chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Profound hearing loss in her right ear. (she passed a hearing test at 25db in both ears the same day before shots were administered) re-occurring ear infection in her right ear. No hearing at 40db in right ear. Otoscopic examination reveals middle ear fluid is present which is purulent left, normal tytmpanic membrane and tympanic membrane erythema right. Right ear pain. congestion, tympanic membrane bulging, inflamed, erythema dn dull. Acute suppurative otits media with out spontaneous rupture of ear drum right. Sore throat. Picky eater. Otoscopic examination reveals dul red with yellow effusion right and no abnormalities left. Cough and fever. 03/16/2005 cough, earache and fever. Eustachian salpingitis, Flu. 12/30/2009 Ongoing ear infections.
She still has swelling and a red area on her arm about the size of a silver dollar; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (She still has swelling and a red area on her arm about the size of a silver dollar) in a female 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.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (She still has swelling and a red area on her arm about the size of a silver dollar). At the time of the report, VACCINATION SITE SWELLING (She still has swelling and a red area on her arm about the size of a silver dollar) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.
As soon as patient received a dose of Moderna, she notified us that her throat was itching. She doesn't have any allergies and has no history of epipen use before. Patient has stated that she was so anxious coming up to the appointment which might have caused this reaction. We escorted to a side away from other patients and measured her blood pressure (186/113, Pulse 77). Her usual blood pressure is around 150/80. We measured blood pressure over 30 minutes. at 12:11pm, blood pressure went down to 168/98 with pulse of 69. Patient complained of itchiness of throat but no swelling or no trouble breathing. There was some tenderness and redness at the injection site. We administered Diphenhydramine 50mg IM on right arm  at 11:46am since patient's face was turning red a little bit. Patient had rested for about 45 minutes and had a glass of water. She was accompanied by her mother and was able to breathe on her own and no more itching sensation in her throat.
developed pericarditis; became paralyzed from the knees down; unable to walk days after the Pfizer vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERICARDITIS (hospitalization, medically significant), outcome "not recovered", described as "developed pericarditis"; PARALYSIS (hospitalization, medically significant), outcome "not recovered", described as "became paralyzed from the knees down"; GAIT INABILITY (hospitalization, medically significant), outcome "not recovered", described as "unable to walk days after the Pfizer vaccine".Therapeutic measures were taken as a result of pericarditis, paralysis, gait inability. It was reported that at the time of reporting the patient remains in a hospital, undergoing therapy to learn how to walk and function normally again.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
the morning after the immunization patient experience nausea, aching, pressure in chest - 24 hours which then passed; she also experienced  pain below injection site, into elbow, difficulty lifting weight these symptoms have not resolved
he experienced rubbing of the inner and outer portions of his heart; high blood pressure/his blood pressure was very high; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunisation. The following information was reported: CARDIAC DISORDER (hospitalization) with onset Oct2022, outcome "recovered" (2023), described as "he experienced rubbing of the inner and outer portions of his heart"; HYPERTENSION (non-serious) with onset Oct2022, outcome "recovered" (2023), described as "high blood pressure/his blood pressure was very high". The events "he experienced rubbing of the inner and outer portions of his heart" and "high blood pressure/his blood pressure was very high" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: 180/99, notes: had a high blood pressure. Clinical course: The caller was calling about the Pfizer BioNTech COVID-19 Vaccine that he received last year in Oct and this was his third dose of Pfizer BioNTech COVID-19 Vaccine that he received. He said when he got the COVID-19 Vaccine last year, he experienced rubbing of the inner and outer portions of his heart and have high blood pressure. He said if he took an Aspirin or Ibuprofen, it would cause his blood pressure to go up to 180 over 99 and he said he could not eat anything like salt, sugar or vegetables because it made his blood pressure go high. He said at the end of the Oct last year, his symptoms started to go away and then he was able to eat chocolate, pizza and spicy food and he said it took about a year to get over it, he has his strength back and he can do things now but he could not do it before." He stated he saw two different cardiologist who didn't know what it was. They had no recommendations or medication to give him.   The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Pt experienced hives, n,v; pt recovered w/in 24hrs; Pt vaccinated w/2nd dose of Hepatitis B & again experienced hives, n,v; Recovered w/in 24hrs;
This spontaneous report was received from an office manager refers to a patient of unknown age who on 05-OCT-2012, was vaccinated with a dose of RECOMBIVAX HB (lot number 671326/1522AA) (dose and route not reported) that was improperly stored. No symptoms reported. This is one of several reports from the same source. Additional information has been requested.
Within 1 day of administration of vaccine, I (patient) developed join pain and limited range of motion in in the shoulder of the arm where the vaccine was injected. Shooting/acute joint pain not constant, but is dependent on arm position and use. After five weeks, condition has not improved or changed.
Severe headache from booster shot which require a visir to ER late morning 10/13.  Headache work me up at 10/13 at Midnight.  For a brief time I could not remember birth date, phone numbers, email address.   My blood pressure was 180 over 90.  The only they could deduce was that it was a result of high blood pressure caused the booster.
A medical assistant reported the occurrence of an injection site reaction in a 4 year old male who was vaccinated with DTAP (Infanrix) for prophylaxis.  The subject had no relevant medical history, concurrent conditions, or concurrent medications. On 05/14/03, the subject received his fifth injection of Infanrix (Lot # DTPA596A2).  On 05/16/03, two days post-immunization, he developed an injection site reaction characterized by swelling and redness. The subject was seen by the physician, who prescribed Benadryl. The injection site reaction resolved on 05/18/03.  The reporter considered the injection site reaction to be unrelated to Infanrix administration.
My knee pain started on after three days; felt like shooting sharp pain in my knees; I feel my knees are still sore in the muscles; I fee sore in the joint of my knees; I feel I can not bending it; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS, ARTHRALGIA, ARTHRALGIA, MYALGIA, and ARTHRALGIA in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concomitant products included TYLENOL for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS. On 27-Mar-2021, the patient experienced ARTHRALGIA, ARTHRALGIA, MYALGIA, and ARTHRALGIA. At the time of the report, MUSCULOSKELETAL STIFFNESS, ARTHRALGIA, ARTHRALGIA , MYALGIA, and ARTHRALGIA outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No medications were taken to help with the symptoms.
Post vax, the pt noted local erythema and swelling. It progressed in size and severity to 12 x 14 cm when pt saw the physician. Pt was treated with Motrin and ice packs.
Fever of 100 degrees, redness and swelling at one injection site on thigh, decreased appetite, vomiting, sleepy but refusal to sleep.  Called doctor's office, still waiting on a call back.
Hemolysis; Feeling miserable/feeling abnormal; Back pain; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HAEMOLYSIS (Hemolysis) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product RAVULIZUMAB (ULTOMIRIS [RAVULIZUMAB]) concentrate for solution for infusion for Paroxysmal nocturnal haemoglobinuria.    Concurrent medical conditions included Paroxysmal nocturnal haemoglobinuria.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and RAVULIZUMAB (ULTOMIRIS [RAVULIZUMAB]) (unknown route) at an unspecified dose. On an unknown date, the patient experienced HAEMOLYSIS (Hemolysis) (seriousness criterion medically significant), FEELING ABNORMAL (Feeling miserable/feeling abnormal), BACK PAIN (Back pain) and PYREXIA (Fever). At the time of the report, HAEMOLYSIS (Hemolysis), FEELING ABNORMAL (Feeling miserable/feeling abnormal), BACK PAIN (Back pain) and PYREXIA (Fever) had resolved.            Company comment: This is a spontaneous case concerning a male patient of an unknown age with medical history of Paroxysmal nocturnal hemoglobinuria (in treatment with Ravulizumab), who experienced the serious (medically significant) unexpected event Hemolysis. The event occurred on an unknown date after receiving the second dose of mRNA-1273. The rechallenge is positive as patient experienced the same event after the third dose. The medical history of  Paroxysmal nocturnal hemoglobinuria remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.   It was reported that  patient  resolved with all the symptoms after his infusion in Nov 2021.Also it was reported that the patient would be following up with physician in JAN 2022.  Concomitant medications were not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2022-451888 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Jan-2022: Follow-up received with no new information.; Sender's Comments: Company comment: This is a spontaneous case concerning a male patient of an unknown age with medical history of Paroxysmal nocturnal hemoglobinuria (in treatment with Ravulizumab), who experienced the serious (medically significant) unexpected event Hemolysis. The event occurred on an unknown date after receiving the second dose of mRNA-1273. The rechallenge is positive as patient experienced the same event after the third dose. The medical history of  Paroxysmal nocturnal hemoglobinuria remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Chills, fatigue, headache, left arm pain at injection site.  No measured temp until next day at 99 after chills went away.
Continual daily joint pain / immobility / paralysis on opposite side of body as injection, starting day after injection and continuing for six weeks so far. Joint pain / immobility / paralysis is sporadic and can be knee, ankle, hip, on any given day and a different joint the next day. Always right side. Usually leg / lower body. As serious as complete inability to move joints or put weight on them.
persistent crying; fever 103; p/pt given shot in AM MD saw pt that evening & hosp x 23 hrs for sz; obs & encephalopathy; site had extreme amount of swelling & redness, bruising & hardness;
teeth pain, ear pain, body aches, red and warm at injection site.         Tylenol
Patient could not be reached, (did not return DPH calls), adverse outcome other than (+) COVID test could not be identified.
Got hot red swollen and painful.  Took Aleve.  Went to Dr two days later and was prescribed antibiotics (Keflex) and symptoms resolved.
Localized area of afebrile erythema, induration and tenderness at the site.
Individual received her COVID vaccine and had no prior symptoms. 24 hours after the injection she developed significant shortness of breath and was seen in the ER where she was diagnosed with bilateral pulmonary embolism.
Left arm ans hand swollen. Faint erythema at injection site with firm arm approx 3.5 inch diameter. C/o difficulty moving left arm.
GARDASIL given on 10-27-09. Mother calls 10-29-09 and states patient had puffy face and eyes the afternoon of 10-27-09. States c/o chest tightness either late PM 10-27 or 10-28 and continues today. BENADRYL 25 mg TID and go to ER for increased sx.
Patient's son came in at 6:15p today 12/03/18 with a prescription for BACTRIM DS. Patient went to the ER today for an infection on the arm where she got the flu shot and the doctor had mentioned to them in the ER it was probably from the flu shot. Patient also had a root canal (unplanned) today as well. The doctor from the ER mentioned that the shot may have been too low so the patient's son let us know that may be the cause for the infection in her arm.
CLIENT STATES 4 DAYS AFTER 2ND DOSE MODERNA DEVELOPED "PARATHESIA" IN ARM SHOULDER DOWN - NOW IN  WRIST AND  CMC JOINT L ARM -
Information has been received from a nurse concerning a 21 year old female who on 05-JUL-2007 was vaccinated with a first dose of Gardasil (lot# unknown) injection.  On an unspecified date the patient reported that she developed a "rash from head to toe" after receiving Gardasil.  Medical attention was sought.  On an unspecified date the patient had seen a dermatologist who did a biopsy and noted the rash was "drug induced".  No further information was provided.  At the time of reporting it was unknown whether the patient had recovered.  The patient was not going to continue the series.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/17/2007. Additional information is not expected.
parent noticed redness, swelling of lt upper arm from elbow to shoulder; warm, tender, streaks through arm to elbow; cont 3 full days; APAP given; parent reported peeling of skin from upper lt arm; shoulder to elbow;
9x9cm pale erythematous macular with 4x4cm central nodularity, more red, increased sleepiness, lesion pruritic body aches.
Tested positive but had the Moderna; Left arm was sore and it went away the next day; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive but had the Moderna) and VACCINATION SITE PAIN (Left arm was sore and it went away the next day) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 COVID-19 (Tested positive but had the Moderna) and VACCINATION SITE PAIN (Left arm was sore and it went away the next day). At the time of the report, COVID-19 (Tested positive but had the Moderna) outcome was unknown and VACCINATION SITE PAIN (Left arm was sore and it went away the next day) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had a reaction with antibody infusion. No concomitant medications were reported. No treatment medications were reported. 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.
2 days post vaccination had severe muscle ache at site of injection, progressed to full body ache, h/a sever with pressure, confusion and disorientaion, short term memory loss.  No fever or seizure.  Severe lethargy.
205/94, HR 70, Resp. 70, Chest discomfort, anxious, anxiety. Pt. complain of chest discomfort after receiving second dose of vaccine.  Emergency personnel. Pt. was transferred to Hospital for further evaluation.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2022US179782_NS (RA). A 38-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: FEELING COLD (non-serious), FEELING HOT (non-serious), outcome "unknown" and all described as "felt hot and cold". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Fever of 105.0, chills, headache,  body aches and passing out.
Patient experienced increased heart rate, palpitations, and shortness of breath. Entire arm of injection site was sore to the touch. According to the patient, her chest "felt heavy". Pharmacy staff called 9-1-1 and paramedics arrived to escort the patient to the hospital. Pharmacist followed up with patient and they shared that they experienced redness on chest and stiff neck.
Half hour after vaccine had feeling akin to being drunk, took a nap, woke up feeling lethargc, with vaccination site swollen. Took 3hr naps the next few days. Swelling decreased.  I am now a week out, vaccine forgotten about, and rubbed my arm because it was itchy.  An hour later I find the vaccination site swollen up to about half a golf ball.
I noticed my arm was sore (expected) and I felt tired.  I want to bed, but apparently did not get there.  When my husband came home he found me sitting on the toilet.  I did not respond when he tried to talk with me.  I remember very little until they gave me something in my IV to raise my blood glucose.  At one point it was 45.  My rectal temp was 93.2.  All other tests were WNL.  Head CT was normal.  I had had extensive blood work, ekg and chest x-ray that morning, as I am trying to donate a kidney.  All looked good.   My day, including my diet, were usual for me.  The only exception was  the PCV13 vaccine.  I made sure to eat last night before bed, but I had less severe symptoms of hypoglycemia this morning, that resolved within an hour of eating.  I did not have testing supplies at home.  I do not have diabetes.
Walk in 11/18/00 reports pain left upper arm stated did not apply any warm or cold compresses since 10/27/00.
The patient had three dosis of the vaccine before the administration. He has cancer and its receiving treatment. The patient is classify as immunocompromised. The dosis that should be administrated was a Booster of Moderna (0.25mL). The dosis administrated to the patient was a full dose of Moderna (0.5mL).
The pt developed excessive sleepiness; onset the day of vaccination and persisted for 1 week. Also fed poorly.
Chills; headache; vomiting; fever; fatigue; sleep disruption; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 01Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "High blood pressure" (ongoing), notes: High blood pressure. Concomitant medication(s) included: LISINOPRIL. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine", notes: Known allergies: Codeine. Vaccination history included: Covid-19 vaccine (Dose number: 3), for COVID-19 immunization; Covid-19 vaccine (Dose number: 2), for COVID-19 immunization; Covid-19 vaccine (Dose number: 1), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 01Aug2022 at 22:30, outcome "recovering"; FATIGUE (non-serious) with onset 01Aug2022 at 22:30, outcome "recovering"; PYREXIA (non-serious) with onset 01Aug2022 at 22:30, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 01Aug2022 at 22:30, outcome "recovering"; SLEEP DISORDER (non-serious) with onset 01Aug2022 at 22:30, outcome "recovering", described as "sleep disruption"; VOMITING (non-serious) with onset 01Aug2022 at 22:30, outcome "recovering". Therapeutic measures were not taken as a result of chills, headache, vomiting, pyrexia, fatigue, sleep disorder.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Also since vaccination, she had not been tested for COVID-19. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Within 2 weeks of vaccination, she received Lisinopril. She reported event such as chills, headache, vomiting, fever, fatigue, and sleep disruption.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Low grade fever, very achy. Left arm at injection site red and swollen approximately 2 inches by 2 inches.
She developed sore throat and tightness in chest 10 minutes after vaccines were given. Patient was given Zyrtec, then Solumedrol and 2 puff of Albuterol.    She did feel better.  Mom left office to pick up epipen and Benadryl from pharmacy while patient stayed with us.  AuviQ was on hand if needed.
Immediate abdominal cramping. Bleeding, bloating, numb legs, ovarian pain, nausea, diarrhea, vomit, dizziness, chills.
Swelling of face, chills, puffy eyes, rash to face and sores to left forearm (after 2 days), pain to left arm (no swelling or redness)
No adverse event reported by patient, expired vaccine was administered. Was transferred from Freezer to fridge on 4/1 however vial expired according to manufacturer expiration on 4/1/2022