chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 31 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/Lot No: EW0217, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 13Oct2021, when the patient was 29-year-old, for COVID-19 immunization, reaction(s): "Low-grade fever", "Chills", "total body aches", "brain fog", "headache", "swollen/painful axillary left lymph node", "swollen/painful axillary left lymph node", "fatigue"; bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 16Feb2021, when the patient was 29-year-old, for COVID-19 immunization; bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 26Jan2021, when the patient was 29-year-old, for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 12Oct2023 at 10:00, outcome "recovered"; PAIN (non-serious) with onset 12Oct2023 at 10:00, outcome "recovered", described as "body aches". Therapeutic measures were not taken as a result of chills, pain. Additional information: Chills and body aches approx 18 hrs after administration.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
18 May 2021 6:00 am woke up with  Muscle/body aches Fatigue/ lethargic Chills Took 400 mg Ibuprofen, body aches went away, chills and fatigue stayed throughout the day. Body aches reoccured at around 7:00 pm , took another 400mg Ibuprofen.  19 May 2021 06:00  Fatigue  and lethargic  NO body aches and no chills
mother had 1st vaccine on Jan28, she tested positive for Covid; mother had 1st vaccine on Jan28, she tested positive for Covid; This is a spontaneous report from a contactable consumer (Patient's daughter) . A female patient of unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: unknown, Expiry Date: unknown) on 28Jan2021 via unspecified route of administration at single dose for COVID-19 immunization. The patients medical history and concomitant medications were not reported. On an unknown date in 2021, after receiving the vaccine, the patient tested positive for Covid. The patient was supposed to get second dose of Covid vaccine on 18Feb2021 while she was in quarantine. The outcome of the events was unknown.  Information on the Lot/batch number has been requested.
Redness, warm to touch 1 1/2 x 4cm area R deltoid in 2nd day post vaccine given had sl redness in 8/14/02. Woke up this am with larger area of redness and warm to touch.
severe chills and trembling, body aches, headache and fever of 103.8.  All of these are expected but due to the severity of the fever, I felt it important to report.  I have not had a fever that high since I was a child.  Probably the highest adult fever I have had is 102.
Headache, Fever, CHILLS, KOINT PAIN, TONGUE NUMBNESS, LOSS OF TASTE, LOSS OF APPETITE, SINUS INFECTION AND PINK EYE Narrative: EMPLOYEE STATES ABOVE LISTED SIDE EFFECTS FEVER RANGE 99.1 TO 104.4F PINK EYE STARTED SECOND DAY AFTER VACCINATION
minor pain at injection sight-immediately and still on going  notable neck pain on right back side of neck. woke up from nap about 2pm Thursday with pain and still continues at constant level.
BULLS EYE REACTION AT THE SITE OF INJECTION, POSSIBLY CELLULITIS, RED WARM TO TOUCH.
This spontaneous report was received from a Licensed Practical Nurse regarding an unspecified number of patient of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date, the patients were vaccinated with improperly stored GARDASIL 9 lot number L019289 and expiration date 14-SEP-2017 and lot # L014415, expiration date 23-JUL-2017 (incorrect product storage). No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
After vaccines were given approximately 35 minutes dad exited the room and asked me to look at the child because she had turned grey. Myself and another nurse witnessed to complexion change and told Dr.
flu like symptoms; pain and soreness on site of injection; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) and VACCINATION SITE PAIN (pain and soreness on site of injection) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms) and VACCINATION SITE PAIN (pain and soreness on site of injection). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) and VACCINATION SITE PAIN (pain and soreness on site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Patient had headache, fever, sweats, and vomiting after receiving flu shot. Patient had also had seizure in ambulance patient had flu shot last year with no problem before.
pt exp rt extremity in arm extending to lt arm to legs, back, thorax to face;has waves of numbness & extreme fatigue;c/o joint pain;leg weakness;back pain;dx chronic hyperventilation;diff breathing;diff getting out of bed;
Dehydration, muscle soreness (slight, e.g. after exercising too much), elevated temperature up to 101.7 F. Drank water, took a nap, and took 500 mg of Tylenol when temperature reached 101.7  F. About an hour after having taken Tylenol, temperature was back at 99.8 F. No further muscle soreness.
p/vax pt c/o lt arm pain & elevated temp x 2 days;T100.7 lt arm red swollen on exterior aspect below needle mark tender to touch, bluish discoloration around the needle mark;tx APAP;warm compress;
Foggy headedness; difficulty concentrating; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot Number: ER8732) via an unspecified route of administration in the left arm on 01Apr2021 at 08:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The medical history of the patient was reported as none. The patient was allergic to fruits and nuts. Concomitant medications included ibuprofen (ADVIL) taken for an unknown indication from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. On 02Apr2021, at 09:30, the patient experienced foggy headedness and difficulty concentrating. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events foggy headedness and difficulty concentrating was recovering at the time of this report.    No follow-up attempts are needed. No further information is expected.
Pt developed sharp chest pain, intermittent, positional, severe at times.  Occurred within 24 hours of 2nd vaccine administration.  Seemed to improve with ibuprofen taken.  Found to have significantly elevated troponin I to 1.5, concerning for myopericarditis.  Echocardiogram was normal.  Plan for NSAIDs as needed for pain and follow-up with Cardiology.
reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported.   On 26-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis.   The administered vaccine underwent a temperature excursion below 2 degrees Celsius (°C) of -40.0 °C for a time frame of 15 minutes; and an excursion above 8°C of 9.6 °C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported.   This is one of several cases, from the same reporter.  combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T026167; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
I have golf ball size lump at my injection site; hurts really bad; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE MASS (I have golf ball size lump at my injection site) and VACCINATION SITE PAIN (hurts really bad) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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, the patient experienced VACCINATION SITE MASS (I have golf ball size lump at my injection site) and VACCINATION SITE PAIN (hurts really bad). At the time of the report, VACCINATION SITE MASS (I have golf ball size lump at my injection site) and VACCINATION SITE PAIN (hurts really bad) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information were reported by the reporter
Allergic reaction (hives), 40 minutes after the shot. Took a Benadryl and will continue to monitor.
warm, raised, reddened area about the size of 1 to 1.5 inch.
Information has been received from a registered nurse concerning a 6 year old female who on 02/03/1997 was vaccinated with a dose of Varivax. On 01/01/02, the patient was seen in the doctor's office with an ear infection. On 01/04/02 the patient developed breakthrough chicken pox lesions located on her back, stomach, arms and groin. It was not known whether the child had been exposed to WTV, however the child was in school. The patient sought unspecified medical attention. It was also reported that the patient's 5 year bother developed chicken pox via secondary transmission. (WAES0201USA02246). Additional information has been requested.
Information has been received from the author in a published literature abstract. This case concerns a 73 year old female with hypertension, chronic hepatitis C and alpha gal allergy. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with zoster vaccine live (manufacturer unknown) for prophylaxis (dose, frequency, route of administration, lot number and expiration date were not reported). On an unknown date, the patient presented to the emergency department for near syncope after epinephrine administration for upper lip, mouth and tongue swelling, experienced 45 minutes after obtaining the zoster vaccine live (manufacturer unknown) (anaphylactic reaction). Per the authors, a review of the vaccination contents revealed use of porcine gelatin - a meat product felt to have induced an immunoglobulin E (IgE) response in the setting of alpha gal allergy. On an unspecified date, the patient was admitted to the hospital, managed with intravenous fluids, and discharged on the following morning. The outcome of anaphylactic reaction was unknown at the time of this report. As reported, this was an unusual case of alpha gal allergy with anaphylaxis induced by zoster vaccine live (manufacturer unknown) due to use of porcine gelatin. Upon internal review, the event anaphylactic reaction was determined to be medically significant.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Vials stored in the refrigerator on 03-Nov-2021. No temperature excursions and no adverse event were noted.  No treatment information was provided.
Shot was administered on March 9, 2023 at 2:00pm.  Did not have any side effects the next day on March 10, 2023, I went to the gym and workout and everything felt normal. When I woke up on March 11, 2023 my temperature was 95 within hours it went up to 101.  For the next 48 hours my fever kept fluctuating from the 96 range to 100.7. I did not have an appetite, when I did eat everything started to come up. Night sweats, weak, and an overall feeling of tiredness.
Swollen lymph nodes left arm pit and left side of neck; This is a spontaneous report from a contactable reporter (healthcare professional). The reporter is the patient.  A 46-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 16Feb2022 at 15:45 (Lot number: unknown) at the age of 46 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Allergy to nuts" (unspecified if ongoing), notes: Known allergies: tree nuts and "Latex allergy" (unspecified if ongoing). Concomitant medication included blood pressure medications (unspecified). Past drug history included: Benzoyl peroxide, reaction: "Drug allergy", notes: Known allergies: Benzoyl Peroxide. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: UNKNOWN; Anatomical location: Right arm; Administration time: 14:00), administration date: 02Jun2021, when the patient was 45 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: UNKNOWN; Anatomical location: Right arm; Administration time: 14:00), administration date: 23Jun2021, when the patient was 45 years old, for COVID-19 immunisation.  The following information was reported: LYMPHADENOPATHY (non-serious) with onset 18Feb2022 at 16:00, outcome "recovering", described as "Swollen lymph nodes left arm pit and left side of neck". The event "Swollen lymph nodes left arm pit and left side of neck " was evaluated at the physician office visit. Therapeutic measures were taken as a result of lymphadenopathy.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Treatment included anti inflammatory medications over the counter (OTC) and warm packs for lymphadenopathy.   The lot number for BNT162b2 was not provided and will be requested during follow-up.
Healthy 2 month old black male received 4 vaccinations, IM, at about noon; fell asleep immediately, taken home, still apparently asleep. Found unresponsive with face down by mother at 18:00. Asystole at the scene. Full term with low birth weight of 4 lbs and 11 oz, NSVD to a 31 year old married G2 P2 with PNC; history of maternal alcohol and marijuana use with first trimester; no maternal disease. Autopsy shows severe eosinophilic infiltrate of muscle at the injection site. Weight at death 9 lbs and 4 oz. Per F/U 5/7/02: COD-SIDS Exam: left thigh injection site showing 2 hemorrhagic puncture defects extending vertically into the deep muscle surrounded by an extensive area of edema and severe acute inflammation composed mostly of eosinophils. Right thigh injection site showing a hemorrhagic puncture defect in the deep muscle and slight focal acute inflammation. Cerebrovascular congestion (mild) and heterotopic neuronal rest, large-cell type, cerebellar white matter; incidental finding. Hospital care facility report states: COD as cardiopulmonary arrest.
patient is under authorized age range; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient is under authorized age range) in a 15-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient is under authorized age range). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient is under authorized age range) outcome was unknown.        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.  Concomitant product use was not provided.  Treatment information was not provided.
single episode of syncope 15 minutes after vaccine after standing up, likely vasovagal vs. orthostatic. completely resolved
gave ProQuad (MMR + Varivax) on 1/26/07-2 weeks later developed both measles like (mac pap) rash and papules (vesicles + pustules approx 10 total) all over-scalp-pruritic + splenomegaly 2 cm.  Both rashes were present after one week.
I have developed ringing in my ears. I have an appointment with an ent doctor May 10,2021
Headaches, tiredness. Sunday still had headaches but worse after waking up. Started developing severe SOB, stomach ache. Early evening, had diarrhea until the next morning. Monday still had SOB, and headache. By Tuesday, SOB had kind of went away but still had headaches.
On the day of the shot, hives?broke out in hives in the evening after a hot shower. Every day I have had itchy skin, almost like the feeling of dry skin, but with a red rash on face, chest, arms, and legs.
Patient presented with pain and swelling in right calf; He is a healthy 20 year old, and a college athlete. he thought he had a claf strain because he is in season and working out a lot. Leg hurt for about six days before he came to ER; started to feel light headed and short of breath two days prior. Not able to put weight on right leg without extreme pain. CT scans and ultrasounds in ER showed DVT and pulmonary embolisms;
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from License Party. The reporter is the patient. Other Case identifier(s): 20211229714 (Reference ID). A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2 (booster), single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Janssen Covid-19 vaccine (we had the J&J, dose, 1 total), for Covid-19 immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown" and all described as "booster after we had the J&J"; IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; ILLNESS (non-serious), outcome "unknown", described as "sickness"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness"; DECREASED APPETITE (non-serious), outcome "unknown", described as "no appetite"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain". Additional information: The patient reported that she and her husband took the Pfizer booster after they had the J&J and got really sick. Her husband had chest pains within 10 minutes and within half hour was hurting all over and no energy. Her AE started the next day and she was in bed for 7 days with joint pain, nausea, dizziness and no appetite, will never take another vaccine. Drug: Janssen Covid-19 vaccine (Covid-19 vaccine AD26. COV2.S) (Suspension for injection) (Covid-19 Vaccine AD26.COV2.S),1. The lot number for bnt162b2 was not provided and will be requested during follow up. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
ABOUT 4 INCHE CIRCULAR RAISED RED, SWOLLEN AREA. PATIENT STATES VERY PAINFUL TO THE TOUCH. DOCTOR TOLD HER IT APPEARS TO BE CELLULTIS. PATIENT ALSO STATES MUSCLES OVER BODY ARE SORE AND ACHY.
Erectile dysfunction. Unable to achieve erection and no reaction to any type of stimulation at all; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 49-years-old via an unspecified route of administration, administered in arm left on 23Mar2021 14:00 (Batch/Lot Number: EN6204) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included lisinopril and hydrochlorothiazide both taken for an unspecified indication, start and stop date were not reported. The patient experienced erectile dysfunction on 25Mar2021. It was further reported that he was unable to achieve erection and no reaction to any type of stimulation at all. Did not have this issue at all prior to receiving vaccine. The patient did not recover from the event.
pt seen in clinic 3 days before hospitalization, was dx'd COVID positive, given monoclonal antibodies the following day; presents to ED with worsening SOB over past week; hypoxic; steroids, antibiotics, remdisivir, baricitinib given; O2 therapy of HFNC with FiO2 of 100%; pt's condition worsened and required BiPAP, O2 sats in 80s; became hypotensive, vasopressors given; intubation; DNR; pt's condition declined and he died in the hosp
About 3-5 minutes after receiving the injection the patient passed out for about 20 seconds before coming to. This happened two more times over the next 10-15 minutes.