chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10 minutes after the vaccine I had sudden cold hands (the kind of inside cold like Propofol gives you), with palpitations and dizziness. Self limited in a few minutes. BP was 150/90 which is high for me. Similar episode but shorter and less intense within next half an hour. There was also a sensation of chest awareness (not pain, but a bit of tension, which I have experienced before with anxiety and put it on anxiety).  After a while decided to go home and while walking I noticed a clear sensation of chest warmth. I decided to stick around the hospital a bit more, pondering about going into the ER. DRank 2 bottles of orange juice and headed home. Then on the way home  I had 2 presyncopal episodes. The fact that I had not eaten all day and wasn't well hydrated might have contributed. However, that was scary enough that I called 911. By the time they arrived I was fine.  DEcided not to go to the ER. I ate some, drank some, and took Benadryl 25 mg.  The chest tightness got better.  I still continued to experience  waves of chest warmth/heat/burning sensation and chest awareness/ tension, coming on in waves and going away in a couple of minutes. I was obviously anxious by this time but I do not believe the warmth was anxiety related. I have had anxiety before but never with this manifestation. I was tired, slept like a baby and this morning I feel at baseline. Some soreness at injection site but none of that chest warmth.
second dose has not been received yet; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 24th June 2020 with batch number C7EX2 and expiry date 26th January 2022).   On an unknown date, the patient received 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 was provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.  The reporter did not consent to follow up.
Took two unrefrigerated doses of Vivotif; Spontaneous report received on 05MAR2020.   A pharmacist reported that a consumer "took two unrefrigerated doses of Vivotif" (PT: Product storage error) for immunisation. The consumer took first and second dose of Vivotif on 28FEB2020 and 01MAR2020 respectively which were not refrigerated. 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 took first two doses of Vivotif which were unrefrigerated (Product storage error). Vivotif must be stored in the refrigerator at the recommended temperature. Considering the nature of the event, the causality of Product storage error is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took first two doses of Vivotif which were unrefrigerated (Product storage error). Vivotif must be stored in the refrigerator at the recommended temperature. Considering the nature of the event, the causality of Product storage error is assessed as not applicable to Vivotif.
This spontaneous report was received from a registered nurse and refers to a 4 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The stock of vaccine was received on 18-JAN-2017. On 13-FEB-2017, the patient was vaccinated with an improperly stored dose of PROQUAD, lot # M038860 with expiration date of 13-MAR-2018 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 27 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA013888.
A couple of week after the 1st Dose Moderna, around 03/10/2021, my boss noticed my face was red. I did not think anything about it. I felt weak. Other people noticed my face was red. I would continue to get very weak. Until I could not function anymore. That is when I went to see my nurse practitioner, she said my pulse rate was 60. She sent me to a cardiologist. The cardiologist gave me a stress test. I ended up with a heart catherization. That's when they found the blocked heart artery. They put me on medication, beta-blocker, toprol 25 mg od, low dose Bear Aspirin od. I have recovered from the AEs with the medication and I am being monitored by my Nurse practioner and my cardiologist . It has slowed me down a little bit, but I'm good. I'm still working. I go back for a check up on 11/08/2021.
arm  is tight where the got shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (arm  is tight where the got shot) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A20, 011A21A and 029K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (arm  is tight where the got shot). At the time of the report, VACCINATION SITE INDURATION (arm  is tight where the got shot) outcome was unknown.            This case was linked to MOD-2021-369389, MOD-2021-369375 (Patient Link).
Information has been received from a consumer referring to her approximately 19 year old daughter. The patient had no pertinent medical history, concomitant medication or drug allergies/drug reactions. The patient received the GARDASIL 3-dose series (strength, dose, frequency and route unknown) in approximately August 2011 (reported as 5 years ago). On an unspecified date in 2016 (reported as a couple months ago), the patient had an abnormal Papanicolaou (PAP) smear, which came back as irregular and no further clarifying information was provided. The patient had an unspecified biopsy performed (unspecified date in 2016) which determined she had cervical dysplasia. No treatment was given for the events. Action taken with suspect therapy was not applicable (It was also reported that therapy with GARDASIL was continued). The outcome of the events and causality assessment were not reported. Additional information is not expected as no consent for follow-up was given.
Vaccination site pain/arm sore after second one; Knee pain/left knee pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain/arm sore after second one) and ARTHRALGIA (Knee pain/left knee pain) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    There was no reported medical history.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain/arm sore after second one) and ARTHRALGIA (Knee pain/left knee pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain/arm sore after second one) and ARTHRALGIA (Knee pain/left knee pain) had resolved.      No concomitant medication details were provided. No treatment medication details were provided.  The reporter's causality for the event vaccination site pain with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event of arthralgia was not provided. ~  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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.   This case was linked to MOD-2021-624271 (Patient Link).
Pt has no adverse reaction, however received the booster shot, but hasn't completed the original series prior to.
I received my second dose of Pfizer on 01/11/2021 @6:30pm. I started feeling my whole body aching and my face was flushed   @8:00am on 01/12/2021 @6pm I felt really bad I had a fever of 102.5 that would not go down, my body was so weak I was unable to move I couldn't feel my feet only my legs, I was shaking from chills I felt really cold but my body was really hot to the touch and my  temp was really high, I felt pressure on the left side of my head like it was going to pop. @ 5am on 01/13/2021 I woke up like nothing ever happened and have been good ever since.
pt had elevated t104R & inconsolable for > 3 hr; pt also devel hives but mo thought hive related to a change of soap; p/48 hr pt was back to nl routine;
Fatigue, unspecified type  Dizziness  Fever, unspecified fever cause  Weakness  COVID-19 virus infection  Office Visit 5/12/20Family Practice PA Family Medicine COVID-19 virus infection +4 more Dx Cough  Reason for Visit Progress Notes (Physician Assistant) ? ? Family Medicine ? ? Encounter Date: 5/12/2021 Cosign Needed Expand AllCollapse All      Assessment/Plan      TENT.    1. covid positive - symptoms and diagnosis occurred x15 days ago. He was improving but starting yesterday he has developed R sided chest pain and has been slightly SOB. Cough has worsened as well. He has not been taking ASA, will rule out PE at this time. STAT chest CTA ordered, CBC, and CMP. Possibility of secondary pneumonia but will hold off on abx for now, review after chest CTA results. Continue Acetominaphen and hydrating. If any symptoms worsen or the following occurs go directly to ED; fever/chills, chest pain, SOB. Patient understands and agrees.    If chest CTA rules out PE and shows pneumonia would cover w/ azithromycin/ceftin/prednisone.    Diagnoses and all orders for this visit:   COVID-19 virus infection -     CBC; Future -     Comprehensive metabolic panel; Future -     CT angiogram chest pulmonary embolism with and without contrast; Future   Fatigue, unspecified type -     CT angiogram chest pulmonary embolism with and without contrast; Future   Other chest pain -     CT angiogram chest pulmonary embolism with and without contrast; Future   Tachycardia -     CT angiogram chest pulmonary embolism with and without contrast; Future
Pfizer COVID Vaccine: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 3/4/2021 and 3/25/2021. Presented to ED 2/17/2022 c/o intermittent chest pain x1 week progressing to severe. EKG showed inferior STEMI sent to cathlab unable to pass wire, CP resolved. Elevated white count and procalcitonin, started on iv abx. 2/18/22 Covid+. Later had a cardiac arrest ACLS x/multiple rounds w/ROSC, intubated. Subsequent CT scan showed probable perforation near the GE junction w/hematoma near spleen. Renal failure and was started on CRRT, circuit kept clotting due to her severe illness and COVID, unable to dialyze. Continued to decompensate and then had severe bradycardia tx'd with transcutaneous pacing and eventually the family made her DNR. Expired on 2/19/2022.
Redness and induration Rt ant thigh at site of PREVNAR shot 1 day after shot.
Breakthrough case admission after 3 vaccines  Pfizer 3/8/21 Lot# EN6200;  Pfizer 3/29/21 Lot# ER8727;  Pfizer 11/18/21 Lot# Ew0183;
Shortly after midnight I woke up due to severe body aches, chills, and a fever of 101. I haven?t been able to sleep since then and my fever has spiked as high as 104.5. I?m also experiencing headache, ear aches, mild sore throat, nausea, and chest tightness/pain during deep breathing. No shortness of breath symptoms though. Aleve and Tylenol do not appear to be helping. I feel worse than when I had Covid back in November.
I came down with COVID in December. I was lightheaded, had chills, fever, and body aches. I had headache and sinus pains. It started on the 18th and continued until the 21st. For the most part the fever broke and everything cleared except the headache, the sinus pressure, and the fatigue. That continued for the rest of the week. Consciously now I am recovered except for the occasional brain fog and my fatigue doesn't seem to clear. The headache seems to come and go, but the exhaustion does not seem to clear. I consulted with the doctor and was not given PAXLOVID because I did not have blood work on file and was not able to go into the lab due to having COVID. I also took the influenza vaccine at the same time as my COVID vaccine in October, in the same arm. I had arm soreness with this but nothing else.
Severely altered and impacts my every day functioning; not had recovery of my smell/taste; not had recovery of my smell/taste; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 18Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, 2 step vaccination I had done in Jan/Feb of last year.), administration date: Jan2021, for COVID-19 immunization.  The following information was reported: ANOSMIA (non-serious), AGEUSIA (non-serious) all with onset 2021, outcome "not recovered" and all described as "not had recovery of my smell/taste"; IMPAIRED QUALITY OF LIFE (non-serious), outcome "unknown", described as "Severely altered and impacts my every day functioning".  Additional information: Forwarded as an Adverse Event by the team on 03Feb2022 Reporter provided verification of contact address on 03Feb2022. Subject: Patient Assistance "Customer Verbatim: Hello, I'm reaching out with concerns in response to the 2 step vaccination I had done in Jan/Feb of last year. Following the 2nd dose 18Feb I have not had recovery of my smell/taste which has been severely altered and impacts my every day functioning. I have been seen by my primary physician without resolution. This concern in on my medical records. Is there guidance, compensations, answers to help bring back my quality of life! I was hopeful time would help heal, it's not!".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccine on 1/30/21, 2/20/21, 9/1/21. Covid + 1/25/22. Admitted 1/21 for acute hypoxemic resp failure 2/2 Covid19 and superimposed bacterial PNA. Per wife sxs onset 1/10, Covid + 1/12. Recived monoclonal antibiodies prior to this admission. Course c/b L arm DVT > compartment syndrome > fasicotomy. Intermittently proned for low P/F, paralyzed, and started on inhaled Velitri. Respiratory acidosis and hypoxia cont to worsen despite interventions required 2 vasopressors. Transitioned to comfort care.  Treated with molnupiravir, ambisome, cefepime,vancomycin, and cresemba. Pt expired on 2/9/22
Developed a sore throat a few hours receiving vaccine on 12-13-21.  Still have sore throat to this day.  In the meantime, I also developed cough (with green mucus), congestion, and overall sickness.  Still battling those symptoms.  On 12-22-21, developed hives.  Over the day and next few days, the hives spread to all over my body.  Still battling hives, itching, and angioedema to this day.  Went to ER on 12/22, 12/24, and 12/25, and then admitted into the hospital as an in-patient on 12/25.  Lips swelled, lost voice, throat felt like it was closing up.  Released on 12/27.  I am still sick with sore throat, cough, congestion, hives, itching, angioedema. Never before had hives in my life.
Started oral typhoid 6/10/02 a.m. In evening had swollen left elbow. No NTV, no headache, no upset stomach, no anorexia. Swelling in antecubital fossa = only sign. no pain.
This spontaneous case was reported by a patient and describes the occurrence of EXTRA DOSE ADMINISTERED (The patient was given two 0.25 ml doses of the Bivalent Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 66-year-old male patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. AS7143C and AS7143C) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Pfizer (Dose 1), Pfizer (Dose 3 (first booster dose)) and Pfizer (Dose 2). Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer. On 02-Sep-2022 at 1:20 PM, the patient received fourth dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 02-Sep-2022 at 2:42 PM, received fifth dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to .25 milliliter. On 02-Sep-2022, the patient experienced EXTRA DOSE ADMINISTERED (The patient was given two 0.25 ml doses of the Bivalent Moderna COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (The patient was given two 0.25 ml doses of the Bivalent Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown. No past illness information for the patient was not provided. The patient had not experienced symptoms with any previous doses of any vaccines. No concomitant medications were reported. The patient had not experienced any symptoms since having the two doses of 0.25 ml. Treatment information was provided as none.
This patient had vaccine administered 01/09/01 at 1:45 PM. The client noted red , slightly raised rash on knees and arms. On 01/11/01 he also noted "pimplish" rash on thighs and calves, lymph nodes "inflammed", no temperature noted. History of cold one week prior to Christmas, progressed to sinus infection. Last dose of Amoxicillin was 01/05/01. Took Pseudoephedrine on 01/09/01 and 01/10/01.
Severe chills started on Saturday, March 6 at11 pm, lasted thru night. Headache, body aches. In morning 6:30 am weak, nausea, dry heaves, sweating, lethargic till Sunday morning at 9:30 am. Able to eat toast and tea, most symptoms  abated, just extremely tired rest of day. By 12 noon on Monday back to normal routine.
This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unspecified dates, the patients were inadvertently vaccinated with GARDASIL (dose, route of administration, lot # and expiration date were not reported) that has been improperly stored. Concomitant therapy was not provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Tired; Injection site soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 51 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) at the age of 51 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Tired"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Injection site soreness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Aches and pains in joints, fever, shooting pains in joints, lethargy, migraine, neck pain. Took Tylenol to try and help with the pain. Lasted for over 36 hours.
felt a chemical rush to my head; dizzy; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 57-year-old non-pregnant female patient received bnt162b2 (Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in left arm on 13Mar2021 (at the age of 65 years old) as single dose for covid-19 immunization. Medical history included allergy to sulfur based drugs. The concomitant medications in two weeks included vitamins. The patient had no other vaccine in four weeks. The patient felt a chemical rush to my head and felt a little dizzy on 13Mar2021. The patient had not COVID prior vaccination and did not have COVID tested post vaccination. No treatment for events. The outcome of events was recovered.   No follow-up attempts are possible. No further information is expected. The information about lot number and expiration date cannot be obtained.
Crohns Disease flare ups; Gastrointestinal issues; COVID; COVID; MARKETING PROGRAM NOT AVAILABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4234680-00.  A 31 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 31Mar2021 (Batch/Lot number: unknown) at the age of 30 years as dose 1, single, intramuscular, administration date 23Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 23Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 27Dec2021, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset 27Dec2021, outcome "not recovered" and all described as "COVID"; CROHN'S DISEASE (medically significant), outcome "not recovered", described as "Crohns Disease flare ups"; GASTROINTESTINAL DISORDER (non-serious), outcome "unknown", described as "Gastrointestinal issues". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Jan2022) negative. The action taken for adalimumab was unknown. Concomitant drugs and dates of administration (Exclude those used to treat event): Concomitant Drugs Not Reported Other Relevant History: Not reported.   The reporter's causality for the event(s) of GASTROINTESTINAL ISSUES, COVID and CROHNS DISEASE FLARE UPS was not provided with HUMIRA(ADALIMUMAB).   The reporter causality for Gastrointestinal disorder, COVID-19, Crohns disease aggravated is possible with PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN).  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information and a possible contributory role of suspect product BNT162B2 to the development of events Crohn's disease flare up, drug ineffective, suspected covid19, gastrointestinal disorder cannot be totally excluded. 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 RAs, Ethics Committees, and Investigators, as appropriate.