chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Gastroparesis; This spontaneous case was reported by a physician and describes the occurrence of IMPAIRED GASTRIC EMPTYING (Gastroparesis) in a 36-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMPAIRED GASTRIC EMPTYING (Gastroparesis) (seriousness criterion medically significant). At the time of the report, IMPAIRED GASTRIC EMPTYING (Gastroparesis) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was given.  It was reported that patient had symptoms after receiving two doses of Moderna vaccine.  Treatment medication was not given.  Company Comment: This spontaneous case concerns a 36-year-old, female patient with no medical history reported, who experienced the unexpected, serious (medically significant) event of impaired gastric emptying (LLT: gastroparesis). The event occurred on an unspecified date after administration of the second dose of the Moderna mRNA-1273 vaccine on an unspecified date. Treatment information and outcome of the event were unknown at the time of the report. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 36-year-old, female patient with no medical history reported, who experienced the unexpected, serious (medically significant) event of impaired gastric emptying (LLT: gastroparesis). The event occurred on an unspecified date after administration of the second dose of the Moderna mRNA-1273 vaccine on an unspecified date. Treatment information and outcome of the event were unknown at the time of the report. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.
Information has been received from a registered nurse (school nurse) concerning a child between the ages of 6 and 11 years old who on 05-OCT-1999, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On approximately 03-DEC-2007, the patient was experiencing chickenpox. It was not specified how many doses of varicella virus vaccine live (Oka/Merck) the patient received. Medical attention was sought via an office visit with the physician. At the time of the report the patient was recovering. There was no product quality complaint involved. No further information was provided. Additional information has been requested. This is one of several reports from the same source.
Moderna Covid-19 Vaccine EUA  Itching, swelling and heat at  and around injection site
Child developed red and tender swelling on R thigh about 8pm 10/31/05, w/o fever.  Exam on 11/03/05 above lesion was 11x11 cm.  child was treated oral Keflex.
BAD SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. No concomitant medications were reported.  On an unspecified date, the subject experienced bad side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bad side effects was not reported. This report was non-serious.
Pt states , Child had had viral illness w/diarrhea one month before incident. He was healthy in appearance and behavior on day of immunizations and was still taking  an antibiotics. In the early am, 3:30, the day after the shots, child awoke with fever of 103 degrees F and had seizure. ER services arrived and client's mom put cool cloth on child who then returned to normal alertness.
Information has been received from a physician, concerning a 21 year old female patient, who on 15-MAY-2007 was vaccinated IM, with the second dose, 0.5ml, of Gardasil (Lot # not provided). There was no concomitant medication. On 01-JUN-2007, the patient began to experience prolonged swelling and tenderness of all her joints, as well as, a decreased mobility of her joints. Diagnostic labs included a complete blood count (CBC) with differential, sedimentation rate, rheumatoid factor C3 and C4, and an autoimmune workup (results were not provided). Treatment included meloxicam (MOBIC), and the patient was referred to a rheumatologist for further evaluation. At the time of this report, the patient had not recovered from the events. The reporting physician considered one or more of the events to be serious, as disabling/incapacitating. Additional information has been requested.
Arrived to ER c/o fall at home, confusion, SOB, hypoxia, bradycardia. COVID + dx w/ COVID pna dx ER. Received O2 by NC, steroids, remdesivir, IS. Improved, discharged home on RA.
Within 45 minutes post vax, this pt developed muscle pain and soreness. Swelling developed 2 days post vax and she was seen in the ER. Physician indicated that she had had allergic reaction to possible vax additive. The pt recovered.
After receiving H1N1 shot Tues 11/24/09 on Thus 11/26/09 AM noted rash on bottom - noted prickly heat rash on arm Friday - Friday PM face, arms, legs noted prickly heat rash - saw school nurse 12/3/09 documented Pt had a rash. Sx resolving - PMD told Pt to contact health dept.
This spontaneous report was received from a quality control individual at a medical facility refers to a patient of unknown age. On 15-NOV-2012, the patient was vaccinated with a dose of M-M-R II (lot # 0234AE, exp: 26-JAN-2014) (Dose and route were not reported). No other co-suspects were reported. No concomitant medications were reported. The reported called for a patient who were administered M-M-R II that was exposed to an unsupported temperature excursion (10.1C for 96 hours). No adverse effect reported. This is one of seven reports from the same source. Additional information has been requested.
It was reported that a 15 year old female received Fluzone SV '99-'00 on 10/26/99. The pt experienced a "rash on her arm down to her elbow that evening. The next day, she developed random swelling of joints, hands and feet, with aching." The event is still present.
back hurts; pee with foam; chest hurts; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back hurts), URINE ABNORMALITY (pee with foam) and CHEST PAIN (chest hurts) in a 40-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (back hurts), URINE ABNORMALITY (pee with foam) and CHEST PAIN (chest hurts). At the time of the report, BACK PAIN (back hurts), URINE ABNORMALITY (pee with foam) and CHEST PAIN (chest hurts) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs provided. Treatment medications was not reported. Requested for follow-up due to incomplete details of the patient.
low grade fever, sore throat, swollen glands, achey body, cough, malaise;lasted 12 hr;
increase high blood pressure; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPERTENSION (increase high blood pressure) 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 an unknown date, the patient experienced HYPERTENSION (increase high blood pressure). At the time of the report, HYPERTENSION (increase high blood pressure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.                            Treatment information was not provided by the reporter.
Tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration on 04Apr2021 at 14:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks prior to the COVID-19 vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 06Apr2021 at 04:30, the patient experienced tinnitus. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event tinnitus was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
1/31/21 0730 am confused and low grade temp 99.5, 12 noon Temp 100.6 and sitting in recliner non responsive twitching.  Sent to Hospital with EMS to rule out stroke. Admitted 1/31/21.
-Fever beginning around 12 hours after injection. At 24 hours, fever hovered between 101-102. At around 36 hours, fever hit 103.2. By 48 hours, fever dropped to around 100. -Full body aches that correlated with fever. Extremely achy and discomfort.  -Mild nausea -Intense dull headache -Injection site muscle pain -By 48 hours after injection, symptoms heavily subsided. Lethargy and fatigue remained until 72 hours.  No symptoms by 96.
I contracted diagnosed this past Friday 04/29/2022. I had extreme headache, Body ache chills. This past weak I have had extreme cough, mucus drainage and muscle aches.
Patent called at 3:00 pm on 12/29/14 with complaints of sore right arm and swelling. Advised to make an appt. with physician immediately.
red blotches; felt sensation at her foot for that she could not walk; experienced chills; hands were shaking; right foot and ankle swelling; right foot and ankle swelling; pain; This is a spontaneous report from a contactable consumer (reporting for herself). An 80-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiration date: 31May2021), via an unspecified route of administration on her left arm on 30Jan2021 to 30Jan2021 at single dose for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took phenytoin sodium (DILANTIN) and carbamazepine (TEGRETOL) and experienced allergy as her reaction to those were sometime between 2010 and 2012. On 30Jan2021 after three and a half hours, the patient felt sensation at her foot for that she could not walk, experienced chills, hands were shaking, had a swollen ankle and foot and pain. Around 5 o clock, the patient stated that it was like a strange sensation in her foot and she also got chills. By 7 o clock, she was in pain. The patient stated that she took two Tylenol. The patient stated that at around 9 o clock, she noticed that her ankle and foot were swollen with red blotches on it so she took two Benadryl and then slept until noon. The patient stated that Benadryl actually gave her some relief, although the pain didn't completely subside, but it subsided a little so that it was more tolerable. The patient stated that she had been debating if she should have gone to the emergency room (ER), but she didn't because she has a high pain tolerance. The outcome of the events was unknown.
Patient had requested to receive the annual flu shot and Moderna Bivalent vaccine. We did not have the Moderna Bivalent vaccine in stock so patient opted to just get the flu shot. When the pharmacy technician giving  vaccines administered the shot, she accidentally administered the Pfizer Bivalent vaccine rather than the flu shot. He opted to still get the flu shot.
Date of Admission  08/11/2021  Chief Complaint Patient reports SOB, chest pain/ muscle pain, diarrhea, feeling dehydrated,  and loss of   History of Present Illness Patient is 66-year-old female with history bilateral hip replacements presented   Still admitted on day from submitted
pain in left leg bulging veins just above the knee were enlarged (I usually have varicose beins) pain was intense and so I wore my compression sock for Friday and Saturday (I have had one prior superficial clot after a  flight 6 years ago)
No adverse event; Patient also received a dose on Feb 27, 2023 booster bivalent dose as second dose; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient also received a dose on Feb 27, 2023 booster bivalent dose as second dose) and NO ADVERSE EVENT (No adverse event) in a 28-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19.  Previously administered products included for Product used for unknown indication: COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE.    On 27-Feb-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Patient also received a dose on Feb 27, 2023 booster bivalent dose as second dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient also received a dose on Feb 27, 2023 booster bivalent dose as second dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient also received a dose on Feb 27, 2023 booster bivalent dose as second dose).    No concomitant medications were reported.  Patient was looked for a second dose of the booster, patient asked for documentation that stated that a second dose was not approved to provide to a doctor. Caller only received a 1st COVID vaccine in 2021 Caller does not have patient previous vaccination card, as patient wanted to re start patient's vaccination process.  No treatment medications were reported.
5-6 hours after receiving the vaccine my right arm began hurting, opposite arm of where I got the shot. By Sunday my right arm was in severe pain and it steadily got worse. Went to my primary DR Monday, he referred me to Orthopedic. Xrays 'right shoulder calcification tendonitis. Both Drs said vaccine was unlikely the cause, but they both said they would not rule it out. Was then referred to Physical therapy. Therapist asked what I did to bring this on, I said the only thing different I did was get my first vaccine dose. Pain was getting better by Friday 3-19, the day I was at therapist. Pain has been getting better each day.
MOC called RN secondary to patient having a local reaction after receiving TDap and Meningitis vaccines. MOC reports approximately 24 hours after vaccination (vaccination on 6/20/23, reaction on 6/21/23) the child had a "golf ball size lump and lots of swelling" at the vaccination site (left deltoid). MOC denied face/throat swelling or difficulty breathing. MOC reports the child said the arm was not painful. MOC reports pt has a hx of a similar reactions when he received DTaP vaccine in a combination formulation as a child.  Per MOC, pt then received Dtap by itself (not combo) and had no reaction or problems after that administration.  Due to his previous reactions being localized to the injection site (previous reaction included swelling and a painful lump), PCP advised MOC to have pt go ahead and receive TDaP vaccine, expecting that he may potentially have a similar reaction as when he was younger. MOC verbalized she understands if pts throat or face started swelling or if pt had difficulty breathing she would call EMS.  Pt was advised at time of vaccination to wait in lobby for 30 minutes post vaccination for observation purposes.  MOC had alerted RN that administered vaccine of pts hx. See note from 6/20/23.
rash/rash on shoulder, back and chest; This case was reported by a other health professional via call center representative and described the occurrence of rash in a 21-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2019-2020 season at an unknown dose. On an unknown date, couple of hours after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were received as follows: The patient experienced rash on shoulder, back and chest a few hours after receiving the vaccine. The reporter did not consented to follow up.  The reporter notesdshe was unable to locate the lot and expiration date since RN did not enter it on the paperwork
Shortness of breath with progressive Dyspnea. Found to have bilateral PE with right sided pulmonary infarct.
Starting on the day of the vaccine 2nd dose 1/26/2021- I had started to feel palpitations, which also was noted during the 1st shot.  The palpitations was about the same, so I decided to see my PCP who  got an EKG which showed abnormal PVC (preventricular contraction).  I was then referred to cardiologist, who did another EKG, ECHO and ordered a holster monitor, which showed significant PAC (premature atrial contraction).   I was prescribed Metoprolol 25mg once a day which I am currently still taking.
A few minutes after receiving vaccine became lightheaded and was given juice and then became short of breath and "chest felt tight."  Has history of asthma. Was given injection of epinephren subcutaneously and taken by wheelchair to emergency room.  There he was evaluated and observed for about an hour, was given an EpiPen, and told to taken Benadryl every 4 hours as needed and was discharged to home.
Information has been received from a physician concerning a 13 year old female, who on 13-JUL-2007 was vaccinated intramuscularly with a first dose of Gardasil.  Subsequently, within 24 hours post vaccination the patient developed "diffuse hives."  It was reported that the patient did use Nair hair remover the morning she received the vaccine which the physician feels could be the cause.  The patient was treated with two doses of BENADRYL.  The patient recovered on an unspecified date.  No product quality complaint was involved.  Additional information has been requested.
Fever 100.4 was first observed the day after injection, and continued through the following day, with some chills. I had a lot more arm pain than expected, and it continued for about 5 days, bad enough to disturb my sleep. A hot red knot formed about 3 inches below the injection site and was there for about a week.  I used a warm moist pack on that to help me sleep. I medicated fever and pain with Advil, taking about 4 pills total.over 5 days.
Injection site immediately, pain and swelling. Starting the next day with onset of rapid symptoms including severe headache, extreme  full body muscle aches and chills that felt painful as if had the flu, no fever,  then the extreme tiredness hit where i had to lay down and sleep.  I had to have my mom come get my young son because i couldn't even stay awake.  muscle twitching in my calf muscles and my right thumb pad, post nasal drip started then stuffiness and that smell you smell when you are sick. So i slept hard for about 5 hours and when i got up i felt 80% better. The headache had been so bad when i opened my eyes it was very painful. My arm still is very tender and sore and swollen, but these symptoms were weirdly short lived. The most scary was the sleepiness that i couldn't control.
Patient had a few spots of chicken pox. Once which appeared to be infected. Mupirocin ointment prescribed.
5/11/21, 5/12/13 Left arm muscular soreness  5/17/21 Left ancillary soreness tenderness, baseball size elevated swelling
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with 0.5 ml dose of VARIVAX (Merck), subcutaneous (lot # and expiration date were not provided) that underwent temperature excursion. No adverse experienced reported. This is one of the several reports from the same reporter. Additional information has been requested.
vial expired 8-31-21, dose given from vial on 9-1-21, no adverse reactions noted
I had vaccination 09/09/2022. I started to experience a scratchy throat and congestion on 02/10/2023. I tested COVID-19 negative on 02/11/2023 and I tested COVID-19 positive on 02/12/2023. I contacted the doctor office on 02/13/2023 and I was prescribed PAXLOVID and cough suppressant with a decongestant over the counter.
Within 5 minutes after receiving vaccine, patient indicated that it felt like her whole body was on fire and she felt faint.  She was already seated for observation following the dose.  An Epi-Pen and ammonia inhalants were removed from the emergency kit  for possible use.  Pt stated she  was not having difficulty  breathing and no closing of her throat.  The ammonia inhalant helped the patient focus and she stated that it made her feel better.  Pharmacy staff called 911 and the EMS crew arrived in approximately 5 minutes.  They evaluated the patient and transported her to the local emergency room.  A couple of hours later the patient called and said she had been discharged and was doing well.  While in the emergency room she broke  out in hives and was given epinephrine and benadryl per her conversation.  Later her father came to the pharmacy and confirmed the same. She will see her primary care doctor on Monday.
The patient had Prevnar on 11/28/2000.  The mom contacted the office.  The patient was examined on 12/15/2000. Confirmed jerking movements of the neck, shoulders,  arms, and occasional  jerking of the legs.
Swelling and tenderness left deltoid approx 0.5 cm erythema at each puncture site.  Approx 4x4 cm erythema with induration distal to injection sites.