chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain immediately right shoulder at injection site,  sore shoulder unable to complete shoulder flex ion beyond 90 degrees without active assist range of motion from my other arm, appeared to look like a rotary cuff injury,  as days progressed  Left palm left foot numbness Heart palpitations after a flight of stairs chest pressure and some shortness of breath  Brain fog, word finding difficulties Anxiety Panic attack unprovoked Insomnia  Feelings of out of body  Dizziness when in moving car laying Down Hair loss Overwhelming fatigue Decreased concentration  Noise sensitivity  Light sensitivity  Leg cramping with running or walking quickly Changes in period 5 days late Chest pressure Impaired short term memory
TINGLING IN RIGHT LEG; HEADACHE; This spontaneous report received from a patient concerned an adult female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced tingling in right leg and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tingling in right leg and headache was not reported. This report was non-serious.
Systemic: increased in blood pressure-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Patient developed numbness in left arm, blood pressure mesured and it was elevated. Patient was monitored for 30 minutes and blood pressure decreased. Patient symptoms resolved on their own.  Patient did not required medical help at time and left with family members.  Patient was counseled to visit primary care or emergency room if symptom returns.
Pt received the anthrax vaccine during deployment, pt developed Rheumatoid Arthritis 5 years later. No family history of RA. Paternal grandmother had history of Multiple Sclerosis. States perhaps a predisposition to autoimmune disorders.60 day follow-up dated 7/21/00 provided no additional data. Per annual report-  Diagnosed with RA in 1998, onset of symptoms beginning 1996.  RA (rheumatoid arthritis) not yet in remission &/or "cured" -in maintenance only-joints in hands and feet bilateral involved, systemic affects also. Per annual report additional comments- no family history of such disease, increased incidence of RA and other autoimmune disorder noted in Gulf War veterans by medical experts but largely unrecognized by US gov't (served in Bahreem-1991).
Patient hospitalized for Laparoscopic Sleeve Gastrectomy with hiatal hernia repair within 6 weeks of receiving covid vaccination.
blood clot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown).  A 52-year-old patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (death, medically significant), 6 days after the suspect product(s) administration, outcome "fatal", described as "blood clot". They lost a family member to a blood clot 6 days after the first covid vaccine. The patient date of death was unknown. Reported cause of death: "blood clot". It was not reported if an autopsy was performed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: blood clot
I got infected with COVID-19; This is a spontaneous report from the Pfizer. A contactable consumer (patient) reported that a patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 03Feb2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that I have my first dose COVID-19 vaccine on 03Feb2021. I got infected with COVID-19 on 05Feb2021. My symptoms are mild. I would like to know if can still get my second vaccine that is scheduled for 24Feb2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Patient came in to report his right arm is still sore and swollen after receiving his flu vaccine.
Approximately 40 minutes after administration of the medication,  general statement to another staff member that she was feeling itchy.  This other staff member reported it to me.  I assessed staff member and her complaints were that her throat was feeling tight and that her arms were itchy and she felt anxious and hot.  No rash noted.  Staff member was given a fan to cool off and she kept insisting that she was fine.  Benadryl 50mg was given po at her request at approximately 50 minutes after vaccine.  About 75 minutes later, she states she feels like it may be getting worse.  I phoned NP and called EMS.  Staff member had her own Epi pen (states she asked for it when she had a reaction to Amoxicillin a while back).   While on the phone with EMS dispatcher, and staff member was answering questions, it was decided to have staff member to go ahead and do her Epi pen auto inject.  It was injected by herself in her Right outer thigh.  Almost immediately staff member states that she felt better.  EMS arrived a short time later, approximately 12 minutes, staff member states felt better, with no further feelings of her throat being tight or itchy.  BP was elevated at 170/90 as per EMS.  Staff member refused to go to ER to be evaluated as she states "I am much better now."  Staff member continued to stay at work for another 30 mins and allowed a fellow staff member to follow her home.  I also checked on her at 745pm via phone and she states that she is just sleepy.
I had a severe headache for 2 days, sneezing, and coughing. I tested positive for COVID-19 at home. I talked to a doctor, and he prescribed me Paxlovid. I did not take the Paxlovid because the symptoms were not severe. I don't have the stamina that I had before COVID-19.
inj site indurated, edematous, reddened;pt c/o weakness, nausea,cough, runny nose;site returning to nl size on 3rd day, constitutional sx remain but are less virulent;
Lymph node swelling in right side neck above clavicle. Showed up day after vaccine. 3 weeks later no change in shape or size. Going for ultrasound tomorrow 3/25/21.
I have a history of Recurrent Idiopathic Pericarditis.  On Thursday, 05/27/2021, thirty days after receiving the 2nd COVID-19 vaccine, I started having symptoms of pericarditis which included shortness of breath, pain in center of chest (worse when lying down), fatigue, and fever of 99.8.  I started taking Advil and Tylenol, and quit treadmill exercising.  On Tuesday, 06/01/2021, symptoms had not improved--I restarted the Recurrent Idiopathic Pericarditis Treatment Protocol--800mg Ibuprofen 3 times daily for 2-4 weeks for recurrence, Colchicine 0.6mg daily for 6 months for recurrence, and a proton pump inhibitor for gastric protection.  (See Continuation Page)  I visited my Cardiologist on Wednesday, 06/02/2021--no labs were drawn since this was my 7th episode of recurrent idiopathic pericarditis in three years, and the symptoms were not severe compared to my last episode of pericarditis,  The symptoms resolved within 2 weeks of treatment.  Addendum:  I also had swollen lymph nodes under both arms and a very large painful/swollen lymph node under the right arm (the first vaccine dose was given in the right arm).  The lymph noted swelling starting approximately 4-5 days after the first COVID vaccine.  The lymph nodes were still swollen when I received the second vaccine dose 21 days later--therefore, I decided to receive the second dose in the opposite arm (my left arm).  The lymph nodes remained swollen for weeks after the second dose.
Patient received Tdap (Adacel) on 3-23-09 @ 3:20 pm.  He awoke @ 8 am on 3-24-09 with joint aches, chills (hot, cold, sweats), malaise, weakness and unable to go to work.  He returned to bed, slept until 2:30 pm and woke up hungry and ate a good meal of chicken soup, toasted cheese sandwich and fruit.  Took Tylenol 1000 mg PO @ 6 pm.  At 8 pm oral T was 100.2-100.4.  (Throughout this entire time period, this has been the measured temperature.)  He drank about a half gallon of water on 3-24-09.  At 12 MN Tylenol dose was repeated.  He then slept throughout the night except for waking twice for the bathroom, each time the pillow was wet and cold.  He then woke up @ 8 am, repeated Tylenol dose, ate, returned to sleep until 2:15 pm.  Then repeated Tylenol @ 2:30 pm and began to feel like he was getting better.  He ate a salad.  He then decided to drive to CVS @ 5:15 pm, then visited his girlfriend and new baby @ 6 pm--who live 5 miles away from his house.  By 6:30 pm he just wanted to sleep, and slept until 7:30 pm, then returned (with difficulty) to home.  Then took another dose of Tylenol, and had a large cup of hot tea @ 8 pm.  He also drank a few glasses of water and Gatorade on 3-25-09.  He then went to sleep @ 8:30 pm and woke up only twice for bathroom trips.  On only one of those trips was the pillow wet.  On 3-26-09, awoke @ 8 am with a feeling of low back pain like "someone put concrete on it", tender and sore left shoulder and axilla--bruise reported, also.  He also reports that the injection is red.
This spontaneous report as received from a medical assistant refers to an unspecified amount of patients (ages and genders not known). On unknown dates the patients were vaccinated with VAQTA lot # M033611 (exp 02-MAR-2018), PROQUAD lot# M038277 exp 16-MAR-2018, PEDVAXHIB lot# M007762 exp 07-DEC-2018, lot# M036057 exp 18-MAY-2019, and VARIVAX lot# M010480 exp 01-MAR-2018. The products were all stored improperly with temperature excursions but were reconstituted with sterile diluent which was stored properly. VAQTA and PEDVAXHIB were stored at 47F to 77F for 40 minutes. PROQUAD and VARIVAX were stored at 6F to 14F for 9 hours 5 minutes and 15F to 46F for 4 hours and 55 minutes. There were no previous excursions. Data logger was yes. No adverse effects were noted. Additional information has been requested.
Large amount of small red bumps present on legs, small amount of small red bumps present to upper arms and chest. Areas are very itchy, unrelieved by anti-histamines and cortisone cream.
Information has been received from a health professional concerning a 12 month old female, with on medical history or allergies, who on 10 February 2006 was vaccinated with a 0.5 ml subcutaneous dose of varicella virus vaccine live (Oka/Merck) (Lot# 652447/0946R). There was no concomitant medication. On 20 February 2006, the patient experienced a rash with less than 20 erythematous papules on her torso and extremities. The patient was treated with diphenhydramine hydrochloride (Benadryl), acetaminophen (Tylenol), and oatmeal baths as needed. At the time of the report the patient had not recovered. There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. No further information was provided. Additional information has been requested.
Information has been received from a physician concerning a male baby whose 25 year old mother with a history of irregular menses who was vaccinated with the first and second dose of VARIVAX (Merck) (doses, route and lot#s not reported) on 02-MAR-2011 and 07-APR-2011, respectively. Secondary suspect included MMR II (doses, routes and lot#s not reported), the first and second on 12-MAR-2010 and the second on 07-APR-2011. Concomitant therapy included famotidine and hepatitis B virus vaccine (manufacturer unknown). On 04-DEC-2011, the patient's mother experienced third degree perineal laceration. The baby was delivered by normal spontaneous vaginal delivery on 04-DEC-2011 and it was reported that there were congenital defects as jaundice, sacral dimple and pilonidal cyst. Patient's new born hospital included: Hospital course without incident/concern, prenatal care provided. Consultant Lactation, antibiotics and duration none, hearing screen pending, breast feeding encouraged. Bottle feeding yes, but transitioning to breast, circumcision patient considering, counseled patient on r/b. 24 hour bilirubin high intermediate risk, redrawing 36h p. Tests needed as outpatient sacral ultrasound. At the time of reporting, the patient's outcome from the events was unknown. Sacral dimple, jaundice and pilonidal cyst were considered to be a congenital anomaly by the physician. The mother's experience has been captured in WAES 1107USA01431. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
pt recv vax & devel a diffusely red, vesicular area that was definitely marginal, not painful, & not febrile;area was 4x3 1/2cm in size;the area was indurated;MD indicated it did not look like discrete pox & was concerned area may be infect
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "MS" (unspecified if ongoing); "Graves Disease" (unspecified if ongoing); "history of PE" (unspecified if ongoing); "Factor V Lieden" (unspecified if ongoing); "Shellfish" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]; BACLOFEN; METFORMIN; NEURONTIN; PROVIGIL [MODAFINIL]; PROTONIX [OMEPRAZOLE]; SINGULAIR; TREXIMET. Past drug history included: Celexa for Known allergies: Celexa; Avonex for Known allergies: Avonex; Copaxone for Known allergies: Copaxone. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid from 17Jul2022 to 22Jul2022 for treatment of COVID-19. Adverse event reported as took Paxlovid and today tested positive again with worsening symptoms. Her doctor says not indicated to start another dose even with diabetes, history of PE, MS, asthma and Graves Disease and adverse event start date was 27Jul2022, ae resulted in none of the above, patient was not recovered for the adverse events and no treatment for the AE.  Product investigation summary conclusion on 28Jul2022 included, the complaint for "PFIZERBIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the ssociated lot(s) of the reported lot FM9992. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality, regulatory, validation and stability. PGS (Site name)  concludes that the reported defect was not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed." PR ID of Previously completed Inv: 7142808, PR Link (Previously investigated CR): 7142605.
Did not complete the Vivotif course; Spontaneous report received on 09DEC2019.  A healthcare professional reported that a 15-year-old female consumer "did not complete the Vivotif course" (PT: Incomplete course of vaccination). She was receiving oral Vivotif for typhoid fever. The consumer did not take the last dose of Vivotif on 30NOV2019. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer did not take the last dose of Vivotif and did not complete the Vivotif course (Incomplete course of vaccination). Considering the nature of the event, the causality of the event is assessed as not related. ; Sender's Comments: A consumer did not take the last dose of Vivotif and did not complete the Vivotif course (Incomplete course of vaccination). Considering the nature of the event, the causality of the event is assessed as not related.
Hospitalized (9.23.21);  COVID-19 positive (9.23.21);  fully vaccinated (per report - no documentation available in EHR)  Admission Date: 9/23/2021 Discharge Date: Sep 30, 2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Hypoxia [R09.02] Pneumonia due to COVID-19 virus [U07.1, J12.82] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 78 y.o. male with h/o COPD, type 2 DM, CAD, CVA, HLD, HTN, PVD, BPH and PTSD, presenting to ER on 9/23 with c/o 2-week h/o worsening dyspnea and fatigue.  He has been fully vaccinated against COVID earlier this year, but reports that his daughter has recently been ill with similar symptoms.  Dyspnea is worsened by exertion, improved marginally with rest.  He has felt warm but measured no objective fevers.  He has a cough occasionally-productive of whitish sputum.  He is a former heavy smoker but quit over 20 years ago.  In the ER, he was afebrile, normotensive to moderately hypertensive, with normal heart rate, tachypneic and saturating in the 80s on baseline room air.  Initial labs were notable for respiratory alkalosis on venous gas, elevated proBNP, normal lactate, normal WBC count, normocytic anemia, and positive COVID screen.  CXR shows extensive bilateral mixed interstitial and airspace opacities, c/w COVID-19 pneumonia. Decadron was given. He began to feel better the day after starting this med, he weaned to room air at rest. Son/POA and patient expressed concern for safety living with his daughter so MSW looked into this. DGMS assisted with insulin management. Pulmonary rehab was consulted and arranged home oxygen: 2L NC with activity. He will complete decadron course as an outpatient. He was enrolled in the COVID at Home monitoring program. He should also follow up with his PCP. He was discharged home in stable condition on 9/30/2021.
On May 14, 2021 approximately at 10:30am, due to syringe malfunction, the entire dose of the moderna covid-19 vaccine did not get administered to the patient (some of the vaccine spilled out of the syringe onto the patients arm and hand).  The exact amount that was injected into the patient is unknown.  Patient had no adverse events.    Called moderna on what the protocol should be and representative stated if less then half or if unknown how much of vaccine was spilled to give another dose immediately on the opposite arm.
No reaction right after the shot then face tingling after a couple of hours for a few hours. The tingling was enough to be noticed but didn't get worse. I went to bed with a sore arm but then around 4am I began to get the chills and I had a lot of pain in my left arm. The chills then lead to body aches, slight headache, and then eventually fever until about 3-4pm on 3/6/2021.  After that, I felt a lot better just tired for the rest of the day and continued with the arm being sore. On Sunday 3/7/2021, I woke up even better and spent most of the day feeling good. By the evening however, some face tingling returned just enough to be noticed and a few hours later, an intense headache. Took tylenol to sleep better but woke up on 3/08/2021 with the headache still lingering.  Overall, not severe reactions but still "reactions." I did expect some of the reactions like sore arm, chills, etc. but the one that surprised me was the face tingling.
SAME DAY OF VACCINE AND 2 DAYS AFTER START OF WELLBUTRIN, PT DEVELOPED PAINFUL RASH ON BOTH ARMS ONLY AND ON HAND.  THERE IS NO ITCHING; AT FIRST, SHE WORKED AND FELT OKAY, BUT THE RASH HAS PROGRESSIVELY GOTTEN WORSE AND IS NOW ON NECK AND FACE AND SHE HAS NOT BEEN ABLE TO WORK.
Event happened during  clinic. The patient said "yes" to my question of "is this your 1st dose?", therefore, I vaccinated her with the Pfizer vaccine, acknowledging that this would be her 1st dose of covid vaccine. The patient did not present her vaccine card nor told anyone about her 1st shot. Then, in the process of vaccinating her husband, their son who was sitting right next to the husband but further away from the mom, overheard and mentioned that they actually received the 1st dose of EstraZeneca in India around 50 days ago. This was after the patient was already vaccinated with the Pfizer. The son explained that this happened because the patient did not speak English very well and probably answered my question without fully understanding. Other pharmacists at the clinic including Bahador, who volunteered to be the witness of this event, all heard the son saying that this was because his mom did not speak good English and I clearly verified if this would be her 1st dose.  We did not vaccinate the husband nor the son, and still had the mom who was vaccinated stay 15 minutes. The patient left the clinic after 15 minutes with no adverse events or any complaints.
10/27 at site on left arm skin irritated red then bubbled up blisters, about 4 fluid filled. Then 11/7 left arm blisters turned to scabs, fever 103, no appetite, overnight had overreactive startle reflex, staring into space and fever between 102 and 103 until 11/11.
Pt received the vaccine on 1/2/18 and then started with pain on 1/21/18. It was described as a burning in the center of her low back and spread anteriorly around her right side. The pain or discomfort progressed to a tingling feeling sparing the buttock but continuing down the back of her right leg and this numbness had worsened over the subsequent 4-5 days. No headaches, fevers, known trauma, walking normally, not feeling good but not feeling weak. No recent trauma. Pt received a lumbosacral xray that was negative and was subsequently referred to Ortho, Physical Therapy and Rheumatology. Sx have continued and are being followed by specialists.
Local swelling and redness as well as tenderness near the injection site. Treatment with ice and CLARITIN. Started treatment today. Will follow up with patient on Monday.
Notified by pharmacy technician that patient had 'passed out' in parking lot. Patient found lying on the ground, pale but awake. Patient had been instructed to wait in the store for 15 minutes after vaccination in case of any adverse reaction but, per police, decided to wait in the car instead. He then began to feel lightheaded and decided to come back into the clinic. He passed out on his way. Civilian notified policeman that patient was passed out and EMS was called. EMS arrived shortly after I went out to parking lot to check on the patient. Patient was alert and oriented for EMS, reported history of HTN. He continued to c/o feeling lightheaded and BP per EMS was 77/48mmHg. Patient taken by ambulance for further evaluation and treatment.