chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Right arm between shoulder and elbow became swollen and itchy. Then right arm became heated per mom.
Pain in injection site, body aches, chills, fever, pain in the base of the skull, headache.
nausea, muscle soreness, shivers, fever, headache, starting about 24 hours after injection, continuing into day 2
Mom states temp 106 two hrs p/infant receive dimmun; States had fever 3-4 days was referred to Med Ctr for conjunctivitis & anemia, temp 101.4R, hosp x 1 wk;
3 hrs p/vax became lethargic, hands & feet cyanotic; seemed to shake, t104.2 seen @ walk-in clinic; given APAP some improvement in temp; t105, some diarrhea;
VOMITING; CHILLS; WEAK LEGS; ACHE; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history and concurrent conditions not reported. Consumer does not have an HCP and usually seen at the health department. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number not reported) dose was not reported, administered on 07-MAR-2021 10:15 for prophylactic vaccination. No concomitant medications were reported.  On 07-MAR-2021, the patient experienced vomiting, chills. weak legs, ache, nausea, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vomiting, chills, weak legs, ache, and nausea, and the outcome of fatigue was not reported. This report was non-serious.
did not have hot flashes for 6-7 days after getting the second dose; arm soreness (2nd Dose); felling "drug out tired" ( 2nd Dose); This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (did not have hot flashes for 6-7 days after getting the second dose), MYALGIA (arm soreness (2nd Dose)) and FATIGUE (felling "drug out tired" ( 2nd Dose)) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21-2A and 018B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE, SERTRALINE, LISINOPRIL, CARVEDILOL and ATORVASTATIN for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-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 THERAPEUTIC RESPONSE UNEXPECTED (did not have hot flashes for 6-7 days after getting the second dose), MYALGIA (arm soreness (2nd Dose)) and FATIGUE (felling "drug out tired" ( 2nd Dose)). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (did not have hot flashes for 6-7 days after getting the second dose), MYALGIA (arm soreness (2nd Dose)) and FATIGUE (felling "drug out tired" ( 2nd Dose)) outcome was unknown.            Treatment received was not provided by the reporter.   This case was linked to MOD-2021-269984 (Patient Link).
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 15-OCT-2015, the patient was vaccinated with a dose of improperly store RECOMBIVAX HB, lot number L016427, expiration date 13-APR-2017, (dose, route and anatomical location were not reported). No adverse effect was reported. There was no concomitant medication reported. This is one of several reports from the same source. Additional information has been requested.
Currently 7 months pregnant. 6 days after the first shot, I noticed what felt like a swollen lymph node in my right arm pit area. The next day, I developed what looked to be a very large mosquito bite that grew bigger and bigger throughout the day, at the injection site. My day 8, it was very large, very warm to the touch and produced a very large, swollen knot under my skin.  It slowly started to shrink in size. By day 11, I noticed that the injection site started to itch a little and by day 12, I have a very large circle rash that is red and hot. It is not really itchy.
PLATELETS WERE REALLY LOW DOWN TO 6; COUGHING SPOTTY BLOOD/COUGHED UP A MOUTH FULL OF BLOOD; SINUS INFECTION; BUNCH OF RED LITTLE DOTS ALL OVER BODY/WORSE ON RIGHT LEG/LIKE HEAT RASH; This spontaneous report received from a patient concerned a 61-year-old white and not Hispanic or Latino male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAY-2021, the patient experienced bunch of red little dots all over body which was worse on right leg like a heat rash. On 29-MAY-2021, patient thought he had sinus infection and started coughing spotty blood and then coughed up a mouth full of blood on 30-MAY-2021, went to emergency room because he was still coughing out blood. Patient's doctor found that patient's platelets were really low down to 6. Patient's doctor gave him bunch of steroid and platelets. Patient was hospitalized on 30-MAY-2021 and discharged on 01-Jun-2021 and was given a steroid 40 mg a day.  The patient recovered from coughing spotty blood/coughed up a mouth full of blood on 01-JUN-2021, and sinus infection, recovered with sequelae from platelets were really low down to 6 on 01-JUN-2021, and was recovering from bunch of red little dots all over body/worse on right leg/like heat rash. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 : 20210616684- JANSSEN COVID-19 VACCINE-Coughing spotty blood , platelet were really low below 6. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
No other AEs; ROTATEQ was administered on 16MAY2023 after the temperature excursion.; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 16-MAY-2023, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 time dose, lot #1938950, expiration date: 31-MAR-2024, administered orrally for prophylaxis (strength and dose were not provided) (Product storage error). It was reported that this vaccine underwent the temperature excursion at 1.8C for 0 hours 9 minutes and 0 seconds, 1.3C for 1 hour 12 minutes and 0 seconds, 1.2C for 1 hour 58 minutes and 0 seconds. There was no previous temperature excursion. No other AEs (No adverse event).  This is one of five reports received from the same reporter.; Sender's Comments:  US-009507513-2305USA006001: US-009507513-2305USA005987: US-009507513-2305USA005974: US-009507513-2305USA005810:
she has been having abnormal menstrual cycles; abnormal bleeding that is not stopping. The bleeding has occurred after each vaccination; itchiness; fever after both shots, 102 degrees fahrenheit at first dose; chills; muscle ache; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (she has been having abnormal menstrual cycles), HEAVY MENSTRUAL BLEEDING (abnormal bleeding that is not stopping. The bleeding has occurred after each vaccination), PRURITUS (itchiness), PYREXIA (fever after both shots, 102 degrees fahrenheit at first dose) and CHILLS (chills) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-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 MENSTRUAL DISORDER (she has been having abnormal menstrual cycles), HEAVY MENSTRUAL BLEEDING (abnormal bleeding that is not stopping. The bleeding has occurred after each vaccination), PRURITUS (itchiness), PYREXIA (fever after both shots, 102 degrees fahrenheit at first dose), CHILLS (chills), MYALGIA (muscle ache) and VACCINATION SITE PAIN (pain at injection site). At the time of the report, MENSTRUAL DISORDER (she has been having abnormal menstrual cycles) and HEAVY MENSTRUAL BLEEDING (abnormal bleeding that is not stopping. The bleeding has occurred after each vaccination) had not resolved and PRURITUS (itchiness), PYREXIA (fever after both shots, 102 degrees fahrenheit at first dose), CHILLS (chills), MYALGIA (muscle ache) and VACCINATION SITE PAIN (pain at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102 Fahrenheit at first dose.     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 concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-351073 (Patient Link).
I experienced  flulike symptoms, chills, body aches about 12 hours after vaccine was given to me.  I took some pain reliever and felt better about 24 hours after vaccine was administered. I did not go a doctor, as I felt much better the next day. This was at home and not at the facility.
Rash, swelling, redness, heat, itchiness at site of injection (circular, radius about 4"); Antihistamine (Zyrtec), Aspirin 325 mg; Persisting 3 days (slightly faded 2 days in)
I got my last dose of COVID19 vaccine on 2/1/21.  I had a positive COVID test on 4/16/21.
Fitful rest night of vaccine. Day following :Fever 101, extreme muscle cramps, body aches, back pain, brown urine,  extreme fatigue, headache, light sensitivity, nausea,  weakness, cold extremities, chest tightness. Day 2 decrease of mentioned symptoms. Day 3 near normal, fatigued, continued cold extremities, mild headache. No treatment or tylenol taken as I was under the impression I wasn't suppose to suppress immune response. I was well hydrated prior to and during response.  Had COVID-19 in July. I will not get second dose secondary to reaction of the first dose.
headache, body aches, fever, fatigue, nausea, trouble sleeping, still happening 3/10
t103.5, fussy, started @ 2AM received vax @ 1030AM 12SEP; By 8AM 13SEP t100; Instructed to give APAP & luke warm bath; push fluids;
14FEB99 inc temp, cloudy nasal drainage APAP,sudafed, amoxicillin; flu dx;
I started with a sore arm and extreme fatigue the first two days. Then a toe on my right foot became increasingly sore.  It spread to all right foot toes. Now three days after the vaccine all 10 toes hurt so much and throb. They feel like needles are going into them.  I also had a low grade fever and nausea on day three.
patients administered Moderna vaccine while temperature excursion assessment was ongoing; patients administered Moderna vaccine while temperature excursion assessment was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) in a 70-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 administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The reporter reported that because their facility had not been able to download the digital data logger, they had been put on hold by the State at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment by the state was made. There had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, this issue was treated as a temperature excursion. The reporter was unable to download the data logger for the months of December 2021, January 2022 and February 2022. The reporter was filling out a temperature excursion assessment with the State.  The reporter mentioned that the patient had been administered dose while the temperature excursion assessment was ongoing. The reporter also reported that, no adverse reactions were reported by the patient.  No treatment information was provided by the reporter.
Tingling/pins and needles sensation in feet that over the next 5-7 hours moved up legs to buttock when patient lied done.  This sensation went away while sleeping, but sometime during the night a severe headache, nausea and vomiting started.  These symptoms lasted approximately 6 days.
Case completed primary Covid vaccine series in March 2021, then was hospitalized for Covid in October 2021 at Hospital Hospitalist.  Pneumonia due to COVID-19 virus Symptoms started about 10/4 based on the patient's history. Tested positive 10/7. He is fully vaccinated. Obesity increases his risk for severe disease. Treated with dexamethasone and remdesivir (he received 3 days of remdesivir while admitted). CRP down trended but had not normalized at discharge. Because he was still requiring supplemental oxygen with activity on the day of discharge and his CRP had not normalized he will complete a course of dexamethasone for the covid infection.   Acute respiratory failure with hypoxia Secondary to covid infection. CTA 10/7 without PE. Procalcitonin negative. Presenting symptoms not consistent with asthma exacerbation, but getting steroids regardless. No history of heart failure and he denies orthopnea, edema. Needed 1-2L NC with activity on the day of discharge.   Severe sepsis Met severe sepsis criteria on admission with tachycardia and tachypnea with respiratory failure. Secondary to covid infection. Sepsis physiology resolved.
Vaccine exposure during pregnancy; Arm discomfort; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) and LIMB DISCOMFORT (Arm discomfort) in a 33-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Live, full-term birth, female 39weeks gestation) on 19-May-2019. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and DOXYLAMINE;PYRIDOXINE for Pregnancy and Vomiting.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 06-Nov-2020 and the estimated date of delivery was 13-Aug-2021. On 16-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) and LIMB DISCOMFORT (Arm discomfort). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  tenth week of the pregnancy. The delivery occurred on an unknown date.  On 17-Jan-2021, LIMB DISCOMFORT (Arm discomfort) had resolved. At the time of the report, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Dec-2020, Pregnancy test: positive (Positive) positive. On 01-Jan-2021, Ultrasound scan: normal (normal) reported normal on 11Jan2021.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were provided. Patient gave birth to a female child on her previous pregnancy.
05/27/2003: Temperature up "warm".  Phone call from mom 05/29/2003.  Reported information support offered.  To call after follow visit to Dr. 05/29/2003: 99.6, nose runny, cough.  Pinpoint rash-red.  No hives.  Back belly ears whinny.  Has Dr appointment in morning.
Fast Heartbeat; Body Aches; Bone Pain; difficulty sleeping; Fever; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast Heartbeat), MYALGIA (Body Aches), BONE PAIN (Bone Pain), INSOMNIA (difficulty sleeping) and PYREXIA (Fever) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (Fast Heartbeat), MYALGIA (Body Aches), BONE PAIN (Bone Pain), INSOMNIA (difficulty sleeping), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, HEART RATE INCREASED (Fast Heartbeat), MYALGIA (Body Aches), BONE PAIN (Bone Pain), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown, INSOMNIA (difficulty sleeping) had not resolved and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included Advil.   This case was linked to MOD-2021-073404 (Patient Link).
This spontaneous report as received from a pharmacist via company representative refers to a patient of unknown age. On 15-NOV-2013, the patient was vaccinated with ZOSTAVAX (lot number, expiry date and route not reported). On 17-NOV-2013, the patient (anonymous) developed a rash after receiving ZOSTAVAX. The outcome of rash was unknown. The causality was not reported. Additional information has been requested.
While getting 4mo shots patient started holding breath after the first vaccine (Hib) was given IM in the RVL (after getting Rotarix orally). Pt. cried when first stuck in RVL but then started holding breath. Pt. continued to hold breath while getting Pediarix and Prevnar in LVL. Pt. held breath after vaccines were finished and I blew in his face. Patient took one deep breath after I blew in his face and then just started blankly looking at me. He became very relaxed in mom's arm and became almost limp but never had LOC. Pt. was silent during the entire episode. Pt. just continued looking at me and mom. I watched patient's eyes and he never had any abnormal movements, he just continued to look straight at me. Never had any twitching or abnormal body movements. I picked patient up out of mom's arm and stood up with him. He pulled his head and chest off of my chest and looked at me and then cuddled his head against my chest for approx. 5 seconds and then pulled head off of my chest and puckered his lips and started to cry. I handed patient back to mom and he stopped crying for a few seconds and then looked back at me and started crying again. Pt. was alert but acted very tired. I went and made the provider aware of situation and she went and examined patient. Provider thought patient may have just had a vagal response. Pt. was alert when provider was in room but looked pale but was smiling appropriately. A couple minutes after provider left the room mom stepped out and said patient was falling asleep. Mom said it was not patient's nap time. Pt. became very sleepy about 5-6 minutes after vaccines were administered and pt. had episode. Provider instructed mom to let patient go to sleep and we would monitor him in clinic for another 10-15 minutes. Provider went back in to check on patient about 10-15 minutes after episode. Patient was still asleep but color was improved but still a little pale per provider. Provider instructed mom to monitor closely this afternoon and to call back if she had trouble getting patient to feed, wake, or any other concerns. I will call to check on patient this afternoon. I called to check on patient at 3:00 p.m.. Mom stated that patient was only eating half of what he normally does, was fussy, and sleeping a lot more than normal. Mom did report that he would smile some when he was awake.
The day following my 2nd vaccine my arm started swelling and was red and painful.  It has now been 4 days and continues to get more redness and now itches.    Taking Benadryl for itching.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of (Oka-Merck) PROQUAD (lot# reported as L023111, expiration date 24-SEP-2016, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Narrative:  Pt reports that he started experiencing a constant burning sensation in bilateral legs from groin to ankles that started about 1 week after receiving the COVID-19 VACCINE (J&J) on 4/10/21. provider completed additional workup with labs to investigate but could not conclude anything. Per primary care provider note on 8/2/22, COVID-19 VACCINE resulted in Guillain-Barre syndrome. Pt still has the sensation to some extent but is it improved and denies any weakness.
24 hours after administration, swollen arm, red, tender warm to touch, pt. said painful, recommend BENADRYL and follow up w/primary care physician. Hives and swelling on right side of neck, didn't feel well.