chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have long COVID even though I'm vaccinated 3 times; I have long COVID even though I'm vaccinated 3 times; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I have long COVID even though I'm vaccinated 3 times".  Clinical course: During the call, the patient stated that patient was sick, became disabled. Patient got Covid and had long Covid even though vaccinated 3 times. Patient was supposed to get vaccinated, get fourth shot yesterday for second booster and patient had a flare up again. So, it gave all kinds of weird symptoms when had long Covid. Patient petrified of it that had long Covid because just a couple of days ago on the news they were talking about long Covid and they gave another slew of symptoms that are associated with long Covid. If patient needed another thing to make scared to death about dementia. As needed anything else to tell, patient could potentially get dementia. The fear was real and then they said the long Covid was showing dementia, brain (inaudible) Those kinds of things. If patient hadn't been vaccinated 3 times, would have died from it for sure because patient had (inaudible) that are auto-immune related. Patient had a heart condition and so had no immune system virtually. Patient got it in the hospital, still got it (Covid).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200051652 master case, dose 1;
coronary artery spasms; This is a spontaneous report received from a contactable consumer (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number Em9810), on 04Feb2021 04:00 PM (at the age of 41-year-old) on left arm at single dose for COVID-19 immunization. It was reported that patient was not pregnant the time of event and at the time of vaccination. The patient's medical history included hypertension, covid prior vaccination and no known allergies. The patient's concomitant medications included buspirone, bupropion and lisinopril. No other vaccines were administered in four weeks prior to vaccination. It was reported that unknown if related but odd that this happened one week after her initial vaccine (11Feb2021 10:00 AM). She was hit with what felt like a heart attack. Emergency room (ER) ruled out heart attack but it was possibly coronary artery spasms. She was getting heart monitor because she continued to have episodes that were decreasing in intensity each time (she got around 2 per week). The event was reported as serious with criteria hospitalization. The patient was hospitalized for one day (Feb2021). Therapeutic measure was taken as a result of the event and included that patient was put on new medicine verapamil. The outcome of the event was resolving.
Fever on and off, up to 104 for 3 weeks. No localizing symptoms. Work-up pending. Referred to Peds.
Patient seen and examined this evening upon arrival to the hospital medicine service.  Patient in semi recumbent position on simple face mask at 4 liters/minute.  Patient states onset of symptoms was during the holiday and has continually gotten worse.  Patient reports chills, shortness of breath and decreased appetite.  Denies chest pain, abdominal pain, nausea, vomiting, headache, dizziness, diarrhea, fevers and chills.
Expired Moderna Covid-19 vaccine given to 6 patients/beyond use date is 17APR2022 and administration date 20 Apr 2022; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine given to 6 patients/beyond use date is 17APR2022 and administration date 20 Apr 2022) in a female patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine given to 6 patients/beyond use date is 17APR2022 and administration date 20 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine given to 6 patients/beyond use date is 17APR2022 and administration date 20 Apr 2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.  The vaccine vial was initially stored in the refrigerator on 23-Mar-2022 and was administered on 20-Apr-2022. The vial did not undergo any temperature excursions. The vaccine was given to 3 Males and 3 Females. Patient's age was not provided.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ACUTE DVT, UNSPECIFIED VEIN  5/28/2022 -- RECURRENCE OF SAME SYMPTOMS
left knee swelling; right hip pain; Cold sore on lip; Redness; Swelling; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), SWELLING (Swelling), MYALGIA (Body aches), ORAL HERPES (Cold sore on lip) and JOINT SWELLING (left knee swelling) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced ERYTHEMA (Redness), SWELLING (Swelling) and MYALGIA (Body aches). On 07-Apr-2021, the patient experienced ORAL HERPES (Cold sore on lip). On an unknown date, the patient experienced JOINT SWELLING (left knee swelling) and ARTHRALGIA (right hip pain). At the time of the report, ERYTHEMA (Redness), SWELLING (Swelling), MYALGIA (Body aches), ORAL HERPES (Cold sore on lip), JOINT SWELLING (left knee swelling) and ARTHRALGIA (right hip pain) outcome was unknown. Not Provided          no treatment information was provided  no concomitant medication was reported   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up received on 18-MAY-2021, contains significant information, added events.
Hospitalized 11/7/2021; COVID-19 positive 11/7/2021; fully vaccinated  BRIEF OVERVIEW:  Admission Date: 11/7/2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute hypoxemic respiratory failure due to COVID-19    HOSPITAL COURSE: 86yo hx COPD, HTN, Fatty liver, tobacco use (quit 1999), presented to ED 11/7 hypoxic in 50's, placed on bipap and nonrebreather but respiratory status worsened and he was intubated in ED. K-6, lactate-7.2. He developed Afib RVR that improved with amio gtt. He required norepi. Pt was transferred to BL and paralyzed.  Vanc/Cefepime given for HAP. He has significant AKI, family unclear with desire for dialysis, now full code, aggressive treatment. Nephrology following and discussing with family need for dialysis. Right peroneal DVT noted on US, started on heparin gtt. Hgb 5.7 11/9, transfused 1 u PRBC, no obvious signs bleeding, heparin held but then resumed as Hgb stabilized. Lasix gtt 11/12. Worsening renal failure and persistently high ventilator requirements. Family conference 11/13, family ultimately decided to transition to comfort care measures. Date/time of death 11/13 at 1754.
HPV administered by MA instead of PCV13; Provider aware and ordered for PCV13 to be administered. Pt. all due vaccines plus the HPV. Pt. monitored for 30 minutes. Report completed. Pt. is to come in two weeks and PRN for any possible side effects or symptoms.
headache in eyes/forehead, chills, fever, sore arm, skin very sensitive all over,
Diarrhea; Fever; Chills; Muscle ache; first dose on 19Dec2020/ second dose on 08Jan2021 at 08:30; first dose on 19Dec2020/ second dose on 08Jan2021 at 08:30; Headache; fatigued; dehydration; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: PAA156051), on 08Jan2021 at 08:30 at single dose intramuscular in right arm for COVID-19 immunisation. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730), on 19Dec2020 at single dose intramuscular in left arm, with no adverse effects. The second dose of BNT162B2 was administered on day 20 after first dose (unapproved schedule). The patient was taking COVID vaccine since healthcare worker (Recreational Therapist) and was vaccinated at state hospital. Patient age at time of vaccination was 24 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient had no relevant medical history and received no concomitant medications. The patient stated she had fever, chills, muscle aches, diarrhea, headache. She didn't report anything to her doctor. Fever started on 08Jan2021 about 12 hours after getting the second vaccine. Chills started around 7pm and headache in the night of 08Jan2021. Muscle aches started on 08Jan2021 about 8 hours after receiving the second vaccine. Diarrhea started on 09Jan2021. These symptoms lasted all day Saturday 09Jan2021, until the night. By Sunday, 10Jan2021, she was still fatigued but she was pretty much better. She reported she had recovered completely from the symptoms but she does still have a little bit of a headache, but that is probably from dehydration. Headache was resolving at the time of reporting, outcome of dehydration was unknown, other events had resolved in Jan2021.
Pt said she felt a little warm, burning and numb for a few seconds after receiving the flu vaccine but it went away. Later on that night, she felt pain & could not move her arm. She went to see her doctor on 9/23/19 in am. She said she was diagnosed with adhesive capsulitis (frozen shoulder) & due to incorredt flu shot.administration site. She said she would need to see a physical therapist. She was prescribed meloxicam, tylenol & ice pack for her current treatment.
Initial information received on 15-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves 14 years old patient who reported medication error, while he/she received vaccine FLUBLOK QIV. (Batch number, expiration date, dose, route and site of administration was not reported for both vaccines) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to Inappropriate age at vaccine administration. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
the intensity of the CIPN increased exponentially; the intensity of the CIPN increased exponentially; This is a spontaneous report from a contactable healthcare professional (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported) at the age of 57-year-old, via an unspecified route of administration, administered in left arm on 20Mar2021 13:30 as single dose for COVID-19 immunisation. Medical history included metastatic breast CA, known allergies to oak tree and pollen, and residual bilateral CIPN in the balls and toes and feet. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination and has not been tested post vaccination. Concomitant medications included olaparib, durvalumab, and levothyroxine sodium (SYNTHROID). On 22Mar2021 07:30 (also reported as two days after receiving the first dose), the intensity of the CIPN increased exponentially. This lasted about 5 days when it slowly started to return to normal levels at 2.5 weeks after the first dose. No treatment was received for the events. The outcome of the events was recovered on Apr2021.  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association a contributory role of BNT162B2  to the reported "intensity of the CIPN increased exponentially" cannot be totally excluded.  Case will be reassessed if additional information is received.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
I noticed on 07/29/2021 that I had urinary track symptoms and went to urgent care on 07/30/2021. I was given a prescription for sulfamethoxazole. After about a day or so I was feeling better. After about 2 weeks the symptoms came back. I visit a clinic in Pharmacy and got another prescription, Nitrofurantoin. After about a day or so I was feeling better. About anther 2 weeks later my symptoms came back again. I went to the minute clinic and they gave me ciprofloxacin. After about a week I got really sick and was vomitting. I also had a fever. I took a COVID test and it was negative. I called dispatch health and they came to my house and they did another urinalyses and the results showed I still had an infection. They administered an IV and antibiotics. I had a tele health appointment with my primary care physician and he referred me to a Urologist. I had my appointment with the Urologist and he prescribed levofloxacin and nitrofurantoin. I took those medications for a couple months then I seemed to get better right away.
Vaccine administrator error. Patient received second dose of Pfizer pediatric covid vaccine 0.2ml 4 days after first dose was given. First dose given 12/3/2021. Second dose was given 12/7/2021. (Mother had signed consent to have a vaccine given in school based health clinic and then taken patient to local pharmacy to get first dose.) Patient did not have any adverse reaction at time of administration. Local health dept was contracted and advised us that adverse event expected but to have parent monitor patient and submit report to local poison control and VAERS. Spoke to mother and advised that no adverse reaction expected but to monitor and let us know if the patient had any problems or concerns. Mother agrees.
Hive like rash appeared on left leg injection was given and spread to left arm as well and developed fever of 100.4.
Pt reported (L) arm pain and swelling at and around injection site. Red, hot and painful to touch. Used TYLENOL and cool compress. Completely resolved 6 days later. Mother informed me of this on 01/03/12.
I am not sure that this is actually an adverse event, but it is a new diagnosis after being  vaccinated, My right pointer finger and joint have shown bone loss and labs indicated in Oct 2021 that I had elevated arthritis markers but was not officially diagnosed with Psoriatic Arthritis until Feb 2022. I am now on Methotrexate weekly and go in for monthly lab monitoring and a check up every 2 months with arthritis doctor.
September 9, 2018: Extreme fatigue. Mild headache. Mildly achy. September 10, 2018: Rash at site of injection. Rash in front of neck and whole left side of neck, rash on lower part of sternum. September 11, 2018: Rash started to resolve. September 12, 2018: Rash mostly gone.
He felt the numbness has advanced from his left arm to his left hand and left leg; He reported the numbness to be worse today; This is a spontaneous report received from a contactable consumer via medical information team. An 88-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, in Arm left, on 22May2021 (on Saturday) (at the age of 88 year) as 1st dose single dose for COVID-19 immunisation. The patient medical history included little numbness in his fingers every once in a while (before vaccination) and ongoing potassium low. Concomitant medication included ongoing potassium for low potassium. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There was no additional vaccines administered on same date of the Pfizer Suspect. Prior Vaccinations, there was no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. On 24May2021 (Monday), the patient reports that he felt numbness in his left arm. He stated that the numbness has advanced from his left arm to his left hand and left leg. Patient had received the injection on the left side. He stated that he is experiencing the occurring numbness off and on. He reported the numbness to be worse today and has noticed that it has progressed to his leg. He is on potassium medication and thinks the numbness could potentially be related to the potassium medication, but he is not sure. It was stated usually the numbness was only in his fingers, but lately it had been in his arm and leg. It was reported that he has an appointment with his doctor. Reporter asked if he should report this to his doctor. Reporter asked if the numbness was a side effect of the vaccine. Adverse events did not require a visit to emergency room and physician office. Outcome of the events was not recovered.  Information on lot/batch number has been requested.
Receive vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a physician assistant and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Receive vaccine while pregnant) in a 32-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20-2A and 029L20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (1 drink /month) on 01-Mar-2021 and Spontaneous abortion (Blighted ovum diagnosed at 10 weeks) on 10-Jul-2020. Previously administered products included for an unreported indication: MARIJUANA (5mg edible every 1-2 times per year) until 01-Mar-2021. Concurrent medical conditions included Asthma (Abuterol inhaler PRN for exacerbation only). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 22-Aug-2020 and the estimated date of delivery was 29-May-2021. On 10-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Receive vaccine while pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 10-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Receive vaccine while pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Sep-2020, Pregnancy test: positive (Positive) Positive. On 20-Nov-2020, Blood test: other (abnormal) The risk of Down syndrome is less than the screeningcut-off. (Maternal Serum Screen- PAPP-A and NT test). On 20-Nov-2020, Human chorionic gonadotropin: other (abnormal) The risk of Down syndrome is less than the screeningcut-off. On 08-Jan-2021, Ultrasound scan: normal (normal) Fetal anatomy scan is normal (OB complete single or first gestation ultrasound). On 22-Feb-2021, Glucose tolerance test: 93 (normal) No evidence of gestational diabetes. (Gestational Diabetes Screening test).     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient had no maternal history of subfertility. The number of fetuses was reported as 1 and had established prenatal care. There was no complications or acute illness during this pregnancy to date.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Live follow up received on 16-Apr-2021: Added HCP contact information, patient's medical historical conditions, current pregnancy details, laboratory tests, second dose information. The action taken changed (from unknown to not applicable).
Menstrual cycle went form being on a 5 day 28 day cycle with pain averaging a 2.  After vaccine cycle started coming 14-21 days and pain is at a 8 with flow being extremely heavy.
Information has been received from a registered nurse concerning a child who recently, in approximately April 2006, was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live.  In approximately April 2006, the patient experienced a fever equal to or greater than 102 degrees Fahrenheit.  A product quality complaint was involved.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements and was released.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/29/2006. Information has been received from a registered nurse concerning a 12 month old female who on 01-MAY-2006, was vaccinated SC in the "left" with a first dose of PROQUAD (Merck upgrade process) (lot #652545/0926R). On 02-MAY-2006, the patient experienced a fever of 103.5 for 48 hours. Unspecified medical attention was sought. The patient's outcome was recovered. A product quality complaint was involved. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Agency abd was rekeased by the regulatory agency. No further information is expected.
Patient developed an itchy red/purple rash near injection site shortly after administration. Patient states she reported to immunizing pharmacy and was told this can be a normal reaction, so she didn't worry about it. Patient reported to different pharmacist she still has a burning sensation and frequent itching at site 13 months later. On 9/23/2016, Pharmacist noted a blotchy reddish/purple area on the back of patient's left arm, and patient states she has pain in that area when lifting her left arm. Please note: Patient states Zostavax was administered in her LEFT arm, and this is where rash was noted. When Rph contacted pharmacist regarding Lot/Exp data for this report, Rph was told it was recorded as vaccine being administered in the RIGHT arm.
Multiple blister-like areas noted with erythema around vaccination site approximately 1.5 cm in diameter. Symptoms started on 1-11-2008. Patient seen by Pediatrician, reports he also had an ear infection and low grade fever.