chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Menveo reconstituted with sterile water; Menveo reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 20th September 2021, the patient received Menveo. On 20th September 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided are as follows: The nurse reported that the patient received a dose of Menveo lyophilized powder reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow-up.
2 hrs post vax pt exp joint pains, weak, tired, h/a, sore throat, SOB;
This spontaneous case, initially received on 17-Oct-2018 from pharmacist, concerns a 54-year-old, adult, female patient. On 15-Oct-2018, while administrating the vaccine, the syringe was leaked at the needle point and the patient received partial dose of FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid batch number: 252229, expiry date: 31-May-2019) (explicitly coded as needle issue and incomplete dose administered). It was reported that a lot of vaccine was lost while administration of vaccine. The patient did not experience any adverse event after vaccination. The reporter assessed this case as non-serious.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH significant for gout, CAD, essential HTN, hyperglycemia, AF, ckd stage 2, basal cell carcinoma, obesity, CHF. Pt was 86 years of age, with no notes of any recent hospitalizations or issues. No notation regarding death. Per database, received one dose of pfizer covid vaccine on 1/25/2021 at outside entity. No notation of 2nd dose received.
After 4th immunization pt get lightheaded and dizzy pale and clammy. Ice to back of neck and snack provided. Seen by FNP. BENADRYL given at 10.25 am. Rested and recovered in clinic till 11:40 am. Ride home from a family member. No rashes or redness to sites noted.
Patient received the J and J vaccine instead of the intended second dose of the Moderna Vaccine. No immediate adverse reaction was observed.
Less than 24 hours after the vaccine, about 4:30 - 5 PM on 7/3/2020 I began to feel very tired and got "tunnel vision." We were out of the house and it was  hot outside so I ignored it at first. By the time we got home, about 6 PM I began to ache and have chills and felt sick. Took my temperature twice, it was 100.2. My normal temp is 1 degree low, I am normally 97.6, so this is very hot for me. I drank some water and laid down and slept for 3 hours. I got up and felt worse. Felt like a flu - achey all over, headache, muscle aches everywhere, and checked temp again and it was coming down, was 99.6.  Went to bed. Could not eat much on 7/4 or 7/5 and had a stomach ache and diahrea. Fever was gone by 48 hours, or the evening of 7/4. Still was very tired, slept 10 - 11 hours each night, and could not concentrate (and I had work to do, and I just couldn't do it.) I was still lethargic at 72 hours (Sunday evening) but the muscle aches were subsiding. On Monday, I was able to work, but had to take a nap (never do, but I was exhausted) and by Tuesday (over 96 hours from the time of the vaccine) I was more or less back to normal. I only drank water and tea, did not take pain killers or any medications.
really sick with it; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (really sick with it) in a male patient of an unknown age 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (really sick with it). At the time of the report, ILLNESS (really sick with it) outcome was unknown.            No concomitant medications were reported.  Treatment information was not provided. Patient got booster shot on a Saturday and he was really sick after that.
Gave Pfizer adult instead of peds  but still drawn at 0.2 ml dose.
Patient scheduled for Moderna Booster.  He is 17 years old and Moderna has not been approved for patient's under 18 so he should have received the Pfizer booster
red/sore at the site of the injection; red/sore at the site of the injection; running a fever; really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red/sore at the site of the injection), VACCINATION SITE PAIN (red/sore at the site of the injection), PYREXIA (running a fever) and HEADACHE (really bad headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red/sore at the site of the injection), VACCINATION SITE PAIN (red/sore at the site of the injection), PYREXIA (running a fever) and HEADACHE (really bad headache). At the time of the report, VACCINATION SITE ERYTHEMA (red/sore at the site of the injection), VACCINATION SITE PAIN (red/sore at the site of the injection), PYREXIA (running a fever) and HEADACHE (really bad headache) had not resolved.            Concomitant medication was not reported. Treatment medication was not reported. The symptoms were still ongoing at the time of the call.
I asked my doctor's office to send this form but when I called to check on it there was no record of it being done so I am following up. Four hours after receiving my "flu shot" in the office I began to have neck and head pain which soon spread to my whole body. It happened so fast and so severely that by 8:30 pm, crying in pain, I went to the ER. I was admitted for two days and sent home with no real diagnosis and still in a lot of pain. During the ER visit my CRP was 148.3 and my WBC was 17,000. The discharge diagnosis was "Leukocytosis". One possible cause was physical and emotional stress, both of which I recently had. (A fall resulting in a fractured foot and a trip to care for my daughter and her family when she had emergency surgery). I was home only one day and decided I could not just endure the pain with no answers any longer and I returned to ER. I had a CT angiogram which was normal. My CRP was down to 89.90 but the WBC was now 19,000. Nothing killed the pain in my head and neck, even Morphine. Although most of the body pain was gone. I was re-admitted and had a consult with a local neurologist who did a lumbar puncture which was also negative. I was given IMITREX which did relieve my head pain some but the severe neck pain continues. The PA who did a very thorough work up in ER the second time was of the opinion that stress had upset my immune system and the flu shot sent it into "overdrive". This makes the most sense to me. I was discharged on Oct 31 being told they did not know what was wrong with me but "It was nothing serious". Since this is the worse thing I ever had to endure, to me it is very serious. I have Parkinson's Disease and my tremor has been out of control ever since. I still feel very weak more days than not. Nearly two months later I am slowly having a few more good days a week. I have moved my appointment with my neurologist up from mid Feb. 2013 to Dec. 20 2013. I have been working with a Chiropractor and Massage Therapist to help my continued neck pain. Labs are all back to normal since Nov. 8, 2013. I forgot to add that I went home on a Prednisone taper that finally relieved the pain. But it blocked the SINEMET.
Patient received Moderna vaccine (Lot: 042L20A) to right deltoid on 01/22/2021. Patient then received Janssen vaccine (042A21A) to left deltoid on 04/07/2021. Patient did not report any adverse effects or reactions.
First dose on 25 feb 2022, 2nd on 28Aug2022; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 52-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on 25th Feb 2022).   On 28th August 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 28th August 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, 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.   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: 29-Aug-2022 Reporters comment:  The reporter given consented to follow up Additional Supportive information: The patient received second dose of Twinrix, later than recommended time interval, which led to lengthening of vaccination schedule.  .
Information has been received from a nurse, referring to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-JAN-2017, the patient was vaccinated with an improperly stored dose of M-M-R II lot # L030162 and expiration date on 11-AUG-2017 (Strength, dose, anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported. It was reported that the vaccine had six previous temperature excursions of unspecified temperatures (all reported as "> 8 Celsius (C) but < 25 C) for 1 hour and 9 minutes; 22 minutes; 25 minutes; 24 minutes; 1 hour and 12 minutes and 26 minutes, on 30-NOV-2016; 22-DEC-2016; 27-DEC-2016; 06-JAN-2017; 12-JAN-2017 and 14-JAN-2017 respectively. It was confirmed that a digital data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1702USA002234: US-009507513-1701USA012268:
Moderna COVID-19 Vaccine EUA   I got the COVID Vaccine on Jan 6th and yesterday (Jan 13th)  I notice that my vaccine site has a hard lump (the size of 2 quarters laying side by side) and is itchy. When I scratch it, it hurts a bit. Internet search says that a lump may occur shortly after vaccination, but there isn?t anything that mentions a lump days after getting vaccinated or the itching.
in about 3 months I noticed intermittent ringing in both ears within 6 months the ringing became constant now ringing is constant and getting worse
Patient developed macular, papular erythematous rash that blocks over trunk, face and extremities, two days after vaccine. Patient also had several days of URI symptoms.
Large, indurated , tender, erythematous , pruritic area at site  3x5 inches!
Very sore arm, headache for a day.  Almost a week after receiving the vaccine shot, I started having very short heart palpitations.  They would only last for a second or two and I would have them probably 15-20 times a day.  These lessened over the next two weeks until I got my second vaccine shot.  They became more frequent but less intense.
Redness, inflammation, heat and swelling at injection site. Redness radius approximately 10 cm
Woke up from sleep with itching on left upper arm, went to bathroom and saw red arm.  Took Benadryl until I fell back asleep.  Reported to employee health services for follow up on 12/18/2014, saw provider for red, itchy, whelped areas on left deltoid.  Prescription for prednisone given.
arm has fever; itching/ itchiness; arm is hard; arm was still red; arm was still sore; arm is swollen; maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm has fever), PRURITUS (itching/ itchiness), VACCINATION SITE INDURATION (arm is hard), VACCINATION SITE ERYTHEMA (arm was still red) and VACCINATION SITE PAIN (arm was still sore) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.    On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced VACCINATION SITE WARMTH (arm has fever), PRURITUS (itching/ itchiness), VACCINATION SITE INDURATION (arm is hard), VACCINATION SITE ERYTHEMA (arm was still red), VACCINATION SITE PAIN (arm was still sore), VACCINATION SITE SWELLING (arm is swollen) and MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) (oral) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (arm has fever), PRURITUS (itching/ itchiness), VACCINATION SITE INDURATION (arm is hard), VACCINATION SITE ERYTHEMA (arm was still red), VACCINATION SITE PAIN (arm was still sore) and VACCINATION SITE SWELLING (arm is swollen) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the event included Benadryl cream.    Reporter did not allow further contact; Sender's Comments: This report is a case of a 25 year old female with a history of maternal  exposure to mRNA 1273 vaccine during pregnancy who developed non-serious adverse reaction, Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded. This patient will be followed up.
There are graphene oxide nanoparticles in your vaccine which lay dormant in bone marrow for years and are toxic to the body.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BONE MARROW DISORDER (non-serious), outcome "unknown", described as "There are graphene oxide nanoparticles in your vaccine which lay dormant in bone marrow for years and are toxic to the body".  Additional information: The reporter stated that the Pfizer Covid vaccine had caused endless suffering to him/her and many others. There were graphene oxide nanoparticles in the vaccine which laid dormant in bone marrow for years and are toxic to the body.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected  Follow-up (01Oct2023): This is a spontaneous follow-up report received from the same contactable Consumer. Updated information included: Reporter information (email address and other) updated; Follow-up activities possible updated.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Symptoms: Hives, rash pruritus located on arms, in the inguinal areas and left side of face. Patient noticed warm spot on arm 7/12/16 at 6:00AM when she woke up. Hives started at 10AM while picking blueberries. By the end of the day 7/12/16 Hives had shown up in inguinal areas and left side of face. Patient took BENADRYL at home. Patient was seen back in office on 7/15/16. Patient was given Cephalexin 500mg, 4 times daily 7 days, Claritin 10 mg, once daily 10 days, Prednisone 20mg, twice daily for 5 days.
Pfizer vaccine was administered outside of the clinic - reported by patient- ? NO LOT NUMBER WERE SUPPLIED -------------------------------------------------------------------------------------------------------------------------------- HYPOTENSION 12/10/2021 DERMATITIS ACUTE RESPIRATORY FAILURE 1/10/2022 DERMATITIS ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/10/2021 DERMATITIS SHOCK, UNSPECIFIED 12/10/2021 DERMATITIS HYPOTENSION 12/10/2021 SEPSIS WO ACUTE ORGAN DYSFUNCTION, W MSSA SEPTICEMIA ACUTE RESPIRATORY FAILURE 1/10/2022 SEPSIS WO ACUTE ORGAN DYSFUNCTION, W MSSA SEPTICEMIA ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/10/2021 SEPSIS WO ACUTE ORGAN DYSFUNCTION, W MSSA SEPTICEMIA SHOCK, UNSPECIFIED 12/10/2021 SEPSIS WO ACUTE ORGAN DYSFUNCTION, W MSSA SEPTICEMIA HYPOTENSION 12/10/2021 HEMATEMESIS ACUTE RESPIRATORY FAILURE 1/10/2022 HEMATEMESIS ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/10/2021 HEMATEMESIS SHOCK, UNSPECIFIED 12/10/2021 HEMATEMESIS HYPOTENSION 12/10/2021 URINARY RETENTION ACUTE RESPIRATORY FAILURE 1/10/2022 URINARY RETENTION ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/10/2021 URINARY RETENTION SHOCK, UNSPECIFIED 12/10/2021 URINARY RETENTION
no adverse event; administered an impropery stored dose of PEDVAX HIB; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. Patient's pertinent medical history, concurrent conditions, past drugs, allergies and concomitant therapies were not reported. On 23-APR-2020, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose and route were not reported) (lot number S023645 and expiration date 10-MAR-2022) for prophylaxis (product storage error). The temperature excursion was noted with a temperature of 51.5 Fahrenheit (F) for 45 minutes. There was no previous temperature excursion. No adverse effects were reported. The call was because of digital data logger. No product quality complaint was reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA002553:
After completion of vaccination, the vaccinating nurse reported the client had received a Bivalent Booster dose and should have received the second dose of Moderna for the primary series.  Dose one of primary series with Moderna was administered on 12/16/2021.  Contact was made to father, reported incorrect vaccine being administered; father states no ill effects and "was glad he received protection from the Omicron" strain.  Following research, message left for father that child needs to come in to have the second dose of the Primary series administered, followed by the Bivalent two months after the second dose of the primary series.
pt recv vax & devel a fever of 104 which resolved w/in 24hr & 50-60 skin lesions which scabbed over p/3 days;pt treated w/oatmeal bath & DPH cream;
Initially had arm soreness, underarm enlarged LAD, then later that evening (about 5 hours later), dizziness with nausea, vomiting, dry heaving.
States 2/9/11 noticed redness with small amt. swelling states size of 50 cents piece with some tenderness. States applied cold compress to site right arm. 2/10/11 states noticed more swelling and redness had increased to fist size but no tenderness, states applied cold compress at 11:00am. At 11:00pm states redness had made a circle around Rt arm. Took TYLENOL in am. 2-11-11 on exam at HD there is extensive redness and induration with edema at injection site and warm to touch no tenderness BP 110/70 P 72 R-20 Temp 98.4 degrees - referred to MD. 2-16-11 client never called health dept. to say if went to see MD. Contacted client's mother who stated client had gone to see Dr. and received a cortisone shot. When Dr. office was contacted to verify visit, MD's office stated client had not been seen by them since 6-2010.
Spasms in leg and thigh, joint pain, heart pain. My heart feel like a feeling I can't quite describe, it feels scary to even think to express appropriately. I know it hurts, and somewhat feels something like flooding. It feels I can't quite describe. It is a feeling I never felt. I lost my taste buds and have a sore throat now. my cough hurts. My chest and heart. I have a lot of mucus in my chest l.
5 minutes after Bexsero was given Pt. started with some dizziness, light headed, hands shaking. B.P. 115/74 HR: 106 @ 9:50. Pt. was given oral hydration. Pt. B.P. 100/67 HR: 109 @ 10:05  B.P. 109/62 HR: 92 @ 10:18 discharge stable B.P. 109/73 HR: 82
This case was reported by a pharmacist via call center representative and described the occurrence of rash in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rash, swelling arm, contusion, feels awful and discomfort. On an unknown date, the outcome of the rash was recovered/resolved and the outcome of the swelling arm, contusion, feels awful and discomfort were unknown. It was unknown if the reporter considered the rash, swelling arm, contusion, feels awful and discomfort to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of SHINGRIX a few months before the date of reporting, unknown how long ago on an unknown arm. The batch number and expiry date was unknown. The patient experienced rash for 4 to 5 days, whole arm was swollen, bruise on arm, feeling really awful, bad and uncomfortable after receiving SHINGRIX. SHINGRIX was not administered at the pharmacy from which the pharmacist was calling. It is unknown which arm SHINGRIX was administered and the arm which was affected by rash, swelling and bruise.
High fever 102.5. Chills body ache. Nausea, vomiting. Went to ER. High heart rate.
I am break through patient of your Pfizer vaccine, I think I got Covid 19; I am break through patient of your Pfizer vaccine, I think I got Covid 19; This is a spontaneous report from a contactable consumer or other non-HCP (Patient).   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, the patient was going to give an advice, the patient was break through patient of Pfizer vaccine (Unspecified Vaccine). The patient thought, the patient got Covid 19 on an unspecified date, and she (the girl) was asking me questions, when patient was fill out with some kind of stuff. The patient asked can you put that into the system and see who the patient was taking to.The outcome of Suspected COVID-19 was unknown  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.