chrisvoncsefalvay/vaers-outcomes huggingface dataset:
C/O fever and ITP x5-6 days - Mom went to ped E.D. 9/15/08 at 10 AM for evaluation - then admitted to inpatient for further mgmt by ped. hematology. Currently being treated with supportive therapy and empiric IV antibiotic therapy - awaiting culture results (see note) and bone marrow pathology. 10/1/08 Reviewed hospital medical records of 9/15-9/18/2008. FINAL DX: atypical idiopathic thrombocytopenic, extension of chronic skin condition Records reveal patient experienced fever x 10 days, nasal congestion, mild periumbilical pain, fatigue, thigh myalgias, bruising/petechia, 4-hour nosebleed, gum bleeding x 1 week.  Tx w/IVF, IV antibiotics, steroids. Derm & Rheum consults done.  Derm felt rash probably viral exanthem.  Rheum felt probable evolving SLE.  Improved & d/c to home on tapering steroids to be f/u in heme/onc clinic.
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events was unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756546A, A0756548A - A0756562A. The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there were 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA 320BA): AFLUCA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
Upper right arm (site where vaccine was given) turned dark red, began to swell, developed erythema and inflammation, and developed shingles-type vesicular lesions at injection site. Fever of 101 noted with fatigue and generalized achiness.  Treated at urgent care center - given Kenalog injection, started on Prednisone for allergic reaction, ice applied to site, ibuprofen given, rest and fluids ordered.
2/12/2023 I woke up and realized there was something wrong with my bladder and urinary system. It felt like I was getting a UTI. I went to the bathroom, and nothing was working right. The pressure and frequency got closer together. It felt like a combination of a bacteria and yeast version. I developed a fever and contemplated calling the ambulance. I was taking ibuprofen and the fever broke. 2/13/23 I called the Urologist and spoke with the physician assistant. I went to their office on 2/14/23 and gave a urine sample. I was prescribed an antibiotic that is traditionally prescribed for a new patient developing a Urinary Tract Infection. After 7 days on the antibiotic, on 2/21/23, it was apparent it was not working. I had a little bit of improvement, but in no way cleared it out. I called the doctor's office and told them the medication was not working. They had lost my urine sample from the previous visit. I went into the office to give another sample. I got a message from the doctor who prescribed CIPRO for 10 days and a prescription for after the CIPRO to take for two days. The frequent urination and very slow draining and incomplete draining was still going on, something was wrong. I called the doctor's office and told them it helped, but I was not cured that something else was going on. I had an appointment to see the doctor on 3/7/23. The lab work that came back and showed no infection. The doctor scheduled a cystoscopy. I had the cystoscopy on 3/24/23. There had been so much inflammation and irritation, it was causing the restriction. I was recommended to have an implant procedure, a Uro-Lift. I am scheduled to have that done on April 19, 2023. I am improving.
apparent swelling/redness - pt self treated with oral steroids, resolved in 3 days
My symptoms from the gadolinium worsened after the vaccine.  Increased neuropathy in extremities, loss of short term memory, tightness of skin on face, nose numb,  sympathetic nervous system engaged, no ability to get out of fight or flight.
Pt. received PREVNAR 13 on 10/23/16. He presented on 10/29/16 with redness on his Rt arm from just below shoulder to about two inches above his elbow. He reported itching. No swelling and no broken skin. Pt. was advised to take BENADRYL and follow up with MD on 10-31, or go to urgent care if it gets worse.
Patient called on 1-15-10 to report pain in left arm and shoulder. Radiates from shoulder down to elbow and to thumb. Pt states "muscle mass sore." Pt denies and redness, swelling or discoloration. Pt. denies any warm, redness (L) arm.
One episode of fecal and urinary incontinence about 15 min after Td. Followed by about 10 mins of feeling cold, sweating and entire body shaking. Then felt weak and tired for about next 24 hrs. Then back to normal feeling and no problem since then.
Patient is 9 months postpartum and developed mastitis of the right breast. Previous to this episode, patient had never had mastitis before. Patient woke up at 3:30am on 6/20/2021 with chills, a painful right breast, and a self-reported fever of 102.5 degrees F. She took ibuprofen (600mg), expressed breastmilk, and placed an ice pack on the right breast before going back to sleep. Upon reawakening, patient had body aches, fatigue, chills, a painful right breast, a painful right arm where the lymph nodes are located, and fever had decreased to 100.5 degrees F. Patient felt mostly better the morning of 6/21/2021, but still was taking ibuprofen and was  fatigued with a low-grade fever. Patient scheduled appointment with doctor at 9:45am on 6/21/2021 (General Medical Visit #16396340) and was diagnosed with mastitis by Dr. and was prescribed Cephalexin 500mg 4x/day for 7 days. Patient did not mention receiving the vaccine recently to the doctor.
pt recv vax 27JUL95 & 5 to 10mins p/vax pt began swing head back & passed out;became stiff & hands were clenched in a fist position;pt recovered;nurse felt pt exp not related to therapy w/vax
This case is a part of cluster report of 2 cases and is linked with the case# 2012-07268, (same reporter, ADACEL vaccine (lot no: U4329AA) and Varicella (lot no: 0591AE). Initial information received from a Health care professional on 26 July 2012. Two patients whose medical history and concomitant medications were not reported received dose of MENACTRA vaccine (lot no U4244AA), ADACEL vaccine (lot no: U4329AA) and VARIVAX (lot no: 0591AE) (Manufacturer was Merck) on an unspecified date. The two patients experienced fever and shaking. Laboratory test and Corrective treatment was not reported. The outcome of the event was recovered however the stop date of the events was not reported. Documents held by sender: none.
patient described little to no reaction following  FIRST shingrix dose, however, following second dose, on the same day as the dose was given, in the afternoon patient reports feeling very ill - enough to be on the couch and unable to do normal daily activities until 48 hours later. Also, patient reports the appearance of a rash on her trunk and upper arm resembling chicken pox. the rash she said was very itchy and she used hydrocortisone cream to help. She reports recalling chickenpox as a child - a very severe case - in the summertime. The rash that came following the vaccination appeared approximately 2 weeks after her second dose of shingrix which was given 8/20/2019.
Three papules appeared on (R) thigh at site of injection, red & swollen 1 cm size local reaction; fever - 102 degrees symptoms appeared 7-10 days after injection.
Information has been received from a physician concerning a 65 year old female patient with hypothyroidism, osteoarthritis, depression, menopause, asthma and allergy to AUGMENTIN who on 02-NOV-2007 was vaccinated IM with her first dose of pneumococcal 23v polysaccharide vaccine, lot #655152/0889F. Concomitant therapy included influenza virus vaccine (unspecified) given the same day in the other arm, SYNTHROID, estradiol, LEXAPRO, and AMBIEN. The patient developed redness and rash at injection site and sought medical attention in office, but no treatment was required. Subsequently, she recovered. Additional information has been requested.
Arm pain in area of injection that evening. I could not lay on that arm due to too much pain. Next morning, I could not move left arm without severe pain. Took ibuprofen and 2 hours later, still had pain, but could somewhat move arm. Very tired/foggy. Took another dose of ibuprofen after lunch and Tylenol before bed. 2/10, continue to have left arm pain. Minimal increase in movement without the severe pain. My normal temp is 97.5. Woke up with 99.3 temp. I feel okay and not as tired. I just have severe left arm pain still.
This initial spontaneous case was received on 05-Dec-2017, from physician and concerns a 2-year-old child patient of unspecified gender. On an unspecified date (reported as 2 months ago), the patient was administered with FLUCELVAX QIV (dose: 0.5ml, route of administration: intramuscular, anatomical location, batch number, expiry date: not reported). It was reported that, 2-year-old child was administered with vaccine. Reporter stated that, after the administration of vaccine, the patient did not experience any adverse reaction. The reporter assessed this case as non-serious.
Post injection body aches, R arm pain 24 hrs later 8x4cm indurated with clear blisters. 5/29/01 dizzy, lethargic, joint pain, shoulder, neck hurt. Given Augmentin 500mg.
Arm was sore; A spontaneous report was received from a consumer concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm was sore.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Batch Number: D11L20A) intramuscularly in right arm for prophylaxis of COVID-19 infection.   On unknown date, the patient experienced arm was sore.  No treatment was information was provided.   Action taken with mRNA-1273 in response to the event arm was sore was not reported.   The outcome of event arm was sore was not reported.; Reporter's Comments: This case concerns a female who experienced a nonserious expected event of injection site pain.  Event onset occurred with unknown latency after the first dose of mRNA-1273. Treatment not reported. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
04/29/04 4:16 vaccine given. 12:30 A Entire arm sore, chills, nausea, diarrhea 8 times, face flushed. Evaluated in ED on 4/30 at 10:30A
Had runny nose the next day, tested positive for COVID-19 on Wednesday 11/17/2021
Next day I was sick to my stomach, high fever, diarrhea, fatigue, heart palpitations, bad heart burn. That lasted about 2 weeks. On 06/25/2021 - 06/29/2021 with an SMV trioses (blood clot in the middle of the chest). I was put on blood thinners.
Nausea; Hot flushing; Metallic taste; This is a spontaneous report received from a Pfizer sponsored program. A contactable female consumer (patient) of an unspecified age received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, on 16Mar2021, for COVID-19 immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, in Mar2021, the patient experienced nausea, hot flushing and had metallic taste. Patient took Tylenol and Phenergan after the first dose. Clinical outcome of the adverse events was unknown at time of this report.   Follow-up attempt have been completed and no further information is expected. The lot number is not available despite follow-up attempts made.
Anthrax was administered on the Left Arm. Patient reports rash of 50mm x 60mm, pain. No induration, no blisters.
patient is complaint of left shoulder pain since the flu shot. The pain started since 12-1-2019 (date of flu shot). Now she can't lift her arm above her shoulder. Patient said after Pharmacy corporate contact her to arrange MD visit, she will like to go see MD and get medical evaluation
Service member was admitted to hospital with chest pains, SOB and elevated enzymes on 30 Sept 06.  Chest pain start: 09/30/2006.  Dyspnea (shortness of breath) start: 09/30/2006, end: 10/02/2006. 12/20/07 Case closed as complete w/medical records that accompanied report.  Patient experienced acute onset chest pain & SOB.  Admitted 9/30-10/4/2006.  Had received initial smallpox vax 9/13/06 that did not take & was revaccinated 9/20/06.  Rehospitalized 1/7/2007 for exertional chest pain.  Consults by cardio, GI & pulmonary at that time were WNL.  Seen in ER 7/26/07 for chest wall pain & dx w/costochondritis.   Continues to have intermittent chest pain & SOB both at rest & w/exertion. FINAL DX: myopericarditis.
Pt developed hives, approx. 1 hour, after vaccination. She was seen in the ER and treated with Benadryl.
PATIENT RECEIVED VACCINATIONS IN SAME ARM AND SAID ARM "LOCKED UP" THE NEXT DAY... WAS IN PAIN
Information has been received from a consumer who is the mother of the 18 year old female patient.  The patient at the beginning of October 2008, was vaccinated with a first dose of GARDASIL.  When the patient received the first dose of GARDASIL, she was supposed to get her menstrual period that next week, but she ended up being two weeks later and when she did get her period it was very light and then it stopped.  Then a few days later she had  gotten her period again which it was light again and then it stopped.  Then a few weeks later the patient got her period again which the bleeding was heavier than it ever has been before.  Last week the patient was spotting again.  As of 24-NOV-2008, the patient had not started her period again.  No further information is available.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient pertinent medical history included hypertension and anxiety. On 11-SEP-2016, the patient was vaccinated with PNEUMOVAX 23 lot # L035687, intramuscular. Concomitant medications included unspecified medication for hypertension and anxiety. On 12-SEP-2016, 2 days after onset of therapy the patient experienced tenderness and swelling of his left arm at the injection site. On 13-SEP-2016, the patient developed rash extending from the injection site to the inside of his left arm. The patient sought medical attention and came to pharmacy. The pharmacist stated that the rash was not itchy and the patient had not required medical treatment at the time of this report. No laboratory tests were performed. The outcome of the events were reported as not recovered. The reporter did not provide the causality between the events and the suspect therapy. Additional information is not expected as the pharmacist did not want to be contacted.
Patient received FLUZONE injection on 10/17/16. Patient return to office on 10/19/16 with a 5 by 3 in swelling and redness in his left deltoid. The same arm the injection was given in.
Intentionally received two doses of vaccine back to back; Intentionally received two doses of vaccine back to back; A spontaneous report  was received from a healthcare professional concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and intentionally received two doses of vaccine back to back.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 4 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 7 Jan 2021, the patient received a second dose of mRNA-1273. The patient intentionally received the two doses of the Moderna COVID-19 vaccine back to back. No treatment information was provided. No other adverse event was reported.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, intentionally received two doses of vaccine back to back, was considered resolved.; Reporter's Comments: This report refers to a case of inappropriate schedule of product administration and intentional product use issue for mRNA-1273.  There were no reported adverse events associated with this case.
Redness; Sore arm; Rash on chest and arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), PAIN IN EXTREMITY (Sore arm) and RASH (Rash on chest and arm) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced ERYTHEMA (Redness) and PAIN IN EXTREMITY (Sore arm). In February 2021, the patient experienced RASH (Rash on chest and arm). At the time of the report, ERYTHEMA (Redness) and PAIN IN EXTREMITY (Sore arm) had resolved and RASH (Rash on chest and arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  Treatment medications was not provided by the reporter
Mild swelling, redness, tenderness at Td site. Flu like symptoms: body aches, fatigue, dizziness) Most symptoms lasted 4 days. Soreness in left arm lasted one week.
Immunization: Smallpox Vaccine Date: 07 Sept 2005, right arm Onset Date: 16-17 Sept 2005 Symptoms:  This 28 year old received his primary smallpox vaccination on 07 Sept 2005.  Approximately 16-17 Sept 2005 he complained of a sudden onset of "moderate midsternal chest pain/pressure" of variable intensity that was eased by sitting up and forward.  This discomfort disturbed his sleep and would wax and wane. He described the pain as feeling "like someone was standing on my chest  worse when lying flat or taking a deep breath". He denies nausea, vomiting, fevers, shortness of breath, or any radiating pain. He stated use of Ibuprofen had "minimal" effects.   He presented to medical clinic on 20 Sept 2005 with above complaints and complained of a rash from his thighs into his groin.  The rash was described as a papular design of the upper thigh in the area covered by his underwear that was diagnosed as "heat rash." His EKG showed NSR rate 73 with inverted T wave, unchanged from December 2004.   He was transferred to a hospital via ambulance for chest pain/pressure rule out myocarditis-pericarditis. Paramedics administered one 325 mg ASA enroute with cardiac monitoring. He described a mild squeezing midsternal type chest pain that began gradually one month ago while at rest with nausea to the nursing staff; however he denied any complaint of chest pain in the ER or while there to the physician.  He completed a cardiac evaluation to include a CBC, BMP, Cardiac panel (184/1.5/<0.04), PT, PTT  all normal; normal CXR and CT chest; and a normal EKG (NSR 66, T wave inversion, early repolarization). Cardiologist consulted and an echocardiogram was done.  He was released with a diagnosis of "non-specific chest pain" with prescriptions for Motrin 800mg and Albuterol inhaler as needed.  Attempts to contact this patient utilizing his cell and with above physician have been unsuccessful between 20 Sept 2005 and 17 Oct 2005. He is no longer in this town and his location is unknown. His cell phone is temporarily out of service.  CHCS II has no updated contact information.
The next day following the first dose of the vaccination, I started experiencing very painful headaches that have continued still to this day.  There is no specific pattern to the headaches, they come and go, but are very painful.   I also experienced a weird quiver type feeling in my left side of my face/cheek area.  This lasted about a week.
PATIENT HAD ALREADY ADMINISTERED THE BIVALENT VACCINE ON 10/06/2022.
Redness to deltoid area - increasing in size. Now about 3cm x 3cm. Positive warmth no tenderness positive itch initially.
Enlarged lymph node in supraclavicular area in same side as vaccine was given. No pain, no fever. Malaise, sore throat 11/10/2005 4:00 am.
5 hours after injection, severe headache and chills. By 12 hrs after, headache, chills, deep body aches, intermittent chest pain, nausea, diarrhea, injection site pain, hurt to move arm, shakey when attempt to stand, felt like brain was swollen, felt like could feel brain stem. Symptoms lasted 32 hrs then relieved rather quickly over course of 3-4 more hours.  Have never passed a more miserable day and my pain/discomfort tolerance level is very high.  Had a flu shot on 10/12/2021.  Had Covid-19 from 09/09 to 09/24/2021.
is taking Paxlovid for covid/how long after finishing the treatment she needs to wait before getting the second Pfizer covid 19 booster; is taking Paxlovid for covid/how long after finishing the treatment she needs to wait before getting the second Pfizer covid 19 booster; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team, Program ID. The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Lot number: EN5318), in arm, on 01Mar2021 as dose 2, single (Lot number: EN6202), in arm and on 02Nov2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 76 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "parathyroidectomy" (unspecified if ongoing), notes: caller had a parathyroidectomy and during the previous year; "knees replacements." (unspecified if ongoing), notes: caller had 2 knees replacements. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08May2022, outcome "unknown" and all described as "is taking Paxlovid for covid/how long after finishing the treatment she needs to wait before getting the second Pfizer covid 19 booster". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08May2022) Positive, notes: Tested positive for Covid Sunday, 08May2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Taking Paxlovid for Covid and wanted to know how long after taking the medication to get her Pfizer booster shot.  The caller confirmed the details provided by the transfer agent. Clarified she is wanting to know how long she has to wait to get her Pfizer COVID-19 vaccine booster. She had two regular COVID-19 shots and one booster already. She has her second COVID-19 Vaccine booster scheduled. Her and her husband both has COVID.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events VACCINATION FAILURE and COVID-19 and BNT162b2.,Linked Report(s) : US-PFIZER INC-202200700315 Same product and event, different patient