chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant referring to a 4 year old patient of unknown gender. Information about medical history, concurrent condition and concomitant medication was unknown. On 16-NOV-2018, the patient received an improperly stored dose of PROQUAD (lot # N021721, expiry date: 10-AUG-2019; dose, frequency and route were not reported) for prophylaxis, which was reconstituted with properly stored sterile diluent. No adverse effects were reported. There was no previous temperature excursion. It was also reported that temperature was from 15 Fahrenheit to 46 Fahrenheit for 8 hours and the data logger was involved. Sender's Comments: US-009507513-1902USA007548: US-009507513-1902USA007542: US-009507513-1902USA007540: US-009507513-1902USA007543: US-009507513-1902USA007546: US-009507513-1902USA007547: US-009507513-1902USA007545: US-009507513-1902USA007539: US-009507513-1902USA007538: US-009507513-1902USA007536: US-009507513-1902USA007541: US-009507513-1902USA007549: US-009507513-1902USA007537: US-009507513-1902USA007544: US-009507513-1901USA008772.
Fatigue and body aches first 24 hours.  Took Aleve and rest.  Second and third day no body aches just still tired.
redness at injection site; indentation at injection site; tingling at injection site; pain at injection site / Stung during administration; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 48-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number EF7N4, expiry date 30th June 2020) for prophylaxis.   On 22nd October 2019, the patient received Fluarix Quadrivalent 2019-2020 season (intramuscular). On 22nd October 2019, less than a day after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site erythema, injection site indentation, injection site tingling and injection site stinging. On an unknown date, the outcome of the injection site erythema, injection site indentation, injection site tingling and injection site stinging were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site indentation, injection site tingling and injection site stinging to be related to Fluarix Quadrivalent 2019-2020 season.  Additional case details were reported as follows: The patient received vaccine in left deltoid. The patient went to urgent care on an unknown date. The reporter consent to follow up.
the patient received by mistake the 2nd part of the flu shot 2 weeks earlier than the 4 weeks period after the first dose. Sanofi scientific department was consulted, no known history of serious complications. Mom was notified, no adverse reaction happened, the patient is doing good, mom was advised to monitor patient and return to the clinic or the ER if any new symptoms. staff recieved training to avoid that in the future.
Took the booster developed a lump underneath armpit near breast. Two inch in diameter arm hurt when arm is raised or make movements.; Took the booster developed a lump underneath armpit near breast. Two inch in diameter arm hurt when arm is raised or make movements. This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: FM8020, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 29Oct2021, when the patient was 40-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: FF2590, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 08Oct2021, when the patient was 40-year-old, for COVID-19 immunization. The following information was reported: BREAST MASS (non-serious) with onset 23May2022 at 02:00, outcome "not recovered", PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "Took the booster developed a lump underneath armpit near breast. Two inch in diameter arm hurt when arm is raised or make movements.". Therapeutic measures were not taken as a result of breast mass. Additional Information: No other medication received in 2weeks. Adverse event Patient Took the booster developed a lump underneath armpit near breast. Two inch in diameter arm hurt when arm is raised or make movements. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
swelling at injection site and arm pain, fatigue, chills, loss of appetite, headache, myalgia
Pt. had both Moderna vaccines as stated. S/O of COVID was 08/07/2021.
My son had a fever for 4 days and irritable. He did not want eat solid food anymore. He did vomiting a few times. I gave him TYLENOL and follow the instruction on the box. My son had a fever of 104.
Pediatric Engerix b administered to adult; Pediatric Engerix b instead adult dose; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a adult patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th September 2022, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 12th September 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product 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 Information: GSK Receipt Date: 13-SEP-2022 Reporter's Comment: The reporter reported a patient were administrated with the pediatric dose of Engerix B instead of the adult dose.  No adverse event was reported. No patient's identifiers were provided No lot number and expiration date were provided. The reporter consented to follow up. Additional Supportive Information: The reporter reported a patient were administrated with the pediatric dose of Engerix B instead of the adult dose, which led to underdose and adult use of a child product. The case had been linked to US2022AMR132515, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR132515:Same reporter
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. Since 01-DEC-2015 the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot# L007560 with expiration date 15-JUN-2017; lot# L016429 with 09-AUG-2017, strength, dose and route were unknown). The patient's concomitant medication was not reported. No adverse effects have been reported. Additional information has been requested.
Period is normally 7 days, ended at day 4.    Lump underneath collar bone
pt found dead in bed autopsy by coroner negative;case signed as SIDS;vax given 20SEP96 w/routine physical;
Admitted with acute contusion to hospital psych ward. Left his children at a gas station and left. Has low grade fever of 100.0, EEG acute encephalopathy, LP 0WBC, nl protein, MRI brain. Motion and fact, no acute abd. CT pelvis 7/16 nl. Is delirious. Transferred from psych to acute medical service 7/14/06. Follow-up: Vaccinated with yellow fever vaccine in ~ June of 2006. 60 day Follow-up Information 11-OCT-2006: This patient was transferred to another hospital and I have not had any contact with him since then.
crying w/fever 102 R; crying was constant for 5 1/2 days; piror stopped when exhausted & slept;
pt recv vax & w/in 24hr pt  exp a fever 103 orally, muscular aching, sl nausea;mom gave APAP, which reduced the fever to 99 orally & took daughter to be evaluated @ local ER;MD felt that the sx were probably r/t vax & would resolve;
Pt was admitted to the hospital through the ER on 31Jul08.  Pt complained of head aches, nausea and the sweats.  Her vaccincation site had also swelled up the size of a half dollar.  She had a red rash on her her neck and back.  The clinic diagnoses was Viral (aseptic)meningitis.
Information has been received from a physician concerning a 15 year old female who on 03-Jan-2007 was vaccinated with a 0.5 ml dose of Gardasil (yeast). There was no concomitant medication. On 03-Jan-2007, after receiving the vaccination, the patient fainted. Unspecified medical attention was sought. Subsequently, the patient recovered. Additional information has been requested.
ca. 30 min after flu shot I experiences symptoms: something like laryngeal spasm, difficulties swallowing, dry mouth, dry cough, feeling of general fatigue... late in afternoon symptoms broadened: muscle pain, runny eyes, muscle pain, voice became hoarse, cough worsened. PLEASE NOTE: on Mo I went to work (this shot is work related) and DID TRY TO REPORT ADVERSE EFFECTS TO NURSE. I WAS RIDICULED AND LAUGHED ABOUT MY SYMPTOMS. I was told that this is nothing and that nurse even can not make any notes in my chart. On Tue + Wed I have lost my voice completely. Voice came back some time Wed night. Today is Fri. I am still severely ill. Respiratory symptoms + painful cough are still present. I was even vomiting a little bit. This is not the first time I am having this type of reaction: in 2004 I was severely ill after flu shot. I did receive shot 4 times in my life, of which 3 times I became ill. I know that we are reporting SEVERE reactions such as anaphylactic shock or Gullain Barre syndrome, but what about this kind of problems??? Yes, I am not dying, but this does not mean I do not have something going on after the flu shot. I am reporting this in hope someone will put this in data base. I also do predict that my statements might be ridiculed or not taken serious, but I know what I know. I am not against immunizations, but I am just reporting my experience. I am PhD scientist who knows well theory about vaccines. According to statistics, I should not have reactions, but I know what I know and I am not making these symptoms up. They are real. Tomorrow, on Sat  10/27/12 I will go and see my doctor and talk to her.
No additional AEs; VARIVAX was administered after temperature excursion; This spontaneous report was received from a medical assistant referring to an 12-month-old patient of unknown gender. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.  On 27-MAR-2023, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (1 time dose, lot #W031811 has been verified to be a valid lot number, expiration date 05-OCT-2024, exact dose, route of administration and anatomical location were not provided) for prophylaxis.  On 27-MAR-2023, the suspect vaccine experienced a temperature excursion of -14.9 degrees Celsius (C) for 59 minutes and -12.8 C for 33 minutes (product storage error). No additional adverse events (AEs) or product quality complaints (PQC) were reported (no adverse event). No previous temperature excursion.
11 year old male received 2nd dose of Pfizer Covid-19 vaccine and inadvertently was administered 12+ dose of Pfizer instead of 5-11 year old dose.
flu; Initial information was received on 04-Nov-2021 regarding an unsolicited valid non-serious social media case from a consumer/non-healthcare professional.  This case involves a patient (unknown demographics) who had flu (influenza), after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   The patient's past medical treatment(s), vaccination(s), concomitant medication(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 and expiry date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed non-serious flu (influenza) (2 weeks) following the administration of INFLUENZA VACCINE.  It was reported "This case is received from Social media. The following potential adverse event has been found on a public post for Flu Shot Fridays page. Since this is a public post on the Sanofi flu shot campaign Flu Shot Fridays we are assuming the consumer is referring to the Sanofi flu vaccine. No Diabolical shot is to be praised. Also have been sharing. I got the flu 2 weeks after I took it. I have not had the flu since. Do not need that Diabolical shot."  It was unknown if the patient experienced any additional symptoms/events.   It was unknown if there were lab data/results available.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.
Over past couple of days, injection site has become very red and swollen. Patient reports pain at the injection site and moving that arm is painful. She showed me the area and the redness is almost a perfect circle, about 6 inches in diameter. I advised her to take Benadryl and ice the area. She asked if she could use OTC pain cream and I said that was fine. I told her to monitor the site closely - if not better within next few days, call Dr.
Chest pressure, out of breath, extreme fatigue, weight loss  Diagnosed with pericarditis.  Fluid drained off left lung twice Echocardiogram  2 night hospital stay
Rash from head to toe; arm sore; This spontaneous case was reported by an other health care professional and describes the occurrence of RASH (Rash from head to toe) and MYALGIA (arm sore) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced MYALGIA (arm sore). On 03-Feb-2021, the patient experienced RASH (Rash from head to toe). The patient was treated with PREDNISONE for Symptomatic treatment, at a dose of 8 days of prednisone. At the time of the report, RASH (Rash from head to toe) and MYALGIA (arm sore) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information also included a steroid injection.
Cause of Death A:  Acute encephalopathy Cause of Death B:  COVID 19 IMMUNIZATION FOLLOWING COVID 19 VIRUS INFECTION Cause of Death Other:  Chronic Schizophrenia
Itchiness, hives, and dermatographia has occured about two weeks after the booster shot. I was not knowingly allergic to anything, but the itchiness was almost unbearable. I started taking benadryl, zyrtec, and applying any anti-itch cream to affected areas. Areas affected are scalp, ears, arms, chest, and feet; but it seemed to occur on almost all parts of my body. About one week after side effects, it's still present, although zyrtec has helped with the symptons.
developed pulmonary elbolism after primary Covid vaccine series, remained on Elquis >6 months, advised to continue Eliquis x 1 month after booster, developed shortness of breath within weeks after stopped Eliquis, workup showed another pulmonary embolism developing
Had rash on ribs since 2nd shot, after booster within 1 week went to my work to the ED around 9am because my throat had started closing, labored breathing, pain in solar plexus and arms, started swelling all over body, extreme itching and pain, headache, rash started spreading all over body from head to toe including in mouth over a span of 3 weeks I was like this. Treatment from Ed and my Doctor was steroids shot and antihistamines (benedryl). I said is it Covid? nobody even knew what it was, how can this be that i had more info than my own Doctor. Still as of today still dealing with small rash on my left ribs.
Large 3? diameter rash, very red, itchy, tiredness - it is now 3 days later rash is lighter in color, arm tender, not itchy, still feeling tired.
dizziness, shivering, chest itching and redness, possible throat swelling Vitals were assessed and 911 was called. Patient was released.
Information regarding Prevnar was received from a healthcare professional regarding a female patient who experienced an injection site eruption followed by a more generalized urticaria eruption. The patient received the third dose in Mar-2006. A physician reported that on an unspecified date in Mar-2006, his daughter developed and injection site urticarial eruption that was followed by a more generalized urticarial eruption. These events occurred in less than 24 hours following the vaccine administration. The outcome is unknown. Additionally, the reporter noted that for this series of immunisations, the vaccines were separated, the first vaccine did not cause any reaction. No additional information was available at the time of this report.
Received a dose of Vaxelis and a dose of Recombivax HB on the same day; This non-serious spontaneous safety report, with case number 02262554 (Interaction number 02262553), was received by a partner, on 06-OCT-2022 and forwarded on 06-OCT-2022 from an other health professional.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event "Received a dose of Vaxelis and a dose of Recombivax HB on the same day".  Further information is expected.
A Varicella immunization was given on 1/18/07 along with 3 other immunizations. After this shot, she developed, a  red streaking with pain in the wrist and the elbow. This resolved after 1-2 days. She did not seek any medical attention. She mentioned this when she came for the next varicella shot on 2/20/07. I asked her more about this reaction and then cleared this with the supervisor for this immunization program R.N.who also checked the web site for further information.The client wanted to proceed with the shots as this had resolved on its own in a short amount of time. I gave her the second varicella in the other arm and asked her to call me the next day so I could see how she was doing. She called for the next 2 days and said that the injection site was red, hot to the touch, swollen  but that there was not pain at the elbow or wrist and no streaking.  I gave her my cell phone number and told her to call me with pain or anything ususual developed. I explained that I was going to be making a VAERS report.
diagnosed with COVID, LOW OXYGEN AT HOME 88%, minimal dry cough, MD Dx COVID pneumonia
Red hot swelling at injection site, pain upon palpating the injection site, pain in the muscles surrounding the injection site, pain in the joints above and below the injection site, generalized malaise, mild dizziness seemingly related to head movement.
My arm swelled; My arm swelled and was very sore; I was very tired/felt exhausted; This is a spontaneous report from a contactable other hcp. A 23-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL9262), dose 1 via an unspecified route of administration, administered in Arm Left on 27Jan2021 as SINGLE DOSE, dose 2 intramuscular, administered in Arm Left on 17Feb2021 10:00 (Batch/Lot Number: EN6201) as SINGLE DOSE for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient was not pregnant. Patient did not receive other vaccine in four weeks of vaccination. Patient did not receive any treatment. Patient was not diagnosed with COVID, prior vaccination.  Patient did not receive other vaccine in four weeks of vaccination. Patient has not been tested for COVID, post vaccination. Patient had no known allergies. The patient experienced my arm swelled on 17Feb2021 16:30, my arm swelled and was very sore at 16:30 with outcome of recovered and i was very felt exhausted. The outcome of the events was recovered.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
On 5/22/2022 My husband went to a crowded event and ended up leaving but he came down with COVID-19 on 5/25. I woke up on 5/29/2022 feeling run down as though I had been run over by a bus and I knew I had COVID. I had a bad cough as well. I contacted my Primary care physician who recommended that I received Monoclonal Antibody Infusion due to my asthma. After I received that treatment, I was feeling better around 24 hours later. I am still experiencing a slight cough, but it is not nearly as bad as it was.
Site: Pain at Injection Site-Medium, Additional Details: Patient reports hearing loss. Doesn't know if related. Was made worse with home remedies - lead to hosp Due to CFS they do usually knock her out harder. Also reports chronic fatigue syndrome
Burkitt's Lymphoma, Pain in Abdomen, Lethargy, Weight Loss, PET Scan, Chemotherapy, Mass discovered in Lymph Node in abdomen CT Scan - May 18, 2021 Blood Work - May 19 and 27, 2021 Tissue Culture and Biopsy - May 19, 2021 PET Scan - May 27, 2021 Echocardiogram - May 28, 2021 Chemotherapy start date - June 2, 2021
pt recv vax 16OCT95 & 18OCT95 pt exp red, hot & swollen arm where the pneumococcal vax was given;By 20OCT95 pt had recovered;no further details were provided;
Febrile seizure 20-30 seconds 9 days after MMR administered. Emergency medical services visited, no treatment given, no rash , positive cranky.  twin brother with seizure 2 days after.
Two male patients received VARIVAX intramuscularly instead of subcutaneously; No additional AE were reported; This spontaneous report was received from a pharmacist, and refers to a male patient of unknown age.  No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX), intramuscularly instead of subcutaneously for prophylaxis (dose, lot number and expiration date were not reported). No adverse events were reported.  This is one of two cases received from the same source.; Sender's Comments:  US-009507513-2109USA003281:
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 08-NOV-2017, the patient was vaccinated with improperly stored dose of VARIVAX (lot# M048203, expiration date 07-DEC-2018, dose and route of administration were not reported) reconstituted with properly stored sterile diluent (STERILE DILUENT MRK) for prophylaxis. Reporter stated that the vaccines were stored in 7 degrees Fahrenheit for 2 hours 1 minute. There was previous temperature excursions on 30-OCT-2017, indicated as 17.6 degrees Fahrenheit for 2 hours 15 minutes. The digital data logger was used. The patient did not experienced any adverse events. Product quality complaint was not involved. This is one of three reports from the same reporter.; Sender's Comments: US-009507513-1712USA009982: US-009507513-1712USA000444: