chrisvoncsefalvay/vaers-outcomes huggingface dataset:
From initial information received on 11Jun04 from a physician regarding an adverse event occurring, it was reported that a 41 year old female pt received  a dose of Acthib, a dose of Daptacel, a dose of Ipol and a dose of Prevnar, on 10Jun04. The lot numbers, routes and sites of administration were not reported. That evening, the pt developed a fever (the exact reading is unk at this time). The pt received the vaccine two years after a bone marrow transplant. Reportedly, the pt recovered from this event.
Patient came into pharmacy for 3rd dose booster. She was confused and thought she had received Pfizer initially. Patient had actually received 2 doses of Moderna.
15MAR91 rt leg & foot pain, numbness; felt swollen lasted 72 hrs; thereafter sharp, intermittant chest pain; 25MAR face rash; 26MAR body rash, itchy cleared in 3 days; Also experienced some dizziness;
purple/brown spot under the left corner of my eye/It doesn't hurt/right underneath the corner of my left eye, it looks like I got punched or ran into a wall; really sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 06Nov2023 at 11:00 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 06Nov2023, outcome "unknown", described as "really sore arm"; SKIN DISCOLOURATION (non-serious) with onset 06Nov2023 at 19:00, outcome "unknown", described as "purple/brown spot under the left corner of my eye/It doesn't hurt/right underneath the corner of my left eye, it looks like I got punched or ran into a wall".  Additional information: The patient developed a really sore arm after the vaccination. He also had a purple/brown spot under the right underneath corner of his left eye that wasn't there before he had the shot. It looked like someone punched him near the eye or walked into a wall but it doesn't hurt. Stated that this showed up about 8 hours after the shot. None of the doctors seem to be overly concerned about it.   The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
As a pharmacist immunizer, I chose to administer and receive Flumist for myself this flu season. I developed severe flu-like symptoms immediately after receiving the vaccine, and now five days later I am continuing to experience worsening symptoms. I have received this vaccine without any issues in previous years. I wanted to report this event in case there is a problem with this season's Flumist vaccine.
Classic ?Covid arm?, subcutaneous hypersensitivity.  Began ten days after shot and currently 48 hours since apparent onset.  Site size steadily increasing, puffy, red, hot to touch. Originally itched but that has decreased.  Still active situation. Not recovered yet.   Note: I had a similar reaction to a pneumonia shot in Spring 2016. Was just surprised this took so long as everything seemed fine. But reading online, it appears normal but still small number with this reaction.
Boiled in their groin area; Cyst in the armpit; This spontaneous case was reported by a nurse and describes the occurrence of FURUNCLE (Boiled in their groin area) and CYST (Cyst in the armpit) in a female 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 FURUNCLE (Boiled in their groin area) and CYST (Cyst in the armpit). At the time of the report, FURUNCLE (Boiled in their groin area) and CYST (Cyst in the armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was unknown if the patient had allergies (medications, food, and other products).  It was reported that the nurse could not provide the information regarding the vaccines the patient had took or personal information. It was unknown if patient had acute and chronic illnesses at the time of vaccination.  No concomitant medications were reported. There was no product complaint associated. No treatment medications were reported. It was unknown if patient ever had COVID positive test or diagnosis.   This case was linked to MOD-2022-500611 (Patient Link).
I developed fever, chills on January 28th. I was kind of certain it would be COVID19 but hoping it wasn't. Took some Tylenol that day. The next day he fever first thing in the morning was 103. I did a self COVID19 test later that day that was positive. Monday I called my Doctor's office. They prescribed Paxlovid. I picked it up later that evening and started taking it on 1/30th . The next day I was feeling much better. The fever was gone, I kept taking the Paxlovid until it was gone. I tested negative on 2/3 and my last dose of Paxlovid was on 2/4.
Syncope following vaccines. Pt lying down on table - BP 100/68, HR = 72. Pt did not eat or drink before coming to office; gave soda, pretzels - waited for 20 min - resolved, discharged to home.
Within 15-minutes of vaccination, the patient reported that their heart was racing. EMS monitored patient on-site. No record of hospital visit.
pt recv vax 26JUL95 & 20AUG5 exp rt testicular pain, significant fever & flank pain;22AUG95 pt was seen @ urgent care facility;dx epididymitis & orchitis;
Severe left upper extremity pain and fatigue for two days after that  I took two Tylenol?s and all the symptoms subsided
Information has been received from a physician concerning a female who on unspecified date was vaccinated with a dose of Gardasil and fainted and then had seizure.  Subsequently, the patient recovered from the seizure and fainting.  Unspecified medical attention was sought.  No other information was provided.  Upon internal review the seizure was found to be an other important medical event.  Additional information has been requested.
Patient developed hives on face and blotchy erythematous skin around eyes approximately 15 minutes after vaccination.
This spontaneous report was received from a medical assistant regarding multiple unspecified patients of unknown age and gender. The patients' medical history, drug reactions or allergies and concomitant medications were not provided. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (dose and route of administration were not provided), Lot # L004014, exp. 04-MAR-2017; L013429, exp. 21-JUL-2017; L014415, exp. 25-JUL-2017; L025733, exp. 28-JUL-2017; L019297, exp. 18-AUG-2017; and L017407, exp. 15-AUG-2017. No adverse effects were reported. No additional information was provided. This is one of six reports received from the same reporter. Additional information has been requested.
Today, we received a call from School, where the child attends reporting that patient received wrong immunizations on 12-8-21 when he was here for his well child visit.  Patient was new to clinic, and was behind on immunizations.  He was to have received a Kinrix, Proquad, Hepatitis B, Influenza but patient also received, inadvertently, a Boostrix.  We did contact GSK, and CDC about receiving extra antigen with the Boostrix of the Tdap.  I have scanned both responses into patients chart.  We have also reached out to Consultant, as it does show in database that both of these immunizations are now invalid.  Per her report, she does not know why it would say invalid, and has reached out to the State Registry to get a clarification on this, but per her recommendation he should be okay, and will receive his last immunization to get caught up in 6 months, which will be his Kinrix (dTap/Polio) and Hepatitis B. She will send me an email in regard to our conversation and it will also be scanned into patient's chart.  An report was completed by nurse administering vaccine, education given on double checking and having a review on what vaccine's are to be given prior to giving them.  We do have a message out to patient's parent, to see how he is doing today, if he has had any adverse reactions or symptoms of anything and a VAERS report will be filed.
Arm swollen, pain in arm, cold chills back pain arm pain right toes hurt fatigue could not sleep tired  dehydrated sleepy shoulder pain  bruising at injection site. Waiting for side affects to subsidize before seeking medical attention
He just feels like achy; Really achy; Chills; He does not feel good now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Dec2022 as dose number unknown, (booster) single (Lot number: Unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 07Dec2022, outcome "unknown"; MALAISE (non-serious) with onset 07Dec2022, outcome "unknown", described as "He does not feel good now"; PAIN (non-serious) with onset 07Dec2022, outcome "unknown", described as "He just feels like achy; Really achy".  Additional information: Reporter (wife) stated, her husband had the shot yesterday (on 06Dec2022) Bivalent and this morning he just felt like achy and he had chills but no fever just really achy. He did not feel good.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Feelings of hot and cold; overall feels terrible; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (Feelings of hot and cold), MALAISE (overall feels terrible) and CHILLS (Chills) in a 57-year-old male patient who received mRNA-1273 (batch nos. 004321A and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Feelings of hot and cold), MALAISE (overall feels terrible) and CHILLS (Chills). At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (Feelings of hot and cold), MALAISE (overall feels terrible) and CHILLS (Chills) had resolved.            No concomitant medications were reported.  No treatment information was reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Event outcome updated. No need to any further FU on this.
SIRVA (Shoulder injury related to vaccine administration); The vaccine was not injected into the muscle itself but into the muscle attachment or possibly the bursa; There is no noticeable improvement yet; Shoulder hurts at night; range of motion were limited; This is a spontaneous report from a contactable other healthcare professional (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that since the vaccination he has been suffering from quite severe shoulder problems, which have been diagnosed with a high degree of certainty as SIRVA (Shoulder injury related to vaccine administration). The vaccine was not injected into the muscle itself but into the muscle attachment or possibly the bursa. The patient wanted to know whether the vaccination was as effective as it would be if it were administered correctly, despite the fact that it was administered incorrectly. He said after more than four months with two cortisone treatments and physical exercises, there was no noticeable improvement so far. The shoulder hurts at night and range of motion were limited. He wanted to know about suggestions for a better therapy. Patient was treated by HCP. The outcome of events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Dizziness, nausea, diaphoresis, syncope/fall.  Totally blacked out and fell.  Helped back to bed, covered in sweat.  No fever.  Layed in bed until next morning around 10am, still dizzy and nauseated.
Physician receiving Daptacel with short expiration dates (4 months out upon receipt), patient had received expired Daptacel because of this; Initial information received on 21-Jun-2019 regarding an unsolicited valid non-serious case received from a physician.  This case linked with AER# 2019SA172651 and 2019SA172658 (same reporter).  This case involves a patient of an unknown age and gender who received an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [Daptacel] lot C5190AA (expiration dates (4 months out upon receipt) in an unknown route on 14-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medication were not provided.  It was an actual medication error case due to expired vaccine used. Physician stated that he had been receiving Daptacel with short expiration dates (4 months out upon receipt). He stated that this was unacceptable. He added that 3 separate patients have received expired Daptacel because of this.  It was not reported whether the patient had any adverse event 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 sender: none.
Information has been received from a physician concerning a patient who was orally vaccinated with a dose of ROTATEQ on an unspecified date. The patient vomited immediately after administration. It was unknown which dose in the series. The patient visit the office and was orally administered another dose of ROTATEQ. On unspecified date, the patient recovered. Additional information has been requested.
Large swelling of Right lower eyelid, apparently with clear fluid. No erythema. No respiratory symptoms-within 15 minutes of shots given 0.4 Epi IM (1:1000) and 40 mg Benadryl p.o. swelling decreased over PM. Observed in ED over 4 hours
Progressive, red, raised," gritty", confluent rash beginning on the trunk and progressing to total body except for soles of feet in about 24 hours.
13 y/o patient who was ordered to receive her Pfizer Bivalent COVID vaccine was administered a Monovalent Pfizer Pediatric Primary series vaccine for 5-11 year old patients instead. Pt has already received her two primary series COVID vaccines on 8/21/21 and 2/26/22.
"Patient received vaccines last week. She did get pneumonia vaccine in the left arm which did create a welt, but this resolved on its own. She denies any issues other than a slight reason the skin. She denies any pain. However, on the right arm she received her influenza vaccine. She states later that day she had some soreness which she has had in the past, however at night it significantly worsened. She states initially she cannot move her arm much at all. This progressed and she has been able to move it slightly more, however does still have trouble with internal rotation and needs assistance stressing. She has a hard time breast-feeding as well as picking up her child hurts her shoulders well. She has not had a reaction like this in the past. She does feel as if her vaccination may been given too high. She has been doing ice in trying different position changes but is having difficulty sleeping".
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 29 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing); "Known allergies: Birth control" (unspecified if ongoing); "Known allergies: Melons (Allergy)" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bactrim, reaction(s): "Allergy"; Levaquin, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient received treatment of Paxlovid started on 24Feb2023 and stopped on 28Feb2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Since the first dose I felt very dizzy and light headed , Also I have been feeling very fatigue. i have been tired before but this is different, it feels more like a weakness in my body , I also feel very nauseous it been happening more  frequently.
Client reported nausea around 6:35PM. The following was obtained with RN translating. The client was provided an emesis bag. Vitals obtained at 6:40PM were as follows: automatic BP 163/100, HR 91. The client denied any other s/s of anaphylaxis. The client was provided a cotton ball with Peppermint oil on it to smell. Repeat vitals obtained at 06:44PM were as follows: manual BP 160/70, HR 82. The client denied persistent nausea at that time. The client denied any s/s of anaphylaxis at 6:48 PM and stated the nausea was improving.  Repeat vitals obtained at 06:54PM were as follows: automatic BP 180/111, HR 82. Repeat manual BP obtained was 165/90. The client denied any s/s of anaphylaxis and stated his nausea resolved at 6:54PM. The client stated that he was feeling nervous today prior to arriving at the vaccination site. The client denied any particular cause for feeling nervous. The client reports a history of anxiety. He states that having his blood pressure taken makes him feel more nervous. Client has no known allergies. The client gets regular vitamin injections, but denies any other chronic medications. The client states he at a burger about one hour ago and has consumed water. The client ambulated unassisted out of the vaccination site at 7:02PM.
Case fell at home and was admitted to hospital. No other Covid symptoms reported. Case was discharged on 02/23/2022.
Pt has a PMH of recurrent pneumonia. Pt came to the ER from a SNF due to weakness and lethargy. Pt was found to be COVID positive and was admitted for dehydration and AKI.
App 30 minutes post vaccination, pt was observed to have facila flushing- asked to take down her mask, we noted facial swelling pt now stated she has some trouble breathing. Assisted to stretcher, VSS 139/96 hr 92 regular, resps 14 no wheenzinf however, possible stridor noted, no tongue swelling clear speech, tolerating secretions, O2 sat 100%- 911 called pt transported to hospital- uneventful.
Within about 5 days post-vaccine receipt, patient noted scalp 'discomfort' above/behind R) ear with some discomfort noted in R) ear, on right cheek and along right jawline. Denies pain or headache; no burning, pressure or aching - only describes as "discomfort". This discomfort lasted a few days and completely resolved. No visual changes; possibly some increased tearing of right eye, but no eye discomfort. No facial numbness or paralysis. No fever or chills. Approximately 5-7 days after symptoms, patient noted 2 papular lesions on the upper right side of his chin, followed by a 3rd lesion below his right lower lip. Lesions remain today - no progression of lesions to vesicles; no new lesions; lesions not painful or pruritic; no lesions in mouth. Patient did not shave over the holidays, but used separate razor to shave area of lesions this morning. No previous history of H. zoster outbreaks. However, patient has had recurrent fever blisters periodically which usually appear in nares on upper lip. Reports fever blister within 1-2 weeks prior to receipt of ZOSTAVAX vaccine. Patient remained symptom free except for static 3 lesions on chin until last p.m. when patient noted new onset pain in his R) ear canal when he tried to put in ear plug at bedtime. Describes the sensation of a "scratch" and very painful Pain has decreased significantly this a.m., but he wonders if there might be lesions in his ear. No recent history of ear infections or trauma. No drainage from ears. Has history of intermittent, recurring itching, usually in left ear, which he treats with cortisone cream as needed; no recent flares. No changes in hearing. Reports mild soreness of L) upper arm in area post-vaccine receipt. No joint pain or weakness. Aching pain not noted until 1-2 days post-vaccine receipt and continues intermittently. No significant or prolonged redness, swelling, or warmth surrounding site. Not restricting ROM.
Throat tightened, rated 5 out of 10, Benadryl given.
rash and itching on right side of body and face (thighs, stomach arm). Reports "feeling hot." itchy throat. Denies swelling in throat, tongue, lips or mouth. Denies SOB. Reports reaction started 40mn after injection but recalls ears turning "red and feeling hot" within first 15mn of injection.
lt arm sore morning p/vax given inj site red & swollen w/red streak running down arm;also swelling under arm;no other sx;fever when seen in ER given ATB & sent home on oral ATB
Was given PNEUMOVAX 23 Vaccine shot in right arm at 11:00 AM May 16, 2018. Started getting fever at 5:00 PM and pain swelling in arm. Fever up to 102 deg. F by 7:30 PM. Called Doctors office and was told to go to the Emergency Room. Went to Hospital, and was admitted. (White blood cell count was 17 on May 9 and 19 when the shot was given). Arm continued to swell and turn red. Was treated in hospital with MERREM, fever went down, but white blood cell count continued to go up to 26.2 by May 19, switched to Vancomycin for two days, white cell count dropped to 17, and fever dropped to normal but developed rash on back, so switched back to MERREM. Arm continued to swell until 5/21/18 then started going down. No fever, but white count started back up to 23.2 when discharged from the hospital on May 23. Mucus sample taken on May 17 contained Pseudomonas Aeruginosa. Went to ENT Doctor May 24, had MRI which showed left Maxillary sinus cavity full of ??. Swab sample sent to lab which showed Pseudomonas Aeruginosa. White blood cell count was 20.3 on May 30. Doctors still trying to determine cause of high white blood cell count. Could it be the Pseudomonas Aeruginosa in the Maxillary sinus cavity?
Red raised area at shot site (L) arm 7.5 cm x 8 cm, warm to touch, splotchy, slightly swollen.
Extensive DVT diagnosed on 4/28.  Patient vaccinated on 4/2 and 4/22.