chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Terrible headache; Headache is migraine quality; Rough side effects; Chills; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), ADVERSE REACTION (Rough side effects), PYREXIA (Slight fever), HEADACHE (Terrible headache) and MIGRAINE (Headache is migraine quality) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced CHILLS (Chills) and PYREXIA (Slight fever). On an unknown date, the patient experienced ADVERSE REACTION (Rough side effects), HEADACHE (Terrible headache) and MIGRAINE (Headache is migraine quality). At the time of the report, CHILLS (Chills), ADVERSE REACTION (Rough side effects), PYREXIA (Slight fever) and MIGRAINE (Headache is migraine quality) had not resolved and HEADACHE (Terrible headache) outcome was unknown.
felt cold and clammy, feeling hypoglycemic, lightheaded Narrative:  Pt with hx of HTN, HLD, DMII c/b neuropathy, obesity, was on 30 mins. observation due to allergy reaction from gabapentin (hx of hives, rash per patient's report nurse). He said, "I just need to eat..." Admitted to not eating after taking Lantus 7 units subq. @ 07:30 including Metformin, Amlodipine, Blue Naturally (herbal), etc. Pt. complained of cold clammy skin, nausea and vomiting x1, and feeling hypoglycemic. BS-422 @ 09:10 & BS-453 @ 09:13. VS: T-96.8, P-92, R-18, RA B/P-108/60, LA B/P 75/50, P-91 @ 09:00-09:05. Repeat VS @ 09:10: P-89, LA B/P-90/53 O2 Sat. 99%, Repeat VS @ 09:23 P-90, RA B/P-119/59, BS-453. When asked patient if his condition improving or worse, patient said "No". called 911 to assist. Paramedic transferred pt to ED. Once in the ED, patient felt completely normal/symptoms resolved. Discharged from ED. Pt noted in ED that he has had mild pain to the center of his chest "like a bruise" x2 days. Pt declined admission for ACS workup. Troponins negative. Pt also stated he does not regularly check his BG; usually at home in 200's up to 300.
This spontaneous report as received from a medical assistant refers to a 64 year old patient. The patient's medical history was not reported. On 18-DEC-2017, the patient was inadvertently vaccinated with VARIVAX lot # N019131, expiration date 22-JUN-2019 for prophylaxis instead of ZOSTAVAX. No adverse effects were reported.
Headache, fatigue, brain fog, shaking feelings, racing heart Tachycardia all started the same day within 30 minutes of shot Symptoms persisted with additional trouble breathing started on April 3. I went to Urgent Care for assistance. Was given albuterol, EpiPen, and steroids. Asked to follow up with Primary doctor on Monday.
Upon 2 weeks of receiving booster shot of Moderna I developed an allergy/ intolerance to Yeast. I have intense itching, red whelped skin that is inflamed with light touch/ scratching of skin.  I am uncomfortable in my skin and it often feels like spider webs on my skin with hyper-sensativitiy of my skin.  I have dermatographia ( skin writing) when I itch my skin lightly.  I have had to eliminate a significant amount of food items from my diet to avoid these symptoms which has made travel/ going out to restaurants difficult.    My father had a similar skin reaction with a new allergy to a food post his covid immunization.
OV 06/07/05: DX with breakthrough varicella. Has approximatelyu 20 lesions on trunk, arms, and several are vesiculated
pt sat for vaccine and then noticed arm feeling numb, pt waited 15 minutes and proceeded to walk to exit with husband and when ambulating pt felt numbness and weakness in legs   notified staff and placed in wheelchair and taken to OBS.  pt states didnt take her iron this morning and once sitting down feeling better  only feeling numbness on and off in arm.  pt given water vs as noted. denies further symptoms   pt dangled and then stood at side of bed with no further weakness feeling in legs  pt ambulated to exit accompanied by husband, mother in law and son at 1212 vs 1203 bp 115/74 hr 64 rr 18 o2 100  1208 dangle bp113/75 hr 57 rr 18 o2 100  1210  standing bp 125/79 hr 70 rr 18 o2 96
Patient presents to clinic for swollen left axillary lymph nodes. Patient states he had his 2nd COVID-19 vaccine on 4/6/21 and he noticed the swelling on 4/9/21. Swelling is now staying the same. Denies pain but there is some discomfort. No change in deodorant.  COVID vaccine received in left arm.  Patient states intermittent  pain of left forearm for the past two week. States an achy feeling. Pain will wake him up at night. States he normally has to turn or stretch arm to make it feel better.  ED visit after 1st COVID vaccination- shortness of breath. He notices if he is taking a strenuous walk he will get short of breath. This has continued since his 1st COVID vaccination.
chills like the flu; felt weak; felt dizzy; swelling on right side of face (between eye and upper cheek area); felt drunk getting out of bed; right eye is slightly closed from the swelling; Fever 102F; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (chills like the flu), ASTHENIA (felt weak), DIZZINESS (felt dizzy), SWELLING FACE (swelling on right side of face (between eye and upper cheek area)) and MALAISE (felt drunk getting out of bed) in a female patient of an unknown age 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 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PYREXIA (Fever 102F). On 31-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (chills like the flu), ASTHENIA (felt weak), DIZZINESS (felt dizzy), SWELLING FACE (swelling on right side of face (between eye and upper cheek area)), MALAISE (felt drunk getting out of bed) and SWELLING OF EYELID (right eye is slightly closed from the swelling). At the time of the report, INFLUENZA LIKE ILLNESS (chills like the flu), ASTHENIA (felt weak), DIZZINESS (felt dizzy), SWELLING FACE (swelling on right side of face (between eye and upper cheek area)), MALAISE (felt drunk getting out of bed), SWELLING OF EYELID (right eye is slightly closed from the swelling) and PYREXIA (Fever 102F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details were not reported by the reporter.
pain in my left achilles in the ankle area; pain in my left achilles in the ankle area; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age (Age: 73; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 28Feb2021 11:30 (Lot Number: EN6205) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included BPH, cholesterol and osteoporosis from an unknown date. Concomitant medication(s) included terazosin, atorvastatin (LIPITOR), alendronate sodium (FOSAMAX), ascorbic acid, biotin, folic acid, iodine, pantothenic acid, pyridoxine hydrochloride, retinol, vitamin b12 nos, vitamin d nos, vitamin e nos, zinc (CENTRUM MULTIGUMMIES), ubidecarenone (COQ10) and colecalciferol (VITAMIN D); all taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2 at the age of 73 years old, dose 1 on 07Feb2021 11:30 AM in the left arm lot number: EN5318 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated, "I began having some pain in my left achilles in the ankle area. It started on the day, Sunday on 28Feb2021 16:00. I received the second vaccine and occurred again on Monday, Tuesday and today for a short period of time. I was able to walk on it after getting the pain and it seemed to just go away. I have never had a problem with my achilles before getting the vaccine. I am wondering if it could be a side effect from the vaccine, or just coincidental. I am contacting you to find out if others have experienced this problem following their injections." No treatment given to the patient for the events. The patient has not been COVID-9 tested since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
When I was walking my dog the following day, I noticed that clear liquid was leaking out of my arm. It was coming from the bandaid that was placed over my vaccination site. I pulled it off to reveal strange blisters, some of which were leaking. They are clear and from afar just appear to be large water droplets. As they do not hurt, or itch, or I have no desire to seek medical advice. I will mention that they are numb.
Patient had some raised red bumps on her forearms.  They were mostly not itchy, but one near the elbow was itchy.  Patient was going to take benadryl to help resolve.
Diarrhea started 3 hours after shot, lasted 8 hours Throat tightness started 24 hours after shot, still continuing 36 hours after shot. taking Benadryl Tachycardia started 24 hours after shot, HR 110. Still continuing 36 hours after shot
Patient describes feeling achy all over and fatigued to the point he needed to lay down and rest.  He then reports "feeling in a funk for the next few days".
After receiving the vaccine I returned to work and then went home, ate dinner, showered and bed. The following morning (Easter Sunday) I woke up at approximately 07:00 AM and when I got out of bed my legs (bi-laterally knee pain) were so weak that I almost fell down,  I had to hold on to various furniture and walls to get to the bathroom.  This weakness and joint pain has been constant and continuous and is still ongoing as of this writing. On 4/8/2021 I called my private physician, and explained what was happening and he prescribed me METHYLPREDNISOLONE 4 MG DOSEPK (medrol). I took the medication as prescribed and had no relief.  On 4/14/2021 I went to ER and had X-rays taken of both knees and was sent home with a suggestion to follow-up with my private physician (on vacation until 4/26/2021) whom I have a telemedicine call scheduled with for that same day 4/26/2021. I have scheduled an appointment with an Orthopedic Specialist  now on 4/20/2021 @ 3:20 PM for an evaluation.
Case number PHEH2014US018594, is an initial spontaneous report from a nurse received on 12 SEP 2014. This report refers to a 24-year-old female pregnant patient. Past medical history and concomitant medications were not reported. Her last menstrual date was 10 APR 2014. This pregnant patient received MENVEO (batch number: unknown) intramuscularly on 04 AUG 2014. No adverse event reported after vaccination.
Rapid heart beat; trouble breathing at the time; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Rapid heart beat) and DYSPNOEA (trouble breathing at the time) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced HEART RATE INCREASED (Rapid heart beat) and DYSPNOEA (trouble breathing at the time). At the time of the report, HEART RATE INCREASED (Rapid heart beat) and DYSPNOEA (trouble breathing at the time) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.    Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Reporter details and vaccine details updated
Pfizer vaccine was administered outside - reported by patient- ? NO LOT NUMBER WERE SUPPLIED ------------------------------------------------------------------------------------------------------------------------------ I95.9 HYPOTENSION 11/25/2022 HEMATOMA, INIT J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 11/14/2022 HEMATOMA, INIT R09.02 HYPOXIA 5/13/2022 HEMATOMA, INIT I95.9 HYPOTENSION 11/25/2022 DIASTOLIC HEART FAILURE, ACUTE J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 11/14/2022 DIASTOLIC HEART FAILURE, ACUTE R09.02 HYPOXIA 5/13/2022 DIASTOLIC HEART FAILURE, ACUTE I95.9 HYPOTENSION 11/25/2022 ATRIAL FIBRILLATION, UNSPECIFIED J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 11/14/2022 ATRIAL FIBRILLATION, UNSPECIFIED R09.02 HYPOXIA 5/13/2022 ATRIAL FIBRILLATION, UNSPECIFIED I95.9 HYPOTENSION 11/25/2022 CHF EXACERBATION, UNSPECIFIED J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 11/14/2022 CHF EXACERBATION, UNSPECIFIED R09.02 HYPOXIA 5/13/2022 CHF EXACERBATION, UNSPECIFIED
pentacel was administered to a patient after it experienced a temperature excursion with no reported adverse event; Initial information was received on 18-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 7 months old female patient who received diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (vero)] after it experienced a temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On 17-Jul-2023, the patient received a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection at dose of 0.5 ml (lot number: UJ757AAA, expiration date: 09-Sep-2023, strength, route, administration site: Unknown) for Immunization (immunisation) after it experienced a temperature excursion with no reported adverse event (poor quality product administered).  No lab data reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event pentacel was administered to a patient after it experienced a temperature excursion with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous unconfirmed report was received from a healthcare worker via a company representative and refers to a patient of unknown age and gender. The reporter read about this information on the internet (unspecified website). No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On an unknown date, the patient was vaccinated with a dose of unidentified Merck HPV vaccine (name, strength, dose, route of administration, anatomical location, lot # and expiration date were not provided). Reporter could not confirm whether the product was GARDASIL or GARDASIL 9. On an unknown date, 36 hours after receiving a dose of unidentified Merck HPV vaccine, the patient died of an unspecified cause. The relatedness between the patient's death and unidentified Merck HPV vaccine was not reported. Upon internal review, the event of death was considered to be medically significant. Additional information is not expected as the reporter did not have any additional information and did not wish to be contacted regarding this report.
Patient had 3 cm induration and an area of redness of about 10 cm in office minutes after receiving the vaccine on the RL
Sunburn rash on chest, upper back, face, neck and arms. Going to be evaluated by PCP today.
Freezing cold Extreme body ache Slept 36 hours straight Soreness at injection site Large red, hot, swelling  around injection
This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination. No Medical History information was reported. On 27-Oct-2021 at 9:57 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 9:57 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The age of patient was provided as 70.05. Concomitant products were not provided. On 27-OCT-2021, Excursion time was reported at 9:00 A.M and 10:00 AM with temperature as 29 and 32 degrees Fahrenheit, total doses given for the day was 116, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 29-SEP-2021 and 05-OCT-2021, vial was moved to clinic on 27-OCT-2021. 2 and 4 vials were sent to clinic. Vaccine BUD date was 29-OCT-2021 and  04-NOV-2021. Vial was stored on cooler 1, on 27-OCT-2021, Excursion duration At 8 AM: 41, 9 AM: 29, 10 AM: 32, 11 AM: 43, 12 AM: 43, PM: 43, 2 PM : 46, 3 PM: 46, 4 PM: 46 and 5 PM : 45. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
mom states pt had t105 p/#2DTP; states fretful all noc; no seizures; mom states pt breathing fast; MD states no Pertussis to be given in future;
Patient got scheduled by front desk to get his Moderna booster. When I was documenting the vaccine I got a warning message saying it was to early for the patient to receive the shot. I hit accept and continued with the administration. The reason why I continued was because I relied that the patient was due for his booster shot as he was in the booster schedule, also we were often getting the warning messages for patients even when they were due for the boosters, so I thought that was the case. Later on when I was filling his vaccination card I realized he got his second dose in August and it was too soon for him to get the booster.  Dose will not be repeated
Site reaction with papular urticaria spreading over 12-24 hrs to involve back/groin/trunk but with concentrated erythema/edema/warmth/discrete blanchable lesions along right upper/lateral arm over injection area.
diffuse/generalized migrating rash severely pruritic, facial edema, elevated inflammatory markers, severe arthralgia limiting ability to ambulate, fever.   Started as joint pain and hives about 22 hrs after vaccination. Progressed to urticarial appearing rash and inability to walk due to pain about 12 hrs later.  Rash and arthralgia waxed and waned. Peak severity of rash on day 3, accompanied by severe sudden onset abdominal pain and fever 101.5.
This case was reported by a physician via sales representative and described the occurrence of fever in a 15-month-old female subject who was vaccinated with KINRIX, (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of KINRIX (unknown) and experienced inappropriate age at vaccine administration. At an unspecified time after vaccination with KINRIX, the subject experienced slight fever and loose stools. KINRIX was administered to a 15-month-old subject. The subject did have a slight fever and loose stool after immunizations, but attributed as normal reaction to immunizations. At the time of reporting the outcome of the slight fever and loose stools was unspecified. The physician considered the events were related to vaccination with KINRIX. The sales representative reported another case on behalf of the physician, please see case A1048925A.
I got in line to wait after receiving my vaccine within a couple minutes I started feeling a numbing tingling sensation on the right side of my face and tongue and top of my head. I also felt very jittery or crawling sensation like I had to much coffee. I called the guards to my car twice and was told it was my nerves. I was released even though I wasn't feeling right and felt like was drunk driving on the way home, the worst of it passed within a hour but the fuzzy feeling lingered with numb spots on my face lasted for a few days.   Now I'm afraid to get my second shot due April 3rd.
Pt presented to office for a nurse visit with a school form vaccine checklist indicating he was due for DTaP, IPV, Hep B, MMR, and Varicella. The other MA and myself did not catch that the pt was too old to receive a DTaP. The CDC indicates that the DTaP can count as a TDaP in this case, and re-vaccination is not necessary.
baby had crying jag for 5 to 6 hrs, wouldn't eat, inc temp treated w/APAP; mom states that @ the end of crying jag pt's eyes rolled back in head;
rash on leg on same side as injection; arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on leg on same side as injection) and VACCINATION SITE PAIN (arm soreness) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 25-Feb-2021, the patient experienced RASH (rash on leg on same side as injection) and VACCINATION SITE PAIN (arm soreness). At the time of the report, RASH (rash on leg on same side as injection) and VACCINATION SITE PAIN (arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications or treatment details reported.
pt recvd 3 doses Engerix-B & had no response; reporter indicated high percentage (around 5%) of noresponders; all heavy (obese);
PT APPEARED LETHARGIC APPROX. 8 HRS AFTER DTP/OPV IMMUN, CHILD HAD SEVERE LETHARGY AND GAGGING EPISODES AND WAS HOSP. FOR OBSERVATION