chrisvoncsefalvay/vaers-outcomes huggingface dataset:
26Nov2019 received first dose, 08Aug2021 received the second; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 26th November 2019).   On 8th August 2021, the patient received the 2nd dose of Shingrix. On 8th August 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient received 2nd dose of Shingrix later than the recommended time interval, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Patient reported very sore and swollen arm with pain. He presented with fever in arm and what he thought was a mild systemic fever with mild aching. By the time he and I spoke, he felt much better but was concerned about the reaction. He did not remember having any previous reaction to any previous flu shot in years past.
ABOUT 10 MINUTES AFTER RECEIVING 1ST PFIZER COVID19 VACCINE, PT COMPLAINED OF EXTREME NAUSEA AND DIZZINESS, AND APPEARED ANXIOUS. PT WAS MONITORED CAREFULLY AND ENCOURAGED TO BREATHE AS COMFORTABLY AS POSSIBLE. AFTER 5 MINUTES, PT STATED HE WAS FEELING MUCH BETTER AND SAID THAT HE WAS FINE. AMBULANCE SERVICES WERE CALLED, AND PT LEFT WITH AMBULANCE PERSONNEL UNDER HIS OWN AMBULATION AND WITHOUT RECEIVING MEDICATION. PT WAS TRANSPORTED TO HOSPITAL, WAS APPARENTLY CHECKED-OVER, AND RELEASED IN ABOUT AN HOUR. PER TELEPHONIC FOLLOW-UP LATER IN THE DAY, PT CONFIRMED TO PHARMACY MANAGER THAT HE FELT FINE, AND THANKED PHARMACY MANAGER FOR FOLLOW-UP.
Patient reports arm was sore Friday night after receiving both injections, some redness around injection site which over the course of 2 days spread down towards elbow on right side. He says that it is only mildly painful, no feeling of heat or numbness but does appear bright red skin.  Patient called doctor's office who advised him to report to pharmacy. Pharmacist recommended using ice and anti-inflammatory acetaminophen to help with rash.
After vaccines administered, while performing routine blood draw, patient passed out. Patient came back to within 2 minutes / developed fixed (R) lateral gaze and 2 tonic-clonic bilateral arm movements before regaining consciousness.
supraventricular tachycardia night of 15SEP93; treated in ER w/Lanoxin & Adneocard
Case number PHEH2014US024952, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 69-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 28 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
Itchy rash on chest and hives on chest. No treatment other than topical anti itch cream. Itching stopped after 24 hours. Still have spots today, but no more itching.
Patient complain of nausea, light-headed, hot flashes, right after injection. Told patient to lay down on back on the table, took some water about 25 minutes recheck BP and pulse. Ok to leave.
joint pain that radiates up and down the arm; joint pain that radiates up and down the arm; inflammation in my right hand and right wrist; inflammation in my right hand and right wrist; Sensation in my right hand at rest; Slightly swollen; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 23-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 at 16:30 as dose 1, 0.3 ml single (Lot number: HG4628) at the age of 23 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "Functional gastrointestinal disorders" (unspecified if ongoing); "Kawasaki disease", start date: 2006 (unspecified if ongoing), notes: Diagnosis date of Kawasaki disease was 2006; "mild congestion" (unspecified if ongoing); "Sacralization", start date: 2015 (unspecified if ongoing), notes: Diagnosis date: 2015. I have a fused L5 in vertebrate in my back. Concomitant medication(s) included: SYMBICORT. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: SENSORY DISTURBANCE (non-serious) with onset 2023, outcome "unknown", described as "Sensation in my right hand at rest"; SWELLING (non-serious) with onset 2023, outcome "unknown", described as "Slightly swollen"; PYREXIA (non-serious) with onset 2023, outcome "recovered" (2023), described as "fever"; INFLAMMATION (non-serious), ARTHRITIS (non-serious) all with onset 2023, outcome "unknown" and all described as "inflammation in my right hand and right wrist"; ARTHRALGIA (non-serious), PAIN (non-serious) all with onset 2023, outcome "unknown" and all described as "joint pain that radiates up and down the arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia, pain, sensory disturbance, swelling, pyrexia.  Additional Information: Patient was having joint pain in right hand and right wrist. She had an x-ray done and it came back fine. She had a lot of inflammation in her right hand and right wrist. She was feeling fine before the vaccine and she had done nothing to injure her right hand and wrist and was wondering if it was a side effect. She read that joint pain was a side effect and asked whether had there been any reports of joint pain in the hand and wrist. She was taking the Symbicort inhaler, it was not really dose it was 2-3 days. She was just prescribed Meloxicam 15 milligrams. No family history relevant to adverse event reported.
Weakness in the body, inability to stand, cannot support the body, inability to eat and swallow. His face twisted the first day, and he seemed lost in time, and he recovered but after a week he still has no modality, and he began to digest his food. No studies or exams just a checkup with the doctor
Red rash on arm approximately 4x5 inches in diameter at injection site. Warm to touch and  painful. The Dr. thought the injection site was infected . He prescribed Keflex twice daily for 7 days and Mupirocin 2% ointment three times daily. Symptoms disappeared slowly over four days. I took all the antibiotics as prescribed.
her arm was a little sore; This is a spontaneous report from a non-contactable consumer (reporter's husband). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 05Jan2021 at a single dose for COVID-19 immunization. The patient's medical history was not reported.  The patient's concomitant medications were not reported. The patient had her first dose too and her arm was a little sore but it felt better after her aerobics class and she was totally fine. The patient was recovering from the event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Uncontrollable shivering began approximately 4 hours after vaccination. This was accompanied by general body aching. This lasted for 3-4 hours until sleep was achieved. The following day, body aches and general soreness were present. The symptoms subsided by the second day after the injection.
Provider stated that the mother told him that he had a fever of 103 piercing cry and weakness in his legs.
This non-serious spontaneous case, initially received on 19-Mar-2018, was reported by other health professional and concerns a 11-year-old child of an unspecified gender. It was reported that, on an unspecified date, the temperature of the refrigerator in which vaccine was stored dropped to 32 F and was out of range for a total of 1 hour off and on for 2 weeks. On 19-Feb-2018, the patient was administered with FLUCELVAX QIV (dose, route of administration: intramuscular, anatomical location: left deltoid, batch number: 195236, expiry date: 31-May-2018) that was stored out of recommended temperature. The patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. Non-significant follow-up received on 07-May-2018: The reporter confirmed that, the patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. Narrative was amended accordingly. Non-significant case correction received with IRD 19-Mar-2018: The expiry date was changed from 31-May-2018 to 30-May-2018 in the product tab. The narrative was amended accordingly.
doses administered past the 30-day use by date; Dose administered past the 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered past the 30-day use by date) and PRODUCT STORAGE ERROR (doses administered past the 30-day use by date) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    In February 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered past the 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (doses administered past the 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered past the 30-day use by date) and PRODUCT STORAGE ERROR (doses administered past the 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the vial was initially stored in the refrigerator on 14-Jan-2022. The administration of vaccines were 14-Feb-2022, 15-Feb-2022, 16-Feb-2022, 18-Feb-2022, 21-Feb-2022. No concomitant medications were reported. The vial had not undergone any temperature excursions. No treatment medications were reported.   This case was linked to MOD-2022-492833 (Patient Link).
Rash appeared shortly after receiving PENTACEL on 4/13/12. Rash started on thighs and continued to spread on the inside of thighs, back, and face. Spiked a temperature of 103 and was taken to ER-prescribed BENADRYL. Treated with prednisolone and ATARAX 4/20/2012.
Information has been received from a physician concerning a 74 year old female with hypertension and hypercholesterolaemia who on 08-FEB-2008 was vaccinated with a dose of ZOSTAVAX (Merck).  Concomitant therapy included losartan potassium-HCTZ (MSD).  In February 2008, the patient experienced rash on her leg and thigh.  The patient has not yet been in to see the physician.  The patient called the physician.  Outcome of the rash was unknown.  No product quality complaint.  Additional information has been requested.
PERSON RECEIVED MODERNA COVID VACCINE DOSE 1 & DOSE 2 AT COUNTY HEALTH DEPARTMENT. TESTED POSITIVE FOR COVID 4/7/21 AND WAS ADMITTED TO HOSPITAL FOR ASPIRATION PNEUMONIA 4/11/21.
1 day Day of shot I had funny feeling in the tongue.  2nd day- minor facial rash with same tongue feeing 3rd day- minor rash on body face and neck same tongue feeling. Began taking Benadryl  4th day-  more noticeable rash on face and body same tongue feeling. Took Benadryl  5th day- skin rash and all over body very itchy. Woke up with swollen lips to include blisters under lip.  5th day I went to urgent care  since symptoms and rash to be worsening prescription were given (hydroxyzine 25mg (1pill 3x a day), prednisone 20mg ( 3 tablets once a day), famotidine 20mg (1 tablet 2x a day). 6th day- facial swollen seemed to subsided but redness is still there now with minor itching
Pt. with history of fainting with blood draws, but not shots was in office for pre-travel vaccines.  Vaccines were administered around 4 pm.  Typhoid administered first without problems, pt. fainted immediately after administration of SQ Japanese Encephalitis.  Pt. lied down with feet up recovered fairly quickly.  Initial BP, just after faining 72/50 w/ pulse of 60.  When stated felt better (about 5-10 minutes) BP 110/62 w/ reg pulse.  Sat up, given  coke to drink and some trail mix.  Stated improvement, returned to desk at 4:40pm.  Received email from patient stated she felt better and was back at her desk.  Returned home for evening at unknown time.  Went out for dinner with roommate around 8pm (dinner was 2 tacos and water).  Did note excessive thirst with dinner drank multiple (around 6 large) glasses of H2O.  At 9pm (still at restaurant, pt began feeling tightness in chest, SOB, and lightheadedness.  Rested for few minutes and then headed home with roommate d/t feeling bad.  Shortly after returned home (~9:30pm), pt states she fainted, and room mate then called 911.  States that was brief LOC and was not told of any seizure movements or urination, or anything unusual.  She just felt chest tightness, tachy HR (per pt report), saw white and went out.  This happened a 2nd time before ambulance arrived again brief.  After transport to Georgetown ER, pt again with similar episodes another 3 times.  Was treated in ER (see #12) and sent home around 3:30am with no diagnosis other than dehydration.  Pt continued to feel tightness in her chest over next day, around 2:30pm experienced similar episode with SOB, increased HR, feeling hot, and lightheaded.  Sat on floor with head between legs and recovered.  No LOC.  At 7:30pm had witnessed LOC at work with brief warning.  Was talking to co-workers, and fell off chair.  She remembers similar feelings as previous, but didn't have time to react.  Wednesday (4/4/07) pt states she still feels off, tightness in chest and subtle lightheadedness, but no further syncope episodes.  Saw consulting MD in employee walk-in clinic who did full assessment without any positive findings.  Encouraged pt. to see neurologist for w/u if has further syncopal episodes. Spoke with pt today (4/5/07) and states she is feeling better, mild tightness in her chest, but no further lightheadedness.
Extreme body aches.   Horrible!  Extreme fatigue.  Started about 12 hours after shot and lasted  about 24 hours.
This spontaneous report as received from a Certified Medical Assistant refers to an unspecified number of patients of unknown ages. On an unknown dates the patients were vaccinated with a improperly stored dose of ROTATEQ, oral (dose, strength, lot# and expiration date was not provided). No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 52-year-old female patient who received SHINGRIX (batch number ZY3X4, expiry date 28th April 2020). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced chills. On an unknown date, the outcome of the chills was unknown. It was unknown if the reporter considered the chills to be related to SHINGRIX. Additional information was received as follows: The health care professional reported that the patient experienced chills or shivering after receiving SHINGRIX. No additional information was provided. This case has been linked with case US2018047705, reported by the same reporter.
10/27/14 Pt told me that she had to go to the ER Saturday (10/25/14) evening because her arm had swelling, tenderness and itching. Began a steroid course as ordered by MD there. Her PCP added KEFLEX 10/27/14 to make sure infection is suppressed. Pt is OK.
The baby was receiving PREVNAR 13 as scheduled. While after vaccination about 1 month, he developed fever, cough, and then pneumonia and admitted in hospital for 1 week treatment. Many friends of mine using PREVNAR 13 and some of them developed pneumonia after that. What a vaccine from Pfizer.
8:50 AM - c/o dizziness. Diaphoreic. BP178/110 P 72  RR 12. Blood sugar 51. Benadryl 50 mg given along with Capri Sun. 9:00 152/94 P 72 RR 12 9:05 156/90 P 72 RR 12 Given animal crackers to eat 9:10 134/78 P 72 RR 12 Blood sugar 74 9:25 116/58 P 72 RR 12 "Feeling a little better, but still weak and dizzy" 9:40 132/62 c/o nausea 10:15 To Hospital for exam
Guillain Barré syndrome:   HOSPITAL COURSE:  The patient was admitted to the general medicine service for management of acute ascending sensory neuropathy c/w atypical GBS variant vs autoimmune process. Neurology was consulted. Every 2 hr vital signs in combination with every 2 hr vital capacity, inspiratory force. The patient did not develop motor symptoms. Neurology felt her syndrome was most c/w a GBS variant versus an autoimmune process based on imaging, symptoms. The patient received a total of 110 grams of IVIG; plasmapheresis was avoided to hypercoagulable state. An LP was performed via radiology with 5 nucleated cells, a glucose of 50, and protein of 18. Gram stain and culture with no growth to date. A paraneoplastic panel, JC virus, Varicella Zoster PCR, arbovirus, west nile virus, HSV, enterovirus, CMV labs are pending at the time of discharge, but felt an encephalitis without encephalopathy or other concerning s/sx is very unlikely. On the day of discharge she was symptom free. Told her to come back if she developed shortness of breath or new weakness, but neuro feels this is very unlikely at this time with her lack of disease progression.
she had an increase in her iron level; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer reported for herself. An 87-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN5318), intramuscular, administered in Arm Left on 05Feb2021 (at the age of 87-year-old) as dose 1, single for Covid-19 immunisation. Medical history included Open heart surgery in 2008, supplementation therapy to gain weight from an unknown date. Concomitant medication(s) included nutrients nos (ENSURE [NUTRIENTS NOS]) taken for supplementation therapy, start and stop date were not reported. Additional vaccines administered on same date of the Pfizer suspect was reported as none. Prior vaccinations (within 4 weeks) and AE(s) following prior vaccinations was reported as none. On 09Feb2021, the patient had a blood test for a routine exam and found she had an increase in her iron level. She was wondering if the covid vaccine would increase her iron level. They told her that she had quite an increase in her iron and they were going to check. Her injection was the only thing that she has had. She has a follow up appointment with her physician. Caller said that her height and weight were unknown. She said that she does not weigh a lot and has been drinking Ensure to get her weight up. She had been taking ensure to gain weight and there was iron in it. She stated she weighs about 107lbs and was about 5ft 5in in her height. The patient underwent lab tests and procedures which included blood iron: increase in her iron level on 09Feb2021, body height: about 5ft 5in and weight: about 107 lbs on an unspecified date. The adverse event resulted in visit to Physician office. The outcome of event was unknown.  Follow-up attempts completed. No further information expected.
Administered / Adjuvant portion only; Administered / Adjuvant portion only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number D4PA4, expiry date 10th February 2023) for prophylaxis.   On 18th August 2021, the patient received the 1st dose of Shingrix. On 18th August 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The practice manager reported a Medical Assistant administered the liquid AS01B Adjuvant portion only of Shingrix, without reconstituting with the lyophilized portion to 60 year old female patient which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This case was linked with case US2021174387, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021174387:Same reporter
Pt vax /w DTP/OPV/HIB/TB TINE TEST /w in 4 hrs pt had grand mal seizure, T was 100.6. Became very lethargic brought to ER then again seizure; admit to Hosp. Seizured again 5 days later 3 times w/no Increase temp.
This spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. There were no medical history nor concurrent conditions reported for the patients. The reporting nurse stated that the unspecified number of patients were vaccinated with improperly stored doses of a GARDASIL lot # K006960 and expiration date 19-FEB-2017 (dose and route were not reported) on 18-JUN-2015, 20-JUN-2015, 25-JUN-2015, 26-JUN-2015, 30-JUN-2015, 04-JUL-2015, 06-JUL-2015, 09-JUL-2015, 12-JUL-2015, 18-JUL-2015, 23-JUL-2015, 24-JUL-2015, 25-JUL-2015, 26-JUL-2015, 30-JUL-2015, 02-AUG-2015, 05-AUG-2015, 06-AUG-2015, 08-AUG-2015, 09-AUG-2015, 11-AUG-2015, 12-AUG-2015, 13-AUG-2015, 15-AUG-2015, 16-AUG-2015, 19-AUG_2015, 20-AUG-2015, 21-AUG-2015, 22-AUG-2015, 24-AUG-2015, 25-AUG-2015, 26-AUG-2015 and 20-AUG-2015. No concomitant medications were reported. No adverse effects were reported. It was unknown if the patients sought medical attention. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Mother states child began running fever of 103.5 at bedtime.  Throat and nose was swollen.  Saw Dr. on 11-8-13.  Dr. stated her nose and throat was swollen and she felt it was a reaction to the flu mist.  Fever was still running at 102 at that time.  Child was prescribed prednisone and an antibiotic.
Patient called 5/11/21 stating today she blew a blood clot from her nose
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's demographics were unknown. There was no information on pertinent medical history and drug reaction or allergies. On 23-JUL-2014, the patient was inadvertently vaccinated with PNEUMOVAX23 (dose, frequency, product#, expiration date, not reported), intramuscularly which expired on 25-JAN-2014. This was supported. No adverse effects were reported. There was no product quality complaints involved. Additional information has been requested.
Low grade fever on and off after a Covid vaccine/pfizer/on6/24/21.  This was the 2nd vaccine. Feels fatigued, more at end of the day. Which is when the temp gets back to upper 99-100 range.  No cold sx/cough/GI/GU sx.  Historically, for the past few years has had lingering low-grade temp after an acute illness.
Red and swollen area on left arm, lower than the recommended injection site. Patient advised to use BENADRYL for the next 24-48 hours and to use cold packs. Follow up in 1-2 days.
Injection site pain, joint pain, fatigue, headaches, nausea, hot flashes