chrisvoncsefalvay/vaers-outcomes huggingface dataset:
big lump forming at the injection site; It's itchy; injection site reaction; little bit of sniffles; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (little bit of sniffles), VACCINATION SITE MASS (big lump forming at the injection site), VACCINATION SITE PRURITUS (It's itchy) and VACCINATION SITE REACTION (injection site reaction) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     No medical history was provided by the reporter.     On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced NASOPHARYNGITIS (little bit of sniffles). On 21-Jan-2021, the patient experienced VACCINATION SITE MASS (big lump forming at the injection site), VACCINATION SITE PRURITUS (It's itchy) and VACCINATION SITE REACTION (injection site reaction). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (little bit of sniffles), VACCINATION SITE MASS (big lump forming at the injection site), VACCINATION SITE PRURITUS (It's itchy) and VACCINATION SITE REACTION (injection site reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details also included Wonder Balm on the area.   Reporter did not allow further contact
Pt. states after receiving 2nd dose of Phizer started experiencing 05/21/2021 week later crippling hand and wrist joint soreness,  Dr. visit 07/02/2021 cortizone shots , Julian Bar Syndrome diagnosed.
09/20/22 4:30 AM: Severe headache started.  7:30 AM, was unable to get out of bed, severe dizziness, severe headache, nausea, physical exhaustion 8 AM low blood pressure, 84 /54, able to go to bathroom. went right back to bed, no energy for anything else Throughout the day I was able to sleep in about 2 hours increments, get up for about 3 to 5 min, go to bathroom, drink a little bit, go back to bed, sleep. 09/23/22 Got up at 7:30 AM, noticed that I slept well through the night. I got up and was okay to do my ADLs, physically fit as before the vaccine and emotionally stressed by what had happened. That fear/anxiety has eased by now too.
4/4/23  I had fatigue, pain in my chest, a cough and body aches. Overnight, I began running a fever that ranged over three days between 101 and 103.  I was sick for three days. I took an at home COVID test and it was positive. I had a telehealth visit on 4/5/23 and was started on Paxlovid. I took the Paxlovid for the five days.
Trouble falling asleep, staying asleep.  Low sex drive.  Constant sinus cold
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hyperventilation-Medium, Systemic: Hypotension-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Severe, Additional Details: PER PATIENTS SISTER, THE PATIENT HAS BEEN DIAGNOSED WITH PANIC DISORDER AND SUFFERS FROM PANIC ATTACKS.
Pt recvd rubella vax 4SEP87 & pt stated that following vax exp number of injuries, including but not limited to, arthritis & arthralgia;
COVID-19 infection after vaccination with 1st shot; Delayed second shot; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 infection after vaccination with 1st shot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed second shot) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 017B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed second shot). On an unknown date, the patient experienced COVID-19 (COVID-19 infection after vaccination with 1st shot). On 09-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed second shot) had resolved. At the time of the report, COVID-19 (COVID-19 infection after vaccination with 1st shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant medications included water pill, vitamins and blood pressure pill.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Reporter email address updated.; Sender's Comments: This is a case of inappropriate schedule of product administration for this 78-year-old, female patient with no disclosed medical history, who experienced the unexpected event of Covid-19. The date of occurrence of Covid 19 after the first dose of Moderna vaccine is unknown. The rechallenge was negative as patient did not report any new AEs on follow up after the second dose. The benefit-risk relationship of Moderna vaccine is not affected by this report.
This spontaneous report Was received from a Medical Assistant referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 09-NOV-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot # N005619, expiration date on 29-OCT-2019 (strength and dose number were not provided) for prophylaxis, however no adverse effects were reported. The temperature and time frame was: 9°C (Celsius) to 25 °C (8.7°C) for 12 hours and 41 minutes. There was a previous temperature excursion of 0°C to 1°C (0.6°C) for 44 minutes. The call was due to data logger. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1711USA011899:
Fainted, administered Epi Pen checked BP every 5 min until EMS arrived then EMS Took him to ER to get follow up by DR.
Information has been received from a Registered Nurse concerning an 18 year old female patient with a history of seizures prior to GARDASIL, who on an unspecified date was vaccinated with a dose of GARDASIL. The nurse advised that the patient experienced seizure and subsequent death after receiving GARDASIL. It was not advised which injection in the series caused the adverse experience or how the injection was administered. The health care professional was contacted by telephone and call would not supply the following information: patient name, date of birth, dates of vaccination/therapy, dose number, lot number and date of event. Seizure was considered to be disabling and immediately life-threatening. Additional information has been requested.
Pt. came to clinic after receiving intranasal flu & ADACEL w/ (R) foot swelling & pain w/ weight bearing & swelling (L) ring finger & pain with movement.
Information has been received from a nurse referring to unspecified number of patients of unknown age and gender. It was reported that 48 doses of improperly stored (Oka/Merck) VARIVAX (lot# was reported as L020001, expiration date 02-JUN-2017, Lot# L021210, expiration date 10-JUN-2017, number of doses administered for each lot was not specified, dose, route and frequency were unknown). No adverse events were reported. Additional information has been requested.
1 month after injection she noted stiffness in hands every am lasting for <30 minutes, continuing and reported on 9/2/2021 since that time. Resolves on own with stretching. Never had prior and has not changed since.
This case was reported by a nurse via sales rep and described the occurrence of injection site rash in a 15-month-old male patient who received INFANRIX (batch number Y5475, expiry date unknown). This case was associated with a product complaint. On 23rd April 2018, the patient received INFANRIX. In April 2018, less than a month after receiving INFANRIX, the patient experienced injection site rash, generalized rash and injection site erythema. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the injection site rash and pharmaceutical product complaint were unknown and the outcome of the generalized rash and injection site erythema were not recovered/not resolved. It was unknown if the reporter considered the injection site rash, generalized rash and injection site erythema to be related to INFANRIX. Additional information was received as follows: The nurse reported that the patient experienced a red rash at injection site that was larger than usual and a systemic rash (rash over body). In total 13 patients received INFANRIX with the same lot number but only 3 patients including this patient experienced reactions. The vaccine was administered at the 15 - 18 month visit. According to the treating physician, the adverse events reported were not due to the INFANRIX but thought it was a normal reaction to DTap. The nurse reported that they had 40 more doses from this lot number and she was not sure if they should use so she had sat them aside in the refrigerator until she hears from GlaxoSmithKline (GSK). The nurse was informed that there had not been a recall on this lot but that investigation would be carried out. The reporter had return one vial from the lot for investigation. This case is link with case US2018GSK080192 and US2018GSK080194, reported by the same reporter. The reported agreed to contact on follow up.
Recieved second dose at 52 days after first one; Broken hip; Fall; This spontaneous case was reported by a consumer and describes the occurrence of HIP FRACTURE (Broken hip) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced HIP FRACTURE (Broken hip) (seriousness criterion medically significant) and FALL (Fall). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Recieved second dose at 52 days after first one). At the time of the report, HIP FRACTURE (Broken hip) and FALL (Fall) outcome was unknown and INTENTIONAL PRODUCT USE ISSUE (Recieved second dose at 52 days after first one) had resolved.            No concomitant medications were reported. Treatment details was not provided. Company comment:This case concerns a 76-year-old female with a serious unexpected event of hip fracture, and non serious unexpected fall and product use issue (received second dose at 52 days after first one). Latency 28 days after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: As per the follow-up document received on 30 Apr 2021 the second dose of vaccine was administered.; Sender's Comments: This case concerns a 76-year-old female with a serious unexpected event of hip fracture, and nonserious unexpected fall and product use issue (received second dose at 52 days after first one). Latency 28 days after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Severe headaches, slurred speech, difficulty walking, malaise, achy joints. Pt missed 1 day of work.
?Neck swelling w/ slight tenderness 12 days after Merck vaccine.  Lasted approximately 12-24 hours.  Could move neck freely;  R swollen upper arm onset 4/10/09.
Patient was given an extra dose of HEP B. Patients mother stated the baby is fine no adverse reactions noted.
I was given Flumist Quad Nasal Suspension due to allergies of the preservatives in the flu shot. When given the first nostril was not a spray but pure liquid that went down my throat and dripped out my nose- the second nostril was a spray. I felt a burning sensation with that. Starting Oct 2 I was very tired, Oct 3 started with sneezing most of day and runny nose then that evening I was very congested, head pain and sick- it is Oct 7 and I still do not feel good. My concern being was the first dose supposed to be pure liquid that ran down my throat and out my nose?
Client reported Abdominal itching to her on-call OB provider.  Was instructed to take Benadryl, which she did. She awakened at 3:00 AM to more itching and noticed 12 welps on abdomen.  By 12:00 Noon on 10/22/2009 she had itching and welps on her legs and lower back. Client had received and seasonal flu vaccine in early Sept. this year and one other time a few years ago.  10/27/09 OB/GYN records received sevice dates 6/25/09 to 10/23/09. Assessment: Hives. Patient reports hives, itching, took benadryl.
My Pfizer shots were delivered on Feb 18 and March 12, 2021. I experienced irregular menstrual symptoms from March 1-March 13 of 2021. My typical menstrual cycle is 26-28 days, with 3-4 days of concentrated bleeding. My previous 3 periods were Dec 18-22. Jan 17-20, and Feb 12-16. On March 1 almost 2 weeks before my expected period, I started spotting and cramping. The light bleeding continued for 2 weeks, at which time it transitioned into my typical period with regular cramps and bleeding, in line with my usual experience. My GYN did not know what could be causing this (I later found out there have been many irregular menstrual symptoms associated with Covid-19 vaccines. I don't regret getting it, this was fairly mild, but if there is a causitive link between the vaccines and mesntrual side effects, women NEED to know this. Menstrual and female reproductive health side effects need to be observed and measured in clinical trials, and female patients need to be advised what to expect.
elderly patient received one dose on Pfizer covid vaccine after completing the moderna series on ( 2-3-2021 & 3-3-2021). Patient was having  symptoms of dementia and denied having been vaccinated previously.  Patient had no immediate adverse effects.
Since my last vaccinated on 8/13/2021 with the Moderna shot I began to experience increased muscle pain in legs over time.  By 12/04/2021 I constantly have knee joint pain and muscle pain in both legs thigh area.  This pain is not due to any one event or exercise.
Eight minutes after receiving the vaccination, she developed mild itching in her throat. She was taken to a private section and monitored. No tongue swelling or facial swelling.  Lungs were clear to auscultation bilaterally. She was given fexofenadine 60 mg tablet times one. Prior to taking the medication, her throat itching started to improve.
High temperature; Swelling on injection site; Redness on injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (High temperature), VACCINATION SITE SWELLING (Swelling on injection site) and VACCINATION SITE ERYTHEMA (Redness on injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (High temperature), VACCINATION SITE SWELLING (Swelling on injection site) and VACCINATION SITE ERYTHEMA (Redness on injection site). At the time of the report, PYREXIA (High temperature), VACCINATION SITE SWELLING (Swelling on injection site) and VACCINATION SITE ERYTHEMA (Redness on injection site) outcome was unknown.            No concomitant medications reported by investigator  No treatment medications provided by the reporter.     This case was linked to MOD21-069742.; Sender's Comments:  MOD21-069742:child case crosslinked
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 06-Oct-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Date of refrigeration of vaccine was reported as 19-Aug-2021.   This case was linked to MOD-2021-363767 (Patient Link).
2/1 vaccination. Right arm had discomfort (other VSAFE report should have L arm for vaccination).  Later that evening, flu like symptoms; hot and cold chills, temp?. Symptoms lasted for about 24 hours.  *COVID + November 2020 *ongoing lack of energy since COVID +, persistent voice coarseness
I had the usual immediate local symptom on days #1-4 (sore arm) and the usual immediate systemic symptoms on days #1-3 (fever, chills, myalgias, fatigue).   However, on day # 7, I started developing slight pruritus at my injection site and by day # 8, I developed significant pruritus (and some pain) with a 6x10cm area of erythema and induration surrounding my injection site which lasted another 3-4 days.    Also, I developed a herpetic outbreak on my lip (worse ever in my life) starting on day #9 which resolved by day #19.    I started Valtrex immediately 1gm BID, then increased dose to TID when I started feeling left sided facial symptoms concerning for early Bell's Palsy on Day #11.  There still is some intermittent, residual, low-grade pain in left arm.
Vaccine stored in refrigerator 17-Nov-2021, expired product 03-Oct-2021, administered date on 23-Nov-2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator 17-Nov-2021, expired product 03-Oct-2021, administered date on 23-Nov-2021) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine stored in refrigerator 17-Nov-2021, expired product 03-Oct-2021, administered date on 23-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator 17-Nov-2021, expired product 03-Oct-2021, administered date on 23-Nov-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The date of vial placed in refrigerator was on 17-NOV-2021 and vaccine did not undergone any temperature excursion. Patient did not experience any adverse event. No concomitant were reported. No treatment were reported.
On 2/28/2021, I got the 1st dose  and about  10 days after the 1st vaccine, I had severe headache, exhaustion and large swollen gland on my right arm pit.  The vaccine was in my left arm.   The swollen gland was painful to the touch.  I did go to Urgent Care and was tested for Covid and Lyme disease and everything came back normal.  I was instructed to go ahead and get the 2nd vaccine even though I was having symptoms.  I got the 2nd vaccine on 3/28/2021 and started feeling even worse.  I did see my doctor, who ran blood work and ultrasound and the blood work showed very low platelets and increased liver enzymes.  I was instructed to go to the ER.  I had a full work up and CAT scan.  I was diagnosed with ITP which is an automimmune disease. I was to follow up with a hematologist. A few days later, I woke up with a large bruise on my neck so I went to the ER again. I was turned away and sent home.  My PCP did blood work again and based on the results from the blood work I was told to go to the ER where they finally admitted me with ITP and I stayed in the hospital for 5 days.  I was given IV medications  to bring my platelets levels back up.  I was discharged with directions to follow with hematologist.   I had to do blood work every week and on my weekly blood work, my liver enzymes were elevated and I was referred to a specialty hospital. On 5/3/2021 I was admitted to be monitored and they did a liver biopsy.  The biopsy showed that I had autoimmune hepatitis.  The doctor said it was a reaction to the vaccine.  I was given high doses of steroids and antirejection medication called Cellcept that I have to take every day.  I did see an rheumatologist who said that my conditions were an adverse reaction from the vaccine.