chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Potential AE due to delay in receiving 2nd dose of Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Potential AE due to delay in receiving 2nd dose of Moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Potential AE due to delay in receiving 2nd dose of Moderna vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Potential AE due to delay in receiving 2nd dose of Moderna vaccine) outcome was unknown.        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.   Concomitant product use was not provided by the reporter. No treatment drugs were reported.   This case was linked to MOD-2021-080280 (Patient Link).
On November 7th, 2022 I was hospitalized for two days recovering from Cardiac procedures. While home convalescing I developed respiratory symptoms in the evening hours on November 20th, 2022. On November 22nd, I was swabbed and received positive COVID-19 and negative for Flu and RSV. I had hoarseness of voice, runny nose, congestion, which increased greatly and continues to plague me. The runny nose resolved a day or so ago. I still have a cough and nasal congestion, which varies in severity and sometimes effects my breathing due to the congestion. I continued to have abdominal discomfort, loss of appetite, weight loss, and fatigue.
pt recd vax & exp morbilliform rash, cough, conjunctivitis, vomiting, left serous otitis media, fever, & gastrointestinal cramps w/sensitivity to light, lethargy & was hospitalized w/dehydration.
The patient stated that she felt light-headed then fell to a seated position when she tried to walk away. She was hot, sweaty, pale, and visibly shaking. She vomited once.
This spontaneous report was received from a Licensed Practical Nurse referring to two patients of unknown age and genders. Patients' medical history and concurrent conditions were not reported. On 01-JAN-2015, the patients were vaccinated with an improperly stored doses of (Merck) PROQUAD (lot #s L019994, expiry date 02-DEC-2016 and L024124, expiry date 30-DEC-2016). No adverse effects were reported for any of these two additional unspecified patients. This is one of three reports from the same reporter source (MARRS linked cases 1510USA002650 and 1510USA002651). Additional information has been requested. Lot # L024124 is a valid lot # for (Merck) PROQUAD.
patient was given just the adjuvant portion of Shingrix; patient was given just the adjuvant portion of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12-MAY-2023, the patient received Shingrix. On 12-MAY-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: patient was given just the adjuvant portion of Shingrix) and inappropriate dose of vaccine administered (Verbatim: patient was given just the adjuvant portion of Shingrix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 12-MAY-2023 The reporter reported that the patient was given just the adjuvant portion of Shingrix and not reconstituted first with the antigen.  The pharmacist had no further information concerning the patient or vaccine itself. The reporter was consented to follow up. The patient received just the adjuvant portion of Shingrix and not reconstituted first with the antigen, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered.
Blurred vision, severe eye pain and increasing numbness would present themselves days to weeks after each injection. These symptoms including lung pain, shortness of breath and general pain less than a 5 days after the 3rd shot.
Pt experienced redness, swelling of arm, arm was warm to the touch, and stated that it was extremely sore (couldn't even lay on it).
Had my last period 06/17/2021 for two days and haven't had my period since. I have never missed a period and I've been on the pill for years. I took a blood pregnancy test and it was negative. I have all the symptoms of my period when I'm supposed to be getting it but it never comes.
Information has been received from a dermatologist concerning a female who on 15-NOV-2006 was vaccinated with a dose of Zostavax. Five days later on 20-NOV-2006, the patient developed severe acute nerve pain. The pain was so severe she thought she had a bad toothache and went to her dentist. The dentist identified her as having herpes zoster with trigeminal nerve involvement and referred her to an ophthalmologist and a dermatologist, the reporting physician. The patient had shingles like blisters in the trigeminal area; scalp, forehead, brow and tip of nose. She was prescribed valacyclovir hydrochloride (VALTREX) 1 gram PO TID for 7 days. The physician believes the patient received "Ostrava" not long prior to the breakout. he thought 1 to 2 weeks. The physician reported that the patient has been deeply distraught, confused and angered by her experience. There was no product quality complaint involved. Additional information has been requested.
This spontaneous report as received from a licensed nurse practitioner via a field representative refers to a 17 year old male patient. He had no pertinent medical history. On 10-APR-2014, the patient was vaccinated with the first dose of GARDASIL lot # J012212. No co-suspected or concomitant medications were reported. Two to three seconds after the vaccination, the patient fainted. He woke up 20 seconds later, and it took him another 2-3 minutes to become fully functional again. He received no treatment for the event. He afterwards admitted that he had not been eating or drinking anything for a long time before receiving the vaccination. Routine blood work was performed (results were not reported). This was his first dose of GARDASIL, and he will not be received the next two. A causality assessment was not provided. Additional information has been requested.
Swelling of face, eyes, lips, tongue, neck, cheeks, breathing disrupted, open sores on inside of mouth, itchy mouth and lips. These all occurred the night of booster vaccine and continued to get worse. I took Benadryl for allergic reaction and finally on day 3 went to urgent care. They gave me prescription for methylprednisolone tablets. After one day of taking meds, I'm still itchy, swollen in the face, mouth and eyes. Symptoms have gotten a bit better but still struggling. Cannot work.
Patient presented to office 3/28/06 with approximately 500 lesions on trunk, arms and head. Mother presented record of Varicella given 3/14/96, but does not remember where it was administered. Mother states he has had fever for 2 days, but presented afebrile in office.
Very sore right arm after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Very sore right arm after 1st dose) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD (Pulmonary issue), Asthma (Pulmonary issue), Dust allergy, Allergy to molds, Grass allergy, Allergy to chemicals (sulfites), Drug allergy (Tylenol), Drug allergy (Sulfar), Drug allergy (Codeine), Allergy to antibiotic (Erythromycin), Allergy to antibiotic (Vancomycin), Allergy to antibiotic (Doxycycline), Drug allergy (very sensitive to Epinephrine), Allergy (Allergic to trees) and Thyroid disorder NOS. Concomitant products included FLUTICASONE PROPIONATE (FLOVENT) for Lung disorder NOS, LEVOTHYROXINE for Thyroid disorder, CLOPIDOGREL BISULFATE (PLAVIX), ESCITALOPRAM OXALATE (LEXAPRO), MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]), FLUTICASONE PROPIONATE and ALBUTEROL [SALBUTAMOL] for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (Very sore right arm after 1st dose). On 20-Feb-2021, PAIN IN EXTREMITY (Very sore right arm after 1st dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient drug allergy include Catfcan.  It was reported that the patient never had COVID positive test or diagnosis. The patient did not receive other vaccines within 1 month prior to Moderna. No treatment medications were taken by patient.   This case was linked to MOD-2022-474566, MOD-2022-474731 (Patient Link).
Pt. Came to clinic on 10/12 for booster Pfizer vaccine. Pt. Has hx of anaphyalxis to allergy shots and was in 30 minute observation waiting area. About 10 minutes after receiving COVID vaccine, Pt. Approached writer and stated that she had numbness and tingling in her lips and her throat felt scratchy. Denied any SOB/chest pain. Vital Signs assessed @ 1347 w/ a HR of 72bpm, RR of 16bpm, pulse ox 98% on RA, and BP 150/90mmhg.  50mg of benadryl IM in R deltoid @ 1347.  W/n 5 minutes of benadryl dose, pt.'s symptoms resolved.  Repeat VS assessed at 1410 were HR 67bpm, RR 16bpm, BP 142/78mmHg, Pulse ox 99% RA.  Pt. States symptoms are improving and throat is no longer scratchy. Continues to deny SOB. Pt. Monitored for 30 minutes after dose of benadryl.  RN recommended pt all call for a ride home, pt declined.
Started having these symptoms which the doctor treated it as gout flareups and kidney failure. How ever it has been going for 4 months now that I know this is an adverse symptoms from the vaccine. After the first dose:  inflammation of both feet, knee, elbow. hands and fingers.  Fever, chills comes and goes After the 2nd dose:  continued inflammation of both feet, knee, elbow comes and goes and fingers.  Hives all over body Headache Feeling extra tired Feeling of body filled with fluid Blood shot eyes - fluid draining from both eyes Neck Pain  Shoulder pain  Pain all over body from head to toe (joints & muscle) Unable to stand at times
felt tired; migraine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 22Apr2021 (Lot number: EW0164) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MIGRAINE (non-serious) with onset 22Apr2021, outcome "not recovered", described as "migraine"; FATIGUE (non-serious) with onset 23Apr2021, outcome "unknown", described as "felt tired".  No follow-up attempts are possible. No further information is expected.
pt admitted to hosp with dehydration, AKI, tested positive for COVID; intubated; suffered an acute CVA in hospital; remained hypotensive despite vasopressors; made a DNR; sepsis with acute organ dysfunction due to COVID - Septic Shock; pt's condition worsened and she expired in the hospital
26 doses administered to adult patients from pediatric vials instead of bivalent vaccine; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials instead of bivalent vaccine).    No concomitant medication was provided.  It was reported that on 8 Oct 2022, 9 Oct 2022 and 10 Oct 2022, they administered 26 doses to adult patients from pediatric vials of Moderna COVID-19 Vaccine instead of bivalent booster. Treatment medication was not provided by the reporter. This case contains information about patient-4 out of 26 patients.
Patient reported redness, swelling, hot to touch and itchiness in arm at injection site along with a bruise about the size of the diameter of a soda can. Swelling subsided but the itchiness worsened so patient went to urgent care where she was seen and given two prescriptions:  cephalexin and prednisone. Symptoms have subsided as of today.
ALL OVER HIVES, ALL OVER FLUSHING. PATIENT TOOK ALLEGRA AT 11:20am.
Presented to ER 9/2021 with complaint of scrotal numbness and bilateral lower extremity numbness.  MRI of the lumbar spine was negative at that time and he was diagnosed with possible GBS.  He was referred to neurology clinic and seen 10/2021 at which time he had persistent numbness in bilateral lower extremities and hyperreflexia.  MRI of the cervical and thoracic spine revealed lesion extending from T5-T6 consistent with likely transverse myelitis.
This spontaneous report as received from a healthcare worker refers to a 4 month old male patient with no pertinent medical history and no drug reactions or allergies reported. On 19-SEP-2014 the patient was vaccinated with a dose of GARDASIL (route, dose, lot # and frequency not reported). No concomitant therapy was reported. On an unknown date in September 2014 the patient experienced redness at the injection site. No adverse symptoms were reported. There was no lab diagnostic studies performed. The outcome of redness at the injection site was reported as recovered/resolved (on an unknown date in September 2014). The patient sought medical attention. The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
Day 1- Pain at injection site. Day 2- Full body joint pain. Day 3- Chills and joint pain. Day 4- Chills and joint pain. Day 5- High BP and headache. Day 6- High BP, headache, stomach pain. Day 7- Stomach pain, head and body ache.
After I got the vaccine I started having serious chest pain. There is no history of heart problems in my family. I went to my primary care doctor and he had no idea what was going on.  I was originally put on anxiety medication until they had realized that this pain is more then anxiety.
Increased pruritis, increased 2-3cm papules (hives) over entire body sparing face - use of aveeno baths.
Patient developed cellulitis in lower deltoid area, closer to bicep. She was seen at an urgent care center and was prescribed cephalexin 500mg four times daily for 7 days, which was dispensed on 7/22/2019
Information has been received from a consumer concerning her 14 year old son who on approximately 01-NOV-2007 was inadvertently vaccinated with a dose of ZOSTAVAX instead of VARIVAX, (duration, dose and indication not reported).  There was no Ae.  It was reported that the patient did not seek medical attention.  There was no product quality complaint.  No further information is available.
the rash as small red dots on the stomach and hip, and it was itchy; the rash as small red dots on the stomach and hip, and it was itchy; experienced a rash on stomach and hip/rash on right part of the abdomen and right hip; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (the rash as small red dots on the stomach and hip, and it was itchy), RASH MACULAR (the rash as small red dots on the stomach and hip, and it was itchy) and RASH (experienced a rash on stomach and hip/rash on right part of the abdomen and right hip) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 074M20A and 030A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, the patient experienced RASH PRURITIC (the rash as small red dots on the stomach and hip, and it was itchy), RASH MACULAR (the rash as small red dots on the stomach and hip, and it was itchy) and RASH (experienced a rash on stomach and hip/rash on right part of the abdomen and right hip). The patient was treated with PREDNISONE for Rash, at an unspecified dose and frequency and CORTISONE for Rash, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (the rash as small red dots on the stomach and hip, and it was itchy), RASH MACULAR (the rash as small red dots on the stomach and hip, and it was itchy) and RASH (experienced a rash on stomach and hip/rash on right part of the abdomen and right hip) had resolved.            Concomitant medication included Blood pressure pills.  The patient reported having a rash on the right side of abdomen and right hip the day after receiving the booster dose. Patient described the rash as small red dots on the stomach and hip, and it was itchy.This reaction was resolved with the treatment given by the doctor. Patient went to the urgent care room and the doctor gave a cortisone shot.   This case was linked to MOD-2021-417555, MOD-2021-417565 (Patient Link).
On 3/16/21, I noticed a rash which closely mirrors what is being described as "COVID arm" at the site of the injection.  This appeared after 72 hours of severe stomach pain and loose stool, combined with fatigue, dizziness, chills/hot spells and lack of appetite.  There has been no fever with any of these symptoms.  The other members of my family who live in my household (Spouse - who also has had one dose of the Moderna vaccine, and our children age 12 and 15) all experienced the same set of symptoms, except the rash at site of vaccine injection.  I thought we had all caught a stomach bug from each other, but now I wonder if my symptoms were related to the rash that I first noticed this morning.
No adverse event; adults received 0.5 ml of Moderna vial intended for ages 6-11; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (adults received 0.5 ml of Moderna vial intended for ages 6-11) and NO ADVERSE EVENT (No adverse event) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (adults received 0.5 ml of Moderna vial intended for ages 6-11). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). On 27-Sep-2022, WRONG PRODUCT ADMINISTERED (adults received 0.5 ml of Moderna vial intended for ages 6-11) outcome was unknown. At the time of the report, NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (adults received 0.5 ml of Moderna vial intended for ages 6-11).    No concomitant medications were reported.  The pharmacist states they accidentally gave a group of people the wrong dosage of the Moderna booster. They wanted the bivalent booster, but they gave the one intended for ages 6-11 years.  No treatment medications were reported.
DEVELOPED PAIN/ITCHY RASH ALL OVER MY STOMACH. RED, BLOTCHY AREAS WITH SCABS FROM BUMPS.
Case number PHEH2014US001289 is an initial spontaneous repot received from a pharamcist on 14 jan 2014 with the follow-up received on 10 Feb 2014. This report refers to a 14-year-old female adolescent who was inadvertently vaccainted with 0.5 ml dose og FLUCELVAX (batch number: 006031A) intramuscular on 07 Jan 2014 at 02:51 pm. No adverse event was reproted following this administration error. Follow-up received from a pharamcist on 10 Feb 2014: Dose and time of vaccination updated. Following an intermal review on 18 Aug 2014, a significant correction was done for the information received on 10 Feb 2014: BPI labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
It started on Monday and we had fevers, chills, aches, diarrhea, exhaustion, it felt like I was dead, my inhalers did not work. I did not have the lack of smell or taste. I thought I had a cold until my children said we should get tested. We went to urgent care and got tested for Covid. They did not give us any medications because they thought it was just a cold. By that night they called us and said the results were positive. They asked a bunch of questions to see if we qualified for monoclonal infusions and we did. I got in in Friday and within 22 minutes I could breath. It was phenomenal. It was like it stopped Covid. We tested ourselves on October 1st and it came back negative.
pt was hospitalized with cellulitis and on iv No new terms added from Discharge Summary rec'd 12/28/2005/sr