chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report has been received from a Health Professional concerning a 10 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 27-Aug-2012. The patient experienced weakness which started on 12-Sep-2012 and body aches, strep pneumoniae, nausea, sore throat, fever and headache which started on 04-Sep-2012. The patient recovered from the event of body aches, strep pneumoniae, nausea, sore throat, fever, headache and weakness on an unspecified date. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune from medical representative on 16-Nov-2012: new event, new reporter, lot number and expiration date. Summary of follow-up information received by AstraZeneca/MedImmune 26-Nov-2012 from HCP was provided new event: Weakness the outcome of events changed to recovered. Corrected report 06-Dec-2012 reporter tab corrected.
Woke in AM with welts, raised, and itchy covers most of body, except face.  Started scratching legs on 08/25/2005 approximately 08:00PM.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 21-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 20 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid 20Jun2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; 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 drug ineffective / COVID-19 cannot be ruled out
Patient was accidently given a Pfizer child dose instead of a Pfizer adult dose.  Patient was informed of this in office she was offered an additional 0.1mL of Pfizer to have her at the correct dosage. Patient refused the 0.1mL dose and said she was fine with the dose she received in office.
Pt slept for 3 hours, post vax, and woke up with a fever of 102F and vomiting when she woke up and had choking, difficulty breathing. Lips and face turned white. Took to hospital ER. Advised it was a possible reaction to a vaccination and to call PCP. The doctor in the office stated it was a definite reaction to pneumococcal vaccine.
Had first of the hep B immunizations and within 10 minutes felt a swelling/lump develop and a "scratchiness" in her throat; had her take 50 mg Benadryl and drank 16+ oz water; monitored and scratchiness went away completely within 45 minutes; pt left the clinic and went home. She does have access to an Epi-pen her husband has in the home.
This is a spontaneous report received from a contactable other HCP. A 58-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 58, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced asthenia (weak), neuralgia (nerve pain), bedridden (she was in bed for 15 days/could not get out of bed), with outcome of recovered; bone pain, dizziness (lightheaded), fall ("about to fall so many times"), amnesia (memory loss) and felt abnormal (had brain fogginess), with outcome of recovering. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
This spontaneous report was received from a Registered nurse regarding a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter.  Sender's Comments: US-009507513-1804USA005153:
?Moderna COVID?19 Vaccine EUA? --Injection site reaction arm pain the day of injection ( for 1.5 days) - 7 days after fatigue, short of breath upon over exertion ( 1 full day) - 9 days : redness at the injection site, fatigue, heavy breathing upon exertion, soreness around left shoulder
12 YEAR OLD PATIENT TO RECEIVE PFIZER COVID VACCINE BOOSTER WAS GIVEN THE PEDIATRIC PFIZER 10MCG VACCINE INSTEAD OF THE ADULT (>=12 YEAR OLD) 30MGC VACCINE.  THERE WAS A DISCREPANCY WITH THE PATIENT'S DOB ON THE VACCINE CONSENT FORM, WHICH INITIALLY STATED THE PATIENT WAS 11 YEARS OLD, BUT THE MOTHER CORRECTED THE  DOB TO STATE THE PATIENT WAS 12 YEARS OLD. IT WAS THEN DISCOVERED THAT HE RECEIVED THE PEDIATRIC PFIZER VACCINE.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown. 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. It was mentioned that the vial was initially refrigerated on 18 Oct 2021, the vial did not undergo any temperature excursion and patient did not experienced any adverse events.
A little sore arm after second shot; first dose of Moderna COVID-19 vaccine on 25FEB2021 and 2nd Moderna COVID-19 vaccine on 21MAR2021; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A little sore arm after second shot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of Moderna COVID-19 vaccine on 25FEB2021 and 2nd Moderna COVID-19 vaccine on 21MAR2021) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced PAIN IN EXTREMITY (A little sore arm after second shot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of Moderna COVID-19 vaccine on 25FEB2021 and 2nd Moderna COVID-19 vaccine on 21MAR2021). On 21-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of Moderna COVID-19 vaccine on 25FEB2021 and 2nd Moderna COVID-19 vaccine on 21MAR2021) had resolved. On 23-Mar-2021, PAIN IN EXTREMITY (A little sore arm after second shot) had resolved.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-386675, MOD-2021-386715 (Patient Link).
Initial report received on 11/Sep/2006 from a health care provider. A cluster of 10 adult patients were inadvertently administered an injection of Daptacel, lot number C2630AA, (instead of Adacel), on 08/Sep/2006. (Daptacel is not recommended for use in adult age groups). Twenty-four hours later, all ten patients complained of muscle aches and one patient complained of a local reaction. The symptoms of all of the patients experiencing muscles aches had resolved except one. At the time of this report, not all of the patients had recovered. Follow-up information received on 10 November 2006 from a health care provider. Individual information was provided for each patient. This patient was a 50-year-old female who experienced a local reaction that was red, sore, and indurated for approximately one week and was limited to the left deltoid Daptacel injection site. The patient recovered from the event. The reporter in this same as the reporter in cases 2006-03043, 2006-03044, 2006-03045, 2006-03046, 2006-03047, 2006-03048, 2006-03049, and 2006-03051.
BUMP ON TOP OF RIGHT INDEX FINGER; HEADACHE; This spontaneous report received from a consumer. 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: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced headache. Treatment medications included: paracetamol. On 12-APR-2021, the subject experienced bump on top of right index finger. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and had not recovered from bump on top of right index finger. This report was non-serious.
Pt recvd vax on Tues & devel a local rxn to rt thigh; 5x6 cm in size areas was red w/induration & tender to touch as per mom;
Tested positive for covid; Tested positive for covid; This is a spontaneous report from a contactable nurse (patient). A 33-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) intramuscularly at right arm on 18Dec2020 14:30 at single dose for COVID-19 immunization. Medical history included asthma. No allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient developed severe nasal burning sensation the first two days of injection along with severe headache that lasted for 4 days. He lost his sense of taste and smell (23Dec2020) 5 days after vaccine was administered, tested positive for Covid (23Dec2020 16:30) with use of ABBOTT rapid test which was performed at his employment. Pending Covid nasal swab fulgent which was obtained on 23Dec2020 and sent out to reference lab. Patient was just wondering if any of these symptoms and/or testing positive after administration was a rare side effect. The adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. The outcome of the events was not recovered.; Sender's Comments: Vaccine BNT162B2 provides protection to COVID-19 after at least 7 days have elapsed from the second dose (21 days post first injection). These conditions are not met in the present report. The reported symptoms are compatible with COVID-19 illness.
Information has been received from a registered nurse concerning a 10.5 year old male who on 01-DEC-2007 was vaccinated with his first dose of varicella virus vaccine live (Oka/Merck) (Lot # not provided). On 05-DEC-2007 the patient developed a varicella rash, consisting of 10-15 itchy lesions on the trunk, neck, shoulder and two crusted pustules. The patient sought unspecified medical attention. At the time of reporting, the patient was recovering. There was no product quality complaint involved. Follow-up information indicated no new information. This is one report of two received from the same source. Additional information is not expected.
sore; This is a spontaneous report from a contactable consumer (patient herself) via Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient was sore after the first dose. The reporter wanted to know if the vaccine will still take effect if it was placed really high up near her rotator cuff and it bled a lot. The outcome of the event was unknown.  Information on Lot/Batch number has been requested  Follow-up attempts are completed. No further information is expected.
Patient was diagnosed with transverse myelitis. Lost almost all physical ability. He was given steroids (6 doses) and had 6 plasmapheresis treatments.
Client was observed for 15 min. after vaccination with no issues and left Clinic.  Client returned to Clinic approx. 5 min. later. She complained of feeling her lips swollen and a little tingling.  Client observed in Clinic. Benadryl 50 mg was given.  Vitals remained stable.   Client reported no tingling to lips and less swollen 1/2 hour after Benadryl.  Client remained in Clinic for 1 hr. and 40 min. after Benadryl given as she was waiting for husband to pick her up. Upon leaving Clinic Client stated felt better, Lips feeling normal.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was subcutaneously vaccinated with an improperly stored dose of VARIVAX lot # M048203, expiration date 07-DEC-2018 (dose and route of administration were not reported). There was no adverse effect reported.  Administered dose of vaccine experienced the temperature excursion between -14 to -10 (also reported as -9.6) degrees Celsius for 93 hours and 45 minutes. Data logger was involved. The vaccine underwent previous excursion reported between -14 to -10 degrees Celsius for 2 hours. No product quality complaint (PQC) was involved.
consumer took her temperature and it read 100.6 F; Felt like going to black out; Woozy; headache; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Felt like going to black out), DIZZINESS (Woozy), HEADACHE (headache) and PYREXIA (consumer took her temperature and it read 100.6 F) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042120A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 18-Jan-2021, the patient experienced PRESYNCOPE (Felt like going to black out), DIZZINESS (Woozy) and HEADACHE (headache). On 20-Jan-2021, the patient experienced PYREXIA (consumer took her temperature and it read 100.6 F). At the time of the report, PRESYNCOPE (Felt like going to black out), DIZZINESS (Woozy), HEADACHE (headache) and PYREXIA (consumer took her temperature and it read 100.6 F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were reported.    No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Shaking; Very Nauseated out of deep sleep; Feverish; A spontaneous report (United Sates) was received from a consumer, concerning an 77 years-old male, who received Moderna's COVID-19 vaccine (mRNA-1273), which patient received the second dose on 04 Mar 2021 an experienced being very nauseated, out of deep sleep shaking, and feverish.   The patient's medical history was not reported. The concomitant medications were Metoprolol and Eliquis.  04 Mar 2021 The 2nd dose of the vaccine prior to the onset event the patient (batch- lot 003A21A), was given intramuscularly in the arm for the prophylaxis of COVID-19 infection.  On 05 Mar 2021, the patient experienced being very nauseated out of deep sleep, shaking and feverish  Action taken with second dose of mRNA-1273 was not applicable.  The outcome of the all events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Participant reported wake up on 01/27/2022 with the following symptoms: Upper lip swollen (resolved by 01/28/2022) Itchiness on the palms of the hands and feet soles (improving by 01/28/2022) Under skin rash in the back. (improving by 01/28/2022) improving by itself,  without help of any  medication The condition was resolved by 01/31/2022
Blisters on my hands & fingers, blister fills with fluid, then will bust on its own, then burns like a burn from a fire or stove.  I reported having blisters before from injections
Called the clinic on 6-16-21 and reported she had some inflammation, redness, and itching to left arm where shot was given. Unsure when symptoms started.
Patient tells me that she got the vaccine on Monday and on Saturday she began to have itchy lesions on her abdomen and then on her breast.   Patient did have a honey-colored crust over the breast lesion.  Patient reports the lesions on the abdomen have been improving.  She denies any fevers, chills, or sweats.  She does not report these lesions are painful.  She has been using Neosporin on the lesion on her breast.  She admits to traveling to her camp on Wednesday or Thursday of that week and does have a lot of insects including spiders in the cabin.  She does leave her closely on the floor in the closet and does question that this may be an insect bite.  Right breast:  Scattered raised and itchy papules on right breast at the 5 o'clock position  Right anterior abdomen in the right lower quadrant.
Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Malignant neoplasm of kidney, except pelvis (Malignant neoplasm of left kidney). Concomitant products included LENVATINIB MESILATE (LENVIMA) for Malignant neoplasm of kidney, except pelvis.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PYREXIA (Fever) and CHILLS (Chills) outcome was unknown. Not Provided          Concomitant products were not provided. Treatment medication were not reported.   This case was linked to MOD-2021-331510 (Patient Link).   Reporter did not allow further contact
She instantly had a very bad stomach ache and didn't know to either vomit or go to the bath room. We were checking out of the doctor and she fainted. She said she felt like she couldn't talk and breathe. She was very hot and sweaty.
I had a headache of *migrane level, debilitating pain* for 66 hours.
The night of the vaccination patient threw up and ran a fever of 103.4. The vomitting continued through the next 2 days along with extreme lethargy and the inability to walk. For the next week patient would not/could not hold her head upright, she was sleeping for 20hours a day and when she was awake she stared into space. She refuse to eat. She could not walk or climb which she had been doing for the last 4 months at that point. I took patient to the hospital about a week and a half after vaccination due to episodes of hypothermia, cyanosis, and the extreme lethargy. She also began having stomach distention shortly after discharge which continued for a month along with the cyanosis. The lethargy lifted after 2 weeks she began holding her head up again and slowly walking again. We began noticing personality trait differences as well. Increased appetite and mood swings which have not gone away
Had LOC syncapol episode walking from seminar room  (where injection took place) to the room across the hallway to wait for 15 mins post injection  stated BP was low but do not know exact numbers
Ear ringing (tinnitus) in left ear the day after 1st vaccine. Has been consistent for a month and got worse after 2nd vaccine on March 26th, 2021. Also having ear pain that has been checked by a doctor that shows no physical signs of infection.
Hive-like rash with intense itching began on 26Dec2021,  starting with abdomen and upper and left side on back. It then spread to upper left arm and shoulder. I took 1 Benadryl which decreased rash on abdomen within a few hours. Noticed rash had spread to left side of neck and a new patch formed in groin area.  Before going to sleep I took another Benadryl. Upon waking the rash on the abdomen had disappeared but the rash on my neck worsened, and spread into my scalp. Rash noticed on eyelids, forehead, and chin.  A few hours later itchiness noticed on arms and hands. New rash appeared on lower back. Another Benadryl tablet taken.
pt recv vax & became weaker during the day;upon admission pt markedly quadraparetic;could move head & speak w/o diff;CBC WNL;adm evolving GBS;intubated on ventilator;tracheostomy;
chills; feverish; shakes; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received first dose of bnt162b2 (BNT162B2, lot number: EH9899), via an unspecified route of administration on 21Jan2021 11:00 at SINGLE DOSE for covid-19 immunisation. Medical history included Blood pressure, Acid reflux, urinary tract. Concomitant medication included enalapril (ENALAPRIL) for Blood pressure, omeprazole (OMEPRAZOLE) for Acid reflux, and took another pill (Unspecified Medication) for urinary tract (Not clarified), 10 mg a day. The consumer reported she had the COVID vaccine 22Jan2021 11:00, was great all day, had no reaction, felt fine, ate, was active and then about 8:15 at night all of a sudden, she started to get the shakes and the chills and was feverish and she guessed it was an adverse reaction to the vaccine or side effect she did not know. Right now she was normal, slept okay but she was just wondering was this a normal. She took 2 Tylenol every night 4-5 hours, 500 mg took 2. The consumer meaned they don't even say this on the form if you get this reaction what you could take so she took it myself and it did help, the fever reducer. The patient underwent lab tests and procedures which included body height was 5 foot 5 and a quarter on an unknown date; body temperature was 101.2 on 21Jan2021, and 98.6 in Jan2021, Swab test on Tuesday (unknown date) with unknown result, didn't get the result yet. The event outcome was recovered in Jan2021.