chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1 hour after vaccination client complained of dizziness, swelling of right hand. No general s/s of anaphylaxis noted.   Pt was given juice, crackers and asked to rest in recumbent position.  Symptoms did not improve and 12.5 mg of benadryl IM given in opposite arm of injection.  After 15 minutes same general symptoms present; another 12.5mg of benadryl IM given again in opposite arm of injection.  Pt remained lying down and 20 min after 2nd dose of benadryl patient reported feeling improved and able to ambulate independently. And monitored in her workplace without further intervention.
Pt recvd 4th dose of vax on 25AUG91 & devel achy joints, swelling, itching @ inject site; skin turned red w/swelling; 27AU91 arm still swollen, red area about the size of hand; rx meds;
This spontaneous report as received from a registered nurse referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M009378, expiration date 23-APR-2018 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of : >46 degrees Fahrenheit but < 77 degrees Fahrenheit for 2 hours 36 minutes according to the data logger. There were no previous excursions reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
Within 24 hours of administration of med., Mom noted redness and swelling, tender to touch. Benadryl applied. Swollen from deltoid to mid-forearm. erythema-deltoid-elbow.
rash; shingles; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   The patient's past medical history included anaphylactic reaction (anaphylactic reaction to azithromycin). Concurrent medical conditions included systemic antibacterial therapy (allergic to antibiotics), bee sting and poison ivy rash.   In September 2020, the patient received the 1st dose of Shingrix (intramuscular) and Influenza vaccine Quadrivalent 2020-2021 season. In September 2020, 1 day after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced shingles and rash. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the shingles and rash were recovered/resolved.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The patient received the 1st dose of Shingrix and an unspecified flu vaccine in September 2020 and about 1 to 2 days later he developed a possible shingles rash. Treatment included Benadryl and the rash has resolved.  The patient had a history of being allergic to antibiotics, bee stings, poison ivy, and had a prior anaphylactic reaction to azithromycin.
Woke up with extreme shaking, chilling and could barely move the arm I received the shot in. My entire upper body was extremely achy, from waist up to the base of my neck; across my shoulders and impacting both arms. I was experiencing these same symptoms through the day, sleeping mostly and was back to normal aside from slight soreness in my shot arm, the following morning. I have a high pain tolerance, and this pretty much took me down for almost 24+hrs.
pt recvd vax;vax was diluted w/ sterile water in oct90;
After 2nd dose: On 4/21/21:  shortness of breath On 4/32/21: shortness of breath, chest pain, leaning over chest pain Diagnosed with pericarditis from cardiologist treatment: Colchine for 30 days and ibuprofen for 10 days
This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 58-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (subcutaneous). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site swelling, injection site erythema and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter thought the patient was 58 years old. This case was reported by physician assistant (PA) via online chat. The PA reported that the patient received a dose of SHINGRIX subcutaneously instead of intramuscular route, which led to inappropriate route of vaccination. The vaccination took place in the reporter's clinic. The reporter asked for recommendation at that point of time. The reporter was at home at the reporting time and the patient just text her a picture of the injection site reaction erythema and minor swelling. The reporter found this 45 seconds before the reporting time. The lot number and expiration was not available. The healthcare professional did not provided in chat, but there was an address in system for him which matched the city and state he provided.
pt recvd vax;had very hard time breathing that pm;very white & pale;to MD;MD said asthma;URI;tx: amoxicillin,beclovent inhaler,proventil;
Started having chills at 9pm followed by nauseas.  At 3 am, was unable to sleep due to body aches, even laying down was hurting.  Body aches were very severe, unable to get out of bed or walk. Three days after the  roof of the mouth is very sore and looks purplish.
VACCINE WAS ADMINSTED 10/21/23 INTO DELTOID MUSCLE - THERE WAS SOME BLEEDING (A LITTLE MORE THAN USUALLY OBSERVED) AFTER ADMINISTRATION, AND A BANDAID AND COTTON BALL WERE PLACED ON SITE OF INJECTION, WHICH SEEMED TO HALT THE BLEEDING AT THE TIME. - PATIENT CALLED PHARMACY 10/22/23 AND REPORTED THAT ADDITIONAL BLEEDING OCCURED WHEN THEY RETURNED HOME, AS WELL AS BRUISING AT SITE OF INJECTION AND PAIN IN SHOULDER. PHARMACIST TOOK DOWN INCIDENT. PATIENT DID NOT STATE IF THEY WERE CURRENTLY TREATING THE PAIN WITH ANY MEDICATION / OTC ITEMS AND PATIENT DID NOT STATE BLEEDING WAS STILL OCCURING 10/22/2023 - PHARMACIST STATED TO PATIENT THAT A VAERS REPORT WILL BE FILED, AS WELL AS A SAFETY REPORT TO THE HEALTHCARE SYSTEM PHARMACY IS A PART OF.
Swelling at site, surrounding redness 3cm red indurated. 4.5 cm surrounding erythema subjective fever headache.
What has commonly become referred to as "CoVid Arm:" Roughly 3.5 inches diameter area at injection site that is swollen, bright red, itchy, sensitive (painful) to touch, and warm to the touch.  It had a distinct, sharp outline on days 1-3 between swollen, red area and normal skin.  Icing the site on Days 2 and 3 reduced itchiness and soreness a bit.  Sensitivity and its distinct outline has started to reduce today, Day 4. Accompanied by headaches, tiredness,  and slight lightheadedness on days 1 and 2 (though some of these effects may be the result of caffeine withdrawal, as I'd  resigned to just spend the days sleeping, and didn't drink my normal coffees).
Pt recv vax on 3/3/99; 20 min post vax pt exp sneezing, edema around eyes & mouth; tx=Benadryl, Epinephrine
Pts states that his arm was very sore the day after receiving vaccine. He states that it has improved a lot but still sore 5 days post vaccination. There is no redness/swelling. This is not unusual but I am reporting because patient brought it to my attention. I answered YES to Item 20 because the patient is recovering.
3" area around inj site red, hot, hard. PAIN IN RT. ARM - STILL THE SAME 3 DAYS AFTER INJ. ADM. ALTHOUGH SYMPTOMS REDUCED
I had fatigue, a cough, a low-grade fever, I used a home COVID-19 test, that came back positive. I called my doctor to discuss my positive test result and symptoms, he prescribed the Paxlovid that I was able to start taking it that day. Once I started taking the antiviral, within three days I was feeling better and have not felt bad since.
Itching in left arm bicep; fluid/inflamation of tissue around bicep Swelling remained for about 10 days after vaccination was administered.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the fourth dose of GARDASIL 9 for prophylaxis (lot#,expiry date, dose and route of administration were not reported). No adverse effects were reported. Additional information is not expected as the reporter did not wish to be contacted.
p/vax pt exp mild hives on stomach; flu-like symptoms; exhaustion; bump on wrist; & two red rings below center of chest; tx w/complete allergy medicine-symptoms resolved
Information has been received from a physician concerning a 13 year old female who was vaccinated with the first dose of GARDASIL, 0.5ml. Subsequently the patient experienced a shaking in her leg. After getting the second dose of GARDASIL 0.5ml the same experience occurred for almost 12 hours. The patient got checked for seizure activity however they did not diagnose her with that. The patient was hospitalized and the length of hospitalization was unknown. The patient did video EEG. At time of the report the patient was not  recovered. Follow-up information has been received from a nurse concerning the patient who received two doses of GARDASIL. The nurse reported that the patient had a grand mal seizure (previously reported as the patient was not diagnosed with seizure activity) and was hospitalized. At time of the report the outcome of the patient was unknown. The patient had follow-up appointment scheduled with the physician on 21-JAN-2009. Additional information has been requested.  1/27/09 Rec vaccine records which did not include Lot #s.  HPV #1 given 7/30/08; HPV #2 given 11/18/98.  1/27/09 Reviewed multiple hospital admit medical records: 12/15-12/16/2008 FINAL DX: status epilipticus Records reveal patient experienced seizure of approx 1 hour.  Preceeded by HA & LLL shaking which proceeded to seizure.  Pt w/history of seizures x 3 mo approx 2x/mo; rencently increased to daily & treated w/oral meds.  Continued w/seizures while hospitalized & transferred to higher level of care. PMH: abnormal EEG & seizure disorder x 3 mos prior to current hospitalization.  1/4/-1/5/2009 FINAL DX: partial complex seizures. Tonic-clonic seizure activity began LLE & progressed to RLL & UEs x 10 min.  Loaded w/antiseizure med, observed overnight & d/c to home  1/6-1/7/2009 FINAL DX: focal seizure disorder. Neuro consult done & patient transferred to higher level of care.  1/9-1/11/2009 FINAL DX: complex partial seizures Records reveal patient continued to experience seizures, metallic tast & HA.  W/U at university hospital was WNL , all meds d/c & suggested psych as underlying cause.  Neuro consult restarted antiseizure meds & referred to psych as well.  2/13/09 Received hospital medical records of 12/16-12/19/2008 & 1/7-1/8/2009. FINAL DX: nonepileptic spells; Pseudoseizures Records reveal patient experienced nonepileptic episodes.  Referred to Psych.
tonic/clonic seizure by mom's hx; family hx of seizures per MD;
Rash; real bad fever; real bad fever blister around mouth; eyes crusting over at night like mucus; it swells up at night real bad gets swollen and crusty; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6201), via an unspecified route of administration, administered in Left shoulder on 09Mar2021 14:45 (at the age of 63 year old) as dose 1, single for COVID-19 immunisation.  Medical history included ongoing meniere's disease from 2015, stroke from 08Jan2019 and Heart attack from 08Jan2021, cholesterol , diabetes mellitus from an unknown date. Patient had done heart valve replacement on an unspecified date. Concomitant medications included warfarin that been taking for 10 1/2 years as blood thinner for Heart valve replaced; pravastatin been taking for 10 years, for cholesterol; metformin for diabetes mellitus, physician just increased the dose last year, before he was taking 750 mg twice a day for 10 years; liraglutide (VICTOZA) been taking for about 5 years for diabetes mellitus; insulin glargine (BASAGLAR) been taking for about 3 years for diabetes mellitus; zaleplon (ZALEPLON) been taking for several years, probably 5 years for sleep aid; acetylsalicylic acid (BABY ASPIRIN) been taking for 2 years for preventive measure. Patient received vaccine on 09Mar2021 (Tuesday), and on 11Mar2021, he developed a rash, real bad fever blister around mouth, and eyes crusting over at night like mucus, and got swollen. He had been to his primary care doctor, dermatologist, and ophthalmologist. It was reported that no one knows what it might be and stated that the only thing that changed during this time was that he had received the COVID vaccine. Relevant tests included, on an unspecified date in Mar2021, skin biopsy, result found to be no skin cancer. Therapeutic measures included steroid eye drop with antibacterial for the event eyes crusting over at night, where at the time of report, it is not as bad, has gotten better. The outcome of the events it swells up at night real bad gets swollen and crusty was recovering and of other events was not recovered.  No follow up attempts are possible. No further information is expected.
Brother with Varicella 11/21/06. On 12/6/06 started with rash on hands, legs, abdomen, forehead, erythema pruritic, some scabbed over from scratching when seen 12/7/06 in office. Continued to get more over next few days. Mom states some blister.
hives, vertigo, dizziness,  knee pain, paralysis of knees down. severe stomach pain.
This is a 55 yo male who contacted his care team on 4/28/21 to report that following his covid vaccine (Moderna dose #2 on 4/24/21), he developed Afib (symptoms = palpitations).  Patient does have a history of Afib, diagnosed in 2011, last seen by cardiology in 2017.  Patient reports that he will have Afib episodes every few months, they last 6-10 hours (with palpitations), then he self-converts back.  In this current episode, it has been persistent.  He was advised to report to ED and f/u with his cardiologist.  No notes regarding an ED visit.  Cardiology visit took place on 5/5/21.  BP=134/90, HR=147, Ht=77in, wt=162.8kg; Labs wnl except chol=224, Trig=180, LDL=142.  EKG=Afib with RVR, rate 125bpm.  Patient was initiated on anticoagulation (apixaban) and completed a cardioversion and TEE on 5/13/21.  Patient was managed on diliazem and flecainide. On 5/18, patient called to report he was back in Afib, however he self converted within 24hr.  Although patient has a history of Afib and the vaccine is not a clear cause, I will report to VAERS as a potentially clinically significant event.
First given TDAP vaccine. Few minutes later, patient given GARDASIL 9 and MENACTRA. Pt immediately felt lightheaded, nausea, sweaty. Pt then collapsed to ground and few seconds later, pt woke up. Cool pack placed on neck, given fluids. Pt recovered well approx. 15-20 min. later.
Had fever, chills, body aches (similar to Pfizer first and second dose) for 48 hours. However, those are not the reasons for this report... the primary reason for this report is that I had extreme pain at the site of injection within hours of receiving the injection. The intense stabbing pain was so severe I could not move my arm for days. The pain would wake me at night. The pain would not go down to a zero in any position although Advil helped me go to sleep, but I could only sleep flat on my back.  Once the pain began to subside and movement was available to me (12/11/21) I realized there was also significant weakness (particularly with abduction and flexion).  Passive range of motion was available with painful end feels at near end of range; however, active range against gravity was not possible. While my arm has been very slowly improving I still have a dull nearly constant pain, significant weakness, and continue to be very limited in my activities of daily living. Treatment has included Advil as needed (primarily for sleep and during the first 2-3 days following injection) and active assisted range of motion in all planes within a painfree range using a warm bath with epsom salt for about 1 hour about 4-5x/week.
Patient called with complaints of muscle aches and pain and feeling completely wiped out. Also reported feeling cold, but no fevers.
Eczema 3 days later. Increased in severity as time went on. After 2 years it has gone down. Hearing loss the evening of vaccine. Hearing loss has not improved and has continued to get worse.
Day one after vaccine, red, swollen and tender about quarter size. Day 2 the area was more red and discolored and around the injection site looks like the skin was burn around it. Day 3 still tender but looks like a burn around the site
196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.; No adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse Event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse Event). At the time of the report, ACCIDENTAL UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.).    Concomitant products were not provided. Treatment medication were not reported.    Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Follow-up contains no new information
Patient experienced syncope shortly after vaccination. Patient fainted while  seated, quickly became alert and oriented. After 20 minutes the patient vomited and an ambulance was required as patient was not progressing. His color was mostly back but still seemed a bit confused and hesitant to respond. He did answer questions appropriately when asked.
Had what felt like shingles in S1 distribution with 1st Moderna vaccine (032H20A?) on 7 Jan (but never had shingles before and was fully vaccinated for shingles).  Sx peaked in 2 weeks and resolved days before 2nd vaccine.  No recurrence of neuropathic symptoms, but shortly after I developed morning stiffness and joint pain, mainly in my hands and feet which progressed to ankles, wrists, and other joints.  Later developed low back pain and worsening neck pain.  Symptoms progressed and persisted.  ANA seroconverted, so I went to Rheumatologist who started me on Celebrex.  Improved but never resolved and worsened again after stopping Celebrex.  Another rheumatologist diagnosed me with psoriatic arthritis.   I am a (Privacy), and am pretty certain this was a reaction to the COVID-19 vaccine, and I consistently reported these symptoms on smartphone based health tool.
Information has been received from a pharmacist referring to a 48 year old female patient. Information regarding concurrent conditions and medical history was not provided. On 26-SEP-2015 the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml ("regular dose/once"), lot # L016283, expiration date: 07-AUG-2016, subcutaneously (application site was not reported). Concomitant therapy was not reported. On 27-SEP-2015, the patient experienced that the injection site was swollen and hard, approximately "softball size". Patient sought medical attention by visiting pharmacist. The gramicidin, NEOSPORIN, BENADRYL and ibuprofen were given as treatment. The outcome of event was reported as not recovered/not resolved. The causality was not reported. Additional information has been requested.
Vaccine recipient  reported a itchy raised bump with  a crust on the injection site, hot to the touch.
Child began deep thirst and urination on January 10. Rushed to hospital on January 11th and subsequently diagnosed with Type 1 Diabetes.
At 9:10 AM - given Menactra LD. 9:11 AM, gave Bexsero RD. Patient slumped over in chair, lost consciousness x approximately 60 seconds. Awoke with a "jerk", asked what happened and said she had a terrible headache and nausea. BP was 129/78. 9:20 patient reported "feel ok except for HA." BP 109/63. Call on 9/20/19 - patient reports she is doing just fine.
I had the same reaction with the first dose on 12/27/20, and it resolved, I received the 2nd dose today and about 40 minutes after dose  I had some tingling in lips,  and then left sided facial pain, along cheek behind eye.  hurts to smile and use that side of face.  have taken a Benadryl  I haven't read about this as a side effect. With the first dose this did resolved after 24 hours
Swelling, redness, and soreness in area 4" x 3" just below injection site. Slowing getting better/swelling reducing.
Initial information received on 18-Jul-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 17 years old female patient who experienced extra dose of MENACTRA given to patient, while she received vaccine MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was reported that patient's last menstrual period was 09-Jul-2018 and patient not pregnant. Concomitant medications included HPV VACCINE for Immunisation; and BEXSERO for Immunisation. It was a case of actual medication error due to extra dose administered. It was unknown if any adverse event was occurred or not following the administration. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. The outcome was not applicable. Documents held by the sender: None.
elevated temp 2JUL92 103 cont w/temp thru Sunday 5JUL92 w/mom treating w/APAP & cool baths; 5JUL92 AM broke out in rash; 5JUL92 PM t105; carried to ER where MD told mom the illness was a reaction to MMR vax;
1/16/2021 PATIENT REPORTING RASH TO CHEST , NECK AND FACE AREA.  DOES NOT APPEAR  AS HIVES OR PETECHIAE. NO RESPIRATORY DISTRESS,FEVER, OR LIFE THREATENING SYMPTOMS. PATIENT RECEIVED VACCINE ON 12/29/2020 DUE TO TIMELINE,  DOES NOT PRESENT AS RELATED TO VACCINE ADMINISTRATION.