chrisvoncsefalvay/vaers-outcomes huggingface dataset:
04/23/04: Seen by NP for redness, swelling at injection site. Dx. with cellulitis and started on antibiotics.
no adverse effects, vaccine given 10/2/2022, lot expired 10/12/2022
69 year old man with history of ESRD due to DM, s/p renal transplant 9/12, post transplant lymphoproliferative disorder (diffuse large B cell lymphoma) in 2016, s/p chemo and maintenance rituxan, type 2 DM, chronic kidney disease with baseline cr 1.4-1.6, right common iliac artery aneurysm who presents with weakness found to have +covid. Pt admitted for covid pneumonia, acute hypoxemic respiratory failure.  1.) covid pneumonia, acute hypoxemic respiratory failure- pt received pfizer vaccine and booster 10/7;  Symptoms started 10/20, tested + at facility 10/23. Pt reportedly received monoclonal ab (regereron while at facility ); pt signed out AMA and presented to ED with weakness and hypoxia. Pt started on remdesivir and decadron. He felt much better on 10/25; denies shortness of breath and able to ambulate in room without hypoxia. US was done to rule out DVT. No evid of DVT. No symptoms to suggest PE and given AKI and improved hypoxia, will not do CT angio chest. Since clinically improving and no longer hypoxic, will plan dc home today.   2.) history of renal transplant- present with AKI; holding cozaar; cr improving. Renal US without hydro; will cont to hold cozaar on dc   3.) elevated trop I- suspect demand ischemia from covid/ AKI; peak trop is 0.06;    4.) DM, hypertension- resume home meds but will hold cozaar   Primary Procedures:  CXR US renal   Secondary Procedures: US LE doppler   Reason for Hospital Admission (Admitting Diagnosis):  covid pneumonia, acute hypoxemic respiratory failure
Sharp, shooting intestinal pain followed by subsequent cramping and pressure the next week. I was unable to digest anything.
vomiting; diarrhea; myalgia; headache; face swelling; pain at the injection site; This is a spontaneous report from a contactable physician reporting for one of her patients. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: Unknown via an unspecified route of administration on 19Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient received the COVID-19 vaccine yesterday (on 19Dec2020) and was experiencing vomiting, diarrhea, face swelling, myalgia, headache, and pain at the injection site on an unspecified date. Expressed being concerned about an anaphylactic reaction and wanted to know how her patient's symptoms compare to it. Then the physician asked for the timing of the anaphylactic symptoms onsets reported in the clinical trials. The event outcome was unknown.  Information on the lot/batch number has been requested.
The lymph nodes above my right collar bone became visibly swollen.  Then the swelling increased to my neck.  Later that evening, the swelling spread to my left neck as well.  There was no pain, but the lymph nodes were physical.  The neck area felt spongy.  I called my doctor that day to report the side effect, but did not receive a call back.
Patient claimed she felt tingling and swelling of throat and her eyes watered.  She was counseled to take a Benadryl and call her doctor, no visible signs, just her feeling.  She said she had to take another Benadryl later that day. She felt better the next day at lunch, about 24 hours after the immunization. Her doctor was notified.
Pain at injection site started night of injection (5/30/2017) but fatigue, tightness in chest, and headache occurred the following day approximately 24 hours after administration.
Patient received vaccination at 1200. Had not adverse events during the first dose. After patient began to leave the clinic and drive away, she began to feel pressure and pain in the middle of her chest. She promptly turned around and returned to the clinic to be accessed by the nursing staff at 1300. Patient presented with chest pressure and pain in the middle of the chest and had blurry vision in her right eye. Heart rate was 112 with blood pressure of 162/102, 02 of 97. Emergency services were called and soon arrived. Patients heart rate had dropped to 103 and blood pressure down to 158/96 by the time EMS arrived on the scene. Patient had blood sugar taken as they are also diabetic and had a blood sugar reading of 286, denies having eaten anything for breakfast.  EMS took patient from there.
Information has been received from a registered nurse concerning an 8 year old female who on 12/8/1997 was vaccinated with a dose of varicella virus vaccine live. On 5/26/2005 the patient developed 8-10 vesicular lesions and a fever of 102F. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Child complained of intermittent chest pain exacerbated by movement/breathing on four occasions.  Out of concern for myocarditis, child was evaluated in the Emergency Department on 8/2/21 and was found to *not* have myocarditis (normal EKG, normal troponin).  D-dimer was mildly elevated.  CXR normal.  Working diagnosis is musculoskeletal chest pain 2/2 general inflammatory response from vaccine.
Patient states woke up the next morning and felt, "awful".  She went to her Kitchen and ,"blacked out".  She states she passed out and hit her head.  He husband was in the next room and came to her aid.  After three days, she began to feel better.
zoster vaccine-related shingles; patient with ALL was administered a zoster vaccine;   This literature marketed report has been received from authors of a published literature article, title as stated above, referring to a 50-years-old male patient with Acute lymphocytic leukaemia (ALL) and pulmonary hypertension.  On an unspecified date, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (dose number, dose, route of administration, lot# and expiration date were not provided) as prophylaxis (contraindicated product administered).  On an unspecified date, the patient experienced zoster vaccine-related shingles (herpes zoster). At the reporting time, the outcome for the herpes zoster was unknown.  The authors considered the herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).  A copy of the published article is attached as further documentation of the patient's experience.
A mother reported, via a company representative, that her 18 month old daughter received the 1st dose of Prevnar vaccine in 11/00. In 12/00, the child developed wheezing and coughing. The mother also reports that her child has been treated with antibiotics every month for ear infections since receiving Prevnar; however, her lungs were clear. In 4/01, the child developed bilateral ear infections with continued cough and was given a dx of Pneumonia. The child recovered. No additional information was available as of the date of this report. See Case ID HQ3176412JUL2001 for AE of bronchiolitis following the 2nd dose of Prevnar for this child. See Case ID HQ3176512JUL2001 for AE in sibling following 1st dose of Prevnar.
local erythema, swelling distal to inj site <24hr p/vax;
This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 10-NOV-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose, lot No., route and anatomical location of administration were not reported). No concomitant therapy was provided. The pharmacist reported that the ZOSTAVAX was reconstituted with normal saline, instead of the intended sterile water. No adverse effects were reported and no Product Quality Complaint (PQC) was involved. Additional information has been requested.
1440 Pt requested medical personnel due to a sudden "warm" feeling that traveled through left arm and sudden rapid heart rate. Pt A&Ox4 upon initial assessment. BP 120/70 left arm, HR 130 and SPO2 99%. RN reclined pt in her vehicle. Pt requested that EMS not be called unless symptoms worsened. RN stood at the side of vehicle for several minutes. HR improved to 105. Pt agreed to stay for at least an additional 15 minutes or until symptoms resolve.  RN back to check on pt at 1505. HR now 74 and pt states that all symptoms have resolved and that she feels safe to drive. Pt left vaccination area at that time.
I don't think this is traceable to the vaccine since it occurred over six months later, but I am trying to cooperate with you and be thorough, despite the considerable hassle involved (!).  At the end of March (2023) I woke up with laryngitis and a sore throat. I  was negative for COVID per self-test. I was tested for strep at an urgent care center four days later (3/24/23) and that was negative. The laryngitis persisted so I contacted my primary caregiver remotely and he prescribed a Z-PaK (Azithromycin) and it cleared up.
Localized induration and erythema on RA - Hep. A and VARIVAX. Diameter of 2in. warm compress TID and IB. May last for 1 wk.
Red streak on injection arm 2 inches long/started seeing red streak forming about 2 hrs after injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE STREAKING (Red streak on injection arm 2 inches long/started seeing red streak forming about 2 hrs after injection) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040azia and 032a21a) for COVID-19 vaccination.     Concomitant products included BISOPROLOL and BENAZEPRIL for Blood pressure management, METFORMIN for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE STREAKING (Red streak on injection arm 2 inches long/started seeing red streak forming about 2 hrs after injection). At the time of the report, VACCINATION SITE STREAKING (Red streak on injection arm 2 inches long/started seeing red streak forming about 2 hrs after injection) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment Medications were not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up received on 10-MAY-2021, Patient information updated. On 22-Jun-2021: Follow up received on 22-JUN-2021: Vaccine lot/batch details updated, Concomitant medications updated, Event outcome updated.
AFib; major side effects at the injection site, her left arm swelled up it got hard and red; major side effects at the injection site, her left arm swelled up it got hard and red; left arm still itchy; This is a spontaneous report from a contactable consumer reporting on behalf of the patient. An 84-year-old female patient (mother) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in left arm on 22Feb2021 at a single dose for COVID-19 immunisation.  Medical history included hives or redness to unspecified medicines in the past.  The patient's concomitant medications were not reported.  The reporter stated that her mother received the first dose of COVID-19 vaccine this Monday (on 22Feb2021) she is 84 years old and she has AFib (unspecified date). The patient has major side effects at the injection site, her left arm swelled up it got hard and red on unspecified date. The reporter asked if it is common/normal that the patient's left arm still itchy after six days. The patient previously experienced hives or redness to unspecified medicines in the past. The reporter wanted to know if the patient should get the second dose as scheduled. Outcome of the events were unknown.   Information on the lot/batch number has been requested.
bells palsy symptoms appeared 4 days after shot #2 Apr 7 and 33 days after shot #1 on March 9. Prednisone tablets were prescribed on 5th day after the April 7 shot (80mg/day for 7 days), which is today, so outcome is as yet unknown.
severe lung disease; immunocompromised; Caller had several coughing spats during call; This is a spontaneous report from a Pfizer sponsored program COVAX US support via a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included covid-19. Family History included Has 19 y/o son and Wife also got Covid. The patient's concomitant medications were not reported. Caller is a Medical Social Worker that runs mental health clinics. Had covid and then got Pfizer covax, but is still immunocompromised. Concerned about Delta variant. Wants to know the effectiveness against. Last dose nearly killed him, 6 months after it, he is on oxygen 24/7 plus has severe lung disease. Receives transfusions every two weeks and is completely vulnerable. Caller had several coughing spats during call, some severe. The outcome of the events was unknown.   Information about batch/ lot number has been requested.
had a boil that may have gotten infected. It's still draining 3 days later; fever blisters; high fever; This is a spontaneous report from contactable consumer. This 67-Year-old female consumer (patient) reported that she received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Apr2021 single dose for COVID-19 immunization.  Medical history and concomitant drugs were not provided. On 17Apr2021, she had a high fever but she didn't think it's anything to do with the vaccine. She had a boil that may have gotten infected. It's still draining 3 days later. Since then she got fever blisters. The virus was running through her body now. Her 2nd dose of the vaccine was scheduled for this Friday. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on temporal relationship and known drug safety profiles, a possible contributory role of suspect vaccine  BNT162B2 cannot be excluded for the reported event fever.
Face broke out in shingles from the vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 4 days after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   The reporter considered the shingles to be possibly related to Shingles vaccine.     Additional Information: GSK Receipt Date: 14-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter reported that his sister received Shingles vaccine she was not wanting it, but her doctor talked her into it. The reporter stated that 4 days after received Shingles vaccine the patient experienced right side of her face broke out in shingles from the vaccine. The reporter stated she definitely not get the vaccine. The reporter did not consent to follow up.
Information has been received from a physician concerning a female patient in her sixties who on 05-JUL-2007, a few hours after vaccination, the patient developed redness and itching involving "almost the whole arm." The physician examined the patient on 06-JUN-2007 and diagnosed her with an allergic C-type reaction. The physician prescribed topical steroid cream and oral antihistamines. A product quality complaint was not involved. Additional information has been requested.
Sore arm; Swollen lymph nodes; Chills; Fever; Headache; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm), LYMPHADENOPATHY (Swollen lymph nodes), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.    Co-suspect product included non-company product BUSPIRONE for an unknown indication.    The patient's past medical history included No adverse event (No medical history was provided.). Concomitant products included ENALAPRIL, FAMOTIDINE, COLECALCIFEROL, FISH OIL (OMEGA 3D), MULTIVITAMIN [VITAMINS NOS], METHOCARBAMOL, LOSARTAN POTASSIUM (COZARIL), GARLIC [ALLIUM SATIVUM], TRAMADOL, ATORVASTATIN and GABAPENTIN (GABAPEN) for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started BUSPIRONE (unknown route) at an unspecified dose. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), LYMPHADENOPATHY (Swollen lymph nodes), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Sore arm), LYMPHADENOPATHY (Swollen lymph nodes), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications included paracetamol.
Vertigo approximately 2 1/2 weeks post 1st dose and continued vertigo 2 weeks post 2nd dose. It has not stopped, still currently experiencing vertigo.
Seizure-like activity which started about 1 hr post injection. vomiting & staggering, Taken to ER. Normal CAT scan. In the ER pulse strong, but was non-reactive. Was admitted.
Patient felt dizzy and fell after getting the vaccine. Ice and cold compress was provided for the patient. Patient was aked to wait for about 45 mins for observation.
flu vaccine was administerd by Rn of L deltoid. No bleeding or redness occured at injection site immediately post injection. Approx 3 hours post injection  employee began experiencing pain of L upper arm. Pain moved to L elbow area the next day.Pain is only present when the arm is moving . No pain noted present when the arm is fully extended, or after arm is flexed . Arm hurts only on initial movement. Duration of symptoms, 37 days.Employee sought medical consult with Occupation health physician. Employee  referred to private physician for further evaluation and treatment of ongoing symptoms
acid reflux flare; acid reflux flare; nausea; mild headache; feeling unwell; severe fatigue; This is a spontaneous report from a non-contactable other healthcare professional reporting for herself. A 32-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number: EL8982, expiry date: 31May2021), via an unspecified route of administration, on 13Jan2021 03:00 PM, at a single dose on the left arm for COVID-19 immunization. Medical history included acid reflux. The patient was not pregnant and had no known allergies. The patient received the vaccine at a country vaccination drive through. Facility type vaccine was other. The patient had not received any other vaccine in four weeks prior to vaccination. Concomitant medications (other medications in two weeks) included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]), ergocalciferol (VITAMIN D [ERGOCALCIFEROL]), ubidecarenone (COQ10), zinc, and magnesium. On 13Jan2021 03:30 PM, half an hour after the vaccination, the patient experienced an acid reflux flare, nausea, mild headache, feeling unwell, and severe fatigue. The symptoms lasted for about 4 hours. The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive any treatment for the reported adverse events. Outcome of the events was recovered on 13Jan2021 07:30 PM.   No follow-up attempts are possible. No further information is expected.
No additional AE reported; HCP reporting PEDVAXHIB, and ROTATEQ were administered after a temperature excursion.; This spontaneous report was received from a medical assistant and referred to a 2-month-old female patient. The patient's medical history was not reported. The patient's concurrent conditions, concomitant medication, pertinent medical history and drug reactions/ allergies were unknown.  On 14-DEC-2022, the patient was vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular injection, in left thigh, lot #W006596 has been verified to be a valid lot number, expiration date was reported as 11-OCT-2024, administered intramuscularly for prophylaxis (strength was not provided), and with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot #1892784 has been verified to be a valid lot number, expiration date was reported as 03-DEC-2023, administered orally for prophylaxis (strength was not provided).   The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Data logger was involved. No adverse event was reported (no adverse event).  This was one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA009088:009507513
Information has been received from a physician concerning a 6 year old male who at the age of 15 months, on 23-JAN-2004 was vaccinated with a first dose of VARIVAX (lot # 647520/1106N) subcutaneously in arm.  On 31-OCT-2007 the patient was vaccinated with a second dose of VARIVAX (lot #658596/1333U).  Last week the patient experienced a fever.  On 20-APR-2009 the patient was diagnosed with mild varicella with less than 50 lesions.  At the time of reporting, the patient's mild varicella with less than 50 lesions persisted, but the fever had since resolved (date not specified).  The patient sought unspecified medical attention.  Follow up information was received from a registered nurse.  It was reported the patient was vaccinated with a first dose of VARIVAX (lot # 647520/1106N) (exp. date: September 2005) into the left arm by subcutaneous route and a second dose of VARIVAX (lot # 658596/1333U) (exp. date August 2009?) into right arm by subcutaneous route.  At 08:42 am on 20-APR-2009 the patient was diagnosed with mild varicella with less than 50 lesions.  There was no illness at time of vaccination.  The patient had no pre-existing allergies, birth defects or medical conditions.  There were no relevant diagnostic tests performed.  Subsequently, on an unspecified date, the patient recovered.  No further information is available.
Extreme headache, fever, jaw pain, shoulder pain, intermittent chest pain, chills, weakness, stomach ache
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 07-JUL-2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, lot, and route # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. The patient was treated at an urgent care for a blistering vesicular outbreak which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.