chrisvoncsefalvay/vaers-outcomes huggingface dataset:
6" diameter, redness, hardness, pain & warmth on L/deltoid & 2" redness & induration to lwr L/arm where #2 injection was given. Pt exercised heavily on 1/10 pm & applied ice to areas. Mom worried about how long rxn will last.
Fatique/fever/chills night of the day she was vaccinated ... lasted about 24 hours.
12 year old female patient got 1st Pfizer shot  on 12/4 @6:15 pm and in less than 15 minutes, while waiting in the waiting area, turned pale, started profusely vomiting, looked lethargic and eventually started sweating. Gave her water and paper towels. Paramedics were called and after assessment, was recommended by paramedics she be taken to ER since she was turning pale every time she stood up. She is currently at the ER so do not have any outcomes.
Information has been received from a health professional concerning a 15 month old female with no known drug allergies and no significant past medical history who on 23 MAR 2001 was vaccinated with MMR. Concomitant therapy included streptococcus pneumoniae vaccine and diphtheria toxoid, pertussis vaccine, tetanus toxoid. On 02 APR 2001 the patient presented with a rash described as raised, discreet, and erythematous. There were papules at the base and an area of pallor like a halo. The rash was itchy and dispersed all over. Unspecified medical attention was sought. No other information was available. It was reported that another patient (WAES # 01040913) had a similar experience. Additional information has been requested.
Foster parent reported rash beginning in AM 5/23/18 to face, neck and knee area.
06/16/2005 - Received call from Mom.  Child's arm is swollen, warm to touch, tender to touch.  Arm swelling extends to elbow.  Has full range of motion, no T, no drainage.  Told Mom Tylenol for discomfort and cold compresses.  Told Mom to call 06/17/2005 if worse, no phone call.  Spoke with Mom 06/26/2005.  She states arm is fine, returned to normal 06/18/2005.
Redness and swelling to L Deltoid area started 7/4/07 and have gotten worse on 7/5/07. Pt was seen by Dr and given Rx for Zyrtec.
Reporter indicated did not convert p/recvd a series of 3 Engerix-B vax; also that several pts innoculated did not convert either;
Received MMR, VZV, HAP 9/5/2012. Grandmom states "ran fever on the 9th and started breaking out on 10th that morning". Grandmom states "put aloe vera on it".
Injection site soreness for couple of days after the shot.  This returned about 10 days later and much less painful.  Redness, warm and a bit swollen.  A few days later, now, a bit itchy.
Deltoid muscle felt real sore where flu shot was given.  This soreness has continued until present.
MCV-4 vaccine given in clinic on 8/14/12. Injection site became swollen, reddened, & warm to touch by 8/16/12. Golf ball size.
This case was reported by a pharmacist via call center representative and described the occurrence of anaphylaxis in a female patient who received Flu Seasonal TIV Dresden for prophylaxis. On an unknown date, the patient received Flu trivalent vaccine at an unknown dose. On an unknown date, unknown after receiving Flu trivalent vaccine, the patient experienced anaphylaxis (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylaxis was unknown. It was unknown if the reporter considered the anaphylaxis to be related to Flu trivalent vaccine. Additional details were provided as follows: The age at vaccination was not reported. Approximately 6 to 7 years before the reporting date, the patient had an anaphylactic reaction after receipt of a flu vaccine. The vaccine was not given in pharmacist's facility. This case has been linked to the US2018GSK172895, reported by the same reporter.
Right hand swollen, numbness and tingling in hand, over night it continued to progress to elbow and shoulder. The next day she had bilateral knee swelling.
Fever chills body aches joint pain headache nausea  12 hrs after injections. Treating with otc pain relievers/ fever reducers.
certain reactions may take place longer than the 15 minute or 30 minute waiting period offered by the vaccination site.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE REACTION (non-serious), outcome "unknown", described as "certain reactions may take place longer than the 15 minute or 30 minute waiting period offered by the vaccination site.". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This was 2nd covid booster. Doctor recommend Moderna for 2nd covid booster. The first three vaccinations were Pfizer. There was no reaction for 15 minutes, but when leaving clinic and walking to the car I had extreme shortness breath with chest pressure, and minimal pain in upper left chest area. This extreme reaction continued for several hours, but took about three days to diminish. Currently, I have shortess of breath when climbing stairs and walking short distances. Most of the time I am unable to take a deep breath, and feel as if I cannot breath when in a confined area. At times the tingling pain is still in the upper left chest area, but goes away in a couple of hours
On 8/6/09, Pt was brought in by her mother.  Pt had a red & swollen arm.  L arm.  She had her immunizations on 8/4/09.
Fever of 100.8 chills body aches nausea loss of appetite and thirst
I received my second shot on 4/26/21.  On 4/27/21, I visited Dr.  to establish care.  My blood pressure recorded lower than normal at that visit(I usually have high blood pressure).  Dr.  ordered blood work.  The WBC,RBC & ABS neutrophil were low.  The numbers were in the normal range on 6/1/21.  Extreme fatigue began by 4/30.  My left arm began to swell by the week of May 3-9.  I was sleeping all day for 3 wks.  I had pain in left arm, shoulder, neck.  I've had tightness in my chest. On May 14, when I visited Dr. for a pap, she noted my fatigue as well. At my visit with  on 6/28/21, I requested an EKG.  It was abnormal, reporting sinus bradychardia. I will see a cardiologist soon.
Pulseless electrical activity, Cardiac arrest, possible PE event, pt spouse reported shortness of breath 3-4 days prior to incident with no recent illness per hospital report.
Itchiness at back of neck and wrists which then spread throughout entire body.  Warmness in ears/burning sensation.  Itchiness lead to hive like bumps and dermographia.  Symptoms flare whenever skin is agitated by anything stronger/denser than clothing .  Able to be managed by taking one antihistamine per day - currently Allegra 24 hour.  At date of report, dermographia is primary symptom even while taking antihistamine.
My ears started ringing last night and haven't stopped yet. It's just now been a little over 24 hours since I got the Booster. From what I read, it seems like this reaction is rather rare, but it does happen, so I thought you'd want to know.
Patient received the Pfizer third ("booster") vaccination on August 16, 2021, at @ 1:00 p.m.  The following morning the patient was too weak to walk without help.  The second day after the vaccination, August 16, 2021, the patient was admitted to the ICU.  Blood analysis showed that the patient's Hemoglobin had dropped to 4.6, requiring the immediate transfusion of three (3) units of blood, and a three day regimen of  IV Vasopressors for extremely low blood pressure.  Initially, treating doctors surmised that the Hemoglobin drop was caused by bleeding in the GI tract.  An endoscopy revealed that not to be the case.  No explanation for the drop in Hemoglobin or extremely low blood pressure has been found by treating physicians and other medical providers.  Patient was discharged on August 22, 2021.  Patient does not know if treating physicians or Primary MD has reported this incident as a possible side effect of the third ("booster") Pfizer vaccination.
Info has been received from a CMA concerning a 43 month old female pt with no allergies or pertinent medical history, who on 11/12/02 was vaccinated, SC in the right arm once with a 0.5mL dose of varicella virus vaccine live. Concomitant vaccine therapy included a dose of MMRII, in the left arm. On 6/11/05, the pt experienced 15 papules on the trunk, arms and back. It was reported that the adverse experience was improved after receiving Benadryl. It was reported that the pt recovered on 6/17/05. There was no product quality complaint reported. The pt sought unspecified medical attention. Additional info is not expected.
Initial mild discomfort near injection site on day of infection. Six days later rash and itching (Erythema) began left forearm  and began in right forearm the following week. Topical cortisone seemed to irritate skin so discontinued. Took Benadryl by mouth, which sometimes reduced severity of symptoms. Saw PCP on November 19, 2020. She prescribed 40 mg Prednisone once per day for five days. Decided to take initial dose of 10 mg. lips and mouth began swelling but ebbed after a few hours. Stopped Prednisone.
6 days after first shot left arm developed bright red  extremely itchy patch in a target shaped circle around injection site. Skin was hard and hot to the touch for 3 full days. Extremely EXHAUSTED the following week.
pneumonia; arm pain; tired; low grade fever; felt bad; This case was reported by a consumer via call center representative and described the occurrence of pneumonia in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th August 2019, the patient received the 1st dose of Shingrix. On 13th August 2019, 1 days after receiving Shingrix, the patient experienced pneumonia (serious criteria GSK medically significant), pain in arm and tiredness. In August 2019, the patient experienced low grade fever and feeling bad. The patient was treated with azithromycin (Z Pak). On an unknown date, the outcome of the pneumonia, pain in arm, tiredness and low grade fever were recovered/resolved and the outcome of the feeling bad was unknown.   It was unknown if the reporter considered the pneumonia, pain in arm, tiredness, low grade fever and feeling bad to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm. The patient experienced symptoms of arm pain, tiredness the day after receiving Shingrix. A few days later she noticed a low grade fever but could have had it prior to the time she actually took her temperature. The doctor prescribed a Zpac which she took but still felt bad a week later after receiving Shingrix and went back to the doctor who diagnosed pneumonia. The reporter consented to follow up.
Patient developed headache and neck pain for 4-5 days. Went to the ER, initially diagnosed with viral meningitis. Symptoms continued with also some confusion and lethargy.  Respiratory panel revealed patient Mycoplasma pneumoniae positive and MRI revealed picture consistent with (ADEM) Acute Disseminated Encephalo Myelitis.
Pt was given 2nd dose of Hep B series at 2:00pm 4-13-09 - At 5:00pm noticed a rash around belt line - progressed to entire body - He had also received an injection of his knee at an Ortho Specialty Clinic that same morning  at 10:30am - He received 3u MARCAINE and 2cc KENALOG and BETADINE cleaner and used prior to injection. Pt saw his Dr the next day - received PREDNISONE 10mg 2Xday X 7days - Was told to take BENADRYL as needed.
No adverse effects reported; The patient received her third dose of GARDASIL 9 on 03-MAY-2019 however she received the first two doses in March of 2018 and in May of 2018, respectively.; This spontaneous report was received from a nurse and refers to a 27 year old female patient. The patient's concurrent conditions, medical history, drug allergies/reactions and concomitant medications, if any, were not reported.    In March 2018, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route of administration, anatomical site of vaccination, lot number and expiration date were not reported) then in May 2018, with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route of administration, anatomical site of vaccination, lot number and expiration date were not reported) and on 03-MAY-2019 with the third dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 1 dose (route of administration and anatomical site of vaccination were not reported; lot number M037770, expiry date: 01-JUN-2019); all doses administered for prophylaxis (inappropriate schedule of product administration). No adverse effects reported.
Patient was administered a prefilled Covid-19 vaccine injection in L deltoid. Patient was monitored for 15 minutes following vaccine administration. Post injection the clinic soon realized the injection was empty without the vaccine present. The "prefilled' Johnson and Johnson vaccine was pulled back to 0.5 ml and individually packed and appeared to be a single use vaccine.  The patient was called and notified via phone call of the situation and that the patient unintentionally did not receive COVID-19 immunization. Advised patient to FU for any questions or concerns. Health department was notified. Patient was understanding and denies any acute concerns.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: HIVES -Mild, Additional Details: SOME HIVES ON RIGHT LITTLE FINGER AND WRIST, LEFT WRIST AND HAND, ALSO BACK
arm greatly discolored (purple black);size of silver dollar w/hard care in middle (size of a quarter);disorientated;improved orientation;discoloration persist;
Immediate onset of pain and burning to left upper arm. Burning sensation went away within 24 hours. Pain has continued for greater than 90+ days at the time of report submission requiring the daily administration of oral NSAIDs to control pain. Pain continues regardless of use/rest. Seen by clinic staff twice via appointment without resolution of symptoms.
Joint soreness in ankles, feet, knees and hips, inability to move. Persists to this day.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2021 as dose 1, single (Lot number: ER8737), in right arm, on 26Apr2021 as dose 2, single (Lot number: EW0172), in right arm and on 01Nov2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 53 years, in right arm for Covid-19 immunisation. The patient's relevant medical history included: "Anxiety/depression" (unspecified if ongoing); "Anxiety/depression" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE; TRAZODONE; CIMETIDINE; CETIRIZINE; FINASTERIDE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID infection"; PULMONARY CONGESTION (medically significant) with onset 27May2022, outcome "unknown", described as "congestion in lungs"; PYREXIA (non-serious) with onset 27May2022, outcome "unknown", described as "fever"; HEADACHE (non-serious) with onset 27May2022, outcome "unknown". Therapeutic measures were taken as a result of vaccination failure, Covid-19. Patient did receive the vaccine. Patient received treatment for COVID-19 as Paxlovid from 28May2022 to 01Jun2022. Adverse event Rebound COVID infection after taking Paxlovid and having symptoms disappear; initial COVID infection manifested as chest cold (congestion in lungs, fever, headache) on 27May, and rebound infection is manifesting as head cold (sneezing, sinus congestion) starting 08Jun. No follow-up attempts are possible. No further information is expected.
Received vaccine on 12/15 at Clinic. Noted on 12/16 that she had a sore arm and a bit of a headache, this was an expected reaction as the pt had similar with the first two doses. Upon waking on 12/17 she noted significant weakness in bilateral lower extremities.  Describes herself as "Bambi" when she tries to stand/walk as her legs are very weak and wobbly.  Pt has continue with LE weakness and been unsteady on her feet since, little to no improvement noted.  Pt did lose balance and lean into wall on 12/26, resulting in slide/fall to floor.  Reports no injuries were sustained.  Pt had went to see PCP on 12/20 related to LE weakness.  Discussed recent vaccination and history of MS.  Pt reports discussion with MD as possible vaccine adverse event vs MS flare up vs MS triggered flare up by vaccine.  Received 3 day treatment of solumedrole with little to no improvement noted since.
Significant increase in volume of tinnitus causing a loss of ability to hear other sounds. The volume is almost unbearable.
Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) 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 dosage form. On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Pain, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Pain in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's medical history was not provided. No relevant concomitant medications were reported. he had been having problems with his arm hurting every day. The pain was  greater in the morning and seems to improved  but not resolved by the evenings. He also noted that his pain was  worse with lying down.
I'm not sure I'd describe this as adverse (in the sense that I did not require medical intervention, or haven't so far), but it was odd enough I thought to report it. My (male) partner and I just had my our second doses at 2PM today (it is 4:38PM as I write this). After receiving both the first and second vaccinations, I experienced what I can only describe as -- and pardon my phrasing here -- being as high as absolute balls. Like, just-ate-a-marijuana-edible high, only I had not used any marijuana in the 24 hours leading up to the event. I have used my electronic cigarette, but sparingly (those J&J lung blood clot stories were freaking me out), and while I am indeed on both Suboxone and Alprazolam, Suboxone does not produce a mental/physical high, especially in opiate-tolerant patients such as myself. Similarly, I took a much smaller dose of Alprazolam (about .25mg) which is less than 1/4 my prescribed dose, and I've been on anxiety meds for years -- suffice it to say that I was not "already high" upon arrival at the vaccine site.  What I experienced included a very strange sort of euphoria and brain fog. It was more pronounced after the first vaccine, but definitely noticeable this second time as well. Both times, my partner was entirely unaffected, which was great, because the effect was strong enough that I'm not confident I could have driven in that state. It is finally wearing off as I write this, but other female friends have reported similar experiences with the Pfizer vaccine, and since the J&J issues seem to affect women only, it may be worth further researching the effect of these vaccines on young females. I am also fairly petite (5'2, about 110 pounds currently) so that may play into it as well. Just wanted to give you all a heads up! I feel fine, but some ladies may need a "designated driver" for this vaccine, haha.
sore at site of injection; had a knot there where it was given; This is a spontaneous report from a contactable consumer (patient). This 67-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on unknown date in Dec2020 at single dose for COVID-19 immunisation.  The patient medical history and the concomitant medications were not reported.  The patient received vaccine last Wednesday, didn't have any side effects.  It was sore at site of injection. Same day, it had a knot there where it was given.  The outcome was unknown.    Information on the lot/ batch number has been requested.
Provider summary: "75-year-old male history chronic obstructive pulmonary disease, tobacco use, CAD, PVD, HTN, HLD, hypothyroidism, and trigeminal neuralgia who presented to the ER on 06/17 for short of breath and weakness.  Of note, recent hospitalization 6/9/22-6/13/22 for urologic procedure to remove left duplicate ureter as this was causing frequent infections.  Procedure was aborted due to difficulty in dissection.  He was discharged in stable condition but upon returning to the ER this time his HGB was 7.2 and given symptoms he was provided 1 unit PRBC.  He did not show any evidence of reduced UOP or gross hematuria and takes ASA/clopidogrel for fem-pop bypass on 03/2022.  CT abdomen/pelvis showed left renal hematoma.  He was hemodynamically stable and antiplatelets were continued given their indication and Urology recommended observation.  His hemoglobin began to trend up the next day and repeat CT scan showed stability hematoma.  Patient was okay for discharge and will follow-up with urology as there are plans for tertiary center evaluation for his GU issues.  No complications during stay.   COVID-19 -positive 6/10/22, vaccinated, asymptomatic, 10 day quarantine from positive test, normoxic, not antiviral candidate"
Hypotonic-hyporesponsive episode >10 min on 2/3/14 requiring ER evaluation and hospitalization.
In January, diagnosed with increased right tricuspid valve regurgitation during a routine scan. It was previously minimal leakage, in January it was described as moderate. No treatment needed, no symptoms.
all around his eye- swollen puffy and corner is very red ("like a bruise"); all around his eye- swollen puffy and corner is very red ("like a bruise"); This is a spontaneous report from a contactable consumer (patient's spouse). A male patient of an unspecified age (reported as "85", unknown unit) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration from 12Jan2021 at a single dose for COVID-19 immunization.  The patient medical history was not reported.  The patient experienced all around his eye- swollen puffy and corner is very red ("like a bruise") on an unspecified date in Jan2021. Outcome of the events was unknown. Patient was taking a blood-thinner and reporter was asking if it was causing the event.  Information about lot/batch number has been requested.
ACUTE NON ST ELEVATION MI 9/17/2022 -- RECURRENCE OF SAME SYMPTOMS
RESTING HEARTRATE IS USUALLY 70 BPM AS OBTAINED FROM MY SPORTS WATCH.  RESTING RATE WENT DOWN TO 40 BPM.  WENT TO CARDIOLOGIST AND IT WAS DETERMINED THAT THERE IS ACTUALLY AN EXCESS BEAT AND THE HEART IS NOT BEATING IN A NORMAL RHYTHM.  I AM CURRENTLY BEING TREATED BY A CARDIOLOGIST THAT SPECIALIZES IN THE HEART RHYTHM/
Serum sickness, arthralgia/fever 5/3/06 Review of 16-page discharge summary indicates final diagnosis of serum sickness.  Additional symptom of polyarthralgia was noted. Sent home on Avapro, Bactrim, and prednisone along with routine meds.