chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My reaction to the first dose of Mederna was pretty normal to what has been described. I got a headache within an hour, aches, musle pain then slept for 24 hours straight!! then i started having chest pains. I thought it was due to the EXTREME stress I was enduring. plus I wanted to avoid hospitals at ALL costs!! then the horrid fatigue hit with blurred vision. I have had a fatgue problem for many years but this is almost to the point of unbearable. I am a single Mom of 3 and caregiver for my elderly parents 83&84 yr. old parents and my mentally ill adult sister. My second dose was almost the same as the first dose. But it seemed to enhance all of my symtoms...Stronger heart pains,chills, painful aches & pains.  The fatigue.... that word does not even come close to what i am feeling....totally wiped out like my heart too tired. So I am trying to hang on and nothing helps. Iwent in on Friday 11/12/2021 and got my booster and flu shot. Headache started almost immediatly. I had my family with me they got theirs too. Home by 1:00 and asleep almost immedatly. Saturday All of my joints ,muscles my entire being was in EXCRUATING pain!!I laid there just crying thinkinking I am going to have to go to hospital.... couldnt stand it!!!  My son brought me water and ibuprophen.it helped a little bit it hurt to swolow.breathe,keep my eyes open,movement of any kind ... i felt like my body turned to glass. Like my skeleton was falling out of my body,Excruciatin! In bed Sunday lesser aches but extremly painful joints and glands..Misery!! still in bed today better except for left underarm going to left breast back to myneck. my reactions seemed very extreme compared to what has been described so i thought i could help others by reporting my experience.  i got my flu shot at the same time as my booster dont know the name of it or the maker..was not provided. i still feel miserable...beyond miserable...
Exactly one week after the MMR vaccination, my son started complaining of neck pain.  He then spiked a fever of 103+ and his neck swelled up to the extent of his face, and he has golf-ball size lymph nodes in his neck.  His breathing was labored and short.  I called the on-call doctor and treated him with Motrin.  He did get violently sick to his stomach one time.  His high fever lasted 2 days, and currently is running a low grade fever and is pale and weak.  His neck is no longer swollen, but his lymph nodes in his neck are still very swollen.
Injection site soreness started about 3 hrs post-injection.  By that evening I was experiencing body aches & chills. I took Advil 400mg with dinner and felt okay for about 4 hours. As soon as the Advil wore off, body aches & chills returned. I did not take anymore Advil that night. My sleep was restless with body aches, chills, & pain at the injection site. I took my temperature during the night and was afebrile. I woke feeling tired with a mild headache. I took Advil after breakfast and currently feel okay.
At 1:30 am the following morning I woke up very nauseous and started vomiting.  Was nauseous all that day needing to take nausea medicine. Unable to eat anything I started to vomit stomach acid. It is now 2 days later and I still have a degree of nausea and am unable to work today. I got the 2nd vaccine on Monday.  It is Wednesday and I still have no appetite for food and have lost about 7 lbs since the weekend. I feel that I am starting to round the corner to recovery though.
headache; nausea; This is a spontaneous report from a contactable consumer via Medical information team. A 48-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient took her 1st dose of the COVID vaccine and experienced side effects such as 9 days of strong headache and 4 days of nausea. The consumer wants to know if her mother should get her 2nd dose or not. The outcome of the events was recovered on unspecified dates.  Information on lot number/batch number has been requested.
injection when he was 2 months and 4 months; injection when he was 2 months and 4 months; This case was reported by a consumer via interactive digital media and described the occurrence of inappropriate age at vaccine administration in a 2-month-old male patient who received Men B NVS (Bexsero) for an unknown indication.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, Men B NVS (Bexsero) for prophylaxis and meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero, Bexsero Pre-Filled Syringe Device, the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device and not applicable after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was the patient's parent. The reporter stated that, his or her son got Bexsero injection when was 2 months and 4 months old, which led to inappropriate age at vaccine administration. The reporter stated that, the patient did not have the last shot. The reporter asked could the patient get a catch up shot now.The patient was 31 months old at the time of reporting.
I started experiencing hot flashes the day after the 1st dose and they continued  5-8 times daily until the second dose of the vaccine, in which they disappeared altogether.
Malaise, headache, muscle aches and all over body pain, fever of 101 (I think higher but that was highest documented), arm pain in the arm I got the shot.  I took Tylenol every 6 hrs for about 36 hrs.  My fever "broke" and didn't return in the middle of the night on day 2.  After that (so on day 2) my arm is still sore and I developed a red swollen, itchy rash about the size of my fist on my shoulder.  I also have lymphadenopathy in the arm pit area that is making the whole arm and down that side sore and painful.
an expired TENIVAC was given to a patient with no reported Adverse event; Initial information was received on 28-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 65 years old female patient who was administered an expired diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT [Tenivac] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine for Prophylactic vaccination.  On 28-Oct-2022, the patient received a Booster dose of suspect standard diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT suspension for injection at a dose of 0.5 ml once (lot C5779AA, expiry date - 10-Feb-2022) via intramuscular route in the left deltoid for Immunization and was administered an expired diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT with no reported adverse event (expired product administered) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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 the 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.
L deltoid pain and intermittent tingling for 1.25 months  after vaccination - which keeps him up at night.
Fevers x 3days followed by maculopapular erythematous diffuse rash, followed by diarrhea and parotitis.
Somnolence; Feeling abnormal; Abdominal discomfort; Limb discomfort; Pyrexia; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Somnolence), FEELING ABNORMAL (Feeling abnormal), ABDOMINAL DISCOMFORT (Abdominal discomfort), LIMB DISCOMFORT (Limb discomfort) and PYREXIA (Pyrexia) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Cataract.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced SOMNOLENCE (Somnolence), FEELING ABNORMAL (Feeling abnormal), ABDOMINAL DISCOMFORT (Abdominal discomfort), LIMB DISCOMFORT (Limb discomfort) and PYREXIA (Pyrexia). At the time of the report, SOMNOLENCE (Somnolence), FEELING ABNORMAL (Feeling abnormal), ABDOMINAL DISCOMFORT (Abdominal discomfort) and LIMB DISCOMFORT (Limb discomfort) outcome was unknown and PYREXIA (Pyrexia) had resolved.            No Concomitant information  provided. No Treatment information  provided   This case was linked to MOD-2021-052773 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Non-significant Additional Info received on 28-Apr-2021.Reprter address updated. Dose 1 details was updated.
VARIVAX was administered outside of the prescribing guidelines, 2nd dose was given at 18 months; No additional AE; This spontaneous report was received from a registered nurse referring to an 18-month-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapy were not reported.   On an unknown date (reported as 12 months of age), the patient was vaccinated with the first dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) injection and varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (both dose, lot#, expiration date, anatomical location and route of administration not reported) as prophylaxis. On an unknown date (reported as 18 months of age), the patient was vaccinated with the second dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) injection and varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (both dose, lot#, expiration date, anatomical location and route of administration not reported). Varicella virus vaccine live (Oka/Merck) (VARIVAX) was administered outside of the primary investigator (PI) guidelines (product administered to patient of inappropriate age). No additional adverse event (AE) was reported (no adverse event).
Information has been received from a nurse concerning a 12 year old femmale who on 25-JAN-2007 was vaccinated with GARDISIL, lot # 653735/0688P in the left arm (second dose). On 25-JAN-2007 after receiving vaccine and getting off table felt dizzy walked to appointment desk and became very "oozy" almost fainted mom caught her put in trendelenberg position, given orange juice quickly felt better. Additional information has been requested.
pt recv vax 11JUN97 & next day pt mom c/o of inj site redness, warmth & swelling;swelling extended from mid-upper arm, 3 inches above the elbow, to top of shoulders;13JUN pt seen in MD office;
Patient came to the ED with shortness of breath and was admitted with Covid pneumonia and treated with remdesivir.
Pfizer Dose 1 6/28/21 (EW0191) Pfizer Dose 2 7/19/21 (EW0191) COVID Positive 1/6/22  1/6/22: Patient is a 45-year-old female with history of type 1 diabetes on insulin who presented to ED via EMS for a suicide attempt with intentional overdose on Lantus.  Per patient she recently had a friend who committed suicide because of her, she felt if she was the cause of someone else's death that she did not deserve to live either.  She reports going to the bar yesterday evening and having a few beers and a shot, her alcohol level on arrival to ED was 183. She then went home and took her regular scheduled Lantus dose of 12 units, then stated she took her insulin pen and administer an unknown amount of insulin.  She immediately started eating crackers and soup at that time, blood glucose level on arrival to ED was 398. Patient's vital signs were stable on arrival to ED. She was seen and examined in ED with her hospital gown over her face crying.  She denies any shortness of breath or chest pain.  She denies any signs or symptoms of hypoglycemia.  No recent fevers.  No nausea, vomiting or diarrhea.  She is not currently seeing Psychiatry. Medication reconciliation shows the patient use to be on Prozac.  It is unclear if the patient is currently taking the medication, she was not very conversational on examination.  1/8/22: 45 female with a history of T2 dm and prior suicide with overdose of Lantus presented to the emergency room complaining that she was taking an excess dose of Lantus because she feels sad that her friend recently committed suicide and she may be contributory to her demise.  She was admitted and placed on D5 W and blood glucose monitored closely.  She had multiple episodes of hypoglycemia managed with D50 intermittently.  This morning the blood sugar has been fairly okay.  The psychiatrist was consulted and she was evaluated by the psych NP who recommended that patient can continue with the current antidepressant fluoxetine 80 mg daily.  Patient stated that it was an impulsive act and she is no longer suicidal.  Of note is that the HbA1c is more than 11% but am not very certain if this patient is taking her insulin dose correctly or not.  I will marginally increased the insulin Lantus to 15 units b.i.d. and continue with current dose of insulin aspart with meals.  Advised her to follow up with PCP in a week.
Host of cyst on various parts of my body. Left cheek, left scapular, vulva area.
fainted, grey color, cool/clammy skin, thready pulse, not responsive.  EMS on site who attended her.  She become responsive while the assessed her.  Their dx was vasal vagal and advised her mom to take daughter to urgent care.  Mother's name is.
administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 168 doses.  The vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to MOD-2022-581986 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live follow up received included non significant information of secondary reporter was added.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful arm) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Painful arm). At the time of the report, PAIN IN EXTREMITY (Painful arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient used putting ice on the arm and that seemed to help.   Reporter did not allow further contact
patient felt dizzy and nauseous after immunization. did not show any signs of allergic reaction. had patient sit with a cold compress on neck for 30 minutes after which patient felt normal and was ready to leave.
I am 70 years old female and had the SHINGRIX 50MCG/0.5ML SUSR 6-month booster. I had several side effects within 24hrs of the dose that left me bed-ridden for 36 hrs. They were flu like symptoms and included feeling tired/weak, headache, shivering, upset stomach, nausea, stomach pain, diarrhea. The symptoms passed by the 3rd day after the injection. I did NOT have these side effects with the first dose taken 6 months earlier.
PT WAS SUPPOSE TO GET DTAP(INFANRIX) BUT RECEIVED TDAP (BOOSTRIX)
Patient had immediate swelling and burning/numbness at injection site that radiated away. Patient felt faint and dizzy. No SOB, no pulse changes. Patient was administered 50 mg diphenhydramine. Within minutes patient started feeling better, pain, burning and numbness subsided. Faintness resolved. Patient was chatting, laughing and engaged in conversation appropriately. No complaints of breathing or pulse issues, after 20 minutes of monitoring in the immunization room, patient asked to leave. Had patient wait an additional 25 minutes in waiting room before releasing. 2 hours after release followed up with a phone call., patient feeling fine with no issues.
Below the  injection area,  arm swollen  like a balloon.  Took tylenol and  cool compress.  Saturday,  May 1st thru currently  5/6/21.
shortness of breath; congestive heart failure; H-pyloria infections in the stomach; fluid around the lungs virus; Missed the second dose due to hospitalization; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (shortness of breath), CARDIAC FAILURE CONGESTIVE (congestive heart failure), HELICOBACTER GASTRITIS (H-pyloria infections in the stomach) and PLEURAL EFFUSION (fluid around the lungs virus) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported adverse event).    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (shortness of breath) (seriousness criterion hospitalization), CARDIAC FAILURE CONGESTIVE (congestive heart failure) (seriousness criterion hospitalization), HELICOBACTER GASTRITIS (H-pyloria infections in the stomach) (seriousness criteria hospitalization and medically significant), PLEURAL EFFUSION (fluid around the lungs virus) (seriousness criterion hospitalization) and INCOMPLETE COURSE OF VACCINATION (Missed the second dose due to hospitalization). The patient was hospitalized from 13-Mar-2021 to 26-Mar-2021 due to CARDIAC FAILURE CONGESTIVE, DYSPNOEA, HELICOBACTER GASTRITIS and PLEURAL EFFUSION. At the time of the report, DYSPNOEA (shortness of breath), CARDIAC FAILURE CONGESTIVE (congestive heart failure), HELICOBACTER GASTRITIS (H-pyloria infections in the stomach), PLEURAL EFFUSION (fluid around the lungs virus) and INCOMPLETE COURSE OF VACCINATION (Missed the second dose due to hospitalization) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient missed the second dose due to hospitalization.  Concomitant and treatment information not provided.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Hospitalized 9/20/2021; COVID-19 positive 9/16/2021; fully vaccinated  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Hypoxia [R09.02] Pneumonia due to COVID-19 virus [U07.1, J12.82]   HOSPITAL COURSE: The patient is a 82 y.o. male with Hx of DM type 2, prostate cancer, CKD 3, atrial fibrillation on Coumadin, and HTN who presented to ED with complaints of worsening shortness of breath. His symptoms started 9/13 and included shortness of breath, cough, fatigue, and decreased appetite. He developed fever of 101.9 on 9/16 and had a positive COVID-19 test from pharmacy on 9/16. He was vaccinated with the J&J vaccine in 3/21.   In the ED, he was tachypneic and hypoxic at 88% on room air. He was placed on 2L NC with improvement in oxygen saturation. His labs were notable for sodium 130, bicarbonate 19, BUN 22, creatinine 1.18, WBC 14, INR 1.9. Chest x-ray showed bilateral pneumonia.  He received decadron 6 and remdesivir. His O2 requirements initially increased to 6L via nasal cannula, but gradually improved. Per pulm rehab he required 1L at rest and 3.5L with activity on the day of discharge. PT/OT recommended home with assist. The patient's hyponatremia improved. His glucose was elevated while on steroids, but decadron was not continued on discharge and he returned to his home medication regimen.   The patient has been enrolled in the COVID at home program and will have visiting nurse services. I have recommended he have an INR drawn 9/28 and that he follow up with the anticoagulation clinic at DC. The patient was discharged home in stable condition with home O2.
The vaccine is Moderna Spikevax  Arm is itchy , hurts to the touch, and  is a little swollen
BODY ACHES; CHILLS; NAUSEA; FEVER; SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 at 14:00 in left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. On 06-APR-2021 19:00, the subject experienced body aches. On 06-APR-2021 19:00, the subject experienced chills. On 06-APR-2021 19:00, the subject experienced nausea. On 06-APR-2021 19:00, the subject experienced fever. On 06-APR-2021 19:00, the subject experienced soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, nausea, and fever on 08-APR-2021, and had not recovered from soreness at injection site. This report was non-serious.
Pt describes swelling in ankles, shortness of breath and fluid retention. Physician prescribed furosemide 60mg for 3 days then 20mg daily. Ordered more diagnostic tests.
Headache, Myalgia, Diarrhea & NauseaVomiting Narrative:  Other Relevant History: