chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Kinrix given to a 12-month-old; Kinrix as third dose of DTaP and IPV; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-month-old female patient who received DTPa-IPV (Kinrix) (batch number 24T2N, expiry date 07-MAY-2023) for prophylaxis.   Previously administered products included Vaxelis (first dose of DTaP and IPV as Vaxelis received on 29 December 2022) and Pediarix (second dose received on 30 January 2023).   On 20-MAR-2023, the patient received the 1st dose of Kinrix. On 20-MAR-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix given to a 12-month-old) and inappropriate schedule of vaccine administered (Verbatim: Kinrix as third dose of DTaP and IPV). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 20-Mar-2023 and 21-Mar-2023 The nurse manager called back to report that patient received their first dose of DTaP and IPV as Vaxelis on 29 December 2022 and second dose of each as Pediarix on 30 January 2023. The nurse called to report that a 12-month old patient accidentally received 3rd dose of Kinrix and wished to know how to proceed. Kinrix was the patient's third dose of DTaP and IPV.The reporter consented to follow up. Information about the vaccine and patient were provided.  The vaccine administration facility was the same as primary reporter. The 12-month old patient accidentally received 3rd dose of Kinrix, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered.
Suffured chest pain, arm pain, and shortness of breath. Less then 24 hours after booster dose. Went to emergency room. Had ekg, xray, and blood work. Then saw my primary doctor.. I was diagnosed with Pericarditis. It is still an on going condition which has not resolved.
8/2/04: Dtap administered. 8/3/04: Pt presented with cellulitis at the immunization site. Right leg. Large swelling, warm to touch, red, and infected. Prescribed Keflex; Pt responding and better.
fever as high as 101.5, chills, severe headache, exhausted, started 6 pm and lasted through the night. fever broke in am but headache continued through the day after along with exhaustion.
Day 4 ½ after second dose. Body aches, headache, extreme chills and then fever for less than 24hrs
My arm was sore for about a day. It was also slightly swollen where I got the shot.
Patient received first dose of Pfizer on 9/12/2021 and began experiencing throat tightness, hot flashes and fatigue that day that progressed over the next 3 days to full blown swelling in face and neck. Patient reported to hospital and was found to have a blood clot in her jugular vein and was consequently treated with blood thinners and hospitalized for one week.  (per phone conversation with patient)
Reddened, slightly swollen, itchy area around site x 3 days. Slightly larger than a quarter.
Approximately 24 hours post vax fever of 103 developed, no rash, no LDC. Ten days post vax pt developed fever of 102.7, with rash on face, chest, and arms. Rash started on abdomen, no pruritis, pt has history of hives. Pt treated with Tylenol and fever decreased. No diarrhea.
Pt admitted with adrenal crisis after second dose of CORONAVIRUS COVID-19 VACCINE.  Received second dose of covid-19 vaccine on 2/25/21 at approximately 230pm, reported only sore arm in the evening of the 25th but later developed fever, chills, and malaise the next morning.  Patient reported falling x 2 but does not recall events of the day, was being cared for by boyfriend who had been giving her water throughout the day, patient was not eating. Patient was later found by a friend who is an anesthesiologist on 2/26/21 and brought to the ER. The patient reported difficulty ambulating and requiring assistance. She can only recall two falls and then sitting in a wheelchair in the ER. Initial vitals 02/26/21 at 1941 BP: 144/69 | Pulse: 97 | Temp: 102.3 °F (39.1 °C) | Resp: 20 | SpO2: 96 %  lowest BP noted 02/26/21 2306 84/46  The patient was initially given 2.5 liter of IVF and hydrocortisone 100 mg iv, zofran.  Ceftriaxone was given for possible UTI but not continued as pt did not have sx c/w UTI (urine culture was eventually negative).  Hydrocortisone 100 mg iv every 8 hours continued and pt started on ivf with bicab for acidosis.  Hypotension resolved.  Pt was tolerating oral intake with resolved nausea and vomiting.
booster dose; her husband has been presenting high sugar levels of 395 even when he gets "quite a bit of insulin"; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 75 year-old male patient received bnt162b2 (BNT162B2), administration date 07Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER: UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER: UNKNOWN), for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 07Dec2021, outcome "unknown", described as "booster dose"; BLOOD GLUCOSE INCREASED (medically significant) with onset Dec2021, outcome "unknown", described as "her husband has been presenting high sugar levels of 395 even when he gets "quite a bit of insulin"". The patient underwent the following laboratory tests and procedures: blood glucose: (Dec2021) high sugar levels of 395, notes: high sugar levels of 395. Therapeutic measures were taken as a result of blood glucose increased.  Additional information: Reporter stated that since then her husband has been presenting high sugar levels of 395 even when he gets "quite a bit of insulin" She queried if this was a reported side effects and for how long will it last. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
third injection administered; A spontaneous report was received from a healthcare professional  concerning a 96-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and  third injection administered.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 7-Jan-2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 037K20A) intramuscularly for prophylaxis of COVID-19 infection. On 9-Feb-2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 010M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 4-Mar-2021, the patient accidently received third injection .Treatment details was not reported.  The patient received both scheduled dose of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.   The outcome of event , third injection administered, was considered resolved.; Reporter's Comments: This report refers to a 96-years-old female patient who was administered a third injection administered (Extra dose administered) for mRNA-1273 (Lot# unknown). There were no reported AEs associated with this case of extra dose administered
Pt complained of itching in left arm and tongue approximately 17 minutes after immunization of MMR and HPV. Dr. was notified. 5-10 minutes later the patient's husband let nursing staff know that patient was having difficulty breathing. Rapid response was called, oxygen was applied, and vitals were taken. Patient was visibly red and had difficulty speaking. Code team responded within minutes and administered epinephrine pen, 50mg IV of benadryl, 1L bolus of lactated ringers, and 20mg of pepsid IV.  Significant tongue swelling was observed. Patient's vitals stabilized enough to transport down to ICU.  Pt remained in the ICU overnight and was transferred back to postpartum unit after 18 hours.
Swelling  and fever at injection  site. Had a rash up and down arm. Was very painful for at least 2 weeks. She was tired for a few days after.
After receiving my booster in October, I have developed three peptic ulcers. I am now taking Nexium OTC BID and Pepcid QD.
He had a heart attack; He died from blood clots and organ failure; He died from blood clots and organ failure; This is a spontaneous report received from a contactable reporter (Consumer), Program ID: (Unknown). A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 2, unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (dose 1, unknown manufacturer), for Covid-19 Immunization. The following information was reported: MYOCARDIAL INFARCTION (death, medically significant), outcome "fatal", described as "He had a heart attack"; THROMBOSIS (death, medically significant), ORGAN FAILURE (death), outcome "fatal" and all described as "He died from blood clots and organ failure". The patient date of death was unknown. Reported cause of death: "He had a heart attack", "He died from blood clots and organ failure". It was not reported if an autopsy was performed. Clinical course: The patient had had a heart attack the next morning after having his 3rd booster and died 7-10 days later after having 5 more heart attacks in a couple days following the booster. He died from blood clots and organ failure. The reporter believe the Pfizer vaccine killed his father.  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.; Reported Cause(s) of Death: He died from blood clots and organ failure; He died from blood clots and organ failure; He had a heart attack
Activation of autoimmune phenomenon / Uveitis / similar to - sarcoidosis; This case was reported by a consumer and described the occurrence of uveitis in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced uveitis (serious criteria GSK medically significant). On an unknown date, the outcome of the uveitis was unknown.   It was unknown if the reporter considered the uveitis to be related to Shingrix.  Additional details were provided as follows: Additional details were provided as follows: The age at vaccination was not applicable for this report. There were case reported for people having activation of autoimmune phenomenon following Shingrix vaccination, including uveitis. This case was linked case US2021AMR102590 and US2021AMR092345 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR102590:Same reporter US-GLAXOSMITHKLINE-US2021AMR092345:Reporter's case
PT WAS IN UNAUTHORIZED AGE GROUP TO RECEIVE THE MODERNA VACCINE (17 AT TIME OF 1ST VACCINATION)  WE DID NOT REALIZE THE ERROR UNTIL PT HAD RECEIVED THE 1ST DOSE OF VACCINE.  HE AND HIS GUARDIAN WERE CONTACTED AND HE DID NOT HAVE ANY ADVERSE EFFECTS.  HIS PARENT HAD FALSIFIED HIS DOB ON OUR ONLINE REGISTRATION TO GET HIM AN APPT AND WE DID NOT REALIZE THIS UNTIL AFTER THE DOSE WAS ADMINISTERED.  WE HAVE NEW POLICIES TO PREVENT THIS FROM HAPPENING AGAIN (CHECKING ID'S IN STORE, VERIFYING DOB MATCHES INFO PROVIDED).  PT WILL BE 18 WHEN HE IS DUE FOR HIS 2ND DOSE.
the patient had cervical cancer; the patient had an abnormal cervical smear shortly after receiving the GARDASIL; This spontaneous report was received from a female patient of unknown age, who was referring to herself. She had a son (described also as the first child), who at the reporting time was approximately 8 years old. There was no information regarding her current conditions nor concomitant therapies provided.  On an unspecified date, after the birth of her first child, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis. On an unknown date, shortly after she received the vaccine, the patient had an abnormal cervical smear and on an unspecified date, she developed cervical cancer. The outcome of the events was unknown.  The patient was convinced that quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) had caused the cancer. The causal relationship between the abnormal cervical smear and the suspect vaccine was not reported.  Upon internal review, the event of cervical cancer was considered to be medically significant.
This spontaneous report as received from a registered nurse, refers to a male patient of unknown age. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On an unknown date in June 2016, the patient was vaccinated with M-M-R II injection, (dose, route of administration, lot # and expiration date were not reported). On the same day, immediately after the vaccination, the patient fainted. Following the patient's fainting, the reporting nurse requested the emergency service, however the patient stated that he was "fine" and declined to be transported to the hospital. There was no treatment given for the adverse event and the patient did not seek any medical attention. The outcome of the event of fainting was considered as recovered/resolved on an unknown date in June 2016, however the patient's present status was unknown for the reporting nurse. The relatedness between the event and M-M-R II was not reported. Additional information has been requested.
Patient standing at check out counter with mother. Alert and oriented x3 no signs of distress. Sudden onset of brief unconsciousness less than 1 min. 1620 VS taken. Resp and HR remained reg. BP (R) arm 113/67 HR69 (L) 96/60 77HR. Resp reg 12. Unlabored. Skin sweaty to touch. (L) BP 109/71 FR 73. Standing BP 117/74 HR 77. Patient states he feels fine and drank water.
got the vaccine still got it/suspected vaccination failure; got the vaccine still got it; sick rite now; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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 and sickness. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the sickness was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and sickness to be related to Shingles vaccine.     Additional Information: GSK receipt date: 6-Aug-2022 Reporter's comment: The case was reported by the patient's sister via interactive digital media. The patient got the shot and still got them. The patient was sick right now. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Mild case of Covid, 1/7/2022.  Sore throat, low fever, congestion, lasting 2-3 days.  Had three full dose Moderna shots: 1/30/2021, 3/1/2021, and last dose on 8/26/2021.  Quarantined.  Full recovery.  Consulted Dr. via email.  He offered some drugs, but I did not feel they were needed.  No visit in person.
I had a breakthrough case of Covid 19 what started out like an upper respiratory infection with fever and sore throat coughing and sinus congestion. I had an irregular heartbeat or rapid heartbeat with low blood sugar. Lung congestion as well.
The vial was initially stored in the refrigerator on 13-Apr-2023, vial was first punctured on 13-Apr-2023 on 10 AM and vaccine was administered on 14-Apr-2023 08:15 AM.; No adverse event; Moderna COVID19 bivalent vaccine dose was administered after 12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID19 bivalent vaccine dose was administered after 12 hours post puncture), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Apr-2023, vial was first punctured on 13-Apr-2023 on 10 AM and vaccine was administered on 14-Apr-2023 08:15 AM.) and NO ADVERSE EVENT (No adverse event) in a 90-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 067h22a) for COVID-19 prophylaxis.   No Medical History information was reported.    On 14-Apr-2023 at 8:15 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Apr-2023 at 8:15 AM, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID19 bivalent vaccine dose was administered after 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Apr-2023, vial was first punctured on 13-Apr-2023 on 10 AM and vaccine was administered on 14-Apr-2023 08:15 AM.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID19 bivalent vaccine dose was administered after 12 hours post puncture), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Apr-2023, vial was first punctured on 13-Apr-2023 on 10 AM and vaccine was administered on 14-Apr-2023 08:15 AM.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna COVID19 bivalent vaccine dose was administered after 12 hours post puncture) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Apr-2023, vial was first punctured on 13-Apr-2023 on 10 AM and vaccine was administered on 14-Apr-2023 08:15 AM.).    No concomitant medications were reported.  Vial size was 5 mL. Post puncture the vial was on room temperature until 3 pm 13-Apr-2023 then the vaccine was put in a syringe in a fridge until administration of the dose on the 14-Apr-2023 8:15 AM. Vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was 4 hours.  No treatment information was provided.
Narrative:  Patient received his second Shingrix vaccine on 5/28/21 and 2 to 3  hours later he had c/o a headache and chest pain that resolved without treatment.  No documentation of any reactions when he received his first vaccine on 7/5/19.
10/19/12 - Received flu vaccine in (L) delt. 10/20/12 Began to experience muscle spasms in chest. Arm spasms fluttering down arm across chest. 11/02/12 - Reported to clinic symptom worse, decreased sleep, increased spasms.
Left eye droop (2hours) Unable to swallow or talk (30seconds intermediate for 4 hours)  Both arms numb (2 days)  Severe headache (14 days )
Woke up the next morning with feet on fire.  I thought it was gout.  That lasted 3 weeks.  Two months after vaccine my joints on both hands started to ache and throb.  Its been 5 months since initial injection.  My joints on my hands continue to hurt.  I wake up with trigger finger in both my index fingers.
"covid arm".  Swelling, itching, burning, fevered, tenderness in injection site 7 days after vaccination.  Significant fatigue since vaccination 8 days ago.
punctured vial that was stored in the refrigerator beyond 12 hours was given to a patient; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (punctured vial that was stored in the refrigerator beyond 12 hours was given to a patient) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (punctured vial that was stored in the refrigerator beyond 12 hours was given to a patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (punctured vial that was stored in the refrigerator beyond 12 hours was given to a patient) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment related information was provided.   Reporter did not allow further contact
After injected into arm,  when the needle retracted into the syringe,  vaccine dripped down the patient's arm. Patient did not receive the full dose of vaccine. At medical director direction, an additional 1/2 dose administered to vaccine recipient.
Pt experienced head congestion, arthralgia, swelling & tenderness of the lt axilla lymph nodes (5cm x 3cm) p/receiving Flu vax in lt deltoid; tx ASA 4 times day; Dx diffuse lymphocytic lymphoma based on tissue biopsy & bone marrow;
Headache; Low grade fever 99.8 or there about; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (Headache) and PYREXIA (Low grade fever 99.8 or there about) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced HEADACHE (Headache) and PYREXIA (Low grade fever 99.8 or there about). On 08-Jan-2021, HEADACHE (Headache) and PYREXIA (Low grade fever 99.8 or there about) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, Body temperature: 99.8 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included acetaminophen for the events.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt. received PNEUMOVAX vaccination on 9/27 & returned to us on 9/29. Pt's arm on inner side was red, inflamed, tender, & warm to touch. Pt. went to clinic & was diagnosed with cellulitis. AUGMENTIN and Ibuprofen was prescribed.