chrisvoncsefalvay/vaers-outcomes huggingface dataset:
WITHIN 48 HOURS OF MY SECOND DOSE OF THE VACCINE, MY HEART RATE DROPPED SIGNIFICANTLY. I HAVE HAD SINUS TACHYCARDIA (HIGH HEART RATE) FOR YEARS AND TAKE A BETA-BLOCKER TO SLOW MY HEART RATE DOWN. 48 HOURS AFTER MY SECOND SHOT, I FELT VERY DIZZY AND WEAK AND MY WATCH THAT MONITORS MY HEART RATE ALERTED ME THAT MY HEART RATE HAD BEEN IN THE 40'S FOR MORE THAN 10 MINUTES. WITH MY MEDICATION MY HEART WOULD NORMALLY BE IN THE HIGH 60'S-70'S SO THIS WAS QUITE A DROP FOR ME. I CONTACTED MY HEART DR WHO TOLD ME IF I COULD NOT GET MY HEART RATE UP TO AT LEAST 50 TO GO TO THE E.R. I DRANK SOME COFFEE AND WALKED UNTIL MY HEART RATE CAME UP. THIS LASTED FOR SEVERAL DAYS AND I WAS ADVISED TO CUT BACK ON MY BETA BLOCKER DOSAGE UNTIL MY HEART RATE COULD COME BACK UP. IT HAS BEEN 6 MONTHS NOW SINCE MY VACCINE AND MY HEART RATE IS STILL LOWER THAN WHAT IT WAS PRIOR TO THE SHOTS. I AM STILL ON THE REDUCED DOSE OF MY BETA-BLOCKER. WHILE IT MAY SEEAM A GOOD THING THAT MY HEART RATE HAS SLOWED, IT WAS VERY UNEXPECTED AND DANGEROUS. THE DAYS FOLLOWING MY SECOND SHOT MY HEART RATE EVEN DROPPED INTO THE 30'S. I WORRY ABOUT THIS BECAUSE WE DON NOT KNOW IF THIS IS A PERMANANT REDUCTION, OR IF MY TACHCARDIA WILL RETURN AND IF SO,WHEN? THERE WERE NO OTHER CHANGES IN MEDICATION OR LIFESTYLE THAT WOULD HAVE CAUSED THIS REDUCTION.
Redness, swelling, tenderness, cellulitis.  Treated with Clindamycin 75mg/5ml, take 15ml po tid x10 days.
patient broke out with body rashes; This spontaneous case was reported by a consumer and describes the occurrence of RASH (patient broke out with body rashes) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 immunization.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (patient broke out with body rashes). At the time of the report, RASH (patient broke out with body rashes) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.  It was reported that, the patient broke out with body rashes that lasted for over a year.   No treatment medications were reported.   Reporter did not allow further contact
coughing; fatigue; vomiting; pain in areas of her body where she previously had injuries such as surgery or injury in lower back and right leg; Pain in areas of her body where she previously had injuries such as surgery or injury in lower back and right leg; Pain in areas of her body where she previously had injuries such as surgery or injury in lower back and right leg; Bowel incontinence; Arm where she had skin cancer has been bothering; This spontaneous case was reported by a patient and describes the occurrence of PAIN (pain in areas of her body where she previously had injuries such as surgery or injury in lower back and right leg), BACK PAIN (Pain in areas of her body where she previously had injuries such as surgery or injury in lower back and right leg), PAIN IN EXTREMITY (Pain in areas of her body where she previously had injuries such as surgery or injury in lower back and right leg), ANAL INCONTINENCE (Bowel incontinence) and LIMB DISCOMFORT (Arm where she had skin cancer has been bothering) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. HRS A04UBZIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medication history was provided.  Concomitant products included SIMVASTATIN, OXYBUTYNIN, acyclovir, HYDROCHLOROTHIAZIDE, CITALOPRAM, LOSARTAN, Albuterol sulfate inhaler, Estradiol Insert, Aspirin and PARACETAMOL (TYLENOL).    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 12-Apr-2021, the patient experienced PAIN (pain in areas of her body where she previously had injuries such as surgery or injury in lower back and right leg), BACK PAIN (Pain in areas of her body where she previously had injuries such as surgery or injury in lower back and right leg), PAIN IN EXTREMITY (Pain in areas of her body where she previously had injuries such as surgery or injury in lower back and right leg), ANAL INCONTINENCE (Bowel incontinence) and LIMB DISCOMFORT (Arm where she had skin cancer has been bothering). On an unknown date, the patient experienced FATIGUE (fatigue), COUGH (coughing) and VOMITING (vomiting). At the time of the report, PAIN (pain in areas of her body where she previously had injuries such as surgery or injury in lower back and right leg), BACK PAIN (Pain in areas of her body where she previously had injuries such as surgery or injury in lower back and right leg), PAIN IN EXTREMITY (Pain in areas of her body where she previously had injuries such as surgery or injury in lower back and right leg), ANAL INCONTINENCE (Bowel incontinence), LIMB DISCOMFORT (Arm where she had skin cancer has been bothering), FATIGUE (fatigue), COUGH (coughing) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was unknown   This case was linked to MOD-2021-209054 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow up received on 4-jun-2021, new events were added.
24 hours after receiving the first dose of the Moderna vaccine I developed mental confusion/short-term memory loss.  I did not remember getting the vaccine or where I got it.  Due to symptoms consistent with neurological problems I was transported to the ER. I was given a CT scan of my head and a blood test.  Results were negative for any problems. The ER doctor said my immune system revved up due to the vaccine.  I was diagnosed with altered mental state which I recovered from a few hours later close to discharge time. Two weeks later I experienced mental confusion again. On the evening of October 6th I  had another bout of mental confusion for about 3 minutes.  Early morning hours of October 7th I awoke 3 times with identical symptoms each time lasting 2-3 minutes. I felt unwell during that day with lack of appetite, chills, and fatigue. I experienced 2 more episodes of mental confusion in the afternoon of October 7th.  The next day I had some waves of vertigo, but no mental confusion and none since October 7th, 2 weeks ago.
became ill; nasal congestion; cough; lose her sense of smell; believed them to be allergy related; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sales representative. A 53-year-old female patient reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single and second dose of bnt162b2 (Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient became ill with nasal congestion and a cough and believed them to be allergy related. The patient did lose her sense of smell but attributed it to the nasal congestion. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Client received vaccines on 12-1-08 and found out on 12-11-08 she is pregnant.
was given only the liquid portion of the Pentacel vaccination; Initial information received on 01-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a five months old male patient who was vaccinated with a 0.5 ml dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot C5447AB, Exp. Date 15-Nov-2019) via intramuscular route in unknown administration site on 01-Jul-2019.  The patient's medical history were not reported.  Concomitant medication included- Prevenar and Rotavirus vaccine administered on 01-Jul-2019.  It was an actual medication error case due to inappropriate reconstitution technique as only liquid component of the Pentacel vaccine was administered to the patient.  It was unknown whether the patient experienced any adverse event post vaccination.  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.  List of documents held by sender: none.
Received Second Dose 10 Days After the First Dose; Initial Report Received on 17-Aug-2020, 18-Aug-2020 and 19-Aug-2020  An Nurse reported that a 32 year-old (race and ethnicity not provided) patient received the second dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization 10 days after the first dose.  No medical history was reported.   No concomitant medications were reported.  06-Jul-2020, the patient received the first dose of HEPLISAV-B (Lot 933623, expiration date 22-Aug-2021 and NDC # not reported).   On 16-Jul-2020, 10 days later, neither the nurse nor the scheduler had verified the dates of the patient's previous vaccines. The second dose of HEPLISAV-B (Lot 933623, expiration date 22-Aug-2021 and NDC # not reported) was administered intramuscularly in her right deltoid. The patient also received a varicella vaccine subcutaneously in her right upper arm on the same day.  At the time of the report, the patient did not have any adverse reactions to either of the HEPLISAV-B doses she received.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
I did not notice it until trying to eat a food after delivering my child but I had suddenly developed afood allergy called oral allergy syndrom. After s subsequent pregnancy and flu shot I then developed anaphylaxis from the oral allergy syndrome.  After a 3rd shot and another pregnancy I developed a allergy to almonds and was in the icu.
It has been 4 weeks since my second dose of Moderna, and I still have joint popping sounds and it hurts. If I move my legs or arms or any joints such as my wrist, sometimes it will make a joint popping/cracking sound and sting for a second then it feels normal. I used to never have any problems with joints and now I do. Before my second dose, this happened right after my first dose as well and I thought it was getting better than my second dose made it flare up again. I have no preexisting conditions and no problems with my joints beforehand. I am hoping within a few months the condition will resolve itself but it is concerning since this all started happening after the vaccine. Other than that, I feel perfectly fine.
Swelling and redness in upper arm.  Did not show up until 2 Weeks after shot.  Itchy and sensitive.
Immediate pain at injection site as expected , as well as fever, headache, chills, fatigue. Towards evening these symptoms worsened. (not adverse).  I hardly slept. (all these not worrisome to me) I'm so glad my vaccine provider warned me that with underlying conditions, the vaccine could make them flare up. Which they did. In the morning I had widespread pain all over. Severe headache, and shortness of breath. Because I already have near emphysema hypoxemia oxygen levels, I checked my Oximeter and my blood oxygen was in the dangerously low 70's.  It stayed there until I put my oxygen concentrator on. Monitoring oxygen levels all day, I was able to keep it in the 80's to 90's, which helped.  40 hrs after injection , symptoms already fading away. All my adverse events were related to underlying conditions responding to the inflammation of the immune response. I feel  protected, glad I had the oxygen handy,  and I feel great about the  J & J vaccine!
Pt stated pt got 2nd covid vaccine Pfizer at 8:30am 7/2/2021 at clinic and pt got swelling on right axillary armpit. Pt applied ice pack on right axillary armpit swelling site. Noted pt has no emergency s/sx at this time. Noted pt has no fever, no pus on swelling site. Pt said the size of swelling is decreased with ice pack. Covid vaccine side effects instructions is given and pt verbalized understanding. Pt scheduled telephone f/u appt with UC provider. ED precautions provided to pt.
Fine red rash, headache, nausea. 5 pox marks on left hand.
No additional adverse effect reported; Patient received a dose of improperly stored ROTATEQ; This spontaneous report was received from a Nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.     On 13-FEB-2020, the patient received one dose of an improperly stored dose (product storage error) of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally for prophylaxis (strength and frequency not reported) (lot # 1660112 had been verified to be valid lot numbers; expiration date: 18-OCT-2020). The temperature excursion was at below 2 degrees Celsius (C) (1.28 C), for a time frame of 2 hours and 30 hours, and no had previous temperature excursion. It was reported that the call was due to data logger. No additional adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2003USA005842:
NUMBNESS IN THE LEFT SIDE OF NECK; TINGLING SENSATION IN THE LEFT SIDE OF NECK AND IN FINGERS; SLURRED SPEECH; STRAIN; LOSS OF SENSATION IN LEFT ARM; CRACK JOINT; UNABLE TO TURN ARM AT 360 DEGREE; PAIN GOES TO LEFT SHOULDER; SORENESS AND PAIN IN LEFT ARM; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 18200095, and expiry: UNKNOWN) dose was not reported, administered on 12-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-JUN-2021, the subject experienced soreness and pain in left arm. On JUL-2021, the subject experienced numbness in the left side of neck. On JUL-2021, the subject experienced tingling sensation in the left side of neck and in fingers. On JUL-2021, the subject experienced slurred speech. On JUL-2021, the subject experienced strain. On JUL-2021, the subject experienced loss of sensation in left arm. On JUL-2021, the subject experienced crack joint. On JUL-2021, the subject experienced unable to turn arm at 360 degree. On JUL-2021, the subject experienced pain goes to left shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness and pain in left arm, numbness in the left side of neck, and slurred speech, and the outcome of tingling sensation in the left side of neck and in fingers, strain, loss of sensation in left arm, crack joint, unable to turn arm at 360 degree and pain goes to left shoulder was not reported. This report was non-serious.
Low grade fever, fussy, crying incolsable, not sleeping for long periods. Jerking and twitching.
weakness lt arm, h/a, weakness lt leg FEB93;weakness rt leg NOV93;NOV94 rt leg paralysis-bladder & bowel involvement severe constipation unable to void;required 3wk hosp
Patient started having sore throat and nasal congestion after leaving the clinic. Pt developed a fever of 101 last night with severe headache and vomited x4.
Very achy all night, lethargic all day.  800 mg ibuprofin helped a bit.  At 4pm, i have a 99.2 fever (my normaln8uscabout 97.8)
felt lightheaded; had a low grade fever; chills; sweating; light and sound was very painful - Similar to a migraine; tired; slept for a long time; light and sound was very painful; light and sound was very painful; This is a spontaneous report from a contactable consumer (reported for herself).  A 58-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration from 28Jan2021 10:00 at a single dose in the right arm for COVID-19 immunization. Medical history included chronic sinus infections. Patient was not pregnant at the time of vaccination and the report. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included trazodone, xylometazoline hydrochloride (SUDAFED), cetirizine hydrochloride (ZYRTEC), and fluticasone. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took clarithromycin (BIAXIN) and experienced allergies (reported as know allergies). About an hour after the injection, on 28Jan2021 11:00 AM, patient felt lightheaded, had a low grade fever, chills and sweating, light and sound was very painful - similar to a migraine even though patient have never had one previously, and patient was very tired and slept for a long time.  These lasted for 5 days. The events required doctor or other healthcare professional office/clinic visit in response to the events. Patient received treatment for the adverse events and was reported as unknown. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events reported was recovering.   Information on the lot/batch number has been requested.
Patient got dizzy around 5 minutes after dose; and began shaking a bit 1 minute later and staring into distance. Sweaty, continued dizziness. responsive at 1 minute after side effects began. Patient drank some water as able, and reported ears were ringing.   Ambulance was called and reported all vitals looked good and patient likely experience syncopal event rather than seizure.
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 11-MAR-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 32 degrees Fahrenheit (0 degrees Celsius) (lowest recorded temperature) for 304 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
On the same day post one dose of varicella virus vaccine live the pt developed 2 spots below injection site. The spots were described as tender, sensitive and pruritic lasting approximately 3-4 days. They were treated with antibiotic ointment to ensure proper healing. The pt developed a tenderness and sensitivity around the waist that was often painful. The pt also developed a fever. She subsequently recovered.
No adverse effect reported.; a patient was administered a dose of improperly stored ROTATEQ; Information has been received from a medical assistant, referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not provided.  On 05-NOV-2019, the patient was vaccinated with a dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # S000961, expiration date 19-OCT-2019, dose and strength were unknown) orally for prophylaxis, which was exposed to a temperature excursion at above 47 degrees Fahrenheit (46.9 degrees Fahrenheit) for 37 minutes prior to administration. There was no previous temperature excursion. The digital data logger was involved. Upon this report, no adverse effect was reported.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. On unknown dates, the patients were vaccinated with improperly stored vaccines possibly including ROTATEQ (lot # K007243; exp. date: 13-DEC-2015) at 68.2 F for 2 hours with previous temperature excursion of 50.4 F for 1 hour and 30 minutes; VARIVAX (Merck) (lot#K005185; exp. date: 10-APR-2016) at 5.5 F for 22 minutes with no previous temperature excursion; VARIVAX (Merck) (lot# L001331; exp. date: 13-JAN-2017) at 5.5 for 22 minutes with no previous temperature excursion; PEDVAXHIB (lot # K008679; exp. date: 05-MAR-2017) at 68.2 F for 2 hours with previous temperature excursion of 50.4 F for 1 hour and 30 minutes; PNEUMOVAX 23 (lot # K008927; exp. date: 17-MAR-2016) at 68.2 F for 2 hours with previous temperature excursion on 50.4 F for 1 hour and 30 minutes and PEDVAXHIB (lot # K000331; exp. date: 23-OCT-2016) at 50.4 F for 1 hour and 30 minutes with no previous temperature excursion. Dose and route of administration were not provided for any of the reported vaccines. Concomitant medication was not reported. No symptoms were reported and no PQC was involved. The vaccines were not administered past the labeled expiry date, however the Medical assistant was not sure which vaccines were involved, therefore she reported the vaccines that were possibly involved. Additional information has been requested.
Received as a first dose a Moderna vaccine and as a second dose a Pfizer vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Received as a first dose a Moderna vaccine and as a second dose a Pfizer vaccine) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Received as a first dose a Moderna vaccine and as a second dose a Pfizer vaccine). On 10-May-2021, INTERCHANGE OF VACCINE PRODUCTS (Received as a first dose a Moderna vaccine and as a second dose a Pfizer vaccine) had resolved. Not Provided      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 reported No treatment drugs were reported
rash over lt arm & chest immediately p/flu shot; came & went over 3 days;
1st dose yesterday arm is real sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 18th June 2022, the patient received the 1st dose of Shingles vaccine. In June 2022, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 19-Jun-2022. Reporter's comments: The patient self-reported the case via interactive digital media. The patient got Shingles vaccine in an unknown arm and his/her arm was real sore. Additional supportive information: Follow up would not be possible as contact details were not provided.