chrisvoncsefalvay/vaers-outcomes huggingface dataset:
accidentally mixed ActHIB with sterile water instead of the diluent, No AE; Initial information was received on 02-Jan-2020 regarding an unsolicited valid non-serious case from a nurse.  This case is linked to cases 2020SA002810, 2020SA002455, 2020SA002812, 2020SA002456 and 2020SA004004 (same reporter).  This case involves a 6 month old patient who received HIB (PRP/T) VACCINE [ACT-HIB] which mixed with sterile water instead of the diluent.  Medical history, medical treatment, vaccination and family history were not provided.  On 19-Dec-2019, the patient received a dose of suspect HIB (PRP/T) VACCINE (lot UJ175AAA, expiry date- 26-11-2020) via unknown route in unknown administration site.  It was a case of actual medication error due to wrong solution used in drug reconstitution.  At the time of report, no adverse event was reported.  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 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.
Pneumococcal 23 valent (Lederle 473341) given to an under 2 year old by mistake. Should have been pneumococcal conjugate vaccine Trivalent. No adverse effect noted. Will re-vaccinate with PCV7.
pt devel a high fever of 103-104 1.5 days p/vax cont about 1wk;no other sx neither any local rxn;
shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 027L20A) 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 12-Mar-2021, 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 experienced HERPES ZOSTER (shingles). The patient was treated with ACYCLOVIR [ACICLOVIR] for Nerve pain, at a dose of 1 dosage form and PREGABALIN (LYRICA) for Nerve pain, at a dose of 1 dosage form. At the time of the report, HERPES ZOSTER (shingles) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by reporter. Treatment medication also included anti-inflammatory drugs.
Received flu shot on Oct 12, 2014 about 2pm. At 5:30pm I was suddenly weak and disoriented. Had to go to bed and could not stand up until 12 hours later - also temp of 100 degrees.
The vaccine on 9/16 and 9/19  I got a ct scan and they said I had a blood clot in my brain and upper part of my heart. I've never had any heart trouble before. I panic and sent me to a heart doctor because it can easily be a stroke if it moved. They put me on Eliquis. on 12/16 I had another ct scan and they said the blood cot was gone. On 1/18 i have to go back to see if i am staying on the Eliquis or not.
Typical post vaccination side effects; Son accidentally vaccinated at age 17; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Typical post vaccination side effects) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Son accidentally vaccinated at age 17) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Tachycardia and Premature ventricular contractions.    On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced VACCINATION COMPLICATION (Typical post vaccination side effects) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Son accidentally vaccinated at age 17). At the time of the report, VACCINATION COMPLICATION (Typical post vaccination side effects) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Son accidentally vaccinated at age 17) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication were provided.
Feeling like I am developing a chest cold during the night and right in the morning when I wake up.; Irritated airways, feels as if I am coming down with bronchitis.; Irritated airways, feels as if I am coming down with bronchitis.; This is a spontaneous report from a contactable consumer, who reported for herself. A 30-years-old female consumer received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot EN6203), via an unspecified route of administration, on 11Mar2021 1400 (at the age of 30-years-old) as a single dose for COVID-19 immunization, in left arm. The facility where COVID-19 vaccine was administered was at a School or Student Health Clinic. She has had no other vaccines or medications in the past 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient has no other relevant medical history and concomitant medications were not reported. On 12Mar2021 at 10:00pm, the patient had Feeling like I am developing a chest cold during the night and right in the morning when I wake up. Irritated airways, feels as if I am coming down with bronchitis. The patient went to see a doctor or other healthcare professional office/clinic visit. Treatment was not received. The clinical outcome of the events chest cold /Irritated airways, feels as if I am coming down with bronchitis was not recovered. It was reported that since the vaccination, the patient had not been tested for COVID-19.  Information about the Lot/batch number has been requested.
felt weak; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt weak) 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.    On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jul-2021, the patient experienced ASTHENIA (felt weak). At the time of the report, ASTHENIA (felt weak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.    This case was linked to MOD-2021-308054 (Patient Link).
About 5 days after vaccine I noticed a bump above  my collar bone. Located on the same side I received the vaccine. I started to have soreness in the same arm again but different location then where the vaccine was given.  Bump is still there as of today. I am monitoring it.
Rash followed by swelling of the face and welt like rash all ovewr face, body and trunk.
She first noticed a sensation of swelling in the middle of her throat.  She says that the sensation has stayed about the same.  She reports feeling a sensation of spinning/motion.  She says that her symptoms have mildly improved over time.  She denies dyspnea, chest pain, stomach discomfort, feeling nauseated, rash/itchiness.
Extreme dizziness, vertigo and disequilibrium causing a fall and lasting 60 minutes on 4/8/21. Vertigo and disequilibrium lasting 30 minutes on 4/9/21 Vertigo and disequilibrium lasting 30 minutes on 4/10/21
PVP 0.5ml administered Mon. 10/10/05 right arm. Approx 7 hrs post injection arm felt warm and next morning c/o arm stiffness and soreness of arm. Denies fever c/o chills. No redness or tenderness noted at injection site. Instructed to put ice to area and call Dr. 2 lg red raised areas noted firm to touch on front and back of upper arm (no redness, tenderness or edema noted at site of injection). Appt made with family physician for 10/13/05. Instr by Dr to cont with ice and use Motrin or Tylenol until seen.
funny sensation in chest; Sore Arm; blood pressure was measured at 155/88 mm Hg; Swollen left under arm lymph node; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (blood pressure was measured at 155/88 mm Hg), PAIN IN EXTREMITY (Sore Arm), CHEST DISCOMFORT (funny sensation in chest) and LYMPHADENOPATHY (Swollen left under arm lymph node) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 030A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATENOLOL for Hypertension.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced HYPERTENSION (blood pressure was measured at 155/88 mm Hg) and LYMPHADENOPATHY (Swollen left under arm lymph node). On 09-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). On an unknown date, the patient experienced CHEST DISCOMFORT (funny sensation in chest). On 08-Apr-2021, HYPERTENSION (blood pressure was measured at 155/88 mm Hg) outcome was unknown. On 10-Apr-2021, PAIN IN EXTREMITY (Sore Arm) had resolved. At the time of the report, CHEST DISCOMFORT (funny sensation in chest) outcome was unknown and LYMPHADENOPATHY (Swollen left under arm lymph node) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, Blood pressure measurement: 153/72 mmHg (abnormal) 153/72 mmHg and 155/88 mmHg (abnormal) 155/88 mmHg. On 08-Apr-2021, Heart rate: heart beats per minute (abnormal) 60s-80s returned to normal 20 mins after vaccination.         Treatment medicines were not reported  Action taken with mRNA-1273 in response to the event was not applicable   This case was linked to MOD21-054562, MOD21-054592, MOD21-054593.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow-up Information Received on 01-JUN-2021 contains No New Information On 09-Jun-2021: Non-significant Follow up received
Severe headache, 10 hours, very tired (still), achy (still), dizzy, chest pain
This spontaneous case reported by a healthcare professional, describes the occurrence of administered expired product (doses administered past the published expiry date) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 047B21A) for COVID-19 immunization. No medical history reported. On Oct 26, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Oct 26, 2021, at 8:00 am, patient administered expired product (doses administered past the published expiry date). On Oct 26, 2021, at 8:00 am, administered expired product (doses administered past the published expiry date) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Myalgia, Fever, chills, fever, fatigue, muscle aches, bloody nose Narrative:  Day 1 12 hours after inj noted with chills, fever of 102.6, fatigue, muscle aches symptoms lasted until day 3; Day 4 - a little fatigue and streaks of blood in nasal mucus
Unevenly distributed nasal mist, into left nostril > 50% approx. 9:30 AM, approx 10:30 progressively worsening left facial no motor involvement. Gradual improvement beginning 12:30AM better by 4:00 PM, gone within 24 hours.
COVID arm. Swollen red patch near injection site that itches and aches. Grew over 24 hours, now is over an inch in diameter.
Legs slightly swollen, purple splotchy coloring. High pitched screaming. Increased WBC count on CBC. Temp. 99.1 (R). TYLENOL given, ice packs to thighs. Apt to recheck patient in AM.
Patient given meningococcal vaccine but had already been vaccinated with MENACTRA on 8/23/07.  No adverse effects at present time.
Sore arm, extreme body aches, weakness, periods of chills, periods of hot flashes, extreme fatigue, low appetite, trouble sleeping partially due to sinuses congesting,  lower gastro irritation the 2nd day. Still low on stamina.  Only had sore arm on the first two vaccinations.
Patient stated that a week after receiving the shot,she started to develop a red raised area on her arm around the injection site.  It grew into a quarter sized area and has grown warm and has increased in size every day.  Patient got Keflex from provider and we are monitoring for cellulitis.
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 79 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 08-Sep-2016, the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Not reported. Batch number: WT53706. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out (temperature) range while there was flu vaccine in it. On 08-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. The patients will be contacted for revaccination.
This spontaneous report was received from a Registered nurse refers to a patient of unknown age and gender. Patient medical history and current condition was not reported. On 23-APR-2015 the patient was vaccinated with (Merck) VARIVAX of unknown dose via subcutaneous route which underwent a supported temperature excursion. No adverse effects reported. Product quality complaint was not reported. The outcome of the event was unknown. Additional information has been requested.
LEG SWELLING/SWELLING WENT UP LEG TO KNEE; ANKLE SWELLING; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and multiple hernias, and other pre-existing medical conditions included the patient had no appendix and gall bladder. The patient experienced drug allergy when treated with naproxen. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1821288 expiry: UNKNOWN) dose was not reported, administered on 05-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUN-2021, the subject experienced leg swelling/swelling went up leg to knee. On 07-JUN-2021, the subject experienced ankle swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from leg swelling/swelling went up leg to knee, and ankle swelling. This report was non-serious.
The patient was vaccinated in approximately 1999. It was reported that in approximately July of 2000, the patient "presented with a chickenpox-like rash and shingles after his brother was vaccinated. The patient's brother had a similar experience following exposure to varicella virus vaccine live. The patient sought unspecified medical attention. Additional information has been requested.
ethmoid sinus congestion/headache; onset at approx 10 mins of dose 1 administration;  resolving in 15 mins
Migraine - lasted from 4/17/2021 @ 3:15am to 4/18/2021 @ 4:30pm - no medications helped Lower back/hip soreness 4/17/2021 @ 10:30 pm to 4/18/2021 @ 3:30pm - heating pad used
After receiving vaccine patient was sitting on dad's lap, patient fainted and fell off of dad's lap, hit head on wall and floor.   Parents picked patient up and placed on treatment table, this nurse called for Dr. to come to room, patient then had episode of incontinence and awoke, crying. C/o of head hurting.   HR of 102 and BP of 124/86 taken per MA.   DR monitoring patient.
focal seizures   the afternoon after my first moderna shot- for about 5-6 hours, i experienced very frequent temporal lobe focal seizures.  I have never had them in such quick succession or for such an extended period of time.
DIFFICULTY BREATHING, WHEEZING, FAST HEART BEAT AND DIZZINESS.
PATIENT RECEIVED 1ST MODERNA VACCINE AT PHARMACY. PATIENT THEN COULD NOT DRIVE THE 4.5 HOURS BACK HOME FOR SECOND DOSE. PATIENT WAS ABLE TO SCHEDULE 2ND DOSE. PATIENT WAS SCREENED AND MENTIONED IT WAS HER 2ND DOSE. THE PHARMACIST THEN REJECTED THE PATIENT AND TURNED HER AWAY STATING SHE COULD NOT RECEIVE THE 2ND DOSE ANY OTHER LOCATION THAN THE LOCATION WHERE SHE RECEIVED THE 1ST DOSE. PATIENT WAS THEN FRUSTRATED BUT ABLE TO SCHEDULE AN APPT WITH ON 3/19. THIS DATE WAS EXACTLY 42 DAYS FROM 1ST DOSE (NOT MORE THAN 42). PATIENT WAS SCREENED AND DID NOT STATE VERBALLY THAT SHE WAS RECIEVING 2ND DOSE.  ALSO NO MENTION OF ORIGINAL 1ST DOSE ON 2/5. SHE AGREED TO RECEIVE HER 1ST DOSE ON 3/19 (WHICH WAS TECHNICALLY HER 2ND- COMPLETION DOSE). PATIENT WAS THEN AUTOMATICALLY SCHEDULED FOR 2ND DOSE AS SHE WAS UNDER THE IMPRESSION SHE WAS TO RESTART THE SERIES BECAUSE OF THE 42 DAY STIPULATION THAT CDC HAS RELAYED AS PUBLIC INFO AND BECAUSE THE APPT WAS SCHEDULED AS 1ST DOSE NOT 2ND DOSE.  UPON ARRIVING FOR 2ND DOSE APPT ON 4/15, PATIENT WAS AGAIN SCREENED AND VERBALIZED SHE WAS HERE TO RECEIVE HER 2ND DOSE. WITH NO MENTION OF ORIGINAL 1ST DOSE ON 2/5. PATIENT WAS GIVEN VACCINE.  UPON STARTING DOCUMENTATION, PATIENT WAS ALREADY MARKED AS COMPLETED AND PHARMACIST WAS ALERTED BY DOCUMENTATION SYSTEM THAT DOSE WOULD HAVE BEEN EXTRANEOUS DOSE. PATIENT WAS THEN NOTIFIED DOSE WAS EXTRANEOUS AND BE COGNIZANT OF COMPOUNDED SIDE EFFECTS. INFORMED PATIENT TO PLEASE RELAY ANY ADDITIONAL SIDE EFFECTS TO THE PHARMACIST SO THEY MAY BE RECORDED INTO VAERS. 12:10PM 4/15/21
Swelling under left armpit. Single soft lump, likely inflammation. Slight soreness.
Severe pain in legs; severe pain in back; could not get out of bed; Patient received Fourth Dose in 14-Mar-2022; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Severe pain in legs), BACK PAIN (severe pain in back), ASTHENIA (could not get out of bed), CHILLS (chills) and EXTRA DOSE ADMINISTERED (Patient received Fourth Dose in 14-Mar-2022) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A, 045B21A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2022, the patient experienced EXTRA DOSE ADMINISTERED (Patient received Fourth Dose in 14-Mar-2022). In March 2022, the patient experienced CHILLS (chills). On 15-Mar-2022 at 2:30 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Severe pain in legs), BACK PAIN (severe pain in back) and ASTHENIA (could not get out of bed). In March 2022, CHILLS (chills) had resolved. At the time of the report, PAIN IN EXTREMITY (Severe pain in legs), BACK PAIN (severe pain in back) and ASTHENIA (could not get out of bed) had resolved and EXTRA DOSE ADMINISTERED (Patient received Fourth Dose in 14-Mar-2022) outcome was unknown.            No Concomitant product use was reported.  The patient was reporting adverse event from their 4th Moderna Covid-19 dose and explained that week after their 4th dose after initial chill in the middle of night at 2:30 AM the patient started to experience severe pain in their back and both legs. The patient said that it was tremendous pain, and it made the patient unable to get out of bed. Reportedly, the patient said that they fully recovered within 24 hours. No other adverse events were reported. The patient also stated that they did not need to visit their primary care doctor and said the patient's reactions was from the shot.   The patient was unable to verify booster versus full dose.  No treatment information was provided.
ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY 10/21/2022 HYPERKALEMIA        HYPOTENSION 12/1/2022 HYPERKALEMIA
IM's (DTAP, HEP B in left thigh and MMR in right thigh) given 05/06/2003.  Mom noticed next evening-mult. raised areas on left thigh and itch.  Felt warm.  No history of hallucinations/confusion.  No difficulty talking or walking.  No difficulty breathing no wheezing.  On exam AM of 05/08/2003-no acute distress.  Alert factor rancuted.  No difficulty breathing.  No lympads espethy left groin.  (+) left upper thigh-4 1/2 x 6 1/2 in erythema.  warm, swollen, conf.  Skin tight.  Fades with pressure.  No abcess palpation.  No streaking.  Diagosed by PRININ - prescribed to "tetanus" of DTaP (local).  Treatment-warm comression ibuprofen, for itch-cold compress, benadryl if neccessary.
pt recv vax 2OCT97 & c/o redness, hardness, & soreness @ inj site fromt he day of inj;traveled down to elbow;pt to MD office;
4 hours after shot, developed cough and nasal congestion c/w (L) sided upper bicep area extending to shoulder and scapular regions, musculoskeletal pain progressing to inability to use (L) UE. L-side vaccine was received.
Approximately about 2-3 months after my booster shot (3rd dose) I experienced the following symptoms: Difficulty in moving my arm (Left arm) I wasn't able to move or even do simple things using my left arm. I was prescribed with Ibuprofen, Medrol by my doctor. It did help a bit with my condition.
Pt was admitted to the hospital on 4/13/2021 after being found to be covid 19 positive. She reported fever, cough and chills. she was febrile 101.2 and tachycardic. She was discharged home on 4/15/2021 on xarelto 10mg for 30 day and decadron 6mg for 3 more days. She was given regeneron during her hospital stay. It was also noted that she had a superficial venous thrombosis of the right greater saphenous vein extending into the upper thigh to the upper calf.
after 17 hours of receiving the vaccine I developed joint pain, muscle aches, severe sinus inflammation requiring inhaled steroid spray, dizziness, headache and lymphadenopathy to left supraclavicular lymph nodes and posterior cervical lymph nodes which are still tender, enlarged, and sore currently.