chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She still had a fever at 03:50 AM, it was 40; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date Dec2021 (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: PYREXIA (non-serious) with onset Dec2021, outcome "unknown", described as "She still had a fever at 03:50 AM, it was 40". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient was given the bnt162b2 vaccine last Tuesday (as reported) and she still had a fever like last time her fever at 03:50 AM, it was 40 which was more than 72 hours after the vaccine. The reporter was informed to reach out to the nearest emergency in case of medical emergency.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
On about March 6, 2023, I had a sinus infection. I was treated with an antibiotic on March 16.  I still had runny nose and sinus headache and called the doctor on March 23.  They said I had to do a COVID-19 test. It was positive. I started Paxlovid that day. I am still hoarse but feel I have recovered.
Information has been received from an unspecified reporter referring to a 10 year old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 10-AUG-2016, the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
PT c/o swelling with erythema and inject site to knee - left side where received DTaP.
arthralgias, fever x 2 days-no localized swelling or redness;
At first it felt like I had COVID-19, I had a 103F, shortness of breath, headache. I was on vacation, I went to an Urgent Care. They felt it was COVID-19 although I tested negative. I was sent how with Prednisone, they thought I was having an asthma flare. Once I got home from vacation, I called my doctor and went in, had x-rays done that showed I had pneumonia. I was treated with an antibiotic. Five days later I called the doctor to let her know I could not lay down and breath at the same time. She told me to go straight to the emergency room. The emergency room tested me for COVID-19, took x-rays, CT scan. I was admitted to the hospital with cavitary pneumonia. I stayed in the hospital for six days.
I started feeling cold and having chills, and later that evening about an hour later I developed a headache and it got worse mainly on my left side and it got worse like a pain I never had before.  I took 2 500 mg of Tylenol with my other meds and went to sleep.  I got really hot and knew I had a fever because I started sweating throughout the night.  When I got up the next morning I took my temperature and it was 100.6 which I knew it had broke by then.  I ended up going because by this time on Monday morning I had a fever of 99.9 and took more Tylenol, went about my day took more Tylenol and later that day I started having a small cough and yesterday the cough had got worse and was real tired like I was the day before.  Went to the clinic and they tested me for Flu and COVID-19 and it was positive and Flu was negative.  I was really in shock that I tested positive.  The PA gave me some Promethazine cough syrup and instructed for me to take over the counter meds.
fever, pain in legs, inability to walk; grandma (who has custody) reports episodes of shaking; sx began 3MAR93 approx 7AM ending 4MAR92 afternoon;
administering second dose who is 5 days early at day 21; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administering second dose who is 5 days early at day 21) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administering second dose who is 5 days early at day 21). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administering second dose who is 5 days early at day 21) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Flu like head and body aches, for 4 days. Tylenol and Advil, rest.
Patient  got 0.25ml ,  Per pts age should have gotten 0.5ml   Inform the recipient of the vaccine administration error. Follow the revaccination guidance in the table below, using an age-appropriate COVID19 vaccine product. Then continue with the recommended schedule of subsequent dose(s) unless For doses recommended to be repeated, some experts suggest delaying the repeat dose for 8 weeks after the invalid dose based on the potential for increased reactogenicity and the rare risk of myocarditis and pericarditis from an mRNA COVID-19 vaccine (i.e., Moderna or Pfizer-BioNTech) or Novavax COVID19 Vaccine, particularly in groups at increased risk for myocarditis and pericarditis (e.g., males ages 12 to 39 years).
Numbness in fingers and toes, body aches, major migrain causing a trip to ER to get a CT scan on head! Sunday 5pm was visit to ER migrain got worse as the day went on. Monday rested at home and tuesday morning woke up drenched in sweat and when i stood up my toes were all stuck upward and was getting muscle spasms from the knees down and right leg from the knee down went numb went to see Primary physician and requested to go to ER to get evaluated and an MRI that was Tuesday 10am
Liver function is very high; horrendous headaches; every bone and muscle in body aches; The patient was in bed for 4 days; lymphoedema; which made them really unwell; their immune system is very low; had two little hemorrhages in their eye; The patient has had double breast cancer this year and radiotherapy; Dose 1, Dose 2 AstraZeneca dose 3 Pfizer then Dose 3 and Dose 4 Moderna; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MDGB22-01054 (Moderna).  A 76-year-old female patient received BNT162b2 (BNT162B2), on 03Nov2021 as dose 3 (booster), single (Lot number: FH3220); coviD-19 vaccine nrvv ad (chadox1 ncov-19) (COVID-19 VACCINE ASTRAZENECA), on 04Feb2021 as dose 1, single (Batch/Lot number: unknown) and on 17Apr2021 as dose 2, single (Lot number: PV46671) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Apr2022 as dose 4 (booster), single (Lot number: 000074A) and on 18Oct2022 as dose 5 (booter), single (Lot number: 000074A) for covid-19 immunisation. The patient's relevant medical history included: "Radiotherapy", start date: 2022 (unspecified if ongoing). Concomitant medication(s) included: COCODAMOL. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 03Nov2021, outcome "unknown", described as "Dose 1, Dose 2 AstraZeneca dose 3 Pfizer then Dose 3 and Dose 4 Moderna"; BREAST CANCER (medically significant) with onset 2022, outcome "unknown", described as "The patient has had double breast cancer this year and radiotherapy"; EYE HAEMORRHAGE (medically significant), outcome "unknown", described as "had two little hemorrhages in their eye"; LIVER FUNCTION TEST ABNORMAL (non-serious), outcome "unknown", described as "Liver function is very high"; HEADACHE (non-serious), outcome "unknown", described as "horrendous headaches"; PAIN (non-serious), outcome "unknown", described as "every bone and muscle in body aches"; BEDRIDDEN (non-serious), outcome "unknown", described as "The patient was in bed for 4 days"; LYMPHOEDEMA (non-serious), outcome "unknown"; MALAISE (non-serious), outcome "unknown", described as "which made them really unwell"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "their immune system is very low". The patient underwent the following laboratory tests and procedures: Liver function test: very high.  No follow-up attempts are possible. No further information is expected.
Soreness, swelling at injection site , injection site hot to touch. Headache. Fever of 101
Patient given Pediatric dose of Pfizer. Child is 12. Patient is fine and no further action is needed. Patient is to receive age appropriate dose when 2nd dose is administered. Patients parent is made aware.
pregnant with my 4th child and due november 16th. 165  lbs My adverse event is directly related to incorrect administration. It was administered into the acromium area. I have a picture of where it was administered on my arm. Was very sore day of (felt different than what it usually feels after flu shot) and got worse. Currently in physical therapy, light duty at work, and awaiting ortho specialist consultation.
a month ago got a breakthrough COVID-19 infection; Lack of efficacy; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (a month ago got a breakthrough COVID-19 infection) and DRUG INEFFECTIVE (Lack of efficacy) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (a month ago got a breakthrough COVID-19 infection) and DRUG INEFFECTIVE (Lack of efficacy). At the time of the report, COVID-19 (a month ago got a breakthrough COVID-19 infection) and DRUG INEFFECTIVE (Lack of efficacy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: Negative.     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 informations were reported. No Treatment informations were reported.; Sender's Comments: This is a case of lack of efficacy of the vaccine with an associated adverse event of Covid-19, therefore causal association between this event is assessed as not applicable. Causality for the event drug ineffective is assessed as possible.  Further information has been requested.
Patient should have received original formulation for her 2nd dose, but received the bivalent instead.
Cold sensation and at night use extra covers like field jacket and blanket or socks help ease tingling. Never went away but seemed to mitigate tingle, but returning more. The numbness in right thigh top side above knee first occurred briefly Feb but returned in April stayed awhile and this fall it returned and stays longer than an hour, a few times 1/2 day and whole day.
Pt received a  dose of pediatric Moderna instead of a bivalent Moderna booster. No ill effects were reported.
Case number PHEH2015US023060, is an initial spontaneous report received from a pharmacist on 06 Nov 2015. This report refers to a 34 year old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515001) on 29 Oct 2015. On the following day after vaccination on 30 Oct 2015 the patient experienced fatigue and dizziness and it was getting progressively worse at the time of this report. Outcome of the event was reported as condition unchanged. Event was reported as non serious and causality was not reported.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # L035882 with expiration date: 19-APR-2017 and lot # L048680 with expiration date: 10-JUN-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 52.8 degrees Fahrenheit for 1 hour and 15 minutes. Data logger was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Mother called on 10/03/2013 to tell nurse that after vaccines given on 9/17/13, her daughter's left arm contracted and hurt from neck to fingertips and she was unable to move arm.  States pain continued and was taken to Dr., arm was placed in sling and consulted with Dr. and was diagnosed with "severed nerve".  Follow up from RN clinic coordinator:  still complains of moderate pain and tingling to left arm and numbness in left fingers.  MRI to be scheduled.  Taking pain medication around the clock and is affecting her daily activities.
Severe pain at injection site, nsaid pain reliever, pain subsided after about 2 days
This is a spontaneous report from a contactable consumer, the patient. A 84-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 11Oct2021 (at the age of 84-years-old) as a single dose for COVID-19 immunisation. Medical history included car accident that had resulted in two weeks in hospital and four weeks in rehabilitation at hospital. Concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 11Oct2021, the patient experienced pain and was unable to lie in bed due to aching in back. She also had low grade fever and pain in neck. Pain got worse at night or when she was lying down. The patient was weak and tired. She boicex more pain than her car accident. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of events and included treatment with ibuprofen (MANUFACTURER UNKNOWN) with minimal relief and oxycodone (MANUFACTURER UNKNOWN), one pill which was left from accident with moderate relief. The clinical outcome of the events pain, aching in back, low grade fever, pain in neck, weak and tired were not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
8pm- face got puffy, mostly around the nose. Itchy as well/seemed like a histamine reaction. Settled down after around an hour. Took screenshot selfie of face with phone. 10-13 days after shot- gums felt inflamed near base. On day 13 went to dentist and he said looked like an allergic reaction/irritation, not gingivitis, as not above teeth but near roof of mouth. Speculated could have reaction to shot in combination with toothpaste. (Evening of shot had chills/ache/low grade fever/head pains/nausea/diarrhea next morning. Took over the counter Tylenol).
I got flu vaccine 12/17. Bend of leg start hurting, back started hurting. Next day stomach started hurting, then but bones started hurting. Still hurting today 1/20/04. Hurts to sit, walk and stand.
About 14 hours after vaccination, I had a (really bad) pulsating headache in a band around my head, body aches (hip flexors, shoulders, back, neck), chills, fever/sweats, and nausea/vomiting (threw up twice, total, about an hour or two apart after not eating for 10 hours - small amount of liquid came up). The nausea/vomiting went away about 4 hours after onset while the other symptoms remained for an additional 42 hours. I also had sinus/eye pressure that began about 22 hours after vaccination and ended with the other symptoms. Could not sleep for the duration because of headache. Very tired/sleepy about 62 hours after injection and was able to nap since headache went away. I still have soreness at injection site about 72 hours after injection.  I would say the worst part of this was the headache because it was so bad, I couldn't sleep or do anything while I had it - I had read that NSAIDs might reduce the uptake of the vaccine so didn't want to take any. Therefore, there was no way to get rid of the headache and it was very unpleasant for almost 3 days. The next worst was the nausea/vomiting, because, well, nausea/vomiting, and especially because there was nothing to bring up. And, unlike vomiting from bad food or something, you don't really feel better afterward, just still nauseated. The other symptoms were more bearable. Did not call or see doctor because I had read about these possible side effects and didn't think there was anything the doctor could do to alleviate them.
Distal paresthesias involving upper and lower extremities. Not sure when this exactly started (~ week or so after flu vaccine). Started as mild tingling, but then spread through her leg. Neurology was involved, nerve conduction study performed. LP done was negative, MRI of the lumbar spine done supportive of diagnosis of Guillain Barre. Received IVIG x 4 days. Numbness and tingling did improve (started using a cane) and was referred to physical therapy as an outpatient.
Chief Complaint: Fever. Subjective: Patient has had a fever for the past one and a half days now, and mom also noticed a rash that seems to be spreading; this started last night. His temperature has maxed to 104. Parents have also noticed that his appetite has been decreased. He has been sleeping a lot more than usual and is less active than usual. He has had no vomiting and no diarrhea recently, although last week he did have diarrhea. He has had a cough and cold for the past two weeks. His runny nose actually has been worse and is thicker and greenish. He has been tugging his left ear and has been fussy. He just got over an ear infection during the first week of November. He had his immunizations 10 days ago. He received MMR, Varivax, and DTaP. The rash is blanching but does not appear to cause any discomfort or itching. Allergies: He has no known drug allergies. Objective: General: On exam, he is alert, in no acute distress. His temperature today is 98.4. Comfortable, playful. Skin: He has a maculopapular erythematous blanching rash scattered over his trunk and upper extremities. None on the palms or soles. HEENT: The right TM is mildly erythematous, otherwise normal light reflex and mobility. The left is bulging and opaque with absent landmarks. Eyes are not injected. No discharge. Nares with thick rhinorrhea. Oropharynx normal. No oral lesions. Neck: Supple. No Mass. Chest/Lungs: Clear to auscultation bilaterally. Heart: Regular rate and rhythm. No murmur. Abdomen: Soft and nontender. No hepatosplenomegaly. Assessment: Fever and rash, most likely secondary to MMR. He also has a concomitant prolonged upper respiratory infection, which could be sinusitis given the current fever. He also had a left otitis media.
No adverse event; Patient received Dose 1 on 04-Sep-2021 and Dose 2 on 05-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received Dose 1 on 04-Sep-2021 and Dose 2 on 05-Apr-2022) and NO ADVERSE EVENT (No adverse event) in an 81-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 002M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Apr-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 05-Apr-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received Dose 1 on 04-Sep-2021 and Dose 2 on 05-Apr-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received Dose 1 on 04-Sep-2021 and Dose 2 on 05-Apr-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received Dose 1 on 04-Sep-2021 and Dose 2 on 05-Apr-2022).    No concomitant medications were reported.  On 04-Sep-2021, the patient received first dose of Moderna COVID-19 Vaccine, Route: Intramuscular with batch/lot number: 037F21A. The dose / volume of first and second dose was reported as 0.5.  Treatment information was not provided.   This case was linked to MOD-2023-722198 (Patient Link).
Injection site of DTaP  hot, red, swollen on 1/7/04. Temp=98.0. Dx: cellulitis. Treatment: Keflex 500mg bid for 2 weeks.
arm soreness and focal hyperemia with diarrhea, starting the day of vaccination, and continuing at least until report date
Covid-19 given at 0845, @ 0855 client complained of left arm numbness and tingling on fingers. Provider onsite:  NP evaluated the client, advised to wait for another 15 minutes. @0932 per client she is feeling better. Provider onsite advised client to see her PMD if the reaction will get worse. Client left the clinic in Ambulatory stable condition.
Individual received vaccine on 12/29, on evening of 12/29, began complaining of left lower back pain. No activities  or history prior to lead to this pain. Awoke 12/30 with severe back pain to left lower back, unable to walk due to pain. C/o numbness and tingling to left foot. C/o "extreme fatigue." Symptoms improved significantly about 5p on 12/30.  On 12/31 complains of left lower back pain which has improved but still present.  Fatigue improved. Left foot numbness and tingling resolved.
Narrative:  COVID infection following COVID vaccine series 0109/, Pfizer, dose #1 01/30 , Pfizer, dose #2 08/23 COVID swab, result: detected 08/19 pt cc: chills, cough, diarrhea fever, headache, loss of taste or smell, myalgias, rhinorrhea exposure: unknown 08/23 SARS-COV-2 Variant Sequencing result: pending
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 12/23/20pfizer,Lot#EK9231 2nd dose: 01/12/21Pfizer,Lot# EL3248 Diagnosed covid positive:08/09/21 Symptom onset:08/06/21 Exposure:Work Symptoms:Nasal congestion, sneezing
Hep A vaccine was expired. Expiration date was 7-26-2020, immunization given on 7-27-2020.
Fever, chills, followed by gross hematuria, nausea and vomiting (possible infection).