chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was offered Pfizer COVID-19 booster  in conjunction with an employee flu shot clinic. She was not adequately screened to determine that it had not yet been 6 months since her 2nd dose, making her ineligible to receive a booster yet. It was given anyway.
Second dose 37 days after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 37 days after the first dose) 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 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 an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 37 days after the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 37 days after the first dose) had resolved.            No concomitant medication were reported. No treatment information was reported.
feeling bad; fever; cough; muscle pain; joint pain; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 28Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient received the vaccine and started feeling bad, had fever cough, muscle pain and joint pain all on an unspecified date in 2021. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Chills, fever, aches, headache, nausea, some diarrhea,  bad taste in mouth,  tired.  Flu like symptoms lasted 2 days.  Nausea,  off balance and bad taste ongoing as of 2/18/2021
There was not an adverse reaction.   The facility did not dilute the Pfizer and gave .3 ml instead of the diluent amount.  At this time the participant has had no issues.    We as a provider wanted to be sure this was notified.  We provide the vaccine to the clinic and their staff administers.     No other Information is known due to it being not our facility.
Both Tdap and PREVNAR 13 was given on left deltoid (IM). Patient was fine after given the vaccines on 0707/2018. We received prescriptions for Triamcinolone ointment and Calamine lotion on 07/10/2018. We contacted patient and discovered the prescriptions were for the severe rash on left arm from deltoid down to middle of forearm.
Initial information received on 10-Sep-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to case 2018SA256250 (Same reporter). This case involves a 4 years old female patient who was vaccinated with 0.5 ml dose of IPOL (Batch number: NIK931M and expiry date: 19-Nov-2010) (dose in series, route and site of administration were not reported) on 30-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to incorrect product storage because the vaccine had been out of range for over 30 minutes and should of been discarded. It was unknown if any adverse event occurred or not. 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. List of documents held by the sender: None.
I didn?t have any pain or itching on my left arm at the injection site after the first few days post shot. And I was reporting daily via the ?VSafe? program via the daily texts... but the day after I stopped receiving those daily texts (day 8 post shot for me), my left arm (around the injection site) became itchy and there was a slightly painful, red swelling that cropped up near my injection site on my left arm. The redness/swelling is about half the size of a  dollar bill on my arm.  I used some hydrochloride based anti itch cream and took an allergy medicine but it didn?t help much the first day that it showed up, 2/28/21. That itchy/red patch became more pronounced yesterday and slightly painful/hard and hot to the touch for about half a day, 3/1/21. The redness is mostly gone this morning (3/2/21) but my left arm/injection site is still slightly swollen/achy in that area and still somewhat itchy.  I?ve not been too worried bc I hear this ?Covid arm? can happen with these vaccines but since it?s happening to me post-VSafe check in?s, I thought I should report it. Anectdotally, I?m on a Covid-19 Vaccination social media started by  (to help each other locate vaccine appt openings) and after posting about my  ?Covid arm?, on this page, there was a big response and ?Covid arm? seems to be a pretty common occurrence but most ppl don?t experience these issues until day 8-13 post injection, past the date that we can auto report to the CDC via the VSafe program... a pharmacist suggested I go ahead and report even though this adverse event isn?t life threatening for me.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 03-OCT-2012, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 19-MAR-2015, the patient was treated at a hospital by a physician for a blistering vesicular outbreak that was diagnosed as severe shingles and post herpetic neuralgia. The patient was prescribed acyclovir and gabapentin for management of his painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown demography. Patient's concurrent conditions and relevant medical history was not reported. On 12-FEB-2015, the patient was vaccinated with improperly stored PROQUAD (dose, frequency and route unspecified) (lot number: K011314 with expiry date of 14-FEB-2016). Concomitant medications were not reported. The reporter stated that, between 07-JAN-2015 through 19-FEB-2015, PROQUAD was exposed to 34.4 Fahrenheit temperature which was outside the recommended condition. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with PROQUAD was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
1 1/2" painful nodule @ site, h/a, malaise, nausea lasting 1-2wk post both inj;
Child received MMR #1, DTaP#4, and Hib#4 on 4/23/13. On 4/25/13 child was at daycare and was reported to have been playing and then dropped to the ground and was jerking. Grandma/guardian states she was there within 5 min. and he was still unresponsive and had some slight jerking motions. Temp was 102. He was taken by ambulance to ER where he had CXR that was clear and other infections ruled out. Grandma states his temp went up to 104 that evening while she was alternating Tylenol and Motrin every 3 hours. Grandma states child has bad eczema and had a terrible flare up after vaccine. Also states he had had a cold before the vaccination but was doing ok by the time he got it.
2day p/vax pt had large bloody stool, followed by 1wk watery diarrhea & crampy abd pain
9/20/2012 - Patient states he got a flu shot and the pnu shot in the same arm, 2 days ago, states the first night he was cold, shaking like a leaf, sweating but cold, states that the next day he felt bad, but did not have the shakes. Today he feels better but he has noticed that below where he got the injections he has redness. No pain. No swelling. Just a bug red place. About the size of a saucer . No fever.
12/31 I had tingling in my throat and was observed in urgent care for two hours with no intervention. It went away by the time I went to bed that night. 1/8 I woke up with a sore arm, did not think much of it and went to work. It was sore all day and when I got home I undressed to take a shower and noticed that it was red, swollen and hot to the touch. I tried hot compresses as I suspected it was cellulitis and marked the borders. It had grown in size the nest morning (1/9) which is when I went back to urgent care and was prescribed 3 days of Keflex. The first dose reduced the swelling and pain in my arm, but by the end of the course of antibiotics it was still red 1/13 I went back to urgent care to be seen for the redness and tenderness. The NP suspected that it may be an immune reaction rather than cellulitis and gave me a single oral dose of decadron with instructions to follow up in 3-4 hours by sending in a picture, and if it did not get better to fill a longer prescription for Keflex. At this point I have taken the prescription to the pharmacy and am waiting until after work to pick it up and begin the script.
Patient c/o being fearful of needles, complaints of feeling light-headed, dizzy, fainting.  Feels cold and clammy, perspiration noted on forehead.    Complains of nausea and pain in left lower quad.
The second Moderna dose was more traumatic than the first.  I again received my period on the same day.  Heavy, cramps and clotting.  But the period was short this time and ended after 7 days.  The day after my vaccine, 10/16/2021,  I was extremely ill: nausea, HIGH fever, chills, headaches.  I was sick for three days.  After my fever broke, I started getting back to life, but then the WORST lower back pain started.  It was so bad I could not walk for three days.  I had to use the bathroom in the shower because I could not sit on the toilet. I could not stand at all, so I had to crawl around.  The extreme pain slowly went away after a week.  It took a month for all the pain to go away.
approximately 10 doses administered past 30 day use by date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (approximately 10 doses administered past 30 day use by date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (approximately 10 doses administered past 30 day use by date). In October 2021, EXPIRED PRODUCT ADMINISTERED (approximately 10 doses administered past 30 day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  Treatment information was not provided.
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 05-MAY-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23-10pk-0.5mlSD-PFS LLokwTip) (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 1368 hours with the lowest recorded temperature of 27 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
pt recvd vax & exp swelling, heat & redness in the arm of inject extending up to the clavicle & into the neck;
Low-grade fever (99.5), joint/muscle aches, fatigue  Delayed menstruation
Missed a couple of doses due to forgetting/oes occasionally miss a dose - approximately 1 dose per; A sore arm; A rash; Soreness at the site; This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (Missed a couple of doses due to forgetting/oes occasionally miss a dose - approximately 1 dose per), PAIN IN EXTREMITY (A sore arm), RASH (A rash) and INJECTION SITE PAIN (Soreness at the site) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Malignant neoplasm of upper-outer quadrant of female breast. Concomitant products included TUCATINIB (TUKYSA) for Breast cancer female, TUCATINIB (TUKYSA) for Malignant neoplasm of upper-outer quadrant of female breast.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MEMORY IMPAIRMENT (Missed a couple of doses due to forgetting/oes occasionally miss a dose - approximately 1 dose per), PAIN IN EXTREMITY (A sore arm), RASH (A rash) and INJECTION SITE PAIN (Soreness at the site). At the time of the report, MEMORY IMPAIRMENT (Missed a couple of doses due to forgetting/oes occasionally miss a dose - approximately 1 dose per), PAIN IN EXTREMITY (A sore arm), RASH (A rash) and INJECTION SITE PAIN (Soreness at the site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information provided.  Tukysa 50mg and 150mg is being discontinued due to no longer working.  Most recent follow up: Does occasionally miss a dose - approximately 1 dose per month   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Non-Significant Follow-up added On 05-Aug-2021: Significant follow-up was received on 05-AUG-2021 and added co suspect medication details.
Dizziness, headache, loss of equilibrium.  checked into the ER, received tests to rule out a heart attack and stoke, received IV fluids and released.  remained home in bed for the remainder of the day, symptoms lasted through the night
This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown dates, an unspecified number of patients were vaccinated with unknown number of doses of PEDVAXHIB, (strength, dose, route, anatomical location, lot number and expiration date were not reported), which were improperly stored. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of three reports received from the same reporter. Additional information has been requested.
Received vaccine 10-27-21 at 10:20  a.m. Sore arm about an hour later. Woke with chills and fever 10-28-21 at 1:00 a.m.  Lasted about an hour.  Took ibuprofen. Tired and had slight fever during the day of 10-28-21.  Took ibuprofen. Reaction was similar, but not as bad, as the reaction I had to 2nd Moderna vaccine on 4-6-21, which I also reported.
71y.o. male with a past medical history of ESRD on HD, DM 2, HTN, dyslipidemia, GERD, orthostatic hypotension who presented to the ED for cc of dizziness. Patient was previously admitted on 10/4-10/7 for similar symptoms and was found to be with orthostatic hypotension. Patient was then noted to have EKG sinus rhythm with first-degree AV block, bifascicular block and EP evaluated. 2D echo with normal LVEF, no wall motion abnormalities. OP evaluation for PPM was recommended and patient was stable for discharge. Shortly after discharge he developed cough, weakness, and dizziness with fall. He does not believe he hit his head. Patient is fully vaccinated against COVID, and has received booster. In the ED, vitals noted Additional information for Item 18:  to be stable. Initial labs remarkable for bicarb 18, potassium 6.1 (hemolyzed)> 4.2, hgb 12.2, troponin 0.09 > 0.12 > 0.11 > 0.10. COVID was positive. EKG w/with normal sinus rhythm, occasional PACs, first-degree AV block. Head CT negative.  CXR with stable RLL opacity and small left pleural effusion.  Patient was admitted with consult to ID, nephrology and EP. Per EP, no need for pacemaker now, however he may require in the future if conduction disease worsens.  Orthostatics were negative. ID recommended a course of remdesivir x3 days. Patient remained stable on RA and did not require steroids. PT/OT rec HHC. HD can accept pt while being COVID+. Over the course of his hospital stay, he remained clinically stable. He is recommended to follow up with cardiology as an OP if needed.
Severe, chronic joint pain and swelling. (Enteric Aspirin) The follow up received on 2/19/03 states joint pain left/right pelvis/hip, left hip, both knees, left wrist; swelling of both hands.
about 5 minutes after receiving the pfizer vaccine patient became sweaty and skin got clammy and he felt like he was going to faint. He lost all color to his face. Blood pressure was taken and it was 92/60. We gave him a cold pack on the back of his neck and had him lay down and elevate his feet  and legs. Also got him some cold water to drink. He started to feel better in about 15 minutes after that. We continued to monitor blood pressure about every 5 to 10 minutes and it got to 99/72 and last check was 120/65. He did not want the ambulance or to go to urgent care. We told him to take it easy the rest of day and to have somebody with him til next morning. And then he and his friend left to go to his parents house.
A report was received from a health care professional on 10/092003 concerning a 41 year old female vaccinee who experienced redness, warmth and itching at the injection site on 10/09/03 after receiving Fluvirin vaccine on 10/09/03. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1, 11/4/2003: Further information received from a health care professional on 11/4/03 indicated that the vaccinee received Fluvirin vaccine on 10/7/03. The event duration was 4 to 5 days. the vaccinee also experienced a grapefruit sized knot an unspecified length of time after receiving Fluvirin. No follow up pending, all information received. Cross reference with: PjP-2003-00785, PJP-2003-00987, PJP-2003-00988.
Walk-in basis, vaccine administered around 4:40. As getting into car, noticed my son pale and clammy, asked if he was ok and he slurred his answer that he didn't feel right, passed out, toppled over in seat, eyes rolled and started convulsions. He had a  history of Febrile seizures so I was concerned when he was unresponsive. Called emergency. EMT stated I was closer to hospital where I was driving towards- than he could get to us. Son came to but was disoriented, eyes unfocused, asked me to call emergency mumbling his chest felt tight and reported a tingling sensation all over his body, passed out again, shaking violently, lips were bluish. Was unable to get out of car and wheeled in still pale, disoriented and unfocused. Vitals taken at ER and went into observation. Followed up with PCP next day. Recommended allergist. Fever of 101.8 that night and rash around injection site.
Pt appeared dizzy, cold and clammy, pale, and flushed. Paramedics accessed pt, found out he was hypotensive. MD on site examined pt and called management. Pt was transported to Hospital via ambulance, accompanied by wife. Pt was alert and oriented x3, EKG done on sinus rhythm .
Patient reported today with restless legs, pain in lower back and in between ribs and back.  She contacted her physician and he suggested that she call us (?).  We referred her back to him.
same day of vax pt exp a lingering severe local react w/arm pain & swelling that persisted for 1 1/2 to 2 wks.
cold sweats, nausea, faintness, terrible pain in injection arm, heart palpitations, and blood pressure went low.
pt. recieved vaccine greater than 12 hours after being drawn up. MD contacted pt. no adverse event. pt. will do revaccination but not at this time.
Redness , pain,swelling,itching 1?x  2? at vaccine site.
Patient received both shots but in different arms Monday around 5:00pm. The following morning, she had the following symptoms: vomiting, chills, body aches, swollen glands, headache, fever. By Tuesday even her symptoms lessened but did not go completely away until Wednesday evening.
COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jul2022, outcome "unknown", COVID-19 (medically significant) with onset Jul2022, outcome "not recovered" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Rebound. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The Patient was received Paxlovid for treatment of Covid-19 from 11Jul2022 to 15Jul2022. Patient did no receive any other medications in 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax & w/in 45mins post vax pt exp blurred vision,facial numbness,elevated BP,inc heart rate;pt was observed;no treatment was given;sx resolved w/in 3hrs;
pt recv vax & exp swelling @ the inj site & redness @ inj site;
The day after I had my vaccine, I had chest pain, shortness of breath, heart pounding, heart racing, dizziness, and was very fatigued. I struggled to walk across the room or sit up for extended periods of time.
first shot in December 2019, never took the second; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in December 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient never took the second dose of Shingrix, which led to incomplete course of vaccination. The patient asked whether they need to get the second one now, almost two years later or need to start over with the first shot.