chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial and follow up information has been received from a RN concerning a female pt (age not reported) who was vaccinated on an unspecified date (previously reported as approx Nov04) (route not reported) with a dose of pneumococcal 23v polysaccharide vaccine (lot648139/0009P). Subsequently, on 28Sep04 the pt developed an injection site reaction, including erythema, swelling, induration, local heat and pain. It was reported that the pt was treated with topical steroids and that she recovered from the injection site pain, redness and swelling on an unspecified date. Follow-up information has been received from the nurse indicating that "they never heard any information about this lot, and they were never advisied as to what they should do. A lot check has been requested. The records of testing prior to release of this lot have been checked by quality Assurance and foundt to be satisfactory. The lot complies with the standards of the center for Biologics Evaluation and Research and released. In addition, a review of the quality control Quarantine/Rejection system revealed that there were no open Quarantines registered against this lot/fill. It was also reorted that one additional patient experienced an adverse event following administration of PNEUMOVAX 23 (lot 645139/0005F)There was no product quality complaint involved. Additional information is not expected. It was also reported that one additional pt experienced an adverse events following administration of pneumococcal 23v polysaccharide vaccine (lot648139/0009P) (WAES0411USA02810).
Change to sense of smell. A smoke-like smell freuently occurs. For about 36 hours now.
Information has been received from a RN concerning an adult pt (age and gender unk) with unk pertinent medical history and unk drug reactions/allergies who, within the last week, in Feb 2006, was vaccinated IM with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot651320/1008P). In Feb 2006, the pt developed redness and swelling at the injection site. The pt's present status was reported as recovering. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
pt recv vax 10MAY96 & 31MAY96 pt exp a typical vesicular rash on face, trunk & extremities;
Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 1:22 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 1:22 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  On 27-Oct-2021, Excursion time was 10 AM, temp was 32, total doses given for the day was unkown, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 05-Oct-2021, vial was moved to clinic on 27-Oct-2021. 4 vial was moved to clinic. Vaccine BUD date was 04-Nov-2021.  Vial was stored on cooler 1 , on 27-Oct-2021, Excursion duration At 8 AM: 41, 9 AM: 29, 10 AM: 32, 11 AM: 43, 12 AM: 43, 1PM : 43, 2 PM : 46, 3 PM: 46, 4 PM: 46 and 5 PM: 45.  Vials only punctured right before administration  It was reported that 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.
11/22/22 I was at a wedding and two days later I got an upper respiratory infection. It got worse and turned into Asthmatic Bronchitis. I was given an inhaler and prednisone by a physician on 11/26/22. I saw my pulmonologist a week later. I had an X-ray of my lungs, which were hyper inflated, and was prescribed another inhaler and another round of prednisone. I was tested for COVID and FLU, both were negative. On 12/20/22 I still had symptoms and tested positive for COVID. I called my PCP and was prescribed PAXLOVID and ended up with a rebound case of COVID a week after I finished PAXLOVID.
History of similar reactions with each flu vac. and therefore she stopped taking flu vacs. 5 years ago. Developed nausea, lightheadedness, headache, and shortness of breath 14 min after vaccine. Vital signs stable on admission to observation area and heartrate regular with apical auscultation. Forty-five min after vaccine, began having some chest pressure and tingling in her arms. Her heart rate irregular at 68 bpm. Employee called her cardiologist who advised her go to the emergency room.  No history of angioedema.
02/21/22 presents to ED for  "progressive dyspnea, productive cough, pain with coughing/inspiration". PMHx of "DM2, chronic MSK pain"
Swelled. bruised, red, and sore at injection site. Took awhile to heal. Major reaction.
12/24/21 presents to ED for "shortness of breath and COVID test positive". PMHx of "asthma and HTN"
Initial information received from another manufacturer (service request number 1-6634173946) on 18 March 2013. The information was originally provided to the other manufacturer from a healthcare professional. A patient whose age, gender, medical history and concomitant medications were not reported, received a dose of were not reported) on an unspecified date. It was reported that the patient experienced a reaction to Rabies Vaccine. The laboratory detail and corrective medications were not reported. The patient's outcome was not reported. Documents held by sender: none.
pt recvd booster dose of a rabies vax in 1988 & a nodule is now present @ the inject site which will reportedly require outpatient surgery for removal;
9 days after my first shot I had COVID arm, and felt fatigue and brain fog. My hands and my scalp were also very sore at this time.
pt recv vax 11OCT95 & 14APR97 pt devel a varicella-like rash consisting of approx 30 lesions on front & back;the rash was non-pruritic;pt recovered from exp;
About an hour later she started experiencing itchy eyes-then red watery eyes and then they finally started to swell. After that she felt a pressure in her chest. At this point she went to the urgent care where they gave her BENADRYL. I spoke with her this morning 10-5 and she feels good. No problems are left over.
Patient is a 74 year old male with a history of afib who was admitted on 2/18/2021 with malaise, weakness, and poor appetite. Patient also reported a cough with mild shortness of breath. CRP was near normal but SCr was elevated above baseline likely due to dehydration. SCr trended down with IV fluids. Patient tested positive for COVID-19 on 2/15/2021. Steroids and remdesivir not indicated during admission. Patient discharged to home on 2/19/2021
VOMITTING, HEADACHE, FACIAL AND EXTREMITY NUMBNESS. PATIENT WAS HOSPITALIZED FOR 3 DAYS/2 NIGHTS PATIENT WAS GIVEN ANTICOAGULANT THERAPY AND PUT ON STROKE WATCH.
Roughly 48 hours after 2nd shot, numbness and pain in right arm, elbow and hand. I had carpal tunnel surgery in the 1990's and the symptoms were similar to those earlier, corrected problems. Dr  arranged for an appointment with Dr.  at Ortho-NY on 3/11/21. He arranged for an EMG to be completed on 3/16/21, followed by a second appt with Dr. on 3/23/21. He stated that there didn't seem to be any significant problems identified by the EMG, nothing correctable by surgery, and a Neurological appointment was made with Dr. on 4/20/21, who is setting up a MRI to further evaluate the continuing problems with right arm and hand.
Received primary dose on 2/17/2021 Booster dose given 3/3/2021 14 days after primary
Patient has been experienced sore arm since vacination date until now.  It has been more than 1 month, and patient still has the sore arm.  She was advised to take Tylenol and encouraged to see her primary care doctors.
Have diverticulosis-bleeding issue and had severe bleed that started on 2/24 and subsided on 2/25-26
To start, I had chicken pox as a child, 6 years old. On April 24, I had laser hair removal on my vagina - which I?m required to shave. The laser really gets into the skin, leaving it raw and open to infection.  I received my vaccine 5 days later.  I experienced chills, body aches for 2 days after, then the rash on vaginal area became extremely inflamed and red. I went to urgent care, doctor stated it did not look like genital herpes, but a skin infection.  The following morning, it was worst, so I went to medical facility, who swabbed it. Came back as HSV-2. A week later, i had blood work G and M, which showed no signs or Antibodies for HSV- 2.  I read an article that the vaccine is related to shingles activation.  From my understanding: A dermatome is the area of skin supplied by a particular nerve. The varicella zoster virus lies dormant in the cranial and spinal nerves. When the virus is reactivated, it travels along the affected nerves to the area of the skin served by those nerves, where it causes a distinctive, stripe-like rash. Which, was my vaginal area after intense laser.  Im also aware the the herpes zoster can be confused with gential, even in a culture that only test for hsv 1 and 2.
8:50AM- patient started exhibiting symptoms of anaphylaxis (difficulty swallowing, difficulty breathing, lip tingling and tenderness.  9:30AM- Benadryl was administered (25mg chewable POx1) 9:30AM vital signs: HR 115, RR 22, O2Sat 98% on room air, BP 123/95,  9:33AM- EMS arrived 9:34AM- Epi pen administered . Patient tolerated well, school nurse notified.   9:45AM- Breathing appears better, still having difficulty swallowing 9:45AM vital signs: HR 120, RR 22, O2sat 95% on room air, BP 132/74 9:53AM EMS administered 10mg dexamethasone IM left deltoid, tele monitor placed on patient
The vaccine was given in clinic on March 9, 2021. On March 14, 2021 she was found at home, unresponsive in her chair.  CPR was administered, 911 was called and she was brought to the ER and subsequently admitted to the PICU.  Brain death examinations were completed x 2 and she was pronounced dead on 3/17/2021
rash; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date in 2021 (Batch/Lot number was not reported) as dose 2, single  for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified for COVID-19 immunisation. The patient experienced rash on an unspecified date in 2021. The outcome of event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
12 hrs p/administration of vax had febrile seizure; had 2nd seizure @ 120PM following day;
Moderna COVID?19 Vaccine EUA - one week after administration, mild redness, swelling and itchiness at injection site, approx 3 inches in diameter.
Approximately 30 minutes after the vaccine, while driving home, my chest area started to feel very warm, then I started to have difficulty breathing.  I was unable to swallow for the first minute or so, then my upper and lower lip got numb. After I was able to swallow   my saliva tasted metallic and a mental fog settled in.  I had difficulty concentrating for the next 2-3 minutes.  All symptoms lasted for  about 5 minutes.  About a week later I developed a skin rash reminiscent to a "zoster."   It was the size of my palm on my left thigh. Although is almost clear now, the affected skin area lost some sensitivity. Another subcutaneous inflammation persist to present day.
ON 2/11/21, DEVELOPED PAIN ALL OVER THAT CAME AND WENT. FELT NAUSEOUS. BODY PAIN, JOINT PAIN, FATIGUE AND HEADACHE.
Neurology evaluation: Normal MRI/MRA. Temporal relationship of headaches to each vaccine administration with persistence after dose #4. A causal relationship between Anthrax and headaches could not be ruled out. Improved headaches but not resolved.
Minutes after receiving vaccine reported feeling "high," this lasted for approximately a half hour then reported he felt hung over and began to feel fatigued. Reported a severe migraine that lasted 3 days and has continued to experience a lingering and pulsating headache for over 6 days. Did not have these symptoms prior to receiving vaccine.
pressure in the eye; photophobia; blurred vision; pain and redness in the eyes; pain and redness in the eyes; This is a spontaneous report from a contactable consumer (patient). A 54-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Wednesday at around 3:40 PM (06Jan2021 15:40) at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient went to the eye doctor due to pressure in the eye, photophobia, blurred vision, pain and redness in the eyes in Jan2021. The events outcome was unknown. The patient reported they were not listed as a side effect of the vaccine but she was wondering if there were any reports related to this?  Information on the batch number has been requested.
MY HUSBAND HAS BEEN HAVING ITCHING IN THE TESTICLES SINCE HE GOT THE TWO DOSE COVID 19 VACCINE IN MAY OF 2021, HE JUST TOLD ME THAT THE ITCH IT'S BEEN GETTING WORSE, IT'S BEEN MORE THAT A WHOLE YEAR AND HE IS STILL SUFFERING, HE HAS BEEN GIVEN ANTIHISTAMINES BY HIS GP DOCTOR BUT HE HAS BEEN TRYING TO SEE A DERMATOLOGIST BECAUSE THE ITCHING IS GETTING WORSE.
skin intact-no rash observed 13NOV97 had gone to ER 11NOV97 w/gen red fine rash told it was rxn to vax;
Side of Head/face went numb.  About 20 minutes after the shot, I could feel an effect on my brain and a foggy sensation to my mental clarity settled in. About 30 minutes after the shot the Right side of my head went numb, from the top of the skull down into my cheek area, It lasted about an hour.  No other adverse effects were noticed.
2 year old received Boostrix in error; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 4M2EZ, expiry date 3rd June 2023) for prophylaxis.   On 31st January 2023, the patient received Boostrix. On 31st January 2023, unknown after receiving Boostrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 31-Jan-2023 Reporter's comment: The reporter called to get instructions on how to care for 2 years old recipient of Boostrix vaccine administered in error. No symptoms was reported. Provided medical information telephone number, transferred to medical information. Emergency room visit required. The reporter consented to follow-up via email. Additional supportive information: The patient received a dose of Boostrix at inappropriate age, which led to inappropriate age at vaccine administration.; Sender's Comments:  US-GSK-US2023015024:same reporter
Patient with history of COVID vaccines who admitted to hospital with COVID detected PCR. Provider d/c note does not mention COVID (asymptomatic).
I was diagnosed with Ulcerative Colitis/Rectosigmoiditis; This is a spontaneous report received from a contactable consumer (Patient). A 45-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0153), via an unspecified route of administration in the right arm on 19Apr2021 at 15:15 (at the age of 45-year-old) as dose 2, 0.3 ml single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8732), via an unspecified route of administration in the right arm on 22Mar2021 at 15:00 (at the age of 45-year-old) as dose 1, 0.3 ml single for COVID-19 immunization. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was reported that within 24-36 hours of his second dose on 19Apr2021, the patient developed diarrhea, multiple times per day, which worsened to include blood after several days. These symptoms, along with abdominal cramping and weight loss, continued until he was diagnosed with ulcerative colitis/rectosigmoiditis following a colonoscopy with biopsy on 08Jun2021. The patient had no prior history of GI (Gastrointestinal) symptoms or disease prior to second dose of this vaccine on 19Apr2021. The patient's treatment for the adverse event included screening for diagnosis and medication. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the event was as unknown.  Information on Lot/Batch number was available. Additional information has been requested.
The patient felt that her mouth and lips began to itch.  She reported her tongue as tingly.
This spontaneous report was received from a pharmacist refers to a 47 year old male patient with immunization. The patient's pertinent drug allergies, medical history and concomitant medications were not reported. On 04-JAN-2019, the patient was accidentally exposed to an unknown amount of M-M-R II route via topical for immunization(accidental exposure to product and exposure via skin contact). One week later, on 11-JAN-2019, 8 days after onset of therapy the patient developed an inflamed rash (rash and inflammation). The outcome of rash and inflammation was reported as not recovered. The patient had called his physician and sent pictures of the rash, but the treatment was known to have been provided yet. No other information is available.
The day after vaccine administered, I experienced severe fatigue and nausea, which was not unexpected. Two days later, I had a severe headache, especially above my right eye, which was not much reduced with pain reliever (Tylenol). The pain persisted and I saw my long time ophthalmologist on Friday, March 26.  He noted that pressure in my right eye was 44 (approximately 3x normal) and that my cornea in that eye was swollen.  Pressure and vision test for my left eye were normal. I was already taking Latanoprost eye drops, so I was told to continue that.  In addition, he added Brimonidine Tartrate drops and Timolol Laleate drops to my treatment.  I seemed to experience some fatigue after starting drops, which improved after a few days.  However, because Dr. office did not respond to questions I submitted to office about various issues, I decided to seek a second opinion. I first saw second Dr. (information provided above) on March 31.  He agreed with first Dr.'s diagnosis and generally with the treatment, but added a diuretic and substituted Rocklatan for the latanoprost drops I had been on. When I visited Dr., the pressure in my eye had reduced to 34.  I continue on the treatment schedule and do feel much improved.  I am next scheduled to see Dr. on April 27 for follow-up.  Both Drs. do not think the vaccine caused the cornea swelling.  Dr. stated that if it were the vaccine, it would have affected both eyes.  Nonetheless, I am concerned the trauma in my right eye may not be a coincidence.
generalized tonic-clonic seizure; frothing at mouth; twitching of limbs; temperature of 102.6 F  5/14/2008 MR received for DOS 3/19-21/2008 with D/C DX:  Febrile Seizure.  Pt presented to local ER after mother found infant making gurgling sounds, frothing at the mouth and limp and unresponsive. In ER infant had an episode of jerking which persisited ~30-40 minutes, initially unresponsive to Valium and Ativan.  Temp was 102.6'F. Seizing stopped as fosphenetoin started.  Transfered to current facility.  No further seizures.
more tired than usual/ completely wiped out/ experiencing some side effects like fatigue and joint pain; more achy/ experiencing some side effects like fatigue and joint pain; This is a spontaneous report received from a contactable consumer for a Pfizer sponsored program (159558). The reporter is the patient.  A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the right (upper) arm, administration date 26Mar2021 11:45 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Rheumatoid arthritis", start date: 1981 (ongoing), notes: normally has aches and pains daily; "lower legs swell" (ongoing), notes: not lymphedema; "poor circulation" (ongoing); "tired" (unspecified if ongoing). Family history included: "stroke" (unspecified if ongoing), notes: her mom died; "emphysema" (unspecified if ongoing), notes: her dad; "heart condition" (unspecified if ongoing), notes: her dad; "Diabetes" (unspecified if ongoing), notes: runs in her family. Concomitant medications included: ASPIRIN [ACETYLSALICYLIC ACID] taken for rheumatoid arthritis; Biologic (not further specified), taken for rheumatoid arthritis, start date: 2018, ongoing.  The following information was reported: The patient has had rheumatoid arthritis for over 30 years and has been more tired than usual and more achy. She stated that she normally has aches and pains daily due to rheumatoid arthritis. She had been doing pretty good before the vaccine shot. She got the shot on the 26Mar2021 (Lot number reported as ER8732 or CR8732). She felt okay on 27Mar2021 (Saturday). She was more tired toward the evening of 27Mar2021. The tiredness started around 16:00. The achiness was all day, but it seemed to intensify toward the evening. On 28Mar2021, she was completely wiped out. The patient mentioned that she was also experiencing some side effects like fatigue and joint pain. The events were reported as non-serious by the consumer. Therapeutic measures were not taken as a result of the events. The patient has not recovered from the events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After two hrs of getting vaccine pt complained of severe pain in arm from shoulder to elbow. Stated arm was swollen and red and very painful to the touch. Pt. was instructed by Dr. to apply cold compress a few times a day and to watch for fever, vomiting or cold chills and to c/b if this happens. After 48 hrs I called pt to see how he was and he stated arm felt better.