chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Affecting my lymph nodes in the armpit right up to behind my ear and under my chin and also to the side of my neck; Pain in left armpit; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (Pain in left armpit) and LYMPH NODE PAIN (Affecting my lymph nodes in the armpit right up to behind my ear and under my chin and also to the side of my neck) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced AXILLARY PAIN (Pain in left armpit). On an unknown date, the patient experienced LYMPH NODE PAIN (Affecting my lymph nodes in the armpit right up to behind my ear and under my chin and also to the side of my neck). At the time of the report, AXILLARY PAIN (Pain in left armpit) and LYMPH NODE PAIN (Affecting my lymph nodes in the armpit right up to behind my ear and under my chin and also to the side of my neck) outcome was unknown.            Concomitant product information was not provided. Treatment information was not provided.   This case was linked to MOD-2021-068895, MOD-2021-068895 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Translation document received on 05 Jul 2021 and events pain in left armpit, affecting many lymph nodes in the armpit right up to behind ear and under chin and also to the side of neck were added On 24-Jul-2021: Follow-up received and contain non-significant information. On 29-Jul-2021: follow-up was received and contains no new information
The facility only had record of the patient's 1st primary dose and thought the patient needed a 2nd primary dose. Based on the database, the patient was due for a booster dose, which is a half dose.
This prospective literature marketed report has been received from the author of a literature article. Objective of this report was to assess availability and use of measles-mumps-rubella (MMR) vaccination documentation for people vaccinated elsewhere. 1500 records were selected from 14 places from March 2013 through July 2015 to determine whether vaccination records were available at the health assessment and integrated into the Advisory Committee on Immunization Practices schedule. Number of doses, dosing interval, and contraindications were assessed. Twelve of 14 (85.7%) places provided data on 1118 (7 4.5%) people. Records for 972 (86.9%) people were available, most from the Centers for Disease Control and Prevention's Electronic Disease Notification system (66.9%). Most people (829; 85.3%) were assessed appropriately for M-M-R II vaccination; 37 (3.8%) should have received the vaccine but did not; 106 (10.9%) did not need the vaccine but were vaccinated. Author reported that 106 patients of unknown gender and age who did not require vaccination, were vaccinated with M-M-R II (inappropriate schedule of drug administration).  This is one of the two reports received from the same reported. Additional information has been requested.; Sender's Comments: US-009507513-1706USA007838:
15AUG95 710AM- sz found in crib p/receiving shots;14 hr p/vax 2nd sz occurred in hosp @ 1031;flown by helicopter hospitalized for 2 1/2 days in hosp;
Hospitalized 7/9/22-7/12/22 diarrhea, weakness, weight loss, vomiting,  abdominal pain, UTI, colitis, cholelithiasis with urete obstruction,
This spontaneous report as received from a physician via a sales representative refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies were not provided. On an unknown date the patient was vaccinated with a dose of RECOMBIVAX HB (route, dose, lot # and expiration date were not provided). Co-suspect therapy and concomitant medications were not provided. On an unknown date, the physician reported that one of his patients, who completed RECOMBIVAX HB (cannot be ruled out), on an unspecified dates, had titer drawn and titer result was negative for Hepatitis B antibody. At the time of the report, the patient's outcome and the relatedness between the event and suspect therapy were unknown. Additional information has been requested.
pt recv vax & exp pain in arm 7 wrist 15-30 min post vax;pt exp dry throat, trouble breathing & a faint feeling;dry throat, trouble breathing & faint feeling subsided w/in 15-20min;pain in arm & wrist w/in 12hr;
Received COVID-19 vaccine (Pfizer) at on 3/16/21 and 2/22/2021. On 4/14 developed chills, cough, headache, nasal congestion, shortness of breath, and sore throat.  Tested positive for COVID-19.
Information has been received via facility from a 55 year old female nurse referring to herself with asthma, sinus infection and migraine. The patient's medical history included separated shoulder. The patient received a flu shot and a tetanus shot in the past. Concomitant therapies included baclofen for migraine and unknown medications for asthma. On 03-MAR-2017 at about 16:30, the patient was vaccinated with PNEUMOVAX23, one dose (lot # and expiration date unknown), intramuscularly in her upper left deltoid one time for prophylaxis. On the same day, since receiving the vaccine, the patient was experiencing muscle pain that was spreading to her shoulder, pectoral muscle in her chest, muscles in her lower neck, the front and back of her rhomboid muscle from her shoulder to her spine. She also had pain in her deltoid and armpit. The pain was so severe she could not abduct or lift her arm and she felt like she had a separated shoulder or a sprained shoulder. She reported she could not lift anything or move her arm to the point that she could not reach behind herself to put on a shirt or bra. She also was experiencing severe pain under her collar bone. The pain was significant enough to cause her to need to brace her arm against her body. She could not get comfortable or sit down. The pain was spreading. Relevant laboratory data for the events was unknown. As of the reporting time, the patient no longer received PNEUMOVAX23 and the events persisted (not resolved). The causality between and PNEUMOVAX23 was not provided. The reporter considered the events to be medically significant. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1703USA002496.
Pt was admitted on 12/11 with a PMH of CHF, CVA, COPD, type 2 diabetes mellitus for intractable headache. On 12/15 pt developed a fever and had difficulty breathing. Tested positive for COVID-19.
pt recv vax 8AM 26JUN96 & 27JUN96 mom states 9AM pt had fever APAP given during the day & cool baths;t running 101-103 & did not respond to APAP or cool baths;10PM fever inc mom not sure how high & pt had sz rushed to ER-did not respond
This spontaneous report as received from a physician refers to multiple, unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patient were vaccinated with improperly stored doses of PROQUAD, lot # K023365, expiration date: 20-MAY-2016, (dose, route of administration and injection site were not reported). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Could not move arm for 2 days(painful). It is now 2 weeks, still in pain. Taking alevea and using aspercreme. I consider myself to have a high tolerance for pain.
woke up 830am with vision changes could not see extremely blurred vision went away within 4hrs yet came back briefly 3hrs later
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium
High fever, febrile seizures, on and off for two days (did not have seizures, had tremors per pt's mother).
Swollen, red, raised rash appeared within 1-2 day of vaccine. BENADRYL cream improved rash.
Client received vaccine and started to feel lightheaded, dizzy and nauseous.  Client exited car for fresh air and symptoms worsened.  Client lowered himself to the ground to prevent falling.  Fire Rescue arrived to evaluate patient.  Client diaphoretic, pale, but A+Ox3.   Vitals all wnl, symptoms began to resolve as client rested and hydrated.  Client was able to ambulate independently back to his vehicle where he continued to recover.  Client declined transport for further evaluation and stated he felt better.  Per Fire Rescue no further evaluation needed at scene.  Client released at 10:45am.
HEADACHE; TIRED; This spontaneous report received from a patient concerned a 60 year old of unspecified sex. The patient's height, and weight were not reported. The patient's past medical history included hives, and concurrent conditions included asthma, ibuprofen allergy, sulfa allergy, non smoker, and abstains from alcohol. The patient experienced drug allergy when treated with acetylsalicylic acid for asthma.  The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 13-MAY-2021, the subject experienced tired. On 21-MAY-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from tired, and had not recovered from headache. This report was non-serious.
Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning a 14 year old female with asthma and no known drug allergies who in JUL-2008, was vaccinated IM with the first dose of GARDASIL 0.5 ml (Lot # 0151X), and in DEC-2008, was vaccinated IM with the second dose of GARDASIL 0.5 ml (Lot # 660389/1968U).  The patient was pregnant at the time of vaccination (gestation-about- 5-6 months).  Concomitant therapy included MSD, XOPENEX and albuterol inhaler (manufacturer unknown).  The patient was currently experience diarrhea.  The outcome of the patient's adverse events was not reported.  It was reported that the patient sought medical attention:  office visit.  Additional information has been requested.
Within 12 hours of the second dose my legs were covered in hives, full body itching, infrequent hives scattered around my other body parts, wheezing, and facial angioedema. I continued on my daily antihistamine regimen, and in about four days the symptoms slowly faded.
No additional adverse effect reported; the patient received one improperly stored dose of PROQUAD; This spontaneous report was received from a nurse practitioner concerning a patient of unknown age and gender. The patient's past drug and pertinent medical history, as well as their concomitant medications and drug reaction or allergies, were not provided.  On 25-FEB-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA) (PROQUAD) for prophylaxis (product storage error) (lot number S012532 has been verified to be a valid lot number, expiration date reported and validated as 20-OCT-2020) (concentration, dose, frequency of vaccination scheme and anatomical location of vaccination were not reported; route of administration was unknown to the reporter).  The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (rHA) (PROQUAD) underwent a temperature excursion between 6 to 14 degrees Fahrenheit (5.69 degrees Fahrenheit) for 1 second as recorded by the data logger. A previous temperature excursion from 6 to 14 degrees Fahrenheit (5.81 degrees Fahrenheit) for 28 minutes was also recorded by the data logger.    The diluent used was properly stored. No additional adverse effects were reported.
reported that with each AVA she received she developed swelling that extended to her elbow associated with redness, warmth and the development of a knot. Each knot would last approx one month. One day after AVA #2 on 29 Jan 03 she reported to the clinic with a new rash over her arms x 2-3 days and denied the use of new products. She was diagnosed with dermatitis. She was seen again in 4 Apr 03 for extension of this rash to her inner thighs and popiteal fossa and was diagnosed with eczematous lesions. She denied any previous hx of skin problems. Currently this rash continues to persist with periods of exacerbations. She was evaluated by Dermatology and through skin testing was found to have a contact dermatitis to 3+ cobalt, 2+nickel, and 1+ formaldehyde. She reports issues of tendonitis involving her knees, feet and wrist since 2005-06. She reported that she received an anthrax vaccine in late June or early of 04 because she found out approx one week later that she was pregnant. The DEERS date base does not verify the administration of AVA #6. It was later discovered that she was pregnant with twins with fatal demise of one twin at 16wks gestation. Ultrasound report noted that one twin had multiple anomalies level 3. The other twin was delivered by C-section at 36-3/7 wks gestation and was healthy. Symptoms: Joint Pain, multiple joints, Miscarriage, Dermatitis, diffuse, generalized, Dermatitis, focal. Dx: 12/2007 Dermatitis, contact and other eczema NOS (692.9), 04/2006 Synovitis NEC (727.09) left knee; 10/01/2005 Tenosynovitis, radial styloid (727.04); 10/2004 Death, intrauterine (656.4) at 15-20 wks gestation, del Feb 05
Bacterial rosacea; broke out" on the left arm, her scalp; broke out on the left arm, her scalp, and eye.; This spontaneous case was reported by a consumer and describes the occurrence of ROSACEA (Bacterial rosacea), DERMATITIS (broke out" on the left arm, her scalp) and EYE INFLAMMATION (broke out on the left arm, her scalp, and eye.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L204 and 013A21A) for COVID-19 vaccination.     The patient's past medical history included Rosacea since an unknown date and COPD. Concurrent medical conditions included Arthritis. Concomitant products included GABAPENTIN and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ROSACEA (Bacterial rosacea), DERMATITIS (broke out" on the left arm, her scalp) and EYE INFLAMMATION (broke out on the left arm, her scalp, and eye.). At the time of the report, ROSACEA (Bacterial rosacea), DERMATITIS (broke out" on the left arm, her scalp) and EYE INFLAMMATION (broke out on the left arm, her scalp, and eye.) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment medication reported.   This case was linked to MOD-2021-265424 (Patient Link).
Right 6th cranial nerve palsy was noted 9 days after the 2nd Shingrix vaccine injection. A clinical exam by an ophthalmologist diagnosed the issue.
Exaggerated local rxn, 8cm warm, red, induration 2 site of inject lt thigh;
Patient experienced soreness on the injection site and a small low grade fever and sore throat the next day after vaccination, only one for day. Patient said s/s cleared up on the 3rd day.
Red swelling to left deltoid where injection was administered. Follow up on 04/20/04: "Everything correct."
Patient had sudden intense headache 20 min post vaccination. Patient stable, released from vaccination site.
About two minutes after receiving the vaccine, the patient was talking to me then suddenly stopped talking and slumped over. He was able to speak to us after about 30 seconds and drink water.
Arm became swollen; This case was reported by a consumer via other manufacturer and described the occurrence of swelling arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced swelling arm. On an unknown date, the outcome of the swelling arm was unknown.   It was unknown if the reporter considered the swelling arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. Consumer reported an unspecified patient received a dose of Shingrix arm became swollen. This case is one of the 3 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR145802:same reporter US-GLAXOSMITHKLINE-US2020AMR145811:same reporter
pt received 1st dose of moderna vaccine on 2/23/21. pt contacted PCP office on 3/11/21 complaining of sinusitis that started '10 days ago'. pt was given a Rx for Amoxicillin 1,000mg PO BID for 10 days. pt received 2nd dose of Moderna Vaccine on 3/23/21. pt contacted clinic again on 3/29/21 with chief complaint of 'laryngitis for 30 days'.  Pt was given a same day OV with covering provider for evaluation. Per provider note- pt stated 'he was treated for sinusitis but this was documented incorrectly as he has only had hoarse voice and no other sx of sinusitis'. Pt was Rx'd voice rest, warm fluids, humidifier, referral to ENT.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 61-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Each one made me sick I missed five days of work each time I got the shot; it was nasty and it was horrible". Therapeutic measures were not taken as a result of illness. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : PFIZER INC-202201056342 same patient, different product and event; PFIZER INC-202201056719 same patient and product, different dose; PFIZER INC-202201056720 same patient and product, different dose;
MMR vaccination 1/14/03. Patient experienced hives on face, itching on neck and chest on 1/16/03. Also axilla red/blotchy in inferior aspect. Tazorac 0.1% gel.
Heat and redness around entire upper left arm for about 4 days.  Intense itchiness that was relieved with antihistamines that lasted for about 7 days.
Migrating local soreness, decreasing after 1 week. Migrating uriticaria treated orally with antihistamines & topically with clobetasol. Continued symptoms 60+ days, back to baseline mid-December. Broke out with shingles early September, treated orally with valacyclovir. Pain relieved with two 325mg acetaminophen tablets.
was sleepy for a couple days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (was sleepy for a couple days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (was sleepy for a couple days). At the time of the report, SOMNOLENCE (was sleepy for a couple days) had resolved.            Patient got the second shot on 15-FEB-2021 and the patient is awaiting for the third dose.  Concomitant medication not provided by reporter.  Treatment information not provided by reporter.
Patient fully vaccinated (Moderna) and boosted (Pfizer), admitted to the hospital on 2/16/22 with COVID-19 and associated hypoxia. Patient was discharged on 2/19/22.
Pain and tingling at injection site; numbness/tingling of left arm (injection arm) and hands; pain in legs; numbness of feet and legs; lightheadedness- I have not been to the physician yet. I plan to go tomorrow if conditions do not improve.
Patient had a sore right arm 3-5 hours after being vaccinated. 12 hours later patient could not move her arm, it started to tingle, became red and raised 12+ inches, very painful required hospitalization and IV antibiotics.
Pt states the scab fell off of his vaccination site 7 days ago and 2 days later pt noticed 2 pustules on his upper left arm near his vaccination and a larger pustule on the left side of his neck.
Extremely sore arm. Had injection at 10:55am on 1/30. 3:00am on 1/31 woke up with body violently shaking like I was cold, but I was not cold. I finally had to lay on my arms to hold them still. It lasted about 15mins.
Information has been received from a pharmacist concerning an approximately 55 year old female pharmacist who administers Zostavax and developed shingles. It was reported that on 21-NOV-2007, she developed a pain in her back and arms. Later, blisters developed on her back. It was reported that she was evaluated by her physician who diagnosed her with shingles and told her it was because she had been administering zoster vaccine live. The varicella zoster virus identification program was offered to the reporter, who stated that, he who let the patient know about the program and she would initiate contact if interested. It was reported that at the time of this report, the patient had not recovered. A product quality complaint was not reported. Shingles was considered to be disabling by the reporter. Additional information has been requested.
Patient reports throat felt itchy and like it was closing up 10 hours after the vaccination. He had tonsil stones and gargled salt water to dislodge tonsils stones took a benadryl, but throat still feels itchy after tonsil stones were removed, although improved. He had difficulty sleeping at night because of throat swelling.
No additional AE information provided; the patient was administered an improperly stored dose of Pneumovax23; This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 19-DEC-2019, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (route and dosage schedule were not reported) lot # S004548 exp date: 12-AUG-2020 for profilaxis. No adverse event was unknown.     The temperature excursion was of 47.3 degrees Fahrenheit, for 20 minutes. No previous temperature excursion reported. A data logger was used.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S004548; expirationdate: 12-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2005USA000302:
Symptoms began: 9/3/2021. Patient was hospitalized due to COVID. Patient is fully vaccinated.