chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Felt migraine coming on), HEADACHE (Headache), FATIGUE (Fatigue) and NAUSEA (Nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 043L20A) for COVID-19 vaccination. No medical history was reported by the reporter. The patient's past medical history included No adverse event. Concomitant products included SIMVASTATIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced HEADACHE (Headache) and NAUSEA (Nausea). 04-Mar-2021, the patient experienced FATIGUE (Fatigue). On 05-Mar-2021, the patient experienced MIGRAINE (Felt migraine coming on). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) (oral) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) (oral) at an unspecified dose and frequency; ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRINIL) (oral) at an unspecified dose and frequency and MELATONIN (oral) at an unspecified dose and frequency. On 05-Mar-2021, MIGRAINE (Felt migraine coming on) had resolved. On 07-Mar-2021, HEADACHE (Headache), FATIGUE (Fatigue) and NAUSEA (Nausea) had resolved. Treatment for the events included Advil, Tylenol, Excedrin, and Melatonin.  This case was linked to MOD-2021-040959. Most recent FOLLOW-UP information incorporated above includes: On 16-May-2021: initial additional
This case was reported by a nurse via sales rep and described the occurrence of injection site rash in a patient who received PEDIARIX. On an unknown date, the patient received PEDIARIX. On an unknown date, an unknown time after receiving PEDIARIX, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was unknown.  It was unknown if the reporter considered the injection site rash to be related to PEDIARIX. Additional details were provided as follows: This case was not previously reported to anyone. The age at vaccination was not reported. The patient had denied permission to contact their physician. The nurse had not requested any follow up and declined to provide details for the report. The details of injection site and patient name were not available. This case has been linked to case US2016073720 and US2016073731, reported by the same reporter.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMIN [VITAMINS NOS], VITAMIN D3, PSYLLIUM HYDROPHILIC MUCILLOID (METAMUCIL [PSYLLIUM HYDROPHILIC MUCILLOID]) from 01-Jan-2000 to an unknown date, MAGNESIUM, ATHLETIC GREENS from 01-Jan-2000 to an unknown date and VITAMIN D [VITAMIN D NOS] from 01-Jan-2000 to an unknown date for an unknown indication.    On 09-Mar-2021 at 8:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) at an unspecified dose and frequency and LORATADINE (CLARITIN [LORATADINE]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       for mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessment.   This case was linked to MOD-2021-089766 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Added patient's demographics and concomitant medications.
started her period after a year of not having it; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (started her period after a year of not having it) in a 54-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENSTRUAL DISORDER (started her period after a year of not having it). At the time of the report, MENSTRUAL DISORDER (started her period after a year of not having it) outcome was unknown.        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.   No treatment medication provided by the reporter. No concomitant medication provided by the reporter. No lab data information provided by the reporter   Reporter did not allow further contact
2.5" circular raised, red, hot, hard, bumpy, itchy at location of injection site, still 10 days later. Cold compress and has not subsided.
Redness & swelling to below the elbow; Seen in ER, poss cellulitis;
This case was received from a health professional in the United States on 31 July 2007. A 15-year-old female patient received an intramuscular right arm injection of Menactra (lot number U2324AA) on 16 July 2007. On 28 July 2007, 12 days after vaccination, the patient experienced headache, fever (103 degrees Fahrenheit) and rash on the face, ears, and hairline. The patient visited her physician on 31 July 2007, and at the time of the report the events had not yet resolved. Medical history included asthma and tinea capitatis treated with Gris-Peg. Follow-up information received on 22 August 2007 from a health care provider. The event did not require medical intervention. Illness at the time of vaccination inclued the the capitis. Additional medically relevant information was not provided.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 34-year-old male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  There have been no power outages that would have impacted the Moderna vaccine. However, reiterates that because facility was unable to download the digital data logger, they will need to treat this issue as a temperature excursion. The data logger that caller was unable to download were for the months of DEC2021, JAN2022, and FEB2022. She says that they are filling out a temperature excursion assessment with the State at this time. The doses was administered while the temperature excursion assessment has been ongoing same.
Bilateral L1 pars fractures             - MRI L-spine with L1 vertebral fracture which extends across the disc space into the posterior inferior aspect of T12 and T12 posterior elements with associated widening at the L1 fracture site; there is also an anterior epidural space collection at L2 suspicious for epidural hematoma Status post mechanical fall Leukocytosis             - WBC 15.7 > 12.3             - afebrile without signs of clinically significant infection             - likely reactive to trauma COVID-19 detected              - positive 1/20/22, asymptomatic             - no hypoxia             - no acute process on chest x-ray Epilepsy             - on 200 mg phenytoin BID Primary hypertension             - by history, not on antihypertensive medications at home, BP may be elevated now secondary to pain, but needs to be optimized pre-operatively
A non-serious, spontaneous report of sore and stiffness in back, neck and shoulders was received from a consumer, concerning a 43 year-old female patient subsequent to FLUMIST. The patient reported no relevant medical history. Concomitant medications include lisdexamfetamine dimesylate. The patient received FLUMIST on 11-Oct-2008 for flu vaccination. That evening the patient reported soreness and stiffness in the back, neck and shoulders. The patient was seen by her primary care physician and suggested the events may be related to physical exertion earlier in the day. The events were ongoing as of 17-Oct-2008 and described as soreness occurring in the triangular area at the base of the back of the neck.
The next day I had injection sight pain, swollen lymph node, fatigue. The fever and back pain for two days. The swollen lymph lasted for 7.
Doses administered after 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   BUD Date the vial was initially stored in the refrigerator: 17Dec2021.  No concomitant medication was provided. No treatment information was provided.
Client states that she received TDAP and Influenza vaccine on 11/17/17 at clinic. Client reports that she started experiencing "tingling of left arm" and "pain on top of left shoulder" on 12/8/2017 the date she gave birth to her infant. At time of vaccine administration client was about 37 weeks pregnant.
A few minutes after receiving the injection I felt "strange," a little weak, and then noticed a rapid, strong heartbeat. (I had started to go to the gym but changed my mind because I didn't feel quite right.)I walked back to the office, got some tea, and took a Tylenol regular strength tablet. The heartbeat subsided and I felt OK within 30-45 minutes.
severe side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient experienced severe side effects from the vaccine but did not provide any further details. The reporter did not consent to follow up. The patient refused for any demographic information.
day after vaccine, expereinced severe cramping and menstrual bleeding very heavily. I was two weeks before my period which is VERY abnormal. lasted for five days
Patient seemed like having syncope, while sitting in chair in waiting room with his parents (few mts after). Heard mom scream to call 911. Had the intern call 911. Patient had fainted while in the chair. Tried to wake patient up. Patient regained consciousness in a few mts. gave some water to drink. Patient was sweaty on forehead. He told, he did not eat anything in morning, may be he got dizzy that's why. Gave him a cereal bar to eat. He drank more water but threw up. EMT arrived. Checked vitals. Told him not to drink more water yet. He was ok after that. Patient signed the release form to not go to ER. EMT left. Had patient wait for another 20 mts to make sure he was ok. Called after an hr at home to check on him, Dad told he was doing fine. Called MD next day to inform of the incidence. Patient did tell EMT that he felt dizzy about a month ago at the gym while working out.
Minor sore throat, head congestion, runny nose, fever of 101.7 for about 6 hours, fatigue.  Symptoms started on Saturday, 10/29.  Diagnosed as COVID-19 with home test on Sunday, 10/30.  Telehealth appointment with primary physician on Sunday evening, 10/30.  Not eligible for Paxlovid due to drug interaction with  Diltiazem.  Doctor recommended bed rest, fluids and monitor symptoms.  Isolate for 5 days.  Symptoms began to improve 10/31 through the present (11/8).  Only minor congestion and runny nose at the present time.
HIVES 11/2/2009 records from OB-GYN MD stating  patient called to MD office stating had hives post vaccination, patient took Benadryl and hives cleared.
Around 2.5 hrs p/receiving flu vax pt began feeling achy & tired; skin is cool & clammy to touch;
I was going home after getting the vaccine and I got a huge black floater right in front of my left eye and then I was seeing flashing lights in my left eye. I went to the doctor on 03/10/2021 and they said the vitreous was pulling on the retina and they told me to keep an eye on it. They did a glaucoma pressure test and they looked at my eyes, they did not give me any medications.
patient felt tremulous and lightheaded after receiving the vaccine.  patient had worked the overnight shift immediately prior to receiving the vaccine.
Patient devoloped red rash approximately 3 in. x 5 in. at site of injection "a day or 2" after immunization. rash was itchy & persisted for 2 weeks from injection date.
patient is late for the second dose / The first dose was administrated on January 2020; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on January 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details was reported as follows: The age at vaccination was not applicable to this report. The age group was not reported but captured adult as per vaccine indication. Till the reporting patient did not received the 2nd dose, which led to incomplete course of vaccination. No patient's identifiers provided no lot number nor expiration date provided no vaccination date provided. The reporter consented to follow up.
Redness and hard bump that was tender to the touch at the injection site; Redness and hard bump that was tender to the touch at the injection site; Redness and hard bump that was tender to the touch at the injection site; Muscle spasms; Tingling in her calves; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in her calves), MUSCLE SPASMS (Muscle spasms), VACCINATION SITE INDURATION (Redness and hard bump that was tender to the touch at the injection site), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Redness and hard bump that was tender to the touch at the injection site) in a 45-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 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced PARAESTHESIA (Tingling in her calves), CHILLS (Chills) and HEADACHE (Headache). On 26-Jan-2021, the patient experienced MUSCLE SPASMS (Muscle spasms). On 05-Feb-2021, the patient experienced VACCINATION SITE INDURATION (Redness and hard bump that was tender to the touch at the injection site), VACCINATION SITE ERYTHEMA (Redness and hard bump that was tender to the touch at the injection site) and VACCINATION SITE PAIN (Redness and hard bump that was tender to the touch at the injection site). On 26-Jan-2021, MUSCLE SPASMS (Muscle spasms) outcome was unknown, CHILLS (Chills) and HEADACHE (Headache) had resolved. At the time of the report, PARAESTHESIA (Tingling in her calves), VACCINATION SITE INDURATION (Redness and hard bump that was tender to the touch at the injection site), VACCINATION SITE ERYTHEMA (Redness and hard bump that was tender to the touch at the injection site) and VACCINATION SITE PAIN (Redness and hard bump that was tender to the touch at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Initially got a large local reaction up to 2inx2.5in 2 days post vaccine.  It was painful and hot.  This gradually receded, leaving the area looking bruised.  But wheal and itching resolved by day 7.  On day 9 it started to itch again and slowly get more red, although bruised area still visible.  Today at day 13 the area of erythema is 3inx4in and continuing to spread.  It is itchy and a bit painful.
Red circular area on vaccinated arm 9 days after injection. Area warm. Person is afebrile
Tingling in face, arms, and hands. Was given BENADRYL at the Student health center. Later that evening around 7 pm she went to the Medical Center ER because she felt dizzy and her throat was closing up.
Patient came into pharmacy at 9AM (3/25/13) had redness, swelling with warmth at injection site. Also vesicles are present at injection site, refer patient to primary care physician for evaluation.
Very sore in the area of the injection, initially.  Spread to neck and head.  Intense shivering, fever of 100 degrees fahrenheit that lasted for approximately 6 hours.  Intense headache initially.  Headache somewhat lessened by Tylenol and Ibuprofen.  Headache worse when sitting upright.
Pt presents to medical with redness and rash along left arm near inoculation site. Pt monitored and given Benadryl 25 mg PO (9) and Motrin 800 mg PO (12). Pt told to follow up if symptoms worsen.
We ate when we got home at noon.  Usually when coming off of a fast everything tastes so delicious, so yummy.  My meal did not.  I didn't even want to finish it, but I did.  Drinking water, which I consume lots of, tasted HORRIBLE.  Yuck.  It made me feel nauseous.  At supper again my meal tasted bad, and the water was sickening to the taste.  This continued until about 2 pm the next day (Oct 18).  It is now nearly 6 pm.  Food tastes okay, water tastes a little off, but drinkable.  Am back to normal.  Yay!
10-23-12 Flu shot Left delt. Lab draw Left AC (another company). 10-24-12 Arm soreness (L). 10-25-12 Left underarm sore & bruised. 10-26-12 Increased pain & bruising armpit to elbow. 10-27-12 Same as 10-26 now red line from armpit to elbow. 10-28-12 ABX started. 10-29-12 ER visit, US - no clot.
Immediately following injection (within 15 minutes) arm pain and numbness/tingling to fingers, slight nausea and dizziness. Lasted approximately 4 hours. Extreme dizziness for approximately 2-3 minutes while sitting still at 4 hour mark - resolved with rest except arm pain, which lessened slightly over the first hour but remained unresolved after 4 hours.  Within 30 minutes post injection - redness, heat, and swelling at injection site.   After injection (approximately 12-13 hours post injection) - Fever (100-101.7 consistently over 3 days), extreme fatigue, headache, muscle aches/joint pain, severe chills. Fever broke midday April 4, and other symptoms except arm pain and headaches slowly resolved by April 7. Arm pain remained at a fairly steady level throughout that time and past April 8 (one week).  Currently (April 14, two weeks post injection) - arm pain has lessened, but remains in upper arm. Particularly sensitive to touch or movement, but can be felt at rest. Redness is gone, but palpable hard lump and heat remain at injection site. Pain and sensitivity noted when medical provider palpated underarm lymph nodes on right side. Not noted in same action under left arm. Headaches continue intermittently.
tight throat/thick tongue, 50mg IM Benadryl in left deltoid. HR 101, O2 99% BP 161/69. observed  for 45 minutes
Beginning  the first week in April developed headache, nausea, generalized abdominal discomfort, dizziness, paresthesias, dyspnea.  Eventually developed severe epipastric pain for 5 days which was associated with left 6th intermittent palsy (normal eye exam.).  Have continued with a dysequilibrium  with a tendency to to the right.  Sensation in legs that they are not feeling correctly and hence I walk in a wide-based gate.  All laboratory has been normal or near normal except for triglycerides (500, non-fasting)
This case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received KINRIX (batch number AC20B235AA, expiry date 15th January 2015). On 29th September 2014, the patient received KINRIX. On 29th September 2014, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. It was unknown if the reporter considered the appropriate age at vaccine administration to be related to KINRIX. Additional information: A dose of KINRIX was given to a 4 month old baby. KINRIX was recommended for children from 4 to 6 years. No adverse event was reported.