chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse concerning a female patient who was vaccinated with a dose of VARIVAX (Oka/Merck) (lot number, dose and route not provided). It was reported that the patient experienced blister like lesions around the injection site. It is unknown if the date of 17-MAR-2008 is the date of vaccination or the AE onset date. It was unspecified if the patient sought medical attention. The patient's outcome was unknown. There was no product quality complaint. Additional information has been requested. Follow-up information has been received from a nurse concerning a 12 month old female who on 07-MAR-2008 was vaccinated with the right thigh with a first dose of VARIVAX (Oka/Merck) (Lot # 659527/1786U) at 9:45 am. On 07-MAR-2008 at 9:45 am the patient was vaccinated into the left thigh with a third dose of ACTHIB. (Sanofi Pasteur) (Lot #UF297AA). There was no illness at the time of vaccination. On 17-MAR-2008 the patient experienced papules on the right anterior thigh 10 days after VARIVAX (Oka/Merck) was administered in the same location. On an unspecified date the patient recovered. Additional information is not expected.
16 year-old female received a third Menactra vaccine today, no AE; Initial information received on 10-Jul-2020 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case involves a 16 year old female patient who received the third dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] 0.5 mL (lot U6565AB, Expiry date 28-Mar-2021) via intramuscular route in the right deltoid on 10-Jul-2020 for prophylactic vaccination (extra dose administered). The patient received her first Menactra in 2015. She received second one in Dec-2019.   The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. She never had the vaccine prior to 2015.  Patient did not receive any other vaccine as concomitant medication.  It was an actual medication error case due to extra dose administered.  It was reported that patient had immunization records from two different doctors and they did not match. Therefore, there was confusion and that 16 year-old female received a third Menactra vaccine today. The patient received her first Menactra in 2015. She received another in Dec-2019.  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 2001/83/EC and Module VI of the Good Pharmacovigilance 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.  There will be no information available on the batch number for first and second dose in this case.
Had a  2 cm erythema at the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Jan-2021 and was forwarded to Moderna on 15-Jan-2021.    This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (Had a  2 cm erythema at the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No prior medical history was reported.).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Had a  2 cm erythema at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Had a  2 cm erythema at the injection site) 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.   Treatment information was not provided. Concomitant medication was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Intense muscle pain that is still persistent 3 weeks after administration; treated with ibuprofen 800mg TID + IcyHot patch topically PRN.
Patient had trouble breathing and took his inhaler. He continued to have trouble breathing and said his throat and chest felt tight. EMT gave 20ml of benadryl and assessed patient. Gave another 20ml of Benadryl. EMT asked and reassessed in 5 - 10 minutes. Patient still felt tightness and said it was getting worse. EMT asked if he wanted epi and patient said yes and said his throat was closing more. EMT explained that he would need to go to the hospital then and patient did not want to go to the hospital. Continued assessment and patient stated he was feeling better after EMT had him drink water and do some deep breathing. Patient stated he felt much better and was released from waiting room. Nurse at employer (Clinic was done on site) stated that this is normal for patient to have SOB as he has COPD and commonly has shortness of breath.
TOOK AN UNREFRIGERATED DOSE OF VIVOTIF; This spontaneous case (PVX2019-1163) was received from a pharmacist on 10-May-2019. It describes a 57-year-old female consumer who "took an unrefrigerated dose of Vivotif". The consumer was receiving Vivotif (lot number: 3003275) for an unknown indication.  Case report: The consumer took the first dose of Vivotif on 09-May-2019, which was unrefrigerated for at least 24 hours.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took an unrefrigerated dose of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took an unrefrigerated dose of Vivotif" was considered as not applicable.
Patient received Moderna COVID vaccine on 3/17/21 (lot # 008B21-2A), 4/14/21 (lot # 036B21A), and 11/11/21 (lot # 045C21A). On 12/21/22, patient admitted to our inpatient facility (med/surg unit) with sepsis (HCC) due to COVID infection and possible aspiration pneumonia, hypoxia due to COVID-19 infection, and acute metabolic encephalopathy in setting of infection. Patient was discharged home on 12/25/22.
paralized; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 12 year-old female patient received bnt162b2 (BNT162B2) (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: PARALYSIS (medically significant), outcome "unknown", described as "paralized". The lot number for bnt162b2 was not provided and will be requested during follow up.
fever; soreness at injection site; chills; pain at injection site; warmth at injection site; headache; lightheadedness; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), INJECTION SITE PAIN (pain at injection site), INJECTION SITE WARMTH (warmth at injection site), HEADACHE (headache) and DIZZINESS (lightheadedness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ATORVASTATIN CALCIUM (LIPITOR), AMLODIPINE BESILATE (NORVASC), ATENOLOL and FAMOTIDINE for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced CHILLS (chills), INJECTION SITE PAIN (pain at injection site), INJECTION SITE WARMTH (warmth at injection site), HEADACHE (headache), DIZZINESS (lightheadedness) and INJECTION SITE PAIN (soreness at injection site). On 17-Feb-2021, the patient experienced PYREXIA (fever). On 17-Feb-2021, CHILLS (chills), INJECTION SITE PAIN (pain at injection site), INJECTION SITE WARMTH (warmth at injection site), HEADACHE (headache) and DIZZINESS (lightheadedness) had resolved. At the time of the report, PYREXIA (fever) and INJECTION SITE PAIN (soreness at injection site) 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.
approx 17 days p/ vax pt devel a typical chickenpox rash w/about 20-30 lesions w/fever & itching over entire body
Painful and decreased range of motion of right shoulder.  Numbness goes down right arm to fingers, mostly 4th and 5th fingers. Diclofenac 1% topical was prescribed. Patient was directed to use 2 mg, 4 times a day as needed for shoulder pain.
HALLUCINATIONS WHILE ASLEEP; OUT OF BODY EXPERIENCE; COULDN'T SLEEP; SO WARM; FEVER; CHILLS; This solicited report received from a patient via media concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-MAR-2021 12:30 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 10-MAR-2021 22:00, the patient experienced chills. On 11-MAR-2021, the patient experienced hallucinations while asleep. On 11-MAR-2021, the patient experienced out of body experience. On 11-MAR-2021, the patient experienced couldn't sleep. On 11-MAR-2021, the patient experienced so warm. On 11-MAR-2021 00:45, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 102 (unit not provided). On 11-MAR-2021 01:30, Laboratory data included: Body temperature (NR: not provided) 103.1 (unit not provided). Treatment medications included: paracetamol. On 11-MAR-2021 02:30, treatment medications included: alprazolam. On 11-MAR-2021 00:45, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from so warm, and fever on 11-MAR-2021, and the outcome of chills, hallucinations while asleep, out of body experience and couldn't sleep was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and hallucinations while asleep, out of body experience, couldn't sleep, chills, so warm, and fever was related.  This report was serious (Other Medically Important Condition).  Version created to amend previously reported information on 11-MAR-2021. Upon review the following information was amended: case level seriousness and previously reported non-serious event of hallucinations was updated to serious. The company causality for all events was updated to related (previously captured as possible); Sender's Comments: Hallucinations while asleep. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are no other factors more likely to be associated with the event(s) than the drug. Therefore, this event(s) is considered related to COVID-19 vaccine ad26.cov2.s.
pt recv vax 13FEB96 & that day, pt devel itching, swelling & 6cm x 6cm area of macular rash/vesicles @ the site of inj;
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 22-FEB-2016 the patient was vaccinated with an improperly stored dose of VAQTA 50U/1ml (lot # L018498, expiration date 28-APR-2016, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 744 with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 168 hours with the lowest recorded temperature of 32 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
received improperly stored vaccine; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's pertinent concurrent condition, medical history, drug reactions/allergies and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, frequency, anatomical location and route were not reported) (1 dosage form and lot # S007075 with expiration date of 06-SEP-2020) for prophylaxis (product storage error). The outcome of product storage error was unknown. It was reported that the vaccine was exposed to a temperature of 32.5 degree Fahrenheit for a time frame of 8 hours. There was no previous temperature excursion reported. No product quality complaint (PQC) was associated with this report.
it was rpt by HCP concerning pt who came in contact w/pt who was vax w/varicella & in 8/20 pt was dx w/herpes zoster. rpt felt herpes zoster not related to therapy w/varicella
Subsequently, 2 weeks after vaccination, the patient was "experiencing ataxia". The patient sought unspecified medical attention. Follow up information from the physician indicated from 08/09/2000 to 08/10/2000 the patient developed a fever to 102F. Briefly on 08/11/2000 only, 3-4 red spots were noted on her face, neck and back. From 08/09/2000 to 08/16/2000 the patient experienced unsteadiness, was "wobbly" and falling more than usual. The patient had a normal exam on 08/11/2000. Subsequently as of 08/16/2000, it was reported that the patient had no symptoms, was doing well and recovered. No further information is expected.
pt vaxed w/Pnu-imune; devel localized react of erythema from shoulder to elbow; no cellulitis; resolved w/in 60 hrs;
Serious nose bleed; Fever 103F; Chills; This spontaneous case was reported by a patient and describes the occurrence of EPISTAXIS (Serious nose bleed), PYREXIA (Fever 103F) and CHILLS (Chills) in a male 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced EPISTAXIS (Serious nose bleed), PYREXIA (Fever 103F) and CHILLS (Chills). At the time of the report, EPISTAXIS (Serious nose bleed), PYREXIA (Fever 103F) and CHILLS (Chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product used was not provided by the reporter. Treatment information was not provided by the reporter.
Difficulty breathing, feeling very hot, elevated body temperature, chills, clenching, nausea.
He got his vaccine, had virtually no reaction until the evening when he tried to do something with his right arm, and he realized that he could not do something, which is not too unusual as he does not have rotator cuffs.  That evening he noticed a cotton puff on his shoulder, and decided there was no wonder for the hurt, from the shot.  He had a little pain when he tried to use the right arm when lifting over his head.  The 2nd day he started with a non-interruptible cough with phlegm and has gone through that before when he had COVID.  That lasted pretty much until last night or early this morning, like about 2:00 AM and kept coughing until about noon trying to keep himself alive.   Last evening he had a temperature of 99.9, and today his temperature is 98.9 when he got up.  He did not take anything for his symptoms.  He is now in state but his medicines for coughing are in other state.  It seems to be going the way he felt when he had COVID.  He is getting back, no longer stumbling around where he is having vertigo.  Yesterday and the day before he feels he did not drink enough water, which happens to him frequently when he doesn't drink water throughout the day.    He has stents in his heart and on 8/1/22 he had open heart surgery with triple bypass.  He is in recovery and her heart stopped and they did CPR for 10-15 minutes and they got his heart going back.   They took him back to surgery and sees the damage due to CPR and he cannot remedy the damage done by that.  He had a second triple bypass surgery on the same day, and 2 of the 3 bypass are being flooded with something that he cannot get out of them so there is no room for the heart and has a single bypass and sews her up again.  Whatever is flowing into the two bypass and now into the main aorta.  He then went to a catheterization to do another procedure to prevent those other areas to flooded.  He went into ICU for 4 days, then had recovery in a nursing home, and he has been better since then, it's going to be a 6 month recovery.
Guillain Barre Syndrome numbness in both hands and feet, trouble walking and writing, weakness in arms and legs. Started just in fingertips 10/20 and progressed to diagnosed on 10/31 at its worst. Treated at hospital for 5 days with IVIG and released on 11/4/2018 recovering presently at home. Regaining strength in arms and legs and able to walk better. Still numbness in fingers and feet. Will be starting physical therapy and followup with neurologist in 4 weeks.
Diffuse macular papular rash 7 days after vaccines. No vesicles. No fevers. He has been irritable and not sleeping well for 2-3 days.
I was positive for COVID-19 on 26NOV2022, I had severe body aches no fever and a dry cough. I was very weak, which kept me in bed. I contacted my doctor and prescribed me paxlovid, I started feeling better after one day of taking it.
pt recvd vax & devel redness warmth & itching @ the inject site; pt was treated w/an ATB, ASA & Triamcinolone cream & has improved; 2 out of 3 pts recvd inject from the same vial developed similar reacts;
Narrative: COVID infection following COVID vaccine series 01/12 Pfizer, dose #1 02/03 Pfizer, dose #2 08/04 pt cc: cough, diarrhea, fever, myalgias, nausea, rhinorrhea, congestion, dyspnea exposure: unknown 08/05 COVID swab, result: detected 8/05-08/09 pt continue symptoms 08/10 clinically resolved
Chills and a low grade fever, Fatigue, Headache and dizziness for two days.
IV dose of Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a adult male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 16th September 2021, the patient received Boostrix (intravenous). On 16th September 2021, unknown after receiving Boostrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details provided were as follows: Age at vaccination was not reported but could be 43 or 34 years old at the time of reporting. Pharmacy intern reported that he patient received a dose of Boostrix by intravenous route, which led to intramuscular formulation administered by other route. Reporter did not have any patient information aside from gender. No vaccine information available to reporter. The reporter did not agree nor declined to follow-up they just have to check with their supervisors. The reporter consented to follow-up.
10/22/2019 Pt in office complaint of waking up the morning after the injection and being unable to lift her arm over her head. The complaint was that her right arm was having this pain. The shot was documented to have been given in the left arm, I spoke with the MA that gave the shot and she confirmed that the patient refused the vaccine in her left arm and requested it be given in her Right  arm. C/O right arm hurting all through the biceps muscle and into the shoulder. At this time the patient was given a Triamcinalone 80/Dexamethasone 4 injection for the inflammation. Also started on Tylenol Arthritis 2 tabs 2 times per day.
Woke up with bad headache next day went to work and left at 12 felt so bad.  No fever, just severe headache, full like symptoms, freezing, body aches, ear ache, jaw ache, teeth hurt, also my eyes were weird like not clear in seeing.    I also have woken up with my body completely wet but not sweating g or cold.  So weird.  This has happened each night after second shot.  I had lower back pain and that started after first shot but I didn?t realize that it was from the 1sr shot done on 03/30/2021.