chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SWOLLEN AT INJECTION SITE; REDNESS AT INJECTION SITE; INJECTION SITE A LITTLE SORE; TEMPERATURE 99.2F IN FOREHEAD, 99.4F IN OTHER PART OF BODY, 100.9F AT INJECTION SITE; About to have chills; HOT TO THE TOUCH; FEELING COLD; ARM OF THE INJECTION WAS A LITTLE BIT ITCHY; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (HOT TO THE TOUCH), FEELING COLD (FEELING COLD), VACCINATION SITE PRURITUS (ARM OF THE INJECTION WAS A LITTLE BIT ITCHY), VACCINATION SITE SWELLING (SWOLLEN AT INJECTION SITE) and VACCINATION SITE ERYTHEMA (REDNESS AT INJECTION SITE) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CEFALEXIN MONOHYDRATE (LEXIPRON) for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (ARM OF THE INJECTION WAS A LITTLE BIT ITCHY). On 19-Feb-2021, the patient experienced VACCINATION SITE WARMTH (HOT TO THE TOUCH), FEELING COLD (FEELING COLD), VACCINATION SITE SWELLING (SWOLLEN AT INJECTION SITE), VACCINATION SITE ERYTHEMA (REDNESS AT INJECTION SITE), VACCINATION SITE PAIN (INJECTION SITE A LITTLE SORE), PYREXIA (TEMPERATURE 99.2F IN FOREHEAD, 99.4F IN OTHER PART OF BODY, 100.9F AT INJECTION SITE) and CHILLS (About to have chills). At the time of the report, VACCINATION SITE WARMTH (HOT TO THE TOUCH), FEELING COLD (FEELING COLD), VACCINATION SITE PRURITUS (ARM OF THE INJECTION WAS A LITTLE BIT ITCHY), VACCINATION SITE SWELLING (SWOLLEN AT INJECTION SITE), VACCINATION SITE ERYTHEMA (REDNESS AT INJECTION SITE), VACCINATION SITE PAIN (INJECTION SITE A LITTLE SORE), PYREXIA (TEMPERATURE 99.2F IN FOREHEAD, 99.4F IN OTHER PART OF BODY, 100.9F AT INJECTION SITE) and CHILLS (About to have chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-255975 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: no new information
I started having rapid heart rate and shortness of breath (8-31-21).  I thought it was the Sudafed I was prescribed for an ear infection.  After a few days of taking, I stopped the Sudafed but still had the symptoms.  I went to a walk-in clinic for poison ivy and had a rapid Covid test, too, to make sure my symptoms weren't from Covid (9-1-21).  My test was negative.  On 9-10-21, I woke up with a terrible pain in my side and went to the ER.  After different tests were ran, it was determined I had pneumonia.  I had another Covid test and it also came back negative.
Narrative: Patient reports arm pain at injection site, resolved within 2 days Other relevant Hx: Symptoms: & arm pain Treatment:
7 cm x 6 cm circular rash with 1 cm round center on left thigh.
12 days p/anthrax #2: inflam arthritis, macular rash, oral ulcers, alopecia, fever;renal bx: mesangial Gn;tx pred, hydroxychloraquine;
the patient confirmed that she was not pregnant when she received the one dose of GARDASIL; adenocarcinoma of the cervix; Information has been received from a 28 years old female physician assistant referring to herself. The patient had no concomitant therapy, pertinent medical history or drug reactions/allergies.  On an unknown date in 2007 (approximately at 19 years old), she received the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (batch/lot #, expiration date, strength, dose and route were unknown) for prophylaxis. She did not receive any additional doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).  On an unspecified date in 2016, she was diagnosed with adenocarcinoma of the cervix. Medical attention was sought with office visits. She had the following procedures colposcopy, loop electrical excision procedure (LEEP) and cold knife conization. On an unknown date, the adenocarcinoma was fully removed with surgery and she recovered from the event. She was monitored every 6 months with Pap smears. Eventually she would have a hysterectomy, however, she was still in her childbearing ears. It was reported at time of diagnosis, the event was not life threatening. However, if she had left the adenocarcinoma untreated, it eventually would have become life threatening. The patient mentioned that she recently had a baby. She confirmed that she was not pregnant when she received the one dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (maternal exposure before pregnancy).  The causality between quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and adenocarcinoma of the cervix was not provided.  Upon internal review, adenocarcinoma of the cervix was determined to be medically significant.
Bruising to the left thigh, redness, swelling and pain below immunization site. It involved almost entire medial surface of thigh.  Right thigh:  blister formed 1 1/2 inch medial to immunization site.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was reported. On an unknown date in November 2016, the patient was vaccinated with the first dose of GARDASIL (dose, route of administration, lot # and expiration date were not not reported). On an unknown date in January 2017, there was an interchange of vaccine and the patient was vaccinated with the second dose of GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
This spontaneous report was received via a company representative from a currently 32 year old female patient who is also a medical intern regarding herself. Concurrent conditions included asthma. The patient's drug reactions/allergies and concomitant medication were unspecified. On an unspecified date between the months of August 2014 and October 2014, the patient was vaccinated with one dose of PNEUMOVAX 23 (route, lot number and expiration date unknown). On an unspecified date after the administration of PNEUMOVAX 23, the patient experienced a painful, local injection site reaction as well as a fever and sought medical attention at an unspecified emergency room. On the same day she was diagnosed with cellulitis at the injection site and was sent home with an unspecified antibiotic. On an unspecified date, the patient had fully recovered from the adverse events. Causality was not provided. Additional information has been requested.
Within 30 minutes of receiving vaccine dose, extreme pain in right arm from injection site to forearm. Could not move arm at all and injection site was swollen, red, hot, light touch to arm was very painful. 7 hours from time of injection symptoms started which included nausea, fever of 100.2, chills, sweating, tightness in chest when inhaling, extreme muscle pain in legs, involuntary crying and burning sensation in both eyes, loss of appetite, and fatigue. Symptoms worsened on Day 2 and Day 3 after receiving vaccine. Fully recovered from all symptoms, including arm/injection site pain, within 10 days from when the vaccine was received.
Fever, severe pain at injection site, muscle and joint pains all over, fatigue, weakness, headache. Took Tylenol and rested
Swollen Left arm with erythema and tenderness 4x4 cm x 2 days, Keflex was prescribed.
Patient called pharmacy and told me that she has severe itching following her second dose of her moderna covid 19 vaccine.  She received her dose on 5/3 and she says she had localized itching at the injection site.  That has steadily spread to her entire body.  She does not have any reported hives or visible rash, but has this wide spread systemic itching.  She has not changed detergents etc. and the vaccine is the only thing that she can contribute to this itching.
This spontaneous report as received from a pharmacist refers to a 58 year old female patient. On 05-JUN-2014 the patient was vaccinated with ZOSTAVAX 0.65 ml, subcutaneous, lot # J008436, expiration date 11-OCT-2014. Concomitant therapies included atorvastatin and tramadol hydrochloride. None pertinent medical history, drug reactions and allergies were reported. On 07-JUN-2014 (reported as 48 hours later), the patient developed a red area on an unspecified arm that was the size of a "tennis ball" after receiving ZOSTAVAX. At them time of the report the outcome of the event was reported as not recovered. The patient sought medical attention, she called the pharmacist on 07-JUN-2014. No treatment was given for the event. The pharmacist also reported that she had see other unspecified patients that developed redness after receiving ZOSTAVAX but never as big as a tennis ball. This is one of two reports from the same reporter (1406USA005593). Additional information has been requested.
This case was reported by a healthcare professional and described the occurrence of allergy to vaccine in a 40-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medical conditions included allergy to yeast. Previous and/or concurrent vaccination included TDAP vaccine (non-gsk); Merck; unknown given on 12 June 2009. On 12 June 2009 and 27 July 2009 the subject received 1st dose and 2nd dose of ENGERIX B (20 mcg, unknown route). On 12 June 2009, less than one day after the 1st vaccination with ENGERIX B, the subject experienced allergy to vaccine. After the next vaccination with ENGERIX B the events recurred. On 27 July 2009, less one than day after the 2nd vaccination with ENGERIX B, the subject experienced allergy to vaccine. At the time of reporting the outcome of the events was unspecified. The healthcare professional reported that the subject on both occasions experienced "seasonal allergy like type of symptoms". The subject believed it may be attributable to the yeast component as she stated she had found out she is allergic to baker's yeast. The subject was due to attend the office to provide more details regarding medical history and specific symptoms.
Hives near injection site on 4/6/2022 4/7/2022 small patch begins (later discovered this was a Herald patch from dermatologist)  4/10/2022 - additional patches begin on abdomen/back 4/11/2022 - small patches appear on arms, thigh, chest with additional spots each day (all patches not itchy/bothersome unless it comes in contact with clothing that irritates it) 4/12/2022 - present, additional patches appear on breast, bikini line, armpits, neck, forearms, hand. Some of the original patches begin becoming flaky/dry patches but patch size/shape remains the same   Sought treatment 4/19/2022 with dermatologist. Patch biopsy taken after examination and fluocinonide 0.05% prescribed. Believes pitaryasis rosea after examination
Headache, nausea, chills, swollen and aching lymph nodes, sore at injection site - severe for about 36 hours
11/12/13 Pneumonia vaccine/flu vaccine administered. 11/13 MD note stated tenderness and slight swelling (L) upper arm after vaccine. KEFLEX 500 mg po QID started. 11/14 MD note: (L) arm redness decreased on antibiotics. Most likely due to vaccination continue antibiotics and MOTRIN.
Pt received vax 4/3 - red, swollen painful at injection site within 24 hours. 4/6 - erythema, warmth, "flushed feeling:, cheeks forehead and chin. Local reaction improved but still present left arm today 4/12/07.
1 week after vaccine I experienced swelling, itching, burning, warm to touch and redness at vaccine site. Symptoms subsided after 2 days.
MODERNA VACCINE BOOSTER 0.25ML DOSE GIVEN TO A 16 Y/O MALE (NOT WITHIN PROTOCOL) IMMUNIZATION REGISTRY CALLED TO NOTIFY OF MISTAKE OR CLARIFICATION. PHARMACIST CALLED PATIENTS MOTHER TO NOTIFY MISTAKE AND IF ANY PROBLEMS WITH PATIENTS HEALTH-MOTHER SAID ALL WAS WELL AND STUDENT HAD GONE TO SCHOOL (12/10/21 AT 9AM) ALSO FOLLOWED UP WITH MOTHER AND TO CALL PHARMACIST AND/OR PHYSCIAN IF SOME TYPE OF ILLNESS IS NOTICED
a rash in the under arm area on the same arm,rash is itching and with redness; a rash in the under arm area on the same arm,rash is itching and with redness; Initial information received on 31-Aug-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves male patient (with unknown demographics) who had a rash in the under arm area on the same arm (rash pruritic) (rash erythematous), while he received vaccine ADACEL.  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication (s) and family history were not provided.   On an unknown date, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiration date not reported) via unknown route in the arm as prophylactic vaccination.  On an unknown date, the patient developed a non-serious rash in the under arm area on the same arm (rash pruritic) (rash erythematous) that began either on the same day or the day after the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  The outcome were unknown for all the events at the time of reporting.  There will be no information on the batch number for this case.
Myalgia left axilla lump Narrative: Had a telephone appt with PCP to evaluate symptoms-myalgia, left axilla lump. was told to self-monitor, take OTC ibuprofen or tylenol to manage symptoms. She did report that she is feeling better and left axilla lump is getting smaller.
Day of vaccine approximately 30 minutes later patient experienced warm sensation in chest, progressed to muscle aches, swelling of foot/ankle. On 1/3/2021 patient still complains of muscle/body aches, joint pain, swelling of foot. On oral steroid for foot swelling. >10days with no improvement.
p/receiving vax, pt became dizzy & light-headed, laid on table, wet compresses applied to head & neck, lt clinc p/approx 30 mins w/o c/o; lt arm became increasingly painful & pt went to ER on  Sat when sx area & lt arm was red & painful;
Narrative:  Patient is an 83y.o. non-decisional MALE with a h/o mechanical falls, diabetes, CAD s/p 3vCABG, unprovoked DVT on eliquis, CKD 3b, multiple past GI bleeds, AAA s/p repair, and pancreatic neuroendocrine tumor with liver mets who presented to agency ER on 10/5/2021 for cough and congestion ongoing x1 week, productive of white sputum. Pt was admitted. Pt was transfered to MICU on 10/7/21. Pt then died on 10/10/21. Death was caused by: Septic Shock secondary to bacterial pneumonia and c. diff colitis. Pt had received covid vaccines on 1/29/2021 & 2/23/2021. This death is likely not related to the vaccinations due to comorbidities, age, and length of time from vaccine administration.
This spontaneous report as received from a Registered Nurse (R.N) concerning a 14 year old female patient with thalassemia trait, history of eczema and no drug allergies/drug reactions. It was reported that on 24-JUN-2014 the patient was vaccinated with the first 0.5 mL dose of GARDASIL (Lot # reported as K004546), intramuscularly into the right arm. Concomitant therapies included FLUARIX which was given into the left arm prior to receiving GARDASIL. On 29-SEP-2014, the patient received the second 0.5 mL dose of GARDASIL (Lot # reported as K004546). The nurse reported that on 29-SEP-2014 the patient experienced being oblivious and then experienced crying, shortness of breath and extreme abdominal pain after receiving GARDASIL. Nurse reported that abdominal pain improved after five to seven minutes. It was reported that the patient was observed for 25 minutes and went home with only mild abdominal pain. Patients vital signs were normal. Shortness of breath resolved completely in 2014. There were no laboratory diagnostic tests performed. The patient informed nurse that the second dose of GARDASIL hurt more than the first dose. Nurse reported that a 25 gauge, one inch needle was used for GARDASIL injection. There was no treatment given for the adverse events. The outcome for being oblivious, crying, extreme abdominal pain was reported as recovering. The outcome of the pain for the first dose was recovered in 2014 and for the pain with the second dose was reported as recovering. Additional information has been requested.
Chills; nausea; This is a spontaneous report from a contactable consumer, the patient. A 13-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration on 03Jun2021(at the age of 13-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as unknown. It was unknown if patient had any allergies. It was unknown if patient received any other medication within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unknown route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown if  the patient received any other vaccines within four weeks prior to the vaccination. On 04Jun2021, the patient experienced chills and nausea. It was unknown whether therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event chills and nausea was resolved on an unknown date in Jun2021.   The batch/lot numbers for BNT162b2 was not provided and will be requested during follow up.
current_age 15; left axial lymph node swelling--size of golf ball; with pain/discomfort; lasting 12 days; left axial lymph node swelling--size of golf ball; with pain/discomfort; lasting 12 days; left axial lymph node swelling--size of golf ball; with pain/discomfort; lasting 12 days; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 15-years-old male patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: ER8731), dose 1 via an unspecified route of administration, administered in Arm Left on 28May2021 13:00 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included   from an unknown date and unknown if ongoing. There were no concomitant medications. No other vaccine in four weeks and no other medications in two weeks. The patient experienced current_age 15 (off label use), left axial lymph node swelling--size of golf ball; with pain/discomfort; lasting 12 days on 01Jun2021 with outcome of recovering.  No follow-up attempts are possible. No further information is expected.  Follow-Up (12Jul2021): Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a Licensed Practical Nurse, referring to a 74 year old female patient. The patient current condition included allergy to sulfas. None pertinent medical history nor concomitant medication was reported. On 16-MAY-2018, the patient was vaccinated with 1 dose of PNEUMOVAX 23, lot # N027624 and expiration date 11-MAY-2019, intramuscular for prophylaxis. (Dose was not reported). On 17-MAY-2018, the patient returned to the physician office with a "bad cellulitis of the left upper inner arm, not where the injection was received". The patient was given a one-time ROCEPHIN injection, dose not specified, and she was prescribed KEFLEX for ten days. None diagnostic laboratories were performed. At the reporting time, the current status of the patient was unknown. The reporter did not assess the causal relationship between therapy with PNEUMOVAX 23 and the cellulitis. Upon internal review the cellulitis was considered to be medically significant. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1805USA009622.
high pitched crying & wheezing (stridor) p/waking from nap;returned to clinic recv decadron Im;
localized rxn (swelling, tenderness, redness), inc temp 101.9, h/a;
Started out as large set of hives around full torso and back. Next morning woke up to full body rash - large swollen rashes covering entire arms (both arms), back, stomach and some areas on my legs. Rashes are hot, painful and raised.
Subsequent to receiving one dose of varicella virus vaccine live the pt developed chickenpox. It was a moderate case, not too red and get crusty before they get too big. The pt was noted as having at least 50 lesions from head to toe. The pt sought unspecified medical treatment. Follow-up information from a physician reported that the pt subsequently recovered.
Location was a drive-thru clinic. Immediately following the injection, I became hot, sweaty, pale, light headed, and nauseous. I was sitting the entire time following and after injection. I immediately found a parking spot and laid my seat back, only to sit back upright and vomit. After several rounds of that I laid back down and fought more nausea on and off for an hour. I would try to sit up but would feel instantly like passing out. After an hour and a half I felt ok to drive. 5 days later and I still have bouts of nausea and I?ve had typical injection site pain that has kept me from laying on that side at all.
I had body aches and low grade temps with the first two vaccines. After the third dose, 48-72hrs extreme fatigue and very intense body aches all over my body, back, chest, both arms, both legs, into my fingers and toes. Fever 101. Sharp chest pains. Random shooting pains (nerve pains?) Shooting like lightning bolts everywhere in my body lasting for 5-10sec 10/10 pain. After each vaccine my chronic cough worsened.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Dec2020 as dose 1, single (Batch/Lot number: unknown), in right arm, on 14Jan2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 24Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Jun2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (10Jun2022) Positive, notes: Rebound COVID on day 11 after first initial positive test. This is 5 days after completing paxlovid; (21Jun2022) Positive, notes: Rebound COVID on day 11 after first initial positive test. This is 5 days after completing paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient received treatment with paxlovid for covid-19 treatment start date was 11Jun2022 and treatment stop date was 16Jun2022. The patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current limited available information, a possible contributory role of the suspect product BNT162b2 to the development of events vaccination failure and COVID-19 cannot be excluded.