chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2nd shot Pfizer  EW 0151 in L arm received at same place 4/2/21. I RECALL that significant hear palpitations began about this time and coincidentally my thyroid levels spiked within the month, so discussions began and weaned off methimazole, but levels came down dramatically and are now very lowest normal level. Still significant PVC's. Getting workup, Holter monitor shows > 1000 PVC per 24 hours (on a slow day)!  I am an experienced RN also, very weird my issues coincided with 2nd shot?  "They" scheduled me for the second vaccine 4/2, 3 weeks after first vaccine. Could that have been a problem too?   I am reporting this as an FYI, not as a KNOWN adverse event from the vaccine.
RASH; This spontaneous case (PVX2019-1354) was received from a nurse on 28-May-2019. It describes a female consumer who developed rash, after the administration of oral Vivotif for typhoid prophylaxis.  Case report: The consumer started taking Vivotif from 16-May-2019. She reported that she developed rash, but she could not remember if it occurred before or after taking Vivotif. She stated that the rash started on her palms and face, spread to her ankles, a little on her calves, behind her knees, legs, and thighs. Thus, she felt itchiness over her body. She started taking oral prednisone (taper down from 50 mg) for the event from 27-May-2019.  The consumer had no medical history, no illnesses at the time or one month prior to vaccination and had no known drug allergies.   The consumer had taken Vivotif before and completely fine at that time.  Action taken with Vivotif was unknown.  Company's Comment: In this case, it was reported that the consumer had rash after intake Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, rash is labeled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer had rash after intake Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, rash is labeled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.
At the moment of the vaccination it didn't have any incidents, but during the night she touched her left arm and feeled a bump (inflammation, edema on the injection site) at the next day she continue to have the edema and redness area. After these days I continued noticing her arm hot to touch and the edema.
Received faxed medical record from IP at hospital. Pt is a 76 yo fully vaccinated patient who presented to the ED after a fall. Pt c/o of weakness, fever. Symptoms started about a week ago. Pt had some confusion. Pt presented due to persistent fever, lethargy, confusion and generalized weakness with falls.
Patient received COVID vaccine on 3/10/2021 and was admitted to the hospital for COVID-19.  Discharge date:  Sep 3, 2021 Admitting diagnosis(es):   (1) Acute respiratory failure with hypoxia **DISCHARGE DIAGNOSIS:   (1) COVID-19 (2) Acute respiratory failure with hypoxia
pt recv vax & exp fever 102.6 given APAP;had runny nose & cough 1wk prior to vax;exp t103 pt refused APAP;mom put in bath tub pt fell backwards;mom picked up seizured & turned blue;called 911 & taken to ER
took all capsules but felt like had cramps, fever & body aches during all four capsules;
all over body pain, headache, body ache, joint aches, very sore arm that was hard to move no redness but hot to touch, periodic cough, runny nose, throat felt like it was closing up, extreme fatigue and body weakness, unable to sleep first night
no additional adverse effects reported; MMR II expired 30-AUG-2020 that was administered to patient; This spontaneous report was received from a pharmacist, referring to a of unknown age or gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  The pharmacist reported that on 02-SEP-2020, the patient received as part of routine vaccination  a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) that had expired on 30-AUG-2020, lot # R024106 (strength, dose, vaccination scheme frequency, route of administration, and anatomical site of vaccination were not reported). No Additional adverse events reported.  Lot number R024106 is an invalid lot number for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II).
rt deltoid red w/swelling-occurred w/in 24 hrs from inject; mom left a/having formal exam from MD p/being told it was probably an allergic react
"soreness in my arm." after the first vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY ("soreness in my arm." after the first vaccine) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), IRBESARTAN (AVAPRO) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced PAIN IN EXTREMITY ("soreness in my arm." after the first vaccine). At the time of the report, PAIN IN EXTREMITY ("soreness in my arm." after the first vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitant medication including supplements was reported.   This case was linked to MOD-2021-063865 (E2B Linked Report).
doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 11:19 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 11:19 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 15-APR-2021, Excursion time was 9 AM, temp was 34 , total doses given for the day was 188, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were moved to clinic. Vaccine BUD date was 09-May-2021.  Vial was stored on cooler 1 , on 15-APR-2021, Excursion duration At  9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM : 43, 2 PM : 44, 3 PM: 44, 4 PM: 42 and 5PM: 42  Concomitant products were not provided.  It was reported that unknown number of patients were 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   This case was linked to MOD-2022-566976 (Patient Link).
soreness in left arm, site of administration; soreness in left arm, site of administration; This is a spontaneous report from a contactable consumer (patient herself).   A 44-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247, Expiration date: Unknown), via an unspecified route of administration in left arm on 02Mar2021 at 11:00 as dose 1, single (at the age of 44-years-old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient was not tested for COVID-19 post vaccination. The patient did not receive any other vaccine in four weeks of vaccination. The patient's known allergies were none. The patient medical history was not reported. The patient's concomitant medications included ibuprofen and fluticasone (FLONASE) taken for an unspecified indication, received within two weeks of vaccination. On 02Mar2021, the patient experienced soreness in left arm, site of administration. The patient was not received any treatment in response to the events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
tenderness; rash at the injection site; itchy, redness; swelling and tenderness; itchy; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tenderness), INJECTION SITE RASH (rash at the injection site), INJECTION SITE ERYTHEMA (itchy, redness), INJECTION SITE SWELLING (swelling and tenderness) and INJECTION SITE PRURITUS (itchy) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS and CANNABIDIOL (CBD OIL) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced TENDERNESS (tenderness), INJECTION SITE RASH (rash at the injection site), INJECTION SITE ERYTHEMA (itchy, redness), INJECTION SITE SWELLING (swelling and tenderness) and INJECTION SITE PRURITUS (itchy). At the time of the report, TENDERNESS (tenderness), INJECTION SITE RASH (rash at the injection site), INJECTION SITE ERYTHEMA (itchy, redness), INJECTION SITE SWELLING (swelling and tenderness) and INJECTION SITE PRURITUS (itchy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received second and did not experience any adverse events. No treatment information was provided.    Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Follow-up received on 23-APR-2021, updated outcome of the events from unknown to recovered.
Child had outbreak of herpes to face and lips starting two days after vaccine. to lower chin and upper right lip
Info has been received from a physician concerning a 35 month old white male with chronic otitis media and no other pre-existing allergies, birth defects or medical conditions who on 3/31/03 (also reported as March 2004), was vaccinated, SC, in the left lower leg, with a 0.5 ml dose of varicella virus vaccine live. The pt was noted to have an upper respiratory infection and viral syndrome at the time of vaccination. Concomitant vaccination that day, included a 1st dose of MMRII, administered in the right lower extremity. Subsequently, on 3/25/05, two years post/vax, the pt was brought into the office with a full chickenpox rash. There were over 50 lesions. Unspecified medical attention was sought. The outcome was reported as recovered. There was no product quality complaint. There were no relevant diagnostic tests or laboratory data. There were no adverse events following prior vaccinations of the pt or his siblings. No additional info is expected.
Patient reports feeling light headed about 10 minutes after receiving the flu shot. She the reported pain in the left side of her neck followed by right sided-jaw pain, left arm pit pain, and some "tightness" in throat. Some nausea reported as well that has subsided. Currently light-headed. Patient states the sensation in her throat improved after talking.
Left shoulder arthralgia. States "Feels like rotator cuff injury." Stated cannot raise arm above shoulder and cannot reach and grab items has to use other arm.
Arm where shot was given was red, swollen ad warm to the touch.  He missed 2 days of work with flu-like symptoms, headaches and chills.
SKIPPED TWO DAYS BEFORE TAKING THIRD DOSE; This spontaneous case report (PVX2019-2839) was received from a nurse on 18-Nov-2019. It described an adult female consumer who "skipped two days before taking dose 3" (PT: Inappropriate schedule of product administration) while being on Vivotif for an unknown indication.  Case report: The consumer took the first and the second dose of Vivotif according to schedule. The doses were taken on 12-Nov-2019 and 14-Nov-2019, respectively. Later, she skipped two days before taking the third dose. The dose was taken on 17-Nov-2019.  Action taken with Vivotif with respect to the reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company Comment: A patient took second dose of Vivotif as per the schedule and skipped two days before taking the third dose (Inappropriate schedule of product administration). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif. ; Sender's Comments: A patient took second dose of Vivotif as per the schedule and skipped two days before taking the third dose (Inappropriate schedule of product administration). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.
It started after my husband and I were walking and I got dizzy, light headed, and felt like I was going to pass out. I walked less than a mile when that started and my breathing was really labored. When we got to the donut shop, I stayed there and my husband walked back to the house to get the car and pick me up. After that, I called my PCP and he had me take a stress test and that came back perfectly normal. I also had a CT taken to make sure that I didn?t have plaque build up in my arteries. That came back normal. So it wasn?t my heart which I thought it might have been. He suggested I go to a pulmonologist. So I made an appointment with Dr., which was yesterday. She had me do a breathing test and also had an x-ray taken of my lungs and I don?t know the results of that yet. Basically, I guess my complaint or issue is- My husband and I, when the weather is cold, we walk and in warm weather we would ride bikes. I used to be in good health and it just so happened that this seemed to be after my shot. I have lost 80 lbs. I used to weigh 240 lb, and now I?m at 160. It?s important to me to be able to do these activities and be active. That?s how I also noticed how my health as changed and breathing became labored because it didn?t use to be like that.
Evening of 04/19/2022 experienced discomfort swallowing went to emergency room throat xrayed no sign of foreign body referred to Ear nose throat doctor 04/25 diagnosis of GERD GastroEsophageal Reflux Disease
10min p/vax exp itchiness around nose, little bumps around upper lip & face blotchy;
Developed  lump in left breast, diagnosed with breast cancer, surgery to be scheduled soon, along with any treatments afterwards
Began experiencing severe mid back and lower back pain on date indicated.  Was different and more intense then usual chronic back pain.  The pain continues without reasonable explanation.  I was contacted by Agency to report adverse event.
COVID-19; SORE ON REAR SIDE OF LEFT; SKIN BECAME DRY; STARTED TURNING DARK; FIRST VACCINATION MADE ARM SORE AT; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), SKIN ULCER (SORE ON REAR SIDE OF LEFT), DRY SKIN (SKIN BECAME DRY), SKIN DISCOLOURATION (STARTED TURNING DARK) and VACCINATION SITE PAIN (FIRST VACCINATION MADE ARM SORE AT) in a 70-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) unknown. In December 2021, the patient experienced COVID-19 (COVID-19), SKIN ULCER (SORE ON REAR SIDE OF LEFT), DRY SKIN (SKIN BECAME DRY), SKIN DISCOLOURATION (STARTED TURNING DARK) and VACCINATION SITE PAIN (FIRST VACCINATION MADE ARM SORE AT). At the time of the report, COVID-19 (COVID-19), SKIN ULCER (SORE ON REAR SIDE OF LEFT), DRY SKIN (SKIN BECAME DRY), SKIN DISCOLOURATION (STARTED TURNING DARK) and VACCINATION SITE PAIN (FIRST VACCINATION MADE ARM SORE AT) had resolved.        mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on an unknown date.       No information on concomitant medication were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for SKYRIZI(RISANKIZUMAB): The reporter's causality for the event(s) of SORE ON REAR SIDE OF LEFT LEG AND SKIN BECAME DRY AND STARTED TURNING DARK unknown onset, FIRST VACCINATION MADE ARM SORE AT INJECTION SIGHT, COVID-19, SORE ON REAR SIDE OF LEFT LEG AND SKIN BECAME DRY AND STARTED TURNING DARK unknown onset and SORE ON REAR SIDE OF LEFT LEG AND SKIN  BECAME DRY AND STARTED TURNING DARK unknown onset with SKYRIZI(RISANKIZUMAB) was no reasonable possibility. No treatment details were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
No additional AE reported; an expired dose of MMR-II was administered; diluted in sterile diluent (lot number: S005088, expiration date reported as 27-SEP-2021, but upon internal validation established as 31-DEC-2014; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 12-MAR-2021, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) (lot number: S006647, expiration date: 05-MAR-2021, also reported as 12-MAR-2021), 0.5 ml (route of administration was not provided) diluted in sterile diluent (lot number: S005088, expiration date reported as 27-SEP-2021, but upon internal validation established as 31-DEC-2014) (expired product administered). No adverse event was reported.
With 24 o vaccine - tired/aches that progressed  to muscle aches, nausea, sore throat, fever as of 5/8/2021 highest 103.8 averale tymp. that recponds  to Ibuprofen 800 mg - down to 101.5 - Fever Reoccurin with chills, appetite decrease. Chills, missed work due to symptoms. Temp. 116/78 PO=99& BMI 41 100.9F R 100 Rec: go to emergency room if does not R=18 73" improve in the next 48 - sooner with provider 316# fever over 101.8 due to No primary care
Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Severe, Systemic: Unable to Sleep-Severe, Additional Details: SEVERE SHOULDER AND NECK PAIN. SHE CAN'T LIFT OR ROTATE HER ARM. SHE CAN'T SLEEP DUE TO THE SEVERE PAIN. THE PAIN STARTED AROUND 4PM ON 7/10, ABOUT 24HRS AFTER THE INJECTION ON 7/9
6 pts who completed a series of Engerix-B inject in late 1991 were found to be non-responders when tested FEB92-MAR92;
A medical assistant reported VARlVAX was improperly stored and administered.; This spontaneous report was received from a medical assistant, referring to a 4-year-old patient of unknown gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not provided.   On 04-JAN-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), as prophylaxis (formulation, strength, dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot number T021824, which has been verified to be valid, expiration date reported and validated as 25-JUN-2022). The vaccine administered experienced a temperature excursion of 16.1 degrees Fahrenheit (product storage error), for a time frame of 1 hour and 45 minutes, as recorded by a data logger. There was no previous temperature excursion reported.     This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2101USA000916:Case number 01835180 US-009507513-2101USA000954:Case number 01835185
my back, my lower back has a stabbing pain in it; in my arm there is lumps now;  Like lump in my armpit near towards my breast tissue; also on my left 'wrist' and then in my arm there is lumps now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1), for COVID-19 immunization. The following information was reported: BACK PAIN (hospitalization), outcome "unknown", described as "my back, my lower back has a stabbing pain in it"; AXILLARY MASS (non-serious), outcome "unknown", described as "in my arm there is lumps now;  Like lump in my armpit near towards my breast tissue"; LIMB MASS (non-serious), outcome "unknown", described as "also on my left 'wrist' and then in my arm there is lumps now".  Clinical course: Patient was fine during the first dose, the patient had not side effects and then patient got the second dose and then patient experienced back lower back has stabbing pain. Patient had received second dose of the pfizer vaccine and patient back, and lower back has a stabbing pain in it now. Patient went to the hospital and further not clarified but patient was perfectly fine, before patient had not received any vaccine and they told to patient they don't know when it is gonna subside and then also on patient left 'wrist' and then in patient arm there is lumps now, they told that it should go away. Patient had an like armpit lump near towards patient breast tissue. Patient stated, she is perfectly healthy, there is really nothing wrong with her at all and has not been and then after patient got the vaccine and then patient back is having the worst pain ever. LOT#: Patient stated, "No, my vaccine card is in the car so I would have to go in the trunk and get it real quick." The patient had no received medications and any lab work. The patient had not received treatment. The patient had not received within 4 weeks prior to the vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
muscle spasms in neck and back , self treated after calling doctor. was told to take 200mg of benadryl and 80mg of pepcid, and 800mg of  ibuprofen.
According to patient 2 days after the shot he experienced rash. It begin one spot then after 2 weeks 10/19/10. He visited the pharmacy for OTC medication because the rash is all over the body. RPH suggestion BENADRYL/CLARITIN (po) and Hydrocortisone cream and visit MD if it get worse.
Patient reports starting the following morning, nausea vomiting, fever of 103 for 24 hours, headache, sore throat, aches, pains, arm sore for 4 days.
06:00PM BP 148/90, HR:107, SO@:97% 06:10PM BP 120/90, HR 64 06:22PM BP 100/90,  HR 80