chrisvoncsefalvay/vaers-outcomes huggingface dataset:
stage 3 acute kidney injury; Anti-GBM Disease; This is a literature report.  IgA nephropathy was the most reported glomerulonephritis post-COVID vaccination. Other reported cases include atypical anti-GBM nephritis, among others. Treatment consists of immunosuppressants and plasmapheresis with renal replacement therapy. Renal outcomes have varied. A case was presented of isolated anti-GBM nephritis in a patient whose renal injury occurred weeks after receiving a booster dose of COVID vaccine. A 59-year-old male with recent history of ureteral stones with stent placement, travel history in the last 6 months and use of doxycycline for suspected Lyme's disease in the last 3 months presented to the emergency department for decreased urine output, fevers, and arthralgias. He also received a Pfizer COVID vaccine booster 6 weeks ago. His symptoms had worsened in the last 2 weeks. On initial evaluation, he was noted to have stage 3 acute kidney injury (AKI) with creatinine 5.3 mg/dL. Although he had findings of nephrolithiasis, no ureteral obstruction or hydronephrosis were noted on imaging. He received extensive infectious work up which was all negative. Hemodialysis was initiated on day 7 for metabolic derangements and volume overload. After infectious work up was negative, renal biopsy was performed revealing linear IgG deposits. Serum anti-GBM antibodies were positive. Despite receiving plasmapheresis, cyclophosphamide and prednisone, the patient continued to require dialysis and was discharged on home hemodialysis. The development of AKI with systemic symptoms occurred about 6 weeks following his COVID vaccine, longer than previously reported cases. The patient also has a history of nephrolithiasis. At this time, direct association of this patient's anti-GBM disease with the COVID vaccine was unclear however remains a clinical consideration. The presentation of anti-GBM disease as unique as disease was limited to renal involvement.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162b2 cannot be excluded for the reported events-Acute Kidney Injury and Anti-GBM disease The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
ACUTE ST ELEVATION MI, RIGHT CORONARY ARTERY ACUTE CORONARY SYNDROME, UNSPECIFIED
For both shots received, 4-5 days later developed sores on inside top of mouth , around 3-4 small chunks of skin inside of mouth missing
Swollen Lymph node under left arm pit 24 hours after vaccine.  Inflamed Tibial Tendon with severe pain ten days after second dose.  Anti SSB (Sjogen's) antibodies and ANA positive 30 days after second dose and again positive 3 months after second dose.
12:15 PM ON 1/30/2020 REFISH, FEVERISH, ITCHING AT INJECTION MODERATE FACE, HEAD, AROUND NECK CHEST RED, HOT TO TOUCH, ITCHING EXTREMELY BAD SEVERE IT'S 6:20PM STILL ITCHING AFTER BEING MEDICATED BY PROVIDER AND RN AT WORK
An RN was located at Vax Room #2 and was in with a parent and her 2 sons.  The RN vaccinated first Pt and did not deploy the retractable syringe after the initial injection and failed to place it in the biohazard sharps containers immediately following the first injection.  The RN prepared the second pt.'s arm for vaccination and picked up the used syringe needle and injected it into the second sibling.  He immediately recognized his error and called for me right away to advise what had happened.  I took corrective action immediately with parent present.  I offered and was given consent to provide the Dose 2 to the child in the opposite arm. PCP office was notified today of the incident.  I spoke with the parent this morning and she advised that there is no redness, edema, soreness at the Left deltoid injection site.  Pt was tired over the weekend, but parent advises that that is how Pt responded after Dose 1.
J& J shot was given aprox. 12:45 mid day  &  by early evening experienced nausea & overall un-wellness tho went to bed at 9pm slept  fine. Slept til 12:45 middle of the night woke up from a deep sleep with pounding heart rate of 115 and fever of 100. Normal temp is slightly below normal of 97.7.  Because of fear of the unknown we read the the paperwork about allergic reactions which  include racing heart,  decided to call 911 after 45 min.of racing pulse. which 2 EMTs arrived, checked BP and  EKG both normal. EMT's stayed about a half hour, decided not to go to emergency because they said 150 heart rate was dangerous  and I was below that so opted to stay home. At 2am I vomited and  after 5-ten min pulse & temp  went immediately to normal. Fell asleep next morning just tired.  Please note that   this side effect  was NOT caused by anxiety,  had no fear or concern to get the J& J shot prior.
Patient had soreness in left shoulder after injection. Soreness was followed by deep ache in shoulder joint which has persisted since injection. Now pain hand activities and reaching behind back. Patient exhibits signs of shoulder impingement syndrome. Treated with steroid dose pack on 10/15/09.
Headache; Fever; Chills; Excessive tiredness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Excessive tiredness) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Concurrent medical conditions included Anemia (Severe anemia).    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 HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Excessive tiredness). At the time of the report, HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Excessive tiredness) outcome was unknown.            No concomitant medication was provided. Patient experienced headache, fever, chills, and excessive tiredness after each of first three Moderna Covid-19 vaccines. It was reported that patient did not provide permission for safety to contact. No treatment information was provided.   This case was linked to MOD-2022-528505, MOD-2022-528529 (Patient Link).
Adverse events that were noted as Minor; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Adverse events that were noted as Minor) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Adverse events that were noted as Minor). At the time of the report, IMMUNISATION REACTION (Adverse events that were noted as Minor) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Extremely heavy periods since vaccination. Four cycles since first vaccination and all are much heavier and closer together than normal, and now containing clots which I have not experienced before.
I always wear compression socks, when I took them off, the first part of January to get in the shower, they were harder to get off. There was a lot of swelling, the next morning the swelling was worse and moving up my leg past my knee into my mid-thigh. I also noticed that it was harder to put my compression socks on, my legs felt heavy, and my knee was swelling, and it was harder to walk. This went on about a week I contacted my doctor and seen her. She diagnosed me with pitting edema and also noticed from my CT scan of my abdomen that I had some fluid buildup around the bottom of my lungs it is a sign of worsening liver disease and could mean other things to. She prescribed me another water pill and after a week I had a blood work up to see if the potassium levels were normal and it showed that they were normal she also compared the liver enzymes were the same and they were. I continued with the two water pills, and I will see her again on 04/10/23. The swelling has gone down a lot, my legs don't feel heavy, swelling only around my ankle, easier to walk now and I am pretty much back to normal.
patient reported about a 1 inch circle of redness around the injection site, she stated that it felt feverish, but no swelling and that it was painful if she pressed on it.  I advised her to use a cool compress and contact her physician if her condition worsened
Child received immunization yesterday 10/19/06 at 2. Mother noticed this PM child RUA was red, hot to touch, firm, and painful. Brought child in at 4pm today. Applied ice to area. Doubtful cellulitis in such a short time period. Most likely local rxn to immunization. No systemic rxn noted. Pt should recover with advise given Ice, Tylenol, Benadryl, observation.
1525 vaccinated  1530 per EMT & family, witnessed vasovagal response to vaccine  HX of   vasovagal response post vac's & blood draws. hx severe PTSD. 1540 witnessed sz like symptoms  clonic/tonic . X2 patient is on anti-sz meds with no previous 525,  pt down on the floor x3 with legs elevated. assisted to W/C x2 people. X2 witnessed vasovagal response per mom 0 medical intervention needed and would be counter predictive due to PTSD hx. respected mother request. Pt transferred to car x2 people legs elevated BP 112/72 - o2 97%. 1700 pt appears stable, escorted EMT & myself assisted to private car. Mother was thankful not to have called for transfer.
Patient describes that minutes after receiving vaccine, she developed tongue swelling, face swelling, chest pain and lightheadedness
she felt very very tired and exhausted; She received the third Pfizer booster shot on Friday 01Oct2021; This is a spontaneous report from a contactable consumer via medical information team. This 90-year-old female consumer (patient) reported.  A 90-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 vaccine, solution for injection, Batch/Lot number was not reported), dose 3 via an unspecified route of administration on 01Oct2021 (90-yerar-old at the time of vaccination) as dose 3 (booster), single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unknown date and patient previously received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unknown date for covid-19 immunisation. On 02Oct2021, the patient she felt very very tired and exhausted. Reporter is a 90 year old, Female, consumer who got the booster dose 01Oct2021. After she got the booster dose she had no relevant reaction to it. However the next day, she felt very tired and exhausted. The Patient reported that she will be having a double root canal tomorrow and is advised to take Amoxicillin an hour before the procedure. The reporter wanted to know if there are any relevant interaction between the booster dose of the COMIRNATY vaccine and that of Amoxicillin (with mainly COMIRNATY affecting the amoxicillin). The patient took Amoxicillin before and she will take it an hour before the dental work. She received the third Pfizer booster shot on Friday 01Oct2021. At first no reaction, then the next day she was really tired and then exhausted. Then the next day she was still tired, but by end of day ok. She is going to have a double root canal tomorrow. She takes Amoxicillin. She is not sure if the booster shot would have any effect on medication she will receive from dentist. The reporter clarified that she has taken Amoxicillin before and she will take it an hour before the dental work. Amoxicillin is ok with other things. The outcome of the event was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Gave patient injection 1:26 pm. Painted fainted at 1:29 pm. After patient regained consciousness BP 116/75. Patient was observed for 15 minutes after injection. No adverse reactions.
30-45 MINUTES POST VACCINE, PT FELT CHEST TIGHTNESS. UPPER ARM BEGAN TO SWELL THROUGHOUT THE DAY, BECAME RED AND PAINFUL BY THE EVENING AROUND 7:00 PM WHEN SHE CONTACTED THE PHARMACY.
limited medical records received on pt; pt had tested positive for COVID on 9/28/21;10/28/21 pt to ED and was DOA; no other medical information received
TROUBLE SPEAKING; FELT DEPRESSED; ISSUE WITH THROAT AND VOICE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced trouble speaking, felt depressed, and issue with throat and voice. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from trouble speaking, and issue with throat and voice, and the outcome of felt depressed was not reported. This report was non-serious.
On Monday after a camping trip, I was feeling lethargic.  I took some ibuprofen because I was also very sore.  I took a nap in the middle of the day.  I spoke with my doctor on Wednesday.  Tuesday, September 6, 2022,  I felt better but developed a sore throat and a bit of a cough.  My headache and body aches went away.  Tuesday night I tested positive for COVID-19.  I was prescribed Paxlovid.  I did not test negative for about 2 weeks.  Thursday night I had a mild sore throat and felt like I had a night fever/night sweat.  My sore throat diminished over time as well as my headache.  I never felt out of breath or lethargic around the house.
woke with uncontrollable itching, hives or welts, from ankles to head,  knees, inside thighs, outside thighs, buttocks, fingers, by underarm pits, chin, eyes, top of legs between knees and torso, urgent care at urgent care, Dr. concluded it was from vaccine,  gave me 3 pills of some type of cortisone , and 4 day course of cortisone tablets next four days, also OTC benedryl, to allow me to sleep
Information has been received from a registered nurse concerning an 18 year old female who was vaccinated with a third dose of Gardasil. Subsequently, three minutes later she passed out and stopped breathing for short period of time. Unspecified medical attention was sought. At the time of the report the patient had recovered. It was unknown whether or not she had the same experience with the first and second dose of Gardasil. Upon internal review, stopped breathing for a short period of time was considered to be an other important medical event. Additional information has been requested.
administered MMRlI intramuscularly; The customer did not report any other adverse event; This spontaneous report as received from a consumer concerning to a 14-month old patient of unknown gender.      The patient's concurrent conditions, medical history, allergies or drug reactions, and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), intramuscularly (dose, frequency, lot# and expiration date were not provided). The reporter did not inform any other adverse event.
24 hours after injection pt noted rash around ankles- red, not raised, itchy. Over the next 24 hours rash spread to neck area and generalized over trunk. Itchy and uncomfortable. Pt also c/o stiff, sore joints. Pt also in track practice, running outside beginning this week. Benadryl seems to relieve itching.
2x3cm erythema and heat over the right deltoid and was prescribed Keflex.
This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. Patient's pertinent medical history and drug reactions or allergies were not reported. On unknown dates, patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot # L009204 and expiration date 17-MAR-2017, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. There was no previous temperature excursion. The temperature of the excursion was 42F and the time frame was 16 hours. This is one of several reports received from the same reporter. Additional information has been requested.
Report rash and itchiness all over day after vaccine given. Treatment Benadryl on day 3 : Outcome complete resolution of symptoms.
Patient reports fatigue and muscle pain all over body. He took a tylenol for symptom relief. Symptoms has resolved today.
4/10-1945  Caller states patient had flu like symptoms post vaccine.  headache fatigue fever diarrhea Cramps.  Cramps and    Diarrhea has continued and is still every 15 minutes . Advised to seek medically attention diarrhea every 15 minutes for days needs medical attention .  4/11-Patient's spouse returned call, patient continues with diarrhea, not as many bouts as yesterday, started taking Immodium as directed today. Will follow up tomorrow.  4/12-Follow Up: He stated he didn't go to the urgent care he just took Pepto Bismol and Loperimide to help with diarhea (which help tremendously). As of 4/11/21 he stated all his symptoms have subsided (diarrhea, headache, etc) and feels a lot better.
The patient reported feeling itchy at the injection site. The itchiness subsided within 15 minutes.
This spontaneous report was received from an allied health and refers to a multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown dates, multiple unspecified patients were vaccinated with improperly stored dose of GARDASIL 9 (lot number L024993 with expiration date 17-OCT-2017, and lot number M023169 with expiration date 03-JUN-2018). No adverse effects were reported. Temperature and time frame of excursion was unknown by the reporter. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent to contact reporter. Sender's Comments: US-009507513-1704USA006553: US-009507513-1704USA005724: US-009507513-1704USA006550: US-009507513-1704USA006551.
Burning sensation (strained muscle sensation) in back of both legs from bottom of buttocks to Achilles' tendons.  Lasted a full days worth.  Happened during the 2nd and 3rd dose of the COVID vaccinations.  2nd dose was Pfizer brand.
more than 36 days since got the first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (more than 36 days since got the first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (more than 36 days since got the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (more than 36 days since got the first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.
SWELLING AND REDNESS ON LARGE AREA ON UNDERSIDE OF FOREARM BETWEEN ARMPIT AND ELBOW.
Pt states at the site of injection, the area is swollen, red, hard lump and warm to the touch. Pt states reaction has gotten larger as the days progress.
This is a spontaneous report from a contactable health care professional via Pfizer sales representative. A 17-year-old female patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced fatigue 3 days after 1st vaccine dose with outcome of unknown. No follow-up attempts are possible. No further information is expected.
Burning, searing pain upon administration. Lingering dull pain and numbness in shoulder (upper and back), outer bicep, and elbow. Sometimes radiates down outer forearm to hand. Most noticeable when I'm typing or sitting down. I still have range of motion, but the "achiness is bothersome". It is day 10 and I still have aches. I plan on seeing my doctor next week if pain continues over the weekend.
Adverse reaction to 1st dose was a one week post vaccine and a red, circular spot at injection site that was itchy for 36 hours.  Adverse reaction to 2nd dose was soreness at the injection site, extreme headache, fatigue, body aches all over. This
Wrong Pfizer vaccine was given. Patient got Pfizer bivalent 12+ 0.3 ml, when it should have been Pfizer bivalent 6m-4y 0.2ml. Mother of the child was notified by RN. RN spoke to mother about emergent symptoms to look for and expected side effects. NP was consulted with and agreed with plan moving forward. Patient and mom waited around 30 minutes in the clinic after vaccine for observation. RN set up telemed with NP for tomorrow to check in with patient. No further action necessary.
Pt w/confirmed pregnancy with known last menstrual cycle of 7/25/19.  Vaccine given 8/1/19
"COVID arm"; hard welts about 4 by 3 inches; itchiness; large red welts; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION ("COVID arm"), VACCINATION SITE URTICARIA (hard welts about 4 by 3 inches), VACCINATION SITE PRURITUS (itchiness) and VACCINATION SITE ERYTHEMA (large red welts) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     Medical history was not provided by the reporter.  Concomitant products included LORATADINE for an unknown indication.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced VACCINATION SITE REACTION ("COVID arm"), VACCINATION SITE URTICARIA (hard welts about 4 by 3 inches), VACCINATION SITE PRURITUS (itchiness) and VACCINATION SITE ERYTHEMA (large red welts). At the time of the report, VACCINATION SITE REACTION ("COVID arm"), VACCINATION SITE URTICARIA (hard welts about 4 by 3 inches), VACCINATION SITE PRURITUS (itchiness) and VACCINATION SITE ERYTHEMA (large red welts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       After 3 days itchiness stopped. Patient still has hard welts  about 4 by 3 inches. No laboratory details was given. No treatment information was given.
Covid Arm    Redness, swelling and itchiness 7 days after injectiom