chrisvoncsefalvay/vaers-outcomes huggingface dataset:
first dose on 17Sep2021 second on 24Feb2022; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 18-month-old female patient who received HAV (Havrix) (batch number YG7YJ, expiry date 3rd February 2023) for prophylaxis.   Previously administered products included Havrix (received 1st dose of Havrix on 17th September 2021 from batch number CE74N with expiry date 19th March 2022).   On 24th February 2022, the patient received the 2nd dose of Havrix. On 24th February 2022, unknown after receiving Havrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were reported as follows: The nurse reported that patient received second dose of Havrix earlier than recommended, which led to shortening of vaccination schedule. The reporter consented to follow up.
Per Dr.'s office representative:  Tremors/shaking (Parkinson-like) that began within one hour of vaccine administration.
Pfizer-BioNTech COVID-19 Vaccine Patient received 2nd dose of vaccine on 1/6/2021.  Was sick the following 5 days with fever, dizziness, chills, severe malaise, and mild cough.  Symptoms subsided after 5 days and rash developed from back of head, down the neck, back, chest, arms and hip.  The rash progress over the last few weeks and it became extremely itchy and dispersing throughout the body.  Saw Dermatologist and he said it was systemic reaction from the vaccine
Menstrual cycle is more frequent, heavier, and painful.  Migraines are associated with my cycle so everything is very heightened.  Chronic fatigue.
The next morning, I woke up and wanted to get out of bed, but I was dizzy, I had to hold on furniture to walk around the house, I called my NP and advised me to go to the ER, I went to the ER on 04/05/2021 and I had MRI and lab work but everything came back normal. Was released that same day and I wasn't given any medications I was told I had vertigo and suggested me to see a Neurologist, which I did but Neurologist did not find anything neither. By the following Monday I was fine.
patient was accidentally given a Pfizer Covid Vaccine instead of a flu shot by a vaccinating certified pharmacy technician. Patient was then given the correct shot which was Afluria Quad PF flu shot.  Patient did not experience any adverse effects to my knowledge. Patient has previously completed his 2 doses of Covid vaccine a little over a month previous to this. This event resulted in the patient getting a 3rd dose of Pfizer covid vaccine. Pt was told to wait 30 minutes for observation. Patient's mother called his doctor to discuss what possible adverse effects to watch out for.
LOW GRADE FEVER; BODY ACHES; 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, intramuscular and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, start therapy date was not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAR-2021, the subject experienced low grade fever. On 09-MAR-2021, the subject experienced body aches. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the low grade fever and body aches was not reported. This report was non-serious.
Pt reports pain to anterior head occurring suddenly a few minutes after receiving vaccine. Describes pain as constant, but states, "I think it's related to my seasonal allergies and I haven't been around people much because I'm scared of COVID." Pt states she took a xanax but it hasn't kicked in yet. VS at 1432: BP 147/70, HR 53, RR 20, O2 sat 96% on RA. Pt reports she is bradycardic at baseline. VS at 1445: BP 116/75, HR 53, RR 18, O2 sat 97% on RA. VS at 1500: BP 130/75, HR 52, RR 18, O2 sat 98% on RA. VSS at time of discharge. No s/s of distress noted. Pt escorted to exit via w/c per protocol.
Always thirsty; Hyperglycemia; Urinary Tract Infection; Chills; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), HYPERGLYCAEMIA (Hyperglycemia), URINARY TRACT INFECTION (Urinary Tract Infection), THIRST (Always thirsty) and CHILLS (Chills) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness) and CHILLS (Chills). On 31-Mar-2021, the patient experienced HYPERGLYCAEMIA (Hyperglycemia) and URINARY TRACT INFECTION (Urinary Tract Infection). On an unknown date, the patient experienced THIRST (Always thirsty). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm soreness), HYPERGLYCAEMIA (Hyperglycemia), URINARY TRACT INFECTION (Urinary Tract Infection), THIRST (Always thirsty) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications also include d an antibiotic.
Have the Pfizer vaccine just tested positive for COVID-19 last night.; Have the Pfizer vaccine just tested positive for COVID-19 last night.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 6-year-old female patient received BNT162b2 (BNT162B2), on 10Nov2021 as dose 1, single (Lot number: FK5127), in arm, on 01Dec2021 as dose 2, single (Lot number: FL0007), in arm and on 09Jun2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 6 years, in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Sep2022, outcome "unknown" and all described as "Have the Pfizer vaccine just tested positive for COVID-19 last night.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Sep2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical information: Reporter was a Pfizer employee and she was trying to report on the website and just could not. Her two kids who have the Pfizer vaccine just tested positive for COVID-19 last night. Her children received two dose plus a booster. Her Husband also tested positive and he had received the Pfizer booster. Reporter confirmed she was reporting on her children and husband.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This literature marketed report as received from a physician refers to a 12 years old male patient. Patient's past medical history was remarkable for DiGeorge syndrome, repaired Tetralogy of Fallot and juvenile idiopathic arthritis diagnosed at 15 months of age, which had been controlled for the past 5 years with weekly injections of the tumor necrosis factor inhibitor etanercept. On an unknown date ten days earlier, the patient was inadvertently vaccinated with MMR (Manufacturer unknown) and VARIVAX (Merck) (Manufacturer unknown), during a well-child visit. With the exception of live virus vaccines, he was otherwise up-to-date with his immunizations. On an unknown date, the patient was admitted to hospital with a 2-day history of tactile fevers, sore throat, rash and conjunctivitis. After he developed the tactile fevers his mother held further doses of etanercept, and he was directly admitted to the hospital. On admission, he was afebrile and appeared well. His examination was remarkable for mild conjunctivitis, palatal petechiae with posterior pharyngeal erythema and a blanching morbilliform rash that was present behind the ears, on the face, neck, back, chest and limbs. Mild post auricular cervical lymphadenopathy was present. There were no Koplik spots or vesicular lesions. Due to the possibility of an atypical varicella rash in a patient on a biologic immunomodulatory medication, intravenous acyclovir was initiated. Both urine and skin samples were positive in triplicate for measles virus by reverse transcription polymerase chain reaction with 100% matched identity. He had recently undergone immune evaluation with a lymphocyte count of 1100 x 109 cells/L, of which the lymphocyte subsets were normal. The lymphocyte mitogen and antigen studies included low normal responses to Candida and phytohemagglutinin and normal responses to tetanus, concanavalin A and pokeweed mitogen. Antibody titers to prior inactivated vaccines were normal. The outcome of tactile fever was unknown. The author stated that although excretion of measles virus in his urine enabled detection and sequencing of the virus as a measles vaccine strain, the diagnosis of vaccine-associated disease was determined from the skin scrapings. Measles virus is present in the skin rash during illness; however, to our knowledge, this is the first reported measles vaccine case in which the vaccine strain was detected and genotyped from the skin rash. Additional information has been requested.
fatigue; loss of appetite; headache; diarrhea; nausea; vomiting; dizziness; muscle pain; tingling in hands and feet; fever; fast heartrate; hot; cold; tremors; weakness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), DECREASED APPETITE (loss of appetite), HEADACHE (headache), DIARRHOEA (diarrhea) and NAUSEA (nausea) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced FATIGUE (fatigue), DECREASED APPETITE (loss of appetite), HEADACHE (headache), DIARRHOEA (diarrhea), NAUSEA (nausea), VOMITING (vomiting), DIZZINESS (dizziness), MYALGIA (muscle pain), PARAESTHESIA (tingling in hands and feet), PYREXIA (fever), TACHYCARDIA (fast heartrate), FEELING HOT (hot), NASOPHARYNGITIS (cold), TREMOR (tremors) and ASTHENIA (weakness). At the time of the report, FATIGUE (fatigue), DECREASED APPETITE (loss of appetite), HEADACHE (headache), DIARRHOEA (diarrhea), NAUSEA (nausea), VOMITING (vomiting), DIZZINESS (dizziness), MYALGIA (muscle pain), PARAESTHESIA (tingling in hands and feet), PYREXIA (fever), TACHYCARDIA (fast heartrate), FEELING HOT (hot), NASOPHARYNGITIS (cold), TREMOR (tremors) and ASTHENIA (weakness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
tested positive for COVID-19; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (tested positive for COVID-19) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (tested positive for COVID-19). At the time of the report, COVID-19 (tested positive for COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Pt broke out in a rash on both R/L upper arms. Pt was prescribed meds by provider and released. Advised to return if any more outbreaks.
First Moderna vaccine (lot number 029L20A, left arm ) on 1/30 with no immediate reaction other than a metallic taste in my mouth for 12-14 hrs.  Second vaccination scheduled for 2/29. On, 2/6, 7 days after the vaccine, the arm that received the Covid became tender, red, hard, swelling, very warm to the touch, metallic taste again.  The raised area was about 2" in diameter.
Starting around 8:00 PM on day of vaccination; Fever of 102.8 F for 6+ hours that was refractory to ibuprofen. Projectile vomiting, chills, and body aches.
I have had left shoulder pain with certain movements since receiving the flu vaccine.  I am unable to raise my left arm over my head and can not rotate my hand into the supinate position.
PATIENT COMPLAINED OF HAVING SEVERE ARM PAIN (WOKE HIM OUT OF HIS SLEEP); DIZZINESS, FREQUENT URINATION (6 TIMES BETWEEN 10:30PM AND 6:30AM WITH FULL BLADDER EACH TIME), AND FAINTING (ONCE AT 6:30AM THE MORNING AFTER RECEIVING THE VACCINE-PT SAID HE HIT HIS FACE ON THE WALL FIXTURES AS HE FELL). SAID HE WAS STILL FEELING WEAK AND A LITTLE DIZZY AT THE TIME OF THE REPORT/COMPLAINT (NOON 9/11/20). HE WAS INSTRUCTED TO IMMEDIATELY SEE A PHYSICIAN.
After I felt fine, the next day I had a general sense of feeling unwell until that night my arm felt puffy. The third day I woke up and my arm had a hard red spot at the injection site, that was very hot to the touch. From there, my arm became inflamed/ puffy, I had a clear, regular temp spot of about an inch, below that I had hives that were also hot. I was rather nauseous through out that day, felt very hot, and had a recurrent migraine.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2022 at 12:37 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In December 2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date). On 28-Feb-2022 at 12:37 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  This vaccine was administered up until its manufacturer expiry date of 04-Apr-2022.  No treatment medications were provided.
Client vaccinated for Covid 19 Moderna - February and March 2021. Admitted to hospital 8/22/2021 with worsening Covid symptoms - fever, SOB, encephalopathy, hypoxia - required 5-6L O2. On IV steroids. Monoclonal antibodies given 8/17/2021. Decadron, Lovenox. Again admitted to hospital 8/31/2021 with Covid 19 pneumonia, already on telemetry health, prednisone, doxycycline. Submitter does not have access to full medical record on this case.
p/receiving a dose of Influenza virus vax, pt noted atrophy @ the inject site for quite some time; Chronic inflammation of the muscle was also found @ the inject site;
I contracted COVID-19 after my fifth dose vaccine.  It started with a really bad sore throat, amongst the worst I have had, I also had fever over 101 degrees. The fever lasted 3-4 days. I had slight nasal congestion, severe fatigue which lasted for four days. I also lost my sense of smell on the third day, lasting about 6 weeks until I got it fully back. I took an at home COVID-19 Test on 02/24/2023 which was positive. I have recovered from my symptoms.
Received my 2nd moderna vaccine on 2 3 2021 at approximately 940am. At approximately 11pm I woke up with severe freezing cold chills, shaking, generalized pain of 10/10 scale. This lasted to its severity until about 630am on 2 4 21. The symptoms are still present but the severity noted improved with 1000mg of acetaminophen.
injected an expired vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 7-year-old patient who received HAV (Havrix) (batch number T57F3, expiry date 16-FEB-2023) for prophylaxis.   On 01-APR-2023, the patient received Havrix. On 01-APR-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: injected an expired vaccine). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-APR-2023 The adverse event was left via voicemail. Pharmacist did not provide date of birth, address, lot number, or expiration date of product. Registered Pharmacist provided the expiration and slight details and their contact for follow-up. It was reported that they had expired Havrix vaccine that was injected into a child. It was Havrix, NDC 58160-0825-52. They needed the directive if they should repeat the shot or wait for a while for a 7-year-old, or it was still a good enough product to count.  Pharmacist provided the patient and vaccine details. The reporter did not consent to follow-up. The patient received a Havrix vaccine which was already expired, which led to expired vaccine used.
pale red polycyclic macular erythema; over entire body 4 wks p/HEP B vax; w/pruritis; tx w/DPH;
Vaccine administered intradermal instead of subcutaneous. Patient has a history of keloid formation. No reactions at this time.
No symptoms with 1st shot on 3/23 2nd shot on 4/21 - symptoms began the next day - sore arm and hot flashes at first.  Then around noon, I got body aches, low grade fever and my head felt like a bowling ball on top of my shoulders.  Took Tylenol and taking a nap.
1 wk p/vax pt devel high fever highest t104; fever up & down for about a week; MD visit made pt had no other s&s;
Patient reported she had cellulitis at the injection site one day after receiving the injection. She visited her doctor which prescribed an antibiotic course which did effectively treat.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Oct2021 as dose 3 booster, single (Lot number: FF2589) at the age of 48 years, in left arm for Covid-19 immunization; 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 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: Zyrtec [Cetirizine Hydrochloride], start date: 01Jan2020, stop date: 11Jun2022, also reported as other medication in 2 weeks. Past drug history included: Tetracycline, reaction(s): "drug allergy"; NSAIDS, reaction(s): "drug allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "BNT162B2: Pfizer/BioNTech: Patient Drug Start date 07Oct2021; Proprietary medicinal product name: Paxlovid". Therapeutic measures were taken as a result of drug ineffective, Covid-19 included Paxlovid started from 06Jun2022 and stopped on 10Jun2022. Clinical course was reported as, Patient experienced symptoms of Blurry vision, Small amount of bleed in stools, Dizziness, Facial rashes and Limbs itchy on 07Jun2022, No treatment received as result of symptoms and outcome of symptoms was unknown.
gave a full dose (0.5ml) for the booster instead of the half dose (0.25ml) to a non-immunocompromised patient; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (gave a full dose (0.5ml) for the booster instead of the half dose (0.25ml) to a non-immunocompromised patient) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (gave a full dose (0.5ml) for the booster instead of the half dose (0.25ml) to a non-immunocompromised patient). On 19-Nov-2021, PRODUCT ADMINISTRATION ERROR (gave a full dose (0.5ml) for the booster instead of the half dose (0.25ml) to a non-immunocompromised patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.  Pharmacist stated that they accidentally gave a full booster dose (0.5ml) instead of the half dose (0.25ml) to a  patient who is not immunocompromised. The patient got the primary series of the Moderna Covid-19 Vaccine around January 2021 time period.
Myalgia, Fever, CoughWheeze, chills, cough Narrative:
Pt felt weak, nausea, dizziness 1/2 hour with vaccine. She ate a meal, vomited, then felt dizzy and weak. I had her lay down 1/2 hour. Pt felt better wanted to leave, she then started to walk. I accompanied her. She fainted second time. Discharged at 9 PM from ER with diagnosis of anemia and dehydration.
pt fell over & hit head became unconscious for about 1min;this happened about 20min p/vax;no c/o SOB, itching or redness @ site;noted rash;VS nl when ambulance came;BP 110/78, P18;
Developed varicella-like rash on 09/05/2004 after younger brother received varicella immunization on 08/25/2004.