chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Atopic dermatitis and Psoriasis vulgaris.    No medical history information was reported.  Concomitant products included PREDNISONE, AZITHROMYCIN (Z-PAK) and NIRMATRELVIR, RITONAVIR (PAXLOVID) for an unknown indication.   On 18-Mar-2022, the patient UPADACITINIB (RINVOQ) (Oral) dosage was changed to 15 milligram once a day. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) 15 milligram once a day. On 26-Jul-2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jul-2022, SARS-CoV-2 test: (Positive) Positive.     No known drug allergy were reported.  No treatment medication reported by reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Co-suspect Rinvoq action taken were unknown.  Company Comment: This is a spontaneous case concerning a 54-year-old male patient with intake of the co-suspect, non-company product UPADACITINIB (RINVOQ), who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 which occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine and approximately 4 months after receiving the co-suspect, non-company product UPADACITINIB (RINVOQ). SARS-CoV-2 test was positive, no further information on risk factors, co morbidities, clinical course and management of the event was available in the report. It was reported that the outcome of the event has not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 54-year-old male patient with intake of the co-suspect, non-company product UPADACITINIB (RINVOQ), who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 which occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine and approximately 4 months after receiving the co-suspect, non-company product UPADACITINIB (RINVOQ). SARS-CoV-2 test was positive, no further information on risk factors, co morbidities, clinical course and management of the event was available in the report. It was reported that the outcome of the event has not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
medical assistant with a supervisor present pulled the wrong drug to give, TDaP (Adacel) was given instead of DTaP/ no AE; 15 month old child who was given the Tdap vaccination (Adacel)/ no AE; Initial information received on 07-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 months old male patient who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot U6273AA and expiry date: 24-Apr-2021 via intramuscular route in the left thigh on 05-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided.  No other vaccines given during this visit.  This was a case of actual medication error due to wrong product administered  and inappropriate age at vaccine administration.   It was reported that the resident ordered Dtap but the medical assistant with a supervisor present pulled the wrong drug to give. Adacel was given.  The patient did not experience any adverse event  (patient was fine).  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 Pharmacovigilance 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.  List of documents held by sender: none.
expired dose administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 12-month-old female patient who received HAV (Havrix) (batch number y4fl4, expiry date 28th January 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st February 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 1st February 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 details were provided as follows: The reporter stated that an expired dose of Havrix was inadvertedley administrated to the patient, which led to expired vaccine used. No further events were reported. The Vaccine administration facility was the same as Primary reporter. The reporter consented to follow up. This case is linked with US2022022664, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022022664:Same reporter.
My stomach was hurting pretty bad, it's kind of like if you have gas; My left arm, it's got sore for about 3 days went away; This is a spontaneous report from a contactable consumer (patient). An 84-years-old patient of unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EW0167, expiry date: un-known) via unspecified route of administration, on 05Aug2021, as dose 2, single for covid-19 immunisation. Historical vaccine included first dose of BNT162B2 via unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation, and got sore (my first and second shot in my left arm, it's got sore for about 3 days went away). Patients medical history and concomitant medications were not reported. After second dose, on an unspecified date in Aug2021, patient got sore for about 3 days went away. This morning five days from last shot, patient woke up and stomach was hurting pretty bad, it's kind of like if you have gas, your stomach will be when you have gas, okay and patient never had a stomach ache in morning. Patient was 84 years old and was just curious as to whether a similar problem might have been reported on this, as such. The outcome of event for pain in arm was recovered on an unspecified date in Aug2021, and stomach ache it was unknown.    .
9 year old child was administered an adult dose (1 mL) of Havrix (hep A); 9 year old child was administered an adult dose (1 mL) of Havrix (hep A); after the dose was administered, it was discovered that the dose was expired; This case was reported by a nurse via sales rep and described the occurrence of overdose in a 9-year-old female patient who received HAV (Havrix adult) for prophylaxis.   On 30th March 2021, the patient received Havrix adult 1 ml. On 30th March 2021, unknown after receiving Havrix adult, the patient experienced overdose, adult product administered to child and expired vaccine used. On an unknown date, the outcome of the overdose, adult product administered to child and expired vaccine used were unknown.  Additional details were provided as follows: The patient who was approximately 9 years old, received an adult dose of Havrix, which led to overdose and adult product administered to child. After the dose was administered, it was discovered that the dose was already expired.
Fever Tm 100 degrees.  Dizziness off & on, nausea 2 days, myalgias.  August 14th called stating s/s began nite of MENACTRA.  Seen in clinic 8-15-08.  Sed rate, CBC, monoron. 8/22/08 Reviewed PCP medical records of 8/13-8/15/08. FINAL DX: viral syndrome vs AE to menactra Records reveal patient experienced good health & was on growth hormone on day of vax.  Parent called next day with c/o stomache, fever & pain in feet.  Seen in office 8/15 w/low grade fever, intermittent dizziness, nausea, pale x 2 days. Advised increase fluids & anti-inflammatory med.
*Client arrived at local outreach to  primarily  Pfizer's 2nd dose  for COVID-19.  To best serve our Community there was 1 lane dedicated to the Moderna immunization only. ------------------------------------------------------------------------------------------------------------ *A car ~ with one person also needing Moderna ended up in our Pfizer only lane and was provided a dose of Pfizer.  ---------------------- *The client was notified at the moment of understanding and educated regarding possible s/sx. -----------------------------------------------*The client was contacted today (3/10) and acknowledged that she had no extra-ordinary reactions.-----------------------------------------
On 11/21/2001 noticed "bumps" on his chest before going to bed. "Bumps" spread under right arm and onto his back. Denies itching or fever. Still has them.
BLEEDING WHILE URINATING; BLEEDING DURING DEFECATION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 2021, the subject experienced bleeding while urinating. On 2021, the subject experienced bleeding during defecation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bleeding while urinating and bleeding during defecation was not reported. This report was non-serious.
Initial report from pharmacist on 16 Nov 2010: The client drew up PNEUMOVAX (batch no: 0866Z) and FLUVIRIN, (batch no: 111798P1) into the same syringe and administered the vaccine (containing both FLUVIRIN and PNEUMOVAX) to the patient on 16 Nov 2010. No adverse reactions occurred since the administration. Combined follow-up report received on 20 Dec 2010: This patient was vaccinated with FLUVIRIN and PNEUMOVAX 0.5 mL intramuscularly on 16 Nov 2010. Both the vaccine were combined in a single syringe and given as a single dose. The patient was hospitalized (unspecified date and event). No adverse event occurred following this administration.
He experienced lightheadedness within the first 5 minutes up until 20 minutes after. We urged him to stay for another 15 minutes after the symptom subsided. Recommended him for any other emergencies to call 911 or seek immediate medical attention for other symptoms such as fainting, chest pain, difficulty breathing, etc.
Fainted within 10 minutes of receiving Tdap, Meningococcal, GARDASILl-9, and Influenza vaccines.  Was allowed to leave office immediately after receiving vaccines.  Fainted in hallway while leaving office.  Hit head on floor.  Brought back into physican's office for observation.  Back of head sore but not swelling.  Vomited approximately 2 hours after falling and again 3 hours after fall.
Moderna COVID-19Vaccine EUA.  I feel like I'm coming down with the seasonal flu.  Achy and slight fever, eyes are tired.  I had a flu shot back in September of 2020.
Incorrect dose given to patient. Patient's age was under 12 at the time of vaccine administration and should have received the pediatric dose.
After the first shot, I woke up with a blood red left eye.  The eye doctor said it was a burst blood vessel (subconjunctival hemorrhage).  We didn't think it was related to the vaccine.  However, when I got my second dose, I woke up the next morning, and it happened again in the same eye.  The left eye felt dry and heavy.  The eye doctor gave me drops, and it improved within 2 weeks after the first vaccine.  I have not gone to the eye doctor the second time.  I am using eyedrops, and it is improving.  I informed my primary care physician as well.
PT DESCRIBES NOTICING LEFT UPPER ARM WAS RED AFTER HE SHOWERED ON 10/13/2017. HE SAID THE ARM WAS WARM TO THE TOUCH. IT DIDN'T HURT. IT WASN'T ITCHY. HE DIDN'T HAVE ANY FEVER. HE HAD AN APPOINTMENT TO SEE HIS MD THE NEXT DAY, SO HE WAITED IT OUT. HE ASKED HIS MD ABOUT IT ON 10/14/17. THE MD SUSPECTED CELLULITIS AND PRESCRIBED CEPHALEXIN, BUT TOLD THE PATIENT NOT TO TAKE THE MEDICATION UNLESS HIS ARM GETS WORSE. THE UPPER ARM WAS NOT AS RED ON 10/16/2017, BUT HE NOTICED THAT THE REDNESS HAD SPREAD TO HIS FOREARM. HE DECIDED TO FILL THE CEPHALEXIN AT OUR PHARMACY. THIS WAS ALSO THE TIME THAT THE WIFE NOTIFIED US OF THE REACTION. WE CALLED THE MD TO LET HIM KNOW THAT THE PATIENT IS FILLING THE RX AS THE REDNESS HAD.
This spontaneous report as received from a physician assistant refers to a patient of unknown age. The patient who was vaccinated with the first two dose in the GARDASIL (lot number not provided) immunization series on unspecified dates in 2008, was currently (02-JAN-2013) in the office to receive the third dose. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Lightheaded, Left eye blurry, palpations, BP 142/88, 100 pulse ox, 82 Heart Rate, 20 respiratory.  Emergency response called
2 days post injection - localized pain at injection site, warm to touch, swollen about 25 cent size. 4 days post injection - redness of arm extending down to elbow, injection site hard to touch, swelling increased 3 fold in size. 7 days and up to 6 weeks post injection this pain, hardness and redness persisted.
A hot cold for 10 hours; Chills for 10 hours; This spontaneous case was reported by an other health care professional and describes the occurrence of NASOPHARYNGITIS (A hot cold for 10 hours) and CHILLS (Chills for 10 hours) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (A hot cold for 10 hours) and CHILLS (Chills for 10 hours). At the time of the report, NASOPHARYNGITIS (A hot cold for 10 hours) and CHILLS (Chills for 10 hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants were provided  No treatment medications  were provided   This case was linked to MOD-2021-282222 (Patient Link).
Information has been received from a certified medical assistant concerning a 23 year old female, with no pertinent medical history, who on 20-APR-2007 was vaccinated IM with a 0.5 ml first dose of Gardasil (lot # 0210U). On 18-JUN-2007 was vaccinated IM into the right deltoid with a 0.5 ml second dose of Gardasil (lot # 0210U). There was no concomitant medication. On 15-JUN-2007 at 3:00 pm, (previously reported as later that evening), the patient experienced dizziness and nausea. Unspecified medical attention was sought. The patient's dizziness and nausea persisted. The certified medical assistant reported that the patient did not experience any difficulties with the 20-APR-2007 first dose. Additional information has been requested.  Additional infromation is not expected.
This spontaneous report was received from a nurse via company representative, and refers to multiple unspecified adolescent patients between 13 and 16 years old. Concurrent conditions, medical history, historical or concomitant drugs were not reported. The nurse stated that on unknown dates, over the past 10 years (approximately since 2008), the patients were vaccinated with an unspecified number of doses of either GARDASIL (strength, dose number, dose, route, anatomical location, lot # and expiration date not reported), or GARDASIL 9 (strength, dose number, dose, route, anatomical location, lot # and expiration date not reported), for prophylaxis. The nurse reported that the patients, on unknown dates, fainted, passed out or became woozy. She further clarified that this happened to the patients between 13 and 16 years old 95 % of the times, if they were vaccinated on an empty stomach. As treatment, she offered them water and crackers and observed them for a little while. The reporting nurse did not provide the outcome of the events and their causal relationship to vaccination with GARDASIL or GARDASIL 9. Upon internal review, loss of consciousness was considered as a medically significant event.
One of the recipients was under 18; A spontaneous report was received from a nurse concerning a male patient who was less than 18 years old (Product administered to patient of inappropriate age) who received Moderna (mRNA-1273).   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    The patient received his first of two planned doses of mRNA-1273 (Batch number:039K20A) on 09 Jan 2021, intramuscularly in the deltoid region for prophylaxis of COVID-19 infection.   On 09Jan2021, one of the recipients was under 18 when he received the first dose of the vaccine on the hospital. He has had no known symptoms and has not taken any treatments since receiving the vaccine.   Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event one of the recipients was under 18 was recovered.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age  for mRNA-1273 (lot number 039K20A) with no associated AEs reported.
"While in the waiting area after receiving her vaccination Pt. developed chest pain with changes in skin color. She denied any shortness of breath. BP 179/71 P 66 R16 SaO2 96% 911 was called Pt. was transported to hospital." Per RN.  Paramedic documented. "Post vaccination pt started to become very light-headed and had near syncopal episode, also c/o chest discomfort over L anterior chest, denied any shortness of breath, Pt was evaluated 911 called, Pt was transported to  hospital for evaluation w/VFD and AMR."
Pain at injection site Muscle pain Weak/Tired Shivering Upset stomach/No appetite
On Oct 12th I noticed that my right nostril was very dry. I inserted a piece of tissue into my nostril and pulled out a very dark piece of snot. The next day I had the same experience and noticed I was swallowing a lot. Went into a tiny shop and was given Strepsils lozenges taking 1 every 3-4 hours. On Oct 14th began having fatigue and disinterest in the tour I was on. Later that day I took an at home COVID-19 test that was negative. On Oct 15th continued to worry and have cold like symptoms. Oct 16th was kind of dragging but thought it was due to lack of sleep. On 17th I was having coughing, runny nose, congestion, and runny eyes. I was on a plane returning home and still thought it was a cold. I also began having sinus pressure. I tested on the flight home and it was positive. When I arrived home I went to bed but took antihistamines, delsom, zinc, and ibuprofen.  All of these helped me feel better and I am drinking less caffeine. On October 20th I had diarrhea. sore throat and gruff voice.
Moderna Bivalent Booster dose was administered to a PT who is 17 years old.  No adverse reaction has been reported.  Pt is counseled. Pharmacy had taken actions to prevent this from happening again.
Pt. was given a 0.2cc dose of undiluted covid vaccine for his age group.
Rash all over body, redness, itching, skin burning. Improved with Benadryl 50 mg PO, Pepsid 20 mg PO, Decadron 10 mg PO.
Viral meningitis 5 weeks after SHINGRIX shot. Hospital attributed this to the shingles vaccine.
Mild pericarditis treated with NSAIDs.  Patient is currently located and was vaccinated abroad.  BP 133/85, HR 63, RR 12, temp 98.2, O2 99% on room air.  Patient c/o back pain and shortness of breath when lying down and dyspnea on exertion.
Pediatric dose administered to an adult; Pediatric dose administered to an adult; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a adult patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced underdose (Verbatim: Pediatric dose administered to an adult) and adult use of a child product (Verbatim: Pediatric dose administered to an adult). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 14-APR-2023 The registered nurse called to ask for recommendations about the administration of pediatric Engerix-B dose to an adult patient. The reporter declined sharing information about patient and the Engerix-B dose given.  The reporter consented to follow up but only shared her facility address. The adult patient received pediatric Engerix-B dose which led to underdose and adult use of a child product.
Right arm with redness, mild pain and tender to touch, inflamed treated with KEFLEX 500mg 3 daily for 5 days, warm compresses.
Breakthrough case admission 3/13/21 Moderna Lot# 010A21A 4/10/21 Moderna Lot # 025B21A
Client reported developing "hives" the evening of 12/23/05.  Was seen ER 12/24/05-was told that hives were probably not related to flu vaccine, unknown what caused hives. Given steroid and Benadryl to take.
pt's husband positive for COVID, pt presents to ED with c/o progressive weakness, N/V/D x 2 wks; fever, non-productive cough, SOB; positive COVID test; pt's condition worsened where she died in the hospital
Rash (left forearm) - appeared on March 24.  Dizziness (felt as if the room was spinning). Onset was March 24 PM.
Patient report sudden onset of weakness, dizziness, and feeling like he was going to pass out about twenty minutes after receiving his vaccine. Paramedic on-duty observed patient to pale and diaphoretic and immediately brought all equipment to patient's side and began care. Patient was placed on cardiac monitor and was observed to be markedly hypotensive and bradycardic. Peripheral IV established and atropine administered followed by fluid bolus. A transport unit was requested and arrived within minutes. Patient was assisted to EMS stretcher and transported emergently to the hospital for futher treatment and evaluation.
Patient presented to hospital on 2/3/2021 for dose 2 of Moderna vaccine. Patient received initial dose of moderna vaccine on 1/4/2021 at the hospital. During review of consent form, noted patient had Covid-19 In November and received Convalescent Plasma tranfusion on November 14, 2020.
A few days after receiving my second dose of the Moderna vaccine, I started experiencing  chest pain.  I'm not exactly sure how to describe it, mostly like a pressure or odd feeling in my chest.  It happened when I was exercising or not, seemingly with equal frequency.  The events got less frequent over time with the last time I experienced it being about a month after the initial onset.
Pt had reaction on left deltoid from DTAP. He had severe cellulitis with blisters and scab at injection site. Seen in ER and given antibiotics and pan meds.
Arm burning/redness at injection site. Diagnosed with cellulitis. MD gave him Keflex. Cellulitis looked about 8-10 inches in diameter from picture.
Developed fever 5 hours after getting immunizations.  Febrile seizure on 7/30/14.  Seen at Emergency Department.  Developed rash on 8/1/14.