chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He also has congestive heart failure/couldn't lay down; has been in a bad funk since he got the shot; He is very concerned; emphysema; made me feel woozy; feel weak; The initial case was missing the following minimum criteria: No product. Upon receipt of follow-up information on 30Nov2021, this case now contains all required information to be considered valid. This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (002191). The reporter is the patient.   A 74 year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), administration date 2021 (Lot number: EE3120, Expiration Date: 31May2022) as dose 1, single for immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The consumer stated he had a lot of concomitant medication. The following information was reported: CARDIAC FAILURE CONGESTIVE (medically significant) with onset 2021, outcome "unknown", described as "He also has congestive heart failure"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "has been in a bad funk since he got the shot"; ANXIETY (non-serious) with onset 2021, outcome "unknown", described as "He is very concerned"; EMPHYSEMA (non-serious) with onset 2021, outcome "unknown", described as "emphysema"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "made me feel woozy"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "feel weak". All events stated about 2 weeks ago in 2021 (based on 30Nov2021). His breathing and patient had a bad heart, he had congestive heart failure (CHF) and he also had emphysema, so whenever he had his breathing impaired it catches his attention by the quickly, it also made he feel weak. Last night patient went to sleep sitting upon on his sofa because he couldn't lay down, it just made he feel woozy, since he first got the vaccine 2 weeks ago. No investigation assessment.   No follow-up attempts are possible. No further information is expected.
No additional AE details were provided; she was given her third dose yesterday 24OCT2022. The clinic then learned after the patient was vaccinated that the patient received all 3 doses of GARDASIL 9 in 2015.; This spontaneous report was received from a nurse regarding a 22-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On unknown dates in 2015, the patient was vaccinated with the first, second, and third doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)  (strength, dosage regimen, lot #, expiry date, and route of administration were not provided) administered as prophylaxis. On 24-OCT-2022, the patient was vaccinated with the fourth dose (in the moment of vaccination the patient stated that before she only received two doses) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)  (strength, dosage regimen, lot #, expiry date, and route of administration were not provided) administered as prophylaxis (Extra dose administered). No adverse events were reported.
There was an excursion from the freezer,vaccine administered to 118 patients; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer,vaccine administered to 118 patients) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer,vaccine administered to 118 patients) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer,vaccine administered to 118 patients) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Breakthrough case admission after 4 vaccines Moderna 3/3/21 Lot# 029A21A;  Moderna 3/31/21 Lot# 016B21A;  Moderna 224/2 Lot# 027L21A;  Moderna 10/26/22 Lot# 030G22B
Patient had gone to emergency room and received a boostrix on march of 2023, patient came in for an office visit on X/XX/23 and received another dose of boostrix 0.5ML.   MA in question was in-serviced and reinforced the need to verify with database as well.   Error reached patient; no patient harm
Got very sick and feverish in the middle of the night, went into the bathroom and sat down.  When I stood up I passed out on the floor, unsure for how long.    Also felt a tightness / slight pain in my chest off and on for 3 months following the vaccine, usually in the AM.
Flu vaccine heavy dose. Next day I experienced bad pain in neck which in the next few days extended into my right hand and left thigh.
This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a elderly female patient who received SHINGRIX for prophylaxis. On 3rd August 2018, the patient received the 2nd dose of SHINGRIX. On 3rd August 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, fatigue, headache and myalgia. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, fatigue, headache and myalgia were recovered/resolved. It was unknown if the reporter considered the injection site pain, fatigue, headache and myalgia to be related to SHINGRIX. Additional details reported as follows: The caller was GlaxoSmithKline employee from R and D that was made aware of two individuals who received SHINGRIX. The event began the evening of the injections. This case has been linked with US2018144841 and US2018144839, reported by same reporter and linked with case US2018144842 reported for same patient for 1st dose).
Severe herpes simplex viral 1 reaction on lower lip with extreme swelling and 100?s of cold sores/blisters.
The patient received his first dose of the Pfizer COVID-19 vaccine on 8/5/21 at approximately 4 pm. He stopped the pharmacy after 9 pm on 8/6/21 to report adverse reactions he was experiencing. The patient reports having no ill effects immediately after receiving the vaccine. He reports that he began to feel worse around midnight after receiving the vaccine. His symptoms include feeling very fatigued, dizzy, having a very sore arm, experiencing insomnia, and feeling very hot/feverish (however, his body temperature did not reflect a true fever). The patient is not currently taking any other medications or therapy. He had not tried any remedies at home prior to presenting to the pharmacy on 8/6/21. We counseled the patient that the effects he was experience fall within what is considered normal for the vaccine. We also recommended that the patient try OTC fever reducers, NSAIDs, and cold compresses/ice pack to help him feel better. The patient did not report seeking any additional medical attention at this time.
date of injection 01/30/2021 CARDIAC ARREST 1/30/2021 Death 1/30/2021
Tachycardia (Heart Rate: 110 BPM); This spontaneous case was reported by a pharmacist and describes the occurrence of TACHYCARDIA (Tachycardia (Heart Rate: 110 BPM)) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced TACHYCARDIA (Tachycardia (Heart Rate: 110 BPM)). On 15-Feb-2021, TACHYCARDIA (Tachycardia (Heart Rate: 110 BPM)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 110 (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment was reported for the events.
Pruritus & urticaria p/FLUZONE 05.ml IM rxn 30 min p/inject; No hx of egg allergy; Tx DPH & topical sterioids;
no additioanl adverse event; PNEUMOVAX 23 that underwent a temperture excursion was administered; This spontaneous report has been received from a health professional referring to a patient of unknown age. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.     On an unknown date, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # T031820 with expiration date of 10-MAY-2022 (strength, dose, route, frequency, and anatomical location were not provided) for prophylaxis. The vaccine was exposed to a temperature between 2°C to 8°C during a time frame of 4 hours and 40 minutes. No previous temperature excursions were reported. No adverse event. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); devicelotnumber: T031820; expirationdate: 10-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
headache; swollen lymphnodes in both armpits; woke up with mastitis in left breast; chills; 102 fever; Migraine occular headache (seeing zig zag lines in vision); trouble breathing--one dry cough after breathing deeply; fast heartbeat; developed a sore left arm; body aches; This is a spontaneous report from a contactable consumer (patient).  A 34-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6204), via an unspecified route of administration in left arm on 19Mar2021 at 16:30 (age at vaccination 34- year-old) at single dose for COVID-19 immunization. Medical history included drug hypersensitivity to penicillin, sulfa drugs, levoquin, some fish oil supplement.      The patient's concomitant medications were not reported.  Vaccination history included: first dose of  bnt162b2 for covid-19 immunization on 26Feb2021 at 16.30 (lot: EN6202) in right arm. On 20Mar2021, patient experienced woke up with sore left arm and body aches. Patient took ibuprofen and felt better. On 21Mar2021, patient woke up with mastitis in left breast, chills, and 102 fever, migraine ocular headache (seeing zig zag lines in vision), trouble breathing--one dry cough after breathing deeply and fast heartbeat. On 22Mar2021, patient had still a headache. She went to doctor for mastitis. A mammogram and ultrasound showed swollen lymphonodes in both armpits (first shot was on right arm). On 23Mar2021, patient had still headache. Patient received antibiotics as treatment for adverse events. Outcome of events was recovering.  Additional information has been requested.
DTaP number 4 was given on 3/20/17 - vaccine had expired on 3/5/17 - (15 days prior). No adverse events noted or reported by parent.
2 hours I had a severe migraine and a fever in 101, and fatigue. A loss of appetite that lasted 4-5 days. 4 Days following the vaccine I had a rash break out on my upper arm, distal to the injection site. I was unable to lift my arm, and it because hot and itchy to the touch. The following morning (day 5) swelling began where the rash was and lasted 24 hours.
A lump and red rash developed on Saturday 1/23/2021. Hot to touch. Today is 1/26/2021 rash has not gone away and has gotten bigger.
Mother states symptoms started about 1:45 pm after returning home after receiving the vaccine. Child began to cry excessively and was inconsolable until 5:00pm. No fever was noticed just major crying. She states that "none of her other children acted this way after shots." She did not give the child TYLENOL for this just lathered him down in lavender oil according to mother's statement. Child finally stopped crying around 5:00pm and has been acting fine since this. Child is playing today 9/13/18 and acts his normal self-according to the mother.
PATIENT WAS ADMINISTERED FLUAD QUAD 2020-2021EXP 05/29/2021 LOT 279794 AT THE SAME TIME AS THE PNEUMOVAX 23 SO36495 09/13/2021.  PATIENT WAS VERY WEAK LATER IN THE DAY AND DEVELOPED A FEVER OR 101 DEGREES F.  PATIENT WAS TAKEN TO THE ER WITH SHIVERING, WEAKNESS, FEVER.  A COVID TEST,STREP AND CHEST XRAY PERFORMED(ALL NEGATIVE).  PATINET WAS GIVEN FLUIDS FOR HYDRATION AND TYLENOL FOR FEVER
heart palpitations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PALPITATIONS (non-serious), outcome "unknown", described as "heart palpitations". Additional information: Three COVID-19 vaccines have caused patient heart palpitations in the last year and a half. Patient was hoping they would pass, however they still came and went. mRNA marker had been affecting patient heart. Palpitations was significantly impacting patient life.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Arm became red and hard with swelling.  As the evening progress, I became nauseated, dizzy light headed, sweaty and then cold and shaky. Passed out and was taken to ER by friend.  My heart was in Afib and my BP was elevated by time I arrived at ER.
C/O SOB < Was recently hospitalized for anemia due to CLL. Diagnosed with covid yesterday.C/O cough,fever and SOB X4 D
PATIENT RETURNED TO PHARMACY 10/20/17 WITH RED INFLAMED SKIN AROUND THE INJECTION SITES. PATIENT STATES THAT ENTIRE ARM WAS HURTING.
Left arm  soreness; Fever; Chills; Headache; Nausea; Fatigue; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm  soreness), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Left arm  soreness), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache), NAUSEA (Nausea), FATIGUE (Fatigue) and MYALGIA (Body aches). At the time of the report, PAIN IN EXTREMITY (Left arm  soreness), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache), NAUSEA (Nausea), FATIGUE (Fatigue) and MYALGIA (Body aches) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.
Pain in my right arm lasting more than 2 days Fly-like symptoms lasting more than 48 hours
CHEST HURTS/PAIN; SWEATING; TWITCHING; VERY SICK; CHILLS; FEVER; This spontaneous report received from a parent concerned a female 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 not reported, batch number: Unknown) dose was not reported, administered on 03-AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.   On 03-AUG-2021, the subject experienced very sick. On 03-AUG-2021, the subject experienced chills. On 03-AUG-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99.6 F. On 04-AUG-2021, the subject experienced chest hurts/pain. On 04-AUG-2021, the subject experienced sweating. On 04-AUG-2021, the subject experienced twitching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest hurts/pain, sweating, twitching, chills, fever, and very sick. This report was non-serious.
Nausea (has since subsided, lasted 2 days), stomach upset/cramping, lower abdominal pain, pain near reproductive organs, some urgency with urination
patient received ActHIB that was prepared with sterile water instead of the proper diluent/no AE; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2019SA276700 same reporter.  This case involves a 2 years old male patient who received vaccine HIB (PRP/T) VACCINE [ACT-HIB] that was prepared with sterile water instead of the proper diluent.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 16-Aug-2019, the patient received a dose of suspect HIB (PRP/T) VACCINE lot UI905AAA via unknown route in the right thigh (The lot of the diluent found by itself is: lot U6057AA expiry 24Oct2019.).  It was a case of actual medication error due to Wrong solution used in drug reconstitution.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the 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.  Documents held by sender: none.
patient administered vaccine at another facility and presented to this facilities ED on 2/24.  Patient with multiple comorbidities:  Bipolar disorder, parkinsons, PD, COPD, DM, PVD, GERD, HTN, Dyslipidemia, sleep apnea.  H/O CVA,  has sacral decubitus and cellulitis of pannus.  presents with sepsis likely secondary to cellulitis of pannus.  Admitted for care then discharged on 2/26
I received my booster shot (moderna) on 11/18/21.  Exactly two weeks after, I started getting chronic hives: flare-ups that would occur spontaneously anywhere on my body (arms, legs, torso, back, face, neck, even head).  The hives show up as either red patches or lines (dermatographia).  On bad days, my back would look like I have been whipped - with lines of red welts.  Hives feel hot and itchy.  They keep me up at night.  If pressure is applied, I will also get hives.  For example, if I wash my face with pressure, my entire face will red and swollen looking.I have never had hives in my entire life prior to this and have no known allergies at all.  I did not introduce anything new to my diet nor exposed myself to new allergans.  To this day (approximately a month and a half later), I still have chronic hives.  I have been taking claritan once a day every day to control it but I still get flare ups.  Flare ups are particularly bad when I eat foods high in histamines (fermented foods like kimchi) although these are not new foods to my diet.  Flare ups are also bad when I'm hot.Note that I did not get hives after my first two moderna shots (in April and May 2021).
Nine days after I received the shot, I had a first-time seizure and I was unconscious for about 30 minutes after. I broke my nose and busted my lip during it. The only signs I can think of that may have been a warning was that I couldn't spell cardiac and I had Deja Vu. My CT and MRI scans came back normal I go for a 24 hour EEG on June 26th. The doctors are unsure of what caused it.
headache; nausea; fatigue; chills; This is a Spontaneous report from contactable consumer (patient) via MEDICAL INFORMATION TEAM. A female patient of age 61 (unspecified units) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 02Apr2021 as 2nd dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 08Apr2021, she had headache, fatigue, nausea, chills. All that symptoms or the side effects, is it possible that would have occurred 6 days after the shot. Patient was informed about Pfizer Medical information department and was provided with the number. Call could not be transferred in Medical information department as the department was busy and the patient was requested to call the number. Limited information was available over the call. It was reported that reason of delay: daily spike of incoming calls due to COVID19 vaccine. The outcome of the events was unknown.   No follow-up information needed. Information on the lot/batch number has been requested. .
I had the vaccine on Wednesday.   On Thursday, the next day, I had aches and no energy.  I spent the day in bed.  I felt fine Friday and Saturday,.  On Sunday, I woke up with hot and chills and aches.  I spent that day in bed.
No additional adverse effects were reported; a 23 year old patient was inadvertently given a dose of PROQUAD; This spontaneous report was received from a medical assistant referring to a 23 year old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.       On 03-MAR-2020, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), 1 dose, for prophylaxis (route of administration, anatomical location, lot # and expiration date were not reported). No additional adverse effects were reported.
Flo-Like symptômes for three days: fever, headache, body aches, nausea. Bedridden and unable to perform any normal activities.
Day 1: Pain at site with mild fever of 100.1 F Day 2: Heavy sore arm with abated fever Day 3: ALL Side effects symptoms disappeared & feel well Day 6-7: Fever mild low grade 99.1F with mild diarrhea (x2 bowel movements same day) Day 10-18: Severe lower limb myalgia with pain climbing and descending stairwells
Information has been received from a nurse concerning a 24 year old female patient who in April 2007, "about two months ago" was vaccinated IM with a first dose of Gardasil. Within about a half an hour, the patient experienced chest pains, nausea, tightening of the throat, and an irregular heartbeat. The nurse reported that the patient has been hospitalized twice for the irregular heartbeat since receiving Gardasil. The nurse also reported that the patient has no prior history of heartbeat irregularities. Laboratory diagnostic studies included blood pressure and monitoring. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.