chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itchy welts/rash as similar to hives; rash which was itchy/80% of her torso from her neck to her upper thighs/rash went down her legs behind her knees and under her arms/rash in the area of her body that sweats; redness; finally able to sleep; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included hypersensitivity (has a history of sensitivity to breaking out in rashes).   On 11th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 14th September 2020, 3 days after receiving Shingrix, the patient experienced red rash and difficulty sleeping. On 14th September 2020 15:00, the patient experienced itchy rash. On 14th September 2020 23:00, the patient experienced urticaria. The patient was treated with ibuprofen and antihistamines for topical use. Shingrix was interrupted. On 15th September 2020, the outcome of the urticaria, red rash and difficulty sleeping were recovered/resolved. On an unknown date, the outcome of the itchy rash was recovering/resolving.   It was unknown if the reporter considered the itchy rash, urticaria, red rash and difficulty sleeping to be related to Shingrix.  Additional details were reported as follows: The patient has a history of sensitivity to breaking out in rashes. The patient received 1st dose of Shingrix and 3 days later on monday she started to break out in a rash which was itchy and changed over time. The patient reported that the rash started around 15:00 and at 23:00 it covered approximately 80 percent of her torso from neck to her upper thighs and described the rash was as similar to hives with redness and itchy welts. The rash went down to legs behind knees and under arms. By 15:00 the rash had calmed down and was finally able to sleep and the following morning everything mostly disappeared. The rash would present itself in pieces and would be very itchy for a short while and then it would die down and some time later it would reappear in another area. The patient took Ibuprofen, stayed calm and applied antihistamine lotion which would help calm the area in 20 minutes. The patient had experienced a slight reappearance of the rash in the area of her body that sweats. Because of her experienced she did not think that she would get the 2nd dose of Shingrix vaccine. The reporter consented to follow up.
Hives. Rash. Extreme itching. Both arms from wrist to armpit. Benadryl 3 times a day for a week. Avoid heat. 3 weeks before I could take a hot shower and not break out
This spontaneous report was received from a nurse practitioner concerning to unspecified patients of unknown age and gender. No medical history or concurrent conditions were reported. On an unspecified date, VARIVAX (Merck) was exposed to temperature of -2.3 C for 4 hours and 20 minutes. At the time of the report, it was unknown if the vaccine was applied to patients. This is one of several reports from the same source. Additional information has been requested.
expired dose of Daptacel was inadvertently administered to a patient; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received from another health professional.  This case involves a male patient (age unknown) who was administered expired diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel] (PT: expired product administered)  Medical history, medical treatment(s), vaccination(s), concomitant medications and and family history were not provided.  On 25-Oct-2019, the patient received expired diphtheria-15/tetanus/5 ac pertussis vaccine (dosing details unknown; lot number: lot: C5307AA; expiry date: 23-Oct-2019), as prophylactic vaccination (PT: expired product administered).  It was a case of actual medication error due to expired vaccine used.  Information on the batch number is available.  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.
At site of injection, experienced lots of itching, redness, swelling and knots/ lumps underneath. Circumference of redness increased in size to a silver dollar and then to 3 1/2"wide. Had MD visit on 06/03/05 and recommended icepacks, antihistamines. Itching and redness have decreased but site is still painful. 06/07/05- Now have allergy sx such as congestion and a a runny nose. Site is still swollen.
Has a fever of 99.9F and felt very tired, no redness, no swelling and no pain at injection site.
11-3-10 Client reports, per phone call, of rash onset 7 days post influenza vaccination. She reports hives starting on neck, head & hairline. Progressing to chest, arms & back, no fever, no other Sx. Continues to have hive crops occurring.
This spontaneous prospective pregnancy report was received from registered nurse concerning a female patient of unknown age. No concurrent conditions or medical history were reported. On 19-MAY-2016, the patient was vaccinated with GARDASIL 9 (dose, Lot No., expiration date, route and anatomical location of administration were not reported). Other suspect therapies included MENACTRA. On an unknown date, reported as prior to receipt of GARDASIL 9 was administered a urine pregnancy test to the patient with result was negative. The reporter stated that shortly after this the patient found she was pregnant and also that according to the "pregnancy wheel", the patient conceived on 02-MAY-2016. The nurse noted that the patient was pregnant at the time she received the GARDASIL 9 and MENACTRA. The last menstrual period (LMP) was of 18-APR-2016 and estimated date of delivery (EDD) of 23-JAN-2017. The pregnancy outcome was pending. Additional information has been requested.
24 hrs -> local allergic rxn; redness, swelling -> seen by provider -> HC cream 1% & BENADRYL prn & ice packs, f/u as necessary.
I was told I could leave the observation site before the 15 minutes and a couple minutes later I fainted while driving and wrecked my car.
For unknown reason (not documented in chart) patient received the first Pfizer COVID-19 Vaccine dose on 09/07/21, the  second dose of Pfizer COVID-19 Vaccine on 09/29/21 and the third/booster dose on 01/25/2022 which is earlier than the required 5 months and outside of the 4-day grace period. There were no adverse events associated with administration of the vaccine. Per CDC guidance, doses inadvertently administered earlier than the grace period should not be repeated.
Patient complained of scratchy throat approximately 5 minutes after receiving vaccine.  HX of anaphylactic reactions in the past with same onset of symptoms.  Requested benadryl,  25mg of benadryl po administered.  Symptoms resolved after 10 minutes.   Pt monitored for 30 mins, VSS, asymptomatic, and was discharged.
Dizziness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and FATIGUE (Fatigue) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091d21a) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness) and FATIGUE (Fatigue). At the time of the report, DIZZINESS (Dizziness) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. No treatment medications were reported.
This spontaneous report was received from a physician referring to a 6 month old patient of an unknown gender. Information about pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medication was not reported. On 17-DEC-2018, the patient was inadvertently vaccinated with a pediatric dose of VAQTA injection (dose detail, route, lot # and expiration date were not reported) for prophylaxis (incorrect dosage administered and product administered to patient of inappropriate age). No adverse effects reported.
Caller received first dose yesterday and noticed "baseball" bruise on right calf after shower.; arm was stiff/average weight in his arm; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 29-years-old male patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on 07Jul2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history included Hepatitis C shot on an unknown date and had stiffness in arm. The patient's concomitant medications were not reported. On 08Jul2021, post vaccination the patient reported that when he woke up this morning and had average weight in his arm. He clarified as stiffness. About an hour after he woke up, he went in the shower and there was a baseball size bruise on his calf, on his right calf. Not at the injection site. The outcome of the events was reported as unknown at the time of report.  Information about batch/lot number has been requested.
vax recvd 22MAY92 & 8hrs later pt noted to be lethargic, pale & dusky, w/little responsive to warm bath;
isn't feeling very well; Initial information was received on 12-Oct-2021 regarding an unsolicited valid non-serious case received from social media from consumer/non-health care professional via Regulatory authority (under reference number - US-SA-SAC20211016000527).  This case involves an unknown age female patient who experienced isn't feeling very well (malaise), after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing Syndrome lupus.  Concomitant medications included COVID-19 VACCINE (COVID-19 VACCINE) for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious isn't feeling very well (malaise) (unknown latency) following the administration of INFLUENZA VACCINE.  No additional laboratory data was reported.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on batch number for this case.
Chills; Fever; Felt tired; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Felt tired) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 001A21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included ROSUVASTATIN, OLANZAPINE, MULTIVITAMINS [VITAMINS NOS], VITAMIN B12 [VITAMIN B12 NOS], FISH OIL and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Felt tired). At the time of the report, CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Felt tired) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2021, Liver function test: abnormal abnormal (High) Alanine aminotransferase level was elevated.         No treatment medications were reported.  The action taken with mRNA 1273 with the events were considered as not applicable.
Persistent nausea; tongue often feels different; This is a spontaneous report from a contactable health care professional (patient). A 42-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 24Feb2021 as an unknown dose number, as a single dose for COVID-19 immunization.  Medical history included familial hypercholesterolemia and hashimotos antibodies both from an unknown date and unknown if ongoing. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included trazodone (manufacturer unknown) and hydroxyzine (manufacturer unknown), both taken for an unspecified indication, start and stop date were not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced persistent nausea and tongue often feels different on 27Feb2021. The events resulted to a doctor or other healthcare professional office/clinic visit. As treatment for the events, the patient's gall bladder was removed (as reported). The events were reported with a seriousness of disability. The outcome of the events was not recovered. The patient had a nasal swab SARS-COV-2 test on 07May2021 with a result of negative.; Sender's Comments: Events represent intercurrent medical conditions and unrelated to BNT162B2 .  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Patient reported a fever of 100.5 F.  Instructed patient's wife to watch fever and let pharmacy and doctor office know if fever got any higher.  Patient was going to try some fever remedies such as Tylenol and Ibuprofen.
Development of painful erythema from skin overlying deltoid medially and down ventromedial surface of upper arm to the elbow over 24-36 hours.
I got my second Moderna dose around noon on 5/4 (yesterday). By the time I went to bed that night, I was feeling some of the common and expected side effects: mild-moderate joint/muscle aches; chills; headache. I woke close to 1 am and got out of bed to go to the bathroom. As soon as I stood up, all of my muscles felt so weak I thought I would collapse. I felt all the blood rush to my head, which started spinning. Once I sat on the toilet, I felt like I was simultaneously going to vomit and pass out. I put my head between my legs. I remember coming to a short time later. I believe I briefly passed out. Still feeling my head swimming, I tried to make it back to bed, but I had to crawl to avoid passing out or vomiting. I had to pause and lie on my back on the floor for several minutes to avoid passing out or vomiting. I finally made it back to bed. A loud buzzing started in my ears and lasted for several minutes. I attempted a couple more times over the next 30 minutes or so to stand up again, but I was unable to stand or walk without having the same symptoms. I finally went back to sleep and woke up the next morning. I was able to get up and walk without feeling weak, faint or nauseous. The other symptoms of joint/muscle aches and chills have persisted today, but have slowly abated over the course of the day. I don't have a history of fainting, allergies to foods or vaccines, and I've never fainted during vaccinations or blood draws.
Administered expired vaccine to the patient, after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration.) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that dose administered after 30 day use by date or after manufacturer date of expiry. 168 doses were administered. On unknown date the vial was stored in the refrigerator. The vial did not undergo any temperature excursions.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received contains non significant information included reporter details.
PFIZER COVID VACCINE #3 GIVEN 9/17/21, LOT #FF2588; 2/6/22 pt had a positive COVID test from Pharmacy; required a hospitalization (dates unknown) for COVID, treated and dc'd to home with O2 supplementation, steroids, Paxlovid; 2/23/22 pt admitted to Hospital with AHRD, Acute Renal Failure; septic shock, bilateral pneumonia, pulmonary embolus; rapid respiratory response occurred and pt required intubation; pt's condition continued to worsen; transitioned to comfort care; pt expired in the hospital
SICK WITH SLIGHT FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient received covid-19 vaccine ad26. cov2. s (manufacturer unspecified)(suspension for injection, route of admin, and batch number were not reported) dose was not reported (dose series 1) , for prophylactic vaccination.  On an unspecified date in NOV-2021, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported (dose series 2), 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 an unspecified date in  NOV-2021, the patient experienced sick with slight fever (dose series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sick with slight fever was not reported. This report was non-serious. This case, from the same reporter is linked to 20211134099.
weak, clammy, swelling in hands and face, shaky, disorientation and confusion, headaches, and leg muscles giving out causing her to collapse twice.  Started at 2 hours after injection into next day.  Update on 9/2 patient is still having symptoms
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021 at 12:34 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Mar-2021 at 12:05 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 25.87 for 031L20A and  25.97 for 003B21A.  No concomitant medications were reported.  Batch number 031L20A administered on 14-Feb-2021 had  temperature 32 at 09:00 AM, 10.00 AM and 11.00 AM and 35 at 02:00 PM and 03.00 PM. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 13-Jan-2021.  Batch number 003B21A administered on 21-Mar-2021 had  temperature 34 at 09:00 AM and 11.00 AM and 32 at 10:00 AM. This vial was moved to fridge on 16-Mar-2021 and beyond use date for the vial was reported as 15-Apr-2021. Product moved to clinic on 21-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported
Next day Fever, body aches. Took BC Powder. Went to sleep got up with had chills, headache, stiff neck, jaw was tight, took a shower, tender and red at the injection site. Went back to sleep, got up later couldn't move arm. Lymph nodes swollen, nausea, diarrhea, fatigue up until an hour ago. Everything else has subsided.
Had a headache for 13 days after the first Pfizer COVID19 shot which started the day after the shot.  I rarely have headaches so this was really noticeable to me.  I'm not sure if this is an adverse reaction or not, but  wanted to report it just in case.  I was told that headaches are common close to after getting the shot, but I didn't expect it to last that long.  After my 2nd shot on 4/22/21 I had flu like symptoms that started about 12 hours after the shot and lasted for a day.
1/21/06 CONTINUOUS HEADACHE @ BASE OF SKULL. 1/22/06 FEVER 99+ . STIFF NECK-CAN'T TURN HEAD SIDE TO SIDE OR UP AND DOWN WITHOUT PAIN. 1/23/06 WENT TO DR FOR CHECK-UP. DR. ADVISED SHE CONTACT THE HEALTH DEPT.
Patient was given 0.5mL of Td vaccine in left deltoid at 1601 on 10.17.14 that had an expiration date of 09.30.14. Patient was notified of the event and came back on 10.20.14 to be readministered the vaccine.
Narrative: Patient received Pneumovax 23 on 11/12/2009. Patient reported unilateral arm swelling and pain x 2 days to a VISN Triage nurse on 11/15/2009. Patient was seen in the ED on 11/16/2009 in which he noted that the pain and swelling decreased.
Developed cough and chest tightness 15 minutes after vaccine. Chest tightness worsened. Vital signs stable. Decreased breath sounds no wheezing no sob Given aspirin, ntg sl, albuterol neb. Transferred to Hospital via squad.