chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was administered covid vaccine (Moderna) at approximately 1025, at that time patient was recommended to sit in observation area for 15 minutes to monitor for reactions. At 1043 patient reported to clinic personnel that she was feeling tingling in her mouth. Nurse guided patient to a private area where patient could lay and be closely monitored. At that time patient reported having tingling in her mouth and a "metallic taste" but denied inability to swallow or shortness of breath. At 1044 nurse administered 25 mg of Benadryl orally to patient and educated her that she should remain in the facility for 30 minutes to monitor that her symptoms wouldn't worsen. At 1054 nurse reassess patient, patient reported that the tingling in her tongue had worsen slightly but denied difficulty swallowing or breathing. At 1104 nurse reassessed patient, patient denied any further advancement of symptoms and that she felt the same as last assessment. At 1113 patient reported that she noticed her swallowing had become more difficult and the tingling had spread to her throat, nurse also noticed that her voice pitch had changed. Nurse manager and supervisor were notified at this time. At 1118 Nurse administered a 0.5 mg dose of epinephrine to patient in her left deltoid and 911 was called. Nurse assessed vitals at this time heart rate was 117, oxygen saturation was at 97%, and her lung sounds were clear. At 1124 emergency personnel arrived and assessed patient, at that time they took over patients care. At 1126 EMS wheeled patient out of clinic on a stretched.
Fever and myalgia. Temp 101.2 Left arm soreness to the point of unable to raise left arm
Around 7 PM on Tuesday, I began to feel fatigued. My abdomen became slightly tender. My arm was sore in the injection site, but that was nothing that I did not expect. As the night went on, I began to feel worse. I developed chills? And became feverish. I did take my temperature and it was 99.5° at one point. I took acetaminophen to help with the fever and bodyaches. Acetaminophen and ibuprofen seem to stem the fever symptoms. The highest my fever has ever been since Tuesday was 100.1°.  When I have a fever I do become congested. So I have not thought anything about congestion as I do develop congestion when I chill. I did develop a muted sense of smell and taste. I can still taste what I am eating and drinking.  My biggest concern is that I would love for my fever to go away. It is making me incredibly fatigued.
Severe muscle and bone pain, high fever for 24 hours; early onset of menstrual cycle after the 2nd shot (9 days early according to very regular menstrual cycle of 26-27 day cycle)
Information has been received from a licensed practical nurse concerning a 4 year old male with developmental delay and no known allergies who on 29-Dec-1999 was vaccinated with a first dose of varicella virus vaccine live (lt #631772/1031K), subcutaneously in the left arm. There was no concomitant medication or illness at the time of vaccination. On 19-Dec-2003 the patient was seen after developing less than 50 lesions on his trunk the day before, on 18-Dec-2003, with itching and a fever. It was also reported that on 18-Dec-2003 the patient developed a "spare papular vesicular rash on trunk, itchy." The patient reportedly had breakthrough chicken pox. The patient was prescribed acetaminophen (Tylenol) or oatmeal baths as needed. Subsequently, the patient recovered from breakthrough chicken pox. There were no relevant diagnostic or laboratory tests. There was no product quality complaint involved. No further information is expected.
A 70 year old male received RSV vaccine or Placebo and Influenza vaccine on 11/05/2002 and 251 days later died.  Obituary stated patient died suddenly, no further information at this time.  The investigator assessed the event as unrelated to the study product.  Follow up information received 08/12/2003.  Subject # 00100989.  The investigator spoke with family member regarding patient's death.  Patient was found by his wife sitting in a chair.  Autopsy was performed and cause of death was listed as "massive myocardial infarction".  Investigator assessed the event as unrelated to the study product.  Additional information received 09/03/2003.  Certificate of Death: Date of death: 07/14/2003.  Manner of Death: Natural cause.  Immediate Cause: Arrythmia/MI.  Approximate interval between onset and death is 1 day.  Due to or as a consequence of: End state emphysema.  Approximate interval between onset and death is years.  Did tobacco use contribute to death: Yes.  Preliminary Anatomic Diagnosis: 07/16/2003.  Diagnosis: Coronary Artery Atherosclerosis: Left circumflex 75% narrowed (left dominant circulation).  Cardiomegaly, 500 grams.  Severe Centriacinar Emphysema, bilateral.  Subsidiary Diagnosis: Nodular hypertrophy of prostate.  Simple renal cyst, left.  Small pulmonary embolus.  Meckel's diverticulum.  Colonic diverticula.  Probable cause of death: Cardiac Arrhythmia secondary to coronary artery disease.  Autopsy Limitations: none.  Embalmed: no.  Pending studies: Toxicology-blood, vitreous humor, bile, liver, stomach contents. Medical Records received on 8/27/2003 states arrythmia and coronary artery disease.
patient states arm was swollen and hurt for 3 days. Symptoms started more than 15 minutes after administration when he was on his way home
Because of previous allergic reactions, Dr. administered .1 (out of .5) and within 10 minutes I experienced minor nasal congestion; after 45 minutes and no other symptoms, they administered the remaining .4.  Within 10 minutes, my nasal congestion worsened, my larynx started to swell and I became hoarse.  Dr. administered an EpiPen and I took 50 mg of benadryl.  Symptoms started to subside, but then return with addition of cough so a second EpiPen was administered along with 40mg prednisone IM.  I was kept in the office under observation for another 2 hours.
Narrative:  PER PCP NOTE, patient reported to dermatitis/rash with vaccine unclear when reaction occurred in relation to vaccine PCP reported SPONGIOTIC DERMAITIS
ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a 25 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958366, 20210958321 and 20210958423.
Patient received Engerix-B instead of Twinrix; This case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 46-year-old female patient who received HBV (Engerix B) (batch number K9HS5, expiry date 18th March 2024) for prophylaxis.   Previously administered products included Twinrix (1st dose received on an unknown date ).   On 27th October 2022, the patient received Engerix B. On 27th October 2022, unknown after receiving Engerix B, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   Additional Information: GSK Receipt Date: 27-OCT-2022 Reporter's Comment: A pharmacist called to ask for information about the administration of Twinrix. The reporter mentioned that the patient received the first dose of Twinrix and, when administering the second dose by error, Engerix-B was administered instead of Twinrix.  The reporter asked if they could combine the dose of Engerix-B already given with a dose of Havrix in order to have a complete dose against HepA-Hep-B.  The reporter did consent to follow up. Additional supportive information: The reporter mentioned that the patient received the first dose of Twinrix and, when administering the second dose by error, Engerix-B was administered instead of Twinrix, which led to wrong vaccine administered.
After 1st shot, post vax, 2 days later, felt weak and had a headache for 1 day. Nine days, post vax, had nausea and vomiting for 2 days. Two days after 2nd shot, I had more nausea for 2 days. Used OTC antacids to prevent vomiting.
Itching in her ear, "like something was crawling in my ear; This is a spontaneous report from a contactable pharmacist, the patient. A 49-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number EW0185), dose 1 via an unspecified route of administration, administered in arm right on 16May2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 18May2021, she stared feeling itching in her ear like something was crawling in her ear and on 19May2021, when coming home from work, she went to the emergency room for the itching in her ear. The emergency room staff looked in her ear and didn't see anything. The emergency room staff flushed her ear and gave her an antibiotic ear drop to use three times daily. she got the prescription for the ear drops on 19May2021 at night and started using them. The outcome of the event was recovered on 21May2021.   Follow-up attempts are needed; information about lot/batch number has been requested.
Itchy bumps on ankle around 8:00pm on 10/20.  Next morning she began to have itchy bumps on hands, feet, knees, elbows.  The following day painful and itchy hives from feet to ears.  Received two steroid medication, one liquid and one cream for 10 days.
Patient is an 80-year-old gentleman who is a patient with a history of chronic hyponatremia, HTN,  presents with lethargy and weakness and nausea; noted to have hyponatremia, in the setting of a week of COVID-19 related GI symptoms. He had no respiratory symptoms, saturated well on RA, did not require COVID specific therapy. Sodium slowly improved with IV hydration and holding hydrochlorothiazide. BP has been elevated in the hospital, but patient reports good control at home, and typically has elevated BP at doc appointments. He is medically stable for discharge.   Hyponatremia Hypokalemia + Suspect secondary to dehydration and poor oral solute due to COVID - admitted with Na 118, now at 130, with IV hydration; baseline per him is in mid-high 120s - continue to hold hydrochlorothiazide at discharge - nausea due to COVID improved and appetite is improving - K improved to normal   Covid infection - Presented with: Nausea, mild diarrhea, anorexia - Symptom onset: 10/1/2023 - Positive COVID-19: 10/3/2023 at home, 10/9  - Vaccination status: Moderna SARS-CoV-2 Vaccination     01/29/2021, 02/26/2021, 10/29/2021, 04/14/2022 - CXR on admission showed Nonacute two-view chest with chronic postsurgical changes. - Oxygen status: Room air - Decadron: Does not qualify without pneumonitis - Remdesivir: Does not qualify without pneumonitis - DVT prophylaxis: Xarelto   PAF  Sinus node dysfunction PPM in place + Status post dual-chamber Medtronic pacemaker 3/2/2022; follows with OPG electrophysiology - cont Flecainide for rhythm control, Metoprolol for rate control, and Xarelto for AC   Insulin-dependent diabetes mellitus + Levemir 10 units nightly, Janumet twice daily, pioglitazone daily -8 units nightly with sliding scale holding p.o. meds - BG well-controlled; resume home regimen at discharge - diabetic diet Essential hypertension - BP elevated but patient states all his home readings are well-controlled; his BP at doctors appointments is typically high due to "white coat HTN" - cont Losartan and Metoprolol; hold hydrochlorothiazide
Pt requested MMR #2 for grad sch. Stated fearful of shots, at 1-2 min after MMR given on exam table pt said "I'm going to pass out". Eyes rolled back, legs shaking - seizure like - at 25-30 sec. Pt alert after 25-30 sec. No incontinence.
11-12-02 to MD for sinus infection. Rx for Avelex. Given Flu shot. 11-13-02 felt general aches. 11-14 Increased soreness, difficulty moving. Pain especially in neck, back. 11-15 increased pain, mobility. Avelex D/C. 11-16 sever pain continued. 11-20 unable to work. 11-21-02 patient returnd to work. Taking muscle relaxant and Aleve for pain. Feels better but not completely recovered.
Patients arm started swelling around 9pm after receiving the vaccine at 4:40pm. Also reported fever in her arm and headache and went to the doctor the next night for treatment at the time of reporting the patient has only taken advil for treatment and reported improvement in symptoms
Patient got first dose of vaccine, and first period afterwards (roughly 2-3 weeks) was significantly more severe, with additional bleeding and pain. Since then,  patient has had more frequent periods with significantly worsened cramps/bleeding/fatigue/muscle aches/two fevers associated with periods since then.
This spontaneous report as received from a registered pharmacist refers to unspecified number of patients. On an unspecified dated the patients were vaccinated with ZOSTAVAX (dose, route and lot# not reported). It was reported that the patients experienced red at the injections site. The event went away in a few days. It was unknown if the patients sought medical attention. This is one of the several reports from the same reporter. Additional information has been requested.
Heart palpitations/ Heart was racing; Shortness of breath; Had gas but could not burp it up; Could not sleep; This spontaneous case was reported by a pharmacist and describes the occurrence of PALPITATIONS (Heart palpitations/ Heart was racing), DYSPNOEA (Shortness of breath), FLATULENCE (Had gas but could not burp it up) and INSOMNIA (Could not sleep) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-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 PALPITATIONS (Heart palpitations/ Heart was racing), DYSPNOEA (Shortness of breath), FLATULENCE (Had gas but could not burp it up) and INSOMNIA (Could not sleep). The patient was treated with ACETYLSALICYLIC ACID (ALKA-SELTZER) at an unspecified dose and frequency. At the time of the report, PALPITATIONS (Heart palpitations/ Heart was racing), DYSPNOEA (Shortness of breath), FLATULENCE (Had gas but could not burp it up) and INSOMNIA (Could not sleep) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jul-2021, Blood pressure measurement: 185/132 (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  The pharmacist declined to give the patient the second dose and told him to go to an urgent care or emergency department.
feeling hot; feeling cold; woke up but could not move anything on his body but his eyelids (It lasted 20 minutes); feeling really tired; arm soreness at end of day; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (feeling hot), FEELING COLD (feeling cold), MOBILITY DECREASED (woke up but could not move anything on his body but his eyelids (It lasted 20 minutes), FATIGUE (feeling really tired) and VACCINATION SITE PAIN (arm soreness at end of day) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lupus syndrome (Patient prone to blood clots and had a concussion last week). Concomitant products included RIVAROXABAN (XARELTO) for Anticoagulant therapy.   On 04-Oct-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Oct-2021, the patient experienced VACCINATION SITE PAIN (arm soreness at end of day). On 05-Oct-2021, the patient experienced FEELING HOT (feeling hot), FEELING COLD (feeling cold), MOBILITY DECREASED (woke up but could not move anything on his body but his eyelids (It lasted 20 minutes)) and FATIGUE (feeling really tired). At the time of the report, FEELING HOT (feeling hot), FEELING COLD (feeling cold), FATIGUE (feeling really tired) and VACCINATION SITE PAIN (arm soreness at end of day) outcome was unknown and MOBILITY DECREASED (woke up but could not move anything on his body but his eyelids (It lasted 20 minutes)) had resolved.            No treatment was reported by the reporter.
Pt devel knot on leg where immunization was given & stayed x 7 days, also red @ immun site;
Covid vaccine breakthrough case: Dose 1 Pfizer 3/8/21 EN6202 Dose 2 Pfizer 3/29/21 ER2613
approx 5-10 mins after receiving the vaccine patient reported dizziness, light headedness, and seeing spots. nurse administering had patient lie down with legs up and checked vital signs. patient did not report anaphylactic type reaction so epipen was not given, but held ready in case.  about 30 mins after dose, patient reported feeling better and sat up in a chair. after additional 2-5 mins patient was not responding to verbal cues and appeared unable to speak or move despite appearing awake. nurse and NP in store suspected seizure. ambulance was called and all vital signs continued to be monitored
pt recv vax 27OCT97 & had no problems until 30OT97 redness & tenderness to rt arm;no signs of infect;
Covid symptoms started mid-January with coughing, fatigue, body aches, and congestion. Symptoms lasted for about a week. I did go to urgent care and that's where I tested positive and they gave me Zyrtec and cough medicine.  After my 3rd dose I also had swollen lymph nodes under my right arm and my arm hurt and that lasted almost 2 weeks.
The pt experienced immediate pain, redness after vax, quarter sized swelling at injection site the evening of the vax, with redness, swollen thigh next morning, too large to pull underpants on. Seen in ER and given Cephalexin for bacterial infection of injection site.
Tired; Slight fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired), PYREXIA (Slight fever) and HEADACHE (Headache) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A, 031M20A and 010M20A) for COVID-19 vaccination.     The patient's past medical history included Cancer (25 years ago).   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tired), PYREXIA (Slight fever) and HEADACHE (Headache). On 28-Aug-2021, FATIGUE (Tired), PYREXIA (Slight fever) and HEADACHE (Headache) had resolved.            No concomitant medications reported.  No treatment information was reported by reporter.   This case was linked to MOD-2021-265490, MOD-2021-265483 (Patient Link).
I experienced a breakthrough case of COVID-19 with a fever, sore throat, body aches and cough.
dose on 04Aug2022, had an expiration date of 31Jul2022; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB34AA, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 4th August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 04-Aug-2022 Reporter's Comments: Medical Assistant reported 18-year-old female patient was administered a dose of Bexsero on 4th August 2022, which had an expiration date of 31st July 2022.  At the time of reporting, dose had not been The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter. Additional Supportive Information: The patient was administered with Bexsero vaccine, which was already expired, which led to expired vaccine used.
Administration Error: 12 year old male patient received booster dose of pediatric Pfizer Vaccine (0.2 ml).
swelling at  injection site; it has been warm to the touch, the area is still hot to the touch, on and off; can feel a fever on it, comes and goes; still has some redness; pain at injection site; A spontaneous report was received from a healthcare professional concerning a 77-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain at injection site, swelling, still has some redness, can feel a fever on it, comes and goes.  The patient's medical history was not provided. Concomitant medications reported were Blood pressure, Cholesterol, 2 Baby Aspirin, Prilosec for drug use for unknown indication.  On 21 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 029L20A) Intramuscularly for prophylaxis of COVID-19 infection.  On 21 Jan 2021, the patient experienced the event(s) pain at injection site, swelling, still has some redness, can feel a fever on it, comes and goes.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), pain at injection site, swelling, still has some redness, can feel a fever on it, comes and goes was unknown.
No adverse event; Received 0.25 ml instead of 0.5 ml of the Bivalent Booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 11-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster). No concomitant medications were reported.  27 adult patients received pediatric dose of Bivalent COVID-19 vaccine 0.25 ml instead of 0.5 ml. No treatment information was provided by the reporter.  This case contains information for the 22 of 27 adult patients described by the reporter.