chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt came to the pharmacy angry because she thought that we gave her the wrong vaccine. The pharmacist had followed all the correct process and given the correct vaccine to the patient on 08/30/2023. Per the pharmacy manager, Pt has cellulitis just under the location where the vaccine was administered. Pt had gotten both these vaccines in the same left arm and the pharmacist had separated two vaccines by 1 inch. Rx manager referred her to go see her provider.
I had a flu shot in my right arm. I did notice that it was higher up then when I got them in the past. The next day is when I started getting sharp pain in the shoulder and down my arm. This happened on October 31st and I've been suffering ever since. My primary care Dr referred me to an orthopedic Dr  on Nov. 13th. He didn't do any tests since he was convinced it was due to the flu shot. He told me to take 4 Ibuprofons a day, get therapy and come back on December 4th. (Two days from now) I never took pain pills due to a history of stomach sensitivity but I had to this time due to the terrible pain. I've had to use my left hand to do  things like wiping off a table etc.
died as a result of the Pfizer BioNTech Covid-19 vaccine; This is a spontaneous report from a contactable consumer received from a Pfizer sponsored program. A 39-year-old male patient (consumer neighbor's son) received BNT162B2 (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at an unspecified age) as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient died as a result of the Pfizer BioNTech Covid-19 vaccine on an unspecified date. It was not reported if an autopsy was performed.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: died as a result of the Pfizer BioNTech Covid-19 vaccine
Flare of plantar fasciitis; Inflammatory arthritis; shingles-like symptoms; 6 stomach ulcers; acute nerve pain in the head and neck; lost 39 pounds; Multisystem inflammatory response; shingles-like pain; This is a spontaneous report from a Non-contactable consumer reported for himself. A 71-year-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot Number: EW0169) via an unspecified route of administration in arm left on 28Apr2021 as dose 2, single (age at vaccination: 71 years) for COVID-19 immunisation. Medical history included heart attack from 2008 to an unknown date, GERD from an unknown date and unknown if ongoing, barrett's esophagus from an unknown date and unknown if ongoing. Concomitant medications included nebivolol hydrochloride (BISTOLIC); atorvastatin (ATORVASTATIN), lipidigril, taken for an unspecified indication, start and stop date were not reported. Historical vaccine includes bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot Number: ew0151) via an unspecified route of administration in arm left on 07Apr2021 as dose 1, single (age at vaccination: 71 years) for COVID-19 immunisation. No other vaccine in four weeks. No covid prior vaccination and did not tested COVID post vaccination. No known allergies. On an unknown date May2021, the patient experienced multisystem inflammatory response. Flare of plantar fasciitis followed by inflammatory arthritis. Within two weeks experiencing shingles-like symptoms without the rash, developed 6 stomach ulcers, and acute nerve pain in the head and neck. No previous symptoms or complaints. As of 19Aug2021 patient has lost 39 pounds, presented at the emergency room 4 times, been hospitalized for 4 days, and is still experiencing shingles-like pain, and complications with ulcers. The adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization. No of days hospitalization was 4 days. Treatment was received, medication to manage symptoms. The clinical outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
DAY AFTER VAX (9/26) ADMINISTRATION PT DEVELOPED SORENESS IN UNDERARM, INJECTION SITE AND NECK. ATTRIBUTED TO NORMAL SIDE EFFECTS AS DESCRIBED IN MANUFACTURER'S INFORMATION. 9/27 DEVELOPED WHEALS. URTICARIAL RASH ON BODY. NO OTHER KNOWN SUBSTANCE THAT WE COULD ATTRIBUTE THE RASH TO.
Severe abdominal pain felt feverish, but normal temp Woke about 4 hours later, covered in sweat.
Fever 104 Taken to Pediatrician, lungs clear no other symptoms, no redness or swelling at injection site
Information has been received from a physician concerning a 16 year old female patient who was vaccinated with two doses GARDASIL. Subsequently the patient may be experiencing irregular menstrual cycles. At the time of this report, the outcome was unknown. The patient sought medical attention via telephone. No further information is available.
Got the vaccine, went home and got home around 3:00, and all of a sudden she was extremely cold, put another blanket on, and got a heating pad and put it on her feet.  She was lying in bed, her heart was hurting to the point that she could not move it.  Around 8:00 she put the electric blanket on, got warm but she would still get a cold chill like she had ice water in her veins.  Was this way all night.  She had a fever, the swelling on her arm.  She did not throw up but just the chills, fever.  She tossed and turned all night until about 3:30 this morning. She then took 1/2 of  Tylenol, dozed off.  She is still cold, not as cold as she was.  The arm is also still sore.
Cough; Shortness of breath (except at rest); Fever; Chills; Weakness; Tiredness; Pain in vaccinated arm; Red blotches/soreness on front of upper arm and shoulder; Red blotches/soreness on front of upper arm and shoulder; Red blotches/soreness on front of upper arm and shoulder; Dizziness; This is a spontaneous report from a contactable consumer (patient).  A 67-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number EN6203), via an unspecified route of administration, in Left arm on 07Mar2021 05:00 PM (at the of 67 years old) as dose 2, single for COVID-19 immunization. Medical history included cancer survivor with ongoing maintenance. Concomitant medications included trastuzumab (HERCEPTIN), carvedilol (CARVEDILOL), valsartan (VALSARTAN) taken in two weeks. Patient had no known allergies. Patient was not tested positive for COVID post vaccination and patient not had COVID prior vaccination. patient had not received any other vaccine in four weeks. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number EL9266), via an unspecified route of administration, in Left arm on 14Feb2021 05:15 PM as dose 1, single for COVID-19 immunization. On 08Mar2021 07:00 AM the patient experienced Fever, chills, weakness, tiredness, pain in vaccinated arm with red blotches/soreness on front of upper arm and shoulder, cough, shortness of breath (except at rest), dizziness. Patient had not received any treatment for events. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
Firm, warm, erythemic area of induration 13 x 10 cm right anterlateral thigh. Nontender, afebrile, full weight bearing, full range of motion.
Hives; Injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (Hives) and VACCINATION SITE ERYTHEMA (Injection site redness) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE URTICARIA (Hives) and VACCINATION SITE ERYTHEMA (Injection site redness). At the time of the report, VACCINATION SITE URTICARIA (Hives) and VACCINATION SITE ERYTHEMA (Injection site redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       She is wondering if she can take the 2nd dose due on 22Apr21. she talk to a pharmacist who advice her to take dexamethasone. She consented to be followed up by the safety department. Concomitant medications were not reported. Treatment details include dexamethasone.
Bruising where vaccine was administered; Swelling where vaccine was administered; A spontaneous report was received from a consumer, regarding herself, afemale patient of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swelling and bruising where the vaccine was administered.   The patient's medical history was not provided. Concomitant medications were not reported.     On 23-Dec-2020, approximately 9 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 01-Jan-2021, the patient developed swelling and bruising around the area where the vaccine was administered. No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not reported.   The outcome of the events, swelling and bruising where vaccine was administered were not reported.; Reporter's Comments: This case concerns a female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the non-serious listed event of Injection site swelling and the non-serious unlisted event of Injection site bruising.  The events occurred 10 days after the first dose of vaccine. Based on the current available information and temporal association between the use of the product and the onset of events after vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Vaccine received at 1:00pm 7:00pm - weird electric/struck by lightning pins and needles feeling in body  8:00pm- severe uncontrollable/involuntary shaking, unlike flu or anything else before  10:00 pm - 103.2 fever until 5:00pm following day  Extreme headaches all night, pounding unable to sleep  Extreme body aches 10:00pm-6:00pm following day
Information has been received from a medical assistant concerning another medical assistant who was administering Gardasil (lot#655154/1210U) to a patient, and upon removal of the needle from the patient's arm, the shield did not work properly to cover the needle and the medical assistant was stuck with the needle in her finger.  No adverse reactions were reported.  No other information was provided.  SR# is 1-2021175912.
4.8.21 4pm. Feeling tired and irritable.  530pm. Muscle aches in back and chest. Headache, no appetite. Took 2 Advil. 9pm. Very achy and suffering from chills. Teeth chattering.  130am 4/9/21. Woke up in confusion.  Couldn't find bathroom in my bedroom. Stood for a long time trying to figure out what to do. Found bathroom. Sweating profusely and took 2 more Advil. 4/9/21 7am tired and a little achy. Fever of 99.5.  By 1130am fell into bed bed freezing and exhausted. Slept until 4pm. Woke up felt 80% better. Totally back to normal self by 4/10/21. Arm soreness did not start until 4/10.
7 days and after Vaccination #2 Pfizer previously healthy patient had sudden onset of severe vertigo that woke him up from his sleep at 2 am. No associated fever, chills, diarrhea, cough. Associated with nausea and emesis x1 and inability walk.  This was not associated with head movement. This lasted 2 -3 hours and he went to sleep and woke with minimal residual. No other associated sick contacts, no Past Medical History, no medications, no allergies, no surgeries,. He hydrates well and is in excellent shape. He cross-trains with multiple circuit conditioning.
Only on the booster dose. Rash under breast and around neck. Benadryl was taken. Given prescription of Hydroxyzine HCL 25mg to be taken by mouth every 6 hours. I only took them for 2 days. The rash went away.
After the vaccination, my arm was sore but I expected this.  Two days after the vaccination, there was swelling around the injection site and the arm continued to be sore.  Three days after the vaccination, the swelling around the injection site worsened, so I went back to the clinic.  The doctor on duty identified it as a staph infection and prescribed Azithromycin.  He told me to take two immediately, then continue to take 1 per day for 6 days.  The arm continued to ache for about a week.
This is a spontaneous report from a non-contactable other HCP. This 45-year-old female other HCP (patient) reported for herself that:A 45-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EL1284), via an unspecified route of administration, administered in left arm as dose 2, single on 20Jan2021 (at the age of 45-year-old) for covid-19 immunisation at hospital. The patient medical history was not reported. Patient had no known allergies. There were no concomitant medications. Historical vaccine included patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EL3302), via an unspecified route of administration, administered in left arm as dose 1, single on 30Dec2020 (at the age of 45-year-old) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and received no other medications within 2 weeks of vaccination. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On unspecified date in Mar2021, two months after her second dose she noticed a swelling in her neck at first it was thought to be just sinus drainage but after a few weeks it just seem to get worse. When she went to PCP there was a mass on her thyroid on unspecified date in Mar2021. Since she had no prior history of any issues and since it seems to have grown in a matter of months it seems as those the two were related. The mass was biopsied and non-cancerous. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included biopsy: unknown results and thyroid function test: The mass was biopsied and non-cancerous. Therapeutic measures were taken as a result of adverse events as thyroid ultrasound and biopsy. At the time of this report, the outcome of events was recovered with lasting effects on unspecified date in 2021. No follow-up attempts are possible. No further information is expected.
rash in her arms now it's worse; itching; This is a spontaneous report form a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 28Jul2021, as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, about a week or a week and a half after the first dose of vaccine, the patient experienced itching; and rash in her arms now it was worse, which got spread to the rest of her body and legs from one to the other. Patient was scheduled for the second dose on an unknown dated however she cancelled her appointment because she was experiencing side effects. Patient enquired whether her side effects got something to do with the vaccine. Patient enquired about what must be done to stop the event. It was reported that, at the time of first dose, patient had not taken steroids and cortisones but because of the rash patient had to put on some because it was itching. The patient was concerned about the events. The clinical outcome of all the events was unknown.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow-up.
Developed  shortness of breath two weeks after second vaccine in March 2021. Diagnosed with pneumonia on 5/28/21. Severe chest and back pain. No cough, no fever. 100% healthy prior to vaccine.  For 3 days after second vaccine developed swollen arm, high fever 103.5. Then 2 weeks later SOB.
During morning shower noted drainage (serous) on bandage. Removed bandage and noted loss of epidermis - about 1 cm  in size. Evaluated in clinic. Applied dry sterile dressing. Advised patient to follow up with PCP if any questions.
Case number PHEH2014US026182, is an initial spontaneous report from a pharmacist received on 31 Dec 2014. This report refers to a 60-year-old male patient. Medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 145021) intramuscularly on 30 Sep 2014. On the same day, the patient experienced soreness of arm at the injection site. The patient consulted the physician and the site appeared fine. Final outcome of the event was unknown. Seriousness and causality of the event was not reported.
Patient stated her arm is sore and still could not lift up since vaccination. her doctor is ordering ultrasound to check out. Patient will notify pharmacy after getting result back.
Patient began heavy menstrual bleeding (apart from her regular menstrual cycle) after first vaccine dose. Heavy bleeding continued for five days and total bleeding for 10 days.
Current dose: Cellulitis (impressive) L upper arm. No fever. Not feeling ill. Starting Augmentin.  Dose one month and one day earlier than this dose. Similar pinkness, time of onset, pain, and rate of progression. Allergy unlikely. Large bruise was present which made family not seek diagnosis, but in hind sight, the early symptoms were identical to those of this infection. I am concerned that there may have been infection present in BOTH doses and that there may be a public health concern with possibly contaminated doses of vaccine causing infection with TWO doses.
"During the flu line on Saturday morning, I received the flu shot in my left arm. It burned more than usual going in.  The pain in my left arm worsened over the next several days to the point of it feeling injured by someone yanking my arm out of place. I was on a cruise the week of 12 Oct and since I was unable to make contact with your office before departing (12th was Columbus Day), I decided to continue to monitor my arm for symptoms during my vacation in the hope it would resolve on its own.  For the first 2 weeks afterward, I hard time with basic arm motions (lifting, reaching, getting dressed) and at times it hurt to just move.  There were also several nights where I experienced pain when laying on my side, the most extreme pain occurring on the 18th. I went to my chiropractor on the 20th for a routine back adjustment and he said he sees this happen every year.  He suspects the shot went directly into a nerve in my upper arm.  He did some work on it yesterday and it feels better, although I'm still experiencing some symptoms.  He said it typically takes 4-6 weeks for everything to be back to normal when this happens."
around 130Pm on 21OCT98 pt was awaken from nap;mom notice jerking & twitching movements of all extremities;mom stated that it lasted approx 3min & then woke up w/o any further events;
About 1 minute after vaccination, the patient fainted briefly while waiting in the post-vaccination waiting area.  No further medical attention was needed other than basic first-aid.
I experienced numbness in both feet, in addition to the typical soreness in my arm. The degree of numbness was relatively severe. I took some Advil during the first few days after the vaccine shot but the numbness did not subside.  The numbness lasted for about two weeks.
LEG TWITCHING IN CALF; BODY ACHE; VENOUS REFLUX (SWOLLEN AND PAINFUL CALF / FOOT PAIN); BACK PAIN; CLAVICLE PAIN; NECK PAIN; HEADACHE; TINGLING FEET; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On APR-2021, the subject experienced tingling feet. On 22-APR-2021, the subject experienced leg twitching in calf. On 22-APR-2021, the subject experienced body ache. On 22-APR-2021, the subject experienced venous reflux (swollen and painful calf / foot pain). On 22-APR-2021, the subject experienced back pain. On 22-APR-2021, the subject experienced clavicle pain. On 22-APR-2021, the subject experienced neck pain. On 22-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from leg twitching in calf, headache, body ache, venous reflux (swollen and painful calf / foot pain), back pain, clavicle pain, and neck pain, and the outcome of tingling feet was not reported. This report was non-serious.
Quick Nursing Assessment at the Scene:  Patient sitting in chair, reports heart palpitations, SOB, dizziness, flushing, blurry visions right after COVID-19 booster. Alert and oriented x3. Able to answer questions appropriately without respiratory distress. Tolerating fluid. Symptoms improved with resting.    Patient Disposition: Reassessed patient every 10 minutes.  Symptoms continued to improve. Vital signs stable. Denies CP, SOB, nausea, dizziness, or difficulty with balance. . Member verbalizes understanding to follow up with PCP if symptoms persists or reoccur. Denies any symptoms at discharge. Member advised to call Clinical Contact Center/Advice for any symptoms or questions.
24 hour injections - developed red, warm, swollen area to upper L thigh.  DTaP #5 (site)?  BENADRYL prn cool compresses.
Headache, Myalgia, Arthralgia, FEVER, CHILLS, PAIN AT INJECTION SITE Narrative:  Other Relevant History:
have not received their 2nd dose due to COVID; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (first dose of shingrix received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were reported as follows: The pharmacist stated that the patients who received the first dose of Shingrix, but did not received second dose due to covid. Inquired for can the dose be administered now. Age at vaccination was not reported. Consented follow up. No exact amounts of patients nor demographics was available at the time of call.