chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt had recent hospitalization for Atrial Fibrillation with RVR, COVID pneumonia, fluid overload; dc'd on 7/17/22; pt to hospital 8/1/22 with positive COVID test; c/o worsening SOB and fatigue; pt had elevated BS and WBCs; ICU; bilateral pulmonary infiltrates; O2 supplementation; experienced Ventricular Fibrillation; cardioversion; elevated potassium levels and worsening renal function; told may need dialysis; pt refused and wished to forego any tx; transitioned to comfort measures and passed away in the hospital
Shortly after receiving the 2nd dose of the Moderna vaccine, she was noted rubbing her eyes frequently.  The observation RN walked over, and asked what was wrong, and the client stated her vision was blurry.  She also reported she did not eat any breakfast this morning and she is approx. 2 months pregnant.  Juice and graham crackers were offered and accepted.  No improvement noted.  Code Blue was activated and EMS was notified.  The client also began scratching her upper body and complained of itchiness.  EMS arrived and the client was transferred to Hospital via stretcher accompanied by EMS attendees.
The next day woke with worse headache of my life , nausea, pain behind my eyes,confusion, throwing up brown liquid, left work early came home , went to bed , next day still really sick , so missed work again , 3 days total missed , thought it should be know men are having bad reactions too
COVID-19; COVID-19; This is a spontaneous report from a contactable consumer reporting same event under the same suspect product for 28 patients. This is one of 28 reports. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced COVID-19 (medically significant) on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on unknown date. The reporter stated that 28 people from a certain University tested positive.  The lot number for bnt162b2 was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101234857 Same reporter/product, different patient/event;US-PFIZER INC-202101258353 Same reporter/product/events, different patient;US-PFIZER INC-202101264507 Same reporter/product/events, different patient;US-PFIZER INC-202101264528 Same reporter/product/events, different patient;US-PFIZER INC-202101264529 Same reporter/product/events, different patient;US-PFIZER INC-202101264530 Same reporter/product/events, different patient;US-PFIZER INC-202101264531 Same reporter/product/events, different patient;US-PFIZER INC-202101264532 Same reporter/product/events, different patient;US-PFIZER INC-202101264508 Same reporter/product/events, different patient;US-PFIZER INC-202101264509 Same reporter/product/events, different patient;US-PFIZER INC-202101264510 Same reporter/product/events, different patient;US-PFIZER INC-202101264511 Same reporter/product/events, different patient;US-PFIZER INC-202101264512 Same reporter/product/events, different patient;US-PFIZER INC-202101264513 Same reporter/product/events, different patient;US-PFIZER INC-202101264514 Same reporter/product/events, different patient;US-PFIZER INC-202101264515 Same reporter/product/events, different patient;US-PFIZER INC-202101264516 Same reporter/product/events, different patient;US-PFIZER INC-202101264517 Same reporter/product/events, different patient;US-PFIZER INC-202101264518 Same reporter/product/events, different patient;US-PFIZER INC-202101264519 Same reporter/product/events, different patient;US-PFIZER INC-202101264520 Same reporter/product/events, different patient;US-PFIZER INC-202101264521 Same reporter/product/events, different patient;US-PFIZER INC-202101264527 Same reporter/product/events, different patient;US-PFIZER INC-202101264526 Same reporter/product/events, different patient;US-PFIZER INC-202101264525 Same reporter/product/events, different patient;US-PFIZER INC-202101264524 Same reporter/product/events, different patient;US-PFIZER INC-202101264522 Same reporter/product/events, different patient;US-PFIZER INC-202101264523 Same reporter/product/events, different patient
dec tone & pallor w/dec responsiveness to stimuli began w/in 5min of vax persisted off & on for 1 1/2hr;
On Oct 5,2006 pt presented to her PMD with vomiting, diarrhea and labs subsequently revealed she had elevated serum bilirubin. By Oct 6 she had progressed to fulminant liver failure with a peak INR of 32! She subsequently underwent orthotopic liver transplantation 6/27/07-records received from facility for DOS 10/5-11/8/06. DC DX: Acute liver Failure. Living related liver transplant. Intubated, ventilator support and subsequent extubation. Acute onset of jaundice, vomitng and fever. On 10/4/06 began having diarrhea, noted retrospectively that she appeared yellow. Vomitng began on 10/5/06. PE. jaundiced with hepatomeglay liver 3cm below LCM.
I95.9 HYPOTENSION 6/24/2022 METABOLIC ENCEPHALOPATHY
This spontaneous report was received from a pharmacist via a company representative regarding a female patient of unknown age. No medical history and concurrent conditions were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot number and expiry date unknown). No concomitant medications were reported. On an unknown date, after vaccination with ZOSTAVAX, the patient developed an unspecified rash that "resembled shingles" at the injection site which traveled down to her unspecified arm. The patient sought medical attention (details unspecified) and received an unspecified antibiotic as treatment. The outcome of the events was unknown. No product quality complaint was reported. Causality assessment was not provided. This is one of the two reports from the same source. Additional information has been requested.
Moderna COVID-19 Vaccine EUA In the midnight of my 2nd shot, my whole body felt freezing cold, and I was trembling, teeth were clinching, I almost passed out. I could not take shower. I turned on all heaters and 3 heat pads in my bed, and I put 4 comforters on top of me, wearing  my down coat in my bed, and tried to sleep. I was afraid to not able to wake up in the morning if I fall into sleep, so I made myself wake up every 15-20 min, to get up and drink hot water. I woke up about 25 times in the whole night to go to the bathroom to pee and flush out medicine, and I kept drinking hot water each time. In the morning, I started to felt better. That is said, I also felt right head a kind of pain , it is around my ears, I say. It lasted about 5 days including today, still felt a little bit, but a lot of better than before.
12/30/20: L arm tender, warm, localized erythema at injection site. Fatigue, mild body aches, generalized headache. Left work at 09:30 am. Went home and slept. Took OTC Tylenol 1000mg.  12/31/20: called in sick. Fever 99.9, body aches, headache more posteriorly with sensitivity to touch. L arm increased erythema, warmth, tender.  Took Motrin/Cetirizine po, and put Arnicare on L arm.  1/1/21: fever and generalized symptoms improved. L arm seemingly improved. Did not take any medications or topical to L arm.  1/5/21: L arm with increased erythema, warmth, tenderness. Took Motrin/Cetirizine po and used Arnicare to L arm.  1/6/21: L arm increased erythema, warmth, tenderness and induration. Measured L arm erythema at work approximately 5-6cm. Continued taking Motrin, Benadryl 50mg every 4 hours x 2 doses.  Put Hydrocortisone cream to L arm as well as ice. Had a video conference with PCP, Dr. Antibiotic Keflex was ordered for 10 days. Told to stop taking after 5 days if improvement.  1/7/21: L arm still with erythema, induration, warmth, not as tender but was itchy. Continued taking Motrin/Cetirizine po, Hydrocortisone cream. 1/8/21: Erythema L arm seemed to spread out more with a surrounding ring, less tender but still with warmth and itchiness. Antibiotics received in the mail but bottle crushed and loose pills in the package. Took Motrin/Cetirizine po and Hydrocortisone to L arm.  1/9/21: L arm improved erythema, warmth and no induration noted. Still with itchiness.  Obtained pictures from 12/30/20, 12/31/20, 1/6/21, 1/7/21, 1/8/21, 1/9/21.
This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Put into the refrigerator on 7OCT2021 and given on 8NOV2021 and 9NOV2021) 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 November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced PRODUCT STORAGE ERROR (Put into the refrigerator on 7OCT2021 and given on 8NOV2021 and 9NOV2021). In November 2021, PRODUCT STORAGE ERROR (Put into the refrigerator on 7OCT2021 and given on 8NOV2021 and 9NOV2021) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.Multiple patients received doses of the Moderna  COVID-19 vaccine after it had spent greater than 30 days  in the refrigerator on 8 -NOV-2021 and  9-NOV-2021.The vaccine was first moved from the freezer to the refrigerator on 7-OCT-2021. The contact believed that most if not all of these doses were booster doses administered. None  have reported any known symptoms or side effects to the contact, and no treatment measures have been attempted.Concomitant medication use was unknown.
Vomiting; Diarrhea; cold chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in arm left, administration date 23Mar2021 11:00 (Batch/Lot number: unknown) at the age of 75 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Diabetic for many years; "Seasonal allergies" (unspecified if ongoing), notes: diagnosed years ago; takes over the counter allergy medication when needed. The patient took concomitant medications. Vaccination history included: Shingles vaccine (Onset: 15Jan2021), administration date: 15Jan2021, when the patient was 75 years old, for immunization, reaction(s): "Chills", "Diarrhea", "Vomiting". The following information was reported: CHILLS (non-serious) with onset 23Mar2021, outcome "recovering", described as "cold chills"; VOMITING (non-serious) with onset 23Mar2021 18:00, outcome "recovering", described as "Vomiting"; DIARRHOEA (non-serious) with onset 23Mar2021 18:00, outcome "recovering", described as "Diarrhea". Additional information: The patient takes the same medications for years. The patient had no prior vaccination within 4 weeks. Chills started at around 15:00-16:00 and lasted until 24Mar2021 03:30. The patient could not get warm and claimed that it was the same side effects when she got the shingles shot but was worse. She threw up twice and got diarrhea 3-4 times. The events did not result in an emergency room or physician office visit.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No adverse effect until 8/23/16. Red, swollen, warm to touch. Took ADVIL still no change. 8/31. Per patient, took BENADRYL and ADVIL and symptoms subsided before even seeing her physician so never saw Dr.
Very sleep the rest of Friday and part of Saturday.  Saturday evening started to itch around chest and neck which settled down after taking Benadryl. Sunday, a mild sore throat for a few hours.  Monday(today) morning upset stomach and chills off and on. Starting to subside somewhat around 10 a.m.
Patient received first dose on 1/3/21 and tested positive for COVID19 on 1/9/21. He was informed by an unknown source that he should wait to receive his second vaccination. He did not receive his 2nd dose until 4/2/21
Its itching/All the problems that I might be having now like itching around my breast; Rash; This is a spontaneous report from a contactable consumer (wife) and a non-contactable consumer (patient, husband). A (age: 81; unit: unknown) male patient (husband) received BNT162B2 (Pfizer) on 20Jan2021 at single dose for covid-19 immunization. Medical history and concomitant medications were not reported. Patient took the Covid shot on Wednesday (20Jan2021) and he has a rash and its itching. Patient stated problem he might be having now like itching around his breast. The outcome of the events was unknown.  Information on lot/batch number has been requested.
This case was reported by a nurse and described the occurrence of chills in a 59-year-old female patient who received SHINGRIX (batch number EK279, expiry date 31st March 2020) for prophylaxis. Additional patient notes included None. On 15th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 16th February 2018, 1 days after receiving SHINGRIX, the patient experienced chills, general body pain and headache. On 17th February 2018, the outcome of the chills, general body pain and headache were recovered/resolved. It was unknown if the reporter considered the chills, general body pain and headache to be related to SHINGRIX. Additional details were provided as follows: The reported adverse events were not associated with medical history or concurrent illness, erroneous administration, suspected transmission of an infectious agent via medicinal product and lack of effect.
Patient presented with 7cm x 7cm area of swelling and extreme tenderness to left lateral thigh with 3cm x 3cm area of centered erythema.  Seen in pediatrician's office for symptoms 10 days after injections.  Patient given Ceftriaxone q day for 3 days and Clindamycin for 10 days.
Shingles outbreak on thigh, extreme skin sensitivity x 1 week, followed by severe nerve pain and shingles rash, still under treatment with ibuprofen and valacyclovir
ACUTE CORONARY SYNDROME, UNSPECIFIED 3/10/2023 HYPERKALEMIA
client was given pediatric dose instead of 12+ dose- no adverse reactions noted.  Guardian choosing to wait 8 weeks to get correct dose.
fully vax tested positive 12/27. dose 1 12/29/21 dose 2 1/21/21
3 days after Zostavax L Deltoid-Pt developed a painful "pox" (blister) in L Thoracic Aura-resolved in 24 hours.
the needle inserted into the left deltoid when vaccine squirted out at the connection between the syringe and the needle NO AE; Most of the vaccine went down the patient's arm/no ae; Most of the vaccine went down the patient's arm/no ae; the needle inserted into the left deltoid when vaccine squirted out at the connection between the syringe and the needle NO AE; Initial information received on 16-Dec-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 66 years old patient to whom most of the INFLUENZA VACCINE TRIVALENT [FLUZONE HIGH DOSE] vaccine went down the patient's arm as the needle inserted into the left deltoid when vaccine squirted out at the connection between the syringe and the needle (lot: UJ308AA, expiry date: 30-Jun-2020), via unknown route, on an unknown date.  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to the Vaccine underdose, Wrong injection technique, exposure via skin contact. It was also a case of syringe issue.   It was unknown if any adverse event occurred.  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 and Module VI of the 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.
I started vomiting with diarrhea flu like symptoms and was told that is what I had, this lasted about two weeks.
Pronounced and strained speech tic/stutter causing difficulty finishing sentences that previously were communicated with no impediment. The patient, our son, would get stuck between words for an extended period of time in these tics, and sometimes be unable to finish sentences that he had been able to say easily prior to vaccination. The onset of the speech tics was three days after the administration of the vaccines, peaking at its worst one week after the administration for 2-3 days, and slowly subsiding in the following two weeks (three weeks after vaccination). Also, he has had an eczema-like rash on much of his body, behind his knees, in and around his armpits, on his lower back and belly, which showed up after vaccination and has still not completely gone away. We noticed marked irritability after vaccination as well, which persisted for about two weeks.
About an hour after the vaccine I developed a jolting pain in my right leg and it felt as if swelling developed in my mouth feeling as if I was having problems swallowing. I went to the ER but nothing was done and was advised it was a heightened immune response to the vaccine and released.
During evening of 10/04/2014. Pt stated he had persistent elevated blood sugar after receiving flu injection requiring more than usual insulin injections. Pt was fatigued from poor sleep, but showed no lasting effects. He reported to clinic A+Ox3 with no significant clinical findings. Pt was sent home to convalesce.
Positive covid test; Positive covid test; scratchy throat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. Other Case identifier(s): NVSC2022US029492_OS.  A 17 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 05Sep2021 (Lot number: FD8448) as dose 3 (booster), single, intramuscular, administered in arm, administration date 04Apr2021 (Lot number: ER8734) as dose 2, single and intramuscular, administered in arm, administration date 14Mar2021 (Lot number: EL1283) as dose 1, single for covid-19 immunisation;(Batch/Lot number: unknown). Relevant medical history included: "AS- arthritis", start date: 2017 (ongoing). Concomitant medication(s) included: REMICADE taken for arthritis. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Positive covid test"; THROAT IRRITATION (non-serious), outcome "unknown", described as "scratchy throat". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The action taken was unknown.  Clinical information: It was reported that the patient had a positive covid test during first few weeks of Cosentyx. There were no reactions to 3 vaccines. There was a weakened immune system and use of medications that suppress the immune system (e.g., high-dose of corticosteroids, cyclosporine, methotrexate, azathioprine, and biologic therapies like rituximab and etanercept).Vaccination Facility Type: Pharmacy or Drug Store.  Follow-up attempts are completed. No further information is expected.
Phone call from mother at 12:40 stating she received a phone call from nanny that the pt "just woke up from 2 hours nap vomiting (x3), dizzy and weak. Denied resp distress. Mother left work to go home and check on child. Mother recontacted office at 12:50 pm, "she looks like she wants to sleep", "she's real weak, and pale and lethargic". Pt had additional emesis while on phone with office. Temp at home per mom was "95.4", no work of breathing reported, pt was "cool" to touch "she feels cool to me". Told to call 911. Mother declined 911 call and stated, "I'll drive her to the ER".
Arm hurting a bit after 1 week; had some side effects not severe ones; Interchange of vaccine products; weird side effect, rash all over the torso; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurting a bit after 1 week), RASH (weird side effect, rash all over the torso), VACCINATION COMPLICATION (had some side effects not severe ones) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: PFIZER on 04-Apr-2021 and pfizer on 25-Apr-2021. Past adverse reactions to the above products included No adverse reaction with PFIZER and pfizer.    On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Nov-2021, the patient experienced RASH (weird side effect, rash all over the torso). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurting a bit after 1 week), VACCINATION COMPLICATION (had some side effects not severe ones) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). On 27-Nov-2021, RASH (weird side effect, rash all over the torso) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm hurting a bit after 1 week) had not resolved and VACCINATION COMPLICATION (had some side effects not severe ones) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.
fever (not meas), dec appetite, lethargy x 1 day; nl urine output, smiling, playing intermittently; fever dec w/APAP;
Adult Pt was given DTaP by mistake when Tdap was ordered. Pt denies any adverse effects. Nurse and MA double checked vaccine but neither are familiar with vaccines and do not have a vast experienced with them. Staff will be inserviced by both myself and the local Public Health Nurse in the hopes of educating new staff and preventing further errors.
This spontaneous case reported by a nurse, describes the occurrence of administered expired product (318 patients received dose from vials beyond 30-day use by date) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 020F21A) for COVID-19 immunization. No medical history reported. On Sep 21, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Sep 21, 2021, patient administered expired product (318 patients received dose from vials beyond 30-day use by date). On Sep 21, 2021, administered expired product (318 patients received dose from vials beyond 30-day use by date) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Patient received the dose from a vial refrigerated on Aug 19, 2021.
Patient called and said that she got blemishes all over her body 5 days after getting 1st dose of pfizer. Blemishes are big and were approximately 2 inches big. Patient reported no SOB and is doing fine now.