chrisvoncsefalvay/vaers-outcomes huggingface dataset:
enlarged lymph node the size of a squashed golf ball in my left armpit; chronic lymphocytic leukemia/small lymphocytic lymphoma; chronic lymphocytic leukemia/small lymphocytic lymphoma; This is a spontaneous report received from contactable reporter(s) (Physician).  A 68-year-old male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), in Jan2020 as dose number unknown (booster), single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Type 2 diabetes mellitus" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN ER taken for type 2 diabetes mellitus; JANUVIA taken for type 2 diabetes mellitus. The following information was reported: CHRONIC LYMPHOCYTIC LEUKAEMIA (medically significant), LYMPHOCYTIC LYMPHOMA (medically significant) all with onset Mar2020, outcome "unknown" and all described as "chronic lymphocytic leukemia/small lymphocytic lymphoma"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "enlarged lymph node the size of a squashed golf ball in my left armpit". The patient underwent the following laboratory tests and procedures: Blood test: Normal. Therapeutic measures were taken as a result of chronic lymphocytic leukaemia, lymphocytic lymphoma, lymphadenopathy. Clinical course included  In Jan2020, Patient  had a pneumonia vaccine booster and the next morning awoke with an enlarged lymph node the size of a squashed golf ball in my left armpit. In Mar2020, the lymph node was removed and I was diagnosed with chronic lymphocytic leukemia/small lymphocytic lymphoma. Patient  underwent 28 radiation treatments to the axilla and sub pectoral areas and had 4 treatments with Rituxan. Patient was doing well with no recurrence of enlarged lymph nodes. My blood tests have been normal. I underwent immunization with the Pfizer Covid vaccines in Jan and Feb2021, and boosters with Pfizer vaccines in Aug2021 and Feb2022.    The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Based on the known safety profile of the vaccine PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN, a causal relation between the reported event chronic lymphocytic leukemia,  lymphocytic lymphoma and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient described that she was seeing black surrounding her after 2 minutes receiving the Covid-19 vaccination. Patient was given 10 ml of Benadryl 12.5 mg /5 ml liquid immediately. After 5 minutes taking Benadryl, patient  complained that she felt that her physical condition is getting worse; she was anxious. I decided to call 911  based on her existing medical condition. The 911 team arrived within 10 minutes and checked her health condition. Patient recovered and went home safe.
Per Public Health, no adverse effects. At the time of this report, I had not notified patient caregiver.
Patient received initial dose of Janssen Covid-19 vaccine 1/10/2022. Nurse at the desk provided patient w/ new Covid vaccination card as patient lost his original card and checked the patient in for Janssen booster. MSA recorded initial date of 1st dose as 10/20/2021 (later RN found this date was the VIS date, not administration date). RN verified the date on the card as 10/20/21 prior to administration of Janssen booster- which would have been 2 months. Janssen booster was administered. When RN went to chart on patient, RN realized the wrong information was provided on patient's COVID vaccine card and patient had just received the initial dose on 1/10/2022.
patient had redness and swelling at the injection site the evening after she got the vaccine, then experienced muscle aches, nausea, SOB, fatigue, headache, and loss of smell over the weekend. Reported feeling much better Monday 3/8/21, but still nauseous and had no sense of smell
Received COVID vaccines 1/20/21 and 12/30/20.  On 4/5/21 developed fatigue, rhinorrhea, and nausea.  tested positive for COVID-19.
A NICKEL SIZE WELT AT INJECTION SITE WITH HALF DOLLAR SIZE REDNESS IN SURROUNDING AREA, PATIENT STAYED IN OFFICE FOR AROUND 30 MINUTES AFTER INJECTION, OUTCOME GOOD.
Chest pains with terrible congestions; Worst sore throat; Terrible coughing; Stuffy and runny nose; Stuffy and runny nose; Chest pains with terrible congestions; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration on 20Mar2021, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 26Mar2021, she tested negative for covid-19. Still on 26Mar2021, 4 hours later, she had the worst sore throat, terrible coughing, stuffy and runny nose, and chest pains with terrible congestions. She took Benadryl to treat the symptoms. Her doctor prescribed her with Azithromycin to treat the symptoms. After taking the medication, she felt better. She is scheduled to receive the 2nd dose on 10Apr2021. On 26Mar2021, she had a Covid test results in the negative. However, four hours later she experienced a sore throat, a stuffy nose and a terrible cough. Caller took Benadryl and Azithromycin. The outcome of the events was recovering. She got tested for Covid again and are still waiting for the results to come back  Information on the lot/batch number has been requested.
Gave vaccine that had been in fridge for 34 days.  Confusion regarding how long the vaccine is good for in fridge.
05/02/02-pm had fever of 100, 05/03/02-pm rash on face, head, neck, chest seen in ER on 05/05/02-crying x 5 hrs and stiffened/breath holding. 05/06/02 seen by pediatrician. 05/08/02-CT scan.
Dizziness, Headache, Myalgia, Arthralgia, Fever,  mental foggy arthralgias/myalgias, chills. 12/31 fever resolved.
Painful armpit / painful lymph nodes on right arm. Pain started 24 hours after vaccine administration and has been non-stop/ consistent even with pain relievers.
Breakthrough case admission after 2 vaccines Moderna 3/30/21 lot# 023M20A;  Moderna 4/2721 lot# 030A21A
I have been extremely dizzy and light headed. I am experiencing extreme signs of vertigo. First I have blurred vision, my ears fill full and then I see the room spinning . After a get a headache (feels like my head is full) in the back of my head.
I had exhaustion and shortness of breath during small distances. I got to the restroom, and I get winded. I also get winded and tired taking a shower I have gone to the doctor, and they do not know what is going on.
severe pain in neck has not gone away at all; can't turn neck to the left or right very much; severe pain in neck / crook in my neck/came as a result of this second shot; first shot didn't affect me at all; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (severe pain in neck has not gone away at all), MUSCULOSKELETAL STIFFNESS (can't turn neck to the left or right very much), NECK PAIN (severe pain in neck / crook in my neck/came as a result of this second shot) and NO ADVERSE EVENT (first shot didn't affect me at all) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 030M20A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included METFORMIN, METOPROLOL, DILTIAZEM, BUMETANIDE, LISINOPRIL, PANTOPRAZOLE, LOVASTATIN, TAMSULOSIN, HYDRALAZINE, GLIPIZIDE, COLECALCIFEROL (VITAMIN D3), GLUCOSAMINE, FISH OIL, MULTIVITAMIN [VITAMINS NOS] and CINNAMOMUM CASSIA (CINNAMON [CINNAMOMUM CASSIA]) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced NO ADVERSE EVENT (first shot didn't affect me at all). On 13-Mar-2021, the patient experienced NECK PAIN (severe pain in neck / crook in my neck/came as a result of this second shot). On 03-Jun-2021, the patient experienced NECK PAIN (severe pain in neck has not gone away at all) and MUSCULOSKELETAL STIFFNESS (can't turn neck to the left or right very much). The patient was treated with PREDNISONE for Pain, at an unspecified dose and frequency and CYCLOBENZAPRINE for Sleeplessness, at an unspecified dose and frequency. At the time of the report, NECK PAIN (severe pain in neck has not gone away at all) had not resolved and MUSCULOSKELETAL STIFFNESS (can't turn neck to the left or right very much), NECK PAIN (severe pain in neck / crook in my neck/came as a result of this second shot) and NO ADVERSE EVENT (first shot didn't affect me at all) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2021, X-ray: normal (normal) nothing wrong with it.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No known allergies were provided.
Fatigue, mild headache, slight nausea, muscle aches, flu-like symptoms.
Info has been received from a physician concerning a teenage pt who was vaccinated with a dose of MMRII as a child and then received it again prior to entering college. The physician noted that the pt reported that when she was collage age, the vaccine gave her hearing loss. At the time of the report, the pt had not recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other info was provided. Hearing loss was considered to be an Other Important Medical Event (OMIC). Additional info is not expected.
On 9/14/22 around 5:30 pm. The patient stated via translator (son) that she already received the first two doses. Consequently, the patient received Pfizer Bivalent as the first dose. The patient had not received the primary series per protocol. There were no adverse reactions. On 9/19/22 the patient was followed up with a call from a translator and nurse. It was verified that the patient only received one dose and that was the Bivalent Pfizer. The CDC  policy was used for vaccine administration errors.
PATIENTS WIFE STATED PATIENT FAINTED WHILE WALKING THE DOG AROUND 5:30 PM ON THE SAME DAY 03/18/2021
SORE ARM ON THE SITE OF VACCINATION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm on the site of vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on the site of vaccination. This report was non-serious.
Approximately 6 minutes after administration of vaccine, urticarial rash appeared in patient's trunk and upper extremities. No stridor, no angioedema, no shortness of breath. Vitals stable.
LIGHT HEADEDNESS; PULSING SENSATION AT BACK OF HEAD; RIGHT LEG FEELS LIKE WEIRD CIRCULATION; CHILLS; CHEST PAIN (LOCATED IN THE CENTRE-LEFT SIDE OF CHEST); This spontaneous report received from a patient concerned a 29 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: seasonal allergy, alcohol user, and non smoker, and other pre-existing medical conditions included: The patient did not had any drug abuse or illicit drug use, no prior medical history, did not take any other medications regularly and had not sought medical advice yet. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1821286 expiry: UNKNOWN) dose was not reported, administered on 11-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-OCT-2021, the patient experienced chest pain (located in the centre-left side of chest). On 12-OCT-2021, the patient experienced right leg feels like weird circulation. On 12-OCT-2021, the patient experienced chills. On 13-OCT-2021, the patient experienced light headedness. On 13-OCT-2021, the patient experienced pulsing sensation at back of head. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 12-OCT-2021, and had not recovered from light headedness, pulsing sensation at back of head, chest pain (located in the centre-left side of chest), and right leg feels like weird circulation. This report was non-serious.
Patient was administered Pfizer covid-19 vaccine at vaccination site on Sat. Mar 27, 2021 at 11:30 am PDT as he is a caregiver.  Two days later, on Mon Mar 29, 2021 at 10:30am PDT, he was administered a Tdap (Adacel) vaccine in "error" acknowledged by the PA-C during first encounter to establish him as a patient at the medical office.  Starting Mon Mar 29, 2021 11pm PDT on patient developed chills, fever, headache and stomach cramps. It is unknown the level of fever he developed until 4:30am Mar 20, 2021 when patient woke up his parent due to persisting headache stating "I'm not well. I had chills and fever which have gone, but I still have a bad headache".  However his temperature was 102.1F even at that point when first measured at 4:30am 3/30.  Fever between 102.8 to 101.0 persisted for 48-hours, and started clearing thereafter going down to 98.5 by  Thur Apr 1, 2021 evening.   He was treated with Tylenol and Advil to manage fever and pain.
This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 65-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included eczema. Concurrent medical conditions included blood pressure and hypothyroidism. Concomitant products included Aspirin, Calcium, LIPITOR, PROLIA, Ranitidine, valsartan, Vitamin D3 and ZYRTEC. On 29th May 2018 13:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site warmth, injection site swelling, tiredness, difficulty sleeping, injection site itching, pain, injection site erythema and muscle soreness. On an unknown date, the outcome of the injection site warmth, injection site swelling, tiredness, difficulty sleeping, injection site itching, pain, injection site erythema and muscle soreness were recovered/resolved. The reporter considered the injection site warmth, injection site swelling, tiredness, difficulty sleeping, injection site itching, pain, injection site erythema and muscle soreness to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX on the left arm. The patient experienced raised, hot, red area at the injection site which was about the size of her hand. The hot and raised area lasted for total of one week. The patient also felt sore muscle, trouble sleeping, tired, and pain which lasted for total of 1 week. The redness at the injection site lasted for total 2 weeks. One and half week after receiving the SHINGRIX vaccine, the patient had itching at the injection site, which lasted for 4 days. The patient gave permission to contact their healthcare provider. No further details were provided.
the next morning I had a rushing air sound in my left ear.  Sound was amplified and distorted, and eventually started to be a ringing tinnitis.
This spontaneous case reported by a consumer, describes the occurrence of fatigue (felt very tired since the shot) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# unknown) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Aug 31, 2021, patient experienced fatigue (felt very tired since the shot). At the time of the report, fatigue (felt very tired since the shot) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.
Nausea, Vomiting, Diarrhea for 18 hours Pain - Discomfort @ injection site
Soreness at injection site several hours later 24 hours later swelling, redness, some warmth at site, fever, chills, temp up to 101 degrees F oral, aches, muscle tightness, mild itching at site. No anaphylaxis. Improved symptoms after 3 days using ibuprofen, ice, TYLENOL for fever.
Developed horrible headache and pain in right upper arm. Began to have tingling in hands and feet several days later. Now progressed up legs up to tailbone. Reports tightness in thighs and pain up to buttocks. Reports dry eyes and stabbing pain in left eye. Worse at night. Develops temporal pressure. Harder time breathing when taking deep breaths. Feels unsteadiness in calves with burning on inside of ankles. Weakness. No history of systemic reactions to vaccines.
Injection was given subcutaneously. No ill effects, but possibility increased for: 1) Vaccine not providing maximum antibody level 2) Break through COVID infection with increased possibility of variant development 3) Lack of sufficient protection of current variations, especially Delta Additionally, improper technique may increase pain, etc creating more negative attitudes toward vaccine. Studies need to be conducted of breakthrough infections to try to determine if improper injection technique was used. States administering training for vaccine administration techs must document follow up training
Allergic Reaction (Hives, Body internally warm, vomiting, swelling)
Suspected vaccination failure; shingles; painful; milder rash; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and rash. On an unknown date, the outcome of the vaccination failure, shingles, pain and rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and rash to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had shingles after getting vaccinated. It was very painful but a milder rash. This case considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles was not reported.
Breakthrough case after Covid vaccination. Dose #1 2/1/2021 Dose #2 3/5/2021. C/O nausea/vomiting and diarrhea onset 8/24/2021
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information regarding patient's concomitant medications, pertinent medical history, drug reactions, or allergies provided. On 21-OCT-2016, the patient was vaccinated with improperly stored dose of ZOSTAVAX, 19400 plaque-forming units (PFU), lot # M001747, expiration date: 07-APR-2017 (dose and route of administration were not provided). No adverse effects were reported. Administered dose of vaccine underwent a temperature excursion of 16 degrees Fahrenheit for 1 hour and 30 minutes, which was detected by a data logger. The temperature was back in range after the excursion. There were no previous excursions reported. This is one of two reports received from the same reporter. Additional information has been requested.
Shingles; This case was reported by a consumer and described the occurrence of shingles in a 75-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  The patient's past medical history included shingles (already had shingles when patient was younger). Previously administered products included FLU VACCINE.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported no more vaccines for him/her as no matter what anyone says dosen't matter what GlaxoSmithKline have (flu, cold, allergies, pneumonia,etc.) they probably would say it's the Covid virus The patient haven't lived all this time with no common sense.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR231589:same reporter
This case was reported by a physician via sales representative and described the occurrence of bad rash in a child subject of unspecified gender who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included FLUARIX; GlaxoSmithKline; unknown; unknown given in 2012. On an unspecified date in 2012 the subject received unspecified dose of KINRIX (unknown). On 2012, immediately after vaccination with KINRIX, the subject experienced bad rash and pharmaceutical product complaint. At the time of reporting the outcome of the bad rash was unspecified. The sales representative called to report on behalf of physician who stated they vaccinated four child subjects with the same lot of KINRIX and all four of the subjects broke out into a bad rash immediately after KINRIX was administered. Three of the child subjects were also given FLUARIX on the same day, but the last subject was not given FLUARIX with KINRIX and that subject still broke out with a rash. The healthcare professional office stated "we are scared to use the remaining vaccine product"; there were six doses remaining to be returned to GSK for investigation. This is 3 of 4 subjects reported by the physician, for the other cases please see A1004132A, A1004135A and A1004137A. Quality Assurance (QA) results received on 20 December 2012. Based on the fact that no precise technical problem was reported, no technical investigation was performed. GlaxoSmithKline Biologicals considered this complaint as unsubstantiated. QA results received on 19 March 2013. The results from the final technical assessment for the case was provided. Based on the fact that no precise technical problem was reported, no technical investigation was performed. GlaxoSmithKline Biologicals considered this complaint as unsubstantiated. QA results and safety assessment received on 4 April 2013. A search was performed in the GSK safety database to retrieve reports with KINRIX in association with the batch number AC20B235AA(and similar batches:AC20B235). There is as of today, no report linked to that batch other than the ones linked to this complaint in the GSK safety database. Currently available safety data and expert assessment of the risk did not suggest any safety concern. GlaxoSmithKline Biologicals considers this complaint as unsubstantiated. Considering all safety available information, it is unlikely that the reported events are related to a manufacturing problem.
the patient received flublok quad which is only fda approved for 18 and older, this patient is only 14  years of age