chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Guillain-Barre; Initial information received on 29-Jun-2023 by health care professional regarding an unsolicited valid serious case issued from a literature article:   This case involves a female patient (age not reported; case 3) who experienced Guillain-Barre while receiving influenza vaccine (latency: unknown).  Her medical history was significant for osteoporosis, diabetes mellitus, chronic kidney disease, essential hypertension, multiple urinary tract infections, remission of squamous cell carcinoma.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed Guillain-Barre (Guillain-Barre syndrome) after influenza vaccination. At the time of reporting she was retired and lived alone, and she had recently become the main caregiver for her husband while he was in hospice.  Action taken: Not applicable Corrective treatment: Unknown Outcome: Unknown Seriousness criteria: Medically significant  Reporter causality: Related; Sender's Comments: Sanofi company comment dated 05-JUL-2023: This case involves an unknown age female patient (case 3) who experienced Guillain-Barre while receiving influenza vaccine. Based on information received the causal role of VACCINE cannot be excluded due to compatible temporal relationship of ADR to the VACCINE. Further information regarding time to onset, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of vaccine cannot be assessed.
On feb 26th I began to have severe chest pains. It went away after 20 min. On 03/05/2021, the pain began again. Again after 20 min it went away. On 03/06/2021, I was getting ready for bed and the chest pain began again. This time the pain radiated to my jaw and around my chest to my back and down both arms. I went to the hospital at about 11 pm. When I got back into a room and after taking nitro for the angina and doing an EKG  they cam to the conclusion that I had a heart attack of the main artery supplying blood to my heart. I was in the hospital for 2 days after receiving a stint to keep my artery open.
Had dose #3 and about 15 min after receiving GARDASIL 9 and MENACTRA - stated she couldn't see; became pale, sweaty - pressure dropped but did not completely Faint.
Patient fainted for a moment and felt down while standing. Patient was conscious right after falling, was able to talk and did not feel any symptoms other than sweetness which could have caused by wearing hat that he was wearing.  EMS took patient.
4-5cm diameter red, hot cellulitis around vaccinatio resolved p/10 days course of keflex;
Soreness such that it was painful to move arm, redness about 3.5 inches wide, swelling as of 9/1/2021. Note: I am still experiencing itching and burning of face and eye irritation from shingles that I came down with  in the face on July 29, 2020.
I developed a rash on my chest, central abdomen, back, neck and face 1 week after my vaccine.  There were no new foods eaten or detergents used.  I never get rashes and there was no other explanation for it.  I did not seek treatment for it and I still have the rash.  It is the same - not getting better or worse.
PATIENT received Booster dose of Moderna 0.25  Patient ? facial and upper extremities tingling.C/o pain to Left arm/shoulder on Vaccinated arm. No perioral edema or redness. Respiration rates WNL, vitals taken and pt denied respiratory distress, not ? oral swelling or swallowing problems. Color normal. Patient denied history of anaphylaxis and was not in any distress. Discussed potential for anaphylaxis and pt initially told site lead he would leave if he needed transport or Epi.   13:15 He was refusing meds and took own oral Benadryl 50mg as that was his treatment for previous mild allergic reactions. He remained stable and symptoms remained unchanged. 13:47 another set of vitals taken, still wanting to leave and was told he needed to remain in observation, he began complaining of some increased redness and heat to his face and felt like a sunburn. No respiratory distress, nor visible signs of facial or oral edema.  13:56 Pt stated his tongue felt like it was starting to swell.  13:57 Epi administered and EMS called and vitals taken after administration of EPI.   Medications administered:  13:57 Epi Pen to Left Thigh   Disposition:  EMS arrived on site at approx 14:00, care transferred to EMS and at 14:10 Vitals per EMS: Pulse 70, BP 148/86 and O2 Sat 100% Pt transported to hospital 14:15
9AUG93 vomited x 3 since 9AM, t102 ax, lt thigh swollen & hard, rt thigh 1/2 dollar size area of redness; 9AUG93 330PM TC mom reports was seen by MD & given rx for nausea;
Post vax, the pt developed cervical adenopathy-right post-aurticular and right and left post cervical approximately 1 1/2 x 2 cm arm and mildly tender. On 10/4, the pt developed a macular papular rash. Symptoms completely resolved.
After the vaccine I had severe IDs and stomach issuesGastroparesisIncreaseAndNerveIssues neurological issuesFeeling like my insides are shakingOr vibratingAnd issues with myRight hand  shakingAnd right leg shaking. My body acted like it was trying to get rid of something starting with head congestionThen nauseaAnd throwing up then diarrhea then the chills all within 20 minutes and then I was fineTwo times in one week
I woke up on Friday and I had hives around my groin, and it was itching. I took some medicine. It kept getting worse - got hives up my neck and different places. Urgent Care they IM - Solumedrol - gave me prescription for 40 mg of Prednisone for three days and then 20 mg of Prednisone for additional 3 days. They gave me Kenalog cream - to use twice a day. Started that on Saturday. They called it contact dermatitis but didn't know what I had. On Sunday, it was worse, my throat felt tight. Came to work; took my Prednisone but still have hives everywhere and went back to Urgent Care and they gave me a shot of 50 mg of Benadryl and then my throat finally eased up. They told me take Benadryl every 6 hours and told me to finish off the Prednisone. They gave me meds for scabies, but it wasn't scabies - treated for that and I'm sure that it isn't it. I must take Benadryl every four hours. If I don't, I start itching. I do have one more day (tomorrow left on Prednisone). I thought the hives weren't bad when I woke up this morning but then I stood up and I was covered in hives again. These are hives - they come and go. I had the flu vaccine about a week before this booster vaccine. I think I got it on a Thursday. I got it at work. I think I got it in my left arm, too. I don't know what brand it was.
t102 ax followed by convuls occurred approx 30 minutes p/arrival; home following 8AM clinc appointment where immun were given; seen in ER:
Combined initial report received from physician via email on 29 Oct 2010 and 03 Nov 2010: This patient was vaccinated with MENVEO (batch number not known) on an unspecified date. The site and route of administration were not known. One week following vaccination, the patient experienced facial paresis and vestibular affection (NOS). The outcome and other details of the events were not provided. The physician did not report any seriousness criterion for the suspect vaccination reaction.
hot flushing feeling, light headed, legs heavy gave patient a chair to sit and candy symptoms resolved by 11:36
This is a  18 Years old  Male  presenting with chest pain for 2 days.  The patient got a booster shot of the COVID-19 vaccination 2 days ago and has since been having chest pain and palpitations.  His chest pain and palpitations were worse on the day after he got his COVID-19 injection.  His symptoms are improved now and he describes them as mild.  His pain began gradually, is described as dull and aching, nonradiating.  No history of the same.  He also had symptoms of a headache and body aches after the shot but those have also improved.   Pain is not worse with exercise. Patient has no decrease in exercise tolerance recently.  He took ibuprofen and acetaminophen initially, which improved his pain. Now it is a lot better, but he is concerned that it is something very severe since he never had these symptoms before.   States he has a history of mild bradycardia in the past.  He has never had tachycardia
Pain on Injection area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain on Injection area) in a  patient of an unknown age and gender 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 VACCINATION SITE PAIN (Pain on Injection area). At the time of the report, VACCINATION SITE PAIN (Pain on Injection area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information provided. No treatment information provided.  It was reported that the patient use Moderna vaccine when complete 2 hours and had pain on Injection area and was carrying because very hard pain in injection area.
Pt c/o Headache, body aches, muscle weakness, chills, sore and swollen joints, nausea,diarrhea, fever.
The next day after the vaccine I got a sore throat, a fever of a 102, and body aches and chills. I did not feel good, I also could not swallow my throat was very painful.
Bright red rash on trunk of body.  Mainly upper abdomen to upper thighs.; This is a spontaneous report from a contactable healthcare professional (patient). A 48-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8732) via an unspecified route of administration on 26Mar2021 at 12:30 (at the age of 48-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included COVID-19 on an unspecified date prior to vaccination and allergies to neomycin and polymyxin. Concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 (lot number EN6205) on 05Mar2021 at 12:30 as a single dose in the right arm for COVID-19 immunization. On 26Mar2021 the patient experienced a bright red rash on trunk of body, mainly upper abdomen to upper thighs. The patient did not receive any treatment for the events. The outcome of bright red rash on trunk of body, mainly upper abdomen to upper thighs was unknown. It was also reported that since the vaccination the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Pt received tetanus booster on 1/27/15 for thumb laceration, ~ 30 min later developed scalp edema and erythema preauricualarly. That night she felt bad and took ibuprofen for a fever of 104 F. Swelling has since spread across her entire head spanning from occiput to below both eyes and including her ears. Scalp is exquisitely tender to touch. Never happened before, no aggravating or alleviating factors. No recollection of a perceived cause, no insect contact, no new cosmetic exposures, no new meds. This morning patient states the swelling and pain have worsened. Reports pain in her joints that is constant. On 1/29/15 she was admitted to the hospital with scalp cellulitis. It is unsure at this time whether this is truly a bacterial cellulitis, however is supported clinically with erythema, edema, fever, mild leukocytosis and appears to originate from a scab on the scalp. Differential diagnosis includes allergic type reaction to the tetanus shot that she received due to the temporal nature of her symptoms. However, patient with no eosinophilia on CBC, no pruritus, or no urticaria. Dermatology was consulted; determined facial dermatitis due to acute drug reaction from Tdap vaccine, therefore recommended antibiotics be d/c and the prescribed topical triamcinolone cream and prednisone in discharged on 2/3/15.
10/8/99 inflammation/swelling noted @ inj site;discomfort w/ROM;heat pack applied, analgesic;10/9/99 localized inflammation increased;>tenderness inj site firm on palpation;ice wrap applied;
Patient received 1st dose of Mpox Jynneos vaccine ID. At 5:09 pm after receiving vaccine, patient complained of lightheadedness, became pale and diaphoretic.  The patient fainted for 3 seconds.  Immediately elevated the legs, applied cold packs, offered water and placed patient on the floor. Initiated vital signs. Observation extended to 30 minutes
Heart issues.  Primarily arrhythmia (slow HB, skipping beats) and palpitations. Symptoms resolved after about 5 months No treatment given
2 hours post vax, the pt returned to the office having a seizure. Seizure stopped without medication intervention. 60 day follow-up states no further seizures but has residual weakness in legs.
AFTER VACCINE IN L DT, PT C/O OF TINGLING L ARM PAIN  THAT "TRICKLED" DOWN TO L LEG W/ PAIN IN NECK, KNEES, AND JOINTS. 911 WAS INICIATED. PT LEFT AMAW/ NO FURTHER INCIDENTS.
Patient tested positive for COVID; Patient tested positive for COVID; This is a spontaneous report from a contactable consumer. A 27-year-old male patient received the first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on Apr2021 (Lot: EW0179) and May2021 (Lot: EW0161), respectively, at the age of 27-years-old, intramuscular as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were none. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. On Jul2021, the patient tested positive for COVID. Laboratory tests included COVID test post vaccination (nasal swab) in Jul2021: positive. The patient was not treated for the event. The clinical outcome of the event was resolved on Jul2021.  No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a 16 year old male who in 1996 was vaccinated with VARIVAX (Oka/Merck).  On 27-JUN-2008 the patient was vaccinated with a second dose of VARIVAX (Oka/Merck) (lot # 659739/0269X).  Concomitant therapy included HAVRIX.  The patient had rash the date after VARIVAX (Oka/Merck) was given.  The rash was first on the chest and then spread to the legs and arms.  One week later, approximately on 04-JUL-2008 the patient experienced swollen and red lip and swollen and red lip.   Unspecified if a reaction developed after the first dose.  Medical attention was sought at the physician's office.  This case was already reported to VAERS from the physician's office.  Additional information has been requested.
Patient received vaccine on 10-16 and by the afternoon of 10-17 his site of injection was red, warm to the touch, and swollen. His wife had a similar reaction including fever and pain in the eyes so they both went to the ER (mainly for her). The doctor recommended diphenhydramine, ZYRTEC, and TYLENOL. They have been taking the medication daily and on 10-22 he reported that the swelling had subsided and that the injection site had a pink tint.
Entire left side went numb for 8 min; This is a spontaneous report from a contactable consumer (reported for herself, not pregnant). A 38-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9266), via an unspecified route of administration on 26Feb2021 14:00 at single dose in left arm for COVID-19 immunisation. The patient's medical history included known allergies Sulfur. The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was Health Clinic facility. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. The patient experienced Entire left side went numb for 8 min on 01Mar2021 10:30. No treatment was received for the adverse event. The adverse event result in Doctor or other healthcare professional office/clinic visit. The event was non-serious per the reporter. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the event was recovering.
The next day after my shot,  I was debilitated. I was in bed with severe chills, nausea, headache, and a sore arm. my muscles hurt all over. I have  history of migraines so I have nausea medication that I used for the nausea. I took Zofran , Flexural, Ibuprofen, Promethazine, and  fioricet over the course of feeling this way so I could manage the side effects. This lasted for a few days and gradually got better. the arm had a red swollen welt at the injection site and was still sore. by 03/20 I still felt bad. on03/21 I started feeling better, the welt was getting bigger and hotter, I put marks on my arm to see if it would surpass the marks, but the next day it had moved completely to a different area on my arm. it's a ways away from the injection site. (03/22) I noticed my face from the cheek/smile crease has fluids swelling up on both sides of my face but the left side is definitely worse. my face is very swollen. its itchy because I normally have rosacea. I had skin cancer on my face once that was removed and usually causes some tingling but the swelling is causing more tingling.
COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Apr2021 as dose 1, single (Lot number: ew0169), in right arm, on 07May2021 as dose 2, single (Lot number: ew0171), in right arm and on 08Dec2021 as dose 3 (booster), single (Lot number: 330308d) at the age of 46 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Sep2022 as dose 4 (booster), single (Lot number: as7145b), in right arm for covid-19 immunisation. The patient's relevant medical history included: "depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "ADHD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08Dec2021, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2023) Positive, notes: tested a strong positive on rapid tests after days of testing faint positives and symptoms clearing up; (Jan2023) Positive, notes: tested a strong positive on rapid tests after days of testing faint positives and symptoms clearing up; (unspecified date) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received COVID 19 treatment with Paxlovid from 08Jan2023 to 12Jan2023.
On 11/23/7 after PPV I had a Very painful left arm which felt like I had been shocked. Later I could not raise my arm without pain which lasted 1 week and had a fever. Reported it to doctor office and advised to use ibuprofen *See Attached
One day post vax the pt developed an injection site reaction characterized by redness, swelling and pain.
Tongue, uvula, and felt like throat swelled within the first 15 minutes but not to a point that I couldn't breath. Tongue, uvula, and felt like throat have stayed inflamed. Within the next 18 hours I developed red welts/hives that are itchy and burn. I feel a restriction or not a relief when I take a deep breath and I have intermittent chest pain. 66 hours post vaccination and no symptoms have gone away
03/14/2021 I woke up at 2 am and I was coughing, I had coughing attacks and it was hard to catch my breath, I had drainage in my throat, runny nose, slight fever, 100.4. Persisted for a few days. Visited Urgent Care
Left upper thigh with small area of induration but no tenderness to the proximal region of the side that was demarcated with sharpie. No erythema. No lymphadenopathy.
The patient developed a fever the following day. The next day on Thursday the patient woke up with full body rash. The rashes were not itchy or painful. She went to the doctor on Thursday who performed a full blood work up and confirmed that the patient did have a reaction to the vaccine. Today is Tuesday, 2/5/19, one week following administration of the vaccine and the patient's reaction is completely cleared up.
death J18.9 - Pneumonia I26.99 - Pulmonary embolism U07.1 - COVID-19
Had stomach pains since then; This is a spontaneous report received from contactable consumer, the patient. A male patient of unspecified age received the first dose of BNT162B2 (solution for injection; batch/lot and expiry information not provided) as a single dose via an unspecified route on 08Mar2021, for COVID-19 immunization. There was no medical history, concomitant medications or past drug history reported. The patient reported that he received his first dose of the COVID vaccine on 08Mar2021 and as soon as he got in his car, he had stomach pains. The consumer inquired if this was a side effect of the vaccine. The outcome of the stomach pains was not recovered.  The consumer reported that he was unsure if the stomach pains were related to the COVID vaccine or not.   The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
swelling of arm down to fingers,  resolved, but not has persistent muscle soreness & pain in entire arm;28MAR96 there was nothing visible or palpable @ site;29APR96 final dx bursitis probably secondary to over use triggered by rxn to vax;
Increased swelling, redness and warmth to skin size of palm below injection site--Topical ice--no other treatment given.
5 minutes after receiving shot I felt a strong headache come on. Tylenol did not alleviate the pain. Later in the day I began to feel flu like symptoms with fever reaching 100.3. Same symptoms Day 2. Now, day 3 I still feel flu like symptoms.
This case was reported by a healthcare professional and described the occurrence of antigenemia in an adult female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The reporter was not aware of any adverse events following previous vaccinations. Concurrent medical conditions included peritoneal dialysis for unspecified condition. On 1 May 2009 the subject received 1st dose of ENGERIX B (details unknown). On 5 May 2009, 4 days after vaccination with ENGERIX B, the subject experienced antigenemia. Positive HEPATITIS B surface antigen was detected in the subject's blood. At the time of reporting the event was unresolved. The healthcare professional considered the event was probably related to vaccination with ENGERIX B. Follow-up information received on 01 June 2009 indicated that the subject was a 59 year old female. The subject received a 4th, or booster dose of ENGERIX B at 40 mcg intramuscularly in the right deltoid on 01 May 2009. A previous three dose series of ENGERIX B was completed in 2008, with doses given on 15 February 2008, 11 March 2008 and 30 September 2008. Antigenemia occurred on 05 May 2009 and resolved later on 12 May 2009. In the reporter's opinion, the event was related to treatment with 4th dose of ENGERIX B. The event was not considered to be serious. Concurrent medications included FERRLECIT and EPOGEN.