chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 19-JUN-2018, the patient was vaccinated with improperly stored doses of PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. Sterile diluent (DILUENT MRK INJ) was properly stored. No adverse effects were reported. No product quality complaint was involved. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1808USA004381: Original Case : 1808USA001261 US-009507513-1808USA004382: Original Case : 1808USA001261 US-009507513-1808USA004383: Original Case : 1808USA001261 US-009507513-1808USA004384: Original Case : 1808USA001261 US-009507513-1808USA004385: Original Case : 1808USA001261 US-009507513-1808USA004362: Original Case : 1808USA001261 US-009507513-1808USA004386: Original Case : 1808USA001261 US-009507513-1808USA004387: Original Case : 1808USA001261 US-009507513-1808USA004388: Original Case : 1808USA001261 US-009507513-1808USA004363: Original Case : 1808USA001261 US-009507513-1808USA004364: Original Case : 1808USA001261 US-009507513-1808USA004389: Original Case : 1808USA001261 US-009507513-1808USA004390: Original Case : 1808USA001261 US-009507513-1808USA004391: Original Case : 1808USA001261 US-009507513-1808USA004365: Original Case : 1808USA001261 US-009507513-1808USA004392: Original Case : 1808USA001261 US-009507513-1808USA004393: Original Case : 1808USA001261 US-009507513-1808USA004394: Original Case : 1808USA001261 US-009507513-1808USA004395: Original Case : 1808USA001261 US-009507513-1808USA004396: Original Case : 1808USA001261 US-009507513-1808USA004366: Original Case : 1808USA001261 US-009507513-1808USA004367: Original Case : 1808USA001261 US-009507513-1808USA004368: Original Case : 1808USA001261 US-009507513-1808USA004397: Original Case : 1808USA001261 US-009507513-1808USA004398: Original Case : 1808USA001261 US-009507513-1808USA004399: Original Case : 1808USA001261 US-009507513-1808USA004369: Original Case : 1808USA001261 US-009507513-1808USA004370: Original Case : 1808USA001261 US-009507513-1808USA004400: Original Case : 1808USA001261 US-009507513-1808USA004401: Original Case : 1808USA001261 US-009507513-1808USA004371: Original Case : 1808USA001261 US-009507513-1808USA004372: Original Case : 1808USA001261 US-009507513-1808USA004373: Original Case : 1808USA001261 US-009507513-1808USA004380: Original Case : 1808USA001261; US-009507513-1808USA004379.
Psorasis flared up on my upper arms and back.  Went to dermatologist on 7/12/2021.  She prescribed a cream and is prescribing Cosentyx.
Fetus stopped developing right after getting the INFLUENZA VIRUS VACC QUAD 3 YRS & OLDER . At 6 weeks.  Patient had a partial molar pregnancy the year before.  No complication before getting the vaccine.
rash on arm; arm ache shortly after 1st dose; Itchy arm; a group of pimples develop in a 4"-5" radius from the point of the injection; This is a spontaneous report from a contactable consumer. This 78-year-old male consumer (patient) received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number EL9265), dose 1 via an unspecified route of administration, administered in Arm Left on 01Feb2021 18:15 as DOSE 1, SINGLE for covid-19 immunisation (Age at vaccination 78 years). Medical history included blood pressure abnormal, cerebrovascular accident, neuropathy peripheral, arthritis, stenosis, blood triglycerides increased, rubber sensitivity and CAT SCAN dye injections allergy. Concomitant medication(s) included lisinopril (LISINOPRIL); simvastatin (SIMVASTATIN); pramipexole (PRAMIPEXOLE); amitriptyline hydrochloride (AMITRIPTYLIN). I was treated for Melanoma Stage Three in 2019 through Feb2020 with the immunotherapy drug Opdivo. I tolerated the drug very well but it has caused full-body itching. I don't know if the effect of the Opdivo on my immune system has effected my reaction to the Covid vaccine. No covid prior vaccination. No covid tested post vaccination. On 01Feb2021 20:00 patient experienced rash on arm, arm ache shortly after 1st dose, itchy arm, a group of pimples develop in a 4"-5" radius from the point of the injection These were very itchy. I expected them to clear-up in 2-3 days but it has been 17 days and I still have remnants of the rash and 2-3 fading "pimples." I have not seen this particular side-effect listed so I thought I should report it. The patient underwent lab tests and procedures which included computerised tomogram: unknown result. I am scheduled to receive my second shot on 22Feb2021. No treatment was received for events. The outcome of all events was recovering.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Although I was 41 years old at the time that I decided to get the GARDASIL vaccine, I had not had any menopausal symptoms. I had very regular menstrual cycles and had not experienced any hot flashes nor did I have other indications of impending menopause. It is my understanding that frequently daughters tend to go through menopause around the same age as their mothers. (My mother did not quit having periods until her mid to late 50s). Immediately after receiving the GARDASIL vaccine my periods stopped. I never had another period. I also experienced (within days to a couple of weeks of receiving the vaccine) menopausal symptoms (i.e.: hot flashes). At the time my doctor ordered hormone testing and was a little surprised at the abruptness of my cycle stopping. Neither him nor I related this early menopause to the GARDASIL vaccine, but I have wondered ever since if it caused menopause in my case. In case there is a connection I thought it prudent to file this report.
loud tinnitus; unilateral tremor in hands; This is a spontaneous report from a non-contactable consumer (patient). A 57-year-old female patient received the second dose of BNT162B2 (COVID19 VACCINE) via an unspecified route of administration on the left arm in Apr2021 at the age of 57-year-old as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The patient didn't received other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. In Apr2021, the patient experienced unilateral tremor in hands developed after second vax and has not gone away. Also developed loud tinnitus after 2nd vax which has not gone away. No treatment was received. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 31 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Endometriosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: moderna (DOSE 4 (BOOSTER), SINGLE), administration date: 22Sep2022, for COVID-19 immunisation; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19 from 25Oct2023 to 30Oct2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300356701 same patient, different drug/events;
Left side of lip swelled up at 8:15 hours after shot with nothing different that I ate or drank and nothing used on lips or face.
Information has been received on 15-NOV-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 12-APR-2012, a physician at a clinic administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 09-OCT-2016, the patient was treated by a nurse practitioner at a medical center for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is unknown. The causality of the events is related. Additional information has been requested.
fever to 104 evening of 1FEB94 responded to APAP; pt didn't want to move much; on awakening 2FEB94 AM had one red lesion on lt abdo; by afternoon initial lesion became 1/2" blister & red maculopapular rash covered most of trunk;
On Thursday, 5/6/21, client was to receive her second dose of Pfizer COVID vaccine (LOT #: EW0167, exp: 8/2021) at approximately 11:40am. RN administered client's second dose in her left deltoid. Client was observed in the Observation Area for 15 minutes with no adverse effects and left vaccination site with a steady gait at approximately 12:05pm. RN finished administering his 6 doses around 11:45am and returned his Pod Participant Form for "Vial 24." RN noticed a duplication in vial number 24 Pod forms. Upon further assessment, RN recognized that she had reconstituted the same Pfizer vial, vial 24, twice with 1.8ml of Normal Saline. Issue was elevated immediately to Clinical Lead who advised to call client back to receive the proper full dose. Client was called at 1:20pm. RN  apologized and explained to client what happened. Client was understanding and verbalized agreement to come back the next day at 11:30am. Client received her second dose of Pfizer COVID vaccine (LOT #: EW0179, exp: 8/2021) on opposite arm at 11:31am. Client denied history of severe allergic reactions. Client was observed in Observation Area for 30 minutes. Client was educated by RN on signs and symptoms of adverse reactions and when to go to the ED/call MD. Client was also encouraged to sign-up on v-safe. Client left vaccination site with a steady gait at approximately 12:06pm.
received vaccine past it's beyond use date.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received vaccine past it's beyond use date.) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received vaccine past it's beyond use date.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received vaccine past it's beyond use date.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Clinical Team Supervisor called to report that she has Moderna COVID-19 vaccine that was placed in the refrigerator on 01-JUN-2021. 30 days came and went and after 01-JUL-2021 the vaccine was used to immunize 3 patients.  All 3 patients are adults. The expired Moderna Covid-19 vaccine was administered sometime between July 6 and July 8.  Concomitant medication not provided.  Treatment information not provided.
singificant loss of strength to the right arm with lot of pain in the elbow area; Weakness; Numbness; Having issues from the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Having issues from the vaccine), PAIN IN EXTREMITY (singificant loss of strength to the right arm with lot of pain in the elbow area), ASTHENIA (Weakness) and HYPOAESTHESIA (Numbness) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION COMPLICATION (Having issues from the vaccine). On 07-Jan-2021, the patient experienced PAIN IN EXTREMITY (singificant loss of strength to the right arm with lot of pain in the elbow area), ASTHENIA (Weakness) and HYPOAESTHESIA (Numbness). At the time of the report, VACCINATION COMPLICATION (Having issues from the vaccine), PAIN IN EXTREMITY (singificant loss of strength to the right arm with lot of pain in the elbow area), ASTHENIA (Weakness) and HYPOAESTHESIA (Numbness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow-up received,Primary reporter's address and vaccine Facility details were updated. Patient's DOB, height and weight, Batch/Lot No. were added. Events: weakness to right arm elbowto hand, numbness to left arm, from shoulder to fingers left side were added.
little pain at the injection site; arm is very sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (little pain at the injection site) and MYALGIA (arm is very sore) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced MYALGIA (arm is very sore). On an unknown date, the patient experienced VACCINATION SITE PAIN (little pain at the injection site). At the time of the report, VACCINATION SITE PAIN (little pain at the injection site) and MYALGIA (arm is very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided   No Treatment medication were provided.  Patient received first shot of vaccine and he experienced little pain at the injection site and patient also reported he felt very sore arm even after 2 weeks after shot.
Elevation in INR from 3.2 prior to vaccination to 4.8 (on 4/14) which then decreased slightly to 3.8 (on 4/19) and then elevated to 4.86 (4/23) despite reduction in daily warfarin dose. On talking with staff at  the clinic where the INR was taken, they informed me that as no other aspects had changed that the elevation in INR may have been a result of the vaccination- as this was a trend they were seeing in other patients. However neither the patients themselves nor the clinic appeared to have reported these to you or the CDC. I reported them to the CDC who recommended I use this portal to report the issue. I still intend to complete the course and receive the second dose of Covid 19 Moderna Vaccine, but have been asked to wait until my INR is back in range before doing so. I am aware that unlike the Pfizer vaccine which is effective at longer lengths between shots, the second Moderna shot should ideally be given between 4-6 weeks after the first. Still not recovered
Patient has chronic ulcer to BLE was seen by Dr. today and sent over for IV antibiotics and admission.   HISTORY OF PRESENT ILLNESS:     80-year-old female past medical history of hypertension, hyperlipidemia, impaired mobility, chronic venous insufficiency, dementia,  Last admission to our service was on December 2020, discharged on January 2021 for septic shock, bacteremia, ileus, and GI bleed, sent to the emergency room by clinic for IV antibiotics for lower extremity wounds.  Due to history of vent dementia patient is unable to provide history, on my evaluation she is AAO x1 and does not know that she was in the hospital or why.  As per discussion with ED provider has been followed by podiatry and has been on multiple courses of antibiotics however patient is unsure if she had been taking any of those antibiotics however we suspect patient is not taking any p.o. antibiotics.  Patient is disheveled and there is also concern for failure to thrive and not being able to take care of herself.  I spoke with patient's son over the phone who lives with her.  Per patient's son she has a problem with urinary incontinence and she urinates on herself which he believes has been making his wounds worse.  He also reports that he had provider at home for wound care however insurance company stopped covering and they are not going home for wound care anymore.  He reports that it is very difficult for him to help her with her wounds and he believes that this is the reason just deteriorating.  He believes that placement would be a good option for them as it is very difficult for them to take care of her.  On my evaluation patient denies any chest pain, shortness of breath, fever, chills, she reports feeling well and denies any acute complaints.  ED vitals noted significant for blood pressure 95/64, respiratory 16, O2 sat 94, heart rate 100.   Labs are interpreted significant for hemoglobin 11.5 (seems to be at baseline), lactic acid 0.9, Covid positive   Chest x-ray showing no acute findings.   In the emergency room patient received cefazolin and vancomycin.Per further discussion with ED provider, per son, patient lives alone at home, takes care of herself and often urinates, which trickles down to her wounds.  Also they do not feel  that she is safe for discharge home, and would benefit from placement in a nursing home.
Patient had no initial side effects until Day 6 after getting the vaccine. He had a seizure for the first time at around 7:10am when he was getting ready for school. He had just begun to brush his teeth when he collapsed and had a seizure. He has no medical reason to have seizures and had never had one until 6 days after getting the vaccine. Patient had to be taken the the ER to be monitored because it was his 1st seizure and then had to follow up the next day with his regular pediatrician. He will have to see Neurology, but won't see that department until January 2022. No medications were given for him to take and his was cleared to resume all normal activities again.
Alerted by vaccination RN at 12:01 PM that the first 8 doses administered of the day had been given in insufficient amount. The RN stated she realized with the last patient of the morning (receiving dose #9) that the syringe was not the 3mL syringe she was used to using, and was in fact a 1mL insulin syringe. She noted that she had been drawing up the vaccine up to 5 (meaning 5 unit, equivalent to 0.05mL) rather than to 50u to give the full dose (0.5mL).  She stated she recognized her error with patient #9 and administered the correct amount (0.5mL) from a 3mL syringe she was used to using.  In addition to contacting COVID-19 provider, the patient was contacted and, using a Spanish interpreter, informed of the incident and asked to reschedule to come back in to receive the full dose (per CDC guidance) as soon as possible. The patient stated she needed to speak to her husband to see when they could both come back to the clinic. The patient was informed of walk-in clinic hours and will be contacted again 5/19 to follow up.  At the end of the day, when counting dose administered and factoring in the estimated amount of vaccine wasted due to insufficient dosages, there was just under 9 doses accounted for. The vaccinating RN was questioned again to see if there was any possibility any of the initial 8 patients received a full dose of the vaccine without her realizing it. She stated she did not believe she ever drew up the 1mL syringe to 50u nor administered a 0.5mL dose using the 3mL syringe, though she stated she couldn't say for sure. She said the container holding the syringes had each type divided in one compartment and separated from each other. The COVID-19 provider was informed of this information and additional guidance was requested.
Myositis - diffuse muscle aches, worst in quads, unable to walk due to pain. Evaluated patient 8/26, exam consistent with myositis. no rhabdomyolysis. no local reaction at site of vaccination.
No Medical History information was reported.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jan-2021, the patient experienced PRURITUS (generalized, mild, intermittent itching). On 09-Jan-2021, the patient experienced PERIPHERAL COLDNESS (feet felt cold), PARAESTHESIA (feet felt cold and tingly) and PAIN IN EXTREMITY (I have little shooting pains in both feet and hands). On 09-Jan-2021, PRURITUS (generalized, mild, intermittent itching) had resolved. At the time of the report, PERIPHERAL COLDNESS (feet felt cold), PARAESTHESIA (feet felt cold and tingly) and PAIN IN EXTREMITY (I have little shooting pains in both feet and hands) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient did not receive any treatment.