chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt called 10/17 stated her rt arm at YF injection site was red warm and swollen to touch. Later that night after the injections she had wheezing difficulty breathing and began itching at midnight and broke out in hives on her abdomen. She did not go to a Dr. She took tylenol allergy sinus felt bad the whole weekend. Hives went away on Monday and breathing was better.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 30-MAY-2012 the patient was vaccinated with the first dose of GARDASIL (lot # unspecified). It was reported that the patient received the second dose on 26-FEB-2013 which was late. No symptoms reported. The outcome of the event was unknown. Additional information has been requested.
Gave pt vaccine in R DM.  approximately 5 mins later pts inj. site turned red and had a dime size induration.  Pt was then seen by Dr.
Swelling in the fingers of my left hand.; Unable to bend fingers back up for a few hours; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Mar2021 at 11:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety, depression, and migraines. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included vilazodone hydrochloride (VIIBRYD), topiramate (TROKENDI), quetiapine fumarate (SEROQUEL); all for unknown indication from unknown date and unknown if ongoing and botulinum toxin type a (BOTOX) for migraines from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Mar2021, the patient experienced swelling in the fingers of her left hand. Mostly in morning, she was unable to bend fingers back up for a few hours. It would go away after a while during the day and return again at night. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event swelling in the fingers of left hand; mostly in morning, unable to bend fingers back up for a few hours; it would go away after a while during the day and return again at night was not resolved at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Complained of arm swelling from shoulder to elbow red, tender to touch.  Pain in arm joint and muscle pain body pain for 2 days.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Jan2021 at 08:45 as dose 1, single (Lot number: EL1284), in left arm, on 23Feb2021 at 09:30 as dose 2, single (Lot number: EL9261), in left arm, on 24Sep2021 at 11:00 as dose 3 (booster), single (Lot number: 301308a), in left arm and on 30Mar2022 at 10:00 as dose 4 (booster), single (Lot number: Fk9896) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hyperfactor VIII" (unspecified if ongoing); "spinal stenosis" (unspecified if ongoing); "rectal incontinence" (unspecified if ongoing); "glaucoma" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "hyper cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies: wellbutrin, reaction(s): "Allergy to Wellbutrin", notes: Known allergies: Wellbutrin; Known allergies: thiomersol, reaction(s): "Allergy to Thiomersol", notes: Known allergies: thiomersol; Known allergies: lisinopril, reaction(s): "Allergy to Lisinopril", notes: Known allergies: lisinopril. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical information: Other medication was given in 2 weeks.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Pt received Prevnar vaccine in right thigh on 4/9/01. Pt returned to clinic on 4/11/01 with a hard knot, redness and swelling. Pt was limping. Dx'd with cellulitis.
Felt like servere case of Flu..headache, swollen glands, streaks of pain n arms and legs,feeling nausea. Call Dr. She said take 650 of Tylenol every 6 hours.  Next morning felt like getting back to normal.
1.25 diameter blue spot at injection site; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 02Apr2021 at 13:15(at the age of 35-year-old) as a single dose for COVID-19 immunisation. The medical history included sulfa allergy, penicillin allergy, egg allergy and milk allergy. The concomitant medications included birth control (MANUFACTURER UNKNOWN), sumatriptan succinate (IMITREX) and meloxicam (MANUFACTURER UNKNOWN), all from an unknown date for an unknown indication. The patient previously took Levaquin and experienced allergy to it. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 07Apr2021 at 00:00, after 5 days of vaccination, the patient experienced 1.25 (unspecified unit) diameter blue spot at injection site which was more noticeable when skin was cooler. The patient did not receive any treatment for the event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event blue spot at injection site was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
pt admit to hospital w/ incidental covid s/p 2 doses of Moderna 8/4/21 & 9/1/21
rash below injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was unknown.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional details were provided as follows: The patient was reporters father. The age at vaccination was not reported. The patient received a dose of Shingrix a couple of days ago and developed rash inches below the injection site. The reporter did not consent to follow-up. This case had been linked to the case US2019141432, reported by the same reporter.
Elevated blood pressure, went to ER, shot given too high, caused severe pain, inflammation of tendon.
Patient was waiting the recommended 15 minutes after vaccination.  Close to the end of the time period, patient starting have chest pain.  Paramedics were contacted and patient was taken to Hospital by ambulance.  Patient was discharged 3 days later on Lovenox therapy for blood clotting.  Per the patient, ER physician stated that patient's prognosis would have been much worse had she not been under supervision of pharmacy vaccination staff and taken to hospital by ambulance.
Patient was given PPSV23 in R deltoid, noticed some pain, swelling and redness approx 5 hours later. Pt was seen in the office the following day and treated with antibiotics for possible infection. Pt is improved.
Pressure was noticed building behind the eyes but it was assumed from the normal seasonal allergies at first. The right eye was extremely painful. Treated it with allergy meds. The eye sight in the right eye started getting  a black ring around with what looked like dna chains squiggling through it. At the same time headaches were awful even with the medications being taken. I never go to the doctors. I try to  take care of things myself. I finally went to the eye doctors on October 7th.  From there they can give you the rest of the information you need.
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnoses include: severe sepsis, pneumonia, toxic shock, and myocarditis.
Pt called physician helpline 2/21/04. Stated Anthrax and smallpox vaccine given 2/11/04. (RA anthrax smallpox LA). Developed localized rash at site 2 days post shot. Seen in surgeon office. Rash spread all over body. Placed on Prednisone and Atarax until 2/23/04. Experiencing swelling to neck area-no airway involvement. Follow up. Pt has follow-up appt with surgeon Tues. 2/24/04 am.
Clammy palms, dizziness, dusty color skin, paleness, unresponsive, eyes rolled.
very cold; flu like symptoms; Patient is experiencing chills/cannot get warm; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (very cold), INFLUENZA LIKE ILLNESS (flu like symptoms) and CHILLS (Patient is experiencing chills/cannot get warm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced NASOPHARYNGITIS (very cold), INFLUENZA LIKE ILLNESS (flu like symptoms) and CHILLS (Patient is experiencing chills/cannot get warm). At the time of the report, NASOPHARYNGITIS (very cold), INFLUENZA LIKE ILLNESS (flu like symptoms) and CHILLS (Patient is experiencing chills/cannot get warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
I woke up in the middle of the night about 8 hours after receiving the second shot. I got up to go the bathroom and passed out. When I came to, I felt an intense wave of heat and nausea move through my body from feet to head. I then tried to get up but couldn't stand or sit as I kept passing out. I crawled back to my bed which was on the floor at the time and went back to sleep. The next day I was able to sit and stand, but had extreme fatigue and muscle weakness and pain w/ even the slightest exertion. Also experienced severe shortness of breath with any sort of exertion (moderate walking, one flight of stairs, slow walking up an incline, etc.). I saw a doctor on 5/14/21, who ran a bunch of tests that call came back within normal results. The fatigue, weakness and pain lasted for a couple of weeks and then improved slightly.  There were a few more weeks of fatigue and muscle weakness & pain. And then a gradual improvement that took months to get close to back to where I was before the shot. The shortness of breath w/ exertion remains as of this VAERS report on 12/22/21.
MA staff administered the incorrect vaccine to the patient. The patient was due, per the System, for a single dose DTaP and this was the vaccine ordered by the provider, however the staff administered the combination Pediarix vaccine.
No adverse effects; The patient was administered one dose of improperly stored Varivax; This spontaneous report was received from a nurse regarding a patient of an unknown age and gender. The patient's pertinent medical history, drug reaction and allergies were unknown. The concomitant therapy included sterile diluent. On 26-AUG-2019, the patient was vaccinated with one dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (reported as injection) (strength, frequency, route was not reported) (lot No S005077 has been verified to be a valid lot number, expiration date reported as 19-JUN-2021, but upon internal validation established as 19-FEB-2021) for prophylaxis (Product storage error). The vaccine underwent temperature excursion of 15 degree Fahrenheit to 46 degree Fahrenheit (36.392 F) for 2.5 hours and 6 degree Fahrenheit to 14 degree Fahrenheit for 1 hour. Previously no temperature excursion was reported. The call was due to digital data logger. No adverse effects reported (no adverse event). Product quality complaint was not involved. Previously no temperature excursion was reported. The call was due to digital data logger.
pt recvd vax in 1984 & pt currently alleges that pt suffers from chronic arthritis; No further details were provided;
SLEPT MOST OF THE DAY AND NIGHT; ARM SORE; BURNED GOING IN; SEVERE FATIGUE; headache; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced slept most of the day and night, arm sore, burned going in, severe fatigue, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the burned going in, arm sore, severe fatigue, headache and slept most of the day and night was not reported. This report was non-serious.
Bad itching; Hardness; Aching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Bad itching), VACCINATION SITE INDURATION (Hardness) and VACCINATION SITE PAIN (Aching) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Historical condition reported).    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 VACCINATION SITE PRURITUS (Bad itching), VACCINATION SITE INDURATION (Hardness) and VACCINATION SITE PAIN (Aching). At the time of the report, VACCINATION SITE PRURITUS (Bad itching), VACCINATION SITE INDURATION (Hardness) and VACCINATION SITE PAIN (Aching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medication provided no treatment given
patient only received a 0.3 ml dose due to a defective syringe with no AE; patient only received a 0.3 ml dose due to a defective syringe with no AE; Initial information regarding an unsolicited valid non-serious was received from a Pharmacist via Medical Information (Reference number- 00618533) and transmitted to Sanofi on 27-May-2021.  This case involves a patient with unknown gender received a 0.3 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number and expiry date were not reported) via unknown route at an unknown administration site (underdose) for prophylactic vaccination due to a defective syringe (syringe issue) on an unknown date.  The patient's medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.   The reporter asked should the patient be revaccinated.  It was an actual medication error case due to vaccine underdose and syringe issue (latency: same day).  At the time of reporting, the patient experienced no adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.  There will be no information on the batch number for this case.
Fever, muscle aches, muscle weakness, fatigue, sore throat began on the 3rd day after the vaccine shot
No adverse event; Monovalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) in a 49-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients).    No relevant concomitant medications were reported.  No treatment information was provided.
Probably 5 minutes after receiving the vaccine I started noticing that my right side of my face was numb. Over time the numbness faded into tingly ness (like after getting a numbing shot at the dentist). It was only the right side of my face and focused around my corner of my mouth and along my jawbone. Over time the feeling subsided probably an hour. While being observed at the clinic they did not notice signs of Bells palsy( facial muscles were still responding symmetrically). Had not sign of allergic reaction at the injection site.
Info has been received from an RN concerning an approximately 33 month old female pt who in approximately 2003, was vaccinated in the afternoon with a dose of MMRII. Concomitant vaccine therapy included multiple unknown vaccinations including influenza virus vaccine (unspecified). The physician reported that about 15-18 hours after the vaccinations, the pt had a generalized urticaria. The pt sought unspecified medical attention. The pt recovered. There was no product quality complaint reported. Follow-up info from the physician, indicated that the morning after vaccination in approx. 2003, the pt woke up with generalized facial swelling and hives all over. There was periorbital edema. There was no chest tightness, wheezing, shortness of breath, GI symptoms, nasal symptoms, dizziness or loss of consciousness. The pt's mother gave her Benadryl and the hives went away after several hours. Prior to that, there had been a history of significant diaper rash at about 18 months. Eggs were taken out of the diet and the problem resolved. Therefore, there was a concern of an egg allergy. It was reported that the pt "does eat" cakes and cookies baked with eggs without any problems. She has eaten Jell-o without any problem. Recently, the pt went for her 2nd follow-up vaccination with MMRII and they refused to give it to her for fear that she would have another reaction. The physician stated that he "doubts that the pt's hive reaction was due to the egg content of the flu vaccine". He stated that "we will obtain MMR vaccine and do skin testing followed by in office challenge". A skin test will also be done for eggs and if possible for gelatin. It was reported that the pt's father has respiratory allergies. Additional info has been requested.
Vaccine exp: Use by date = 10/7/22 8 wk after defrost Exp. Date = 10/31/2024
Mom called, stated left leg swollen and red, sore took to MD.  Better today.  MD's office states no cellulitis, just red and swollen.
Dizziness, NauseaVomiting,  decreased appetite, soreness at injection site  Narrative:
Rash, Pityriasis Rosea diagnosed on 11/26/04, appeared on 11/19/04 with fine red bumps on chest wall, discussed by phone, worsened on 11/26 and seen, not ill with any systemic symptoms, no fever or malaise, rash is very slightly itchy.
This case was reported by a other health professional and described the occurrence of inappropriate age at vaccination in a 2-year-old female patient who received FLUARIX QIV (batch number 5J9E9, expiry date 20th May 2015). On an unknown date, the patient received FLUARIX. On an unkonwn date, an unknown time after receiving FLUARIX, the patient experienced inappropriate age at vaccination. On an unknown date, the outcome of the inappropriate age at vaccination was unknown. It was unknown if the reporter considered the inappropriate age at vaccination to be related to FLUARIX. Additional information: FLUARIX QIV was inadvertently given to a 2 years old patient which led to maladministration. FLUARIX QIV was approved for use in persons 3 years of age and older. No adverse event reported.
17 year old male was given Pfizer vaccine booster shot. Waited 15 minutes in vehicle with mother. No untoward reactions noted. Left to go home after the required wait.
On Saturday, January 30, 2021 I began experiencing an altered sense of taste with a metallic taste all through my mouth and tingling in my mouth.  I mostly felt ill throughout the day with low-grade fever, fatigue, body aches.  This continued on Sunday, January 31, 2021 and Sunday evening, I noticed a small droop in the upper lip on the right side of my mouth.  When I awakened, Monday, February 1, 2021, I had full right-side paralysis of the face, severe right eye, right jaw and right ear pain, severe fatigue, continued body aches.  After going to the ER where tests were performed to rule out stroke and sepsis, I was diagnosed with Bell's Palsy.
2OCT97 pt recv vax & 4OCT had 3 hives above the lt knee;they were red & scratchy;pt called MD & prescribed DPH capsules which is taking now;not there is no fever or any other sx;
PT FELT "WEIRD" AND FAINT. FORGOT TO TAKE HER HYPERTENSION MEDS, BLOOD PRESSURE WAS 200/110, HR 88. TAKEN TO HOSPITAL.
sore spot where he had the vaccine; had a sore arms where he received the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported INJECTION SITE PAIN (non-serious), outcome unknown; PAIN IN EXTREMITY (non-serious), outcome unknown.  The patient did not have COVID prior to vaccine.   No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Redness and tenderness coving a 4x3 inch area on right arm around vaccine site. No warmth. Benadryl did not help with reaction. Patient brought in for inspection and observation. No treatment considered warranted.
Patient received Moderna injection for 2nd dose in series and should have received Pfizer.  Patient's son was consulted by infectious disease physician.  Patient's son reported that patient was no experiencing adverse symptoms.