chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe allergic reaction; itched at the injection site; violent red pustule; Initial information regarding an unsolicited valid non-serious case received from a consumer/non-hcp and transmitted to Sanofi on 06-Nov-2019.  This case involves an unknown age female patient who received influenza vaccine, and reported severe allergic reaction (PT- Vaccination site hypersensitivity) with violent red pustule (PT- Injection site erythema) and it itched at the injection site (PT- Injection site pruritus).  The past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer lot number not reported via unknown route.  On unknown date, (latency unknown) patient who received influenza vaccine, and reported severe allergic reaction (PT- Vaccination site hypersensitivity) with violent red pustule (PT- Injection site erythema) and it itched at the injection site (PT- Injection site pruritus).   It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown for all events.  Information on the batch number was requested.
He said that his arm has been sore since he got the shot and has not improved in the 3 weeks since.  He said it feels like he was punched in the muscle, but there was no  swelling or impairment of movement.  He did not want to go to the  doctor yet and would monitor for the next few days.  He did not seem overly concerned but wanted to let us know as it did not seem to be improving
About 10 seconds after the injection, my head began to hurt, I began to shake and from there I passed out. I woke up covered in sweat and was told that I had passed out for about a minute and had been shaking in a seizure like way for the entirety of the  time I was passed out. I then regained consciousness and laid down for a while while drinking juice and eating something.
a sore arm after getting the first dose.; red circle around initial injection site; warm to touch; initial injection site and was warm to touch and sore again.; and still looks swollen; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730), via an unspecified route of administration in left arm on 26Mar2021 at 14:00 (at the age of 43 years) as single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. On 04Apr2021 at 09:00, patient experienced sore arm, red circle around initial injection site, warm to touch, vaccination site pain and injection site swelling. The patient reported that she had nothing but a sore arm after getting the first dose. 8 days after shot (4/4) her arm had a quarter size red circle around initial injection site and was warm to touch and sore again. It continued to grow and was then a 3"x3" area and still looked swollen and red. The patient did not receive any treatment for the reported adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event sore arm, red circle around initial injection site, warm to touch, vaccination site pain and injection site swelling were not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
nausea & burn/tingle at the injection site.    Resolved w/o treatment - pt. declined EMS.
Patient is underage and received Moderna instead of Pfizer adult. Patient notified and advised to monitor for any reaction. Patient stated he was fine and asymptomatic.
Vaccine given on 03/07/2016 had expired on 03/04/2016.
MMRV was given instead of MMR. As well as the Varicalla was given.
Pt phoned office to report that by the next day after vaccination, 1/13/2022, she was feeling generally poorly and then later in the day at school she had a brief loss of consciousness. Reports that a familly friend who is a nurse to her by her work place and checked her vital signs which she said were fine; and she stayed with her that night and had started feeling a bit better this morning. At the nurse friends recommendation pt is going to get tested for covid
Pt recvd DTP on 22JUL91 @ 1130AM & started vomiting, & had elevated temp; Seen by MD on 22JUL91 evening; breathing deep & fast; 23JUL91 t103.5, returned to MD office; 24JUL91 afebrile;
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown date the patient was vaccinated with VAQTA, intramuscular. Route, dose, dose number, frequency and lot number were not reported. The nurse reported that improperly stored VAQTA may have been administered to unspecified patients. VAQTA was exposed to temperatures of 31.5F for 4 hours and 31.5F for 1.5 hours. No adverse effects were reported. This case is linked to 1309USA013283, 1309USA013284 and 1309USA013284 (same reporter link). Additional information is expected.
Patient presented to nursing clinic to pick up lab results and complained to nurse about ongoing pain/soreness/bruising in left arm following vaccine administration. Patient had a Tdap administered to left deltoid during routine physical exam 2 weeks ago. Patient made no mention to the vaccinating nurse of past history of neuropathy in left arm secondary to gangrenous infection in Left foot at age 30. Patient made no mention in medical history of any reason why the left arm should not be used for vaccine administration.
Increase in my standing heart rate after the vaccine. Sore arm -1st day. Fatigue-2-3days. Flu like symptoms. More flare ups of mast cell activation disorder.
A report has been received from a consumer concerning a 9 years old Female patient. No relevant history and concomitant diseases were reported. The patient had been receiving FLUMIST quadrivalent (intranasal), 0.2 millilitres, as one/single administration during Aug-2013. It was reported that three days after her daughter received the vaccine she began losing her vision and her head began a ticking motion to the left. She was later diagnosed with migraine with auras. Five months after the vaccination was given, in Jan 2014, she had a Grand mal seizure. Reporter stated that since that time her seizures have increased, her migraines have increased, and she now had hallucinations. The reporter's mother stated that her daughter could no longer attend public school due to these health issues. The daughter of the consumer was declared to be disabled. Action taken with FLUMIST quadrivalent was unknown. The outcome of the events of losing vision, Grand mal seizure, head began a ticking motion to the left, migraine with auras and hallucinations was unknown. The company physician considered the events of losing vision and Grand mal seizure as serious due to criteria of Important medical event and disability.
After getting the vaccine. the first day looked like a big red spot under the injection site and then got bigger and bigger, few days after, it turned purple, and it was defusing into the arm. After 36 hrs. my arm was fine, but then one day, I woke up , went to work and by the afternoon my arm was red again. And then went to the clinic and the doctor said to put heat and ice in the arm. I did that and my arm was better. No need to see the doctor again.
pt 2wk p/varicella exposure devel 4 distinct papules-2 were vesicles & 2 were scabbed lesions consistent w/varicella;
No additional AE; healthcare provider prescribed but she has never had any lung problems and does not believe she is in the high risk group; This spontaneous report as received from a female patient of unknown age. Information regarding the patient's concurrent conditions, medical history and concomitant medications was not provided.  On an unspecified dates, the patient  was vaccinated with  pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and pneumococcal vaccine conj 7v (CRM197). Then on 17-MAR-2021, her healthcare provided prescribed again vaccine, polyvalent (23-valent)(PNEUMOVAX23) (route, lot number and expiration date not reported) for prophylaxis. The patient stated that she had never had any lung problems and did not believe she was in the high risk group for pneumococcal infection. The caller reported she was confused as to why the healthcare provider prescribed her a second dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23). The pharmacist did not give her the second dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23). No additional adverse event was provided.
On 10/11 woke up with horrible muscle aches and just very tired, felt like I was getting sick. All I did was sleep and work the next few days, even on my days off I would just lay around. On 10/15 I was returning home from a dentist appointment that I didn't feel well enough to go to, but I had to go. I got home around 10 am that day. Starting throwing up until there was nothing in my stomach. A hour into puking, I started having diarrhea. The puking stoped but the diarrhea didnt stop until the next day 10/16 around 2 am. Today 10/16 12:30 pm I still have horrible muscle aches. Was able to eat approx. 1/2 cup of soup broth. Stomach feels as if someone is squeezing it. And I don't want to move off of the couch. All of my joints hurt horribly tho and I cannot get comfortable. Very dehydrated but not thirsty.  Trying to sip water and ginger ale as much as possible.
REDNESS TO (L) ARM IMM-SITE TREATMENT MOTRIN; ICE
pt recvd vax; pt had severe musculoskeletal, stiff neck, stiff back & febrile rxn;
Very sore throat, swollen neck. No fever or other symptoms. Started 2 days ago and has not improved.
This non-serious medically confirmed report (initial receipt 10-Dec-2014) concerns a 60 year old female patient who had drug allergies to sulfa drugs, tetanus immunoglobulin, cyclosporine, ciprofloxacin, letrozole, exemestane and anastrozole. It was not known whether the patient had received AFLURIA in the past. The patient had received a flu vaccine before including GlaxoSmithKline's vaccine in 2009. The patient had no history of arm of shoulder injury. On the 11-Oct-2014, the patient received AFLURIA (batch number 10049221B) 0.5 mL annually via the intramuscular route in the left arm for the prevention of influenza. On the 12-Oct-2014, one day later, she noticed at the injection site that her arm was painful, red, swollen and warm to touch. On the 13-Oct-2014, she visited her physician who prescribed cephalexin, diphenhydramine and cortisone for her symptoms. As of the 10-Dec-2014, all the patient's symptoms had disappeared except for the pain which was affecting her range of motion. Outcome was not recovered.
Soreness in left breast; Nausea; Extreme fatigue; Experienced weakness with in 10-15 mins after receiving vaccine/All patient wanted to do was lay down after receiving the vaccine; Equilibrium issues; Perfused perspiration/Woke up midnight with perfused sweating; Lack of appetite; General malaise; Low grade flu; Confusion borderline delirium and couldn't find papers that were given to her and they were sitting underneath the candy on the table; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Experienced weakness with in 10-15 mins after receiving vaccine/All patient wanted to do was lay down after receiving the vaccine), BALANCE DISORDER (Equilibrium issues), HYPERHIDROSIS (Perfused perspiration/Woke up midnight with perfused sweating), DECREASED APPETITE (Lack of appetite) and MALAISE (General malaise) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, the patient experienced ASTHENIA (Experienced weakness with in 10-15 mins after receiving vaccine/All patient wanted to do was lay down after receiving the vaccine), BALANCE DISORDER (Equilibrium issues), HYPERHIDROSIS (Perfused perspiration/Woke up midnight with perfused sweating), DECREASED APPETITE (Lack of appetite), MALAISE (General malaise), INFLUENZA (Low grade flu), CONFUSIONAL STATE (Confusion borderline delirium and couldn't find papers that were given to her and they were sitting underneath the candy on the table), NAUSEA (Nausea) and FATIGUE (Extreme fatigue). On 18-Jun-2021, the patient experienced BREAST PAIN (Soreness in left breast). On 18-Jun-2021, HYPERHIDROSIS (Perfused perspiration/Woke up midnight with perfused sweating), CONFUSIONAL STATE (Confusion borderline delirium and couldn't find papers that were given to her and they were sitting underneath the candy on the table) and NAUSEA (Nausea) had resolved. At the time of the report, ASTHENIA (Experienced weakness with in 10-15 mins after receiving vaccine/All patient wanted to do was lay down after receiving the vaccine), BALANCE DISORDER (Equilibrium issues), DECREASED APPETITE (Lack of appetite), MALAISE (General malaise), INFLUENZA (Low grade flu), BREAST PAIN (Soreness in left breast) and FATIGUE (Extreme fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment drugs were reported.
PATIENT STATES THAT AT THE MOMENT SHE RECEIVED THE INJECTION SHE HAD MORE PAIN THAN ANY OTHER VACCINE SHE HAS HAD IN THE PAST YEARS. (NO OTHER RECENT VACCINES)  SHE REPORTS THAT SHE FELT THAT THE VACCINE WAS GIVEN HIGHER ON THE DELTOID THAN SHE HAD PREVIOUSLY EXPERIENCED BY OTHER VACCINES IN HER LIFETIME. HER PAIN IS WORSE WITH MOVEMENT, EXAMPLE SHE GAVE WAS THAT PULLING ON HER PANTS IS CHALLENGING. HER PAIN IS DESCRIBED AS CONSISTENT AND NOT IMPROVING SINCE SHE GOT THE VACCINE 8/24/2022, 1 WEEK AGO.  SHE HAS TRIED ADVIL WITH NO RELIEF.  SUGGESTED SHE MAY TRY TYLENOL AND COOL PACKS ON HER ARM. SHE HAS BEEN TRYING TO CONTACT HER PRIMARY PHYSICIAN BUT HAS NOT BEEN ABLE TO GET THROUGH, THE LINE HAS BEEN BUSY.  SHE WILL CONTINUE TO REACH OUT TO HER PRIMARY MD TO DISCUSS THIS WITH HER. REPORTED TO PHARMACY INCIDENT HOTLINE
pt reports hives-like rash over entire body 4 days following vax, 2nd dose;pt was seen by MD & given cortisone & took DPH;skin cleared in 48hrs
Pt reported to pharmacy to get flu shot and stated her arm has been terribly bruised since she received the second SHINGRIX shot. Showed me her arm and it is still very bruised, yellow, and purple.
This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 22-JUL-2016 the patient was vaccinated with an improperly stored dose of PROQUAD with lot # M001152 Expiration date: 05-JUL-2017 (dose, route and anatomical location of administration were not reported). No concomitant therapy was provided. The temperature was -14 C for 4 days. No data logger and no previous excursions were involved. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of three reports received from the same source. Additional information has been requested.
Approximately 24 hours after receiving second series of Moderna vaccine, patient developed chest pain, shortness of breath.
Rec'd Hep B 6/2/11 on 6/5/11 early am, noted to have 3 papule on (R) wrist. No temp, no somatic sxs. Exam on 6/8/11 reflects likely contact rash.
2 hrs 45 min p/receiving vax child vomited, became pale & lifeless, temp 97.3;
From initial information received on June 27 2005 from a health care professional regarding an adverse event, it was reported that a 16 year old male patient received a dose of Menactra vaccine, lot number U1589AA, administered in the right arm at 3:10pm on June 14 2004. twenty minutes later the patient left the building and fainted in his car. it was not reported if the patient needed any treatment. reportedly the patient recovered from this event. The reporter of this is the same reporter of cases: 200501235, 200501236, 200501237, 200501238 and 200501240.
While working online the morning of Thursday, Feb. 4, my arm was itching. I felt a lump. When checked, I had a prominent red rash from the injection site extending 2/3 of the way to the elbow. There were 2 red patches and 2 "lumps" both in the lower patch. One lump was larger than the other and looked purple, like a bruise. That was the itchiest point. There was no pain. Onset was 8 days after injection. I notified my doctor's office. I took Tylenol PM 3 times (mostly for the Benedryl it contains) when I went to bed on  the nights of Feb. 5, Feb. 7 and Feb. 9. It is mostly gone, but I can still see where the lower rash patch and lump were - they are still minimally present. Therefore, I am checking "unknown" below where it asks if patient has recovered from the adverse event. I took pictures of the rash if needed.
I started noticing that when I yelled there was an echo afterwards, I would sing to my dogs and I would hear an echo so  ignored it, I think that was connected to the fist dose because after the 2nd dose both of ears would ring. It first started on my left and then both ear were ringing and it was annoying. I went to my doctor, MD and he said there was nothing he could do. I had a hearing test and everything came back fine. I just hope it goes away on its own. I am not getting the booster because I feel like this will be getting worse and I don't wanna take that chance right now.
seemed to have affect arthritis in my hands pain level 10 seemed to get better over time but a month later pain is still there comes and goes. also muscle fatigue. whole body fatigue. diarrhea all the next day.  extreme headache that night and next day. that also has subsided some but i have headache everyday still.  body pain flares up still. also noticed some swelling at ankle area not sure if its related or not. but waiting for dr to tell me what test to have done on it. xray?
Random skin itching, no whelps or visible signs of rash.  Itching in one spot which is migratory.
Pale, lethargic, Vomiting. Site of injection was red, inflamed, swollen, right after received injection. Very lethargic after shot. Vomiting started 8/20/16? He couldn't even keep mild or water down. Tried to give Pedialght but wouldn't drink. All symptoms lasted multiple days. Gave small amounts of breast milk & water.
whole left arm hurt including the top of the shoulder/ the whole Left arm, shoulder and wrist, is sore; whole left arm hurt including the top of the shoulder/ the whole Left arm, shoulder and wrist, is sore; a little pain at the site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 74 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Feb2021 (Batch/Lot number: unknown) at the age of 74 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Feb2021, outcome "unknown", described as "a little pain at the site"; PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious) all with onset Mar2021, outcome "unknown" and all described as "whole left arm hurt including the top of the shoulder/ the whole Left arm, shoulder and wrist, is sore". The events "a little pain at the site", "whole left arm hurt including the top of the shoulder/ the whole left arm, shoulder and wrist, is sore" and "whole left arm hurt including the top of the shoulder/ the whole left arm, shoulder and wrist, is sore" were evaluated at the physician office visit. Therapeutic measures were taken as a result of vaccination site pain, pain in extremity, arthralgia; patient was given gabapentin and a topical cream .  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Significant right arm redness swelling from injection sight inferior to just above elbow and extending superiorly to right shoulder, also next day developed right sided facial swelling.  pt also developed fever.  Fever lasted for less than 24 hours.  Face swelling improved after less than 24 hours.  Arm swelling also improved in 24 hours.
Tested positive for Covid19 on 18Apr2021, with symptoms starting on 16Apr2021, after receiving her first dose of the Covid Vaccine on 07Apr2021; Cough; Runny nose; This is a spontaneous report from a Pfizer sponsored program. A contactable Nurse reported for her 17-year-old daughter (patient). A 17-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0150; Expiration Date: 31Jul2021), dose 1 via an unspecified route of administration, administered in left arm on 07Apr2021 at 09:50 (at the age of 17 years) as 1st dose, single for COVID-19 immunisation. The patient had no medical and familial history. The patient did not take any concomitant medications. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect. The patient had no other additional vaccines administered on same date of the Pfizer suspect. Patient had no prior vaccinations within 4 weeks. On 16Apr2021, evening, the patient started with a slight cough and runny nose and thought it was allergies. The reporter stated that the patient's friend tested positive on Thursday and they were also tested Thursday and she was negative and then Sunday, she tested again and was positive. On 18Apr2021, the patient was tested positive for Covid 19 and was clear now. The patient recovered from her symptoms by 23Apr2021 but she was isolated for the full 10 days. The reporter asked whether it was okay to take second dose after testing positive for COVID-19. The patient did not receive any treatment other than rest. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 18Apr2021 and negative on unspecified date in 2021. The outcome of the event Covid-19 was unknown, and outcome of the event cough and runny nose was recovered on 23Apr2021.  No follow-up attempts are needed. No further information is expected.
I experienced a high fever (102F) throughout the night following my second dose. About 36 hours after receiving the shot I experienced severe vertigo, which continued for multiple days, leading me to seek care from my doctor.
This non-serious spontaneous case, initially received from a pharmacist on 24-Jan-2018, concerns a female pregnant patient of an unspecified age. On an unspecified date, the pregnant patient was administered with FLUVIRIN (dose, route of administration, anatomical location, batch number and expiry date: not reported) (explicitly coded as vaccine exposure during pregnancy).
Diaphoresis, fainting, unconsc 3-4 sec, weak, pallor, H2O 36 oz, ice pk, elevated feet, laid down for 20 min.
Lg local reaction redness 7 1/2 inches / 4 1/2 inches plus induration 2 1/2 inches at site.