chrisvoncsefalvay/vaers-outcomes huggingface dataset:
never came back for the second dose within the recommended dosing schedul; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 48-year-old female patient who received HBV (Engerix B adult) for prophylaxis.   Previously administered products included Engerix B adult (received first dose on 5th December 2022 of batch number NT9X3 and expiry date 9th September 2024).   On an unknown date, the patient did not receive the 2nd dose of Engerix B adult. On an unknown date, an unknown time after receiving Engerix B adult, the patient experienced incomplete course of vaccination (Verbatim: never came back for the second dose within the recommended dosing schedul). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 6-Jun-2023 The pharmacist called to inquired that how to proceed. The patient never came back for the second dose within the recommended dosing schedule. The reporter asked that any guidance. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive the second dose of Engerix-B adult, which led to incomplete course of vaccination.
INCREASED PAIN; HEADACHE; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (INCREASED PAIN) and HEADACHE (HEADACHE) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product (HUMIRA) for Psoriatic arthritis.    Previously administered products included for Drug use for unknown indication: AMOXICILLIN, CEPHALOSPORIN NOS and CARBAMAZEPINE. Past adverse reactions to the above products included No adverse event with AMOXICILLIN, CARBAMAZEPINE and CEPHALOSPORIN NOS. Concurrent medical conditions included Sulfonamide allergy (SULFA ALLERGY), Allergy to antibiotic (CEPHALOSPORIN ALLERGY), Allergy to antibiotic (AMOXICILLIN) and Drug allergy (CARBAMAZEPINE). Concomitant products included DIPHENHYDRAMINE, FUROSEMIDE, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HYDROCHLOROTHIAZIDE ACTAVIS), METFORMIN, PREDNISONE, PRENATAL + DHA, LANSOPRAZOLE (PREVACID), MONTELUKAST SODIUM (SINGULAIR), VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]), VITAMIN D2 and POTASSIUM for an unknown indication.   In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jun-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. 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. In 2021, the patient experienced HEADACHE (HEADACHE). In October 2021, the patient experienced PAIN (INCREASED PAIN). At the time of the report, PAIN (INCREASED PAIN) and HEADACHE (HEADACHE) outcome was unknown.            The reporters causality for the events of INCREASED PAIN BELIEVED RELATED TO BOOSTER VACCINE and HEADACHE was not provided.  No treatment medication were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna
Employee reports she began having pain at the injection site approximately one hour after the vaccine was administered. She stated that the pain continued through out the day (pain is described as soreness), and into the night. She further stated that the pain woke her up twice during the night, and upon waking up this morning she noticed that the injection site area was red and swollen.
fever, body aches, muscle aches, fatigue, rash on inner arms, skin sensitive to the touch, headaches.  Unable to do anything for 2+ days.  This is the most extreme reaction I've ever had to a vaccine; it's worse than having the flu.  The nurse who administered the shots said there would be unlikely to be any reaction.
Patient passed out approximately 10 mins after receiving 1st Pfizer Pediatric vaccine. Patient regained consciousness within 45 seconds, appeared clammy and pale, ice packs were applied to forehead and neck.
Admit Date:  7/28/2022   Discharge Date:   7/31/2022   Discharge Diagnosis:  Principal Problem:   Acute metabolic encephalopathy Active Problems:   Hyponatremia   UTI (urinary tract infection)   COVID-19 virus detected   Type 2 diabetes mellitus   Essential hypertension     Hospital Course:  75 year old female who was treated with Paxlovid on 7/18 for Covid-19 infection was admitted on 7/28 after developing encephalopathy from UTI. She also had hyponatremia. She did not require treatment with either Remdesivir or steroids. She has been on Rocephin since admission and mental status improved. Neurology saw her and ruled out stroke after MRI showed no acute findings. Urine culture grew pan sensitive Klebsiella and E coli. Na is stable at 130. She will be discharged home today in stable condition on oral antibiotic. Patient educated on appropriate level of care post-discharge. Follow up with Primary Care Doctor in 5-7 days.   Physical Exam on the day of discharge: Last Recorded Vital Signs: Temp: 97.2 °F (36.2 °C) Heart Rate (Monitor): 61 Pulse: 67 BP: 143/75 Respirations: 14 SpO2: 97 % O2 Flow Rate (l/min): 0 l/min General Appearance: no distress  Eyes: PERRLA ENT: moist mucus membranes, no adenopathy Lungs: clear to auscultation bilaterally  Heart: regular rate and rhythm Abdomen: soft, non-tender  Skin: No rashes or lesions  Extremities: full ROM Neuro: alert, normal strength and tone    Consults:  IP CONSULT TO NEUROLOGY IP CONSULT TO SOCIAL WORK   Significant Diagnostic Studies:   MRI head, CT head   Operations: none   Disposition:  Home    Discharge Condition:  Fair
Symptoms: malaise, fatigue, muscle aches, muscle cramps, sore throat. Time course: one day. Outcome: symptoms resolved.
Pain at injection site; swelling at injection site; redness injection site; Ringing in left ear; Shaking; Lethargy; Chills; Headache; Fever; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included paracetamol (Acetaminophen).   On 12th September 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 12th September 2020, 8 hrs after receiving Shingrix, the patient experienced injection site pain, injection site swelling, injection site erythema, ringing in ears, tremor, lethargy, chills, headache and fever. On 15th September 2020, the outcome of the tremor, lethargy, chills, headache and fever were recovered/resolved. On 22nd September 2020, the outcome of the injection site pain, injection site swelling and injection site erythema were recovered/resolved. On an unknown date, the outcome of the ringing in ears was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, ringing in ears, tremor, lethargy, chills, headache and fever to be related to Shingrix. The reporter considered the injection site swelling and injection site erythema to be related to Shingrix.  Additional details were as follows: After receiving 1st dose of Shingrix, the patient experienced injection site erythema, injection site pain, injection site swelling recovery taken more than a week., fever, headache, chills, lethargy, shaking lasted 2 to 3 days until recovery and ringing in the left ear . The reporter reported that, limited information available. The reporter reported that, patient refused to provide any other details. The reporter said she sounded a patient was less than than 50 years old but agent could not confirm as patient was an angry caller. The patient mentioned that after starting to experience symptoms, she started taking Tylenol. The reporter consented to follow up.
Strabismus in here left eye; Seeing double vision; Numbness in her right side, her leg, her arm; The complications are also on the left side; This spontaneous case was reported by a consumer and describes the occurrence of DIPLOPIA (Seeing double vision), HYPOAESTHESIA (Numbness in her right side, her leg, her arm), VACCINATION COMPLICATION (The complications are also on the left side) and STRABISMUS (Strabismus in here left eye) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A and 058E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, the patient experienced DIPLOPIA (Seeing double vision), HYPOAESTHESIA (Numbness in her right side, her leg, her arm) and VACCINATION COMPLICATION (The complications are also on the left side). On 25-Nov-2021, the patient experienced STRABISMUS (Strabismus in here left eye). At the time of the report, DIPLOPIA (Seeing double vision), HYPOAESTHESIA (Numbness in her right side, her leg, her arm) and VACCINATION COMPLICATION (The complications are also on the left side) had not resolved and STRABISMUS (Strabismus in here left eye) outcome was unknown.            No concomitant medications were provided.  No treatment medications were reported.   This case was linked to MOD-2021-396458 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Nov-2021: follow up received on 25-nov-2021 contains significant information Event added.
Hot, red and swollen upper L arm. Took Benadryl with relief with cool packs 7/20/05-instructed pt to continue Benadryl/prn and cool packs.
Patient experienced immediate vomiting; throat tightness. Medical Doctor -  was on scene and administered IM Epinephrine 0.3ml  Time line and Vital Signs  14:20 - BP 148/82  HR: 110   Epi administered 14:32 - BP 140/80 14:34 - O2 sat: 99%  HR: 110  BP: 155/82 EMS Called 14:39 14:48  BP 146/78  Patient was alert and was able to ambulate.
CHEST PAIN; PAIN IN SHOULDER; SLEPT ALL THE DAY; TOTALLY TIRED, FATIGUE; LOSS OF ENERGY; HARD TO BREATH; FELT VERY DIFFERENT LIKE SOMETHING WAS TIGHT IN HEART; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. The patient's past medical history included slightly elevated cholesterol/high cholesterol, and stomach acidity. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. Concomitant medications included cholesterol, and ergocalciferol.  On 2021, the subject experienced hard to breath. On 2021, the subject experienced felt very different like something was tight in heart. On 2021, the subject experienced loss of energy. On 14-MAR-2021, the subject experienced slept all the day. On 14-MAR-2021, the subject experienced totally tired, fatigue. On 20-MAR-2021, the subject experienced chest pain. On 20-MAR-2021, the subject experienced pain in shoulder. Treatment medications (dates unspecified) included: omeprazole. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from totally tired, fatigue, chest pain, pain in shoulder, and hard to breath, and the outcome of slept all the day, loss of energy and felt very different like something was tight in heart was not reported. This report was non-serious.; Sender's Comments: V0. Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Patient is 28 y/o male presented to clinic for booster dose of Moderna COVID-19 vaccine and 2021-2022 flu vaccine. After vaccination, it was realized that patient had been given the flu vaccine for individuals 65 years and older which has not been approved for his age group. Patient informed and asked if he could wait in the clinic for an extra few minutes while we consulted a provider. Patient consented and stated that he was feeling well 15 minutes post vaccination. Consulted with provider and the Fluad Quad package insert. Instructed patient that the dose for 65 and older that he had received includes a stronger dose of the flu vaccine than the one that would usually be provided. Reinforced education on the possibility of side effects of the vaccine, including arm pain, headache, and fever. Patient stated that his hands were beginning to feel hot and that his hands had not felt hot like this before. Patient also asked further about myocarditis and pericarditis after Covid vaccination. Patient appeared to be anxious.  Reinforced education and brought patient a bottle of water. Patient appeared less anxious. Instructed patient to stay at the clinic until he felt well but that he  would be free to go when he felt well. Instructed patient to call the clinic if he had questions after he left. Informed patient that he would be checked on again in 10 minutes. Returned to patient's room after 10 minutes, and patient had left.
day 1 sore arm, pain at injection site, very stiff arm. day 2- pain in right leg, unable to walk or apply any pressure. lasted about 1 month
Information has been received from 2 physicians concerning a 5 year old white male with no known allergies and no prior medical history who on 11/30/01 was vaccinated with the 2nd dose of MMRII (lot 640634/1093L). There was no concomitant medication. On 12/18/01, the pt developed a pruritic rash on his face and trunk and a papular, erythematous rash on his arms, palms and soles bilaterally. He did not have a fever. The physician also reported that the pt developed a "target lesion" on a foot and lesions on his posterior pharynx and buccal areas. On 12/19/01, the pt presented to the physician's office with a pruritic and papular rash on his face and trunk; red areas on his buccal mucosa and pharynx and his post/anterior nodes behind his ears were enlarged. The pt was treated with Benadryl, 2 teaspoons 3 X daily for 8 days. Subsequently, in 12/01, the pt recovered from the papular erythematous and pruritic rash, pharyngeal and buccal lesions and target lesion on the foot. Additional information is not expected.
Swollen injection site to this day; large(4 inch diameter) red patch which is itchy; listless for 5 days; slept 4 to 5 extra hours per day.; didn?t feel like eating. Felt certain it would go away each night, but it didn?t. Have pictures of site.
Warm arm; This is a spontaneous report from a contactable consumer or other non hcp (patient). This report is for first dose. A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Not Reported) via an unspecified route of administration, on 26Jan2021 (at the age of 77 years), as dose 1, single for COVID-19 immunization. Medical history included ongoing hypertension, ongoing COPD (chronic obstructive pulmonary disease) and ongoing acid reflux. Concomitant medication included ongoing Metoprolol succinate for hypertension, ongoing Alprazolam (XANAX) for anxiety, Albuterol for chronic obstructive pulmonary disease, ongoing Budesonide for chronic obstructive pulmonary disease, ongoing Arformoterol tartrate (BROVANA) for chronic obstructive pulmonary disease, Tiotropium bromide (SPIRIVA) as a bronchodilator, Aspirin for unspecified indication, Omeprazole (PROTONIX) for Acid reflux, ongoing Diltiazem for hypertension, Prednisone and unspecified Vitamins. The patient stated first vaccine dose had no reaction, just a little warm arm on unspecified date. The event accessed as a non serious. The outcome of event was unknown.  Follow-up attempts completed. No further information expected.
Approximately 12 hours after the second dose, he developed symptoms of left-sided chest pain, muscle aches, nausea without vomiting, fever, and was pale.
No adverse event, symptoms; Was advised to fill out because patient is 68 years old and ADACEL is approved only until age 64. No other problem reported.
3 days after receiving my 2nd Covid shot I had sharp pains in my chest that progressed to constant pressure. I went to Urgent Care when I also became light-headed and my left hand was going numb. They immediately did and EKG, which was abnormal, and sent me to the ER. I continued to have episodes of blood pressure and heart rate spiking with continuous chest pain. They did bloodwork, a chest X-ray, a CT scan of my lungs as well as 2 more EKG's. My bloodwork was elevated for heart enzymes and possible blood clot. 2 days later I was back in the ER for the same issues, 2 more abnormal EKG's and a chest X-ray. I saw a cardiologist 3 days later, he sent me to the ER right from his office and I had a cardiac catheterization later that same day. This whole time I'd been having chest pain and pressure, shortness of breath, fatigue, high blood pressure episodes. I was allowed to go home but have continued to have chest pain ever since with no explanation. I had bloodwork drawn again yesterday, now testing for myocarditis.
light that can be seen in the right side of the eye; eye pain; little dots and floaters in vision; pressure in eye; pressure in head; pain on roof of head; slight fever; headache; vitreous degeneration; blurred dark circles in vision which were darkest on outside; noticeably different vision; This spontaneous case was reported by a consumer and describes the occurrence of VITREOUS DEGENERATION (vitreous degeneration) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (acetaminophen with codein). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and MULTIVITAMINS;MINERALS for an unknown indication.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced VISUAL IMPAIRMENT (noticeably different vision). On 25-Apr-2021, the patient experienced VITREOUS DEGENERATION (vitreous degeneration) (seriousness criterion medically significant), VISION BLURRED (blurred dark circles in vision which were darkest on outside), EYE DISORDER (light that can be seen in the right side of the eye), EYE PAIN (eye pain), VITREOUS FLOATERS (little dots and floaters in vision), OCULAR DISCOMFORT (pressure in eye), HEAD DISCOMFORT (pressure in head), PAIN (pain on roof of head), PYREXIA (slight fever) and HEADACHE (headache). At the time of the report, VITREOUS DEGENERATION (vitreous degeneration), VISION BLURRED (blurred dark circles in vision which were darkest on outside), VISUAL IMPAIRMENT (noticeably different vision), EYE DISORDER (light that can be seen in the right side of the eye), EYE PAIN (eye pain), VITREOUS FLOATERS (little dots and floaters in vision), OCULAR DISCOMFORT (pressure in eye), HEAD DISCOMFORT (pressure in head), PAIN (pain on roof of head), PYREXIA (slight fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Company comment: 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.
premature ventricular contractions; High Blood pressure; This is a spontaneous report from a non-contactable consumer, the patient. A 51-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Apr2021 (at the age of 51-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications 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 COVID vaccine. On an unknown date in Apr2021, the patient experienced high blood pressure and premature ventricular contractions. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events high blood pressure and premature ventricular contractions was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax; exp a grand mal seizure,lasted approx 5 mins;adm to hosp x 48 hrs;no anti convuls were prescribed;t 101.5;discharged w/ so sequelae;no further szs; recovered
Moderna 3/2/21, 3/30/21, 11/1/21. Positive on 7/21/22
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about concomitant medication, pertinent medical history and drug reactions/allergies was provided. On 16-JUN-2015, the patient was inadvertently vaccinated with a dose of (Oka/Merck) VARIVAX (dose, frequency, route of administration, lot# not reported) which expired on 05-JUN-2015. No adverse effects were reported. Additional information has been requested.
Information has been received from an individual concerning an 11 year old female pt who on approx. 7/11/00, was vaccinated with a 1st dose of Hep-B and within 10 minutes, post vax, the pt fainted. It was noted that she was "completely out" and "at some point" woke up with a headache and red streaks on the base of her hands in between her fingers. Unspecified medical attention was sought. The pt subsequently recovered. Additional information has been requested.
A 4 month old female received her 1st vaccines and was seen in the clinic on 5/24/2000. That evening, she was hospitalized. On 5/25/2000, inpatient laboratory tests were performed and the pt underwent a Kasai procedure. Post surgery, she developed massive ascites. The pt was transferred to a tertiary care facility on 5/27/2000 and a liver transplant was performed. She developed post surgical complications and expired on 6/8/2000. The reporter indicated that the pt's death was "clearly unrelated to vaccination". Cause of death was not provided.
The patient already received the Moderna Bivalent Covid booster in October of 2022. As of right now patient has not reported any symptoms or side effects.
TESTED POSITIVE FOR COVID 19; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced tested positive for covid 19. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid 19 was not reported. This report was non-serious. This case, from the same reporter is linked to 20220109542.
PATIENT RECEIVED SMALLPOX VACCINE 03/01/2018 AND ON 03/08/2018 PT STATES THAT HE STARTED TO SEE SMALL RED BUMPS ALONG HIS HAIRLINE. PT PRESENTED TO CLINIC 03/15/2018 AND STATES THAT HE HAS RED BUMPS ON HIS CHEST AND BACK. TWO BUMPS ON THE BACK HAS FORMED PUSTULES. PT HAS BEEN PLACED ON BED REST FOR 72 HRS AND INSTRUCTED TO RETURN TO THE CLINIC IF RASH GETS WORSE.