chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a physician on 09 November 2016. This case involves a female patient (age not reported) who was vaccinated with a dose of Fluzone High dose (Batch number: UI697AB, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed abdominal pain, diarrhea and mild thickening of colon (suspected colitis) (showed by CT scan). Patient's lab test were normal, stool tests were negative and urine culture was normal. Patient received intravenous (IV) fluids as corrective treatment. On an unspecified date, in two days the patient recovered from all the events. Upon internal review, the company decided to consider the case serious because of important medical events mild thickening of colon (suspected colitis). List of documents held by sender: none. Sender's Comments: This case concerns a female patient who developed abdominal pain and diarrhea after receiving INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was reported that the imaging study (CT scan) showed mild thickening of colon with impression as suspected colitis. Details regarding latency from vaccination, medical history of the patient, vaccination history, concomitant medications, immune status of the patient and reporter causality were not reported. However details regarding latency, medical history of the patient, concurrent conditions, vaccination history, concomitant medications, immune status of the patient and other etiologies would be helpful to further assess this case.
A sales representative reported that a 9 month old developed "strep. pneumonia meningitis" approx. 3 months after the 2nd dose of Prevnar. The child had a recent medical history of otitis media. The sales representative stated that he was "pretty" certain that the child was hospitalized. The reporter indicated that a physician specializing in Pediatric Infectious Diseases performed lab, blood, titer and serotyping and the child reportedly was positive for 1 of the 7 serotypes contained in Prevnar. He stated that the healthcare provider indicated that the child was very ill with a poor prognosis. F/U info rec'd 6/11/01 indicated that blood cultures and lumbar puncture were performed both were positive for Strep pneumo. The reporter idicated that the pt had not recovered and was now disabled. Upon review on 9/22/01, this event is reclssified as expected.
Ten days after the vaccination, patient began feeling itchy around scalp at 10:30 PM. Awoke at 2:30 AM with hives on torso and right leg. Hives were raised, red, and extremely itchy. Treated with calamine lotion and later Zyrtec, which calmed symptoms. Hives persisted throughout day. Patient awoke at 2 AM the next morning with the feeling of a lump in the throat, similar to indigestion or a pill caught in the back of the throat. Patient did not have trouble breathing, fever, or other symptoms of anaphylaxis. Went to the ER where vital signs were normal. Pill caught in throat feeling persisted for approximately 24 hours before subsiding, possibly with the help of Pepcid A/C. Hives persisted over the next week and were joined by periods of angioedema in the feet and hands. Angioedema episodes coincided with periods of physical activity, hot showers, and alcohol consumption. Hives and angioedema have slowly started to subside beginning on January 2. Both respond well to Zyrtec and Pepcid. Hives remain. Interesting other factor is that the patient's mother displayed similar symptoms approximately 10 days after receiving the Moderna vaccine. Her symptoms are also ongoing.
Pt is having problem with pain in shoulder, and some range of motion problems due to the pain that immunization was given in. Pts Drs office has diagnosed pt with contusion.
Patient had shortness of breath, hoarse/sore throat drove to hospital - "pumped full of DEMEROL" stayed for 2 nights at hospital w/ IV fluids.
This spontaneous report was received from a registered nurse referring to a 1 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 06-OCT-2017, the patient was inadvertently vaccinated with a dose of PNEUMOVAX 23 lot number M042324 and expiration date of 10-JUN-2018, 0.5 ml, intramuscularly for prophylaxis. No adverse effects were reported.
no adverse event; expired vaccine used/ patient recieved expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used/ patient recieved expired vaccine) and NO ADVERSE EVENT (no adverse event) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used/ patient recieved expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine used/ patient recieved expired vaccine) and 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 EXPIRED PRODUCT ADMINISTERED (expired vaccine used/ patient recieved expired vaccine).    No concomitant medications were reported.  Reporter started that patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine reported as Unknown and did not had information about previous COVID-19 vaccination doses.  The vial was exposed to room temperature for about 15-20 minutes.  Reporter stated that there were two patients 35-40 years old. One was male and one was female, and They dispensed 2 expired vaccines. It was first thawed yesterday 6-Dec-2022.  No treatment medications were reported.
Kinrix was given to a patient less than 4 years of age; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a child patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, unknown after receiving Kinrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: The reporter reported that Kinrix was given to a patient less than 4 years of age which led to inappropriate age at vaccine administration. The follow up consent was not granted. This was a medication error without harm.
Hve not had their 2nd dose after getting their 1st dose on 27Apr2021; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Hve not had their 2nd dose after getting their 1st dose on 27Apr2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-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 (Hve not had their 2nd dose after getting their 1st dose on 27Apr2021). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Hve not had their 2nd dose after getting their 1st dose on 27Apr2021) had resolved.            Concomitant medications were not reported. Treatment medications were not reported.
This spontaneous report was received from a nurse and refers to a 5-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 08-AUG-2018, the patient was vaccinated with improperly stored VARIVAX lot # N035941 with expiration date on 18-DEC-2018 and M-M-R II lot # R002930 with expiration date on 31-JAN-2019 (reported as 30-JAN-2019) (doses, route and site of administration were not reported) for prophylaxis. It was unknown if the sterile diluent used for reconstitution was properly stored. Administered dose of VARIVAX experienced the temperature excursion of 15 to 46 degrees Fahrenheit for 72 hours. Administered dose of M-M-R II experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 72 hours. Digital data logger was involved. There were no previous temperature excursions reported. No adverse effect was reported. Additional information is not expected.; Sender's Comments: US-009507513-1809USA008879:
patient received Moderna on 06/17/2021.  No adverse effects from receiving this dose
UNCONTROLLABLE  FULL BODY CHILLS, LASTING OVER AN HOUR, REQUIRING BED REST WITH MULTIPLE     BEDCOVERS TO SLOWLY REDUCE THE CHILLS.  FULL RECOVERY WITHIN 12 HOURS.
From initial correspondence received at AP Inc on 11/21/2002, from manufacturer (reference number A0378256A), it was reported that a 3 year old male child received 0.5ml dosage of Tripedia, Lot # U0581AA, in the right leg on 08/14/02.  Nurse thinks the dose number in series is #5.  Pt experienced large areas of erythema and a warm, swollen patch around the injection site (2x3 inches).  Onset date is unknown. The site of the erythema was not reported. The pt recovered.
Patient brought into the ED for unresponsiveness and found to be in severe metabolic acidosis and DKA.  Patient was recently treated for Covid 19 at a Hospital.  Patients condition decline and she could not protect her airway and was intubated the patient repeat CAT scan show diffuse white matter change discussed with the ramify the possibility that she might have severe stroke or severe encephalitis.  Recommend hospice and family agree to proceed.  Patient expired on 02/03/2022.
Rash, erythema, pruruitis, Erythema at injection site,Urticaria, Non-prescription medication and Prescription medication used
Right hip pain: on and off pain. Almost constant but no pain right at this moment. Hurts when getting in the car and stepping up (bed in and out). Vaccine given to right deltoid. Pain started 10 days after the shot.
dizziness; Nausea; fatigue; hives; headache; This is a spontaneous report from a contactable Other HCP (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EJ1685) intramuscular in left arm on 30Dec2020 08:00 at single dose for COVID-19 immunization. Medical history included Crohn's Disease, rheumatoid arthritis. The patient was known allergic to IV contrast dye, sulfa, darvacet, demoral (coded as demerol). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included citalopram and clarithromycin (CLARITIN). The patient experienced Nausea, hives, dizziness, headache, and fatigue on 01Jan2021 12:00 PM. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. Received Hydroxizine as treatment for the adverse event. Events outcome was recovering.
1 pm shot. 2;30 am woke up with chills, rigors, muscle aches, fever of 103.5,  headache, sweats. Started to feel better around 6 pm. Next day bicep of left arm bright red, hot to touch, tight, painful to touch, felt slight better next day...
Left Deltoid red, warm, itchy. Came to clinic for PPD reading & revealed vaccine site.  Skin intact, red & warm. Has full movement of left arm.
Information has been received from a health professional concerning a female who was vaccinated with a first and second dose of MMR II. The nurse reported that the pt had received at least 2 doses of MMR II since 1979 and the pt had not seroconverted for measles. Unspecified medical attention had been sought. Additional info has been requested.
Even when I try to move and rotate my arm the pain still stays there.; I was sore 30 minutes after getting the vaccine injection/woke up the next today and I have extreme soreness and pain in my arm where I got the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Even when I try to move and rotate my arm the pain still stays there.) and VACCINATION SITE PAIN (I was sore 30 minutes after getting the vaccine injection/woke up the next today and I have extreme soreness and pain in my arm where I got the vaccine) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concurrent medical conditions included No adverse event.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE PAIN (I was sore 30 minutes after getting the vaccine injection/woke up the next today and I have extreme soreness and pain in my arm where I got the vaccine). On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Even when I try to move and rotate my arm the pain still stays there.). At the time of the report, PAIN IN EXTREMITY (Even when I try to move and rotate my arm the pain still stays there.) and VACCINATION SITE PAIN (I was sore 30 minutes after getting the vaccine injection/woke up the next today and I have extreme soreness and pain in my arm where I got the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Non drug treatment provided include cold pack on the arm. The patient reported that after receiving the vaccine for 30 minutes her arm was sore but the soreness went away. The patient  woke up the next  morning, 12 Mar 2021 and  the extreme soreness started again.
Heart pounding, accelerated heart rate, anxious, stressed  Lasted for 15 minutes. Relax es, laid down and breathed slowly and then heart rate stabilized.  After a couple of hours, body aches, fever for the next 24 hrs.
12-20-12 Client took 2nd oral Typhoid pill - felt nausea, crampy, had gas, felt "hot & flushed", and had a headache. 12-22-12 Client took 3rd oral typhoid pill - felt "flu like symptoms" - worsening of above s/s - went to bed & rested x 2 days. Did not take last #4 pill. Called today to say still doesn't "feel well". Advised to seek medical care.
PFIZER COVID VACCINE #3 GIVEN 11/17/21, LOT #FF8839; pt admitted to hospital from ED for recurrent falls; laceration to scalf required stapling; CT of brain was negative for acute intracranial abnormalities; CXR also showed no acute abnormalities; husband not comfortable having her at home due to falling; while getting ready for dc from hospital, pt tested positive for COVID; initially there were no O2 requirements; developed aspiration pneumonia; condition worsened; respiratory failure and shock; pt passed away in the hospital
Muscle pain Chills Headache Dizziness Heart palpitations Unsure of blood pressure or fever Hot and cold Injection site pain
Headache, neck, muscle pains for past 3 days. Nauseated for past 3 days, but no vomiting. Diarrhea. Shivers during night after receiving vaccines (09/25/18) with flu-like sxs, but no fever. Looks like mosquito bite: firm, red, tender, and hot to touch lump of 3in on LA where PNEUMOVAX was administered.
The jabbed me in my left shoulder. The site became sore shortly afterward. The soreness/tenderness lessened over time but never went away. Two full months later I still feel tender in my left shoulder joint, especially upon awakening from sleep and when moving/rotating the shoulder joint.
This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source.   Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful.   Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 7-months old patient of unspecified gender, with no known drug allergies and no illness at the time of vaccination. The patient was vaccinated with the second dose of ROTATEQ (oral, batch/lot #J004875, expiration date 17-OCT-2014), on 21-JAN-2014 at 10:30 AM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). The parents of the patient were going to consult with physician to repeat the dose at no charge. No adverse event was reported for the patient. The reporter reported the outcome as unknown. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Seen on 8/21/08 - dx with Bell's palsy - sx include L ear pain, sore throat, "can't move L side of face".  Placed on prednisone 20mg bid x5d.
Single occurrence of violent, explosive diarrhea without warning (no stomach upset, cramps, etc.)
Dose 1 and dose 2 were administered 7 days apart; A spontaneous report was received from a health care professional concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and resulting in the event of inappropriate schedule of product administration.  The patient's medical history was not provided. Concomitant medications were not reported.  On an unspecified date, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unspecified date the patient received the vaccine and stated that he did not receive any vaccinations in the last four weeks, but the nurse coordinator reported that the patient was in another rehab facility and did receive the COVID vaccine and dose 1 and 2 were administered 7 days apart instead of 28 days interval.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event inappropriate schedule of product administration were considered resolved.  The reporter did not provide a causality assessment of the event.; Reporter's Comments: This report refers to a case of inappropriate schedule of product administration for mRNA-1273.  There were no reported adverse events associated with this case.
I contracted COVID-19. I had a sore throat, fatigue, and a runny/stuffy nose. I received Paxlovid medication to treat my symptoms.
When she lifts her arm it hurts to move; Left arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (When she lifts her arm it hurts to move) and MYALGIA (Left arm was sore) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced PAIN IN EXTREMITY (When she lifts her arm it hurts to move) and MYALGIA (Left arm was sore). At the time of the report, PAIN IN EXTREMITY (When she lifts her arm it hurts to move) and MYALGIA (Left arm was sore) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medication was reported.  Treatment medication was not provided by the reporter.
Client presented to Covid vaccination site on 10/05/2022 to receive Pfizer COVID pediatric booster vaccine Lot# FT1551 on left arm. At approximately 1108 while sitting in the observation area on mother?s lap, mother  notified lead nurse that client felt ?dizzy.? Client?s face appeared to be pale. Client was able to move to the gravity chair without assistance. Nurse in observation area proceeded to take client?s vital signs; BP: 100/80mmHg, HR: 62, RR:25, O2: 99%. Client denies shortness of breath or itchiness on any part of her body. Per client?s mother, client has history of dizziness due to being anxious after blood draws and vaccines. Client?s mother also stated client had cereal and milk for lunch. Per client?s mother, no adverse reactions to previous Covid vaccines and flu, no known allergies, and no medical conditions. A juice was provided to client.  Client?s mother was offered to have EMS activated. Client?s mother denied activating EMS.  At approximately 1113 client denied dizziness. At approximately 1118 vital signs were retaken by nurse ; BP: 106/76mmHg, HR: 69, RR:22, O2: 99%. Client reported she was feeling ?fine.? At approximately 1125 vital signs were retaken by nurse; BP:108/75mmHg, HR: 66, RR:24, O2:99%. Client remained in the gravity chair while mother got vaccinated. At approximately 1133 lead nurse educated client and client?s mother on possible side effects of the vaccine and when to seek medical care. Client and client?s mother verbalized understanding. At approximately 1148 vital signs were retaken by nurse; BP: 108/66mmHg, HR: 64, RR: 22, O2: 99%. Client was able to stand up without assistance and denied dizziness. At 1153 client and client?s mother left the vaccination area with a steady gait.
BECAME UNCONSCIOUS, EYE ROLLING, BODY TREMBLING LAST 5 TILL 10 SECONDS.
pt recvd vax 12JUL95 & the same day devel an almost hive-like red rash all over chest & neck;following day it had spread to back, neck & pelvic area; noted that affected area would blanch when pressed & was warm to touch;
This case was reported by a health professional and described the occurrence of Guillain Barre Syndrome in an adult male subject who was vaccinated with hepatitis B vaccine recombinant for prophylaxis. On 4/21/05 the subject received first dose of Engerix B (lot number not specified) to the left arm. On an unspecified date, four to five weeks after vaccination with Engerix B, the subject experienced limb numbness, numb toes, couldn't walk (inability to walk), and did not know where he was (disorientation). He was seen by a physician and diagnosed with Guillain Barre Syndrome. This case was assessed as medically serious (OMIC). At the time of reporting, on 8/8/05, the outcome of the events were unspecified.
Onset: pain/swollen R axillary lymph node, woke me up at 3 am 12/30; then late afternoon 12/30 onset pain/swollen R supraclavicular lymph node. Duration for both was approx. 8 days with very gradual lessening of severity. Can still palpate slightly swollen R axillary, but soreness almost completely resolved.
Pt vaccinated w/1st dose of vax 6NOV90 subsequently developed a rash which persisted for 3 wks & then remitted; No further details were provided;
Information has been received from a physician concerning an 18 year old female who on 21-AUG-2008 was vaccinated with the second dose of GARDASIL vaccine (yeast) (Lot # 659184/0843X) and experienced pain in wrists, hands and arm. The physician diagnosed her with juvenile arthritis. The patient's events persisted. The patient sought physician's medical attention. Additional information has been requested.
Started with severe charley horses in his lower legs lasted for 3 days.  Then his knees were very painful for ~ 3 days.  Then developed on his Right wrist a lump, the joint hurt, that went away, now his shoulder blade spasms and hurts like crazy.  Helps to massage it, taking Aleve.
Severe migraine lasting 5 days after onset. Sensation of heavy pressure at rear base of skull (right-side). Fatigue, difficulty breathing and recurrent migraines (2-4 per week) lasting 4 months.