chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient given pediatric Influenza. Parent notified and encouraged to bring patient back for correct dosage of Influenza.
needle stick; This non-serious case was reported by a other health professional via call center representative and described the occurrence of needle stick/puncture in a female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number MC355), (batch number A75G3) and (batch number 9E5KE) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent. On an unknown date, an unknown time after receiving FluLaval Quadrivalent, the patient experienced needle stick/puncture (Verbatim: needle stick).  The outcome of the needle stick/puncture was not resolved.   It was unknown if the reporter considered the needle stick/puncture to be related to FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device.     It was unknown if the company considered the needle stick/puncture to be related to FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device.   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: 12-OCT-2023 The reporter is the nurse manager who stated one medical assistant received a needle stick after administering the Flulaval vaccine to a patient. No harm was done to the patient. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter.
I26.99 ACUTE PULMONARY EMBOLISM 5/8/2022 PNEUMONIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/8/2022 PNEUMONIA I26.99 ACUTE PULMONARY EMBOLISM 5/8/2022 COVID-19 PNEUMONIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/8/2022 COVID-19 PNEUMONIA I26.99 ACUTE PULMONARY EMBOLISM 5/8/2022 SYNCOPE AND COLLAPSE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/8/2022 SYNCOPE AND COLLAPSE
pt recv vax 15JAN96 & pt exp being covered w/chickenpox;
child broke out w/single blister pock @ inj site on thigh on 8/23/99 had no temp-no other areas-sites sl itchy-no other s/s;
02/06/22 presents to Birth Center Triage for "labor". PMHx of "Anemia"
Patient received the second dose too early; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose too early) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 048B21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ISOSORBIDE for an unknown indication.   On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose too early). On 06-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose too early) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: Non-significant Follow-up added to include certified mail returned. Phone Number, Fax Number and e-mail address updated in Reporter Information tab and pregnancy status updated in patient tab.
When I got the second shot, o felt it burn my arm and immediately my arm felt heavy was paralyzed; When I got the second shot, o felt it burn my arm and immediately my arm felt heavy was paralyzed; When I got the second shot, o felt it burn my arm and immediately my arm felt heavy was paralyzed; My lymph nodes swelled up and that lasted a few days; This is a spontaneous report from a contactable consumer or other non hcp. A 38-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection,Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 15Apr2021 13:15 (Age at time of vaccination 38-years-old ) as 2ND DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history, concomitant medications was not reported. The patient previously taken historic vaccine first dose BNT162B2(PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number: ER8730) administered in Arm Left on 24Mar2021 01:45 pm for covid-19 immunization. The patient did not administer other vaccine in four week and no other medication in two week. The patient was not covid vaccination prior and post vaccination. On 04Apr2021 the patient underwent lab tests and procedures which included sars-cov-2 test: negative Covid test type: Nasal swab  Covid test name: PCR  Covid test result: Negative. On an unspecified date the patient experienced when i got the second shot, o felt it burn my arm and immediately my arm felt heavy was paralyzed, my lymph nodes swelled up and that lasted a few days. The outcome of events was recovered with sequelae.  Information about the Lot/batch number has been requested.
No adverse effects. Patient and patient's mother arrived for their second Pfizer shot at day 21 of first shot. Patient's mother stated that her birthday is actually year 2004 which has the patient at the age of 14  when she received the first shot. The mother admitted to being dishonest about her age and about bringing her insurance and ID card on the first visit because "she was so sick from a prior H1N1 infection that she had to get it then even though she didn't qualify." The mother also stated that she accepted any consequence of her dishonesty but it was for her daughter. I had called Coordinator in Charge to initially verbally report the incident and to get direction on the second shot. Since the patient currently qualifies at the current time we administered the second vaccine and also filing a VAERS report. Mother's address is the same as daughter.
I have had a reoccurring rash for two weeks. It started two days after my flu shot. I've also had chest pains every few days.
(forearm/elbow) L arm redness/swelling not near injection site, c/o "felt hot". Benadryl provided per fellow employee, advised to apply ice pack, no c/o SOB. 10:00 AM- HR sent email to employee and employee states "she is feeling fine." 11:10 AM- per employee, "I feel fine," local reaction resolved with Benadryl and fluids.
Patient presents post vaccination complaining of heart palpitations, new sore throat, redness and pain at injection site and reporting "feeling different". RN triaged patient and took patient to ER for further evaluation.
11/12/21 presents to EC ED for "abdominal pain" "mainly in the epigastric region". PMHx "HTN, Obesity, and OSA"
About 5-10 minutes after the vaccine I began to feel extremely dizzy and began sweating. About 10 minutes 10 minutes later I also noticed that the left side of my face and throat began to get swollen and sore. I was taken to the ER via ambulance and was treated with prednisone and pain medications
Red, slightly swollen near injection site. No treatment yet. Advised Pt to take benadryl and see if things improved, worsened, no change.
PFIZER COVID VACCINE PRIMARY DOSE 3 WAS GIVEN TOO EARLY AT 3 WEEKS INSTEAD OF THE RECOMMENDED  8 WKS IN ERROR ON 08/03/22. FAMILY WAS CONTACTED TODAY 08/04/22 @ 11:58 TO INFORM OF ERROR AND ACCORDING TO MOTHER OF CHILD HE IS DOING WELL, NO SYMPTOMS OR CONCERNS.
arm pain/pain is still there; rash; muscle pain; pulsing pain/throbbing; This spontaneous case was reported by a patient and describes the occurrence of PAIN (pulsing pain/throbbing), PAIN IN EXTREMITY (arm pain/pain is still there), RASH (rash) and MYALGIA (muscle pain) in a 71-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient's past medical history included Kidney transplant. Concurrent medical conditions included Blood pressure high.    On 03-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Oct-2022, the patient experienced PAIN IN EXTREMITY (arm pain/pain is still there). In October 2022, the patient experienced PAIN (pulsing pain/throbbing), RASH (rash) and MYALGIA (muscle pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (pulsing pain/throbbing), RASH (rash) and MYALGIA (muscle pain) outcome was unknown and PAIN IN EXTREMITY (arm pain/pain is still there) had not resolved.            Concomitant medication not reported.
Booster doses of 0.5 ml administered instead of 0.25ml.  0.25ml was warranted dose for subject patient.
This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 70-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. The patient's past medical history included shingles (for years). Concomitant products included VALTREX. In April 2018, the patient received the 1st dose of SHINGRIX. In June 2018, the patient received the 2nd dose of SHINGRIX. In November 2018, less than a year after receiving SHINGRIX and SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced rash and feeling unwell. On an unknown date, the outcome of the vaccination failure, shingles, rash and feeling unwell were unknown. It was unknown if the reporter considered the vaccination failure, shingles, rash and feeling unwell to be related to SHINGRIX and SHINGRIX. Addition details were received as follows: The age at vaccination was not reported. The patient was plagued with recurring shingles for years. The old shingles vaccine did not work to prevent regular outbreaks. After 60 days, the patient received 2nd dose of SHINGRIX. The patient was on VALTREX, 1gram dose, daily, for about 5 years. After SHINGRIX shot, the patient continued on VALTREX for 90 days and weaned off it over this period of time. The patient felt so healthy and awesome, no shingles for several months. However, beginning of November the patient started to feel all the symptoms of coming down with shingles again. The patient had shingles, not a lot of rash but symptoms were brutal. The patient back on the Valtrex and definitely not feeling the best from the lingering effects. The patient did not take any medications, only supplements. The patient was physically fit and eat a nutritional diet. The patient was asking about others who were having this problem.
My daughter experienced an allergic reaction to the flu shot at school on Friday, October 13, just before 2 pm after receiving the flu shot at school at approximately 1:45pm. She had hives all over her left arm; her left arm was red, swollen, and hot to the touch; her left leg was red and hot to the touch; and most significantly, her throat was tight. School staff administered an EpiPen after my daughter told them her throat felt tight. EMS were called immediately thereafter. The school nurse gave my daughter 25 mg of Benadryl with my permission, and the paramedics told me to either take her to the hospital or to our doctor, so we went directly from school to our pediatrician. Our pediatrician was concerned that we might have to go to the hospital because when the EpiPen wears off, the allergic reaction can resume. Our pediatrician consulted another pediatrician, as well as an allergist. The allergist thought that my daughter most likely reacted to the preservative in the flu shot, and all three doctors concluded that we could stay in the office until they closed, so our physician could monitor my daughter's condition while the epinephrine wore off. My daughter was told to continue taking Benadryl and was prescribed prednisone for three days, along with additional EpiPens in case the reaction were to resume. Our pediatrician told us that my daughter can never have a flu shot again.
Pt recvd vax 20OCT92 & the next day devel a flu-like illness w/chills & skin sensitive to touch; also had swelling & pain in both feet upt knees as well as pruritic rash on feet; patchy rash persisted;
Patient came for 2nd dose of Moderna vaccine primary series.  Patient was given Moderna Bivalent instead of Moderna Monovalent.  No adverse reaction was noted.
"Pfizer-BioNTech COVID-19 Vaccine EUA" Received vaccine Thursday evening, Friday evening noticed tightness in right side of face. Saturday morning woke up with right side of face very swollen. Did a video dr appt they advised to visit the ER, ER prescribed antibiotics. Facial swelling has continued to get worse and I have scheduled an appointment with my primary dr today. NO other symptoms just very swollen right side of face with no relief.
Patient was walking around the store shortly after vaccination, when he lost consciousness and began shaking. This lasted approximately 1 minute per store employee whom was present. Patient regained consciousness and sat upright on the floor, he was alert for a short time (less than 1 minute), then again lost consciousness and experienced labored/gurgled breathing. Employee laid patient on his side and called for pharmacy and EMS> When I arrived at patient side his skin was very pale/grey and he did not appear to be breathing. After checking for responsiveness for a few seconds, patient began breathing again and regained consciousness.  He was sat upright and we checked for alertness, medical history, contact info and stayed with patient until EMS arrived and took over. Per EMS, patient did not have low blood sugar, but was experiencing some orthostatic hypotension.
10/31/10: Patient was brought to ER presenting with fever of 103 and confusion.  11/1/10, 1PM: He was examined by a neurologist who noted he still had a fever, confusion and rigors. 11/10/10: discharged from hospital 11/15/10: re-admitted to hospital for Altered mental status pt dx with Meningoencephalitis, secondary to influenza vaccine
Rash around waistline, top of legs, left ankle area - no pain, no itching. Patient said she would take BENADRYL 25mg.
RECEIVED SHINGLES VACCINE AT APPROX 11:30AM ON FRIDAY, FEB 1, 2008. SAT. FEB2, WOKE UP WITH SORE ARM - HURT BUT NOT RED, SLIGHTLY WARM, STARTED TO ITCH ALL OVER BY NOON - DOCTOR PRESCRIBED BENADRYL. ITCHING STOPPED BY MONDAY AM
He is miserable; Got burning sensation under his breast area, under his skin and it is under his armpits and down to the side of his body upper, torso area and down his back; underneath burning, it was his skin is burning or underneath the skin was burning; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 73 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Feb2021 (Lot number: EN6200) at the age of 73 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Verbatim: Diabetes. Concomitant medication(s) included: PREDNISONE (ongoing); CAPSAICIN; OZEMPIC; JARDIANCE.  The following information was reported: BURNING SENSATION (non-serious) with onset 25Feb2021, outcome "not recovered", described as "Got burning sensation under his breast area, under his skin and it is under his armpits and down to the side of his body upper, torso area and down his back"; SKIN BURNING SENSATION (non-serious) with onset 25Feb2021, outcome "not recovered", described as "underneath burning, it was his skin is burning or underneath the skin was burning"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "He is miserable". The events "got burning sensation under his breast area, under his skin and it is under his armpits and down to the side of his body upper, torso area and down his back" and "underneath burning, it was his skin is burning or underneath the skin was burning" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of burning sensation, skin burning sensation.  Additional information: The patient called his primary doctor and gave him 10 days of prednisone. He went and took some of prednisone and still taking but it was not helping. He went to the emergency room and was told that he have sore muscles and gave him Capsaicin cream to put on it and according to the patient his muscles are not sore, it is underneath burning, it was his skin is burning or underneath the skin was burning.   No follow-up attempts are possible. No further information is expected.
after expiration date,Expired moderna vaccine given to 7 patients/The patient was administered her second dose of an expired dose of Moderna; The first dose was given on 28 Sep 2021 and second dose on 04 Nov 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (after expiration date,Expired moderna vaccine given to 7 patients/The patient was administered her second dose of an expired dose of Moderna) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The first dose was given on 28 Sep 2021 and second dose on 04 Nov 2021) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The first dose was given on 28 Sep 2021 and second dose on 04 Nov 2021). On 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (after expiration date,Expired moderna vaccine given to 7 patients/The patient was administered her second dose of an expired dose of Moderna). On 04-Nov-2021, EXPIRED PRODUCT ADMINISTERED (after expiration date,Expired moderna vaccine given to 7 patients/The patient was administered her second dose of an expired dose of Moderna) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The first dose was given on 28 Sep 2021 and second dose on 04 Nov 2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter. No treatment information was provided.  Patient first dose vial moved from freezer to refrigerator on 28 Sep 2021, same day dose was administered. The second dose vial was removed from the freezer to refrigerator on 04 Nov 2021.   This case was linked to MOD-2021-400101 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Dec-2021: Updated report type. Added patient demographics, dosage details and new event.
Received the vaccine at 11am on 01/23/2021, had nausea and fatigue all day, in the evening at 1130pm-12:30pm my symptoms got worse, with high fever of 102F, chills to the point my teeth chattered, joint pain, muscle aches, underarm pain, my hip/pelvic area hurt,  felt like my ovaries were tearing, my back to the point I couldn't move much I was in bed all day on Sunday, with al the symptoms, had a little bit of hard time breathing too. I did take advil,  tylenol and even al eve to help with the fever and aches,  Missed half of day of work on Monday the 24th,  started to get headaches even taking OTC NSAIDS with no relief, the aches lingered until Tuesday, but the headache was very sever until Thursday , to the point that I had to leave work on Weds, the headache was severe, similar to a Migraine . I felt a lot better by the weekend on 1/30/2021. I did have COVID in November and just felt like I had it allover again. this was my first dose
vaccine was mixed with a sterile diluent but not the one that comes with the vaccine, no AE; Initial information was received on 30-Apr-2021 regarding an unsolicited valid non-serious case from a other health professional in.  This case involves a patient (demographics unknown) who was administered DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] mixed with a sterile diluent but not the one that came with the vaccine, (lot number not reported) via unknown route in unknown administration site for prophylactic vaccination on an unknown date (Product preparation error).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   It was a case of an actual medication error due to Wrong diluent used (latency same day).  At the time of report, no adverse event was reported.  The caller stated that they administered a dose of Pentacel and that the vaccine was mixed with a sterile diluent but not the one that comes with the vaccine. She had questions about side effects and re-administering the vaccine. she would like to know when they can give another Pentacel dose since it is not considered a valid dose. She would like to know if they can give it as soon as possible or do they have to wait. She said they were planning on giving another Pentacel dose to the patient not until the week of the 10th. The Caller had questions about side effects and re-administering the vaccine. She was referred to the Pentacel Reconstitution Guide. She was asked for additional information for the adverse event (AE) report and she said that she does not know if she would give accurate information. She said she does not believe it was reconstituted the way that it should have been. This is all the information she provided at the time of her call.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Pt. stated several days later arm was sore and had difficulty moving arm. Immunization was given on 2/16/15. Pt called pharmacy on 3/8/15 stating her arm still hurt. Advised pt to see Dr.
Patient complained of chest pain,Non-Cardiac   . Onsite EMS was called vitals were taken BP 169/97      96% O2 room air HR 60.Patient treated, Left aginst medical advice.   .
I started having Covid symptoms 2 days after my first vaccine.  Sore throat, fever, body aches, headache, extreme fatigue, etc. I tested positive 3 days later.
UrticariaPruritus erythematous ring around injection site Narrative:  Developed raised, erythematous ring around entire deltoid of inoculated arm with sparing of interior (interior normal skin turgor and color) days after vaccination. Described as mildly pruritic and resolved within 24 hours of appearing. No therapies tried or applied to treat. No associated rash, hives, sloughing, induration, erythema or other adverse effects noted.
This spontaneous report as received from a pharmacist refers to a patient of unknown age with herpes outbreak. On an unknown date the patient was vaccinated with ZOSTAVAX. Concomitant therapies included Acyclovir. The patient was taking acyclovir intermittently for herpes outbreak and received a dose of ZOSTAVAX on unspecified date. Patient has not taken acyclovir for quite some time but exact date when patient last took acyclovir was unspecified. No adverse effects reported. No additional information provided. This is report 2 of 2 from same reporter. Additional information has been requested.