chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a 14 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 26-JUN-2014 the patient was vaccinated with first dose of GARDASIL (dose, frequency and route of administration were not reported) (lot # K005083, expiry date: 04-NOV-2016) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for GARDASIL. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012929, 1407USA012930, 1407USA012931, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA013014 (same reporter link). Additional information has been requested.
Patient states on 10/25/19 that got fever/ chills / muscle aches from the vaccination on 10/24/19.  Patient was informed that these were some of the possible side effects of vaccination and that they usually only last a couple of days and to call physician if they persist.
p/pt recv vax got very pale & fainted w/sz like activity noted but regained consciousness w/in few min;pt then c/o dizziness, blurred vision & aching in extremity of inj;c/o blurred vision this AM;
A 20 year old male experienced fever, headache, and vomiting on 12/11/2000 after receiving  RabAvertfor postexposure prophylaxis. The patient was previously immunized two years ago, in 1998, with 3 doses of rabies vaccine.   he was bitten by a skunk while working at the zoo. Twenty-four hours after his first dose of RabAvert on 12/10/2000, the patient developed a fever of 192 degrees F, headache, nausea and vomiting. He recovered on 12/13/2000. On 12/14/2000, the subject was vaccinated with Imovax Im lot #R1105.  the treating physician believed that the adverse events were due to gastroenteritis and not related to the RabAvert vaccine. The patient is currently taking oral Augmentin.
pt admitted to hosp (from outside hospital) with cardiogenic shock with inferior STEMI after cath/IABP; found to be positive for COVID; treated for COVID ARDS with dexamethasone and remdesivir; pt is intubated on mechanical ventilation; in CCU; pt is DNR; condition worsened; multisystem organ failure; pt placed on comfort care; withdrew life supporting care and cessation of vent; pt died in the hospital
On the right arm at the injection site, there occurred a knot or rise the size of a large grape.   First told to apply heat and on Saturday (16th) was told to apply an ice pack, I applied ice on Saturday  and Sunday the rise on my arm had shrunk a little.  The knot on my arm is still there as of Monday afternoon.
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Patient was sitting on the bench waiting for his 15 minute interval. A few minutes after sitting there, he passed out & fell on the floor. Said he got dizzy & didn't remember falling: was able to talk & answer questions within a few seconds. He was exremely pale, sweaty but remained responsive & stayed on floor until EMS arrived. Unsure if he hit his head or injured during fall. EMS assessed as syncope & possible dehydration. BP didn't stabilize so he went to ER for fluids & was released.
Patient with a history of syncope, anxiety, and depression received vaccines at approximately 0900. Immediately after receiving last vaccine HPV patient fell forward hitting her forehead on the ground from a 3 feet fall. She was "out cold" ashen color, cool extremities. Never lost pulse, vital signs WNL times taken 0906, 0910, 0919. Patient did not have breakfast this morning. Rapid response was called and patient transferred to PICU. Loss of consciousness reported to be less than 30 seconds. Patient was alert and oriented but with headache. She was monitored in the PICU with every hour neurochecks. All of which were normal. She was on telemetry with showed no abnormalities. TYLENOL was given for pain. C-collar was cleared and patient was able to eat and drink without difficultly. She walked throughout the unit without any dizziness. Patient was released mid afternoon that same day. With instructions to follow up with PCP to determine need for concussion clinic.
Adverse events: Hives   Treatment: Ice and Oral Benadryl       Outcome: Minimal Hives in localized area
Pt presented to ED w/ dyspnea x2 days and L calf pain.  Dx w/ Bilateral pulmonary emboli; tx- Apixaban
Patient was given 0.5 ml pneumoccocal vaccine.  Developed swelling at injection site.
Developed an itchy rash on my back and neck within 48 hours of receiving vaccine.  Been taking benadryl, using benadryl  spray and cortizone cream beginning March 11, 2021.  Gives temporary itch relief only.
Local erythema 9.0 cm x 5.0 cm and induration.
Patient was given the vaccine 2 month before his 12 birthday. The vaccine is recommended 12 and older
Patient tested positive for covid on 9/17and has been symptomatic for 2 weeks with dry cough, myalgias, subjective fevers, fatigue and dyspnea on exertion. Patient was transferred to the ED on 9/24/21 from the infusion center when noted to have O2 sat in the 80s requiring 2-4L NC.  Patient was initiated on dexamethasone and remdesivir, however, his oxygen requirements have been escalating from NC to HFNC so he was transferred to the MICU. Patient foudn to have sputum culture positive for aspergillus and was started on posaconazole per ID/ Additional treatment with reeneron was provided. Patient developed renal failure and was started on CVVHD. Acute desaturation event on 10/24 requiring re-paralysis. In the setting of inability to continue with CVVHD and severe refractory respiratory failure, he was made CMO. Patient passed on 11/2/21.
After pt was given Tdap vaccine she developed swelling and pain at injection site. Pt stated sx continued for approx 1 week that she decided to go to urgent care. Pt was diagnosed with cellulitis and treated with KEFLEX. Her arm did improve on KEFLEX and will f/u with RP if needed.
Moderna COVID-19 Vaccine EUA: patient hospitalized with acute on chronic hypoxemic respiratory failure and pneumonia due to COVID-19. Received steroids, supplemental oxygen, and antibiotics. Discharged to home medically stable.
4 patients were given vaccine  after 24 hours in a prefilled syringe & 2 other patients given 0.5ml of the vaccine after 26 hours in a prefilled syringe.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 patients were given vaccine  after 24 hours in a prefilled syringe & 2 other patients given 0.5ml of the vaccine after 26 hours in a prefilled syringe.) 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 EXPIRED PRODUCT ADMINISTERED (4 patients were given vaccine  after 24 hours in a prefilled syringe & 2 other patients given 0.5ml of the vaccine after 26 hours in a prefilled syringe.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 patients were given vaccine  after 24 hours in a prefilled syringe & 2 other patients given 0.5ml of the vaccine after 26 hours in a prefilled syringe.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.
pt recv vax;T 101.8 R;d,poor feeding;dx w/ gastroenteritis;rocephin & apap given;to hosp;lab for CBC,Blood cultures;adm to hosp;dx of sepsis,fever,rash,T 102.8R;30jul95 dx of hyperpyrexia probably to hep B vax;
This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients), PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients) and NO ADVERSE EVENT (No adverse event) in a 48-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.       For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines stored in the refrigerator that underwent several temperature excursions, that were administered to patients).    Concomitant medication information was not provided.  It was unknown patient had been ever diagnosed with or tested positive for COVID-19.  On an unknown date, patient received first, second and third doses of Moderna COVID-19 vaccine via intramuscular route and site of administration was reported as deltoid muscle. The patient received the fourth dose of Moderna COVID-19 bivalent vaccine on deltoid muscle.  The nurse reported about Moderna monovalent and bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back to Aug-2022 that were administered to patients.  It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation.   On 07 Sep 2022 vials moved from freezer to refrigerator.  It was reported that no adverse reactions were reported to their knowledge for any patients.  No treatment information was provided.
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (Ringing in ears got worse after second shot) and HEADACHE (very bad headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TINNITUS (Ringing in ears got worse after second shot) and HEADACHE (very bad headache). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Ringing in ears, at a dose of 1 dosage form. At the time of the report, TINNITUS (Ringing in ears got worse after second shot) had not resolved and HEADACHE (very bad headache) outcome was unknown.            No Concomitant medications was reported   This case was linked to MOD-2021-047842, MOD-2021-047851 (Patient Link  Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Contact information updated
2 days post vax, inject site noted to be edematous w/blotchy, raised, non itchy rash site approx 4cm in size; edema, erythema
When she had the previous 2 doses she felt fatigue and common symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15Mar2021 (Lot number: EN6206) at the age of 69 years as dose 1, single and administered in arm right, administration date 05Apr2021 (Lot number: EW0150) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: NEXIUM taken for gastrooesophageal reflux disease (ongoing); FLU VACCINE VII taken for immunisation, administration date 04Sep2021. Vaccination history included: Fluzone shot (Adverse Event: Fluzone shot kicked her in the rear and was not used to it, Vaccine/Brand Name: Fluzone , Vaccination Date: 4 years ago), when the patient was 65 years old. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "When she had the previous 2 doses she felt fatigue and common symptoms".  No follow-up attempts are possible. No further information is expected.
15-20 min after receiving vaccine, pt broke out in a sweat. Felt dizziness, light headed, and nausea. Right arm shook uncontrollably for a few minutes. Felt fatigue on 11/25/14 pt woke up nauseous and vomitied a few times. Continued to feel dizzy and fatigued. Eyes were itchy and burning. Joints were aching and was painful to walk.
severe body aches; headache; fatigue; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (severe body aches), HEADACHE (headache), FATIGUE (fatigue), CHILLS (chills) and NAUSEA (nausea) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 immunisation.     No medical history was provided by the reporter.  Concomitant products included APREMILAST (OTEZLA) for an unknown indication.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced MYALGIA (severe body aches), HEADACHE (headache), FATIGUE (fatigue), CHILLS (chills) and NAUSEA (nausea). The patient was treated with IBUPROFEN ongoing since an unknown date for Myalgia, Headache and Fatigue, at an unspecified dose and frequency and PARACETAMOL (TYLENOL 8 HOUR) for Myalgia, Headache, Fatigue and Chills, at an unspecified dose and frequency. At the time of the report, HEADACHE (headache), FATIGUE (fatigue) and NAUSEA (nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
back pain; Muscles hurt in her back; Fatique; This is a spontaneous report from a Pfizer Sponsored Program . A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation .  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced back pain, muscles hurt in her back, fatigue on an unspecified date. The outcome of events wsa unknown.    Information on the lot/batch number has been requested.
According to the dr, my nerves are likely inflamed. Symptoms are feeling of numbness but no loss of circulation. Most often feelings of cold in random parts of my body but especially my left leg (same side as injection). Both sensations appear to only be that because to the touch nothing is colder and to the eye nothing appears cold (blue). This started Friday 04/09 and was initially tingling in my left leg and quickly changed to feeling cold. (Interestingly the day I was vaccinated a few hours later I felt what I thought was the vaccine go through this same leg) Since Friday the cold feelings have randomly been in both both legs, both arms and both hands, less often in my face (left side mainly) and the top of my head. It?s not everywhere simultaneously but sometimes different places at one. Sometimes it can actually associated with being a little cold, but other times with no cause. Regardless it?s an exaggerated cold feeling. First it was like ice cold water being poured into whatever spot it was. It?s now less icy but still cold. Very strange
Drug ineffective; positive COVID-19 test; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Lot number: EP6965), in Apr2021 as dose 2, single (Lot number: EP6965) and in Dec2021 as dose 3 (booster), single (Lot number: FA8027) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 26Apr2022, outcome "unknown", described as "Drug ineffective "; COVID-19 (medically significant) with onset 26Apr2022, outcome "unknown", described as "positive COVID-19 test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Apr2022) Positive, notes: covid test type post vaccination-Nasal Swab.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the Covid-19 vaccine. Prior to vaccination, patient was not diagnosed with Covid-19. Since the vaccination, patient was tested for covid-19.  No follow-up attempts are possible. No further information is expected.
Patient was administered vaccine on 4/16/12. The following day the patient's mother called & reported some redness & swelling at injection site. Patient returned to our office on 4/18/12 & exam revealed a large indurated, erythematous, homogenous & tender area on (R) deltoid, 4 x 4.5 circumference & warm to touch. No rashy pustules, ulceration or discharge. Suspect allergic reaction to Tdap vaccine component - localized.
This patient developed a sore throat with post nasal drip, a severe cough followed with a fever; within 2 days after his vaccination.
"Trouble breathing", arm pain, requested to see MD. BP 107/73; HR 85 RR 24 SpO2 100%
70yo Male.  with no significant PMHX.  Presents with LLE swelling.   States swelling started 1 day after his first moderna covid vaccination.   He was found to have extensive DVT LLE.   He denies recent travel or prolonged immobilization, he denies injury to the leg, he denies previous blood clots/blood disorder/cancer.   This is sooner than I would expect patient to begin having symptoms after DVT after covid vaccination however I have no other clear etiology at this time.
arm hurt; head feels swooshy; ears were clogged up; This is a spontaneous report from a contactable consumer. A 30-year-old male patient (reporter's son) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; lot number: unknown) dose 1 via an unspecified route of administration on 05Apr2021 as DOSE 1, SINGLE for covid-19 immunisation, second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; lot number: unknown) via an unspecified route of administration on an unspecified date in Apr2021 as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient experienced arm hurt, of course, and it was really weird. A day or two later her son said my head feels swooshy and his ears were clogged up. We thought it was water in his ears. The outcome of events was unknown.  Information on the lot/batch number has been requested; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021863091 same reporter/drug/AE, different patient
7 years old patient took the 4th dose of depatcel today with no reported adverse event; 7 years old patient took the 4th dose of depatcel today with no reported adverse event; Initial information received on 23-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 7 years old male patient who took the 4th dose of depatcel today with no reported adverse event while receiving vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-Aug-2021, the patient received a 0.25 mL to 2 mL dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (strength, formulation, route,lot number not reported) in unknown administration site. On 20-Nov-2021 he also received a  dose of the same vaccine  with an unknown batch number. On 20-Oct-2021 he also received a  dose of the same vaccine  with an unknown batch number. On 23-Aug-2022 he also received a  dose of the same vaccine  with an unknown batch number via unknown route.  On 23-AUG-2022 the patient reported 7 years old patient took the 4th dose of depatcel today with no reported adverse event (inappropriate schedule of product administration) (off-label use) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events.    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 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.; Sender's Comments:  0124120:
Pain onset about 2 hours after administration. Difficulty lifting arm, weakness, difficulty with grip, burning/searing pain.