chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received / first dose of the shingrix / October of 2019 / received / second dose April 2021 / late dose; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date in October 2019).   In April 2021, the patient received the 2nd dose of Shingrix. In April 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 follows: This case was reported by the patient herself. The patient received second dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. No symptoms reported. Patient declined health care professional information. The reporter did not consent to follow up.
Got the shot on March 16, and came down with a fever and aches by 9pm. Overnight I got a 103 fever and had a 99.9 fever for the next day. On March 18, I noticed what I thought looked like razor bumps from shaving but they really hurt. I had not been sexually active and was confused what they would be. Went to the gyno and she thought they were in grown hairs from shaving and sweating from my fever. Then over the weekend I experienced more red spots on my crotch and severe pain that kept me up at night and made me want to cry. I called the emergency line for the gynocologist and she prescribed something for a bacterial infection as well as for type 1 herpes. I then went in the following thursday and was seen again for the bumps. The bumps felt exactly like described in other cases i recently read about - shingles. I was in pain for 2-3 weeks and would use zinc and witch hazel and advil to try to get through the pain. It did eventually feel better and go away.
LIGHT HEADACHE; POSSIBLE ANXIETY; This spontaneous report received from a patient concerned a 29 year old female. 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: 201A201A expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAY-2021, the subject experienced possible anxiety. On 13-MAY-2021, the subject experienced light headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the light headache and possible anxiety was not reported. This report was non-serious.
This spontaneous report as received from a physician assistant refers to a 58 year old female patient. On 19-JUL-2013 the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # were not reported). On the same day (time not specified) the patient experienced severe leg cramps in both legs and hips; as well as joint pain to the point that the patient visited a walk-in urgent care facility where the patient was administered a steroid injection (brand, manufacturer, and dose unspecified). Within hours the patient showed immediate improvements. Additional information has been requested.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 30-JAN-2012, the patient received improperly stored VARIVAX dose 2, from lot # 669842/0931AA, expiry date 13-JUN-2013 (dose, vaccination site, route unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Low-grade fever on 5/25/01. Subsequently, hospitalized. On 5/29/01, dx'd with strep pneumoniae Meningitis and bilateral otitis media. Rx'd with cefotaxime 500mg; Vancomycin 100mg. Transferred to another hospital on 5/29/01, due to seizures. Continues to be hospitalized. On 6/20/01, now discharged from hospital.
Patient received vaccine at mass vaccination clinic.  Proceeded to observation area and fainting sitting in chair.  Patient protected in chair from fall but loss consciousness 2 more times.  Episode lasted 46 minutes.  Patient given ginger ale and recovered.
NUMBNESS/TINGLING LIPS. PT HAD SAME RXN WITH 1ST COVID SHOT, BUT WAS CLEARED BY ALLERGIST TO RECEIVE 2ND WITH PT TAKING 25MG BENADRYL PO BEFORE VACCINE AND 25MG PO AFTER. PT WAS GIVEN 25MG BENADRYL IM AFTER VACCINE INSTEAD. PT HELD FOR 45 MINUTES POST VACCINE UNTIL NUMBNESS TO LIPS SUBSIDED. PT INSTRUCTED TO GO TO ED OR CALL 911 IF S/S REOCCURED. PT STATES UNDERSTANDING.
Onset of sustained atrial fibulation  beginning approximately 22 hours post vaccination (second shot) pulse running between 110-145
Tiredness afternoon throughout following day,  lower back pain began during late afternoon on right side, by next morning, across full lower back.  Afternoon of day after (2/18/22) severe pain in left leg at hip joint at groin area.  This pain was so severe had to have assistance walking, sitting and standing up, undressing.  The day after vaccine also had chills causing shaking of hands in the mid-afternoon, relieved by adding blankets. Woke on Friday the 19th feeling normal
Severe tiredness and Fever 102 for days even on Tylenol (lowered the fever) starting 5-6 hours after 2nd vaccination). Hives/Rash after throughout body worsening on day 5. Went to ER with fever, rash, difficulty breathing, elevated blood pressure and pulse.
Hives noted throughout body, concentrated proximally. No fever noted. No difficulty breathing - lungs CTA (B). No lip edema.
Localized redness and soreness around injection site. No signs of anaphylaxis, joint soreness or cellulitis.
Doses were stored in the fridge since 20Dec2022 and vaccines were administered on 24Jan2023; No adverse event; Pediatric patient was administered with Moderna COVID-19 Vaccine Bivalent doses after 30-day Use By Date (34 days); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pediatric patient was administered with Moderna COVID-19 Vaccine Bivalent doses after 30-day Use By Date (34 days)), PRODUCT STORAGE ERROR (Doses were stored in the fridge since 20Dec2022 and vaccines were administered on 24Jan2023) and NO ADVERSE EVENT (No adverse event) in an infant patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 24-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Pediatric patient was administered with Moderna COVID-19 Vaccine Bivalent doses after 30-day Use By Date (34 days)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Doses were stored in the fridge since 20Dec2022 and vaccines were administered on 24Jan2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pediatric patient was administered with Moderna COVID-19 Vaccine Bivalent doses after 30-day Use By Date (34 days)), PRODUCT STORAGE ERROR (Doses were stored in the fridge since 20Dec2022 and vaccines were administered on 24Jan2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Pediatric patient was administered with Moderna COVID-19 Vaccine Bivalent doses after 30-day Use By Date (34 days)) and PRODUCT STORAGE ERROR (Doses were stored in the fridge since 20Dec2022 and vaccines were administered on 24Jan2023).    Concomitant product use was not provided by the reporter. This case has information of 1 pediatric patient out of 2 pediatric patient case. Patient received initial booster dose.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-706726 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706726:Patient 2 of 2
Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna vaccine on 1/29/21, 2/26/21, 8/19/21, and 4/1/22. Presented to outside ER c/o progressive confusion since Covid infection 6/19/22. Vaccinated 4x, last booster 4/1/22. DX'd w/Covid 6/28/22, rec'd Paxlovid x 5/days. Normal head CT and CXR with multifocal PNA. Transferred to the ICU 7/6 for worsening mental status. Intubated failed attempts at extubation. Refractory shock w/worsening P/F ratios requiring max doses of multiple vasopressors c/b encephalopathy. Transitioned to DNR/AND. Patient treated with Paxlovid, Merrem, bactrim, micafungin, cefepime, and vancomycin. Expired 7/28/22.
patient had an anaphylactic reaction to the PNEUMOVAX23 vaccine/ Caller states that within 1 hour, her throat, was itchy, she experienced chest heaviness/ tightness, wheezing upon examination; This spontaneous report was received from a physician referring to a 18-year-old female patient. The patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions were unknown by the reporter.  On 06-JAN-2016, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) 1 time dose as vaccination (prophylaxis); lot number L035687 and expiration date was not reported, but upon internal validation established as 16-FEB-2017 (strength, number of administered dose, route of administration and anatomical location were not reported).    On the same date, whit in an hour of vaccination, the patient's throat was itchy, also, she experienced chest heaviness/ tightness and wheezing upon examination which was also reported as anaphylactic reaction to pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), the patient sought medical attention and a dose of epinephrine hydrochloride (EPIPEN) was given as treatment, it was unknown by the reporter if any laboratory diagnostic or studies were performed.  On an unspecified date in January 2016, the patient recovered from anaphylactic reaction (reported as she did better).   The causality between the event anaphylactic reaction and Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23) was considered related.  Upon internal review, the event anaphylactic reaction was considered medically significant. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: L035687; expirationdate: 16-FEB-2017; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Patient came to Vaccination Clinic to receive first dose of Pfizer vaccine on 3/15/2021. Patient was vaccinated at 1147 and began to walk toward EMT monitoring area at 1153. While the patient was walking, the patient reported feeling faint. RN, followed the patient from behind. RN noticed patient beginning to fall and was able to catch her using her leg as support and guided patient to the floor. Both RN and patient decline sustaining any injuries related to this event. When on the floor, patient appeared pale, had cold and clammy hands, and was diaphoretic. RN assisted the patient by holding her legs in the air while the patient layed on her back. Patient was A&Ox4 at 1155 with a BP of 121/76. At 1159, patient reported feeling "better" and was transferred to zero-gravity chair. The patient's blood pressure was reassessed at 1201, 1221, and 1227 and reported to be 124/81, 122/74, and 125/79, respectively. The patient refused transport via EMS and stated she preferred to drive herself home. Patient able to ambulate without assistance. Patient left to her car at 1230. Upon departure, patient was ambulatory, A&Ox4, with no reports of trouble breathing, dizziness, or lightheadedness. The patient was given education related to when to seek medical care, including shortness of breath, chest tightness, and sensation of throat tightness. The patient was provided with additional guidance on what to do when receiving a second dose, including notifying the nurse that she has had a history of fainting.
Muscle soreness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle soreness) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No medical history information was given by the reporter.  Concomitant products included EZETIMIBE (ZETIA), CANDESARTAN, TICAGRELOR (BRILINTA), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), FINASTERIDE (PROSCAR) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced MYALGIA (Muscle soreness). On 04-Feb-2021, MYALGIA (Muscle soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product used included zetia, candesartan, brilinta, aspirin 81 mg, proscar and Lipitor.  No treatment medications provided by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 22-May-2021: Live follow up received on 22-May-2021. No new information was updated.
Pt had his shots on the 19th and on the 20th he woke up having a seizure that lasted 20-30 minutes. He had never had a seizure before! He was born extremely early and at birth had a suspicious possible seizure that was never confirmed or saw by any of his healthcare team in the NICU. He had no health problems or sickness prior to receiving this vaccinations.
Chills, fever, diarrhea, achy body and headache. This was gone in less than 24 hours,
On 5/26/19 patient developed tingling and numbness in lips, fingers, hands and feet. On June 1 patient developed weakness and pain in lower extremities  On June 4  she saw her primary care physician who ordered an MRI  of head. MRI was negative.  On June 7 she went to ED at (hospital) because she could hardly walk and was in extreme pain. She was given a pain injection and sent home. On June 8 she developed right-sided mouth droopy.  She went back to ED on June 9 and was admitted.A CT scan was done on June 9 and was negative.  An MRI was done on June 11.  Lumbar puncture and EMG were done on June 12. Dr, a neurologist, diagnosed her with Bell's Palsy and Guillian-Barre Syndrome.  In the hospital she was treated with prednisone, gabapentin, and IVIG infusions given on 6/12 thru 6/16.  She was released from hospital on 6/17.
Following day of vaccine, woke up and nearly fainted. Had tunnel vision, unresponsive, and turned white. Dizzy and nauseous. Two days later still complains about sore arm, nauseous, and feeling very weak and out of sorts. Saw her primary doctor Friday, and said it would need to run its course and he advised he has never had a patient with such a reaction. Sent home with directions that we watch over her.
Are became very sore and 4 to 5 days after she started having very bad vertigo. She fell down at work and went to the doctor and that what she was diagnosed with. She never had that before taking the vaccine.
hurting with a swollen knot; swollen knot; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (hurting with a swollen knot) and INJECTION SITE SWELLING (swollen knot) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (hurting with a swollen knot) and INJECTION SITE SWELLING (swollen knot). At the time of the report, INJECTION SITE PAIN (hurting with a swollen knot) and INJECTION SITE SWELLING (swollen knot) had not resolved.            The patient had the events after second dose.  Treatment medication was not provided
About 30 mins after receiving the vaccine I developed a strong headache while driving that affected my vision. Later that evening I got a stomach ache, the chills/hot flashes, arm soreness and the shakes. Most lasted until the following morning when I got up at 6:15am for work. The following morning I was only experiencing shakiness and arm soreness. About a week in a half later, I developed a rash at the injection site that looked like two large red blobs. The rash was slightly itchy and lasted only a couple of days.
a few minutes after the vaccines were administered, patient had blotchy red rash on face, vomited, and remained irritable for about 20 minutes. No urticaria elsewhere. No rash at any injection site. Administered diphenhydramine. 15-20 min later patient asymptomatic, happy, smiling. Called father later that evening, and patient has remained well.
Patient experienced severe pain (9 out of 10) several hours after receiving the vaccine. Two hours later, her pain went down to 3 out of 10 and by next day it was resolved.
Right thigh swollen, red Cephalexin 250/5 1 tsp po TID x 10 days.
Initial information received on 13-Nov-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked with 2018SA315883, 2018SA315878, 2018SA315885, 2018SA315886, 2018SA315887, 2018SA315882, 2018SA315884. This case involves a 2 years old male patient who for whom vaccines were exposed to a max temp of 52 F for 27 hours was reported, while he received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines given that day. On an unknown date, the patient received a 0.25 ml dose 1 of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT625QNA expiry date: 30-Jun-2019 via intramuscular route in the right thigh. The patient received vaccines which were exposed to a max temp of 52 F for 27 hours following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was reported that this excursion was on 02-Nov-2018 prior to the 12-Nov-2018, excursion already reported, they found that one patient inadvertently received FLUZONE QUADRIVALENT. Lab data was not reported. Final diagnosis was vaccines were exposed to a max temp of 52 F for 27 hours. It was an actual medication error due to incorrect product storage. It was not reported that if any adverse event occurred or not. Outcome of event was not applicable. 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. Documents held by sender: none.
Bright red rash on left arm, resolved within 12 hours with steroid anti-itch cream Sore, swollen arm, not resolved by ibuprofen or acetaminophen
Patient is Deceased.  Date of Death: 11/15/21 Time of Death:  7:40 PM Preliminary Cause of Death: COVID-19   See VAERS #706111 for initial hospitalization reporting.   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute on chronic diastolic congestive heart failure (HCC) [I50.33] Pneumonia due to COVID-19 virus [U07.1, J12.82] COVID-19 [U07.1] Acute respiratory distress [R06.03] HOSPITAL COURSE: This is a 72 y/o male with past medical history significant for AL amyloidosis on active chemo, diastolic CHF, AS s/p bioprosthetic AV replacement 5/2021, diastolic CHF, CKD 3b, CAD, Paroxysmal afib, and OSA. He was admitted on 10/31 with acute hypoxic respiratory failure secondary to COVID PNA and has been under the oncology service. Patient developed symptoms around 10/19 and tested positive on 10/25. He is fully vaccinated and is s/p both booster vaccination. Patient was started on decadron and completed treatment with Remdesivir. He also received monoclonal Ab infusion. He was started on empiric heparin gtt for rising d-dimer. Dopplers were negative for DVT. CTA has been avoided in the setting of his chronic kidney disease. He has been aggressively diuresed and was started on empiric CAP coverage 11/3. Sputum culture 11/4 positive for MSSA. ID was consulted and ordered BDG and aspergillus Ag which are pending. Cardiology was consulted for decompensated diastolic CHF exacerbation. Echo was performed noting EF of 71% and was without critical valve disease. Work up with RHC was not recommended. Nephrology was also following for assistance with diuresis management in the setting of his kidney disease. Lasix was placed on hold 11/6 due to improvement in fluid status/ Pt is also s/p albumin infusions.  Despite this, worsening respiratory status continued and pt was transferred to ICU 11/9 and intubated 11/11 after reconfirming code status with him and his wife. There is no desire for prolonged efforts at resuscitation in this regard however.  Patient's condition declined.  Wife wished to proceed with comfprt care measures on 11/15/2021.  Patient passed away peacefully at 1940 on 11/15/2021 with wife and ster daughter at bedside.
Complains of Right Shoulder Pain. Gabapentin, Shoulder Xray, Opioid Analgesics, Rest.