chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness, swelling, heat in injection site LD. Painful blistered. Rx'd BENADRYL and KEXAFOLIN.
pt recv vax 17JUN97 1135AM & later mom called & reported red blotches all over body;seen by MD w/hives given DPH & reduced rash by 1PM;
SHINGLES FOR A MONTH; This spontaneous report received from a patient concerned a male of unspecified age. 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 (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced shingles for a month. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shingles for a month. This report was non-serious.
FEVER ON 11/15-11/18; RASH OVER WHOLE UPPER ARM; HARD RASH NEAR SITE 5" RADIUS; BUBBLING ON 11/17 ON HARD RASH; BUBBLES CONNECTED, BURST, OOZED, DRAINED AND SKIN SLOUGHED OFF; LEFT WITH RAW 5" PATCH OF OPEN AREA WITH NO SKIN, NEW SKIN RAW ON 11/19/2013; SAW DR. COVERED WOUND, NO INFECTION.
This spontaneous report was received from a registered nurse refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On unspecified dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 (lot # L019835 with expiry date 23-MAR-2017 and lot # M020521 with expiry date 17-NOV-2017, dose, strength, dose number, vaccination site, route not provided). The temperature excursions were reported as 1.6 C for 39 minutes on 09-AUG-2016, 0.6 C for 1 hour and 40 minutes on 10-AUG-2016, 1.5 C for 55 minutes on 11-AUG-2016, 1.5 C for 1 hour 7 minutes on 28-AUG-2016. No adverse effect were reported. Product quality complain (PQC) was not involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Vacine head brain fog.. Felt like a Heavy Grey blanket from head to waist. Headaches  Mentally Disconnected And more, much more.
I also had a bad case of COVID Aug2021; I also had a bad case of COVID Aug2021; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2020 as dose 1, single (Lot number: EK5730), in left arm and on 13Jan2021 as dose 2, single (Lot number: EK9231) at the age of 57 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure treated for 10 years" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "sleep apnea with CPAP" (unspecified if ongoing); "sleep apnea with CPAP" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I also had a bad case of COVID Aug2021". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course : The patient Recvied treatment with Eliquis on 24Oct2022; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162b2 to the reported events of vaccination failure and COVID-19 cannot be ruled out given the known suspect product profile and temporal association.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Nov2021 as dose 3 (booster), single (Lot number: EW0196) at the age of 44 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 15Mar2021 as dose 1, single (Lot number: 001B21A), in left arm and on 12Apr2021 as dose 2, single (Lot number: 042B21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: SPIRONOLACTONE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jun2022) Positive, notes: positive test noted on Day 9 post treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other concomitant medication of the patient includes Women's Health Vitamin. Patient had COVID-19 treatment with Paxlovid from 23May2022 to 28May2022.
Headache; being tired; experienced severe allergic reactions including hives and rash.; She had rash, hives, and redness.; She had rash, hives, and redness.; This is a spontaneous report received from a contactable consumer(patient). A 52-year-old female patient received first dose of BNT162B2 (BNT162B2, Formulation: solution for injection, Lot number : EL9263) via an unspecified route of administration in left arm on 28Jan2021 at 07:30 PM (at the age of 52 year) as single dose for COVID-19 immunization. Patient relevant medical history allergic to animals, overweight were reported. She took Benadryl as a treatment for allergic reactions. On 28Jan2021 7:35 pm, the patient experienced severe allergic reactions including hives and rash on her face and neck, Headache, being tired. The events outcome were Recovering/resolving. all the events are non-serious.
One episode of small amount of blood in stool, occurred about 6 hours after vaccine administration.
Chills, muscle aches, joint soreness, headache, sore skin across entire body.
Queasy, nauseous, lightheaded, chest pressure/pain, weakness during morning, afternoon and evening of May 25, 2021 at home, then in emergency room at a HCF until ambulance took me to be admitted to the Hospital for more intensive care.    On May 26th, 2021 about 9:00am had angiogram procedure that inserted stent for 60-70% blockage and low flow in LAD artery.  Ultrasound performed on heart.  On May 27, 2021 discharged to return home.
A report has been received from a health professional concerning a female subject, height: 67.0 cm; weight: 7.99 kg, who received FLUMIST Quadrivalent (intranasal). FLUMIST Quadrivalent started on 11-Nov-2015. The nurse working in the family health team administered FLUMIST to a 7 month old child. The outcome of FLUMIST given to a child under 2 is unknown. The reporter's description of the event(s) was as follows: healthy child. The report was considered to be non-serious. The reporter considered that there was no causal relationship between FLUMIST given to a child under 2 and FLUMIST Quadrivalent.
tested for COVID-19/tested positive; tested for COVID-19/tested positive; fever; minor coughing; headaches; This is a spontaneous report from a contactable consumer (patient's husband) via the medical information team. This consumer (patient's husband) reported similar events for two patients. This is the second of two reports.  An 80-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The consumer (patient's husband) and the patient received the first dose of the Pfizer-BioNTech COVID-19 vaccine, and they were due to receive the second dose on 14Feb2021. The consumer mentioned that when they went for their second dose, the patient had a "little fever" and they were therefore asked to go get tested for COVID-19. The consumer said that the patient tested positive and he tested negative that day, but he also tested positive the next day. The consumer specified they had "minor coughing, headaches and fever". They were in quarantine for 14 days. The consumer asked: "once the quarantine is completed, when does Pfizer recommend for us to receive the second dose? if I get the first dose of the Pfizer-BioNTech COVID-19, I should get the second dose from Pfizer, right." The consumer asked if how he could obtain an appointment for the second dose of the Pfizer-BioNTech COVID-19 vaccine. The consumer considered the case as non-serious. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021167315 same reporter/drug/events, different patient
Information has been received from a certain MA concerning a 54 year old male who on 10OCT2003 was vaccinated in the left deltoid with a dose of pneumococcal vaccine 23 polysaccharide vaccine. On 12OCT2003, about two days later, the pt developed a fine, red rash on his trunk, facial swelling and vomiting. Medical attention was sought and the pt was treated with abx. Within 5 days, all symptoms were reported to have resolved and it was reported  that the pt had recovered. No product quality complaint was involved. Additional info has been requested.
Myalgias, chills, dizziness and restlessness, feeling unwell.  The dizziness and restlessness resolved with an antihistamine ( Cetirizine 10 ml, one dose) and tylenol was used for myalgias and chills with good response.
1st day, evening sore throat, cough continuing with headache chills and ear ache.  2nd day with body ache.  3rd day all symptoms continuing with temperature 99.3 and increasing, difficulty breathing, wheezing and heart missing beats and some fast beats and chest pains and dizziness in the evening.  Tool Tylenol and albuterol for breathing.  4th day, breathing and heart better, sore throat, cough and head congestion.  8th day, doctor gave amoxicillin for next 7 days and nasal decongestant.
a patient received only the liquid portion of Pentacel/ No AE; Initial information received on 31-Mar-2021 regarding an unsolicited valid non-serious case received from an other health care professional (HCP) via Medical Information (Reference number- 00542797).  This case is linked to case 2021SA128613 (same reporter).  This case involves a five months old female patient who received only the liquid portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] 0.5 ml third dose (batch number: UJ162AB, expiry date: 24-APR-2021, frequency: once, strength: standard) via an unknown route in unknown administration site on 01-Mar-2021 for prophylactic vaccination (product preparation issue).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), HEPATITIS B VACCINE and ROTAVIRUS VACCINE for prophylactic vaccination.  It was an actual medication error due to inappropriate reconstitution technique (latency: same day).  Potential Product Technique Complain: No, Description: Stated that the liquid portion of Pentacel was given to two children and want to know what to do. HCP who reports two patients received the liquid portion of Pentacel. She stated they are unsure which patient received the incorrect dose and asks what to do about potentially giving an extra dose. Treatment: none. Emergency Room/ Doctor Visit and date: none. Reporter relationship: HCP. Product used: Used.   At the time of reporting, patient had no 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 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.
The 2nd day I notice I had pain in my right arm were I had the vaccine. I also notice I had the same pain in my right arm after. I also had pain in my left arm, it also spread up to my shoulder, also had problems raining arm. I saw my doctor & received some blood work to identify what the problem was. I also had some pain in my ankles & knees. The doctor put me on steroids for 2 weeks & then I was on it again for 6 days. The steroids helps a little, but I am not fully recovered from this.
pt presented in office 24JUL96 w/swollen, red warm (4" diameter) area on lt deltoid tx w/med;26JUL96 lt upper arm more red &swollen (7" x 4" area);tx w/IV med; rechecked 27JUL & 29JUL tx w/ATB x 7 days;
3 minutes after the shot I had a tingly and at times itchy sensation in my left hand, 16 minutes after the shot I started coughing (I had not coughed prior to the shot). About 2 hours later I started feeling blah (you know How sometimes you feel just blah) and tired but I was able to continue work. This I took a nap around 2pm and felt better when I woke up. Around 7pm started feeling blah and tired again so I went to bed. Woke up Saturday and I felt fine. However during the day i would alternate between blah and fine. However I was still able to continue with Norman activities. Woke up today, Sunday, feeling great.
Headache, stiff neck 1/26/21 about 6hours after injection Mild fever 99.6 1/27/21  about 24h after injection
nerve pain and everything that had gone away with the surgery,came back roaring; Her legs had multiple cramps; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (nerve pain and everything that had gone away with the surgery,came back roaring) and MUSCLE SPASMS (Her legs had multiple cramps) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Nerve pain and Spinal operation NOS.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEURALGIA (nerve pain and everything that had gone away with the surgery,came back roaring) and MUSCLE SPASMS (Her legs had multiple cramps). At the time of the report, NEURALGIA (nerve pain and everything that had gone away with the surgery,came back roaring) had not resolved and MUSCLE SPASMS (Her legs had multiple cramps) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  Patient used ice packs on her for the adverse reactions. Patient had not diagnosed with COVID 19, myocarditis or pericarditis.   This case was linked to MOD-2021-409114 (Patient Link).
Muscle pain; Chills; Tired; Arm swollen; could not move; had no strength in arms or legs, could not call for help and was lying on floor; Teeth hurt; arm swollen - hot and red; Severe headache; Next day at night-couldn't catch breath-gasping for air &breath; arm swollen - hot and red; This is a spontaneous report from a contactable consumer (patient). A 74-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9266), dose 2, single via an unspecified route of administration on the left arm on 15Mar2021 at 08:45 at age of 74 years old for COVID-19 immunization. The past drug included BNT162B2 dose 1, single, (lot/Batch no: unknown) via an unspecified route of administration on 22Feb2021 08:45 at age of 74 years old for COVID-19 immunization. The patient did not have symptoms associated with COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. Medical history included diabetes, obesity and receiving Electroconvulsive therapy (ECT) treatments. Concomitant medications included bupropion (WELLBUTRIN), desvenlafaxine (PRISTIQ), trazodone (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and carvedilol (MANUFACTURER UNKNOWN) for unknown indications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that on the next day at night (16Mar2021), she could not catch breath- gasping for air & breath, she could move but had no strength in arms or legs, could not call for help and was lying on floor, could not move, had severe headache, arm swollen - hot and red, tired, had chills, muscle pain and even teeth hurt. No therapeutics measures were taken for the events. The clinical outcome of all the events were reported as resolved with sequelae on an unspecified date in Mar2021.   No follow-up attempts are possible. No further information is expected.
Localized reaction, redness, warmth, pain, induration around injection site. Appx 1 week later.
heart fluttering; arrhythmias; Fever; chills; intense pressure behind eyes; headache; muscle weakness; fatigue; brain fog; intense body pains/aches; intense body pains/aches - especially at joints (knees, wrists, ankles); heart pounding; insomnia; lack of appetite; migraine with aura; lethargy; This is a spontaneous report from a contactable pharmacist (patient). A 30-years-old male patient received bnt162b2 (unspecified trade name), dose 2 via an unspecified route of administration, administered in Arm Left on 21Apr2021 16:00 (Lot Number: EW0171) as single dose for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Public Health Clinic/facility. The patient medical history was not reported. No known allergies. The patient's concomitant medications were none. No other vaccine in four weeks. No other medication in two weeks. The patient previous received the first dose on 31Mar2021 11:00 (Lot number=ER8737) as single dose at Left arm for covid-19 immunization. The patient had no reaction on previous exposure to vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced Fever, chills, intense pressure behind eyes, headache, muscle weakness, fatigue, brain fog, intense body pains/aches - especially at joints (knees, wrists, ankles), arrhythmias/heart fluttering, heart pounding, insomnia, lack of appetite, migraine with aura, lethargy on 22Apr2021 13:00. The outcome of the events was recovering. No treatment received.; Sender's Comments: The contributory role of the suspect product bnt162b2 (unspecified trade name), dose 2 via an unspecified route of administration, administered in Arm Left on 21Apr2021 16:00 (Lot Number: EW0171) as single dose for covid-19 immunization to reported events is possible based on temporal association and known profile of the product.
Dad reports baby started vomiting after getting vaccines today. Advised to hold food and fluids for 1 hour. Start fluids slowly. Will monitor sx.
Fever, leg stiffness and ? ataxia "seemed drunk" per mom & grandma x about 24 hr then resolved.
Retrobulbar neuritis, Left; h/o RRMS, stable since 2008, on Glatiramer; given Shingrix 10 days before onset of retrobulbar neuritis, and Hep B vaccine 11 days prior.
pt recv & devel shingles, distributed on lt waist & upper buttock;pt presented w/vesicles in clusters on lt chest to midline (some crusting) w/3-4 on leg;
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with GARDASIL, 0.5 ml, intramuscular (lot # and expiration date were not provided). On an unknown date, GARDASIL was stored at 30F for 34 hours. Excursion was not supported. Medical assistant stated that several different lots and expiration dates were involved, but she did not have access to the information. On unknown dates, many patients had been administered the not supported GARDASIL but she had no patients' information to provide because her office had not pulled the records. No adverse effects had been noted by any patients. The patients did not seek medical attention. At the time of the report, the patients status was unknown. Additional information has been requested.
one week after shot, injection site on left arm started to turn red, raised, hot to the touch, and painful.  feels like i got punched hard (but delayed by one week after injection)
This the first time I receiving both vaccines at the same time.  Today is the 3 full day of symptoms.   When lying (flat) down at night I get dizzy for a few seconds and when I first get up in the morning I feel light headed (few seconds).  After I get out of bed and during the day when I am stand, sitting upright or resting I do not feel light head or get dizzy.   These durations are starting to be shorter in time.     Ring is both ears has been continuous through the day. Ringing is starting to be not as loud as the first & second day.  Occasionally I get ringing in both ears for short period of time, average 1 day per week.  They normally last 5-15 minutes.  Breathing exercise causes them to stop ringing.     Blood pressure and heart rate is with my normal daily range ( < 140/85, and > 105/65; HR 70-85), Blood O2 is 94-97.  These are taken before I go the sleep and before I get out of bed in the morning.  They both remain within my normal range during the day.  When exercising or performing yard work heart rate goes up but blood pressure & O2 remain within my normal ranges  Both vaccines (Oct 2022) were giving by Pharmacy.  Covid 19 vaccine history: initial series - Pfizer (Feb-Mar 2021), LOT EN6205 & LOT EN6198;    1st booster - (Moderna (Dec 2021), LOT 0669F21A ;   2nd booster - Pfizer (Oct 2022), LOT GJ3275 OR 6J3275
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.A 28 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 13Jan2021 09:30 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Low testosterone", start date: 27Jan2021 (ongoing); "Skin disorder" (unspecified if ongoing). Family history included: "Low testosterone" (unspecified if ongoing), notes: Low testosterone, Father. Concomitant medication(s) included: FLUCELVAX QUADRIVALENT, administration date 25Sep2021; DEPO-TESTOSTERONE taken for blood testosterone decreased, start date: Jan2021 (ongoing); DEXAMETHASONE taken for surgery, start date: 29Dec2021, stop date: 29Dec2021; HYDROCODONE/ACETAMINOPHEN taken for pain, start date: 30Dec2021, stop date: 01Jan2022; IBUPROFEN taken for pain, start date: 30Dec2021, stop date: 06Jan2022; ONDANSETRON/ ZOFRAN taken for nausea, start date: 30Dec2021, stop date: 30Dec2021; CEFADROXIL taken for infection prophylaxis, start date: 31Dec2021, stop date: 07Jan2022; MUCINEX FAST MAX SEVERE CONGESTION AND COUGH taken for cough, start date: 31Dec2021, stop date: 07Jan2022; RETIN-A taken for skin disorder, start date: 2018 (ongoing); HUMAN CHORIONIC GONADOTROPIN taken for blood testosterone decreased, start date: Jan2021 (ongoing).The following information was reported: BLOOD TESTOSTERONE DECREASED (non serious) with onset 27Jan2021, outcome "unknown", described as "Low testosterone". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Dec2021) negative; (04Jan2022) positive, notes: N/A; (04Jan2022) positive, notes: Second confirmatory positive test; (07Jan2022) positive, notes: N/A; (08Jan2022) positive, notes: N/A; (09Jan2022) negative, notes: N/A; (10Jan2022) negative, notes: Second confirmatory positive test. Therapeutic measures were taken as a result of blood testosterone decreased.No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.