chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3rd dose of Shingrix was inadvertently administered; dose 2 on 7/28/2020; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number 3B2YJ, expiry date 16-AUG-2025) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 15th October 2019).   On 22-SEP-2023, the patient received the 3rd dose of Shingrix. On 28-JUL-2020, the patient received the 2nd dose of Shingrix. On 28-JUL-2020, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: dose 2 on 7/28/2020). On 22-SEP-2023, the patient experienced extra dose administered (Verbatim: 3rd dose of Shingrix was inadvertently administered).  The outcome of the extra dose administered and drug dose administration interval too long were unknown.   Additional Information: GSK Receipt Date: 22-SEP-2023 The pharmacist stated a 3rd dose of Shingrix was inadvertently administered.  The patient had received 1st and 2nd (which was also a late dose).  The first 2 doses were administered at another pharmacy. The vaccine administration facility was the same as primary reporter. The patient received late 2nd dose, which led to lengthening of dose schedule. The patient was administered with 3rd dose, which led to extra dose administration.  The reporter consented to follow up via postal.
Anaphylaxis; allergic reactions; She began feeling an itching sensation all over; This is a spontaneous report from a Pfizer-sponsored program. A contactable pharmacist (patient) reported that a 49-old-year female patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 27Oct2021 between 5:30 and 6:00 PM (Batch/Lot Number: EW0178) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced anaphylaxis and allergic reactions on an unspecified date. On 28Oct2021, she began feeling an itching sensation all over, declined hives. The outcome of the events was unknown.
72-year-old male with past medical history of melanoma status post excision in 2015 and hypertension presented to the emergency department complaints of shortness of breath.  Patient reports that he was usual state of health until approximately 1.5 weeks ago when he started noticing some shortness of breath along with cough.  Patient reports that he got fully vaccinated with Moderna against COVID-19 on February 19, 2021.  Patient reports that his symptoms were worrisome therefore, couple of days later, he got tested positive for COVID-19.  Patient reports that he initially isolated and had only mild cough with congestion however, his symptoms continued to worsen.   Tested positive on 9/14/2021 72-year-old male with past medical history of melanoma status post excision in 2015 and hypertension presented to the emergency department complaints of shortness of breath.  Patient reports that he was usual state of health until approximately 1.5 weeks ago when he started noticing some shortness of breath along with cough.  Patient reports that he got fully vaccinated with Moderna against COVID-19 on February 19, 2021.  Patient reports that his symptoms were worrisome therefore, couple of days later, he got tested positive for COVID-19.  Patient reports that he initially isolated and had only mild cough with congestion however, his symptoms continued to worsen.  Patient has had multiple episodes of pneumonia in the past.  He tried to wait as he thought his symptoms would improve.  Went to get regeneron 4 days ago.  Patient reports that his symptoms continued to worsen and he has had multiple episodes of fevers/chills along with cough and congestion.  Also has had muscle aches and weakness.  Has had very poor oral intake.  He was not improving therefore, his daughter convinced him to come to the emergency department for further evaluation. Upon arrival to the emergency department, patient was found to have acute hypoxemic respiratory failure secondary to sepsis in the setting of COVID 19 pneumonia and possible superimposed bacterial pneumonia, hyperglycemia, uremia, acute renal failure, elevated troponin/type 2 MI, elevated BNP, and lactic acidosis.
I felt ok at first, then I got really hot, then it went away pretty quick. My face kinda felt funny. After about 20 minutes, I couldn't feel the left side of my face and the left side of my body was like with you go to the dentist and have lidocaine.  The next day I felt like I had been hit by a mack truck. I felt like that until about January 6, 2021. I also had SOB, joint pain, headache, extreme fatigue and body aches, sore arm and redness at the injection site.
18MAR95 1130AM mom states pt body felt hot to touch-body started jerking both eyes rolled back-then leaned against mom & body felt limp; also states pt couldn't hear, appearing weak & tired;exp 3 episodes lasting 60sec;t105
Inadvertently put in the freezer. It has not been administered.; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted product storage error in a patient who received Herpes zoster (Shingrix) (batch number 299J9, expiry date 1st July 2023) for prophylaxis.   On an unknown date, the patient did not receive Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted product storage error. On an unknown date, the outcome of the intercepted product storage error was unknown.   Additional Information: GSK Receipt Date: 23-JUN-2022 Reporter's Comment: Pharmacy intern reported that the Shingrix was inadvertently put in the freezer. It had not been administered. The reporter did not consent to follow-up. Additional supportive information: The Shingrix vaccine was inadvertently put in the freezer. It had not been administered, which led to intercepted product storage error.
On March  19th I started experiencing tingling and pain to my left thigh and leg, on the 20th I had sharp pain behind my left knee without any mechanism of injury. On Monday March 22nd I started having a painful rash that formed behind my left knee and continued pain to my left thigh which radiated down my left leg. The rash worsened and started having lesions/ bumps that formed. I contacted a provider on March 26th due to worsening symptoms. I used the Clinic and the provider gave the diagnosed of shingles. I was placed on acyclovir 800mg po every 4hrs for a week. I have no prior history of shingles nor any exposure to anyone with shingles.
shortness of breath; COVID-19 positive diagnosis; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (shortness of breath) and COVID-19 (COVID-19 positive diagnosis) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COPD.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced DYSPNOEA (shortness of breath) and COVID-19 (COVID-19 positive diagnosis). On 26-Mar-2021, DYSPNOEA (shortness of breath) had resolved. At the time of the report, COVID-19 (COVID-19 positive diagnosis) outcome was unknown. Unknown    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that he was still under quarantine, but felt well. Patient reported that he was originally scheduled to receive his second Moderna dose on 25Mar2021, but it had been rescheduled for 5Apr2021 due to his isolation.   No concomitant medication reported.  Patient went to emergency room visit for treatment.
Patient was administered 1 ml on their 1st covid dose. The correct dose is 0.5ml. No adverse events were reported. This was discovered shortly after the dose was administered.
AFIB; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (AFIB) 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, the patient experienced ATRIAL FIBRILLATION (AFIB) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (AFIB) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was  not reported. Relevant concomitant medications were not provided by the reporter. It was reported that "two people that work for reporter had the vaxx had to quite shortly after they got the vax because they developed AFIB. Their lives have changed".  Company Comment: This case concerns an unknown age and unknown gender patient with no relevant medical history, who experienced the unexpected event of atrial fibrillation. The event occurred unknown number of days after a dose of mRNA-1273 vaccine.  It is not clear from the source document whether this was a first or second dose. The rechallenge was unknown since there's not enough information to assess this in the source document. The benefit-risk relationship of the vaccine not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2021-361454 (E2B Linked Report).; Sender's Comments: This case concerns an unknown age and unknown gender patient with no relevant medical history, who experienced the unexpected event of atrial fibrillation. The event occurred unknown number of days after a dose of mRNA-1273 vaccine.  It is not clear from the source document whether this was a first or second dose. The rechallenge was unknown since there's not enough information to assess this in the source document. The benefit-risk relationship of the vaccine not affected by this report. US-MODERNATX, INC.-MOD-2021-361454:Crosslinked case (same reporter)
Information has been received from a male consumer who on 26-JAN-2011 and 26-MAR-2011 was vaccinated with his first and second doses of the GARDASIL vaccine in an unknown site (lot number not reported). The patient reported he experienced "getting herpes (not the human papillomavirus) after receiving all three doses of the GARDASIL shots." The company representative spoke to the GARDASIL helpline regarding the patient and was informed, "he purchased his first dose 26-JAN-2011 and received his second injection 26-MAR-2011. He sent in his rebate forms on 06-APR-2011, that should take six to eight weeks to process." The patient's outcome was unknown at the time of the report. The patient's event of getting herpes (not the human papillomavirus) after receiving all three doses of the GARDASIL vaccine in relation to therapy with the GARDASIL vaccine was not provided. Additional information has been requested.
Case number PHEH2016US023343, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 41 years old patient of unknown gender. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml, intramuscularly, in left arm on 12 Jan 2016. On 12 Jan 2016, FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursions was administered to patient. The nurse stated that, no adverse event was reported following this medication error.
I got puffy eyes after getting vaccinated; This spontaneous case was reported by a consumer and describes the occurrence of PERIORBITAL SWELLING (I got puffy eyes after getting vaccinated) 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.    In July 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced PERIORBITAL SWELLING (I got puffy eyes after getting vaccinated). At the time of the report, PERIORBITAL SWELLING (I got puffy eyes after getting vaccinated) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The Consumer stated that he or she received Moderna vaccine three weeks ago. The Consumer stated that they got puffy eyes post-vaccination and it has been three weeks.  No concomitant product use was provided by the reporter.   No treatment medications were reported.
Momentarily lost consciousness within seconds following vaccination. Remained pale and light-headed with low blood pressure for at least 15 minutes after regaining consciousness. Paramedics came about 15 minutes after vaccination and removed him from the store.  I called the patient this afternoon and he said he is okay today but was dehydrated yesterday.
arm got hot after second dose; arm got red after second dose; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (arm got hot after second dose) and ERYTHEMA (arm got red after second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 21-Feb-2021, the patient experienced ERYTHEMA (arm got red after second dose). On an unknown date, the patient experienced FEELING HOT (arm got hot after second dose). The patient was treated with CORTISONE for Adverse event, at a dose of unk, CREAM. At the time of the report, FEELING HOT (arm got hot after second dose) and ERYTHEMA (arm got red after second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment medication of the patient included - Aloe and Moisturizer.
Post vaccine administration pt presented to the PSR desk with c/o dizziness and difficulty breathing.  Nurse immediately escorted pt to exam room and she was assessed by the Physician.  She was pale, diaphoretic and dyspneic.  VS - BP 145/93, pulse 104, O2 sat 83% - pt was put on oxygen.  3:48 the Code Team and 911 called. She then began seizure activity which subsided but she continue to be dyspneic.  EKG obtained - Normal Sinus Rhythm.  Normal Saline IV started - bolus of 250ml given, 25mg Benadryl given IV push.  VS - 121/77, pule 106, O2 100%, glucose 103.  Paramedics arrived, report given and patient transported to hospital.  Released same day.
Patient given expired vaccine Trihibit (DTAP and HIB).  Attempted to contact family by phone, unsuccessful, will contact by mail.  Spoke with Mom 08/08/2005 patient will return at 18 months for repeat vaccines.
had trouble hearing the previous consultant and the hold music; rheumatoid nodules; Extremely itchy/ itching; she started having blisters,rash/rash like blisters; rash started on her head when she was working outside and progressed to the tops of her arms, back, hands and surgical sites; Initial information received on 11-Jun-2020 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case involves a 59 years old female patient who developed blisters, rash/rash like blisters (rash vesicular) ,rash started on her head when she was working outside and progressed to the tops of her arms, back, hands and surgical sites (rash) and extremely itchy/ itching (pruritus), trouble hearing the previous consultant and the hold music (hypoacusis) and rheumatoid nodules (rheumatoid nodule), while she received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history included Biopsy.  On an unknown date somewhere in July, the patient received a dose of suspect RABIES (HDC) VACCINE (lot number and expiration date not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date in Oct-2019, the patient developed a non-serious blisters, rash/rash like blisters (rash vesicular) ,rash started on her head when she was working outside and progressed to the tops of her arms, back, hands and surgical sites (rash) and extremely itchy/ itching (pruritus) (Unknown latency) following the administration of RABIES (HDC) VACCINE. On an unknown date, the patient developed a non-serious had trouble hearing the previous consultant and the hold music (hypoacusis) and rheumatoid nodules (rheumatoid nodule) (Unknown latency) following the administration of RABIES (HDC) VACCINE.  Patient also stated that she has been on steroids for blisters and that really helps but it all comes back when she goes off the steroids. States the rash, blisters and itching have been a little better over time but she hesitates to do the acceleration treatment. Mentions she took a couple of doses in March but stopped in February 2020, her liver enzymes were climbing higher and higher and came down when she stopped taking the medication.  Relevant laboratory test results included: On an unknown date: Hepatic enzyme increased:  climbing higher and higher On an unknown date: Lymphocyte count - fairly low  Final diagnosis was rash vesicular, rash, pruritus, hypoacusis and rheumatoid nodule.    An corrective treatment  of steroids was received.  At the time of reporting, the patient was recovering from pruritus, rash and rash vesicular, while the outcome was unknown for  the other two events.  There will be no information on the batch number for this case.
The following day after the 2nd Pfizer covid vaccine, I have SEVERE arthralgias, myalgias, malaise & chills (no fever).
Pt received Moderna vaccine on 5/4/21. Then again on 6/1/21. Was inadvertently also vaccinated with Pfizer vaccine on 6/1/21 so had both Moderna and Pfizer vaccines on the same day in different arms
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via Pfizer concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805025 expiry: UNKNOWN) dose was not reported, 1 total, administered on 18-MAR-2021 on left arm for covid-19 prophylaxis. Concomitant medications included statin. The patient received two doses of non-company suspect vaccine (Pfizer covid-19 vaccine) tozinameran (Dose number in series 2) (form of admin and route of admin were not reported, batch number: 330268D expiry: UNKNOWN) dose was not reported, administered on 08-NOV-2021 on left arm and patient received another dose (form of admin and route of admin were not reported, batch number: LP7139 expiry: UNKNOWN) administered on 01-AUG-2022 on left arm for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 2). On 17-OCT-2022, the patient experienced (Mild symptoms and tested positive for COVID. Runny nose, slight fever and cough) confirmed covid-19 infection (Dose number in series 2) and had confirmed clinical vaccination failure (Dose number in series 1). On 18-OCT-2022, Laboratory data included: (Flowflex) COVID-19 virus test Positive (nasal swab). The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure and revaccination with different covid-19 vaccine was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000257175.; Sender's Comments: V0: 20221055802-confirmed clinical vaccination failure . The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.
warm, erythemic area around inj site;hard area (lump) around inj site smaller than red area;
Chills x 4 days. Localized red/warm/itch x 7 days. Rx'd ice, Tyl. Benadryl.
Started with itching on the right side of his back that broke out into a shingles like rash and spread to his chest. Was seen by his dermatologist, who confirmed shingles and was given anti vral medication and was improved within 2 weeks.
Site of injection is red and swollen; site of injection become blue and black; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Mar-2021 and was forwarded to Moderna on 02-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Site of injection is red and swollen) and VACCINATION SITE DISCOLOURATION (site of injection become blue and black) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Site of injection is red and swollen) and VACCINATION SITE DISCOLOURATION (site of injection become blue and black). At the time of the report, VACCINATION SITE SWELLING (Site of injection is red and swollen) and VACCINATION SITE DISCOLOURATION (site of injection become blue and black) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
My husband is totally weak, he cannot walk or be out of bed longer than 15-30 minutes.  ER said he probably had a virus.
Significant pain, fever up to 103, myalgias, later developed redness at site.
Case number PHEH2014US024993, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 75-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 25 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
Pain day of shot and continued to get worse when moving arm, chronic pain (ongoing) shooting pain. Bad pain at night can't sleep.
Fever chills and body pains starting at 4 hours after vaccine shot and lasting into next day 32 hours after vaccine shot was given. The symptoms are ongoing currently.  Vaccine was- Moderna COVID-19 Vaccine
Patient was given 0.2ml of Covid-19 vaccine prior to reconstitution. Patient waited 15 min after vaccination and had no side effects. We discovered the error at about 4pm and contacted the covidvaxinquiry line for further instruction. Notified parents and child was doing fine still at this point. Patient received a total of 30mcg of Covid-19 vaccine rather than the 3mcg had it been reconstituted. Patient was also instructed to register on V-Safe and told us they will do that.