chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Experiencing stomach cramps; Constipation; Incontinence; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Experiencing stomach cramps), CONSTIPATION (Constipation), INCONTINENCE (Incontinence) and CHILLS (Chills) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Chronic kidney disease stage 3, Breast cancer NOS stage III and Thyroid cancer stage III. Concomitant products included LEVOTHYROXINE SODIUM (LEVOXYL), ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), CLONAZEPAM, LOSARTAN, DARIFENACIN HYDROBROMIDE (ENABLEX [DARIFENACIN HYDROBROMIDE]), FERROUS SULFATE and VITAMIN D3 for an unknown indication.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Experiencing stomach cramps), CONSTIPATION (Constipation), INCONTINENCE (Incontinence) and CHILLS (Chills). At the time of the report, ABDOMINAL PAIN UPPER (Experiencing stomach cramps), CONSTIPATION (Constipation), INCONTINENCE (Incontinence) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.   Per source, the patient said she saw a medication that starts with "N", but could not recall the full name. The patient wanted to know if she could take that medication due to her kidney disease. She said it sounds like "NSAID" but it is not an NSAID. No further information was provided.
Vaccinated - 15-20 minutes later participant fell to the floor. Witness witnessed a few seconds of seizure. Participant states he felt nervous and saw "black sparkles." Pulse 75, slightly sweaty, pale. Gave 500 ml Gatorade, cold pack to back of head. After 15 minutes pulse was 70 and strong. He was less sweaty.
Vaccination given 4/13. Patient came into pharmacy 4/15 with redness, swelling and heat of about an inch to two inches around inj site. Advised BENADRYL & NSAID. Came back 4/17 after going to Dr. - swelling had travelled to elbow but redness & heat were gone.
Pt has had a series of 3 vax /w Engerix B & still has not developed titers
red wheal 22x15mm immed p/MMR given; DPH elixir given;
injection site pain; hit her head; hurt her back; woke up with a dull headache; nausea; passed out; This case was reported by a consumer via call center representative and described the occurrence of passed out in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received in 2013).   On 19th February 2020 13:47, the patient received Shingrix. In February 2020, 12 hrs 13 min after receiving Shingrix, the patient experienced passed out (serious criteria GSK medically significant), head injury, back injury, headache and nausea. On 19th February 2020, the patient experienced injection site pain. On an unknown date, the outcome of the passed out, head injury, back injury and nausea were unknown and the outcome of the injection site pain and headache were recovering/resolving.   It was unknown if the reporter considered the passed out, injection site pain, head injury, back injury, headache and nausea to be related to Shingrix.  Additional information was provided as follows: The patient was weighs 100 lbs less than her husband. The patient received vaccine at 1:47 PM, she woke up at 2:00 AM, walked to the bathroom , passed out , hit her head and hurt her back. The patient was taken to the hospital, her vital signs were checked and she was released. The patient woke up with a dull headache in the morning on the day of reporting. The patient did not feel that she should get the same dose as someone much larger. The reporter consented to follow up. Emergency visit required. The outcome of the event injection site pain and headache were reported in source document as fatal, however it was reported as recovering and resolving in system.
After getting the shot the day of i felt ok but I had gone to bed the next day and woke up around 1:30am and i could not see at all. It felt like a liquid and something sharp was poured into my eyes I rubbed them but it didn't help i washed them out with water after running into everything getting to the sink. Spent a good half hour to hour freaking out rinsing and on text to talk with my mom asking what to do. After a while I was able to see a little bit of the kitchen light and I just decided to go to bed and hope its better in the morning. I woke up and my eyes hurt horribly but I am able to see a small amount with a ton of blurriness but I could see so I figure it will get better. I still am having a crazy hard time seeing everything is still really blurry. I have two toddler boys and an infant I am starting to stress out that its not coming back so I am making an appointment with my dr. My sister told me to report it to the cdc so I am.
rash on chest/It is just itching/she noticed it was a little worse. It is more red; rash on chest/It is just itching/she noticed it was a little worse. It is more red; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: not provided), via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunization, reported as "prevent COVID 19". Medical history included ongoing allergy to penicillin.  There were no concomitant medications and investigation assessment.  On 19Jan2021, the patient developed rash on chest. She wanted to know if she can put something topical in it or if she could take antihistamines to treat the rash. 20Jan2021 (today), it was not hurting but reported that it was just itching. Patient was wondering if she can put a topical on it. Patient has had no trouble breathing. She gets the same rash when she was in the sun too much. Patient signed up for V-safe. The patient does not have her doctor information. She just got a new doctor. Patient reported that it got better last night, but then this morning she noticed it was a little worse. It was more red. She drove with her husband when he got his, and they offered her a vaccine too. She got it to not get COVID 19. Outcome of the event was not recovered (reported as ongoing).  Information on the lot/ batch number has been requested.
No adverse effects; improperly stored vaccines since 3/29/2019; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, previous drug reactions, allergies or medical history.  On 29-MAR-2019, the patient was vaccinated with an improperly stored doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot numbers: R024024 and R024023, expiration date for both lot numbers on: 22-AUG-2020; and with (rHA) Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot # R030794 and R017801, expiration dates on: 22-APR-2020 and 19-DEC-2019 respectively, (dosage schedule, route, anatomical location and indication were not reported for the vaccines). The vaccines were reconstituted with properly stored diluent.   The administered doses of vaccines were exposed to a temperature of multiples excursions of 6 degrees Fahrenheit to 14 degrees Fahrenheit (minus 14 degrees Celsius to minus 10 degrees Celsius) for 100 minutes cumulative. There was no previous temperature excursion reported. The call was placed because of a Digital Data logger report. No adverse effects were reported  This is one of several reports received from the same reporter.
This spontaneous report was received from a male patient of unknown age referring to himself. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 02-MAY-2018, the patient was scheduled to receive the first dose of ZOSTAVAX subcutaneously, for prophylaxis (lot # and expiration date were not reported). It was stated that the patient had potentially received SHINGRIX (lot # and expiration date were not reported) instead of ZOSTAVAX. No adverse effect was reported.
Patient states that by the end of August (vaccine given 8/20/21) he felt like he had "low lung capacity" and felt short of breath. Increasing shortness of breath every since. Generally he is very active.  Patient came to Hospital ED 11/2/21 with SOB.
10/31/22 presents to ED for "syncope". PMHx of "CABG, CHF, AF, DM, HTN, and CVA"
pain, redness, and swelling at the site. Pain and swelling of lymph nodes of neck, chest, and armpit of the left side. I also had nausea, headaches, joint pain, chills,  hot and cold sweats, and a lack of appetite.
19JAN95 mom reports fever 102-103; 20JAN95 mom reports fever 103.5 & vomiting all noc; feeling better this AM but not well referred to PMC;
This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 22-OCT-2016, the patient was inoculated with ZOSTAVAX at a pharmacy for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX, the patient began to experience shooting pains around her temple, and a feeling of itchiness and discomfort throughout her body. In response to these complaints, on 27-OCT-2016, the patient presented to a physician and was diagnosed as suffering from shingles. Thereafter, on 18-NOV-2016, she returned to physician for a follow up appointment and was diagnosed as suffering from post-herpetic neuralgia. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was considered related. Additional information has been requested.
when the HCP took off the needle, she bleed; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE HAEMORRHAGE (when the HCP took off the needle, she bleed) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced INJECTION SITE HAEMORRHAGE (when the HCP took off the needle, she bleed). At the time of the report, INJECTION SITE HAEMORRHAGE (when the HCP took off the needle, she bleed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
1/27/2021 01:30 NURSE CALLED TO 3RD FLOOR UNIT BY CNA FOR EMERGENT SITUATION IN PROGRESS. FOUND RESIDENT BENT OVER FORWARD IN CHAIR AT BEDSIDE GASPING FOR AIR, RESIDENT STATES "HELP I CAN'T BREATHE, RESIDENT IS PALE IN COLOR AND STATES SHE IS WEAK IN STAMINA, VS 97.9 70 24 168/50 SPO2 87% ON RA, O2 APPLIED AT 2L NC, RESIDENT STATES SHE WANTS TO GO TO HOSPITAL, SHE STATES SHE IS AFRAID SHE IS GOING TO DIE. CALL PLACED TO EXCHANGE TO INFORM ON CALL MD, NP RETURNED CALL AND GAVE NEW ORDERS FOR STAT LABS, CXR, AND BREATHING TX, AND INCREASE O2 TO 6 LITERS, RESIDENT STATES NO I WANT TO GO TO THE HOSPITAL NOW, ON CALL N.P. INFORMED AND AGREES WITH RESIDENT TO SEND OUT. O2 SATS DECREASING WITH 6L TO HIGH 70'S LOW 80'S, AMBULANCE CALLED, POA NOTIFIED, ON CALL NURSE MANAGER NOTIFIED, REPORT CALLED TO HOSPITAL  1/27/2021 02:00  AMBULANCE ARRIVED AND RESIDENT PLACED ON NON REBREATHER MASK SHE IS SAYING I TOOK THE SECOND SHOT OF COVID-19 VACCINE AND SHE FEELS SHE IS HAVING A REACTION TO IT. TRANSPORTED TO AMBULANCE VIA GURNEY   1/27/2021 03:17  HOSPITAL CALLED FACILITY WITH UPDATE, RESIDENT IS POSITIVE FOR COVID-19, SHE IS BEING ADMITTED FOR RESPIRATORY DISTRESS AND WILL BE PLACED ON BIPAP OR INTUBATED IF NO IMPROVEMENT IN BREATHING. ON CALL MANAGER UPDATED, HOSPITAL CALLING POA TO UPDATE
Bleeding in his gut; A spontaneous report was received from a consumer, male patient of unknow age, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced bleeding in his gut (gastrointestinal haemorrhage).  The patient's medical history was not reported. No concomitant medications were reported.  On an unknown date, prior to the onset of event, the patient received their second planned dose of mRNA-1273 (batch number: unknown), for the prophylaxis of COVID-19 infection.  On an unknown date, the patient stated that he was bleeding in his gut, but he had the symptoms before receiving the vaccine. The patient got disconnected during call and was unavailable during call back. No treatment medication information was provided  Action taken with second dose of mRNA-1273 in response to the event was not applicable.   The outcome of the event, bleeding in his gut, was not reported.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Syncope after injection 1 week later had petechial rash on extremities and chest.
BREAKTHROUGH COVID: PT IS FULLY VACCINATED WITH 2 BOOSTERS. PT is a 90-year-old female who presented with acute metabolic encephalopathy superimposed on baseline dementia suspect 2/2 UTI.  Patient placed on IV antibiotics .DX Aspiration pneumonitis AKI,.  MRI was ordered to further evaluate altered mental status but patient was unable to tolerate. Patient tested positive for COVID during SNF check.  She has no symptoms of hypoxia thus did not warrant specific COVID treatment.
This spontaneous report was received on 08-MAY-2017 from a licensed practical nurse and refers to a 6 month old infant, gender unknown.  There was no information about the patient's concurrent conditions, concomitant therapy or medical history provided.  On 22-AUG-2016, the 6 month old infant received vaccination with an improperly stored dose of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported.  The administered dose of vaccine experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. The licensed practical nurse stated they did not know why the temperature excursions occurred but there were no further excursions. Reference MARRS number 1705USA004893 for report on RECOMIVAX HB. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1608USA012794: US-009507513-1705USA004973: US-009507513-1705USA004965: US-009507513-1705USA004967: US-009507513-1705USA004952: US-009507513-1705USA004960: US-009507513-1705USA004942: US-009507513-1705USA004944: US-009507513-1705USA004945: US-009507513-1705USA004947: US-009507513-1705USA004948: US-009507513-1705USA004949: US-009507513-1705USA004950: US-009507513-1705USA004951: US-009507513-1705USA004953: US-009507513-1705USA004954: US-009507513-1705USA004955: US-009507513-1705USA004946: US-009507513-1705USA004956: US-009507513-1705USA004957: US-009507513-1705USA004958: US-009507513-1705USA004959: US-009507513-1705USA004962: US-009507513-1705USA004963: US-009507513-1705USA004964: US-009507513-1705USA004966: US-009507513-1705USA004968: US-009507513-1705USA004969: US-009507513-1705USA004970: US-009507513-1705USA004971: US-009507513-1705USA004972: US-009507513-1705USA004974: US-009507513-1705USA004975: US-009507513-1705USA004976: US-009507513-1705USA004977: US-009507513-1705USA004978: US-009507513-1705USA004979: US-009507513-1705USA004980: US-009507513-1705USA004981: US-009507513-1705USA004982: US-009507513-1705USA004983: US-009507513-1705USA004984: US-009507513-1705USA004985: US-009507513-1705USA005004: US-009507513-1705USA005005: US-009507513-1705USA005006: US-009507513-1705USA005007: US-009507513-1608USA012916: US-009507513-1608USA012908: US-009507513-1705USA004887: US-009507513-1705USA004888: US-009507513-1705USA004889: US-009507513-1705USA004890: US-009507513-1705USA004891: US-009507513-1705USA004892: US-009507513-1705USA004893: 1705USA004893 (This is same patient, RECOMBIVAX HB case.) US-009507513-1705USA004894: US-009507513-1705USA004895: US-009507513-1705USA004896: US-009507513-1705USA004897: US-009507513-1705USA004898: US-009507513-1705USA004899: US-009507513-1705USA004943:
Pt runs everyday, since vaccine, stride is off, knees don't come up, looks like speed walking rather than running. Balance is off, strength in legs has decreased joint pain. Condition has improved but very slowly still far from recovery. Has been seen by doctors at college 3 times and by the family doctor, test results for blood test are pending as well as an MRI.
pt devel Henoch-Schonlein purpura;Annual follow-up dated 11/20/00 provided no additional data.
hand shingles again after second shot in my eye and ear area\ Suspected Vaccination failure; shingles again  in my eye; shingles again  in ear area / still got shingles twice!; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster and shingles were unknown.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient had Shingles shot several years before the date of reporting when insurance did not pay for it. The patient had shingles again about 2 to 3 years ago after second Shingles shot in eye and ear area. The patient stated he/she still got shingles twice. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
The day after receiving the TDAP, pt. felt tired and c/o body aches, joint pain, (R) arm & arm pit pain & swelling, (R) lymph nodes swelling, tiredness, throat and neck swelling with hives. Today 11/3, 7 days later all but lymph nodes increased have resolved. He spent the weekend in bed.
Fever, nonspecific skin disorder, rash, infection, swelling. 11/13 pt recv vaxs. 12/4 pt had fever. 12/6 pt exp blister-like red rash-hands, arms, feet, & face. Dr saw her 12/7 & 12/14. 12/14 ulcerated lessions on face, arms, feet. (cont). 60 day follow-up received on 10/25/00 states that the pt has not yet recovered.
I had no acute immediate reaction that was not typical, but after 2/3 days I felt hot and cold for about 4-5 days but no actual fever or tachycardia.  Then noticed that I had a significant delay in my menstrual cycle that was very abnormal for me. I was suppose to start my regular cycle 6 days after vaccination.  I am very regular and my menses were delayed by two weeks. In addition,  when it came back there was a change in my flow (very short duration). I am concerned about possible implications of the vaccine regarding my menses.
This is a 19y/o who was in his usual health until 11/15/03. He received his primary Smallpox vaccination on 11/04/03. He received appropriate briefings and screening prior to the administration of his vaccination. On 11/15/03 at ~ 0900 was awakened by chest pain (3-4/10). Pain progressed to 6/10 over the next hour and he went to the Emergency Room (ER).  At ER, he was given EC ASA, had cardiac monitoring and had blood drawn at this time. His pain progressed to 9/10 and he became extremely short of breath. Approximately one hour after taking the ASA his pain began to resolved and subsided. He subsequently was released to follow-up with cardiologist on 11/17/03.
Deep muscular pain throughout the whole body, starting gradually at first and worsening steadily to severe pain, resulting in patient contact at their local hospital. Pain began about 9 hours after the vaccination was given, "eased" the following morning, and was completely resolved by 12:00pm of the following day.
Booster dose #2 given in error. Booster #1 was given  on Jan 14  2022. Patient does not qualify for a second booster and the interval between the 2 boosters was 3 months and 1 week.
pt recv vax 29APR94 & 7MAY94 devel a maculopapular rash on torso w/severe pruritus; tx Pred, & Medrol;
This spontaneous report was received from a medical assistant referring to multiple patients of unknown demographics. The pertinent medical history, concurrent conditions and concomitant therapies of the patients were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot# M034187, expiration date: 17-MAY-2019) (dose, route of administration and anatomical location were not provided), for prophylaxis. The vaccines underwent the temperature excursion of more than 32 Fahrenheit degrees (F) but less than 35 F for 3 hours and 20 minutes, which was detected by a data logger. No previous temperature excursions were reported. No adverse effects were reported. No Product Quality Complaint (PQC) was filed. Follow up information has been received from the medical assistant on 10-MAY-2017, reported that the temperature excursion occurred in the middle of the night when no one was present and the cause was unknown. Follow up information has been received from the medical assistant on 07-JUN-2017. The patients' identifiers, age and gender were provided. The patient was a 6 months old female patient and was vaccinated with LIQUID PEDVAXHIB)in a clinic by a clinic nurse. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA006513: US-009507513-1704USA010745: US-009507513-1705USA013407: US-009507513-1705USA013406: US-009507513-1705USA013408: US-009507513-1706USA009002: US-009507513-1706USA009007: US-009507513-1706USA009001: US-009507513-1706USA009003: US-009507513-1706USA009006: US-009507513-1706USA009005: US-009507513-1706USA003615:
Cellulitis at site of immunization on left arm. No fever. Pt acting well otherwise.