chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received dose on 11/25/2020, but never had second; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 25th Nov 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 05-OCT-2022 Reporters comment: This case was reported by a consumer via interactive digital media. The patient received the first dose of shingrix but never had the second dose. The patient asked that what should I do. Additional Supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination .
patient tested positive for COVID and subsequently again stopped the medication; patient tested positive for COVID and subsequently again stopped the medication; This is a spontaneous report from a contactable consumer.   A 72-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on unspecified date as dose 1, single and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 06May2021 as dose 2, single for COVID-19 immunisation. Medical history included ongoing rheumatoid arthritis without rheumatoid factor, right hand. Concomitant medication included etanercept (ENBREL) taken 50 milligrams, weekly (lot number: 1133614, Expiration Date: 31Oct2023) for rheumatoid arthritis, start and stop date on May2021. On 21Aug2021 patient tested COVID positive while receiving Enbrel with Single Dose Prefilled Autoinjector.  No treatment information was received. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Redness, irritation near site of injection beginning 10 days after injection was administered. Pt also mentioned continued soreness in the arm 28 days after administration
MILD HAND AND FOOT SYNDROME; JOINT PAIN; BODY/MUSCLE PAIN; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's weight was 155 pounds, and height was 69.5 inches. The patient's concurrent conditions included: metastases to brain, metastases to right lung and left lung, metastases to intra-abdominal lymph nodes, seasonal allergic rhinitis, hypertension, major depressive disorder, fluid overload, toxic gastroenteritis, toxic colitis, acute renal failure, pericarditis, and malignant neoplasm of right kidney except renal pelvis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 29-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included lenvatinib mesilate for malignant neoplasm of right kidney except renal pelvis, amlodipine besilate, everolimus, fluticasone propionate, levothyroxine sodium, loratadine/pseudoephedrine sulfate, losartan potassium, and zinc. On 30-SEP-2021, the patient experienced joint pain. On 30-SEP-2021, the patient experienced body/muscle pain. On an unspecified date, the patient experienced mild hand and foot syndrome. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body/muscle pain, joint pain and mild hand and foot syndrome was not reported. This report was non-serious.
Narrative:  hx HTN, hypothyroidism, BPH, CKD, hx rectal CA s/p chemoXRT/resection (1989) presenting with 3 days of constant, non- radiating epigastric/periumbilical pain. Admitted with breakthrough infection.
One month post 4th vax, acute severe dizziness began again and didn't stop. Changed to daily migraines mid August. Daily migraines continue to present day. Still have dizziness.
One week after vaccination my arm started to itch. When I looked at it it was pink, about an inch around. Also at the same time the lymph node under my arm, on the same side as the vaccine site, started hurting. Over the next 24 hours the spot on my arm grew to about four inches around and got brighter red. It alternated between itching and burning, much of the time feeling like a sunburn. One day after it started I did an online doctor visit. She said it was most likely "Covid arm" and after reading about it online I agree.  Now almost 48 hours after symptoms started there is improvement, it has gone back to a dark pink. Lymph node still hurts but it has also improved.
7 1/2cm erythematous swelling with warmth. Tenderness at site of injection.
Hypercalcemia AKI encephalopathy acute vomiting fatigue acute  ER  2/15 ICU 2/15 Hospitalized till 2/2021 IVs  extensive electrolyte medications
Sored arm; flu-like symptoms  (chills, general body pain); flu-like symptoms  (chills, general body pain); tiredness; sleepy; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0151) via an unspecified route of administration in the right arm on 05Apr2021 at 08:45 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not receive any other medications within two weeks of vaccination. 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 COVID-19 vaccine. On 05Apr2021 at 11:00, the patient had experienced sore arm, flu-like symptoms (chills and general body pain), tiredness and sleepy. Therapeutic measures were taken as a result of adverse events ad included Advil. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events sored arm, flu-like symptoms (chills and general body pain), tiredness and sleepy was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a nurse refers to a 4 month old male patient. On 15-NOV-2013 the patient was vaccinated with ROTATEQ vial, 2 ml, oral. Lot number was reported as 0056AE and expiry date 12-SEP-2013. The patient had received an expired dose of ROTATEQ. No adverse effect was reported Additional information has been requested.
Presented for covid-like sx x3 days; pt's wife tested positive at same time. O2 83% on RA for EMS, up to 98% on O2. Sx include worsening SOB, cough, weakness. Admit for sepsis & pneumonia due to COVID 19. Tx: dexamethasone, azithromycin, rocephin, O2 via NC, Remdesivir. DC to rehab.
1 & 1/2 cm round inflammation site around site of injection, inflammation & pain from elbow to hand.
mom raised question of rxn to vax stated that pt was irritable x 6-8hrs p/shot w/a neurogenic type cry;mom is an MD;febrile to 102 only;not related to pain @ shot site;listless the next day;mom did not call ofc;cried abn
Received first dose of Pfizer on 6/4. Four days later (6/8)  I developed debilitating dizziness and accompanying nausea. After 24 hours of vomiting I visited the emergency room (6/10) and received IV fluids. Head CT scan, ECG, blood, and urine all tested negative. Nausea subsided but dizziness continued. Consulted ENT on 6/15 and was diagnosed with vestibular neuritis. Confirmed with ENG/VNG testing on 6/25. As of 7/3 I am still experiencing disorientation when moving head. Activities like driving and grocery shopping are difficult. Next step will be vestibular rehabilitation therapy. Not sure if this will be a permanent condition.
Information has been received from a registered nurse referring to a 10 year old female patient with juvenile idiopathic arthritis. The patient had drug allergy to azithromycin and OMNICEF. On 27-OCT-2015 the patient was vaccinated with PNEUMOVAX 23 (strength, dose and route were unknown) and FLUARIX (strength, dose and route were unknown) concomitantly. The patient had no concomitant medication. On 28-OCT-2015, the patient experienced seizure. The reporter stated the patient had never had a seizure before and the patient was seen in the emergency room and was admitted to the hospital on 28-OCT-2015. Blood work, chest x-ray and computerized tomography (CT) scan of head was performed. Action taken with PNEUMOVAX 23 was reported as "continued". The outcome of seizure was reported as recovering/resolving. The causality between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Jaundice, elevated liver enzymes. Etiology unclear after extensive work up.  Not clearly related to Moderna vaccine.
Patient is a 81 y.o. male patient of MD with history of  Cardiomyopathy, CAD, DM, HLD, HTN, Renal Disease.  Patient presented with shortness of breath and hypoxia.    Assessment and Plan   Acute HFrEF exacerbation Acute hypoxic respiratory failure Ischemic cardiomyopathy s/p ICD Bilateral pleural effusion COVID-19 infection Shortness of breath and dyspnea resolved after thoracentesis bipap not well tolerated currently on room air; not on home oxygen Initial chest x-ray with bilateral pneumonia. WBC 12=> 7 Tested positive for COVID-19 on 7/16; vaccinated x3 Discontinue dexamethasone 6 mg daily, day 6 Large pleural effusion s/p thoracentesis; removed 1 L from the right side and 250 ml  from the left side Postprocedure chest x-ray: small bilateral left greater than right pleural effusions isolation through 7/26 Monitor input and output Incentive spirometry BNP 10,294 Continue home Lasix EKG paced rhythm; 2D echo on 4/5/2022 with EF of 39% Discharge after Foley removal and trial of void Follow-up with cardiology clinic within 1 week   NSTEMI type II Elevated troponin due to acute illness and CHF No chest pain Troponin 38=> 105=> 153 Continue metoprolol   CKD stage III/IV CRT 2 => baseline 1.8-2.50 Avoid nephrotoxic agents Continue to follow-up with nephrology clinic     A. fib without RVR Currently rate controlled Continue metoprolol 100 mg Continue Xarelto    Hypertension, benign. BP controlled. Continue home metoprolol, amlodipine   Diabetes mellitus type 2 Hemoglobin A1C 7.4 % on 4/5/22 Continue home regimen   Gout Continue home allopurinol   BPH Continue home finasteride and Flomax.
Hives by history and photograph with 12 24 lines of immunizations. No other illness a identifiable cause of hives Treated with Aveeno
suspected vaccination failure/Got vaccination but still got them; Still got them, it was mild probably; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   The reporter considered the vaccination failure and shingles to be probably related to Shingles vaccine.     Additional Information: GSK receipt date: 8-Jan-2023 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the vaccination but still got them (shingles).  It was mild probably because of the vaccination. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Patient developed chest pains shortly after vaccination.  Aspirin was given and patient was transported to ER via EMS.
-Right hand & forearm numbness/within 10 minutes of vaccine -Fever, Bodyacheeks, headackes, -Pain on the right side - Jaw, neck & right -Lyphnote under the right arm is swollen. -Neck & under armpit pain because of this -The night after getting the 2nd vaccine Covid I started getting chills, fever of 102+ Extreme body ackes -Right arm armpit lymph nodes swollen the size of my fist -Right side of my neck also swollen -The Right lower back hurts as well -From 1 to 10 is an 8 acute pain
Patient came to the pharmacy on 06/29/2019 and notified me that she had developed an adverse reaction months ago when she was given her pneumonia vaccination. She stated her arm was swollen, red, and extremely painful and showed a picture from her cell phone and described the red rash as going down her arm. Her orthopedic doctor referred her to her primary or the emergency room when he saw it the next day during her appointment. She went and saw Dr. who diagnosed her with cellulitis and prescribed her Keflex. She then saw Dr. (her primary doctor) for the follow up. I asked her current status and her arm is healed now.
I called the doctor because I had horrible pain in my stomach, but I wasn't sure if it was due to the vaccine. I had cramping in my abdomen on the right side, and that lasted a couple hours. It eventually got better, and she thought it could be my appendix. So, I waited until the next day to see if I was fine, but again, I'm not sure if it had anything to do with the vaccine.
Rash at vaccination site occurred 10 days after vaccination.  Itchy, red bumps.  Still some itching today with dried, red, bumps (Jan. 29) raised on arm similar to dry skin bumps, maybe red because of being scratched.
On 1/29/10, pt. contacted health center to report that she has had severe arm pain since day of vaccination.  States she works as housekeeper and has difficulty lifting arm.  States she has a lot of pain and has alredy tried taking Motrin, applying warm compresses and nothing seems to alleviate the pain.  Stated that 2 months have elapsed since vaccination and pain intensity has not diminished.  Pt. was instructed to seek help from her own PMD and to contact CDC to report adverse effects.
Reviewed pt's history & consent form.  States she received 3 Pfizer vaccines previously without any difficulty,  Pfizer Bivalent vaccine (GH9702) given in L deltoid.  After receiving vaccine, pt requests to go to Ladies Room, which is done the hall.  Returning from restroom, pt is clearly wheezing & anxious.  Pt states, "I'm wheezing!".  Had her sit down, concentrate on slow breathing.  Water given.  Asked her if she has history of asthma & she nods "yes".  Asked if she had her inhaler with her & she nods, "No."  Dr. & Clinic RN Manager notified immediately.  Dr. orders albuterol nebulizer treatment.  RN located nebulizer equipment & starts treatment (Albuterol 10 mg with 5cc NS).  Pt immediately responded to albuterol nebulizer treatment.  Pt refused vital signs to be taken.  States "I always have this happen at change of seasons."  Directed to always carry her inhaler with her in the future.  She agrees.  10:55AM Dr in to check back on patient.  Agrees she can leave the clinic.  Pt has a friend with her who will drive her home.  Pt left clinic at 11AM in alert and stable condition.
Contacted patient to inform him/her of an issue that was discovered on the date of this patient?s covid vaccination  It was determined that this patient received a dose of the vaccine from a vial that was beyond the 12 hr post puncture time limit but within the expiration date of the product. No temperature excursion occurred. Pfizer, the manufacturer was contacted on 4/20/22 to inquire about the stability of the vaccine after more than 12 hrs post puncture.  The only relevant point to the 12 page information sent by Pfizer was with ?microbiological risk to be considered when using vaccine in vials punctured for longer than 12 hrs.?  This is a theoretical risk of this microbiological risk of decreased efficacy but this risk has not been scientifically proven or even evaluated.   This information was reviewed with 2 supervising physicians in the office.  There was no consensus (as the risk has not been scientifically proven or even evaluated) that revaccination is needed.  One physician advised that this is a case of shared decision making with the patient and that it would ultimately be patient preference once presented with this information.  If patient chose to be revaccinated the advice from one of the physicians was is to wait 5 days from previous vaccination, as that is the guidance to someone who is covid + and has not been vaccinated.  Once a person is out of quarantine, they are urged to get vaccinated right after that even though they have some antibodies from the resolved infection. Presented information to patient as above in very simple terms.  Patient asked questions about potential for waiting a few months. I indicated this would not be considered a revaccination as it is separate timeframe from this vaccination and we do not know if/when additional boosters might be needed within that timeframe.  I apologized for this experience and advised that we have instituted new practices to ensure that the discarding of the vaccines occurs promptly at the 12 hr mark to prevent any future occurrences. Patient was thankful for the notification and information. Patient does not wish revaccination at this time.  Patient advised to contact us if any side effects from vaccine occurred.  As of this writing, patient has not contacted us for any acute respiratory issues or other symptoms of covid 19.
Status Epilepticus with generalized seizure without regaining consciousness for 1hr requiring intubation and generalized anesthetics with paralytics.
PINK/REDNESS SURROUNDING INJECTION SITE THE NEXT MORNING (DAY 2) AFTER INJECTION. PATIENT IS TAKING FEXOFENADINE DAILY AND TOOK A DOSE OF BENADRYL IN ADDITION AS A ONE TIME DOSE.  THE PINK/REDNESS SPREAD TO QUARTER SIZE THEN HALF-DOLLAR SIZE AND WAS INSTRUCTED TO SEE DR IF THE AREA SPREAD. PATIENT WENT TO ER TO GET PREDNISONE TAPER (DAY 5)
This spontaneous report as received from a medical assistant regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 11-NOV-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L018501, expiry date-22-JUN-2017) (dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
contracted the flu; had received the flu vaccine and still contracted the flu, Lack of efficacy; Based on additional information received on 06-DEC-2019, this case initially considered as non-case was upgraded to serious: patient received the flu vaccine and still contracted the flu.   Initial information was received on 04-Dec-2019 regarding an unsolicited valid serious case from a consumer.  This case involves male patient of an unknown age who experienced flu (influenza), while he received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route at an unknown administration site.  On an unknown date, the patient developed a serious flu (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  It was also reported as a case of vaccination failure. Patient had received the flu vaccine and still contracted the flu. Lack of efficacy.  (Other relevant tests included no laboratory data.)  Final diagnosis was influenza and vaccination failure.  It was not reported if the patient received a corrective treatment.  The outcome of the event was unknown.  Information on the batch number was requested.  Follow-up information was received on 06-DEC-2019 from a consumer.  This case initially considered as non-case was upgraded to serious: patient received the flu vaccine and still contracted the flu.; Sender's Comments: This case concerns male patient of an unknown demographics who experienced  influenza after and despite vaccination with INFLUENZA VACCINE produced by unknown manufacturer. The time to onset is unknown. More ever, there is no information regarding patient's condition at time of vaccination, immune status and congenital predisposition to respiratory tract infections. Based upon the reported information, the role of the vaccine and a case of vaccination failure cannot be assessed.
The patient reported feeling like his throat was closing up 15 minutes after receiving the vaccine.  Reports he has h/o anaphylaxis to oysters in past 4 different times with h/o anaphylaxis.  Pt refused epi-pen multiple times.  He asked for oral medication.  Reviewed risks/benefits.  Vitals were stable with BP 150/84, Pulse-99, O2-97%.  Pt without any swelling, SOB, chest pain, no rash, no tongue or lip swelling, no respiratory distress.  He was given 25 mg Benadryl per pt request - reviewed risks.  States that it was helping.  Was taken by EMS to hospital via ambulance - pt was able to walk with them without issues.  Was taken for observation.
This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash all over the body with itching), VACCINATION SITE SWELLING (swollen arm left arm) and VACCINATION SITE PRURITUS (rash witn itching left arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-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 RASH (Rash all over the body with itching), VACCINATION SITE SWELLING (swollen arm left arm) and VACCINATION SITE PRURITUS (rash witn itching left arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH (Rash all over the body with itching), VACCINATION SITE SWELLING (swollen arm left arm) and VACCINATION SITE PRURITUS (rash witn itching left arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information in response to events was not provided.   Reporter did not allow further contact