chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Date and time adverse event started:  3/18/2021 approx. 4-5 hours after rcvding the 2nd dose at 10:15am. she had chills, and then approx. after 9pm that evening after she gone to bed she woke up over heated, had muscle and joint pain, and felt extremely exhausted the very next morning. Patient advised she felt better a couple of days later.
received an expired dose as a booster dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received an expired dose as a booster dose) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received an expired dose as a booster dose). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received an expired dose as a booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported. Date the vial was initially stored in the refrigerator: 26-Oct-2021. The vial did not undergo any temperature excursions.   This case was linked to MOD-2021-365107 (Patient Link).
I received my vaccine on 05/09/2022. 24 hr. later I had a low grade fever, body ache and fatigue. Stayed home for about two days. ON 5/16/2022 I woke up with throbbing pain on my left calf below the knee. I went to urgent care that day and did ultra sound and  was prescribed diclofenac and was diagnosed with a surface blood clot in left calf (not deep vain). 10 days later I went to f/u appointment with pcp i did another ultra sound on leg was determined that the blood clot had grown significantly. I was prescribed Xarelto for 45 days to return once finished.
Soreness in arm the day of, and one day after, the injection. Starting two days after the injection: consistent fever, 100° F to 102° F, body aching in muscles (specifically legs), and chills throughout body. Most intense waking up and before bed (symptoms usually worsen around 8:00 pm).
injection site rash; injection site swelling; Tenderness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (injection site rash), INJECTION SITE SWELLING (injection site swelling) and VACCINATION SITE PAIN (Tenderness at injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 008B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INJECTION SITE RASH (injection site rash), INJECTION SITE SWELLING (injection site swelling) and VACCINATION SITE PAIN (Tenderness at injection site). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, INJECTION SITE RASH (injection site rash), INJECTION SITE SWELLING (injection site swelling) and VACCINATION SITE PAIN (Tenderness at injection site) outcome was unknown.            No information provided about concomitant medications. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-066081 (Patient Link).
Patient may have received double dose, 58 mcg, in single injection. Unsure of exact dilution used. Once one vaccine was administered and error was discovered, no other doses administered. Patient experienced side effects consistent with vaccine side effects.
On Day 7 he began to notice runny nose, chills and aching. Since the 21st he has been waking up with migraines (no hx of headaches), extreme hangover type feeling and just not feeling right. No Medical attention.
raised heart rate to 90+bpm; GI Nausea; shortness of breath; Rash on legs/ Rash on both arms and torso; Itching; loose bowel movement; Fatigue; red finger tips/bright red palms; red nail area; purple fingers to knuckle area; This is a spontaneous report from a contactable consumer (Patient). A 63-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7533), dose 1 via an unspecified route of administration, administered in Arm Left in Apr2021 at 02:30 PM (Age at vaccination: 63 years) as dose 1, single for covid-19 immunisation. Patient had known allergies to penicillin, sulfa, ibuprofen, flu vaccine, chocolate, pepper, citrus, chemical senitiviies. Other medical history included asthma, IBS, allergies. Concomitant medications included vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]). Patient did not receive other vaccines in 4 weeks. The patient experienced raised heart rate to 90+bpm, gi nausea, shortness of breath, rash on legs/ rash on both arms and torso, itching, loose bowel movement, fatigue, red fingertips/bright red palms, red nail area, purple fingers to knuckle area in Apr2021. Immediately after injection raised heart rate to 90+bpm, GI Nausea. Within 5 minutes shortness of breath occured. 50mg of Benadryl (Diphenhydra-mine HCL) within 10 minutes of vaccine was given. Heart rate decreased to 79 bpm; shortness of breath was decreased within 25 minutes of first Benadryl dose. Rash on legs first 30 mins. Heart monitored at ER for two hours with no incident found. Pulse after discharge was 88 and blood pressure was at 164/86. There was Rash on both arms and torso later in the day along with itching. Aggressive rash/itching continued on arms for 4 for days requiring Benadryl 50mg/4 hours. Day 5 Benadryl reduced to 50mg/6 hour then 8 hours and by day 6 rash was gone. Shortness of breath subsided within 2 hours. Nausea resulted in 1 loose bowel movement within first hour post vaccine with no other GI issues. Fatigue was on day 2 only. Covid fingers day 3 thru day 5, with stronger symptoms on left hand. Symptoms changed but included red fingertips, red nail area, purple fingers to knuckle area, bright red palms. Treatment for the events included Benadryl 50mg/4 hour for 4.5 days. Patient did not have COVID prior vaccination. Patient did not test COVID post vaccination. The patient underwent lab tests and procedures which included blood pressure measurement: 164/86 on blood pressure at 164/86, raised heart rate to 90+bpm in Apr2021, heart rate: 79 bpm, Heart rate decreased to 79 bpm, heart rate: pulse after discharge was 88. The outcome of the events was recovered in 2021.  No follow-up attempts are possible. No further information is expected.
Woke up 1am-severe itching both legs and arm w/shot. Very red and hot, welts on legs. Called nurse. Inst: BENADRYL, Hydrocortisone and cold wash cloths. 1/2hr later was better, except arm. Arm still red. No infection, per RN.
Admit 6/15, vaccine 2/3, 3/8. Admit for progressive wound worsening after L toe amputation. H/O PAD, HTN, DM. COVID +, COVID PNA noted during hospitalization. Treated w/abx, steroids. DC'd to rehab. At time of DC pt on RA and off precautions.
Fever, chills, headache, tiredness, severe pain at injection site (left deltoid), pain left armpit & left chest, swelling of left armpit & left chest.  All symptoms occurred simultaneously on the following day of the injection.  Swelling increased on day three (Sunday) following the Thursday injection.
9/6/22 pt to ED with SOB; found to be positive for COVID; COVID pneumonia with possible secondary bacterial pneumonia; given Decadron and ABX; comfort care decided upon for the pt; she passed away in the hospital
Mom states child cried uncontrollably for over 2 hrs, had heat type rash and fever of 102 deg-she called the ER but did not take child.
Approximately 1.5in diameter red spot at the injection site appeared 9 days after the jab; Rash; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6204) via unspecified route of administration in left arm on 12Mar2021 at 08:30 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included allergic to blackberry. Concomitant medication included centrum (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Mar2021, the patient experienced 1.5 in diameter red spot at the injection site which appeared 9 days after the jab. On an unknown date in Mar2021, the patient experienced no pain, itching, tenderness was associated with the rash. No therapeutic measures were taken for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events red spot at injection site and rash was recovered at an unknown date.   No follow-up attempts are needed. No further information is expected.
room temperature for more than 12 hours; interval > 35 days per her physician's recommendation; interval > 35 days per her physician's recommendation; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (interval > 35 days per her physician's recommendation), EXPIRED PRODUCT ADMINISTERED (room temperature for more than 12 hours) and OFF LABEL USE (interval > 35 days per her physician's recommendation) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 001B21A) for COVID-19 vaccination.     The patient's past medical history included Blood transfusion.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (interval > 35 days per her physician's recommendation) and OFF LABEL USE (interval > 35 days per her physician's recommendation). On 03-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (room temperature for more than 12 hours). On 03-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (interval > 35 days per her physician's recommendation), EXPIRED PRODUCT ADMINISTERED (room temperature for more than 12 hours) and OFF LABEL USE (interval > 35 days per her physician's recommendation) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   ? No treatment information was provided. ?
Client received vaccine 2 days ago.  States that she has never had any issues or side effects after any previous vaccine and she states that she always receives all vaccines in this arm (left).  She states that the evening of the vaccine, she experienced subjective fever (didn't use thermometer), chills, general body aches.  By the next morning on 11/1/22 she felt okay.  By the evening of 11/1/22 she was experiencing a mild cough but this was gone by today 11/2/22.  However, on 10/31/22 around 3:00pm she started to notice arm pain which has gradually worsened over the last two days.  She reports feeling an 8 or 9 out of 10 of throbbing pain which radiates down through her bicep and through her underarm.  She states there is possible mild swelling at the site but otherwise no lump, redness, bruising, or anything else unusual.  She has taken ibuprofen and placed ice on the site and her pain has come down to a 4/10.  She does not notice any change in her ability to move her arm or in her range of motion but her arm is very painful to move.  She felt she should call and report this as she has never had this much pain after a vaccine before. She has not received any medical care for this. I have advised her she should have an appt with her PCP or go to an urgent care for an evaluation.
joint pain in the hips, back, shoulders and wrists.; This case was reported by a consumer via call center representative and described the occurrence of generalized joint pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd September 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 1 week after receiving Shingrix, the patient experienced generalized joint pain. On an unknown date, the outcome of the generalized joint pain was not recovered/not resolved.   It was unknown if the reporter considered the generalized joint pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient reported that one week after vaccination, he experienced joint pain in the hips, back, shoulders and wrists. The reporter did not consent to follow up.
Patient experienced mild tenderness at vaccination site x 2-3 days.  From about day 1 following vaccination until the present time, patient gradually developed  mild wheezing and dyspnea on exertion.  She also complained of of headache, fatigue, and achiness, and general malaise over a period of around 5 days.  Symptoms were not sufficient to require any major alteration in her routine or to cause her to seek medical attention.  She has had wheezing in the past in association with URI's.   She is currently being treated with inhaled albuterol and fluticasone.
Spoke with mother of 15 yo who states "took child to ER for c/o terrible headache.  No nausea/vomiting slight temperature 99.4.  Per mom has taken childhood immunizations OK in the past (still has not been seen by MD).
vaginal blood spotting; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on 08Mar2021 (Lot Number: EN6202, at the age of 63-year-old) as single dose for covid-19 immunisation.  Medical history included abnormal cervical papanicolaou smear, ongoing eustachian tube dysfunction, ongoing Factor V Leiden Thrombophilia, ongoing hearing loss, laparoscopic Gynecology (GYN) surgery in 2007, an outpatient surgery to scrap the walls of her uterus similar to a dilation and curettage (D&C) in 2005, blood clots, excessive bleeding, ongoing Factor V Leiden heterozygote. Concomitant medication included ongoing multivitamins. Soon after her first vaccine on 08Mar2021 she started vaginal blood spotting. She had not had a period for over 15 years. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Received MMR on 6/29/04: 9 days later developed fully body rash. By 7/9 and 7/10 searing burning pain from both elbows to finger tips x 2 days. The deep pain abated over several days to numbness and tingling right hand.
Headache, Myalgia, Arthralgia, Fever, Chills, left arm pain Narrative:
Extreme swelling at the site, uncontrollable screaming and crying for 3 days straight, high fever, unable to sleep, and constipation.
This spontaneous report was received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # N017698; expiration date: 09-JUN-2019)  or  (lot # N017701; expiration date: 09-JUN-2019) for prophylaxis, which had a temperature excursion of 6F to 14F for 2 hours 12 minutes on an unknown date. Previous temperature excursions included the same previous temperature for 2 hours 48 minutes and 15F to 46F for 1 hour 59 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (Merck sterile diluent). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1801USA005992.
I was having recurring episodes of dermatographia due to unknown causes. It was mostly presenting on my back, however, it showed up almost everywhere on my body and it was extremely itchy.
Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Diarrhea-Medium, Systemic: Fever-Medium, Systemic: Hypertension-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe
Parent said Pt wasn't feeling well after her first covid shot.  Her pulse was low when I checked her.  She looked very pale, and she said she felt hot.  She said her breathing was fine so no epipen was given.  Pt was able to walk after she rested, and her mom took her to the hospital.
administration /of the lless that 0,5 ml of the/ vaccine / While retrieving /the needle detached and a few drops fell of; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number 59LK9, expiry date 18th December 2022) for prophylaxis.   On 18th June 2021, the patient received the 2nd dose of Shingrix. On 18th June 2021, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.  Additional details were provided as follows: The age at vaccination was not reported. Pharmacist reported that patient received Shingrix and while retrieving the vaccine from the patient the needle detached and a few drops fell of, less than 0.5 ml of the Shingrix vaccine was administered, which led to accidental underdose. HCP did not consent nor deny follow up.  No further events were reported.
She began to feel light-headed and dizzy about 5-10 minutes after the vaccination and then her blood pressure began to fall and it did not come back up
-fever to 101 deg F; shaking chills; body aches; swelling and induration at the injection site.  Started about 24 hours after the shot.  Mostly resolved in about 14 hours.  I am a physician who runs an inpatient unit and virtually everyone who got the shot on my unit had the same symptoms - my APRN who is only 29 years old had a fever of 102 deg and had to stay home the day after his shot.
Vasculitis of hands and feet. Symptoms first noted in hands on 1/17/2021 - intermittent - adverse reaction on 1/18/2021 at 11:08 pm - hands became bright red as well as feet. Burning sensation (similar to taking Niacin) Color changed in feet from bright red to dark red with some purple in digits 2 and 3 of both feet. Appears swollen. I was informed on 1/12 (4 days after being vaccinated) that my daughter had been exposed to COVID. We family quarantined. The adverse reaction led me to go to an urgent care clinic to be tested for COVID. I had the POC test performed and came back positive. My temperature was recorded at 99.3 F.
approximately three weeks after the shot, I developed sudden on-set dizziness with aural fullness and tinnitus
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Nov2021 (Lot number: Ff8841) at the age of 74 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included Dibities (unspecified if ongoing); BP (unspecified if ongoing); Allergy (unspecified if ongoing). The patient took concomitant medications. Vaccination history included Moderna (Dose Number: 2, Batch/Lot No: 013L20A, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 18Jan2021, for COVID-19 immunization; Moderna (Dose Number: 1, Batch/Lot No: 016H20A, Location of injection: Arm Left, Vaccine Administration Time: 02:00 AM), administration date: 15Feb2021, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 12Nov2021, outcome unknown; RASH (non-serious), BLISTER (non-serious), PRURITUS (non-serious), PAIN (non-serious) all with onset 16Nov2021, outcome not recovered; HERPES ZOSTER (non-serious) with onset 16Nov2021, outcome not recovered. Doctor said it's singles and were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of rash, blister, pruritus, pain. Therapeutic measures were taken as a result of herpes zoster.   The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received medications for diabetics and BP within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19, Since the vaccination. Patient received 1 g vvalacyclovir for shingles.
CHIEF COMPLAINT Shortness of breath   HISTORY OF PRESENT ILLNESS: The patient is a 76 y.o. female who presents with shortness of breath. Her pertinent medical comorbidities include HFrEF (LVEF 25%) coronary artery disease (based on noninvasive testing, atrial fibrillation on Eliquis, Parkinson's disease, CKD stage 3b-4, left renal artery stenosis, obstructive sleep apnea, sick sinus syndrome s/p pacemaker implantation.    The patient was in her usual state of health until 3 days ago, when she began to develop increasing dyspnea, orthopnea, weight gain, and swelling in her face and hands.  She has a home dose of torsemide 40 mg p.o. q.d. and noticed decreasing urine output on this dose.  She try to double her prescribed dose, an even triple the dose the day prior to admission with little improvement in urine output.  She had no chest pain, fevers, chills, night sweats, or worsening lower extremity edema (though she has kept her legs wrapped recently due to new bilateral rash seen by wound care).  With concerns for the symptoms, she presented to the Hospital Emergency Department for further evaluation and management.
Rash at injection side, swelling, redness, fever, sore to touch Had prescription cream from derm for another skin issue, used on rash on 2-23-2021 Has taken tylenol with arthritis for pain as well as regular tylenol
PATIENT STARTED EXPERIENCING EXCESSIVE SWEATING /FEVER THE 2ND DAY AFTER GETTING VACCINE, GENERALIZED BODY ACHES, CHILLS AND EXTREME TIREDNESS- SHE ALSO EXPERIENCED NUMBNESS IN HER LEGS . SHE IS FEELING BETTER TODAY BUT STILL VERY TIRED
Fever - 6/25 evening 101F max - treated symptomatically CXR normal, wheezing - treated with Albuterol, Zyrtec
This spontaneous report as received from a employee refers to a 70 year old male patient (reporter's brother in law). The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy was unknown. On an unknown date the patient was vaccinated with shingles shot (Zoster Vaccine Live) (manufacturer unknown) subcutaneously (dose, units and frequency were unknown), (lot number and expiration date unknown). On an unknown date, it was reported that the shingles rash has started to scab over (herpes zoster and scab). The outcome of herpes zoster and scab was reported as recovering/resolving. The causal relationship between the events shingles rash has started to scab over and shingles shot (zoster Vaccine Live) (manufacturer unknown) was not reported.
Patient had severe muscle and joint pain, weakness, tiredness and was shaky walking. These symptoms began on 9/8/13 and continued to worsen. Emergency room visit was on 9/9/13. Taken by ambulance. Patient was given shot of Hydromorphone (Dilaudid 1 mg) at 7:03 PM.