chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She got her vaccine and  within 8 days she had severe headaches where her eyes were pulsating.  Then on 9/14/21 she went to the eye doctor as her eye was blood shot.  She didn't know what it was from.  She told him about the headaches, and did not mention about the vaccine.  He recommended her to monitor it and then to also go see her PCP.  That the blood shot should be gone within a week.  He felt that she may have broken a blood vessel.  She started having blood noses, chest pain over time.  The only reason she is reporting it is that it is severe.  She went to UC on Saturday and they said that it was her BP and that she needed to FU with her doctor to have labs done to see if she needs to be put on some type of medication.  She does not have any history of any problems with her BP or any other conditions.  She was telling the UC that she has been suffering with issues for months, and is aware that vaccine can cause heart conditions.   She has extreme fatigue, headache, numbness in her fingers and toes.  She forces herself to go to work and sometimes has to call in due to the symptoms.  It is affecting her everyday life over the last month.  She has always been a healthy, outgoing person and feels like this is sucking the life out of her.   She has an APT to see her PCP tomorrow.
Information has been received from a physician concerning a 12 year old female who on approximately 26-JUL-2006 was vaccinated SQ with a 0.5 ml second dose of Varivax (lot# 652725/0249F). Concomitant vaccination included BOOSTRIX. On 26-JUL-2006 the patient developed erythema at the injection site. Unspecified medical attention was sought. At the time of the report the patient was recovering. There was no product quality complaint involved. Additional information has been requested.
patient was given Menactra today that had an expiration date of 8/14/19/no AE; Initial information received on 26-Aug-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient of unknown demographics who received an expired dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  It was unknown whether adverse event was observed or not.  Information on the batch number was requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Right arm moderate erythema, tender, swollen, med ecchymosis upper arm. Fever. Abscess. Augmentin x 7d. Area 3.5-4 cm diameter. Seen ER 5-22-08.
STORAGE IN REFRIGERATOR  ( 2°c -8°c )  UP TO 30 DAYS. ( VACCINE USED AFTER 10 -16-2021 )
I have had 4 adverse events over the course of the 2 shot series.  I did not realize these represented adverse events until after the 2nd dose.  30 minutes after the 1st shot (this is the one I noted in this report), while driving home from the vaccination center, my face became itchy and hot.  I became panicked, and had a panic attack. I pulled off the road, and dealt with my panic symptoms which were  typical for me when I have panic attacks (sense of doom, extreme fear that I am dying, depersonalization).  I forgot that it was triggered by itching.  In fact, I did not report a reaction to the vaccine center when I got my 2nd shot because I considered it a panic attack, which is not new, and I had forgotten about the itching.  I  remembered this happened when I received the 2nd shot on 2/2/21 at 2:00 and remained at the center for 30 min (due to my sulfa allergy).  Again driving home (abt 45 min  after the vaccine) my face became itchy and hot.  It lasted approximately 20 min, and resolved.  No other acute symptoms .  However, I've developed a mild stomatitis after both shots.  Several days after the first shot I woke up to find extensive sloughing of my buccal mucosa.  .  There was no pain, but I continued to have sloughing  for several  days.  it was extremely noticeable the first 2 days, and tapered off.  I also developed a metallic taste in my mouth (that was the most bothersome part) this was very strong for 3-4 days, and has lessened but not resolved completely.    I did not connect any of this with the vaccine.   Today 3 days after the second shot, I woke with more mucosal sloughing in my mouth.  It is  localized to one particular area nearand seems to be deeper layers because there is some tenderness to the area and a lesion. I have some metallic taste in my mouth but it is mild.
Patient fainted approximately 10-15 minutes after receiving vaccine.  Patient was told to stay on the ground. He was sitting and was told to put his head between his knees, after about 10 minutes some sips of water  patient was feeling better and his color came back to his face.
Cough; Chills; Fever; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), PAIN IN EXTREMITY (Arm soreness), CHILLS (Chills) and PYREXIA (Fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Esophagitis.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness). On 11-Jan-2021, the patient experienced CHILLS (Chills) and PYREXIA (Fever). On 12-Jan-2021, the patient experienced COUGH (Cough). On 12-Jan-2021, CHILLS (Chills) had resolved. At the time of the report, COUGH (Cough), PAIN IN EXTREMITY (Arm soreness) and PYREXIA (Fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, Body temperature: 99-100 f (Borderline) Fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
1. Inconsolable, crying within 6 hrs. 2. Not having lower extremities 3. Hypersensitive below waste line
This case was reported by a pharmacist via call center representative and described the occurrence of injection site discomfort in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site discomfort. On an unknown date, the outcome of the injection site discomfort was unknown. It was unknown if the reporter considered the injection site discomfort to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a bizarre feeling in the muscle of the arm in which she received the SHINGRIX. The pharmacist did not have details readily available as the pharmacist reported from home and vaccine was administered at the pharmacy. The pharmacist has not seen the patient since the vaccine was administered.
DVT; This is a spontaneous report received from non-contactable reporter (physician) from a sales representative. The reporter is the patient.  A male patient in his 50's 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: DEEP VEIN THROMBOSIS (medically significant), outcome "unknown", described as "DVT". The patient underwent the following laboratory tests and procedures: Weight: Normal. Clinical course: Physician himself developed DVT after taking initial dose of COVID vaccine. It was reported that he was healthy with normal weight.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of DEEP VEIN THROMBOSIS due to temporal relationship and current known drug safety profile.  Case will be re-assessed upon the additional information provided. 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.
This spontaneous report as received from a medical assistant refers to an unspecified number of patient of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. The patients were vaccinated with the doses of GARDASIL 9 injection, lot # L006547, expiration date 04-MAR-2017 (dose and route of administration were not reported), which were exposed to temperatures outside of the recommended range for much longer than originally realized and had been administered to the patients since these excursions began to occur on an unspecified date in July 2015. The refrigerator, in which the vaccine was stored, had been "losing power" each night for 8 hours since an unspecified date in July 2015. The vaccine was exposed to temperatures as high as 66 Fahrenheit (F) for as long as 8 hours each night since an unspecified date in July 2015. The reporter's facility started to use a data logger, which was how the daily (also reported as each night) power interruption was discovered. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
2 weeks after the 1st dose I Began feeling as if I was getting a panic attack. Had shortness of breath chills and a feeling of anxiety and disconnection. Went to the ER because of shortness of breath I was diagnosed with acute gastritis and anxiety . I?ve been feeling sadness and fatigued ever since. Then 13 days after my second dose I began feeling the same way, chills nausea and a great sadness and disconnected from myself. I?ve reached out to my doctor and she is sending me to get checked. I?ve always been healthy, happy and very energetic this has been the healthiest and happiest I had ever been and then all of a sudden this is the only new thing in my body. Now it?s difficult to find joy in the things that I used to before. I randomly start feeling nauseous and cannot eat for a few days. I randomly cry and feel as if I am not connected to myself. There is nothing else that I can think of that can cause what I?m feeling. Many people who I?ve spoken to about this have said they have felt similar symptoms and they also received the Moderna vaccine
have colds; respiratory issue for the last week; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported similar events for 2 patients (Herself and Husband). This is 2nd of 2 reports. This consumer reported for a male patient (husband) that:  A male patient of unspecified age had received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on unknown date as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patient had colds and their 2nd dose is due tomorrow and have had enough of respiratory issue. Consumer stated, "I am not sure if it is the right place but my husband and I have the COVID-19 Vaccine three weeks ago. We are due to have it again tomorrow but we have had enough of respiratory issue for the last week and my doctor said she thought it would be best if we postpone taking the second dose for at least two weeks and I am trying to let them know that we can't come tomorrow for the appointment to get our second injection and how will that affect us as far as being protected if we wait another 2 weeks". "I am trying to cancel the appointment, how I can I cancel this appointment. At the time of reporting, the outcome of the events were unknown.  Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021199393 Different patient, same drug and event
"Generalized weakness"; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA ("Generalized weakness") in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA ("Generalized weakness"). At the time of the report, ASTHENIA ("Generalized weakness") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-142497, US-MODERNATX, INC.-MOD-2021-142886, MOD21-091689 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-142497:Crosslink US-MODERNATX, INC.-MOD-2021-142886:Crosslink MOD21-091689:Crosslink
This case was reported by a nurse via call center representative and described the occurrence of vomiting in a male patient who received BEXSERO. On an unknown date, the patient received the 2nd dose of BEXSERO. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced vomiting, tingling, chills and fever. On an unknown date, the outcome of the vomiting, tingling, chills and fever were not recovered/not resolved. It was unknown if the reporter considered the vomiting, tingling, chills and fever to be related to BEXSERO. Additional details were provided as follows: The reporter stated that, she would be able to obtain information related to vaccination dates, lot numbers and expiration dates at a later time, but she wanted to talk to a medical information scientist urgently, as the patient was actively experiencing symptoms at the time of the call. This case has been linked with US2016088237 reported by the same reporter for the same patient.
Only for 2nd dose\vaccine (did NOT have adverse reaction to 1 st dose): Onset of symptoms about 12 hours post injection - SEVERE flu-like symptoms, ie body aches & shaking from head to toe, chills/sweats/fever, serious headache, lasting about 4-4.5 hours first, then coming in waves every few hours throughout the next day. Symptoms waned around 32 hours post injection.
pt was scheduled for 11 yr wcc  shots were given as if he was actually 11 when in reality he was 12 and alrady had the shots
This spontaneous report as received from a medical assistant refers to a 8 months old (also reported as 9 month old) patient. On 21-DEC-2012 the patient was vaccinated with a dose of VAQTA (Lot#, dose and route not reported) instead of dose of RECOMBIVAX HB. No adverse effect was reported. It was not known if the patient sought for medical attention. Additional information has been requested.
About 5 minutes after he received the vaccine, the patient reported feeling tightness and swelling in his throat. We called the emergency number. I had him sit down. He further complained of having rapid heart rate and no feeling in his hands. I have him 1 shot of epinephrine 0.3mg in his left thigh and gave him 2 tablets of diphenhydramine 25mg, which he said he swallowed with difficulty. His face became ashen colored. I asked him to lie on his back on the floor and raised his feet. I acquired a wet compress and placed it on his forehead and supported him until EMTs arrived. They supported him and transported him to the ER. Later around 4:00pm we learned he was doing fine and had left the hospital.
Pain at injection sight = 12/18/14 Advised to take MOTRIN.  Redness and swelling = 12/19/14 nausea and vomiting advised to take BENADRYL and to see MD if sx worsen. 12/20 pt given abx. Diagn cellulitis.
Swelling and redness 3-4 inches below injection site, hives that itch in a large area across arm. Taking 40mg prednisone 3 days, Allegra 180, hydrocortisone cream.
little soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (little soreness) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder and Blood pressure high. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (little soreness). At the time of the report, PAIN (little soreness) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient's concomitant medication also included unspecified blood thinner twice daily for irregular heart beat and for blood pressure.  No treatment information was provided.   This case was linked to MOD-2021-049445 (Patient Link).
Shot given: PENTACEL. persistent fever- 3 days of 100-102 degrees. Red blotch around shot site 3 inches in diameter and beginning to spread to the inside of the child's leg. abnormal shape, similar to the infinity shape. shot site came to a head and was warm to the touch. More than 5 days after the immunization was given the shot site was still warm and came to a head. Rash on the back of the child's head developed, unable to determine whether or not related to shot or not. Rash on the outer side of child's leg and bottom developed but unable to determine whether or not it was related to shot. Both of these occurrences developed 2-3 days after shot was given.
reports bruising and pain at LA after vaccine. Pain radiates to Lt wrist & shoulder with decreased range of motion. Was seen by provider 4/25/2022 with work restrictions.
summary of her symptoms: 1 hr post vaccination - feeling tired and sneezing excessively for a couple of days. 3rd day post vaccination-skin tingling sensation all over that resolved with oatmeal bath. 5th day post vaccination-was seen by pcp who told she was fine. received a call from pa from office to inform her she had an allergic rxn and was not to receive the second vaccine. today-she is asymptomatic.
Patient received Pfizer Bivalent Booster in clinic on 9/26/22 and then again on 10/20/22.
patient scheduled for a Pfizer booster (3rd dose) and arrived without vaccine card. The person adminsitering the dose verbally confirmed with the patient that does one and two were Pfizer. Person administering failed to verify the medical record prior to administering. After administering she accessed the record and saw that the patient had been vaccinated with Moderna (dose one and dose two) on 1/4/21 and 2/1/21.
Timer set for 15min and pt left in exam room with mother, brother. Immediately after and for about 10 minutes, mom says pt complained of pain in her Left arm. Pt moved from exam table to sit in chair next to mom. Around 14 minutes after vaccines were given, pt seemed to lean heavily on mom, and mom said it seemed like she fainted, and her L arm "spasmed." Brother ran into hallway to get a nurse, and by time nurse came in pt was alert again, although drowsy. She said "everything went black." Entire episode lasted about 20 seconds. Nurse moved patient to exam table to lie down. Declined any water. She denied headache, dizziness, or nausea, and left clinic about 10-15 minutes later.
welts and itching at and around the vaccine injection site - taking Benadryl and cortisone cream to help
Patient is a 50 y.o. female with a history of Afib (on Eliquis), DM-2, HTN, ovarian cancer with bilateral oophorectomy, breast cancer with right mastectomy who is currently undergoing chemotherapy. She presented to ED 6/5/23 with sore throat, runny nose, headache and fatigue. Found to have COVID and neutropenia. She was transferred to Hospital 6/6/2023 for management. Completed Paxlovid. ANC improved with neupogen and >3K on 6/11/23. Discharged home on 6/12/23.  1. COVID 19 Infection: Pt immunocompromised as she is currently on chemo for breast cancer. S/p vaccinated and boosted x 1. Symptoms: sore throat, no fever, no hypoxia on admit. Paxlovid initiated 6/8/23; complete course on 6/12/23. ID following.  2. Neutropenia: ANC 540, in setting of chemotherapy. No fever on admit. ANC 380 on 6/7/23. Neutropenic precautions continued. Oncology added daily neupogen until ANC >3000; last dose given on 6/10/23. ANC improved to >3K on 6/11/23. 3. Pancytopenia: due to chemotherapy. Last chemo 1 week PTA. Hgb down to 6.8 on 6/7/23, transfused 1u pRBC 6/7/23 and again on 6/11/23. WBC and Plt counts stable.  4. AKI: mild to 1.19 on 6/11/23. Diuretics held on 6/11/23. Encouraged increased PO intake. Stable on 6/12/23.  5. Epistaxis: rhino rocket placed in L nare 6/8/23 per ENT; removed 6/9/23 per patient request. ENT recommended outpatient follow up. S/p Empiric keflex. 6. Breast Cancer: Triple Negative Invasive Ductal Carcinoma. S/p right mastectomy 10/2021 with Dr. (Breast Surgery). Follows with Dr. (Medical Oncology). Currently receiving adjuvant chemotherapy (missed session 6/6/23 and to hold on 6/13/23 per Dr.). Oncology followed.  7. Chronic HFrEF with Dilated Cardiomyopathy: Per history, initially related to postpartum cardiomyopathy 16 years ago. S/p AICD in 2012. NYHA Class II. Follows with Dr. (Cardiology). Continued home HDMT. Statin held while on paxlovid; OK to resume 6/15/23. 8. Pulmonary HTN: per history. Continued Tadalafil at reduced dose while on paxlovid; OK to resume home dose on 6/15/23. 9. Persistent Atrial Fibrillation: Continued home BB and Eliquis. (Eliquis dose reduced while on paxlovid; OK to resume home dose on 6/15/23) 10. Hypertension: continued home meds.  11. DM2: Uncontrolled, A1c 10 on 6/6/23. Insulin continued, oral agents resumed on DC.  12. History of Ovarian Cancer: History of yolk sac tumor/endodermal sinus tumor of the left ovary with right ovary serous cystadenoma ~28 years ago, received chemotherapy at that time. S/p bilateral oophorectomy (left 1994, right 2007).  13. Toenail Injury: to Left great toe nail from stubbed toe 1 week prior to admit. Toenail removed 6/7/23 by Dr. (podiatry). No sign of infection--OTA as noted 6/12/23. . 14. Obesity: BMI 36. Lifestyle modifications advised
Patient was given a 3rd dose of Janssen COVID-19 vaccine instead of a COVID bivalent booster.
This spontaneous report has been received from a physician referring to a currently 11 year old female patient. Information regarding medical history, drug reactions, allergies, concurrent conditions and concomitant therapies were not provided. On 29-JUN-2006, the patient was vaccinated with the first dose of VARIVAX, (strength, route of administration, frequency, lot# and expiration date were not provided) for prophylaxis, then on 02-AUG-2016 was vaccinated with a second dose of VARIVAX (strength, route of administration, frequency, lot# and expiration date were not provided) for prophylaxis. No adverse effects were reported. Additional information has been requested.
LGSIL pap, HPV effects 1 year after GARDASIL vaccines referred to Gyn.