chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion); patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 68-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The reporter was an internal medicine manager.  Concomitant medication of the patient was not reported.  The reporter reported that because their facility had not been able to download the digital data logger, they had been put on hold by the State at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment by the state was made. There had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, this issue was treated as a temperature excursion. The reporter was unable to download the data logger for the months of December 2021, January 2022 and February 2022. The reporter was filling out a temperature excursion assessment with the State.   The reporter mentioned that the patient had been administered dose while the temperature excursion assessment was ongoing. The reporter also reported that, no adverse reactions were reported by the patient.  No treatment information was provided by the reporter.
At approximately 4:30pm I began to feel very achy with chills. I also became slightly disoriented  and had a severe headache. I went to bed and woke up at approximately 2:30 AM feeling very hot, dizzy and nauseous with continuation of above symptoms. I made my way to my bathroom and realized I had diarrhea. I sat on the toilet and passed out. I woke up on my bathroom floor. Length of time unknown. I could not stand because of dizziness and extreme nausea. I crawled  back to my bed and fell asleep.  Upon waking in the morning I opened up my eyes and the room was spinning very fast?apparently vertigo which I?ve never had prior. I closed my eyes and reopened them I saw a flash of white before my eyes and my eyes went up to the left upper corner of my ceiling and I felt a tremor in my body?I thought I was possibly starting a seizure. I blacked out and awoke again with extreme vertigo which subsided and I was able to get out of bed. The vertigo continued for 3 days. I felt weak and had brain fog for approximately 9 days.
Received first injection on 1/4/21 with only side effect of arm soreness.  Then, on 1/12/21, L arm became itchy and I noted a 3cm x 3cm red, warm, raised, and firm circle at the injection site.  On 1/13, reaction grew to 6cm x 4.5cm, with slightly less firmness.  Still warm and tender.  No other symptoms (fever, SOB, etc) noted.
9 days post smallpox vaccination pt presented with pustular lesions spreading from the site of the vaccination to his shoulder and back.
Patient hot and flushed.  Felt tingling sensation in arms.  Given benadryl.  Feeling better after 30 minutes.
I was eating lunch with friends around 1pm when I suddenly began having a tingling feeling all over my body. I became hot, flush, sweaty, and dizzy. I proceeded to the bathroom where I appeared pale. I took my pulse which was extremely slow (20-40bpm). I realized I may die or pass out. I reached for the door and I don't remember anything until waking up on the bathroom floor. I was able to get up on my own. I was able to compose myself and walk to my car. I got a ride home. I remained dizzy and having heart palpitations for about 1 hour. I did not seek medical care. I continued to having hot flashing and tingling feelings throughout the evening. Today, 3/5, I have joint pain and fatigue and occasional dizziness.
Received Vaccine on 1/2/2021 at 10AM , at 3PM employee felt itchy, took a nap, and at 8PM she had a circular redden skin rash on her arms, legs, and torso. Temperature: 99 degrees. Employee took Tylenol and Claritin for rash, complained of diarrhea, vomiting, and weakness of both knees within 24 hours all symptoms were gone.
Information has been received from a physician concerning a 42 month old female who on 14-NOV-2003 was vaccinated with varicella virus vaccine live (Oka/Merck) (lot#644087/0975M). There was no concomitant medication. On 22-MAY-2006 the patient experienced moderate breakthrough case of chicken pox. The patient did not undergo any lab/diagnostic tests. The only reported adverse reaction were the varicella lesions, a few lesions with no fever or puritis. Additional information is not expected.
no adverse event; Interchange of vaccine products; This spontaneous report was received from a nurse referred to a 52-year-old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  The patient had already received 2 previous doses of A vaccine INACT, hepatitis B vaccine RHBSAG (YEAST) (TWINRIX). On 06-FEB-2023, the patient was vaccinated with the first dose of hepatitis A vaccine INACT, hepatitis B vaccine RHBSAG (YEAST) (TWINRIX) as prophylaxis. On 12-MAR-2023, the patient was vaccinated with the second dose of hepatitis A vaccine INACT, hepatitis B vaccine RHBSAG (YEAST) (TWINRIX) as prophylaxis. On 17-AUG-2023, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, 1 milliliter, lot #W036194, expiration date: 29-SEP-2025, as prophylaxis (strength, and route of administration were not provided), which was used to complete a Hepatitis B series as the third dose of hepatitis A vaccine INACT, hepatitis B vaccine RHBSAG (YEAST) (TWINRIX) (Interchange of vaccine products). No further adverse event (no adverse event) was reported.
12/4/15 pt received vaccine. Patient states soreness in arm has not gone away. Very sore after sleeping hard to raise arm.
Itching under my skin in my arm; This case was reported by a consumer via interactive digital media and described the occurrence of itchy skin in a 77-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (experienced shingles problem in year 2002 at the age of 57 years, it was first attack, from back of his/her head down to neck and to whole arm right side its so much pain and burning, the patient asked the best medicine and the sales lady gave cream (unspecified) but still patient felt pain so much itching but did not scratch it).  On an unknown date, the patient received Shingrix. On an unknown date, more than a year after receiving Shingrix, the patient experienced itchy skin. On an unknown date, the outcome of the itchy skin was not recovered/not resolved.  It was unknown if the reporter considered the itchy skin to be related to Shingrix.  RERUN Additional details were reported as follows: This patient self reported the case. The age at vaccination was not reported. The patient received shingle shot in 2018 and since then, yearly felt itching under skin in arm just for 3 months. The follow up would not be possible as no contact details were available. This case has been linked with case US2021AMR177031 and US2021AMR177044, reported by the same reporter
permanent tingling in both hands and arms/ long term damage; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious), outcome "unknown", described as "permanent tingling in both hands and arms/ long term damage". The events "permanent tingling in both hands and arms/ long term damage" required emergency room visit.  Additional information: Patient got the first one ended up in the ER that night, now have permanent tingling in both hands and arms Tks a lot Now that were finding out the long term damage this untested chemical mixture has caused but no recourse to those affected because the stupid protection.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Violent vomiting 1 hr after injection, nausea for 3 days after, hives started later that night. Hives became severe over next few days until I was started on steroids.
pt recv vax & during the procedure of fingerstick for blood work pt pale & dizzy;
I am on hormonal birth control and I always start my period 3 days into the placebo pills. This month (2 weeks after the second dose) my period started before I finished the hormones. About 3 days before they were done. I also had noticibly more cramping and the bleeding was light but a very dark brown. I haven't done anything for it yet. I am monitoring it to see if it gets better or worse. I believe that maybe the vaccine did something to my hormones because the morning after Vax #2 my breasts and nipples were sore.
Shingles outbreak on abdomen - right side - in a vertical pattern (streak) from mid-abdomen to mid-back Fatigue, lethargy  Stabbing pain in area
Patient had stated that he got a reaction the first time he received the vaccine, but the MD recommended he get it again. After the vaccine, he came back a few hours later to the pharmacy and stated he had the same side effects as the first time he got it 5 years ago. The adverse events were as follows: burning in the eyes, diarrhea, and yellowy thick discharge coming out of the corners of his eye. I told him to proceed with some OTC treatments and if anything worsened to contact his MD.
Patient stated that she felt dizzy immediately following administration of the 1st dose of Moderna vaccine. Patient refused vital signs and assessment. Patient stated that she did not want to upset husband by staying long and that her dizziness was a result of anxiety.
Four days after the vaccine I started experiencing foot pain and extremity swelling with some shooting pains throughout body. General Practioner recommended taking aspirin and seeing specialists to determine what adverse reaction was coming from.  Saw gastroenterologist, cardiologist, podiatrist, neurologist.  Symptons/swelling lasted approximately 2 months- making it extremely difficult to walk without pain.  Vaccination site recommended not getting another MRNA type vaccine due to adverse response. I did participate in VAERS program at the time.
NUMEROUS BLOOD CLOTS IN RIGHT LEG; This spontaneous report received from a patient concerned a patient. The patient's height and weight were not reported. No medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total dose administered in MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date (about 6 weeks later), the patient developed numerous blood clots in right leg. In JUN-2021, the patient visited to primary doctor. The doctor asked the patient to keep an eye on the clots, as the patient had not experienced any pain. By AUG-2021, the clots started hurting, stinging, and burning. In SEP-2021, the patient called the doctor and went for examination. The doctor performed a procedure and instructed the patient to return in a month. On 20-OCT-2021, the patient had second visit to the doctor. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of numerous blood clots in right leg was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211061595-Covid-19 vaccine ad26.cov2.s- Numerous blood clots in right leg,. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Noticed blood in my urine two days after receiving the first Moderna shot, something that has never happened before. Noticeable at the end of the urination stream, very red and not very dilute. About that same time, I noticed a burning sensation in my urethra, mostly near my penis head. Spotty bleeding continued 2x-3x/week from September 2021 through to April 19, 2022...it's been a week without noticing any blood however.
at the time of vaccine at the location, I had a rash and hives within 5 minutes of the vaccine.  At 30 min past the vaccine the vaccine center gave me 25 mg of benadryl and had me follow up with an urgent care center.  I went home and took hydrozine because I continued to have hives and a rash, I could not afford to seek emergency help at the urgent care center and stated that to the vaccine center.  The vaccine center said because I was able to breathe they could not transport me to the emergency room or urgent care center.
Large lump in armpit.  Not the arm I was injected with the vaccine.  Went to Dr and he said it was an inflamed lymph node.  He put me on Keflex for 10 days and told me to call him after 10 days to let him know if it went away.
9/20/23 patient came into pharmacy flu clinic to get flu shot, received it, and then left the pharmacy. When we tried to bill the insurance, the insurance rejected the claim indicating that patient already received the flu shot at another pharmacy 9/6/23, which was confirmed with pharmacy. Patient received 2 flu shots in a month timeframe. When we spoke to the patient via phone today 9/21/23, patient was confused and said he didn't remembering getting flu shot at other pharmacy. His story was not consistent. Patient reports of no ADR reports, feeling good.
lethargic; sore throat; radh; This is a spontaneous report from a contactable consumer or other non hcp.  This consumer reported for a 15-years-old non-pregnant female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 14May2021 16:30 as 1ST DOSE, SINGLE for covid-19 immunisation .  The patient's medical history was none.  Patient's concomitant medications were not reported. Patient had no known allergies. On17May2021, 3 days after vaccine, she had a very sore throat, radh and was lethargic. Patient treatment was unknown. It was reported that most recent COVID-19 vaccine was administered at Public Health Clinic. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine.  Patient did not received any medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been not tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test and strep: negative  on 19May2021. The outcome of all event was recovering.  Information on the batch/lot number has been requested.
injection site pain, fatigue, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, malaise
Patient reported  symptoms of chest pain, headache and dizziness. EKG, continuous telemetry, oxygen and labs were done. Chest pain lessened, headache remained the same and patient was given Tylenol. MD felt headache was probably r/t pre existing osteopathic changes in her neck and shoulder. Patient received meclizine and acetaminophen.
had side effects of "tongue feels swollen and globus sensation in my throat."; had side effects of "tongue feels swollen and globus sensation in my throat."; she did not have a lot of injection site pain, it very minimal.; bruise or ecchymosis at the injection site; bruise or ecchymosis at the injection site; This is a spontaneous report from a contactable physician (patient) via a Pfizer sponsored program Pfizer First Connect. A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EH9899) via intramuscular on 19Dec2020 09:00 on left deltoid at a single dose for COVID-19 prophylaxis. The patient medical history, family history and relevant tests were reported as none. Current concomitant medications included multivitamin took 2 chewable gummies sporadically for years as supplementation therapy. The patient previously took Flu shots she got a sore arm. It was not bad. Tetanus gives her a sore arm, but that was all. Caller wanted to know what she should do for preparation to safely get second dose of Covid vaccine and how to fix what she was feeling right now, making sure it doesn't get worse, considering she is still having symptoms. Caller stated that she had side effects of tongue felt swollen and globus sensation in her throat. The transferring agent stated that he has a caller on the line that was calling about the Covid-19 Vaccine and reported that the patient got the shot on the 19Dec2020 and was inquiring about to proceed with her weird side effects. Caller had not told her physician about her symptoms yet. Caller clarified that she said a half an hour after the dose on 19Dec2020 09:30 she said that she had a Globus sensation or like a lump in her throat. Caller also reported that the back of her tongue felt swollen. Caller said that the Globus sensation was intermittent and it was not as prominent now as it was. Caller said that it was medically significant, but she has not sought medical treatment yet. Caller said that she still had a bruise or ecchymosis at the injection site. She said that the injection was high but reported that she did not have a lot of injection site pain, it very minimal. No emergency room or physician office required. The outcome of the event tongue felt swollen and globus sensation in her throat was recovering and the outcome of the event a bruise or ecchymosis at the injection site was not recovered and the outcome of the event minimal injection site pain was unknown.; Sender's Comments: There is a plausible chronological association between vaccine administration and onset of the events. Causality cannot be completely excluded.
Got a rash and bumps all over body to include a shingles breakout on left leg.  Still have a rash and shingles 12 days later.  Also seem to have slight headaches throughout the day
This spontaneous report as received from a healthcare worker refers to a patient of unknown gender and age. On an unknown date the patient was vaccinated with GARDASIL. On an unknown date the patient experienced itchy rash and swelling on her face. The outcome of itchy rash and swelling on her face is unknown. Additional information has been requested.
I started itching and having a little redness on my penis the following evening after receiving the vaccine, then by the next day It was itching and continued to get worse, and now it's swollen too. My doctor called me in medication for a yeast infection, but it didn't help it, I had taken 2 rounds of medicine for it, and today they had to call in more medicine for it because it doesn't want to go away and I am sure it's from the 2nd Covid vaccine I received, how I know is because my girlfriend got the yeast infection too, but we hadn't had sex in months, so sex didn't cause it. And my girlfriend got the shot the same day I got mine, so now we both have a infection from it
Pharmacist called and reported that a 48 year old female received the first dose of GARDASIL-9 a few months ago. No additional AE reported. No PQC reported. No additional information provided.; Pharmacist called and reported that a 48 year old female received the first dose of GARDASIL-9 a few months ago. No additional AE reported. No PQC reported. No additional information provided.; This spontaneous report was received from a pharmacist and referred to a 48-years-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not reported.  On an unknown date reported as "a few months ago",  the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, dose number, frequency, route, anatomical location, lot number, and expiration date were not reported), for prophylaxis (product administered to patient of inappropriate age); no adverse event was reported.
One of the physician observers wrote: From what I understand she had her shot and switched places with her sister and was standing and then just went down. I don?t believe she hit her head we didn?t see a lump. She came too right away and got nauseated and light-headed again sitting up so we took her to lay down on the stretcher. She was doing ok but laying down when I left.   The nurse that administered the immunization wrote: She got vaccinated, tolerated it well. Told her sister she barely felt it and expressed relief. Sat for a minute while in handed her mom paperwork ( vaccination card). Then got up, stood with mom and brother. Was standing one minute and went down without warning, standing next to brother and mom. I had just finished vaccinating the sister, I was putting a bandaid on her when it happened so couldn't have been more than a couple of minutes.   Dr.  observed this patient after they passed out at the vaccination clinic and subsequently released her home with the family.