respiratory (subsumed under suspected Covid-19 infection), no cough or fever. On 27-DEC-2021, the patient had done home kit test [not PCR (polymerase chain reaction) test] and was tested positive for Covid-19, hence had suspected clinical vaccination failure (Dose number in series 1 and 2). She was fully vaccinated. The action taken with covid-19 vaccine ad26.cov2.s, and BNT 162 was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000209408.; Sender's Comments: V0: 20211260954-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Local skin reaction. 10 X 8 1/2 cm mildly warm to touch. Errythema throughout with increased errythema at the edge along with a mild papular nonvesicular, nonpustule rash noted. Benadryl recommended prn, cool compresses. No medication prescribed.
TINGLING, DIZZINESS, BURNING IN HAND, SMOTHERING IN CHEST BUT NO BREATHING ISSUES, WHEN STANDING HAD SOME TRANSIANT CHEST TIGHTING RX 25MG BYNADRYL, 16OZ WATER
As reported by the patient: Deep red rash on left arm from the injection site to the elbow that lasted three to four days, soreness that lasted three to four days, choking/difficulty breathing/breathlessness that lasted one day, fatigue that lasted three to four days.
3/15/2022- Presents to ED, c/o feeling sick, SOB, wheezing and  productive cough.  Recent PCP visit and completed 14 days of Doxycycline. Afebrile,  BP:183/98, P-122 and RR 20. O2 93% on RA, on walking sat drops to 85%, on 2L via NC. WBC :13.  Admit hypoxemic respiratory failure d/t Covid 19. Received IV ceftriaxone and doxy in ED. Ordered IV azithromycin, Decadron and Lovenox.  3/16/2022-AM: Sinus tach 120's consistent. Anxious, flushed and diaphoretic. On 1.5 L NC sating 93%. Atarax ordered and given. HR decreased to 110's.   PM; HR consistently in the 100-110's. 3/17/2022- Wheezing significantly improved.  Weaned off oxygen to RA with o2 sat levels above 90.  3/18/2022- Improved, on RA for 24 hours. Discharged to home, with additional 4 days of dexamethasone.
This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a patient who received BEXSERO. Co-suspect products included Meningococcal ACWY Vaccine (potential MENVEO)). On an unknown date, the patient received BEXSERO and Meningococcal ACWY Vaccine (potential MENVEO). On an unknown date, unknown after receiving BEXSERO and Meningococcal ACWY Vaccine (potential MENVEO), the patient experienced injection site pain, fever and fatigue. On an unknown date, the outcome of the injection site pain, fever and fatigue were unknown. It was unknown if the reporter considered the injection site pain, fever and fatigue to be related to BEXSERO and Meningococcal ACWY Vaccine (potential MENVEO). Additional details were reported as follows: The age at vaccination was not reported. The reporter emailed a GlaxoSmithKline Sales representative who then emailed a GlaxoSmithKline Medical Science Liaison on the same day who contacted the GSK response center. It was reported that, the reporter had started giving BEXSERO along with the meningococcal vaccine (MCV4) to a 12th grade student. The GlaxoSmithKline Medical Science Liaison said that, email form the GlaxoSmithKline Sales representative stated that, the reporter said a 12th grader whose age and gender is now unknown to the GlaxoSmithKline Medical Science Liaison had a sores arm at the injection site as well as fatigue and fever following vaccine administration which occurred on a Monday. The GlaxoSmithKline Medical Science Liaison said that she spoke with the reporter but did not discuss about this patient and had no further related details to provided. This was the first of two patients whose demographics were unknown beyond being 12th graders which the reporter mentioned in her email according to the GSK Medical Science Liaison.
Injection site pain and soreness; This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a female 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 2 years after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient experienced injection site pain and soreness for 3 days after vaccination. The reporter did not agree to the follow up.
stiffness of left arm and pain where injection of PPV Vacine..with severe rash and inflammation the following day
pt brought to hospital critically ill with decubitus ulcer requiring wound care; positive test for COVID; O2 supplementation; CT of chest showed left sided pleural effusion; thoracentesis showed transudative effusion, but no changes of COVID on CT, therefore not treated with remdesivir; given ABX; pt rapidly worsened requiring more O2 supplementation; DNR/DNI; pt passed away in the hospital
The patient supposed to received VARIVAX and MMR II but instead inadvertently received both VARIVAX and PROQUAD due to human error; No additional adverse events were reported; This spontaneous report was received from a nurse referring to a 12-month-old patient of an unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  The patient supposed to received varicella virus vaccine live (Oka/Merck) (VARIVAX) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR II) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis but instead inadvertently received both varicella virus vaccine live (Oka/Merck) (VARIVAX) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis due to human error (reported as today date unspecified) (wrong vaccine administered). No additional adverse events were reported (no adverse event).
On 3/29/2000, post vax, noticed local induration, 10cm x 7cm, erythema and tenderness.
Patient is a 19yo female ADSM with who experienced onset of generalized pruritic erythematous dermatitis described as urticaria on awakening day 1 after receipt of Pfizer BioNTech COVID vaccine #1. She did not respond to oral benadryl or topical OTC steroid and was treated with oral prednisone and the dermatitis resolved about 6 days after onset. Provider note day 3 documents 'Maculopapular rash with visible hives which extends over patient's back, stomach, neck, and bilateral upper extremities without any evidence of desquamation, cracking or bleeding'
Nausea, diarrhea, fever, chills, muscle aches, extreme fatigue, headache
Have had had pretty constant headaches and neck ache.  it has been a week today and still happening.  Our Medical Director where I work (Rose Research Center) suggested I report it.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 20-DEC-2021, the patient received incorrectly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 1 dosage form, lot #T042014 with expiration date on 23-JUL-2023, administered for prophylaxis (route of administration were not provided). The vaccine underwent temperature excursion of 35.4 Fahrenheit degrees for 5 hours, 34.5 Fahrenheit degrees for 17 hours, 34.3 Fahrenheit degrees for 10 hours and 34.8 Fahrenheit degrees for 2 hours. No adverse event was reported.
adverse local erythema rash: 10 days mac-pap rash; sun-exposed x/face & stomach;
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 01/11/21, Moderna Lot#012L20A 2nd dose02/08/21Moderna lot#012M20A Diagnosed covid positive:08/03/21 Symptom onset:07/30/21 Exposure:Community Symptoms:Runny nose,sneezing
The patient was a 4-month-old previously healthy, full-term female. After receiving her first set of immunizations -- DTaP, Hib, polio, and Pneumococcal conjugate vaccine -- in a pediatrician's office, she experienced a prolonged period of crying and difficulty catching her breath. She was stimulated to encourage respirations. She had no cyanosis. After returning home, she was in her usual state of health until the evening, when she again had difficulty catching her breath and suffered several episodes of decreased tone, decreased responsiveness, and cessation of respiration. Again, she had no cyanosis. She was taken to the ED, then transferred to for admission. She was discharged the next day. Evaluation: Hypotonic-hyporesponsive episode (HHE) is characterized by the sudden onset of reduced muscle tone, hyporesponsiveness, and change of skin color (paleness or cyanosis). HHE has been documented to occur after the administration of diphtheria, tetanus, Haemophilus influenza type B and hepatitis B vaccines, but usually follows pertussis-containing vaccines (1-3). HHE has been observed more frequently following whole cell pertussis vaccines than following acellular pertussis vaccines.  Summary: hypotonic-hyporesponsive episode after DTaP, Hib, polio, and Pneumococcal conjugate vaccinations; probably secondary to pertussis.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 20-JUN-2007 the patient was vaccinated with ZOSTAVAX. On or about 31-OCT-2016, the patient was treated by healthcare providers for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages as a result of shingles and other zoster-related injuries. Additional information has been requested.