chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client developed fever 6-6-17 p.m. Parents report not able to keep down with TYLENOL. At 12:30 pm on 6-7-17 fever was 103, so took client to ER. ER did strep test and treated fever with TYLENOL rotating with MOTRIN, which is what Dad reported cont. to do on 6-8-17. Still running fever on 6-8-17 at 8:30 a.m. (101 degree F).
Had flu shot 12/16/2003. 3 days later, Friday, 12/19/2003 rash developed. Rash all over body. Some itching mostly today, Monday, 12/22/2003.
Stuffy nose; Throat hurts; Headache; broke out around injection site; little bumps; itching; a bump around injection site and it was itchy; little sick; bump around injection site; Sore arm; Fever; hurting when touch; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Stuffy nose), OROPHARYNGEAL PAIN (Throat hurts), ILLNESS (little sick), INJECTION SITE MASS (bump around injection site) and INJECTION SITE REACTION (broke out around injection site) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LOSARTAN for Blood pressure management.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (hurting when touch), MYALGIA (Sore arm) and PYREXIA (Fever). On 01-Apr-2021, the patient experienced ILLNESS (little sick), INJECTION SITE MASS (bump around injection site) and INJECTION SITE PRURITUS (a bump around injection site and it was itchy). On 16-Apr-2021, the patient experienced INJECTION SITE REACTION (broke out around injection site), MASS (little bumps) and PRURITUS (itching). On 17-Apr-2021, the patient experienced NASAL CONGESTION (Stuffy nose), OROPHARYNGEAL PAIN (Throat hurts) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form. On 01-Apr-2021, PAIN IN EXTREMITY (hurting when touch), MYALGIA (Sore arm) and PYREXIA (Fever) had resolved. At the time of the report, NASAL CONGESTION (Stuffy nose), OROPHARYNGEAL PAIN (Throat hurts), ILLNESS (little sick), INJECTION SITE MASS (bump around injection site), INJECTION SITE REACTION (broke out around injection site), MASS (little bumps), PRURITUS (itching), HEADACHE (Headache) and INJECTION SITE PRURITUS (a bump around injection site and it was itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment drugs were not provided.
No additional AE information.; Nurse practitioner reported expired dose of PNEUMOVAX23 administered to patient.; This spontaneous report was received from a nurse practitioner (also reported as nurse prescriber) and refers to a patient of unknown age and gender. There was no information regarding patient's medical history, concurrent conditions or concomitant therapies provided.  On 20-APR-2022, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliter injection, lot # T027110, expiration date: 23-MAR-2022, (route of administration and anatomical location were not provided) for prophylaxis. No adverse events reported.
Approx 24 hrs after injection patient developed erythematous wheal overlaying injection site, 1/10 pain.
47 patients received an expired vaccine (The vaccine was expired on 07NOV2021 and was administered on 16NOV2021); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (47 patients received an expired vaccine (The vaccine was expired on 07NOV2021 and was administered on 16NOV2021)) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (47 patients received an expired vaccine (The vaccine was expired on 07NOV2021 and was administered on 16NOV2021)). On 16-Nov-2021, EXPIRED PRODUCT ADMINISTERED (47 patients received an expired vaccine (The vaccine was expired on 07NOV2021 and was administered on 16NOV2021)) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported.  No treatment information was provided.
I started to experience symptoms around noon time on the day of vaccination.  It started with a low-grade fever.  Slowly over the course of the day, I started to experience body aches, chills and headaches.  My left arm where I received the vaccine felt strange.  My fever got up to 100.4.  During the night I had chills.  It felt like my fever broke early in the morning.  I woke up okay and I feel like I could go about my day with no problem.  I no longer have a fever.
Patient reports no symptoms until 1/8/21 at which time a rash developed along with fatigue and fevers.  Patient was seen in ED 1/8 and 1/11/21.  Was admitted 1/11/21 with Concern for STevens Johnson and sepsis.  Patient subsequently developed full body macular rash and mucosal lesions.  Fevers to 102-104.
Patient received Moderna Dose #1 on 3/2/2021 and then received Pfizer dose on 8/1/2021. Patient returned 8/27/2021 to receive second dose of Pfizer vaccine and was disqualified and advised she is considered fully vaccinated.
On the day after vaccination with MMR, the employee noticed increased swelling, redness, and induration at the site, with maximum syptoms by day 7 after vaccination. Additionally she experienced nausea, some vomiting and a 7 cm cellulitis at the injection site area with some lymphangitis into the R axilla. The employee visited the Emergency Department twice and received fluids, antibiotics, and steroids. There was a attempt at aspiration of fluid from the area of cellulitis but no fluid was able to be aspirated. The patients symptoms have continued to diminish since her treatment.
Patient was given the second HPV vaccine dose 17 days after the first dose.  CDC called and there should be no adverse effect on patient.  The second dose that was given is considered an extra dose, and will need real second dose 2 months from "extra"second dose.  Parent notified.
Red, itchy, looks like hives. Treatment: 50mg diphenhydramine.
This spontaneous report as received from a patient's daughter, refers to a 58 year old female patient. The patient's concurrent conditions included arthritis, high blood pressure, high cholesterol, unspecified ear and throat disorder (reported as 'ears and throat was bothering her') and allergy to sulfur. The patient went to her physician's office on 27-OCT-2015 for administration of PNEUMOVAX 23 in advance of a planned back surgery which would require an extended stay in the hospital. The patient's ears and her throat were "bothering her" so the physician prescribed oral antibiotics for her. No tests were done during the visit to determine if she had an infection. The patient was administered PNEUMOVAX 23 (lot # L012215, expiration date: January 2017, dose and route were not reported) on 27-OCT-2015, because she was not running a fever and the physician determined it was safe to administer. Concomitant medications included unspecified antibiotics, "something for nausea" and "something for pain/headache", unspecified blood pressure medication and unspecified cholesterol medication. After the visit, on an unspecified date in October 2015, the patient developed a very large welt at the injection site, her head was "killing her" and she had a fever climbing over 102 (units not provided) and she couldn't stop vomiting. She was taken to the emergency room (ER) in the evening of 29-OCT-2015 and kept for observation. The tests for flu and strep performed on the same day came back negative. Based on the test results, the ER physicians believed the patient was infected by PNEUMOVAX 23. At the time of reporting, the patient was on unspecified intravenous (IV) antibiotics. The physicians were not sure if the infection has spread to her muscles or not. The welt has not improved. They might have to cut into the welt to drain the infection from her muscle. The outcome of all the events was reported as not recovered/not resolved. The reporter did not assess the relatedness between the events and PNEUMOVAX 23. Additional information has been requested.
Breakthrough case admission after 3 vaccines Pfizer 3/29/21 Lot# ER8730;  Pfizer 4/23/21 lot# Ew0172;  Pfizer 3/6/22 lot# FK9895
Small amount of meconium in amniotic fluid, NICU team removed a negligible amount from the infant's lungs immediately after birth; This spontaneous case was reported by a consumer and describes the occurrence of MECONIUM IN AMNIOTIC FLUID (Small amount of meconium in amniotic fluid, NICU team removed a negligible amount from the infant's lungs immediately after birth) in a 15-day-old female neonate exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): The mother's past medical history included Alcohol use (Prior use) on 17-Oct-2020.    MEDICAL HISTORY (Patient): The patient's past medical history included No adverse event.  On an unknown date, the mother received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The mother's last menstrual period was on 15-Sep-2020 and the estimated date of delivery was 13-Jun-2021. On an unknown date, the neonate was diagnosed with MECONIUM IN AMNIOTIC FLUID (Small amount of meconium in amniotic fluid, NICU team removed a negligible amount from the infant's lungs immediately after birth) (seriousness criterion medically significant). The Neonate was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. The vaginal delivery occurred, which was reported as Full-term. For neonate 1, with an APGAR score of 8 and 9 at (1, 5 minutes). At the time of the report, MECONIUM IN AMNIOTIC FLUID (Small amount of meconium in amniotic fluid, NICU team removed a negligible amount from the infant's lungs immediately after birth) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Transmammary) was unknown.  No concomitant medication listed.  No treatment details reported.  Company Comment: This is a case of product exposure during pregnancy with Associated AE for this 32-year-old female..Patient will continue to be contacted for further monitoring of AEs   This case was linked to MOD-2021-058822 (Parent-Child Link).   See case MOD-2021-058822 for details regarding the Parent case.  Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Upon internal review on 16-Sep-2022, non-significant correction was performed to update case received from field.; Sender's Comments: This is a case of product exposure during pregnancy with Associated AE for this 32-year-old female..Patient will continue to be contacted for further monitoring of AEs
Information has been received from a physician concerning a 67 year old female who on approximately 25-Oct-2006 was vaccinated with a dose of varicella-zoster virus vaccine live.  On 03-Nov-2006, the patient developed acute varicella characterized by pruritic lesions on her chest and a low-grade fever of 99.4 degrees Fahrenheit.  Unspecified medical attention was sought and the patient was being treated with valacyclovir hydrochloride (VALTREX) 1 gm TID.  A product quality complaint was not involved.  Acute varicella was considered to be an other important medical event by the physician.  Additional information has been requested. (OMIC)
5/8 Large red, swollen, hard welt. Painful to the touch and minor pain when left alone. A little larger than a deck of cards. On 5/9 and 5/10 it became itchy. I took Benadryl and used a cool compress. Today, 5/11, it's less swollen and hard, it seems to be improving.
Itchy, sore tricep area of (R) arm, with 10 cm across x 8 1/2 cm long red raised, warm nodule with deeper red center. Measures 4cm across x 1 1/2cm high. Arm "throbs", from axilla  -> ulnar wrist.
Fever spiked at 101.9 14 hours after the shot but has was completely gone 28 hours after the shot.  Mild headache the day following the shot.  Arm is mildly sore two days after the shot.
Vertigo within minutes of receiving vaccine. pt states she has similar symptoms when BP is too high. Blood glucose 323 prior to arrival at site (taken at home). BP 147/73, HR 113, 100% on RA. Given water and monitored for 45 minutes. Symptoms started to improve without further intervention.
Within 24 hrs of vaccination reported "knots with ? bumps. No fever. Returned Day 3, afebrile but with vesicular rash (Rt) mid deltoid. Painful, red, edematous. PN: HSVI-asymptomatic now.
Patient reported tongue pain located on the edges of the tongue, dizziness, shortness of breath.  Initial vital signs  108- HR 99% Pulse OX room air- 220/100
C/o headaches onset 12/26 x4 days; Nausea chills onset 12/30 x 2 days; Body aches onset 1/1/21 x 4 days. Visited urgent care 1/2/21 - labs done & released w/ return to work 2-5 days.
Vaccines given IM approximately 3:00 PM 6/12/06. Per mom, persistent fever, irritability started within 10-15 minutes of vaccine completions. Fever became somewhat persistent through evening with temp max of 102+. Trin qq+ until broke approximately 1:30 PM 6/13/06. Continued irritability throughout. Mom gave PO Motrin drops, massaged sites with cold compresses.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions or medical history provided. On 15-NOV-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX injection (lot# M028798, expiry date 18-AUG-2018; dose and route of administration were not reported). There were no concomitant therapies reported. Administered dose of ZOSTAVAX was exposed to a temperature excursion of 5.2 degrees Fahrenheit for 22 hours on 03-NOV-2016, 19.8 degrees Fahrenheit for 4 hours and 16 minutes on 04-NOV-2016, 16.6 degrees Fahrenheit for 4 hours and 5 minutes on 08-NOV-2016, 16.2 degrees Fahrenheit for 1 hours and 36 minutes on 09-NOV-2016, 7.7 degrees Fahrenheit for 21 hours and 24 minutes on 10-NOV-2016, 9.4 degrees Fahrenheit for 23 hours and 30 min on 13-NOV-2016,  11.9 degrees Fahrenheit for 30 minutes 14-NOV-2016 and 7.7 degrees Fahrenheit for 4 hours and 48 minutes on 15-NOV-2016. It was unknown if any previous temperature excursions took place or if there was a digital data logger involved. No adverse symptoms were reported. There was no product quality complaint involved. Additional information has been requested.
Gave vaccination to patient and the patient passed out and seemed to have a slight seizure. He stated that it has happened before with other IV and Blood drawings. He had Pfizer for his first two doses and said it did not happen.He refused medical attention because he had it happen before. I did a follow up call and he said he was fine.
12 hours after receiving the vaccine I had chills and a fever. Then I had a headache. I had the worst brain fog that went on for months. A month later I ended up in the ER because I was dizzy, lethargic, nauseas, had extreme fatigue, and abdominal pain. They found a kidney stone. My potassium had dropped down to 2.8. I never had that issue before. I went to my PCP, and they pumped me full on fluids. I took 2 giant pills. They checked me two days later then it was back to normal. I kept having symptoms of brain fog, cognitive issues, and headaches all year. I switched doctors and my new doctor texted me and said I was wasting potassium. My kidneys are not holding onto my potassium. I have been in and out of the hospital with potassium issues. I am taking 3000mg of potassium a day. I have also been taking spironolactone since December 2021. I have extreme thirst. I get dehydrated easily. I now have Hydro Nephrosis. My urine is backing up into my kidneys which is causing them to swell. My appendix and gallbladder has also swollen. I also take Zofran if I feel like I'm going to throw up. I was also taking migraine medications a lot. I am going to get an endoscopy done next week.
6 1/2 x 6 cm area of redness on (L) thigh, swelling of thigh - 14 cm circumference on (R), 15.5 cm circumference on (L).
Patient became very nervous five minutes after having vaccination, fainted to the floor with body tremors, BP 81/38 P45, Resp. 18, EMT at side with nursing staff, was put on stretcher, and complained of dizziness, nausea and lightheadedness, Later BP 114/55, P67 Resp.17. Patient transferred to ER. Recovered, no medications administered.
The next morning post flu mist vaccine the patient woke up with pain in 1 leg, attempted to walk and stretch the leg but couldn't. Day 2, attempted to walk again and is limping, bow legged as if his knee is turned inward
02/20/23 presents to ED for "fever, weakness, cough and DIB (difficulty in breathing)" PMHx of "CML on chemo, RA and migraine".
Patient complained of pain in her R arm.  After one week pain moved to her shoulder blades.
Undiluted covax vaccine administered to client. At this time no reports of needed treatments or adverse reactions.
Myalgia, Diarrhea, NauseaVomiting, SOB, CHILLS Narrative:
Had a regular screening mammogram on August 5 2021  - part of the hospital.   it showed a suspicious area on mammogram and so they needed me to come in for additional mammogram scans and an ultrasound. The next date was Friday, Aug. 13th at the same place for those tests. I had a core needle (big one) biopsy (and a mammogram because they inserted a marker to show where cancer area was) on  August 19th. They did the pathology from that and the Pathology results showed Breast Cancer - August 19th and results on the 20th. Saw oncologist on 8/24 and he had me do an MRI of breasts on 8/26.  Breast surgeon on August 30th and Had a breast reconstruction doctor on Aug 31 and genetic counseling and testing done because two of my sisters tested positive for breast cancer in the last month and a half. Oncologist dr: (unlisted dr information). I met with the radiation oncologist Sept 1st and had an EKG and pre-op surgery before surgery and that was on 7th of September. 14th - had  a procedure to insert additional marker in my breast to show where cancer was located. CT Scan - urinary incontinences and flank bank to see if there was a kidney stone - there was not (9/15/2021). Dye injected on my left breast so the dye would go to the sentinel node - Sept 16th and then I had my breast cancer - lumpectomy and breast reconstruction surgery on Sept 17th.   Follow up appts since then: with Breast surgeon on Sept 27th and I also saw the plastic surgeon before that date because of some complications from my incision area: I had a rash from adhesive from the sterile drape and I had a little bit of bleeding and draining from the incision and an area of necrotic skin at the t junction. That appt with the plastic surgeon was Sept 22. On the 24th, I had blood on my sputum - coughed up small amt of blood - I went to the Hospital ER - everything was fine. Sept 28th, saw the oncologist. Today, I had a  previously scheduled appt with PCP doctor and I had the flu vaccine.  The oncologist and breast surgeon went over my surgical pathology report with me - the diagnosis -  left breast lumpectomy - invasive carcinoma of no special type. Histological grade and came up with a Nottingham score of 1. Tumor size 11 mm. Invasive carcinoma in that one single site with no lympho-vascular invasion. Lymph node was uninvolved with the tumor. All good news.  Cancer is removed but I'm waiting for my test results. Yesterday, they sent my tissue off to see if the cancer will re-occur in my body based on my personal genetics and to see if the chemotherapy will be of benefit to me.Will get results on 10/13.  I will have to have radiation.
Her arm had swollen; Her lymph node underneath her arm are swollen; she can hardly move her arm; She is in lot of pain; sick at home; This is a spontaneous report from a non-contactable consumer or other non hcp (patient's mother). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch/Lot number and expiration dates were not reported), via an unspecified route of administration on an unspecified date in 2021 as dose 1, single for COVID-19 immunization. Medical history patient had Covid back in January. The patient's concomitant medications were not reported. On an unspecified date after receiving the vaccination the patient experienced her arm had swollen, lymph node underneath her arm were swollen and she could hardly move her arm. She was in lot of pain, and sick at home. The patient mother enquired if they could get same reaction post second dose or not. The reported seriousness was unspecified. The outcome of the events was unknown.  Information on the lot/batch number cannot be obtained.
was found to be COVID-19 positive, but she is asymptomatic, and normal toxic.   Oncology visits which had to be rescheduled due to prior COVID
Rt arm tender, area around injection site firm to touch, hot to touch, and itchy. Area of redness approximately the size of a half-dollar around injection site.
A few hours later around 1:00 pm the bumps began to turn pink and red, similar to hives; A few hours later around 1:00 pm the bumps began to turn pink and red, similar to hives; woke up with bumps on both of the arms; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 16Jan2021 12:30 at a single dose on left arm for COVID-19 immunization. Medical history included asthma, osteoarthritis, allergies: general anaesthesia. The patient was not pregnant. Concomitant medication included phentermine and vitamin D3. On 17Jan2021 at 10:00 am the patient woke up with bumps on both of the arms. A few hours later around 1:00 pm the bumps began to turn pink and red, similar to hives. Patient began to take Benadryl twice a day. On 18Jan2021 at 6:00 am the hives began to appear on both arms again and back. On 19Jan2021 the patient woke up at 6:00 am and the hives appeared on both arms, back, chest, stomach, both legs, neck and parts of the face. Therapeutic measures were taken as a result of rash papular and urticaria which included Benadryl, while no treatment received for skin disorder. The outcome of the events was not recovered. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Facility type vaccine was other. No other vaccine in four weeks. No COVID prior vaccination. Not COVID tested post vaccination.  Information on lot/batch number has been requested.
Arms flailing, eyes rolling for 4-10 minutes. Apparent seizure activity. Fever 103.9 rectal.
SORENESS IN ARM, TIREDNESS, DIZZINESS - OTHER ARM ODDLY EXPERIENCED SAME SORENESS BUT NOT AS INTENSE.
Sore injection site began 24 hours after injection.  Swelling and redness at injection site. Also began then.  Sore shoulders developed on that day as well. 36 to 40 hours after injection I developed swollen lymph nodes under left arm.  They diminished after 24 hours.  Injection site began itching about 4 days after injection.  All have gone away by 7 days with the exception of the injection site.  9 days after injection it is still slightly tender.