chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dx sz, back arched, eyes rolled back in head, tongue hanging out, pale blue in color-parent shook & pt seemed to recover-rt side of face droopy, rt side arm, legs did not want to work;sz occurred multiple times & cont;
Given 0.3 ML dose for 12 and older.  Dose for 5-11yrs is 0.2 ml
on 3/25/06 i began having severe chills, fever, headache which have continued at varying degress of seriouness.  on 3/28 i went to the emergency room and a took blood tests and a had head catscan due to my headaches.  i called in sick for work on 3/29 for a 3 day rotaion of flying (i am a flight attendant) due to my 101.6 fever.
Patient was administered only liquid component; Patient was administered only liquid component; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 22-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAX641A, expiry date 30th June 2023) for prophylaxis.   On 22nd April 2022, the patient received Menveo. On 22nd April 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 22-APR-2022  Reporter's Comments: Physician assistant reported on the day of reporting, that the patient was administered with conjugate vaccine liquid component without the meningococcal A lyophilized conjugate vaccine component. It was accidentally forgot to ask for follow up. Additional Supportive Information: The patient received only liquid component of Menveo which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Four patients received vaccine that was left out room temperature for over 12 hours after being punctured; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Four patients received vaccine that was left out room temperature for over 12 hours after being punctured) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Four patients received vaccine that was left out room temperature for over 12 hours after being punctured). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Four patients received vaccine that was left out room temperature for over 12 hours after being punctured) had resolved.        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 relevant concomitant medications were reported. No treatment information was provided.
Patient had seizure event minutes after administration. Staff immediately called 911. Fire truck and ambulance arrived within minutes. Pharmacist attempted to administer epinephrine but failed.   Seizure event lasted for approximately 30 seconds. Patient passed out but regained consciousness within a few seconds. Once patient regained consciousness, staff questioned patient about his whereabouts. Patient was able to answer questions about his name, date of birth and whereabouts.
12/22/11 2 yr old in for check up administered INFLUENZA vaccine 0.25 IM RT - 5 hours later father heard noise & went to infants crib child "gasping for air" eyes rolled upward. EMS to ED - Dx croup.
Red rash on both arms with some itching started approximately 1 hour post immunization. Patient took diphenhydramine orally. She called MD. MD called in prednisone but said MD said it did not sound too severe that she may not need to take the prednisone.
This spontaneous report was received from a physician via company representative and refers to a patient of unknown age and gender. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On 29-JUN-2015, the patient was vaccinated with an expired dose of M-M-R II, subcutaneously, (batch# J006139, lot # 1684AA, expiration date 17-APR-2015) (dose and indication were not reported). No known adverse effects were reported. Additional information has been requested.
Elderly to inpatient [Pt here with history of dementia. Very weak, had fever on EMS arrival. Some viral URI symptoms as well.]  Bivalent boost 10/2022
right inside armpit, had large lymphnode last week, it is now smaller. Then new large behind lymphnode behind left ear started two days ago, today small lymphnode on left side neck 4 inch; This is a spontaneous report from a contactable Other HCP. This 51-year-old non-pregnant female patient/ Other HCP reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date in Jan2021 at 02:00 PM in right arm as dose 1, single for COVID-19 immunization. The medical history of the patient included allergy to chemicals, was overweight, neck and back injury, gout and neck and back injury. It was mentioned that patient did not receive other vaccine in four week and was prescribed other medications in two weeks. The patient did not have covid prior vaccination and was not tested for covid post vaccination. On an unknown date in Jan2021 the patient experienced right inside armpit, had large lymphnode last week, it was now smaller. Then new large behind lymphnode behind left ear started two days ago, today small lymphnode on left side neck 4 inch below the left ear (lymphadenopathy). It was unknown if any treatment was received. The patient had not recovered.  Information about Batch/Lot number has been requested.
On 24th onset of severe pain on trigeminal nerve and fever of up to 101. Continued through 25th, went to Urgent care on 26th. Started on prednisone. Assumed just a trigeminal flare up. Then blisters erupted on gum and roof of mouth on 27th making it clear it was shingles. Started on antiviral (valtrex) that day. I had chicken pox as an adult in my mid 20s and have had two bouts of shingles before this. This was the worst by far. I had the first dose of Shingrex about 2 years before vaccination. Was also given antibiotic on 26th, which I did not take as the doctor said not to as long as it appeared viral. Which it turned out to definitely be. My GP on my visit today said to use the form here to report this.
HAD DIFFICULTY INJECTING THE ZOSTAVAX VACCINE INTO HER LEFT ARM....HAD TO REMOVE NEEDLE, REPLACE WITH DIFFERENT NEEDLE, AND POKE AGAIN...THIS HAPPENED 3 MORE TIMES IN LEFT ARM...ON FIFTH TRY, INJECTED INTO HER RIGHT ARM, SAME PROBLEM..0.04ML OF VACCINE REMAINED.
Redness in both arms and pain that kept her up all night. Went to ER and was put on anitbiotics (clindamycin 150mg).
3/13 (4pm):  disordered thinking, confusion, "something is going to happen". 3/14 (3am): "something is not right". Confused, disturbed thoughts. (5pm): grand mal seizure, 911 to hostpital, Admitted. 2nd seizure 8pm. Treated with keppra IV and kept 3 days.  MRI, CT, EKG, EEG all within normal range.  No indication of heart issues. Discharged 3/17 with keppra prescription (2 AM/2 PM). Increased "absence" seizures - confusion, unable to verablize but was aware of issues. Diagnosed UTI. Treated with antibiotics, additional anti-convulsent (trileptal) added. UTI resolved. Added Remeron at follow-up. Keppra and trileptal have since been reduced but not eliminated. Follow-up in October. No grand mal seizures since 3/15, and no absence seizures since 3/29.  Over time, keppra and trileptal have been reduced. No prior seizure history in patient, or family. No history of epilepsy in patient or family.
Sore mouth; Rash on the injection site; Pain at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of ORAL PAIN (Sore mouth), VACCINATION SITE PAIN (Pain at the site of injection) and VACCINATION SITE RASH (Rash on the injection site) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at the site of injection). In April 2021, the patient experienced ORAL PAIN (Sore mouth) and VACCINATION SITE RASH (Rash on the injection site). At the time of the report, ORAL PAIN (Sore mouth) and VACCINATION SITE RASH (Rash on the injection site) outcome was unknown and VACCINATION SITE PAIN (Pain at the site of injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Left arm has been sore, painful, and slightly numb since vaccination. General malaise and extended but mild flu symptoms.
immed p/vax pt felt faint; when got home was nauseated & vomited some-felt like somebody "beat me up" has felt tired since yesterday; feels like flu; sleepy all the time-last noc had rash on lt arm where got inj; arms feel achy, nasal drain
12:37 pm Patient complaint of numbness, tingling and edema in left upper extremity. Denies pain. BP 132/80 P 67 R 18 O2 97%. Denies shortness of breath.  Reports history of COPD and allergies. Did not take Zyrtec today. Capillary refill under 3 seconds.  Left arm elevated x 30 minutes. Reassessment patient reports decreased symptoms. Refuses to seek medical treatment. States she will take Zyrtec once home. 1309 pm BP 124/78 P 67 R 18 O2 97%. Departed from clinic.
I had body aches and fever for about day. I tested positive for COVID-19 on 12/14/2022. I had scratchy throat and body aches, and I was sick for a good two weeks. I didn't really start feeling better until 03/2023. I am glad I did have the vaccines as I can't imagine how I would have been without them. I contacted a medical provider and got the prescription for PAXLOVID. It left a terrible taste in my mouth.
Chills, felt achy, irritation and discomfort of right deltoid, low grade temperature, redness around injection area.
Swelling on the same arm, neck and shoulder that she got the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling on the same arm, neck and shoulder that she got the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced SWELLING (Swelling on the same arm, neck and shoulder that she got the vaccine). At the time of the report, SWELLING (Swelling on the same arm, neck and shoulder that she got the vaccine) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
7min after shot Swelling of face, numbness in lips, difficulty breathing,  felt lump in throat, and faint feeling
Exactly one week after the shot, I got a bit of covid arm meaning the injection site was visibly red but there was no swelling or itching. Now, starting yesterday, I am dealing with all-over body hives. Yesterday much of my neck was swollen and bright red. Today my hands are swollen and bright red with hives elsewhere on my body. I?ve been taking Benadryl.
Information has been received from a certified medical assistant (CMA) concerning her 63 year old mother who approximately three weeks priori to this report in about February 2006, was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. On an unspecified date after vaccination, the patient experienced a rash on her forearm. Unspecified medical attention was sought. There was no information regarding outcome at the time of this report. Additional information has been requested.
Bodily aches and pains, Fatigue, Lightheadedness,  Fever, Acute and extreme weakness (Rushed to Hospital) Dehydration
Mother called office 2 hrs after vaccinations were given. Child had hive- like rash on legs and abdomen. Instructed to give antihistamine.
none.         This child did not have any adverse effects that have been reported, the vaccine had expired on 4/5/2008 and it was given on 4/24/2008. This dose will be repeated in 30 days. Our state immunization coordinator instructed me to complete this report
Received influenza vaccine-2003 on 11/04/2003 at 09:00.  Noticed he was breaking out with a rash to arms by around 16:00.  On 11/04/2003, continued to break out with rash to arms, trunk and legs.  Rash pinpoint raised and red.  Also complained of rash being itchy.  Seen at medical center on 11/06/2003 by MD and advised to take Benadryl 50mg, every 4 hours as needed and to return for re-check on 11/07/2003.  Does state he had a cold about 1 week ago which is almost gone.
Moderna COVID-19 Vaccine EUA  Allergic reaction got hot and really red and red dotes on my chest and itchy  Benadry , Famotidine ,methyIPEDBISOLONE
5 year old male patient was having trouble being willing to receive vaccine. It took multiple attempts as child was moving around and refusing to be stuck during the time of admin. There was some light bleeding and bruising related to attempts.
approx 2-3 days post vaccine, started having diarrhea and rhinorrhea.  The developed some abd pain (different than his usual pain).  Followed by frequent vomiting leading to his emergency department visit today.
Pfizer  7 hrs afterward had pulse rate up to 153, elevated bp- went to er
Just after receiving vaccine client c/o of feeling "weird and now everything is going black." Client lost consciousness momentarily for approximately 15 seconds and then was pale, nauseated and lightheaded after that.  Used cold gel pack on back of client's neck and forehead and client took sips of cold water. Client was sitting in chair leaning against her mother and supported by the nurse during episode. After approximately 20 minutes child recovered completely and left with mother.
ED to Hosp-Admission Discharged 8/30/2021 - 9/1/2021 (2 days) Hospital   Hospital Problems -     * (Principal) COVID-19,   Pneumonia due to COVID-19 virus, Hyponatremia, Chronic obstructive pulmonary disease   Chief Complaint Patient presents with ? Shortness of Breath   Patient is an 85 y.o. female.   Past medical history of COPD hypertension history of breast cancer and nodules presented with cough shortness of breath last 3 to 4 days.  Patient went to primary care physician for cough for sore throat low-grade fevers and shortness of breath since few days.  Complains of sore throat pain on coughing 3 but intensity sharp in nature increase in coughing no relieving factors.  Complains of low-grade fevers and chills and generalized weakness, complains of associated shortness of breath on exertion and coughing denies any PND orthopnea has chronic lower extremity edema.   Patient has history of COPD on 2 L oxygen at home on inhalers sees a pulmonologist  Patient on HCTZ stable History of lung nodules refusing biopsy   In the emergency room chest x-ray negative for infiltrate subcutaneous breast shadows initially was hypoxic when she came in but improved with 2 L, EKG sinus rhythm CBC normal BMP showed hyponatremia sodium levels of 124   Review of Systems  Constitutional: Positive for fatigue and fever. Negative for activity change and appetite change.  HENT: Negative.  Negative for congestion, dental problem and drooling.   Eyes: Negative.   Respiratory: Positive for cough and shortness of breath. Negative for apnea, choking, chest tightness, wheezing and stridor.   Cardiovascular: Negative for chest pain, palpitations and leg swelling.  Gastrointestinal: Negative.   Endocrine: Negative.   Genitourinary: Negative.   Musculoskeletal: Negative.   Skin: Negative.   Allergic/Immunologic: Negative.   Neurological: Positive for weakness. Negative for seizures, syncope, speech difficulty, light-headedness and numbness.  Hematological: Negative.   Psychiatric/Behavioral: Negative.  The patient is not hyperactive.
Fevers with a Tmax of 102; Chills; Conjunctivitis; Stocking glove rash to the hands and feet; C-reactive protein increased; Ejection fraction decreased; Red blood cell sedimentation rate increased; Tongue eruption; Troponin I increased; White blood cell count increased; Respiratory Viral Panel; Brain natriuretic peptide; This is a spontaneous report from a non contactable consumer, reports were pulled from the FDA VAERS site by a Pfizer Colleague. The consumer reported for a 17-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: none, Expiry Date: not reported),via intramuscular on an unknown site on 26Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route on an unspecified date as dose 1, single for covid-19 immunisation. Patient presented 4 days after the start of symptoms, which started 14 days after the second dose of the vaccine. Patient presented with fevers with a Tmax of 102, chills, conjunctivitis, stocking glove rash to the hands and feet, C-reactive protein increased, ejection fraction decreased, red blood cell sedimentation rate increased, tongue eruption, troponin I increased, white blood cell count increased, respiratory viral panel, brain natriuretic peptide on an unknown date in 2021. The patient was hospitalized for 3 days due to all events on an unspecified date and all events were considered as life-threatening. The patient did not visit emergency room or physician office. The patient underwent lab tests and procedures on an unspecified date in 2021 which included body temperature: 102, brain natriuretic peptide: unknown, c-reactive protein: increased, ejection fraction: decreased, red blood cell sedimentation rate: increased, respiratory viral panel: unknown, sars-cov-2 test: negative, troponin i: increased, white blood cell count: increased. The outcome of all event was recovered on unspecified date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccination Administration error.  Team lean diluted gray top Pfizer with diluent and administer the diluted Pfizer vaccine to the Client.
pt recv vax & devel chicken pox 1-2 wk later;no complications;
undiluted Hib portion of Pentacel was in their office, and the corresponding DTaP-IPV diluent was missing, Nurse presumes a patient was given the diluent alone, no AE; Initial information received on 27-Jul-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a patient (age and gender not reported) who received a 0.5 mL dose of only diluent component of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ217AAA, expiry date 06-Apr-2021 via an unknown route at an unknown administration site) as prophylactic vaccination on an unknown date (product preparation issue).   The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to inappropriate reconstitution technique.  It was reported that undiluted Hib portion of Pentacel was in their office, and the corresponding DTaP-IPV diluent was missing. Nurse presumed a patient was given the diluent alone, does not know which particular patient was involved because it has been a very busy Monday at their office.   At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report was received from a registered nurse and refers to a multiple unspecified patients of an 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 GARDASIL 9 lot # N007931 with an expiration date 17-NOV-2019 and lot# N009173 with an expiration date 20-NOV-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of GARDASIL 9 experienced the temperature excursion of 26 degrees Celsius for 1 hour and 43 minutes. There was previous excursions reported from 9 degrees Celsius to 25 degrees Celsius for 2 hours and 33 minutes and for 3 hours and 48 minutes. Data logger was involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1710USA001676.
Inj. site sensitivity, red, swollen, hot to touch, hard, size of a nickel.
Approximately 7-10 minutes after the injection I felt my tongue start to swell and get itchy, lips tingle and throat started to feel swollen when I swallow.  My eyesight is strained a bit and hearing feels liked by ears are cupped.   My lower back, buttocks and legs feel exhausted.       *Same reaction when I received Covid vaccine.   ** Did not have this reaction last year to influenza vaccine.
Around 10 Days after his first shot he developed an erythematous patch on his R forehead measuring about a 1.5cmx1.8cm. A few days after that he developed a similar sized lesion on his R anterior shoulder with a similar appearance. The patch was erythematous, not really raised, not pruritic, painful or otherwise. This was not very concerning. However about 4 days after getting his second dose similar erythematous lesions erupted diffusely over his entire back and shoulders, some on his neck as well as medial R upper arm. Lesions were similar in color and appearance to his original lesions but smaller all measuring <1cm^2 in no particular pattern. This prompted his physician to give a topical antifungal body wash. At the time pt also requested treatment for his face and body acne and was treated with doxycycline which had worked well for him previously. For the following 5 days (9 days after the 2nd dose) he used the antifungal 3x and the rash began to fade. Today 3/8/21 the rash is very faint but still visible in fluorescent light how
Pt vaccinated with DTP/OPV experienced high pitch cry for 3 day after DTP administered.
Dose 1 was given on 1/22/2021.  This second dose of Covid Vaccine was inadvertently administered only 14 days after dose 1
After administering vaccine, patient passed out. After being eased to floor body became stiff and head twitched slightly. Patient was given fluids by mouth and crackers. Patient sent home.
approx 8hr p/vax pt had fussy spell then became limp, eyes rolled back & noted perioral cyanosis;woke up had similar episode 5min later;
Angioedema  injection site erythema and warmth  Narrative:  left arm hot to touch and spread from place of injection to left forearm then lips and tongue swollen and tingly