chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Not feeling well due to receiving COVID-19 vaccine shot; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well due to receiving COVID-19 vaccine shot) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Plaque psoriasis and Rheumatoid arthritis.    No Medical History information was reported.   On 25-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 25-Apr-2022, the patient experienced MALAISE (Not feeling well due to receiving COVID-19 vaccine shot). At the time of the report, MALAISE (Not feeling well due to receiving COVID-19 vaccine shot) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial . Concomitant medications were not reported.  No treatment information was provided by the reporter. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
On 7/6/12, 2 days after injection, at injection site - it was hot to the touch, swelling and redness started shortly after, very painful and itchy.
encephalitis; shingles; death; This spontaneous report was received from a lawyer and a patient of unknown age and gender regarding a case in litigation on 02-SEP-2021. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. In or around September 2012, the patient was inoculated with Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, and anatomical location was not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving Zoster Vaccine Live (ZOSTAVAX), the patient suffered shingles and encephalitis. As a direct and proximate result of these injuries, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient suffered significant medical expenses, severe pain and suffering, other damages, and ultimately death on 23-SEP-2018. As direct and proximate result of Zoster Vaccine Live (ZOSTAVAX), the patient suffered serious and dangerous side effects, including death, as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of patients conduct, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the reporting time, the outcome of encephalitis and shingles was not recovered. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the event of encephalitis was considered to be medically significant.
The day after the vaccine, I had tiredness, cold feeling, and body aches. I was feeling fine the next. Then a few days, I noticed my lymph node was swollen on both side of my neck. It was painful and sensitive. I took a half day off work because I was feeling bad and tired. I noticed a bump behind my right ear that was painful that was itchy. I also had a more swollen area on my right side on my collar bone. My right breast felt very tender and my right arm hurt. I did a telehealth visit 04/27/2022 and they said was possible due to the vaccine and give it a couple of weeks for the swelling to go down. I had a schedule appt for an ENT, I mentioned my issues and he noticed the lymph node was enlarged and my ear. I was prescribed a Z-pak. I went to work this morning and the red bumps on my neck and ear was irritated. I took my first dose of Z-pak. A nurse looked at it and states it could be infected so I called my doctor and he said the same thing. I was advised to seek medical treatment if it got worse.
Pre-dosed benedryl 25mg po at 7:00am, due to the previous reaction to covid vaccine number 1, where she stated she developed hives. Received second vaccine dose at 07:30. Around 7:45 co itchiness, no hives.  At 0800, throat itchy, c/o not feeling well, dizzy, b/p144/96, hr88.  taken to ER.
Red, swollen - left arm - warm to touch; was instructed to take Clarinex or Benadryl 1% Hydrocortisone cream to skin - ice; notify if any worse - 2/4/08- No follow up complaint from patient.
Chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 23-Feb-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 23-Feb-2021, the patient experienced CHILLS (Chills) and PYREXIA (fever). At the time of the report, CHILLS (Chills) and PYREXIA (fever) outcome was unknown.            No concomitant medication was provided.  No treatment details were provided.    This case was linked to MOD-2021-026273 (Patient Link).
Information has been received from a RN with environmental allergies and no significant health history who in 1996 was vaccinated with a booster dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). She had previously been vaccinated as a child with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). There were no concomitant medications. Subsequently laboratory evaluation revealed that a titer, which was done on an unspecified date, was negative for mumps. No adverse symptoms were reported. Unspecified medical attention was sought. The RN also reported that her son had experienced pervasive developmental disorder ADHD, autism, severe dairy allergy, cellulitis at injection site and a negative titer for mumps. Additional information has been requested.
p/vax pt devel finger joints extremely swollen & disfigured;all fingers on both hands extremely swollen (outer joints) & disfigures x/for rt fingers;also rt shoulder & ankle pain;lt ankle pain;
itch like a mosquito bite; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itch like a mosquito bite) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse events reported).    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itch like a mosquito bite). At the time of the report, PRURITUS (itch like a mosquito bite) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Upon in internal review on 21 May 2021, the age was corrected to unknown age.
Telephone call with mom, reports massive swelling, warm in left arm, post vax, Called ER X 3; gave child ibuprofen as directed, to decrease swelling. He developed fever of 101F while taking ibuprofen. Swelling extended from below elbow to collar bone/arm pit area. Resolved by 1/2/01. Not seen by a MD.
Due to similar reaction with first injection in Nov, I took qty 1 Advil every 6 hrs At 8:00pm I felt tired At 10:00pm, I had chills and felt increasing body aches Fever with Advil 101.7  Body aches so bad that I couldn?t sleep - awakened 5-6 times between 1130and 0830 Fever at 0830 approx 101 With Advil next day, body aches continued, unable to work full day. Fever until 11:00pm in 99.7 prior to Advil  Similar symptoms with first does, except I was sick to stomach.
arm was sore and it felt like someone had punched him in the arm; sharp pain in the shoulder/nail stuck in his shoulder; Throbbing pain/pounding; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 months after receiving Shingrix and an unknown time after starting ibuprofen, the patient experienced pain in arm, shoulder pain and throbbing pain. The patient was treated with ibuprofen. On an unknown date, the outcome of the pain in arm and shoulder pain were not recovered/not resolved and the outcome of the throbbing pain was recovering/resolving.   It was unknown if the reporter considered the pain in arm, shoulder pain and throbbing pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix around the second week of Christmas. He stated that after the injection his arm was sore and it felt like someone had punched him in the arm.  The caller described the pain as throbbing and pounding. The caller stated that the initial soreness and pain went away but he has a sharp pain in the shoulder. He stated that the sharp pain starts at the end of the day and goes on through the middle of the night. He stated that he feels as if there was a nail stuck in his shoulder. He stated he can still move the arm around and that he takes Ibuprofen for the sharp pain.  The caller stated that he has had injections throughout his life and has never had this happen before.  The caller had name of health care professional clinic but not the address.  The reporter consented to follow up.
No additional AE; The vaccine was administered to a 1 year old infant; This spontaneous report has been received from a physician concerning a 1-year-old infant of unknown gender.  The patient's concurrent conditions, medical history, drug/allergy reactions, and concomitant therapies, were not reported.  On 10-MAY-2022, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) at a dose of 0.5 mL (lot # T039467 with expiration date on 20-MAY-2023), administered intramuscularly for prophylaxis (Product administered to patient of inappropriate age). No additional adverse events (AE) were reported.
Nausea, chills, headache, fever within 24 hours of immunization.  Felt improved in 24 hours.
Vaccine was put in the refrigerator on 15-Jun-2022, patient administerd Moderna vaccine on 19-Jul-2022; administered with the vaccine that has been stored in the refrigerator for more than 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with the vaccine that has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (Vaccine was put in the refrigerator on 15-Jun-2022, patient administerd Moderna vaccine on 19-Jul-2022) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with the vaccine that has been stored in the refrigerator for more than 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was put in the refrigerator on 15-Jun-2022, patient administerd Moderna vaccine on 19-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with the vaccine that has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (Vaccine was put in the refrigerator on 15-Jun-2022, patient administerd Moderna vaccine on 19-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter.  Treatment details was not reported by the reporter.
Patient has been using Advate for many years. After last 2 doses, patient reports flushing, glassy eyes, chest/abdomen/shoulder pain, and upper body rash. Patient reports quick onset after Advate dose, which resolves within 10 minutes.
The injection site became red, warm, and swollen (similar to the size of a spider bite).  Patient went to the Emergency room under the advice of the home nurse.  The emergency room doctor gave her an antibiotic to prevent an infection.
Leg cramps, fever (100 F), fatigue, muscle pain, weakness, right arm pain more than left one, trouble sleeping because of the pain and cramps. Took aspirin and ibuprofen after 3 hours.
Approx 30 hrs after injection, a Singles/Chicken Pox rash developed under the arm (arm and chest) area of the same arm that was vaccinated.  The area was  approximately the 6  inches around on both the arm and chest.
Patient received 2nd COVID vaccine on 1.28.2021. Patient states she  experienced fever, vomiting, headache, and body aches beginning a few hours after  receiving the second vaccine. Patient states all side effects except for the  fever have resolved as of this morning. Patient also reports that she began  having hallucinations this morning (2/1). She says she is seeing spiders all over  her home. Put the patient on hold and reached out to family practice staff.  Patient states that hospice nurse is coming at 1:30pm today. I told the patient  about informing her PCP due to the hallucinations. The patient does not voice any  other complaints. Instructed the patient to seek emergency care for  severe/concerning symptoms
Numb at left arm IM injection site; immediate pain to below elbow - radiating to finger tips - tingling; left-side shoulder to neck strange feeling; creepy crawly sensations in brain/head; dizziness; neurological fog; extreme fatigue; blurred vision; pain in eyes all within hours after first dose.  By next morning - approximately 15 hours after injection the tops of my feet/shins were on fire (as if a blowtorch was being used on them) -- > as day progressed/within 24 hours, this fire radiated through my entire body - especially in my peripheral areas (feet/legs, hands/arms).  The fire pain remains and has moments of being very intense.  I received the vaccination 5 days ago at this point.  I am livid with how it has made me feel and I am concerned for my well-being.
Bruising all over body 10/24/19 Bloody Gums 10/28/19 Heavy Menses 11/1/19 Hospital 11/4/19 Platelets decreased 15,000 (ITP) Multiple doctor visits to rule out cause of symptoms Platelets IV - Reaction had to be medicated with Benadryl, antihistamines, steroids. Has to get weekly lab to monitor platelets count. Been on reduction Prednisone (since hospitalization) Dr - Rheumatologist Dr - Hematologist/Oncologist Dr - GI/Family Practice Dr - GYN office visit after event.
chills; sore throat; weak butt muscle; Pain and weakness at injection; diarrhea; shooting pin headache; Pain and weakness at injection; nausea; extremely fatigued; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), MUSCULAR WEAKNESS (weak butt muscle), ASTHENIA (Pain and weakness at injection), DIARRHOEA (diarrhea) and HEADACHE (shooting pin headache) in a 57-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for Flu vaccination.    No Medical History information was reported.   In September 2023, the patient received dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 19-Sep-2023 at 7:00 PM, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 21-Sep-2023, the patient experienced OROPHARYNGEAL PAIN (sore throat), MUSCULAR WEAKNESS (weak butt muscle), ASTHENIA (Pain and weakness at injection), DIARRHOEA (diarrhea), HEADACHE (shooting pin headache), VACCINATION SITE PAIN (Pain and weakness at injection), NAUSEA (nausea) and FATIGUE (extremely fatigued). On 24-Sep-2023, the patient experienced CHILLS (chills). The patient was treated with CALCIUM CARBONATE (TUMS EX) at an unspecified dose and frequency and BISMUTH SUBSALICYLATE (PEPTO-BISMOL) on 30-Sep-2023 at an unspecified dose and frequency. On 01-Oct-2023, OROPHARYNGEAL PAIN (sore throat), MUSCULAR WEAKNESS (weak butt muscle), ASTHENIA (Pain and weakness at injection), DIARRHOEA (diarrhea), HEADACHE (shooting pin headache), VACCINATION SITE PAIN (Pain and weakness at injection), NAUSEA (nausea), FATIGUE (extremely fatigued) and CHILLS (chills) had resolved.            On Sunday morning (24-Sep-2023), patient had minor chills. Patient took probiotic capsules and Tums EX frequently which did not help and then finally on 30-Sep-2023, patient took Pepto Bismol (ginger and chamomile). Patient also ate rice porridge mixed with mushroom soup or rice porridge with Chicken Flavored Better than Bullion. Patient drank plenty of water and for last 2 days slept on and off all day before recovering and feeling much better after awakening at 5:30 PM on 02-Oct-2023. Causality of the events with FLU vaccine was not reported by the reporter.
Woke up day after injection with severe body/muscle aches /weakness.  Hot red welt at site of injection.  time of illness - 24 hrs.  still have red welt at site of injection
Individual complained of slight lethargy. Soreness to LT Deltoid, with  2 1/2x 1 1/2 inch red irritation, warmth, circular  pattern redness. Physician stated treatment should consist of intermitted cold compress performed via individual. Individual received office visit with a doctor via Medical clinic-Telemed on 1/24/20. Physician stated follow-up will be performed on 1/26/20 at 16:00.
Pt recv vax on 8/24/98; on 8/25/98 pt exp cellulitis. Pt tx= Keflex 250 mg/1 tsp PO/ 4xdy/7 dys.
heavy left arm; Arm pain; head aid; diarrhea; cold sweet; dizzy; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Mar2022 (Batch/Lot number: unknown) at the age of 41 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Fabriomalgya" (unspecified if ongoing); "migraines" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization. The following information was reported: LIMB DISCOMFORT (non-serious) with onset 01Mar2022 20:00, outcome "not recovered", described as "heavy left arm"; PAIN IN EXTREMITY (non-serious) with onset 01Mar2022 20:00, outcome "not recovered", described as "Arm pain"; HEAD DISCOMFORT (non-serious) with onset 01Mar2022 20:00, outcome "not recovered", described as "head aid"; DIARRHOEA (non-serious) with onset 01Mar2022 20:00, outcome "not recovered", described as "diarrhea"; COLD SWEAT (non-serious) with onset 01Mar2022 20:00, outcome "not recovered", described as "cold sweet"; DIZZINESS (non-serious) with onset 01Mar2022 20:00, outcome "not recovered", described as "dizzy"; FATIGUE (non-serious) with onset 01Mar2022 20:00, outcome "not recovered", described as "fatigue". The events "heavy left arm", "arm pain", "head aid", "diarrhea", "cold sweet", "dizzy" and "fatigue" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of limb discomfort, pain in extremity, head discomfort, diarrhoea, cold sweat, dizziness, fatigue.  Additional information: Pharmacy or Drug Store was reported as facility type vaccine. There was no other vaccine administered in four weeks. The patient did not receive any other medications within four week. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Early 2nd dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Men B NVS (Bexsero) for prophylaxis.   Concomitant products included MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO).   On 30-JUN-2023, the patient received the 2nd dose of Bexsero. On 30-JUN-2023, an unknown time after receiving Bexsero and an unknown time after receiving BEXSERO, the patient experienced drug dose administration interval too short (Verbatim: Early 2nd dose). The outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 20-JUL-2023 A nurse reported that a patient received the first dose of Bexsero back in 22 June 2023, received the second dose on 30 June 2023.  The reporter did not consent to follow-up. The patient received early the 2nd dose which led to Drug dose administration interval too short.
presented w/lt upper arm soreness, skin hot to touch, colored pink orange size area;to MD to f/o cellulitis, lymphedema or drug rxn;
After receiving the flu vaccine at 0800 on 10/18/17 Pt. stated that same day at approximately 1800, she started to flush from chest up to entire face, was started to swell, felt itchiness to feet than hands. She took two OTC BENADRYL which alleviated the symptoms.
Swelling, erythema, tenderness and induration at site of injection 24 hours after injection
This spontaneous report was received from a licensed vocational nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not provided. On 28-MAR-2017, the patient was vaccinated with a dose of M-M-R II lot #M029918, expiration date 13-JUN-2018 (dose and route of administration were not reported). The vaccine was reconstituted with sterile diluent (STERILE DILUENT) once, lot #M015993, expiration date 23-DEC-2018 (strength, dose and route of administration were not provided). After reconstitution, the vaccine was lighter in color than normal. No adverse effects were reported. Product quality complaint was filed. Additional information has been requested.
She states that 12 days after second dose of moderna, she started getting more short of breath than usual, no fever, got congested, had a bad headache, nausea, no appetite.
Patient received influenza vaccine on 10/3/08.  Reported that about 2 or 3 days later, developed cough and sinusitis.  Symptoms resolved in slightly over 1 week.
Approx 1-2 min after pt received vaccine and administering person left the exam room, mom opened exam room & called for help. State pt had brief shaking in left arm and mouth/(L) arm looked "blue." Staff & I arrived immediately to find pt awake, alert, anxious - appearing in mom's arms, HR 80, BP / , O2 sat 100% RA. Pt interactive, denied complaints. Neuro exam normal, cardiac exam nl.
pt recvd vax & was pale; limp; dusky, poor suck preceeded by an abnorm cry; tx w/ O2, improved over 1-1 1/2 hrs;