chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got shingles a couple months later/suspected vaccination failure; got shingles a couple months later; This serious 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got shingles a couple months later/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles a couple months later). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 18-SEP-2023 The case was received from the consumer interactive digital media. The reporter stated that two people (patient) in the neighborhood got the shingles vaccine and they were also the only two people in the neighborhood who got shingles a couple months later. The reporter stated that people were starting to wake up. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting. This case is linked with US2023AMR128169, reported by same reporter. The follow-up would not required per process.; Sender's Comments:  US-GSK-US2023AMR128169:Original Case : US2023AMR128156
Patient had SOB, however also had COPD patient had to visit ER for medication. Could not be determined if vaccine caused SOB.
Peri-oral Angioedema:   Mild but obvious angioedema of left lower lip started around 30 hours post-injection on 1/29/21, which subsided overnight and migrated to involve predominantly the right lower lip the following day (1/30/21), which similarly subsided spontaneously over a few hours, followed with very mild (noticeable to patient but less obvious to others) angioedema of the upper lip appearing on morning of 1/31/21, fully resolved by around noon that day and has not recurred.
We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in a 30-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). In October 2021, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.  The vial was initially stored in the refrigerator on 24 Sep 2021 . The vial did not undergo any temperature excursion.
Shingles like rash /rash occurred on her neck and back; This non-serious case was reported by a consumer via call center representative and described the occurrence of vesicular rash in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vesicular rash (Verbatim: Shingles like rash /rash occurred on her neck and back). The outcome of the vesicular rash was resolved.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.     It was unknown if the company considered the vesicular rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 02-JUN-2023 The patient received 1st dose about a year ago. After the vaccination, she got a shingles like rash off and on over the year. She informed that she was never diagnosed with Shingles and rash occurred on her neck and back (no side indicated). She waited to get her second Shingrix vaccine due to these symptoms, which ended up later than the recommended 6 months. She received the 2nd dose on June 02, 2023 on the left arm. The reporter did not consent to follow up the health care professionals (HCP).
Tried to urinate; cannot urinate; Felt my mouth was extremely dry; This is a spontaneous report from a contactable consumer reporting for her/him self. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient stated, "I got my vaccine, first vaccination shot yesterday, and I am having some problems. Everything worked fine, except this morning or very early in the morning (15Jan2021), I tried to urinate and I cannot urinate. And I felt my mouth was extremely dry." The outcome of the events were unknown.   Information on the lot/batch number has been requested.
Within 15 minutes of vaccine administration I experienced itching in my throat. Within the next hour, I experienced widespread itching in my ears,eyes, nose, throat, arms, legs and at the site of administration. I also experienced a skin rash on the right arm and some mild wheezing. All  symptoms remained for a total of 4-6 hours and were eventually relieved with Benadryl and xyzal. I followed up with my allergist a couple of days after the episode and she stated that the recommendations had changed for people with suspected allergy to the vaccine and that she was no longer skin testing to see if an allergy was present.
Feeling lightheaded; Lethargic; Arm weakness; Sluggish when answering questions; This is a spontaneous report from a non-contactable healthcare professional. A 66-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration on 22Feb2021 at 09:15 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient previously received influenza vaccine (MANUFACTURER UNKNOWN) (reported as H1N1 vaccine) for an unknown indication on an unknown date and experienced allergy to vaccine. On an unknown date in Feb2021, following the injection, the patient reported feeling lightheaded, lethargic, arm weakness, and she was sluggish when answering questions. The events resulted in emergency room/department or urgent care. The clinical outcome of the events feeling lightheaded, lethargic, arm weakness and sluggish when answering questions was unknown at the time of this report.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Upon review of our records, we discovered that patient received two Pfizer pediatric vaccines 12 days apart. The standard is 21 days apart.  The patient was brought to the center for a scheduled appointment on 12/27/21 by his father and on 01/08/22 for a walk-in appointment by his mother. Each parent listed the same phone number but different e-mail addresses when registering this patient. The second intake form indicates he was to receive his 1st vaccine. This box is usually (but not always) filled out by our administrative staff. An orange sticker indicating the proper vaccine was placed on the form with the number "1" on it indicating the patient was here for his first dose.  On his first intake form, only his father's surname was used whereas on the 2nd visit, both surnames where listed. I do not know if the slight difference in surnames played a role when admin staff should have checked his name in the system which should have indicated when he already received his first dose.  Patients or admin staff register the patients into the system which is separate from the system. I don't believe the vaccine applicator would have seen the previous dose given when the patient reached them.  At this time I don't have any indication the computer system gave any warning to the vaccinator that the dose was being applied prematurely. This makes me wonder if the difference in surnames or failure to check the name broadly resulted in this error.  As of today, system lists his name with both surnames and both vaccines listed.
Injection site soreness immediately after injection at 7am. General body aches progressed throughout the day. By 6pm same day all of the following: injection site pain, joint pain, muscle aches, fever>100deg, upset stomach, fatigue and mild headache. All symptoms lasted from 12/30 to 1/1. Fever peaked at 102deg.
This spontaneous report as received from a consumer via company representative refers to her 10 month old daughter. The patient's medical history included familial risk factor of autoimmune disorders. The patient concurrent conditions were not provided. On an unknown date, the patient was vaccinated with a dose of M-M-R II (route, lot # and expiration date were not provided). Concomitant medication information was not provided. On an unknown date, the patient experienced pyrexia described as a fever of 105 degrees and pain in extremity. The patient sought medical attention by an office visit. On an unknown date, the epinephrine levels were measured but the results were not provided. At the time of the report, the outcome of pain in extremity and pyrexia was unknown. Additional information is not expected. There was no consumer information to contact for follow-up.
Patient is a 82 y.o. female who presented from home on 8/29/2023 with CC found down by family, AMS, diarrhea. Found to be hypoxic, hypotensive, and encephalopathic. Workup revealed COVID-19 and possible PE. She had a relatively quick recovery after initiation of supportive care /IVF which makes me suspect her mental status/dehydration was the main driver of her hypoxia. Steroids and remdesivir discontinued . Discharged home on RA. Started on AC for her possible PE. COVID-19  - Presented with: confusion, hypoxia, diarrhea (found nearly unresponsive with diarrhea noted around the house) - Symptom onset: unclear  - Positive COVID-19: 8/29 at Facility - Vaccination status: vaccinated X 5, last was moderna 5/2022  - CTPE on admission showed small RUL PE but o/w no acute process  - Oxygen status: 2L -- >1L NC -- >RA - Decadron: Yes. Stopped early - Remdesivir: Yes. Stopped early  - DVT prophylaxis: Currently on full anticoagulation   Acute PE - possible small acute RUL PE seen on CTPA vs artifact - given RF covid plan to treat as provoked pe - no prior pe - no CT e/o RHS - venous duplex negative for DVT  - eliquis 10 bid x 7 then 5 bid , plan 3 mo , probably can stop after    Rhabdomyolysis - due to being down for unknown period of time  - CPK 1823 on admission, continues to trend down - stop IVF   AKI - Cr 1.34 on admission, baseline < 1 , resolved with IVF - AM RFP   Lactic acidosis  - lactic acid 2.3 related to hypovolemia  - resolved with IVF   Urinary retention - related to acute illness/immobility - resolved - of note ua/culture checked and in process, hold on treatment with abx given her sx resolved and she has no dysuria, fevers, etc Abnormal CT abd/pelvis and RUQ US - GB distention noted on both CT abd/pelvis and RUQ US without gallstones. Polyps were noted on RUQ US - GS evaluated, monitor for sx, if remains asymptomatic OP follow up   Addison's disease - BP stable and Na 136, K 4.6 - hold prednisone while on decadron, transition back to pred 5 q am and pred 2.5 q pm   - cont fludrocortisone 0.1 daily   Hypothyroidism - cont levothyroxine 112 mcg daily
PT CAME IN ON 9/12/21 FOR A FLU SHOT BUT RECEIVED THE MODERNA COVID SHOT INSTEAD. THE PT SAID THAT THEY NEEDED THE SHOT FOR AN APPLICATION SUBMISSION FOR A FOSTER CHILD AND WOULD RETURN TO THE STORE WITHIN THE NEXT DAY OR SO FOR THE CORRECT VACCINE.  SHE WAS CONCERNED THAT THEY RECEIVED THE JOHNSON AND JOHNSON VACCINE IN APRIL 2021 AT PHARMACY.  THE PHARMACIST ON DUTY CALLED CDC AND SPOKE WITH A NURSE WHO CONFIRMED THAT WE NEEDED TO CALL AND REPORT THE VACCINATION ERROR  AND TO NOT ADMINISTER A SECOND DOSE OF MODERNA.
none COVID 19 VACCINE EXPIRED 11/2022 GIVEN 12/10/2022
anaphylaxis following vaccine in 5/5/21, POA states pharmacy reported, otherwise (+) covid home test on 1/26, (+) COVID PCR test on 2/22/21
Moderna COVID-19 Vaccine EUA.   Fatigue, slight chills and headache during the 2nd day after shot. Slept a lot.   Extreme arm pain.  Late in the day 6:00-ish - extreme light headedness, nausea and vomiting.   Returned to bed and rested for about 30 minutes.  Improved greatly and quickly.   Ack to normal by 3rd day.    Arm discomfort continued for a few more days.
infanrix instead of boostrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old female patient who received DTPa (Infanrix) (batch number AK443, expiry date 16-SEP-2023) for prophylaxis.   On an unknown date, the patient received Infanrix. On an unknown date, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: infanrix instead of boostrix). The outcome of the wrong vaccine administered was 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: 6-Jun-2023 The reporter consented to follow-up. The patient received an infanrix dose but the patient was supposed to receive a boostrix dose, which led to wrong vaccine administered.
Error resulting in administration of expired vaccine; Expired vaccine used; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 11-Oct-2021, PRODUCT ADMINISTRATION ERROR (Error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. No treatment medication was reported by reporter.
DIZZINESS; This spontaneous report received from a patient concerned a 46 year old male. The patient's weight was 180 pounds, and height was 64 inches. The patient's past medical history included gout, and concurrent conditions included allergy to grass, and allergy to hay. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness on 09-APR-2021. This report was non-serious.
Microscopic Colitis; Diarrhea/watery stool; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS MICROSCOPIC (Microscopic Colitis) and DIARRHOEA (Diarrhea/watery stool) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 047A21A) for COVID-19 vaccination.     The patient's past medical history included Shingles and Hepatitis.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced DIARRHOEA (Diarrhea/watery stool) (seriousness criterion intervention required). On an unknown date, the patient experienced COLITIS MICROSCOPIC (Microscopic Colitis) (seriousness criterion medically significant). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency; BISMUTH SUBSALICYLATE, CALCIUM CARBONATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE;CALCIUM CARBONATE]) at an unspecified dose and frequency; BISMUTH SUBSALICYLATE (KAOPECTATE [BISMUTH SUBSALICYLATE]) at an unspecified dose and frequency and Budesonide at a dose of 9 mg. At the time of the report, COLITIS MICROSCOPIC (Microscopic Colitis) and DIARRHOEA (Diarrhea/watery stool) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jun-2021, Colonoscopy: microscopic colitis (Inconclusive) Microscopic Colitis.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient also takes an unknown "eye supplement."  Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Developed rash day 5 on scalp and then more lesions and fever day 6 and 7 unable to eat, body aches, kidney infection, now lesions in ears, mouth and back. To Ed for hydration and released.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: after receiving the Moderna Covid 19 vaccine, the patient passed out in the chair. When I got to him, he was unresponsive, but within seconds he became alert. He said he had a history of passing out after medical procedures (when seeing a md after finger surgery). He layed down for about 20 minutes, then sat back in chair. About 30 min after passing out, he said he was dizzy and passed out a 2nd time. He became alert after about 10 seconds. He was here about 30 more min then felt ok and left.
20APR93 devel cluster of pimple like lesions over vax area w/ sl swelling & circle redness; 2.5 cm @ site w/joint erythema; no induration or tenderness;
Pt had extremely sore shoulder (R) within 12 hours of injection on 8/1/18 at 8:30 AM. Gradually both shoulders became very achy with general malaise. Her pain has since traveled also to pelvic girdle, often extreme. Pt very debilitated.
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 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: EN6198), in left arm, on 30Mar2021 as dose 2, single (Lot number: ER8727), in left arm and on 26Sep2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "anxiety" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT, start date: 01Jun2021. The patient has no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Negative, notes: Rebound of positive test on days 9-10 since symptom onset, following negative tests on day 7-8; Positive, notes: Rebound of positive test on days 9-10 since symptom onset, following negative tests on day 7-8. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid (treatment start date: 20Sep2022, treatment stop date: 24Sep2022, Lot number: 2815236).
Client received three vaccines at approximately 9:53 AM.  Client's guardian alerted nurse that client was complaining of itching at all three injection sites at approximately 10:05 AM. Nurse inspected injection sites and noted small skin-colored welts at all three injection sites (10:05 AM). Supervisor notified of incident and nurse protocol consulted. Nurse administered 10 mL of diphenhydramine suspension to client at 10:14 AM. After 15 minutes of observation, client confirmed that itching had completely subsided. Client's guardian encouraged to continue observing client for further allergic symptoms, to administer more diphenhydramine in 6 hours if needed, and to consult pediatrician as soon as possible about incident.
Next morning and all day - headache, achy, nauseous, fatigue, arm soreness. 2 days after - fatigue and arm soreness. 4 days later - left armpit lymph node tender; worsened becoming VERY swollen and tender 5th day until now, 6 days after still with no reduction swelling or pain.
first dose of Shingrix in October of 2019 / second dose in February of 2021; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in October 2019).   In February 2021, the patient received the 2nd dose of Shingrix. In February 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 follow: This case was reported by consumer herself. The age at the vaccination was not reported. The patient received her 2nd dose later than the recommended interval, which lead to lengthing of vaccination schedule. The patient did not consent to follow-up.