chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacy technician refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot #, expiration date, dose were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 72.68 degrees Fahrenheit for 84 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected as not consent was given for further contact.
Delayed rash on left arm; Rash starts at the injection site and is crossed-banded; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Delayed rash on left arm) and VACCINATION SITE RASH (Rash starts at the injection site and is crossed-banded) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 011A21A and 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Drug allergy (Allergic to Lisinopril.).   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Dec-2021, the patient experienced RASH (Delayed rash on left arm) and VACCINATION SITE RASH (Rash starts at the injection site and is crossed-banded). At the time of the report, RASH (Delayed rash on left arm) and VACCINATION SITE RASH (Rash starts at the injection site and is crossed-banded) outcome was unknown.            No concomitant product use was provided by the reporter. No treatment medication was provided.
On 06/09/2016 at 2:00PM.  Patient came into the pharmacy reported Adverse reaction occured the day after pt being vaccinated.  Patient stated redness, harden to touch, fluid pocket away from the injection side towards innard arm.  No chills, no fever.  The adverse reactions went away after 6 days report per patient.  Patient did not call to report the adverse reaction during that 6 days period. She did not report to doctor's office either.  Patient stated that the injection site and her arm went back to normal after 6 days. Pharmacist looked at patient's arm and the injection site on 06/09/2016 - no adveres reaction noted at this time.
I experienced 4 hours after injection high BP 200 (my normal bp is 120) and I was dizzy and felt like passing out, I had a stint put in heart 6 years ago, I have A-fib and not sure if I should get the 2nd dose.
Inappropriate schedule of vaccine administered (3rd dose administered on 01-JUL-2010); This spontaneous report has been received from a physician via a medical record (MR) from a case in litigation for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (MARRS # 2309USA005464) concerning a 2-month-old male patient. Concomitant therapies included haemophilus b conjugate vaccine (meningococcal protein conjugate)(manufacturer unknown), unspecified polio vaccine inactive, unspecified diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (DTAP) and Hepatitis B Vaccine  (manufacturer unknown). His historical vaccines included unspecified Hepatitis B Immune Globulin. The patient's medical history and concurrent conditions were not provided.       On 02-FEB-2010, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (manufacturer unknown) orally, (dose, lot # and expiration date were not provided). On 09-APR-2010, he was vaccinated with the second dose of rotavirus vaccine, live, oral, pentavalent (manufacturer unknown) orally, (dose, lot # and expiration date were not provided). On 01-JUL-2010, the patient was adminstered the third dose of rotavirus vaccine, live, oral, pentavalent (manufacturer unknown) orally, (dose, lot # and expiration date were not provided) (inappropriate schedule of product administered).   This is one of 4 reports reffering to the same patient (linked # 2309USA005464, 2309USA008645 and 2309USA008647).; Sender's Comments:  US-009507513-2309USA008645: US-009507513-2309USA008647: US-009507513-2309USA005464:
Pain to left arm injection site; Swelling & pain to left armpit; swelling & pain to left armpit; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 08Dec2021 01:15 (Lot number: FH8027) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Pfizer (DOSE 2, SINGLE, Batch/Lot No: EL3246, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 09Jan2021, when the patient was 42 years old, for Covid-19 immunization; Pfizer (DOSE 1, SINGLE, Batch/Lot No: EH9899, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 19Dec2020, when the patient was 42 years old, for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 09Dec2021 07:00, outcome "unknown", described as "Pain to left arm injection site"; SWELLING (non-serious) with onset 09Dec2021 07:00, outcome "unknown", described as "Swelling & pain to left armpit"; AXILLARY PAIN (non-serious) with onset 09Dec2021 07:00, outcome "unknown", described as "swelling & pain to left armpit". Therapeutic measures were not taken as a result of vaccination site pain, swelling, axillary pain.  No follow-up attempts are possible. No further information is expected.
I started my period at least 4 days early. I'm on birth control and my period is extremely regular. Usually after removing the NuvaRing, I start bleeding several days later, but I randomly start my period a few hours after being vaccinated, had cramping, and low-back pain.
Febrile seizure post immunizations of 104.2 temp. TYLENOL was given for fever, IV normal saline bolus. Pt responded to treatment by decreased fever/temp.
I got the vaccine, and got shingles/Suspected vaccination failure; Got shingles on face and part of my head; Very painful; Trauma of the tooth pulled, brought out the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included tooth extraction.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and trauma. On an unknown date, the outcome of the vaccination failure, shingles, pain and trauma were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and trauma to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 09-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient got shingles on face and part of head which was very painful. The patient had tooth pulled and they said because of the trauma of getting the tooth pulled it brought out the shingles. The patient stated that, Shingles vaccine was not guaranteed, but it was less worse with the shot. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory test confirming shingles were unknown at the time of reporting.
Discomfort in area of injection - rash noticed 5 days post injection 6" x 2". 11/5/14 today area 9" x 3" - red/warm.
Pt felt chest tightness immediately after injection.  Itching in her mouth 10 mins after vaccine
Nausea, vomiting, diarrhea, headache, fever, chills .   Vomiting for 2.5 hours, diarrhea for 3 days.  Fever broke overnight after a couple of hours.
Fever 101.5; headache; back pain; hip pain; dizziness; nausea; arm pain; This is a spontaneous report from a contactable consumer (patient, self-reported). A 61-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL 9269 and Expiry date: unknown), dose 2 via an unspecified route of administration, in the left arm, on 06Feb2021 at 11:30 (age at vaccination 61-year-old), as single for COVID-19 immunization in the hospital. The patient's medical history included psoriasis, fibromyalgia and vitamin b12 deficiency. The patient had drug allergy which were contrast media allergy, vancomycin allergy. The patient concomitant medications included amitriptyline, vitamin B12 NOS, vitamin D NOS taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL8982 and Expiry date: unknown), dose 1 via an unspecified route of administration, in the left arm, on 17Jan2021 at 11:30, as single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 06Feb2021, the patient experienced fever 101.5, headache, back pain, hip pain, dizziness, nausea, arm pain. The patient underwent lab tests and procedures which included body temperature 101.5 on 06Feb2021. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Shot injected into left shoulder. Immediate shock/pain radiated down arm into fingers.  Not able to move arm past elbow.   Cannot straighten left arm.  Cannot lift left arm straight out or above head.
Developed rash. Started on face and spread over 1 day to trunk, neck, hands and legs but spared his palms. No fever associated with rash.
Initial report received from a health care professional on 25 May 2010: This adolescent was vaccinated with MENVEO (batch no: 100001, expiry date: 2011), (dose: unknown) intramuscularly on 30 Apr 2010. The patient was administered MENVEO that was not reconstituted before administration and the lyophilized portion was not administered. The outcome of the event was not reported. Follow up report received from a health care professional on 08 Jun 2010: The patient was revaccinated with MENVEO (dose and batch number unknown) intramuscularly on 25 May 2010. No other information provided.
3 days after vaccine - severe pain in lower stomach( feeling like labor pains), which traveled to feet.  Chills and nausea Continuing and present  Severe Itching at the area of the Vaccine shot  (right arm.
Information has been received from a physician concerning a 35 year old female with no medical history and no allergies who was vaccinated with a first, second, and third 0.5mL  subcutaneous dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot #644212/1297N) in 1973, 1991 and in 2004 respectively. There was no concomitant medication. A titer done in May of 2007 was negative for mumps. At the time of this report, the patient was not recovered. Unspecified medical attention was sought. No additional information was available. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report was received from a physician and refers to a patient of unknown age (also reported as "0") and gender. No information about the patient's pertinent medical history, concomitant medications and concurrent conditions was provided. On 25-APR-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ oral solution, lot # M041181 (dose, and expiry date were not specified) for prophylaxis. The administered dose of ROTATEQ underwent a temperature excursion of 48 Fahrenheit degrees for 30 minutes. There was no Digital Data Logger involved. No previous temperature excursion was reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all available information has been received. ; Sender's Comments: US-009507513-1704USA001661:
He was supposed to receive Bivalent vaccine for booster, but Comirnaty was given accidently.
it was rpt fr MD whose twin children were vax & on 12/5/98 pt exp 30-40 papules & pustules. pt seen by dermatologist. pt rash was pruritic.
This spontaneous report has been received from a non-pregnant, 50-year-old female consumer patient, reporting on herself. The patient's concurrent conditions included allergy to unspecified antibiotics and to morphine. The patient had none medical history and was not taking concomitant medications. On 22-OCT-2018, the patient was vaccinated with one injection of VAQTA, (route reported as "injection" and dose was not provided), lot # R022983 with expiration date 09-AUG-2019, for hepatitis A prevention. On 22-OCT-2018, within an hour of getting the vaccine, the patient broke out in hives (urticaria papular). She experienced her skin feeling sensitive (sensitive skin) and hot (skin warm) with red bumps, for a duration of 15 hours. The patient did not sought medical attention and no treatment was given for the events. Laboratory diagnostics or studies were not performed. At the time of reporting, the patient had recovered. The reporter did not assess the relationship between the vaccination with VAQTA and the events.
COVID; COVID; Rebound COVID 3 days after completion of Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Lot number: ER8733), on 20Apr2021 as dose 2, single (Lot number: ER8732), on 23Aug2021 as dose 3 (booster), single (Lot number: FC3181), in left arm and on 27Jan2022 at 09:45 as dose 4 (booster), single (Lot number: FK9729) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Generalized anxiety" (unspecified if ongoing); "AIHA" (unspecified if ongoing); "GVHD" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "MDS" (unspecified if ongoing). Concomitant medication(s) included: HAILEY 1.5/30 oral, start date: 25Aug2020; PENICILLIN V POTASSIUM oral, start date: 12Sep2017; HYDROXYZINE oral, start date: 03Nov2020; CYANOCOBALAMIN oral; CALCIUM oral; CHOLECALCIFEROL oral. Past drug history included: Levaquin, reaction(s): "Known allergies: Levaquin".  The following information was reported: DISEASE RECURRENCE (medically significant) with onset 18Aug2022, outcome "recovered" (01Sep2022), described as "Rebound COVID 3 days after completion of Paxlovid"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Covid-19 treatment; Negative, notes: a negative test; Negative, notes: Rebound COVID lasted 7-8 days; then again tested negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of disease recurrence.  Clinical course: The patient was treated with Paxlovid from 10Aug2022 to 15Aug2022 orally. Rebound COVID 3 days after completion of Paxlovid and a negative test. Rebound COVID lasted 7-8 days; then again tested negative. Mild cold-like symptoms and sore throat.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
broke out in hive-type rash; lasted for 1 wk; seen by dermatologist;
Information has been received from a licensed practical nurse concerning a 7 year old male who on 1/7/1999 was vaccinated subcutaneously in the right thigh with the first dose of varicella virus vaccine live (lot 628246/1655H). Concomitant vaccination on that same day included the first dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) given subcutaneously in the left lateral thigh (lot 628884/1542H). ON the morning of 4/4/2005 the patient developed breakthrough varicella. The LPN reported that the patient was seen in the afternoon with over 30 papular and a couple vesicular lesions. It was reported by the LPN that the patient recovered by 4/11/2005 (within one week per his mother). No additional information is expected.
Fever; Body aches; Made me sick for 24 hours; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness, fever and general body pain. On an unknown date, the outcome of the sickness, fever and general body pain were unknown.   It was unknown if the reporter considered the sickness, fever and general body pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for himself/herself. The age at vaccination was not reported. The patient's Insurance had been covered. The patient stated that second dose made him/her sick for 24 hours. The patient experience fever and body aches. The reporter was sure better, that getting shingles. The follow-up could not be possible as no contact details were available.
Left deltoid swollen, reddened, warm to touch and client c/o pain when area is touched. Client states unable to sleep. Swelling extends under left arm to left breast with warm/tenderness. Client instructed to go to PCP/ER. Client did go to PCP 8/19/13 - swelling down - no pain.
Fever and headaches 24 hours after receiving the vaccine. Fever lasted 48 hours
This was a vaccine error, not an adverse reaction. The nurse reconstituted yellow fever with sterile water instead of sodium chloride. According to the CDC and Sanofi Pasteur this error renders the vaccine ineffective. Patient notified and made aware.
p/recv vax pt later that day devel diarrhea; pt had 12 stools in 12 hr; diarrhea persisted, seen by MD3/1/99; stool specimen was positive for rotavirus antigens
On 2/21/03, initially noticed red bumps on arms and legs with itching and no burning. Seen in Flight Med by MD and referred to ER. Seen in ER with back, legs, neck, face and arm with bumps. Treated with Zyrtec and told to follow-up on Thursday with internal med doctor and dx'd with urticaria.
Patient had a rash starting at the site of the injection down at the elbow area, fever, muscle pain and tenderness by the collar bone.
Pentacel was 4th dose of DTaP and IPV and the  3rd dose of Hib. Previous doses had been through Pediarix and the Merck Hib. On the night of 3/25, she had felt warm and fatigued. Around midnight she was sleeping on her father's chest when she began to have a single generalized, tonic-clonic seizure of unknown duration. The family called EMS and she was taken to the ED, where she had a 102.9 fever. She was given ibuprofen, which helped her feel better. Physical exam was normal with no focal findings and they were discharged to follow-up with a PCP. No lab tests were done in the ED.
UTI; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported by the patient that she currently has a UTI. She is ready for her second dose of the COVID Vaccine on 26Jan2021. The outcome of the event was unknown.  No follow-up attempts are possible, information about lot/batch cannot be obtained. No further information is expected.
Minor Swelling at right injection site for 1 day,  fussiness and lethargy for 2-3 days, low grade fever was instructed to give Tylenol.  Lasted a few hours.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Anti-viral details: Product= COVID 19 Treatment; brand= Paxlovid; Treatment start date=29Nov2022; Treatment stop date=04Dec2022; Indication=Treatment of COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
5ml syringes that had been provided by Health Authority were used to draw up diluent for mixing the 5-11 year old Pfizer COVID-19 vaccine vial on 12/23/21.  Diluent drawn up and injected into the vaccine vial was 1.6ml rather than 1.3ml.  Diluent was measured on the 5ml syringes incorrectly:  Counting each mark as 0.1 rather than 0.2ml.  This resulted in the vial being mixed with 0.3ml extra diluent.  Vial had a bonus dose (so 11 doses total).  Patient was given a vaccine dose at 90% of the correct concentration.  Error has been reported to Pfizer.  Families are currently being contacted by letter and by phone to be alerted of the error and offered a re-dose if they would like this.  No adverse effects to patients have been reported.
Fever of up to 101.3 the entire day after vaccination and tired and sleepy all day.   Fever was gone the following day.
There was an IOP created  by staff(to the best of our knowledge). The IOP dealt with ADA  accessibility(lack of)  to the marketing website. Not sure what the description/name of IOP is. As you know we only have a few IOP so I?m guessing it should not be difficult to identify. Could you please find the IOP and provide the IOP number, expiration date for implementation of action plan and provide it?
Patient recieved the vaccine and her husband stated his wife didnt "no where" she was and was confussed & dizzy. Patient appeared diapheretic. Onsite EMS was called at 2:42pm HR 64 BP 76/47 Blood pressure did not recover by 2:58 pm and refused transport to the hospital.