chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 07 May 2021 received 1st dose,  On 20 Sep 2021 received 2nd dose; PSORIASIS FLAREUP TO SCALP; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (PSORIASIS FLAREUP TO SCALP) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 07 May 2021 received 1st dose, On 20 Sep 2021 received 2nd dose) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriasis.  No Medical History information was reported.   On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In May 2021, the patient experienced PSORIASIS (PSORIASIS FLAREUP TO SCALP). On 20-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 07 May 2021 received 1st dose, On 20 Sep 2021 received 2nd dose). At the time of the report, PSORIASIS (PSORIASIS FLAREUP TO SCALP) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 07 May 2021 received 1st dose, On 20 Sep 2021 received 2nd dose) outcome was unknown.         This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication information was provided. The patient stated that the physician was increasing the dosages of SKYRIZI because she continued to have a flakey and itchy scalp. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was provided.
Narrative:  anaphylaxis following COVID-19 Moderna vaccine. no O2 desaturation, +rash, + swelling, + short of breath. Recovered well after epi- pen, diphenhydramine, and solu-medrol. Sent home with prednisone taperr
26 hours later came down with like symptoms temperature with 100 degrees F, headache, fatigue, body ache.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH significant for congestive cardiomyopathy, COPD, paronychia, HTN, Diabetes, tobacco use, vitamin d deficiency, mantoux positive, cocaine abuse. proteinuria, anemia. Per note, patient passed away in home 5/3. No cause of death noted.
Experienced visual disturbance that lasted about 4 minutes.  A colorful, prismatic flashing effect to the right of my field of vision caused half of words to be unreadable.  For example, on the word Jackson  I could only see Jac.   This was visualized with the right eye closed and also upon closing left eye and opening right eye.   There were no residual effects after 4 minute event.  However, I felt it was enough to be worthy of reporting.
This spontaneous report was received from a medical assistant and refers to a currently 7 year old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored doses of M-M-R II lot # N025894,expiration date 19-SEP-2019, lot#N025898, expiration date 19-SEP-2019 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. It was unknown, which lot# was administered to the patient. The doses of vaccines experienced the temperature excursion of 47.12 degrees Fahrenheit for 40 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA010333:Original Case : 1809USA008636, US-009507513-1809USA010334: US-009507513-1809USA010335:US-009507513-1809USA008636.
No additional adverse effects.; an unspecified two week old patient was inadvertently administered one dose of ROTATEQ along with five other unspecified GSK vaccines; This spontaneous report has been received from a physician referring to a 2 week old patient of unknown gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ), orally (indication, strength, frequency, dose, lot # and expiration date were not provided) for prophylaxis ( product administered to patient of inappropriate age).  On the same date, the patient was vaccinated with other unspecified GSK vaccines. No additional adverse effects.
Information has been received from a health professional concerning a male who was vaccinated with a dose of MMR. Other vaccinations were routine childhood vaccinations including varicella virus vaccine live and maybe hepatitis B virus vaccine. Subsequently, the patient exhibited signs of autism. Unspecified medical attention was sought. There was no product quality complaint involved. Upon internal review, the patient's autism was considered to be an other important medical event (OMIC). Additional information is not expected.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Additional Details: pt fainted after receiving second dose of vaccine; lack of food in stomach plus cannabis inhalation earlier in the morning
pt exp cardiac arrest about 2 1/2 hr p/vax;was sleeping @ time;t99.0;?SIDS
Pt recv vax 11April97 & 21April97 pt devel fever of 104. Cluster of spots/rash on arm & all over body.Spots smaller than pox. Pt had not had chickenpox before, siblings had.Rx Motrin & Tylenol.
Moderna Covid-19 Vaccine EUA Vaccine found to be out of date after dose was administered on 8/4/21
Pt with marked hoarseness, SOB, & Wheezing. O2 sat 89%, O2 applied. Benadryl 25mg given PO, Solumedrol 125mg given IM, Epi pen administered x2 doses. Transported via ambulance to hospital.
23hr p/vax began to itch;hives on face, neck, hands;ears & neck hot & burning;lips swollen, eyes burning & itchy;throat & chest felt tight;took DPH & sx gradually subsided;
2-24-21 patient with development of cough, fatigue, increasing on chronic disability worsening debility and falls.  scheduled for office visit 2-25.21 0900 call from spouse 0210 am patient was not breathing and lvad alarming low flow alarm on arrival of ems confirm asystolic  not breathing and dead
ERROR: Age- UNAUTHORIZED AGE GROUP (14 years old, Pfizer EUA approved only for children 16 years and older. Parent signed consent form with incorrect DOB indicating age greater than 16yo). Event discovered and forwarded for VAERS reporting. Signs and symptoms: None known Diagnosis and treatment: None known Outcome: No adverse reaction reported
received a dose from a vial with more than 12 hours of punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose from a vial with more than 12 hours of punctured) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose from a vial with more than 12 hours of punctured). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a dose from a vial with more than 12 hours of punctured) had resolved.        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. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Email address added, Fax number added
Vasovagal syncopal episode, fainted within 10 minutes of vaccine, rapid returned to baseline after episode
NOTIFIED PHYSICIAN FIRST, THEN LEFT VOICEMAIL FOR MOTHER WITH NO RESPONSE
Red raised fevered ltr; t99.8; approx 55x55 mm started Sat w/itching, soreness from elbow to shoulder;
Throughout the day (2/4), I felt very medicated.  As it got later into the afternoon of the day, my muscles felt stiff.  Into the evening, I felt stiff and could not stay warm.  My muscles hurt as I was walking up stairs.  I did not have a fever.  I went to bed early and still felt unwell the morning of February 5.  As the day, went on into the afternoon, I began to feel better and side effects subsided.  There have not been any issues since and I have resumed daily activities.
This spontaneous report was received from a pharmacist via company representative regarding a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 concomitantly with ZOSTAVAX, (dose, route, anatomical location, lot number and expiration date were not reported for both vaccines above described). No adverse effects were reported. Follow up information was received from a pharmacist on 04-NOV-2017. The patient was a male. He did not receive any other vaccinations within 4 weeks prior this vaccination, he had no illness at time of vaccination, no pre-existing physician diagnosed allergies, no birth defects, and no other medical conditions. On an unspecified dates, the patient experienced: arm swelled up due to pneumonia shot, rash and pain. The patient went to emergency room and was prescribed unspecified treatment for the events. Subsequently, on an unspecified date, the patient recovered.
pt recv vax & pt's arm has been aching & has not been able to lie on the arm;
Slightly itchy fine raised rash over trunk, neck, arms, upper legs. No treatement. Rash remained in morning, but no longer itchy, and gone later in the day.
temperature of 100.4 for 24 hours swelling/soreness redness (spot about 1" x 4")
No adverse event; Patient 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 (Patient 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 (Patient 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 (Patient 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 (Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster).    No concomitant medication was 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 19 of 27 adult patients described by the reporter.
Pt vaccinated with DTP one of three children who received immunization in the buttocks area & the following day, mother called to report swelling at injection site with redness & pain.
Fever of 104 the day after, chills and extreme body aches, headache and nausea. This all happened when I woke up then next day.
Nausea, severe aches all over, headache, cold chills and fever. Upset stomach including real bad heartburn, bloated, diarrhea and cant eat.
Ascending tingling that began in left foot and spread to bilateral upper legs/saddle within 30 minutes, bilteral arm tingling began 2 days later, still with random paresthesia of all extremities; 5 weeks post 2nd dose developed episodes of tachycardia, rapidly increase in BP, feeling of brain fog, pressure on head - episodes last for 5-6 hours and resolve spontaneously
Covid shot burned/felt like stinging as it was administered, and feeling lasted for a few hours after injection before starting to subside. Starting the morning of 10/4 woke up tired/fatigued with a headache and body aches. Arm very sore at injection site and hurts to lift arm. Had taken 400mg Advil the evening of 10/3 around 10pm, and again 10/4 around 3am and 8am. Around 3:30pm of 10/4 existing symptoms got worse and additionally got chills and a fever of 101.1F. Took 500mg Tylenol around 5pm and chills subsided around 5:30 and temperature went down to 99F. Morning of 10/5 woke up with no fever and had taken no additional medication, still tired/fatigued with a headache and muscle aches but all less severe than 10/4.  Arm still very sore and painful to raise arm. Around 9:30pm noticed the injection site now had a large red blotch over it
Muscle soreness, muscle spasm in left deltoid extending up into left trapezius musculature.
Information has been received from a pharmacist and a physician concerning a 66 year old female who on 9/17/03 at 1030 (previously reported as 9/22/03) was vaccinated IM in the left deltoid with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot # 646320/0531N). Shortly after the vaccination, the patient developed an elevated temperature, and redness throughout the vaccinated arm which was painful to the touch. The patient also had numbness down to the fingers. The reaction began to subside in an hour. Subsequently, the patient was seen by a physician who gave her rofecoxib and told her to apply moist heat. On 9/22/03 a follow up visit was scheduled where it was noted that the patient had recovered. No product quality complaint was involved. It was also reported that another patient was vaccinated IM with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot # 646320/0531N) and developed redness, pain and numbness. No further information is expected.
Moderna Covid 19 Vaccine EAU severe flu-like symptoms  escalating to incontinence, cumulating in fainting and being unable to move any body part except one index finger.  After that subsided, foggy brain, fever.  Eventually a day of diarrea.
Pt c/o tongue swelling on 11/10/05 with food tasting funny on 11/10/05. Today 11/11/05 right eye won't close and right side of mouth dribbles and droops.
a week after 2nd shot sob on exertion,chills,sev. ere headache all joints and bones hurting. approx 5 days.dizziness
SHINGLES AFFECTING THE LEFT SIDE OF THE SCALP DOWN TO THE EYE.  TREATMENT CONSISTS OF 500MG OF FAMCYCLOVIR 3 TIMES DAILY FOR ONE WEEK, PLUS AN EYE OINTMENT OF GANCICLOVIR GEL 0.15% 5 TIMES DAILY.
Information has been received from a physician's assistant concerning a 66 year old female with high cholesterol and no drug allergies who on 17-DEC-2007 was vaccinated SC with one dose of Zostavax (Oka/Merck). Concomitant vaccination administered on that same day included a dose of influenza virus vaccine (unspecified). On approximately 18-DEC-2007 24 to 48 hours after vaccination, the patient experienced mild hoarseness in her voice and mild itching on her chest. Both symptoms resolved within a day or two on approximately 20-DEC-2007. On 27-DEC-2007 the patient woke up with severe bilateral ear pain. Upon examination at the physician's office she was found to have "red" ear drums. The patient was treated with an antibiotic for a suspected ear infection. The patient's ear pain continued and her hearing became worse. On approximately 31-DEC-2007 2 weeks after vaccination, the patient went to a specialist for a hearing test which showed moderate to severe nerve damage. The physician thought the event was due to a viral infection and treated the patient with FAMVIR and a steroid. On 28-JAN-2008 the patient had a repeat hearing test which showed mild improvements even though the patient still had trouble hearing other people. The patient was noted to be recovering. There was no product quality complaint. Hearing loss was considered to be disabling by the reporter. Additional information has been requested.
Cold chills for three days post vaccination. Diarhea for 12 days post vaccination. Lump near ear NOT a gland from day 4 - 13 post vaccination. Numbness in top of left foot from day 4-13 post vaccination. Hazy thinking trouble concentrating from day 9-10 post vaccination. Altered "poop cycle" from day 2-13 post vaccination. Headaches, not migraine intense only 4-5 on a 1-10 scale from day 2-day 15 (currently still have them but only a 2 on a scale to 10).
Swelling at injection site with redness. Welt with fluid/heat still present 72 hours post injection. the swelling is getting better slowly.
My Mom received the COVID shot on Friday January 29th.  On Friday Feb 5 one week later she suffered a major heart attack and had to be rushed to the hospital.  There has not been any heart conditions in her medical history her entire life.  The family is wondering is the COVID shot had any thing to cause this and if there have been any other reported cases.
Information has been received from a physician concerning about 5 female patients who on unspecified dates were vaccinated IM with 3 doses of GARDASIL (Lot # not reported). In approximately 2008 (report as "two years ago"), the patients came in the office with high risk HPV. High risk HPV was considered to be an other important medical event by the reporter. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Generalized weakness, tingling, numbness, starting 9/19 "I could not walk"
p/pt recvd vax devel generalized tonic clonic movements w/eyes rolling lasting 3-4 mins; pt beginning crying p/onset of episode;
Did not receive second dose of Moderna COVID-19 vaccine; Slight mini headache; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Did not receive second dose of Moderna COVID-19 vaccine) and HEADACHE (Slight mini headache) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced HEADACHE (Slight mini headache). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not receive second dose of Moderna COVID-19 vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Did not receive second dose of Moderna COVID-19 vaccine) and HEADACHE (Slight mini headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other relevant concomitant medications included, multivitamins were reported.   Treatment information was not provided.    Reporter did not allow further contact
On 3/21/13 at 8:05am, patient reported inflammation at the injection site.
01/18/22 presents to EC ED for "fall with left knee and right ankle pain". PMHx of "A. fib on Eliquis, hypertension, sick sinus syndrome status post pacemaker placement, chronic dizziness"
Very High fever 105 with temporal artery thermometer, put straight in tub to cool down, and administered tylonol, fever reduced to 102 rectally, with alternation between tylonol and motrin fever is staying between normal and 100
Information has been received from a pharmacist concerning an adult female who in May 2007, was vaccinated with a dose of Zostavax (Oka/Merck).  In May 2007, after vaccination the patient developed chicken pox.  It was reported that the patient was covered from head to toe.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been requested.
covid infection; covid infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Feb2021 14:00 (Lot number: EL3247) at the age of 26 years as dose 2, single and administered in arm right, administration date 27Jan2021 13:45 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LAMOTRIGINE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Dec2021 20:00, outcome "recovering" and all described as "covid infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Additional information: Reporter stated  patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No  No follow-up attempts are possible. No further information is expected.
Had vax in AM started itching on arms & legs in PM; some redness that looked like a sunburn-itching came & went x 5 days;
ED to Hosp-Admission Discharged   9/17/2021 - 9/22/2021 (5 days) Hospital  MD  Last attending ? Treatment team Non-intractable vomiting with nausea, unspecified vomiting type  Principal problem  Patient is a 76 y.o. male with significant PMHx of HTN,hyperlipidemia,morbid obesity, A fib presents to Hospital on 9/17/2021 with complaints of nausea and vomiting with weakness/dizziness.    1.  Nausea/vomiting.  Likely secondary to Covid infection.  CT of the abdomen and pelvis with no acute finding.  Patient states that he has not has bowel movement for 2 weeks.  We will place him on aggressive bowel regimen as well.  Supportive care with IV fluid, antiemetics.  Check UA to rule out urinary tract infection.   2.  Covid 19 breakthrough infection on a pt who was vaccinated by Pfizer( 4/2021, 5/2021)  Continue with supportive care.  Will check chest x-ray and inflammatory marker.  Patient was at 92% on room air when I saw the patient.  There was one episode where he desatted to 89% when trying to ambulate but has been above 90% throughout the hospital stay.  He denies any respiratory symptoms.  I will hold off on treatment with convalescent plasma remdesivir or dexamethasone at this time.  If started getting hypoxic or started having respiratory symptoms will reconsider
Vomiting, nausea, rash/redness and swelling over whole upper arm
T105 occ less than 24 hrs p/receipt of vax; cold sx-cough "noisy chest"; Seen in ER 27DEC92; admitted to hosp & dx by MD as resp virus;
Pt scheduled moderna vaccine appointment online and received both doses. Pt answered the screening questions inaccurately. Pt had previously received 2 pfizer doses in March and April.
Acute back pain leading to numbness in both legs causing paralysis in both legs, facial paralysis, blurred and double vision, trouble urinating and having bowel movements. Has been diagnosed with GBS/ Miller-fisher disease.