chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax 29DEC95 & it was noted that pt was properly stored & administered;29AUG96 pt devel a fever & breakthrough chickenpox w/over 300 lesions all over the body & in the mouth;
Breakthrough case admission after three vaccines Moderna 10/30/21 Lot# 007M20A;  Moderna 2/27/212 Lot# 010A21A;  Moderna 12/15/21 Lot# 012H21B
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of (ROTATEQ), once orally, lot # L033543, expiration date: 30-MAY-2017 (dose was not provided). There were no concomitant medications reported. It was stated that the vaccine underwent temperature excursions of 30 degrees Fahrenheit for 73 hours and 49 degrees Fahrenheit for 25 hours, respectively, that were captured using digital data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
Vaccine kept in refrigerator on 11/17/2021, expiration date is 10/3/2021, administered on 11/29/2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine kept in refrigerator on 11/17/2021, expiration date is 10/3/2021, administered on 11/29/2021) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine kept in refrigerator on 11/17/2021, expiration date is 10/3/2021, administered on 11/29/2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine kept in refrigerator on 11/17/2021, expiration date is 10/3/2021, administered on 11/29/2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Date the vial was placed in the refrigerator was 17-Nov-2021. There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.  The patient did not experience any adverse event.  No treatment information was provided by the reporter.
My daughter had her 4yr old injections, she has always had a slight fever with each vaccination. This time however she hasn't been producing much urine at all. On the thurs she had 10ml of urine in her bladder whilst we were at the hosp. She hasn't been going to the tiolet nearly as often. All kidney tests were carried out & results were fine. Just curious if this is related, as it only started the same day we had the injection.
The patient fell down on the floor about less than 5 min after vaccinated (while waiting for the 15min observation period), hit his head on the shelf.  After turned him over, his eyes were half closed, unconscious, non-responsive and were not breathing properly. Administered an epi-pen 0.3mg, the patient woke up immediately. Also called 911, EMS came and he was able to get up and walk.
Patient complained of feeling terrible, achy and running a fever the following day. On the second day after immunizations, she reported a rash. The rash is a bit lower than the injection sites. She came to the pharmacy and the area was very red and inflamed. She did say she had applied ASPERCREME the previous day because of the hurting. She was advised to stick with ice packs and to take some acetaminophen if needed. She did say she was feeling much better today (the 2nd day after). We will follow up with her over the next couple days. The symptoms can not be linked to one vaccine rather than the other.
Pt reports mild swelling and tenderness at injection site the following day, started to subside on Day 2, then had a return of further swelling on lateral upper arm where vaccine was administered along with axillary swelling on the same side.
red rash; itching rash; peeling rash; burning rash; vaccination site rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash), RASH PRURITIC (itching rash), SKIN EXFOLIATION (peeling rash), SKIN BURNING SENSATION (burning rash) and VACCINATION SITE RASH (vaccination site rash) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced RASH ERYTHEMATOUS (red rash), RASH PRURITIC (itching rash), SKIN EXFOLIATION (peeling rash), SKIN BURNING SENSATION (burning rash) and VACCINATION SITE RASH (vaccination site rash). The patient was treated with PREDNISONE at a dose of 1 dosage form. On 08-Apr-2021, RASH ERYTHEMATOUS (red rash), RASH PRURITIC (itching rash), SKIN EXFOLIATION (peeling rash), SKIN BURNING SENSATION (burning rash) and VACCINATION SITE RASH (vaccination site rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.
Report an adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Report an adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Report an adverse event). At the time of the report, IMMUNISATION REACTION (Report an adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant mediations were not reported Treatment information was not reported
mom said pt sustained shark bite & fx elbow;to er;recv vax,ATB,apap;w/in 2 min "solid streaks of white radiating down arm;swelling;to hosp;dx cellulitis;paresthesia,tremor,HA & coma;local rxn at inject site;myasthenia;pt to see neurologist
Hives occurred 1/2 hour, post vax. Pt also had blood drawn with latex gloves right after shots. Sites with satellite hives on arms, hands, legs and red face. None on trunk. Received 12.5 mg, IM Benadryl.
1100 After receiving first dose Pifzer vaccine and was standing at desk making appointment, 2 minutes after actual vaccination felt overwhelming nausea feeling, dizziness, and actual vision blacked out. Within seconds, opened eyes and said, where am I? BP 116/78 P88 R20 Pulse ox 99%. Color initially pale. Registration person states she did not hit her head as she sat to floor on own prior to passing out. 1107 States has history of passing out with any type of procedures. She passed out 2/2018 with Nexaplanon implant for birthcontrol insertion. She also passed out in spring 2019 in grocery store. 1110. Sat up in chair. BP 124/88 P84 R18 Pulse ox 98%. States feeling much better. Skin warm and dry. Color now pink. States feeling better but anxious and shakiness of arms. Benadryl 25 mg po given for anxiety and shakiness. 1130 BP 120/81 P84 R 18 Pulse ox 99%..  1145 Still recumbent on cot, states symptoms relieved. Has been drinking fluids and ate crackers. BP 123/71 P84 R 18 Pulse ox 99%. Sat up in high fowlers to check orthostatic BP. 123/71 P84 R18 Pulse ox 99%  No further complaints at this time.  1215 Left facility. Denies any further complaints. Encouraged to follow up with PCP and advise of recent events.
This spontaneous report was received from a healthcare worker (also reported as office manager) refers to multiple unspecified patients of unknown demographics. No relevant medical history of the patients was reported. On unspecified dates the multiple unspecified patients were vaccinated with (Oka/Merck) VARIVAX (strength, dose, route, site of administration and lot number were not reported). There were no concomitant medications reported. It ws reported that the multiple unspecified patients were administered with (Oka/Merck) VARIVAX that was stored improperly on unknown dates. There were no adverse effects reported.  It was unspecified whether the patient had sought any medical attention. There was  no product quality complaint involved.   Follow up information has been received from office manager, who stated she may call back for fax information as it become available. Also , reported that M-M-R II was not mentioned int he original call, but did experience a temperature excursion. No further information was available at that time.   Follow up information as received from office manager refers to a 5 years old patient. On 05-JUN-2014 the patient was vaccinated with a dose of improperly   stored M-M-R II (lot # J013315, expiration date 18-OCT-2015) (strength, dose, route and site of administration were not reported). This is one of several reports from the same source. Additional information has been requested.
Scabby, itchy eyelid, swelling; Scabby, itchy eyelid, swelling; Scabbing, itchiness, pain, left breast; Scabby, itchy eyelid, swelling; Scabbing, itchiness, pain, left breast; Scabbing, itchiness, pain, left breast; Sore throat; Swollen tonsils; Mild fever; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route on 13Apr2021 in the left arm (at an age of 29-years-old), as single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cetirizine hydrochloride (ZYRTEC) 10mg for unspecified indication from unknown date and unknown if ongoing. The patient did not receive any other vaccination within 4 weeks of COVID vaccine. On 19Apr2021, approx. 6 days after shot, the patient experienced sore throat, swollen tonsils, mild fever. On 20Apr2021, approx. 7 days after shot, the patient experienced scabbing, itchiness, pain, left breast. On 22Apr2021, approx. 9 days after shot, the patient experienced scabby, itchy eyelid and swelling. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events of sore throat, swollen tonsils, mild fever, scabbing, itchiness, pain, left breast, scabby, itchy eyelid and swelling were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Hi. I don't know how to find the correct location for this message. I received the second dose of covid vaccine  today. 1 hour after the injection I do not believe it actually went in my arm. Understand that the first dose caused a horrible many days reaction. This second dose: 1: I felt no prick or jab from the needle. Nothing! 2: There is no bandage where the shot is supposed to have happened. 3: There is no red mark from the needle puncture. 4: There is no spot on my arm which is tender, no felt indication of actual shot. 5: I feel no effects a hour after the injection. Please contact me to let me know you got this message. Perhaps you can help me find a solution. I simply cannot find any aid or phone number or website to find help. The place where I received the shot is simply non responsive providing NO help what so ever.
no adverse effect; The following 10 patients were administered the VAQTA Lot # S009943 that had undergone temperature excursion; This spontaneous report was received from an office manager concerning a 22-months-old female patient. The patient's concurrent conditions, medical history and drug reactions or allergies were not reported.  On 10-OCT-2019, hepatitis a vaccine, inactivated (VAQTA) experienced temperature excursion at -1.49ºC for a timeframe of three days. On 23-OCT-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (lot # S009943 and expiration date: 26-JUL-2020) as prophylaxis (strength, route of administration and anatomical location were not reported) (incorrect product storage). On 31-OCT-2019, hepatitis a vaccine, inactivated (VAQTA) experienced another temperature excursion at 11.49ºC for a timeframe of fifteen minutes. There was no previous temperature excursion. The call was due to digital data logger.   No adverse effects were reported.  This is one of several cases received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; deviceage and unit: 0 ; malfunction: No; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-1911USA007567:
Initial report was received on 20 February 2014 from an electronic lay press article. A 55 year-old male patient (date of birth not reported) with a history of diabetes had received an influenza vaccine (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later developed the flu. The patient first became ill on a Thursday. "That afternoon, his blood sugar spiked, and they were unable to get it down. So they took him to the hospital and from there he flat - lined three times". By Friday night the patient was flown to another hospital where he died in a diabetic coma. Outcome was fatal. Documents held by sender: none.
Vaccine given approximately at 11:00 am on 6/20/06. Symptoms presented at ER 6/21/06 @00:23 with fever 104, severe body aches, soreness at site of injection (rt. arm), migraine H.A.
lt arm from shoulder to elbow, swollen red & warm to touch;small raised pustule noted @ inj site;
Itching/redness at injection site and up neck.  Administered 50mg Benadryl PO .  Staff called and observed for 30 min.  Discharge to husband's care.
the patient is not experiencing any symptoms at this time; PROQUAD was administered with VARIVAX inadvertently, instead of pure MMR-II; Inappropriate schedule of product administration; PROQUAD was administered with VARIVAX inadvertently, instead of pure MMR-II; This spontaneous report has been received from Other Health Professional and refers to an 1-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 08-MAR-2023, the patient was inadvertently vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, administered for prophylaxis (strength, lot number, expiration date, and route of administration were not provided); and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, administered for prophylaxis (strength, lot number, expiration date, and route of administration were not provided) (inappropriate schedule of product administration and accidental overdose), instead of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (wrong product administered ). The patient did not experienced any symptoms at the moment of the report. No additional adverse event reported.
Severe muscle spasms all over, migraine type headache, profuse perspiration, fever, chills and uncontrollable shaking.
dizzyness n nausea withing an hr of the Johnson n Johnson shot.  Took phenergan n Tylenol.  Today, okay little dizzy.
Noticed extreme confusion and difficulty concentrating, no ability to focus, brain cloud after second dose. Thought would go away after couple of weeks, never did. Doctor has now placed on antidepressants thinking it will help with focus/concentration issues. Can't even watch a movie without losing track of what is going on. Just foggy all the time and really tired.
The patient noted a redness around site of injection along with warmth of the skin. Was and oblong shape, no larger than 2 inches in diameter.
Adverse event was giving an expired dose of the Moderna 6 months through 5 yrs vaccine.  Overall expiration date was 2/10/23, however refrigerator date of expiration was 8/7/22 and dose was given 8/19/22 at 1610 in the left thigh, IM.  Error discovered 8/25/22.     Reports to programs, parents and provider in process of completion at this time.
He developed a fever and started  throwing up the night of his vaccine. He is very small/skinny at 4'10" and 95 pounds. The fever continued the next day, and along with severe fatigue/vomiting, and he wasn't able to swallow/keep down his seizure meds. After giving him Motrin orally and Compazine with suppository, his fever broke in the evening and he was able to eat a little and keep down his seizure meds
Progressive SOB and palpitations 10 hours after the injection, was seen in ER 8/16/11. Received inhalation therapy and steroids and released with Rx for oral prednisone; Dx exacerbation asthma.
Mental disturbances, extreme feelings of depression and despondency and suicidal ideation without intent, lasting approx. 12-18 hours; with no previous diagnosis or history of depression.  Did not seek medical care.
Has been miserable for 4 months being sick with the shot; For the first three weeks all the caller did was asleep; This is a spontaneous report from a contactable other healthcare professional (patient). A 83-years-old female patient received bnt162b2 (PFIZER COVID 19, Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 06Mar2021 (at the age of 83-years-old) as dose 1, single for covid-19 immunisation. Medical history included osteoporosis (caller has osteoporosis. Caller states her mother had osteoporosis too) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Investigation Assessment was no. The caller was a retired Advanced Nurse Practitioner who states she has been miserable for 4 months being sick with this Pfizer Covid 19 shot. For the first three weeks all, the caller did was asleep. The caller could not hold eyes open. She received the first shot on 06Mar2021, and the caller was sleepy for the whole three weeks before getting the second dose Pfizer Covid 19 shot. The caller states she shrunk to 5 feet. The caller has osteoporosis. The caller clarifies this occurred prior to receiving the Pfizer Covid 19 shot. The caller had osteoporosis prior to receiving the Pfizer Covid 19 shot. The caller states her mother had osteoporosis too. The caller was still sleepy now. The caller states the sleepiness was getting better now. The caller gave her vaccine card to her daughter and the caller's daughter was at work. The outcome of event has been miserable for 4 months being sick with the shot was unknown and for the first three weeks all the caller did was asleep was resolving.  The batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Patient went to e.d. at night 11/7/07 with fever and upper right arm swelling.  Told to take Benedryl and follow up in clinic in a.m.  Patient came to clinic 11/8/07, arm warm to touch from elbow to shoulder right arm.  Told to continue benedryl and if no improvement, return to clinic or go to e.d.
Very sore arm; Fatigue; This is a spontaneous report from a contactable pharmacist. This report was received via a company representative. A 25-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not reported), intramuscularly on 26Mar2021 (at the age of 25-year-old) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. On 26Mar2021, the patient experienced very sore arm and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for the events. The clinical outcome of the events very sore arm and fatigue was recovered in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: events details added (no treatment was received).
Redness, warmth, inflammation. Went to doctor who said it was an infection and prescribed cephalexin three times daily for 7 days.
Left shoulder pain severely restricting range of motion of left arm. Pain required NSAIDs,, with partial relief. Unable to safely drive for 5 days due to inability to use left arm. No fever or local injection site reaction. Pain has diminished but continues on Day #8.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 13Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Other medical history: Ulcerative colitis" (unspecified if ongoing), notes: Other medical history: Ulcerative colitis. Concomitant medication(s) in 2 weeks included: PREDNISONE; LIALDA. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (07Sep2022) Negative, notes: Tested negative for Covid on 07Sep; (12Sep2022) Positive, notes: Tested positive again on 12Sep. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient took anti-viral product Paxlovid for Treatment of COVID-19 started from 02Sep2022 to 06Sep2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information and possible temporal association the causal relationship between the reported events and suspect BNT162B2 cannot be excluded .The case will be reviewed further with FU information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate