chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a Medical assistant refers to an unknown number of patients of unknown age and gender. The reporter mentioned that an unknown number of patients have received VARIVAX (Merck) (lot number and expiry date not reported) (dosing regimen and frequency unknown) from January 2013 to 16-DEC-2013 that may had an unknown number of excursions with temperatures from 3 degrees C to 7 degrees C and each excursion being 64 hours. No adverse effects reported. No product quality issue was reported. Follow-up information has been received from a medical assistant (who called to report specific administration dates), concerning a patient of unknown age and gender. On 21-JUN-2013 the patient had received a dose of VARIVAX (Merck) (lot number # H011233, exp. date: 06-JUN-2014) (dosing regimen and frequency were not provided). This dose of VARIVAX (Merck) had an unknown number of excursions with temperatures from minus 3 Celsius degree to minus 7 Celsius degree and each excursions being 64 hours. No adverse experiences were reported. This is one of 9 reports from the same source (# 1312USA011519; #1312USA011525; #1312USA011520; #1312USA008561; #1312USA011522; #1312USA011523; #1312USA011524; #1312USA011526). Additional information has been requested.
23 yo male received Moderna #1 27 JUL 21 (023c21A) and dose #2 24 AUG 21 (03c2231A). He presented to ER 09 SEP with two day history of n/v/d and new onset 8/10 substernal sharp CP intermittent with waxing and waning to 2/10, radiation to his neck bilat and dyspnea.
she had severe hives throughout her body; This spontaneous case was reported by an other health care professional and describes the occurrence of URTICARIA (she had severe hives throughout her body) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced URTICARIA (she had severe hives throughout her body). The patient was treated with METHYLPREDNISOLONE (MEDROL DOSEPAK) for Hives, at a dose of UNK dosage form and PREDNISONE for Hives, at a dose of 40 mg. At the time of the report, URTICARIA (she had severe hives throughout her body) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.
after receiving vaccinations, pt was standing in room talking with RN and became pale and diaphoretic, passed out and assisted to the floor by RN. No injuries noted. Dr. called to the room and assessed patient. pt HR dropped to the 40's and he c/o of feeling nauseous. BP and HR readings at 0840- 78/44 HR 41, 0846- 85/44 HR 52, 0848- 92/52 HR 57 O2 sat 100%, at 0855 pt sitting up on floor BP 109/67 HR 55 and at 0901- 99/50 HR 53. pt reported feeling fine and was assisted up to chair and then to standing, provided with water and crackers. Pt father arrived and drove pt home. Vital signs stable.
Pt vaccinated w/DTP experienced unconsolable, high pitched scream for 3-4hrs aft DPT.  No more "P" to be given.
PATIENT CALLED YESTERDAY COMPLAINING ABOUT SORENESS OF ARM AND WAS TOLD THAT IT DOES CAUSE SOME SORENESS AND USUALLY GOES AWAY AFTER 3 DAYS. SHE SAID AT THE TIME OF THE SHOT SHE FEEL THE SORENESS AND TODAY TUESDAY 10/3/17 SHE CAME TO THE PHARMACY AND SHOWED THE RPH THAT HER ARM ARE STILL SORE AND COMPLAINING ABOUT FEELING NAUSEATED. PER PATIENT SHE CALLED HER DR AND WILL BE SEEN BY DR TOMORROW 10/4/17.
Hives started at 9pm 5-1-08.  Varivax given at 5pm on 5-1-08.  Hives noted again on R thigh 6am 5-2-08-subsiding by 10:00am on 5-2-08.  (Hives were first on L elbow and R knee).
Bowel discomfort and stuffed right ear, partial hearing loss, vertigo, nausea, shingle like rash on right side of the body. Treated with antibiotic and beclomethasone , seems to help with vertigo. vertigo came back one week later after finishing the antibiotics round. now on 30 days round of doxycycline, no vertigo , very little dizziness and nausea. 2 weeks back started a high dose of vitamin C that it seems to help with the dizziness and nausea. Right ear still stuffed and feeling weakness from time to time.
pt recvd vax & cried on 18MAR to 19MAR & was inconsolable; pt had fever w/ t102; pt cried for 2 days;
Patient vaccinated 8/28/2021.  Developed COVID symptoms on 9/20/2021, with positive Antigen test.  Symptoms of MIS began on 9/23/2021.  Admitted to ICU for 5 day treatment. Discharged on 9/28/2021.
Based on additional information received on 01-FEB-2016, this case became medically confirmed. Initial unsolicited report received from a consumer on 19-Oct-2015. This case involves a 38-year-old female patient who was vaccinated with a dose of Adacel (batch number and route of administration was not reported) in left deltoid on 13-Oct-2015. Illness at time of vaccination was reported as allergies (unspecified) and pre-existing physician diagnosed allergies was reported as erythromycin allergy. other medical history and concomitant medications were not reported. On 16-Oct-2015, three days after vaccination, the patient experienced malaise, body ache, fever to 101.7 degree Farenheit, chills, Headache, sweating and nausea. The symptoms persisted and the patient had called a healthcare professional Other Laboratory investigations were not reported. Corrective treatments were not reported. The outcome of all the events was reported as not recovered. Documents held by sender: none. Follow up information received from a pharmacist on 01-Feb-2016. Patient received Adacel (batch number: X4J7D) at 13 October 2015 at approx at 7:30 Am. Patient had no other vaccination within 4 weeks prior. Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as azithromycin allergy (initially it was reported as erythromycin allergy). On 14 October 2015, one day following the vaccination patient experienced the events. On an unspecified date, patient had recovered.
No adverse reactions at the time vaccine was given. Approx 16 hours later she was seen in the ER for a febrile seizure.
Statement of Incident:  A partially used vial of Moderna was returned to the refrigerator instead of being discarded on 30 Dec 2020.  On 4 Jan 2021, the partially used vial was used to vaccinate at least six patients. On 5 Jan 2021, the Immunizations Team was discussing wasted vaccines and was reminded of the 6 hour expiration timeframe once a vial is punctured.  One of the members realized that they used the above mentioned open vial on 4 Jan 2021 well beyond the 6 hour timeframe. In addition, once a vial is punctured and brought to room temperature, placing the vial back into the refrigerator will invalidate the vial and make it unusable.  Impact: A minimum of six patients received invalidated vaccine. Consultation with Agency concurred the doses given from this vial should be considered invalid and recommend that all patients who received vaccine from this vial be revaccinated. Corrective Action Required/Taken:  Medical Staff and the Staff were notified to report the patient safety error.  The team identified ten patients who did or possible did receive the invalid vaccine.  After consulting with Risk Management, the Specialist and Agency, all ten patients were contacted, received full disclosures, and were recommended to receive repeat Dose 1 as soon as possible.  Eight patients were revaccinated on 6 Jan 2021.  Two declined revaccination and plan to get Dose 2 as previously scheduled.  A Concise Incident Analysis (mini- Root Cause Analysis) is being conducted to determine root causes and ensure effective process improvements are implemented.
Next day hives started. 3-4 scattered over body. Would change location over time. Took BENADRYL at one point for itching recommended by doctor. Stopped sometime last month. Thought related to something new in diet but did not affect.
contracted COVID; granddaughter is pregnant; This case was received via an unknown source (no reference has been entered for the regulatory authority) on 10-Dec-2021 and was forwarded to Moderna on 10-Dec-2021. This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of COVID-19 and MATERNAL EXPOSURE DURING PREGNANCY in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pregnant.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced COVID-19 and MATERNAL EXPOSURE DURING PREGNANCY. At the time of the report, COVID-19 outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       No concomitant and treatment drugs were provided.  This is a spontaneous case concerning an adult pregnant female patient with no relevant medical history reported, who experienced the unexpected events of maternal exposure during pregnancy and Covid-19. The patient experience Covid-19 and received a dose of mRNA - 1273 vaccine on an unknown date. The last menstrual period and estimated date of delivery were also not provided. At the time of report outcome of Covid-19 was still unknown. The reporter's assessment was not provided in this case. The benefit-risk relationship of the vaccine is not affected by this report.
- lethargic - headache -dizzy - fever over 100.79 today and past few days (it's been 5 days since second dose of Pfizer) - upset stomach - extremely sore, bruised arm from both doses that lasted around 1.5 weeks - very sore throat, very painful to swallow
sore arm, stomach cramping and diarreah started at 5pm and got worse.
Tips of toes turning red; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6201) via an unspecified route of administration in the left arm on 13Feb2021 at 13:00 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetic and stage 3 kidney disorder. The patient did not have a history of allergies to medications, food, or other products. Concomitant medication included acetyl salicylic acid (ASPIRIN), atorvastatin (MANUFACTURER UNKNOWN), ezetimibe (MANUFACTURER UNKNOWN), fenofibrate (MANUFACTURER UNKNOWN)  and more (unspecified) all started on unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Jan2021 at 12:00 the patient experienced tips of toes turning red (localised erythema). On an unknown date, the patient underwent lab test and procedure which included COVID-19 virus test and the result was found to be negative. No therapeutic measures  were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event tips of toes turning red was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pain in arm; kind of diminished for a day and then it came back; He can't even sleep; pain injection site radiating to elbow; pain injection site radiating to elbow; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 75-years-old male patient received BNT162B2 (Formulation: Solution for injection, dose 1 intramuscular, administered in Deltoid Right on 18Feb2021 (at the age of 75-years-old) (Batch/Lot Number: EL9267) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced pain in arm; kind of diminished for a day and then it came back and he can't even sleep. One week ago, on the 18Feb2021, patient had taken the first shot but had not taken the second shot. Patient stated, he just want to report and ask some advice about the pain after the vaccine. Patient stated, he was still having pain 7 days after the shot in his arm.  Reporter stated, it had gotten worse since Monday, every day it gets a little worse. Pain at injection site radiating to elbow AM of 20Feb2021, the extreme pain lasting 2-3 days. Now no pain in arm and he can sleep. He had not any lab tests. There was no anti-pyretic use around date of vaccination. The patient had no emergency room visit for adverse event. The outcome of the event was recovered on an unspecified date.  Follow-up attempts are needed Information on Lot/Batch number was available, additional information has been requested.  Follow up (18Jun2021): New information reported from a contactable consumer includes suspect product information, event details and outcome updated.
Janssen COVID-19 Vaccine EUA Headache, muscle aches, very tired Vaccine was given at 10:00 AM; Symptoms started around midnight that night and lasted about 12 to 13 hours.  All symptoms began to dissipate between noon and 1:00pm the day after the vaccination.
CLIENT RECEIVED COVID19 3RD DOSE FOR IMMUNOCOMPROMISED PER CONSENT FORM. WOKE UP THAT EVENING, WENT TO BATHROOM, FELL AND HURT HER HAND. FAMILY ARRIVED AND CALLED THE AMBULANCE- WAS TAKEN TO HOSPITAL IN NEARBY CITY (50 MILES) CLIENT REPORTS HER TEMP 100.5- BP 88/43.  REPORTS SHE HAD REQUESTED ONLY HALF DOSE ON THE MODERNA. AT THAT TIME, GUIDANCE HAD NOT BEEN RECEIVED TO ALLOW US TO GIVE HALF DOSES.  CLIENT INSISTENT THAT THE FULL DOSE OF MODERNA CAUSED THIS ADVERSE REACTION.
Within 30 days of the booster shot on 12/21/2021 patient suddenly developed double vision. No pain of other problems .. right eye began to severely droop, and could only see by squinting and everything was double vision as if looking through kaleidoscope.
Pt developed raised red bumps on face and trunk one day post vax that last for 10 days.
Pillow was soaking wet/swetted it out/Night sweats; left arm was killing me; No energy; Joints hurt; Exhausted; chills; Couldn't eat/no appetite; Very, very ill; Couldn't wake up; Dizzy; Slept for 34 hours; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Couldn't eat/no appetite), ILLNESS (Very, very ill), SOMNOLENCE (Couldn't wake up), DIZZINESS (Dizzy) and SOMNOLENCE (Slept for 34 hours) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A, 013L20A and 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Immunocompromised. Concomitant products included GLIPIZIDE, METFORMIN, SIMVASTATIN, LISINOPRIL and LEVOTHYROXINE for an unknown indication. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Oct-2021, the patient experienced SOMNOLENCE (Slept for 34 hours). On 10-Oct-2021, the patient experienced DECREASED APPETITE (Couldn't eat/no appetite), ILLNESS (Very, very ill), SOMNOLENCE (Couldn't wake up), DIZZINESS (Dizzy), FATIGUE (Exhausted) and CHILLS (chills). On 11-Oct-2021, the patient experienced ASTHENIA (No energy), PAIN IN EXTREMITY (left arm was killing me) and ARTHRALGIA (Joints hurt). On 12-Oct-2021, the patient experienced NIGHT SWEATS (Pillow was soaking wet/swetted it out/Night sweats). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (Couldn't eat/no appetite) had not resolved and ILLNESS (Very, very ill), SOMNOLENCE (Couldn't wake up), DIZZINESS (Dizzy), SOMNOLENCE (Slept for 34 hours), ASTHENIA (No energy), NIGHT SWEATS (Pillow was soaking wet/swetted it out/Night sweats), PAIN IN EXTREMITY (left arm was killing me), FATIGUE (Exhausted), CHILLS (chills) and ARTHRALGIA (Joints hurt) outcome was unknown.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This case was linked to MOD-2021-349585 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: Patient decline for the nervousness event.
48 hours post vax, the pt developed a rash, fever, arthralgia, and myalgias. 72 hours post vax, the pt developed maculopapular exanthema, one target lesion, and edema of left lower leg.
Pt recvd series of 3 Recombivax; test results 30MAY89 neg. for HBSAB.4th dose of Recombivax given;test results 27JUN89 again neg.A 5th dose using Engerix-B given 24JUL90;test remained neg.
Administration of expired vaccine; This case was reported by a other health professional and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number unknown, expiry date 15th January 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th February 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 16th February 2022, unknown after receiving Kinrix and Kinrix 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 details were provided as follows: The patient received an expired dose of Kinrix, which led to expired vaccine used. No reactions were noted.
Red stripe starting under the vaccinated arm, about 2-3" thick ending just past my rib cage, mid abdomen with a thin red line across my chest towards my heart.  Gone at 12 noon on 3/10, less than 24 hours after shot. Fatigue, light sensitivity, headache.
DTaP #1 IPV #4 MMR #2 given-a few minutes later, pt started sneezing, eyes started swelling and red-+wheezing. Epinephrine 0.3 u; / Benadryl 25mg IM given. Pt lung field  cleaned-transferred to ER. Not anaphylaxis. Anaphylactic reaction to MMR #2 (DTaP #5/ IPV #4 also given).  Nurse follow up on 05/25/04 states: "Complete."
Patient developed a rash on his left lower leg that lasted for 1 week. He did not treat the rash with any medications and it resolved on its own.
This is a spontaneous report from a contactable other hcp (front desk staff) who was reporting on behalf of the physician via a Pfizer sales representative. A female patient of an unspecified age and ethnicity received a single dose of TRUMENBA, via an unspecified route of administration on an unspecified date. Medical history was not reported. There were no concomitant medications. The patient was taken to the emergency room with a severe headache on an unspecified date. The outcome of the event was unknown. Follow-up (16JAN2015): Follow-up attempts completed. No further information expected.
Rash on legs and abdomen, couple on face began 9/12/09 especially upper thighs and feet, forearms 9/14 already stated to recede without fever. no itching rash dissipated by 9/16/09 - appetite improved 9/15/09. Client's parent called 9/16/09 stating that child developed a rash on 9/12/09; it was located on legs, abdomen, feet, forearms. More lesions noted on upper thighs and feet. "It started on face with a couple dots. I took him to the doctor and he asked me to talk to the health dept as he had had shots on September 8th. He had no fever, no itching. By 9/14 it had started to fade." Called parent 9/21/09; reports that rash completely gone by 9/16. " Plan: continue to vaccinate. PCV due in one month.
Fatigue; Chills; Nausea; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), CHILLS (Chills), NAUSEA (Nausea) and MYALGIA (Body aches) 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 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced FATIGUE (Fatigue), CHILLS (Chills), NAUSEA (Nausea) and MYALGIA (Body aches). At the time of the report, FATIGUE (Fatigue), CHILLS (Chills), NAUSEA (Nausea) and MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   Reporter did not allow further contact
injection site pain; site swelling; Tiredness; Chills; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 24Mar2021 (Lot number: ER8733) at the age of 57 years as dose 1, 30ug single for covid-19 immunisation. Relevant medical history included: "Type II diabetes" (ongoing), notes: She thinks that she was diagnosed over ten years ago.; "Hypertension" (ongoing), notes: She states that she was diagnosed over 10 years ago.; "kidney disease" (ongoing), notes: She states that she was diagnosed 8 to 10 years ago. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 24Mar2021, outcome "not recovered", described as "injection site pain"; VACCINATION SITE SWELLING (non-serious) with onset 24Mar2021, outcome "recovering", described as "site swelling"; FATIGUE (non-serious) with onset 24Mar2021, outcome "not recovered", described as "Tiredness"; CHILLS (non-serious) with onset 24Mar2021, outcome "not recovered", described as "Chills". Additional Information: The patient has not taken any other products. The patient wanted to know what she can do about her injection site pain, site swelling, tiredness, and chills. Injection site pain started yesterday, 24Mar2021, as well as site swelling started last night. Tiredness started also yesterday, and chills yesterday last night. She received her first dose of the COVID-19 vaccine yesterday, 24Mar2021. She was supposed to have a letter stating that she has those problems, and she brought the letter with her, but they did not take. The time of vaccination was around 12:45 or 12:46PM. The patient has no history of all previous immunization with COVID-19 Vaccine, and has no additional vaccines administered on same date of the COVID-19 Vaccine. The adverse events did not require emergency room nor physician office visit. The patient has no prior vaccinations within 4 weeks and has no adverse events prior vaccinations. The patient has no family medical history relevant to the adverse events and has no relevant tests done.  No follow-up attempts are possible. No further information is expected.
Narrative:  Death not suspected to be related to COVID-19 vaccine administration. Patient was on Hospice care for Acute on chronic mixed respiratory failure with acute on chronic pleural effusions secondary to HFrEF/RVR and RLL adenocarcinoma.
About 24 hours after the vaccine I started feeling achy and tired.  The following day I was extremely tired, achy, hot and cold, and had stomach issues (throwing up a few times).  Sunday night I woke up sweating and had a hard time sleeping (unusual for me). I also have "covid" arm, which is red, swollen, a hard knot, and warm to the touch.