chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe chills lasting approx 4 hours, 1 degree temperature, fatigue, substantial swelling, redness of injection site lasting 5 days. Redness of injection site lasting 8 days.
Pt. presented to ED via EMS for emergent coma.  EMS intubated patient in field due to respiratory failure.  Pt. was severely hypertensive with nearly total loss of brainstem reflexes.  Patient had known L MCA cerebral aneurysm with appointment to undergo intervention to address in the near future.  NCCT reported massive multifocal brain hemorrhage, SAH, SDH, and parenchymal hemmorhage with midline shift and subfalcine herniation.  Due to dismal/poor prognosis, family requested withdrawal of support approximately 4 hours after presentation and patient expired shortly thereafter.
4:36- patient noticed itching on back and over her body. Taken to separate observation area. Flat, diffuse rash noted on back and abdomen. 4:40 pm. Benadryl 25mg po administered by HCP; continuous monitoring by EMS last BP 143/77- hr 78- SATS 98% on RA. Discharged home at 5:33 pm
Feeling 'funny," metallic taste, pain with injection site, irritated throat, sinus congestion, opposite-arm numbness, lip tingling - 2 doses of 25 mg oral diphenhydarmine liquid 10 minutes apart.
really fatigue/tired; chills; JOINT PAIN; MUSCLE PAIN; pain at injecton site; fever; A spontaneous report was received from a consumer concerning a 26 year-old, female patient participating in the mRNA-1273 Emergency Use Program and experienced fatigue, chills, joint pain, muscle pain, pain at the site of injection, and fever.   The patient's medical history, as provided by the reporter, included COVID-19. No relevant concomitant medications were reported.   On 24 Dec 2020 at 11:30 am, approximately 10 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot #039K20A) intramuscularly for prophylaxis of COVID-19 infection.   On 24 Dec 2020 at about 9:30 pm, the patient started to feel really fatigue and started to get chills, joint pain, and muscle pain. It was reported that the pain first started at the site of injection and then spread to other parts "just like when you workout". Fever was reported at 99.9F. On 26 Dec 2020, the patient reports that "most of symptoms resolved just feeling tired". Treatment for the event included acetaminophen and ibuprofen.   Action taken with mRNA-1273 in response to the events was not reported.   The events, chills, joint pain, muscle pain, pain at the site of injection, and fever, were considered recovered/resolved on 26 Dec 2020. The event, fatigue, was considered recovering/resolving.    The reporter did not provide assessment of the event in relation to study drug.; Reporter's Comments: This case concerns a 26-years-old female patient, with a history of COVID-19 (2 months prior to event onset), who experienced a non-serious expected event of fatigue, chills, pyrexia, arthralgia, myalgia, and injection site pain. The events occurred 1 days (same day) after first dose of mRNA-1273, lot # 039K20A.  Treatment included Tylenol and Aleve. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.
Source of report and patient demography: This spontaneous case was initially received on 15-Apr-2016. The case report was received from a Non Health Professional and concerns a female patient. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received Influenza vaccine on an unknown date. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On an unknown date, after starting / treatment with Influenza vaccine the patient experienced Drug allergies (non serious, outcome: Unknown). Reporter's assessment. Listedness: According to the Reference Safety Information, the event Drug allergies is a listed event of Influenza vaccine. Case Causality: Unassessable/unclassifiable due to insufficient information.
This infant received his immunizations approximately 1:30 PM. At 6:30 PM, he began crying, fever (101), vomited x3. His crying lasted 3 hours but no loose bowel movements. The infant was given Tylenol, the parent were also advised to contact there pediatrician. The fever lasted all night and was always 101.
Patient reports developing neuropathy in arms and legs that lasted for 2 weeks. Patient also had a sharp pain in the left calf muscle and was concerned about clotting, but followed up with PCP. They did blood work and everything came back fine. Patient now feels normal.
Patient had a syncopal episode with complete LOC and question of seizure activity.  Was found to be tachycardic, BP within normal range.
Caused headache with Dry heaves, vomited twice about 15 minutes after leaving clinic.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On an unknown date "five or more years ago", the patient was vaccinated with the first dose ZOSTAVAX (dose, lot number, expiration date were not reported). On 04-NOV-2014, the patient was vaccinated with the second dose ZOSTAVAX (dose, lot number, expiration date were not reported). No adverse symptoms was reported. Additional information has been requested.
SECONDARY TRANSMISSION  Close contact (breast feeding) mother, to husband who was immunized with vaccinia vaccine on 05/07/03.
Weaken immunity for 2 months. Was diagnosed with Strep A, an illness that has never been previously documented in my records.
This solicited report has been received from a 65 years old female patient, who was enrolled in a Marked Research concerning herself. The patient's medical history, concurrent conditions and concomitant therapies were unknown. On an unknown date the patient was vaccinated with PNEUMOVAX23 (dose, route, lot# and expiration date were not reported) for prophylaxis. On an unknown date the patient reported that it would make her sick when she was not. The outcome of the event was unknown. Causality between PNEUMOVAX23 and the event was not provided. Additional information has been requested.
Information has been received from a nurse concerning a 4 year old patient who on 04-SEP-2007 was administered a 0.5ml dose of Zostavax instead of Varicella. This was human error and not product confusion. No symptoms reported. Additional information has been requested.
Case number PHEH2015US004680, is an initial spontaneous report from the consumer (patient) received on 09 Mar 2015. This report refers 46-year-old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly on 01 Dec 2013. It was reported that, she is still experiencing the arm discomfort at the date of reporting. The final outcome of the event was unknown. The seriousness and causality assessment of the event was not reported.
Person got vaccination answered no to questions on contraindications. Witnesses mentioned he went around the corner and may or may not have been doing drugs. He walked down the street 15 minutes later and had someone call 911. We were not present at the time of the call.
Headache, Myalgia, Arthralgia, Fever, Fatigue Narrative:  Other Relevant History:
ACUTE NON ST ELEVATION MI 3/18/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Severe dry mouth) and DYSGEUSIA (Metallic taste in his mouth) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03UA21A and 016M70A) for COVID-19 vaccination. Concurrent medical conditions included Sjogren's disease. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced DYSGEUSIA (Metallic taste in his mouth). In June 2021, the patient experienced DRY MOUTH (Severe dry mouth). The patient was treated with PILOCARPINE ongoing since an unknown date for Dry mouth, at a dose of 5 mg; GLUCOSE OXIDASE, LACTOFERRIN, LACTOPEROXIDASE, LYSOZYME (BIOTENE [GLUCOSE OXIDASE;LACTOFERRIN;LACTOPEROXIDASE;LYSOZYME]) (oral) ongoing since an unknown date for Dry mouth, at a dose of 1 dosage form and XYLITOL (ACT DRY MOUTH LOZENGES) (oral) for Dry mouth, at a dose of 1 dosage form. At the time of the report, DRY MOUTH (Severe dry mouth) had not resolved and DYSGEUSIA (Metallic taste in his mouth) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: abnormal (abnormal) bloodwork done and Sjogren's  disease was ruled out. An additional treatment medication is Xylomelts lozenges and ACT rinse was reported for an indication of dry mouth. No concomitant medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: Event and reporter information updated.
allergies; Initial information regarding an unsolicited valid non-serious case was received from physician (Reference number- 00448644) and transmitted to Sanofi on 27-Jan-2021.  This case involves patient (age and gender not specified) who had allergies (hypersensitivity), while patient received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), past vaccination(s) concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious allergies (hypersensitivity) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Laboratory data was not provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Lightheaded Blurred vision ALS assessment completed with Sinus on monitor . After sitting in Ambulance , pt states  feeling better and denies transport to hospital. Pt signed refusal , left in own care.  VS 70/41, 85, 20 O2 sat 99 %, 90/55, 88, 16 O2 sat 99 %, 98/60, 86, 18, O2 sat 99 %.
Pt here for WCC 3/5/03. Received DTap, Comvax L ant thigh and MMR R thigh. Within 6-12 hours developed hive like rash and local erythema and induration on L thigh.
After the immunization of Moderna COVID-19 vaccines, I had experienced moderate headackes, fatigue and large areas of red rashes in my back, both legs and arms.  The red rashes started about 2 days after the vaccination were very very itching and lasted more than 1 month.  I also have experienced swelling joints and oint pains with my hands and my knees.  In early 2022, I started experencing additional problems with sudden ponding heart, short of breaths and headaches.
Mom called our office on 2/27/13 saying no redness, no bruising, had fever yesterday but none today.  "Knot the size of a walnut." Office visit notes of 2/28/13:  Had vaccination for 1 year shots on Monday (3 days ago).  2 days ago in the location of the shots given on the right upper anterior thigh patient started to have a "knot" at the injection site. Hard.  No redness, bruising, discharge, fever.  No pain noted.  Moving limbs equally.  Feeding stooling and voiding normally. Subcutaneous hard mass 2cm by 1cm in diameter located on the upper anterior lateral thigh.  No discoloration, discharge or tenderness to palpation.
Next day after first vaccination (Feb9) I developed large purple- pinkish spot below the place of a shot with a purple dot in the middle, looked like a ring worms ( I googled) but it did not itch. Looked very weird. I applied anti fungal cream and it got better. I decided it was not related to a vaccination.  But a day after second doze of vaccine ( March 4) I developed huge bright red spot below the place of a shot the size of my palm. It was tender and looked very strange. It took 4 days for it to turn purple and then it started to disappear.
Initial pregnancy report received from a healthcare professional on 22 April 2013. A 24-year-old female patient, had received first dose of ADACEL (batch number: C4365AA, expiry date: 06/25/2015) intramuscularly on the left deltoid on 20 April 2013. The patient was pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. The patient's health during pregnancy and risk factors were unknown. The patient's last menstrual period was not reported and the expected delivery date was reported as 08 June 2013. At the time of this report the patient had not experienced any adverse event. List of documents held by sender: None.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with one dose of PNEUMOVAX 23 (lot # and dose not reported). On an unknown date (two year after the first dose of PNEUMOVAX 23, the patient received the second dose of PNEUNOVAX 23 (lot # and dose not reported). Then on an unknown date, the patient experienced swelling at injection site and overall swelling in the arm that the second dose of vaccine was administered. The patient was treated with unspecified steroids on unspecified date. At the time of report, the patient had been fully recovered. This is one of several reports received from the same source. Additional information is not expected because the reporter did not want to be contacted.
:  Left Arm, Swelling. Redness, sore with lump which still has these symptoms.  , Messaged her PCP today 01.27.2021
Back pain that radiated to the back of legs. Experienced chills and fever 102.6.
Mother claims baby was doing well developmental wise until he was vaccinated with MMR and Varicella, then he started regressing by not talking.
Information has been received from a registered nurse concerning an 81 year old white female with allergies to penicillin and phenobarbital who on 10/30/2002 was vaccinated in the left arm with a second dose of pneumococcal vaccine 23 polyvalent (Lot # 643251/0445M).  Concomitant vaccination on 10/30/2002 given IM in the right arm included a dose of influenza virus vaccine (FLUVIRIN)(Lot # E32852GA).  It was reported that the patient had several previous doses of the latter vaccine.  The patient had gallstones at the time of vaccination.  On 10/30/2002 the patient developed cellulitis of the left arm.  The patient had pain, redness, itching and swelling in the injected arm.  She was given cephalexin (KEFLEX) 500mg one four times daily.  The symptoms subsided in a few days.  It was reported that the patient recovered on 11/02/2002.  It was also reported that one other patient received the same vaccine and developed a cellulitis-type reaction (WAES # 0301USA02553).  No further information is expected.
Started to swell the evening after vaccine given and painful for 3 to 4 days. Later became bruised but no longer painful.
She also mentioned that 2 weeks ago she found out that her lung cancer is back.; She also mentioned that 2 weeks ago she found out that her lung cancer is back.; I was tested for antibodies. I am Negative; This is a spontaneous report from contactable consumers. A 70-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: "reported as EL0262 or EL9262" on 22Jan2021 18:30 and second dose (lot number: EN6201) on 19Feb2021, both via an unspecified route of administration, administered in left arm for Covid-19 immunisation; mycophenolate mofetil hydrochloride (CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included interstitial lung coughing, (she states that she didn't have a transplant but has interstitial lung coughing), arm got red, arm hurt and lung cancer. There were no concomitant medications. On an unspecified date, the patient reported that she went for an antibody test, which came back completely negative. She also mentioned that 2 weeks ago (unspecified date), she found out that her lung cancer was back. The action taken in response to the events for mycophenolate mofetil hydrochloride was permanently withdrawn on an unspecified date. The outcome of the events was unknown.
I developed an itchy rash about one week after I got my 3rd dose of modern (the booster). Rash started on my chest then went to my scalp/neck and is now mostly on my neck, arms, and legs. There is no distinct pattern to this rash, just red marks in the skin if rubbed against and/or itched. Allergy medicine such as Benadryl does help to make it go away. Heat makes it worse.
Pt woke up this morning with hives on his torso and head, and his head was itchy.  He also woke up with the normal fever reaction to the Moderna shot.  Pt was instructed to take an antihistamine by a family friend nurse, so he took loratadine 10mg tablet and has felt fine since.
several of my friends went through the same thing,similar knee pain like her; 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 ARTHRALGIA (several of my friends went through the same thing,similar knee pain like her) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (several of my friends went through the same thing,similar knee pain like her). At the time of the report, ARTHRALGIA (several of my friends went through the same thing,similar knee pain like her) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were reported. No treatment medication details were reported.  Crosslinked to MOD21-117465, MOD21-168423, MOD21-168424, and MOD21-168425
14 year old was administered Fluzone High Dose, no AE; 14 year old was administered Fluzone High Dose, no AE; Initial and follow up information received on 06-Sep-2019 and 10-Sep-2019 regarding an unsolicited valid non-serious case received from a other healthcare professional.  This case is linked to cases 2019SA251863 and 2019SA251864 (same reporter).  This case involves a 14 years old patient who was received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ232AA, Exp. Date 10-Apr-2020) via intramuscular route in the left deltoid on 05-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to inappropriate age at vaccine administration.  It was also a case of overdose.  At the time of reporting no adverse reactions were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
INJECTION SITE SORE FOR 3 DAYS. 1/29 BURNING RASH ON RIGHT SIDE OF NOSE AND ABOVE BROW AREA FOR ONE DAY. 1/31 JOINT ACHE, FATIGUE RESOLVED 2/2/21 Narrative:
Rash at injection site - present 2/26 (8 days post injection). Large, hot to touch, red hive-like rash began as a few small bumps and developed into a large rash from approximately injection site to mid-upper arm.  Needle stick also reappeared and scabbed.  Physician prescribed antibiotic and steroid.
Patient complains of memory changes since vaccination, started not long after the injection and has persisted now 8 months. Says he cannot remember people or names, forgetful, and sometimes off balance
A report has been received from a health professional concerning a patient born on 20-NOV-1999, female subject, who had been receivinig nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on an unknown date. Reporter stated that the patients had been administered an expired FLUMIST Quadrivalent. The otucome of the event of administration of expired product is unknown. The report was considered to be non-serious.
patient received an expired IMOVAX RABIES vaccine with no reported adverse event; Initial information received on 08-Nov-2022 regarding an unsolicited valid non-serious case received via pharmacist. GMI number: 01358059.  This case involves an 89-year-old male patient to whom expired Rabies (HDC) Vaccine [Imovax Rabies] vaccine with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Immunoglobulins Nos for Immunization.  On 08-Nov-2022, the patient received a 2nd dose of an expired suspect RABIES (HDC) VACCINE at (unknown: formulation, strength) at dose 1ml once (lot: T1E943M, expiry date: 14-Oct-2022) via intramuscular route in the right deltoid for immunization with no reported adverse event (expired product administered) at same day latency.  It was reported that "Pharmacist reporting that a patient received an expired IMOVAX RABIES vaccines and was calling for further guidance. Pharmacist asked if patient needs to repeat the dose. The Pharmacist wanted to know if the vaccine was live. This situation is reported as a medication error due to giving an expired dose."   Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
pt recvd vax 26OCT92 & 18 hrs following vax on 27OCT92 pt devel vomiting, diarrhea, chills, malaise & a t100; pt's MD recommended that additional inject not be administered;