chrisvoncsefalvay/vaers-outcomes huggingface dataset:
beginning 1/16/21 sore arm - immediately tiredness 3pm upset stomach & nausea  11pm - 1am  1/17/21 chills, shaking (convultions)  12am - 4am fever 4am - 11am  1/22/21 sore arm is gone still tired, but not the exhaustion I felt in beginning
After my first dose on 12/23 I began have heart palpitations while working out from 12/23-1/1 while working out with then gradually getting more frequent throughout the week. I just got my second dose on 1/21 and on 1/22 I had my first heart palpitation while putting on my socks. I can?t feel my radial pulse and my heart pounds out of my chest.
Patient is only 16 years of age and received a second COVID vaccination at our store. After talking to patient, he states he received his first dose at a drive through clinic on 02/22/2021 out of the lot 022M20A. Informed patient after the fact that one must be 18 years old to receive this vaccine.
Tonic clonic movement of arm x 30 seconds and baby looking "glassy-eyed" 2 hours after shots.
I just had a body rash - it was itchy and raised, it looked very similar to the reaction I have with amoxicillin  on the front of my chest. The treatment they gave me was steroid cream and they also gave me OTC allergy medicine with Benadryl. That helped resolve the rash.
This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed Moderna COVID-19 Vaccine second dose, more than 42 days have passed since first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-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 PRODUCT DOSE OMISSION ISSUE (Missed Moderna COVID-19 Vaccine second dose, more than 42 days have passed since first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed Moderna COVID-19 Vaccine second dose, more than 42 days have passed since first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant products were reported.  No treatment information was provided.   Reporter did not allow further contact
Injection  arm starting itching a lot and got warm . It now has a raised red bumpy rash. 7 days from shot
neck was swollen; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SWELLING (non-serious), outcome "unknown", described as "neck was swollen".  Additional information: No patient identifiers were provided but the reporter has first hand knowledge of the patient and was reporting on a specific patient. Below is the verbatim report. Caller wanted to know if she took the vaccine will that vaccine cause tb germs to become active. Caller also said that her husband took the vaccine and the glands in his neck was swollen. Submitted AE.  Medical Information (MI): There were any medical questions addressed by this program forwarded/addressed by this program forwarded/referred to medical information. Customer and/or medical inquiry forwarded or referred to MI.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information was received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not provided. On unspecified dates, multiple unspecified patients were vaccinated with improperly stored PROQUAD (lot# M012986 with expiration date 12-SEP-2017; concentration, route and frequency were unknown) for prophylaxis. No adverse effects were reported. The vaccines were stored at more than minus 15 Celsius degree (C) but less than minus 10 C for 1 hour 38 minutes. The data logger was involved. There was no previous temperature excursion. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA012153: US-009507513-1703USA005921.
W/in 12 hrs following immun, pt exp an inject site reaction consisting of swelling & erythema (size of a 50 cent piece), nausea & severe h/a; no treatment initiated; pt recovered;
Narrative: Patient received two doses of covid vaccine. HTN, NICM (EF 35-40%), CKD III, severe pulmonary hypertension, and prostate cancer in remission, anemia, gout, restrictive pulmonary disease on oxygen via nasal cannula. Patient was transferred to hospital on 3/23/21 and diagnosed with pneumonia. Patient passed away at hospital on 4/5/21. Reporting per instructions.
I have cellulitis in my arm.; I am allergic to it.; This serious case was reported by a consumer via interactive digital media and described the occurrence of cellulitis of arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced cellulitis of arm (Verbatim: I have cellulitis in my arm.) (serious criteria GSK medically significant) and allergy (Verbatim: I am allergic to it.). The patient was treated with steroids nos (Steroids). The outcome of the cellulitis of arm was not recovered/not resolved and the outcome of the allergy was not reported.   It was unknown if the reporter considered the cellulitis of arm and allergy to be related to Shingles vaccine.   It was unknown if the company considered the cellulitis of arm and allergy to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-MAR-2023 This case was reported by a patient via interactive digital media. The patient got the shingle shot last week and he/she was allergic to it.  Now he/she had cellulitis in his/her arm.  The reporter stated that he/she did not know what was worse cellulitis or shingles.  The reporter further stated that both were bad.  The doctor gave him/her 3 days of steroids and he/she hoped it healed soon.  The reporter stated that no more shots for him/her.  The patient had done the same with the flu shot. The follow up would not possible as no contact details were available.
Chills; headakc; tiers; body acks; This is a spontaneous report received from a contactable consumer. A 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Em6203), via an unspecified route of administration on 27Mar2021 at 11:00 and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Em6203), via an unspecified route of administration on 27Feb2021 at 11:00, both on left arm as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient was pregnant during time of vaccination. On 28Mar2021, the patient experienced Chills, headache, tiers, body aches. Outcome of events reported as recovered on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
DONOR STATES FEELING FEVERISH ACCOMPANIED WITH BODYACHES AND HEADACHE WHICH LASTED FOR THE MOST PART OF THE DAY UNTIL 5:00 PM.
-sore stiff neck one month previous with a headache w/ no trauma to head or neck  -6/27/2021 woke up with nausea , left sided numbness -Dx: acute right cerebellar infarct, FLAIR  and hyperintensity at right occipital lobe, vertebral artery dissection, left sided numbness, right facial droop, dysarthria,
Presented with SOB; admit with Covid PNA; tx with supplemental O2, maxipime, steroids, remdesivir, Vit C, Zinc presented to hospital with SOB, found to have acute hypoxemic resp failure secondary to covid-19 pneumonia. ID was consulted and pt received few doses of IV dexamethasone and remdesivir. Pt was weaned down on supplemetnal O2, and was eventually discharged home with home O2 in good spirits.
Day two: Injection site redness/swelling,  Headache and nausea, full body-ache, joint pain, dry mouth, dehydration, chills/night sweats. Day three: Most symptoms resolved. Only injection site tenderness, redness, elevated reaction site bump, hot to touch and itchy.
Local redness and swelling on L upper arm. No noted generalized rashes. No respiratory distress. MD made. MD reassured pt mom. Pt was assessed by MD.
Syncope + few seconds.  Diaphoresis.  Pale.  Remained presyncopal/dizzy for 2 hrs after.
couldn't eat; vomited 1 time; sick all day; tired; nausea; Couldn't walk; stomach cramps; bad cold chills; was shaking; fever of 101; felt really lightheaded; Blood pressure was low at 80/51; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (bad cold chills), TREMOR (was shaking), PYREXIA (fever of 101), DIZZINESS (felt really lightheaded) and HYPOTENSION (Blood pressure was low at 80/51) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included heart medication and bp medication for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced CHILLS (bad cold chills), TREMOR (was shaking), PYREXIA (fever of 101), DIZZINESS (felt really lightheaded) and HYPOTENSION (Blood pressure was low at 80/51). On 29-Jan-2021, the patient experienced DECREASED APPETITE (couldn't eat), VOMITING (vomited 1 time), ILLNESS (sick all day), FATIGUE (tired), NAUSEA (nausea), GAIT DISTURBANCE (Couldn't walk) and ABDOMINAL PAIN UPPER (stomach cramps). At the time of the report, CHILLS (bad cold chills), TREMOR (was shaking), PYREXIA (fever of 101), DIZZINESS (felt really lightheaded), HYPOTENSION (Blood pressure was low at 80/51), DECREASED APPETITE (couldn't eat), VOMITING (vomited 1 time), ILLNESS (sick all day), FATIGUE (tired), NAUSEA (nausea), GAIT DISTURBANCE (Couldn't walk) and ABDOMINAL PAIN UPPER (stomach cramps) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Treatment details included Tylenol   Reporter did not allow further contact
cardiac arrest Narrative:  Patient received dose 2 series of Moderna COVID-19 vaccine. First dose was received on 1/17/21 and second dose received 2/14/21. After both doses patient was observed for 15 minutes and did not have any adverse reaction per administering RN. No data in database or database as to any other adverse events occurring 15 minutes post-vaccination. On 3/20/21, EMS was called to patient's home who was discovered on the floor with an unknown breathing status and pulse. AED was attached to the patient. A very weak pulse was found and patient had agonal respirations. Cardiac monitor was attached to patient with a HR of 32. 1mg of atropine was administered and patient's rhythm changed to PEA with no respirations or pulse. Per patient's wife and son, he was a DNR, therefore all resuscitation attempts were stopped (patient was never admitted to the hospital). Patient was never known to be previously positive to COVID. PMH that may have predisposed patient to this adverse event leading to death include h/o DVT on chronic anticoagulation, COPD, and abdominal aortic aneurysm. There is insufficient information to determine the exact cause of death or what led to the cardiac arrest given that the time from last vaccination to the adverse event was almost a month apart.
No adverse outcome.  Vaccines were stored in freezer.  Defrosted in fridge.  Opened and doses drawn out while maintaining temperature/minimizing temperature loss.  Immediately returned to refrigeration.  Temp of refrigerator is 2 degrees C.   Additional doses drawn out within 12 hours and not the 6 hours recommended.  No noted adverse patient outcomes.
On Sunday 12/20 I started to get a significant sharp headache on the left side that radiated down my left neck and arm to the point of injection site. My left arm was also sore as to be expected with typical injection but this sensation was different. It caused a sharp neuromuscular pain that was also itchy/burning. Extended in the region of sternocleidomastoid site. No rash development but seemed like symptoms of shingles. Continued through until approx 12/26/20. Improved with heat pack, Tylenol and Motrin.   Was evacuated by physician on 12/21/20 with no testing or medication provided as symptoms were unclear.
Large red welt appeared on skin over entire bicep muscle (not at injection site but on the injected arm). Welt was warm and painful to the touch, some burning. Welt did not itch or produce rash. Arm was painful to move and extend.
Ongoing irregular periods (too frequent, heavier than normal, longer than normal, etc). I have had normal periods for roughly 15 years leading up to the time I was vaccinated, except I often will have light spotting around ovulation mid-period. I also was not on birth control for about 6 years prior, but in April 2021 (three weeks after initial Moderna shot) I got the Nexplanon implant. Here's a record of my unusual menstruation:  March 30-April 4: Period came roughly a week after the last normal period pre-vaccine (March 19-23). Period came as normal April 17-20. Mid-period period happened again May 1-8 (very long, heavy) Spotting happened for 4 days leading up to next regular period (spotting May 18-21, period May 22-27) Mid-period period June 10-17 (very long, heavy) Period June 26-July 1 Mid-period period July 9-12 (shorter, heavy flow) Period Aug. 7-12 Light spotting Aug. 23-29 Period Sept. 9-13 Period Oct. 10-17 (unusually long, VERY heavy) Second very heavy full period Oct. 24-28 Spotting began Nov. 8-10, today (Nov. 11) full period appears to be beginning again.  I informed my doctor about this two weeks ago and she suggested I keep notes and we will talk about it during my regular annual exam in Janaury.
Flu like symptioms; slightly raised bright pink mark the size of a avocado at the injection upper right arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INFLAMMATION (slightly raised bright pink mark the size of a avocado at the injection upper right arm) and INFLUENZA LIKE ILLNESS (Flu like symptioms) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced INJECTION SITE INFLAMMATION (slightly raised bright pink mark the size of a avocado at the injection upper right arm). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptioms). At the time of the report, INJECTION SITE INFLAMMATION (slightly raised bright pink mark the size of a avocado at the injection upper right arm) and INFLUENZA LIKE ILLNESS (Flu like symptioms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient states 5 min after vaccine administration she experienced a unpleasant metallic taste in her mouth and a burning sensation in her vagina along with an increased urge to urinate. Symptoms subsided fully by 3:52 pm.
Pain and discomfort in wrist area in arm of injection. Dr prescribed steroids. Outcome N/A as of date
Rehab inpatient resident was administered second booster 6 days early. No adverse events to report
pt recv vax 26JUN97 & 27JUN97 pt devel a urticarial pruritic rash;pt recovered from exp;
Case number PHEH2014US025355, is an initial spontaneous report received from a medical assistant on 16 Dec 2014. This report refers to a 73 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 145701, expiry date: Mar 2015), at a dose of 0.5 ml intramuscularly in the left deltoid on 28 Oct 2014, that was stored at minus 0.6 degrees Celsius for 2 hours and 50 minutes. No adverse event was reported following this administration error.
Breakthrough case admission after three vaccines Moderna 1/21/21 Lot# 012L20A;  Moderna 2/16/21 Lot# 007M20A;  MOderna 12/28/21 Lot# 012H21B
I have a red rash on my arm in the area of the shot about 5 inches by 3 inches.  It is itchy and swollen.
Pt. had nasal flu mist. Fell back in waiting room ? Fainted. Hit back of head on floor. Sent to ER by ambulance, then to another hospital.  9/8/09 Hospital records received DOS 8/27/09 to 8/29/09. Assessment: Closed head injury. Patient felt faint, queasy, and though she might 'pass out'. Syncopal event. Found on floor with clenched jaw and a little stiff. Incontinent, combative, and not making sense. Post impact seizure. (L) parietal scalp hematoma, contra coupe small (R) subarachnoid tempo-parietal bleed. Presented very upset, moaning about headache. Erythematous dermatitic rash LS area and buttocks. Abrased, scratched areas.
Fatigue; severe chills; slight fever; received second dose of bnt162b2 on 04Feb202; received the first dose of bnt162b2 on 12Jan2021; This is a spontaneous report from a contactable other health professional. A 41-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, in the left arm, on 04Feb2021 13:30 at SINGLE DOSE for covid-19 immunization. Medical history included IgA nephropathy, chronic kidney disease, hypertension, familial hyperlipidemia and pre diabetes/metabolic syndrome. The patient received the first dose of bnt162b2 on 12Jan2021 at 14:15 in the left arm, covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medication included losartan and labetalol, both from an unspecified date for an unknown indication. On 05Feb2021 07:15, the patient experienced fatigue, severe chills and slight fever. The outcome of events fatigue, severe chills and slight fever was recovering. Outcome of the other event was unknown.  Follow-up attempts are completed. The information on the batch/lot number has been obtained.
Patient brought to the ED by EMS on 2/28/23 for shortness of breath and fever. Per EMS the patient was noted by assisted living facility staff to have had increased work of breathing and change in his level of consciousness. In the ED he was noted to have a fever. A COVID PCR test done in the ED returned positive. He was admitted 2/28/23 - 3/17/23 and was found to have sepsis secondary to UTI and COVID-19 infection. The patient did not improve with treatment and family ultimately decided to transition to comfort cares. During admission, patient completed dexamethasone 6 mg daily. He was discharged to an assisted living facility with hospice. Of note, the patient has received the primary COVID vaccine series and two boosters.
Headache, overall aches, nausea - 8hrs after lasted about - 30hrs.
chills; fatigue; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), FATIGUE (fatigue) and PYREXIA (fever) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2. On 20-Apr-2021, the patient experienced CHILLS (chills), FATIGUE (fatigue) and PYREXIA (fever). At the time of the report, CHILLS (chills), FATIGUE (fatigue) and PYREXIA (fever) outcome was unknown. Not Provided          Caller wants to knowif he can take naproxen after getting the vaccine? Does his side effects fall under the normal range? When are the side expected to start? Treatment naproxen  concomitant medication use was not provided  by the reporter.
Patient developed chills, fatigue, clammy, fever,  lightheadedness, nausea, vomiting, near syncope at least 2 hours after vaccine administration. Patient was taken to Urgent care where BP was 60 systolic. Patient was rushed to the ER, given IVF in transport. Patient was observed in the ER and discharged the same day.
Exactly one week after receiving the first dose of the vaccine, a rash appeared at the injection site. It was raised, red, a little itchy, slightly warm to the touch, and a little tender.  It is not bothersome, but it has gotten a little larger. As of today I still have the reaction.
Within 25 mins of receiving vaccine, face flushed and generalized itching appeared. No breathing difficulties at any time. Flushing lasted 6 hrs, itching lasted 2 days. Meds: took 50mg Benadryl 3 hrs after onset of sx. No further medication or rx necessary.
Developed a 2" x 3' reddened. Warm to touch area around injection site.
1 day post PO oral typhoid:  fever, angry, tired.  "Feels like to shout".
COVID-19 Treatment; COVID-19 Treatment; Moderna, Dose Number: 4, 5 ; Pfizer/BioNTech, Dose Number: 1, 2, 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 18Feb2021 as dose 1, single (Lot number: El9266), in left arm, on 11Mar2021 as dose 2, single (Lot number: En6207), in left arm and on 21Sep2021 as dose 3 (booster), single (Lot number: 20ff2589) at the age of 65 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Jul2022 as dose 4 (booster), single (Lot number: 013822A), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 11Oct2022 as dose 5 (booster), single (Lot number: As7145B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Enlarged prostrat" (unspecified if ongoing); "known allergies: Bactria meloxicam" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Jul2022, outcome "unknown", described as "Moderna, Dose Number: 4, 5 ; Pfizer/BioNTech, Dose Number: 1, 2, 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Feb2023, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Feb2023) Positive. Therapeutic measures were taken with Paxlovid as a result of drug ineffective, covid-19.
Information has been received from a physician concerning a "few" female who were vaccinated with a 0.5 mL dose of Gardasil. The physician reported that she had a "few" patients complain that their menstrual system was irregular. The patients sought unspecified medical attention. The patient's outcome was unknown. Additional information has been requested.
15 seconds post vax rapid heart rate; 5-10 minutes post vax itching, flushing redness; 10 min post vax SOB;