chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE; patient was administered the first dose of the primary series of PEDVAX HIB on 16MAR2022 and the second dose on 02MAY2022; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 16-MAR-2022, the patient was vaccinated with the first dose of primary series of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (exact dose, formulation, strength, lot #, expiration date, site and route of administration were not provided) for prophylaxis. On 02-MAY-2022, the patient was vaccinated with the second dose (inappropriate schedule of product administration) of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 ml, lot #: U014992, expiration date: 29-OCT-2023 (formulation, strength, site and route of administration were not provided) for prophylaxis. There was no additional adverse event reported.
pt exp chills, fever, soreness in throat, some diff breathing, elevated temp & h/a;sx cont 20hr later w/x/to temp now nl;
approx 20-25 mins p/vax pt got weak, hot, nausea had to leave work & go home
Moderna COVID-19 Vaccine EUA  All of the reactions occurred roughly 20-30 minutes after receiving vaccine  Both arms numb from shoulder down. Lasted for about 6 hrs Neck muscle sore/strained feeling. Lasted for most of the day Slight loss of smell. This lasted about 36 hrs  Nose became numb. This lasted about 36 hrs as well Vertigo/dizziness. Lasted about 20 minutes Tiredness. I took a 2 hr nap and was not tired afterwards. FYI its not normal for me to take naps at all.  Arm at injection site very sore and weak for about 3 days after
when I awoke the next morning, I had extreme fatigue, a headache, and my arm had a rash at the vax site.  It's still there.  It's itchy and red and like a hard lump.  Also, it's warm compared to the surrounding skin.  Makes my arm hurt.  The fatigue and headache were pretty much exactly like when I had COVID-19 in November last year.  I was instructed to get the booster because I work in a healthcare setting.
5 days after having the vaccine, I had a nocturnal grand mal seizure, I had a very stressful day the day before the seizure happened.  I was also sleep deprived (approx. 2 hours of sleep. I taught school and private music lessons for 6.5 hours, but came home with a headache, nausea, and felt very unwell. I'm sure I was also dehydrated.  I went to bed early (approx. 8pm) without dinner and woke up around 3am.  Then I got back to sleep and had the grand mal seizure in my sleep around 6am.  I do not remember the event, but my husband has told me the details.  I screamed, convulsed for around 2 minutes, and bit my tongue.  I was post ictal for some time, and do not remember anything from about 6am-7am. My husband called 911, and after the emergency medical person checked me, my husband drove me to the ER.
Per letter received from patient and phone interview, patient has long history of severe Glaucoma. Patient reports being blind in right eye for many years. Doctors have treated the left eye successfully with medications since the age of 35 to prevent blindness of the left eye. Patient reports pressure in left eye has been well controlled with 4 different Glaucoma eye drops daily. Pressure in the left eye has been maintained at 10 and 12. Patient states his vision was stable until second Moderna vaccination on 02/05/2021. Within a few days, the patient noticed change in his vision. After 1.5 weeks, patient reached out to doctor. Patient was seem by Dr. on 2/24/21 and found left eye pressure had increased to 30. Patient was immediately referred to a Glaucoma Specialist. That same day, about 4-5 hours later, he noted the pressure had increased to 40. Dr. agreed to perform shunt surgery, and did so on 3/10/21. Initially this reduced the pressure to 8. During the next week or 2, it increased to 11. During the patient's most recent follow up visit, the pressure was at 15. At that point, Dr. decided to remove a suture to reduce the pressure more. Patient reports vision has only slightly improved since this all began. Next follow up appt is on 4/28/21. Patient states in his opinion, he has sustained significant vision impairment as a result of the second Moderna vaccine.
Information has been received from a medical assistant concerning a 14 day old patient, who on 27-DEC-2010 was inadvertently administered a dose of ROTATEQ (Lot # not reported) orally when the infant's mother provided the incorrect birth date. No known adverse effects were reported. Follow up information was received from the medical assistant who reported that the patient had been experiencing diarrhea since receipt the vaccine. At the time of the report, the outcome of the patient was unknown. Follow up information was received from the medical assistant indicating that the male patient with respiratory distress, left club foot and a history of prematurity, with no illness at time of vaccination, had vomiting and diarrhea on approximately 28-DEC-2010, "next day" of vaccination with a first dose of ROTATEQ (Lot # 667989/0687Z). The patient did not seek medical attention. The patient recovered on 19-JAN-2011. Additional information is not expected.
Patient started swelling in the left hands on Saturday May 08th and inflammation in the bowel during Monday morning May 10th. She was not able to eat and had nausea. Patient stayed at Hospital until May 13th and got many exams as endoscopy and colonoscopy and did not find any reason for such inflammation. Also, blood exams were ok. The swelling in the hands combined with inflammation on the bowel sound suspect of reaction of Pfizer vaccine as there is no event close to this date to create abnormal effects of swelling and inflammation.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 40 (unit not provided) female patient received PREVNAR 13 on unspecified date, at single dose. On an unspecified date after vaccination the patient experienced erythema in her arm. Outcome of the reported event was unknown.   Follow-up (07-FEB-2014): Follow-up attempts completed. No further information expected.
Pt devel rash on face, fever of 101, runny nose, slight cough, sore throat, cheeks swollen following vax;
The morning after vaccination, on 3/11/22 around 6am patient reported to have profuse sweating and severe dizziness affecting his ability to stand/walk around. When patient reported this to the pharmacy at around 5pm, he was still experiencing these symptoms without improvement. He said that he will go to the hospital to have this checked out.
Woke up around 2 am with stomach cramps, loose bowels, nausea, chills, sweating, dizziness, sore left arm, very shaky feeling.  Went to bathroom for bowel movement, had trash can in front of me in case of vomiting.  Apparently passed out and fell off toilet.  Woke up on floor, on my right side, with very cold chills and sweating.  Finished going to bathroom.  Noticed small cut on forehead, with dried blood, probably from hitting my head on trash can I was holding.  Went back to bed.  Still dizzy, chills, sweating, stomach cramps, nausea, sore arm, and aching all over.  These symptoms persisted for hours.  Finally fell asleep, woke up around 7:30 am, still dizzy, stomach cramps.  Took temperature, normal, took blood Additional information for Item 18: pressure, also normal.  Called office of primary care doctor, not open on Friday, declined appointment with another doctor, left detailed message, and was told they would contact me on Monday.  Went back to sleep, woke around 11:15 am, still nauseous and stomach cramps and dizzy.  Went back to sleep until around 2:30 pm.  Woke up feeling better, still sore left arm, sore stomach, achy and very tired.
Very sleepy and tired; Very sleepy and tired; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Very sleepy and tired) and FATIGUE (Very sleepy and tired) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Heart disorder.   On 20-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced SOMNOLENCE (Very sleepy and tired) and FATIGUE (Very sleepy and tired). At the time of the report, SOMNOLENCE (Very sleepy and tired) and FATIGUE (Very sleepy and tired) had not resolved. Not Provided          No concomitant medication details was reported. No treatment medication details was reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Non-significant follow-up received, patient denied further follow-up.
Patient experienced sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Patient experienced sick) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for an unknown indication.    Co-suspect product included non-company product BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY) tablet for an unknown indication.    No Medical History information was reported.   In July 2022, the patient started BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY) (unknown route) at an unspecified dose. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Patient experienced sick). At the time of the report, ILLNESS (Patient experienced sick) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2022, CD4 lymphocytes: 46.         No concomitant medication information was provided. No treatment medication were provided.  Reporter causality for co-suspect drug(BIKTARVY) was reported as Not Reported.
I had chest pains and then I could not get out of bed as my heartrate would increase, my doctor told me to go to the ER. I went to see my doctor and he performed an EKG he diagnosed pericarditis and I was in a lot of pain. I was told to take ibuprofen for two weeks and colchicine I took this for three months. The symptoms stopped but occurred again in October 2022 when I had to go the emergency room due to an increased rate heartrate and chest pains.
Client was given Pfizer (6 mo-4year) Bivalent Booster after having 3 primary series COVID vaccinations -- No adverse effects after vaccination
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 15-FEB-2016, the patient was inadvertently vaccinated with an expired dose of PROQUAD (Merck) injection (lot# K010211, expiry date 17-JAN-2016; dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effect was reported. There was no product quality complaint involved. Additional information has been requested.
Information has been received from a physician concerning a 16 year old male who on 14-OCT-1994 was vaccinated with a first dose of MMR II (route, site, dose and lot number not reported). On 22-SEP-1997, the patient was vaccinated with a second dose of MMR II (route, site, dose and lot number not reported). On 16-NOV-2009, the patient experienced mumps (though the date diagnosed was reported as 20-NOV-2009). The patient was afebrile and had R parotitis, right side neck swollen. The outcome for mumps was not reported. Follow up information has been received indicating that the 16 year old male patient who on 27-NOV-2009 was vaccinated with a third dose of MMR II (Lot number 664886/0776Y). On 22-DEC-2009 the patient experienced mumps (previously reported as 16-NOV-2009). The patient was diagnosed on 22-DEC-2009, the patient was afebrile and had left parotitis. The first blood work was performed on 22-DEC-2009: immunoglobulin M test (IgM) <1:10; immunoglobulin G test (IgG) 5.46 and serum amylase 86. This is one of several reports from the same source. No further information is available.
PT c/o Tingling in her throat and Tongue. PT. moved to private Treatment area. History and vitals obtained. PT. was able to speak in full sentences and drink water bottle. PT. monitored for 30 mins. PT. stated she felt better and could go home. PT. released and advised to call 911 w/ any further problems.
Lightheadeness, BP 159/97 - my normal is ca. 120/87, Pulse 57 my normal  51.  O2 - 92 my normal ca.96, belching,, difficulty keeping balance, slight fever 98.4, nausea, feeling miserable - un-comfortable  sitting or standing,, chills
Client received Td and flu on 10/11/02 around 11 AM or 1 PM. At 9 pm, she experienced slight fever, slight swelling & itching of arm where Td was given. These symptoms were more pronounced 24 hours later. She presented at health department on 10/15/02 with left arm red & swollen to elbow. She was referred her private doctor who diagnosed cellulitis and advised Keflex and a topical ointment 10/16/02. She reports improvement and will see doctor on Monday.
INFLAMED FACE, NECK, CHEST AND RIGHT ARM. STUFFY NOSE.
Hands and feet started turning red and itchy and then plaque started building up on  hands. Feet started really thickening up in places - toes - bottom of feet- side of feet and between my toes. Nails eventually turned yellow (toenails). It started spreading up my legs, behind my knees across my lower back across my check where my mastectomy's is and my shoulders  were really patchy for a long time. I had done a Prednisone course - but itching came back once I was finished with that.   At first I was taking 2 Loratadine a day and Benadryl throughout the day so I could stop scratching. I have done nystatin cream and cortisone cream in the beginning. Triamcinolone  and Acetonide creams after that. Clobetasol after that. And Propionate - 0.05% - after those he put me on: an Oral med for skin - one that is normally for really bad acne: Acitretin - 25 mg. I stopped taking that one last week - it started giving me more muscle aches and itchy eyes. Tremfya - 7 weeks ago and I took it and my insurance said they wouldn't cover it. Finally started up on that again last week - last Thursday - so now I'm on Zofran again because that Tremfya  make me nauseous - yesterday I had to take a full dose and I hadn't had to do that for 2 years. . The next round of Tremfya will be in three weeks from today and then I'll have to do it every 2 months.  Compazine and Phenergan - I am taking these for nausea to - alternating with the Zofran.  It starts spreading again if I am not on the meds. In taking it the plaque kind of stays down. My feet, where the skin was thickened has thinned out somewhat but they are still bright red like they've been scalded in water. I still have the red spots all over my body where it had been plaquened. Diagnosis: Psoriatic Arthritis. I didn't have this before. I just had a little arthritis before when it rained - would feel it in my knee or something. Now I feel it badly in my hip, my knees, my feet, etc.  2nd Vaccine - 2/5/2021 - Lot #030M20A - Intramuscular - arm, side unknown
pt recv vax 8JAN98 & 7DEC97 6 days pt exp fever, h/a, sweating, chills, n/v, abd cramping, body aches, & light sensitivity; saw MD & sx resolved;pt exp optic neuritis, dec visual fields & h/a;
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose03/09/2021 2nd dose03/30/2021 Diagnosed covid positive:09/06/21 Symptom onset:09/07/21 Exposure: Symptoms:fatigue,sore throat,diarrhea,runny nose
Client had never had a flu shot before and reported allergy to bee stings/pcn. After administering shot, nurse instructed patient to remain on premises. In approx 15 minutes, client returned and reported shortness of breath and chest heaviness. Nurse administered 0.5cc of 1:1000 epinephrine and called 911. EMT's arrived, monitored patient for 15 mintues. Patient declined transport to hospital, as she was breathing normally with normal EKG.
THE PATIENT FAINTED IMMEDIATELY AFTER RECEIVING THE VACCINE  AND BACOME PALE.  THE PATIENT WAS POSITITION SUPINE WITH HIS BILATERAL FEEL ELEVATED.  A COOL COMPRESS WAS PLACED BEHIND HIS NECK.  THE PATIENT COMPLAINTED OF BEING HOT, DIZZY AND A HEADACHE.  THIS WAS RESOLVED AFTER 15 MINUTES.
SEEING FLOATING TINY CIRCLES, LINES AND DOTS IN FIELD OF VISION; FEELING TIRED; This spontaneous report received from a patient concerned a female of unspecified age. 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: 1805022, and batch number: 1805022 expiry: 31-MAY-2021) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced seeing floating tiny circles, lines and dots in field of vision. On 15-MAR-2021, the subject experienced feeling tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from seeing floating tiny circles, lines and dots in field of vision, and the outcome of feeling tired was not reported. This report was non-serious.
1st dose Moderna 4/19/21 (lot # 007C21A ? Left arm) at pharmacy.  Patient had no significant past medical history.  He received Moderna COVID Vaccine on 4/19/2021.   Patient present to ED on 4/28/21 and found to be COVID -19 positive with a chief complaint of cough, fever, and dyspnea.   Patient had significant hypoxemia at 50% upon arrival.  File this incident for record keeping.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION, OROPHARYNGEAL PAIN, DIZZINESS, MUSCULOSKELETAL STIFFNESS, and NIGHT SWEATS in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017b21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroiditis. Concurrent medical conditions included Sjogren's syndrome, Sarcoidosis, Fibromyalgia, Ankylosing spondylitis, Osteoarthritis, Rheumatoid arthritis and Dermatitis. Concomitant products included LEVOTHYROXINE for Thyroid disorder.   On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE REACTION, OROPHARYNGEAL PAIN, DIZZINESS, MUSCULOSKELETAL STIFFNESS, NIGHT SWEATS, DIZZINESS POSTURAL, DRY EYE, DRY MOUTH, MUSCULOSKELETAL STIFFNESS, PRURITUS, BALANCE DISORDER, TREMOR, NAUSEA, FATIGUE, CHILLS, HEADACHE, VACCINATION SITE INDURATION, and VACCINATION SITE RASH. On 05-Apr-2021, the patient experienced SWELLING FACE, VACCINATION SITE SWELLING, VACCINATION SITE PAIN, and VACCINATION SITE ERYTHEMA. At the time of the report, VACCINATION SITE REACTION, OROPHARYNGEAL PAIN, DIZZINESS, MUSCULOSKELETAL STIFFNESS, NIGHT SWEATS, DIZZINESS POSTURAL, DRY EYE, DRY MOUTH, MUSCULOSKELETAL STIFFNESS, PRURITUS, BALANCE DISORDER, TREMOR, SWELLING FACE, Slightly red but do not itch. The look like they are going to blister, NAUSEA, FATIGUE, CHILLS, HEADACHE, VACCINATION SITE INDURATION, VACCINATION SITE RASH, VACCINATION SITE SWELLING, VACCINATION SITE PAIN, and VACCINATION SITE ERYTHEMA outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was reported.   Most recent FOLLOW-UP information incorporated above On 20-May-2021: No specific follow-up information recorded.
Patient reported redness, itching and swelling at the injection site that was occurring a few days after vaccination.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date in 2011, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2015, the patient was treated by a physician for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
chest pain, heart so heavy can hardly breathe; chest pain, heart so heavy can hardly breathe; Fever; serious headaches, which whole body hurts and in pain; body aches; This is a spontaneous report from a contactable consumer (Patient) reporting herself.  A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3247), dose 2 via an unspecified route of administration, administered in Arm Left on 08Feb2021 (14:00-15:00, as reported), (at the age of 33-years-old) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications was not reported. Patient took first done of bnt162b2 (Lot Number/Expiry Date: EL1283, unable to provide expiry) in Arm Left on 23Jan2021 for covid-19 immunization. On 09Feb2021 03:00, the patient experienced chest pain, heart so heavy can hardly breathe, fever, serious headaches, which whole body hurts and in pain and body aches. No emergency room and physician office visit. Outcome of the events was not recovered.   Additional Context: Caller reports, the second shot yesterday and has come down with side effects so bad and she can't go to the emergency room due to no insurance. Received the second shot 08Feb. Has had fever, chest pain with heart so heavy she can barely breathe, body so hot, serious headaches, which whole body hurting and in pain, body aches that all started at 3am this morning. No further details provided. Unable to provide NDC, expiry, or dose for second Covid vaccine. No other vaccines given the same day. 4 weeks prior did get the first Covid vaccine, 23Jan and provides a lot number of EL1283. Mentions with that one it was in same arm and she had side effects, but not as much as this second one. Had light headache, nausea, pain in left hand. Again, mentions second vaccine much worse. No history of problems with vaccines in past. No further details provided. Mentions she has already missed work and looking to see what Pfizer can do to help her with side effects, looking for medical advice. Talks about a form she saw with help for medical care. Recommended caller for further medical advice to seek medical care, Pfizer is unable to provide medical advice. No further details provided.  Follow-up attempts completed. No further information expected.
The day i got it my throat felt soo sore on the left side. I also woke up the next day with very swollen lips and headache. I had slight pain on the left side of my head. I felt as if i had precovid symptoms. The 2nd day after my lip was broken out on the inside on the left side