chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immediately after vaccination, patient felt dizzy, lightheaded, and nauseous. Immediately laid down. Observed to be pale and diaphoretic. No loss of consciousness, alert and oriented throughout. Patient reported that he has previously had fainting episodes associated with blood draws but not previously with injections. Patient was evaluated by staff and EMS.  After 5-10 minutes lying down, felt better and was able to ambulate. Vaccination occurred at 1:35 pm; BP at 1:40 pm (lying down): 90/62. BP at 1:50 pm (sitting up): 110/78, HR 70, SpO2 100%. Patient felt better and refused transport to ED for further evaluation.
Anaphylaxis Narrative: Approximately 1 hour after vaccination, patient vomited and became sweaty, then developed hives, difficulty breathing, and panic. EMS called. Patient reports that she was treated with IV diphenhydramine and transported to ED where she continued to receive IV medication. Discharged to home after a few hours of observation. Continued to take oral antihistamine for several more days. Symptoms fully resolved 3 days later.
inflammation of her left arm; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 67-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; tofacitinib citrate (XELJANZ). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLAMMATION (non-serious), outcome "unknown", described as "inflammation of her left arm". The action taken for tofacitinib citrate was dosage permanently withdrawn. Additional information: Patient states that she is no longer on Xeljanz (5 mg) because she had inflammation of her left arm during the time when she took Xeljanz and her doctor changed Xeljanz to Rinvoq to see how it works. She did not know if it was caused by Xeljanz or her COVID vaccines. She has been on Rinvoq for two months now.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
clot in the leg; Safety information originally reported under manufacturer case 202101559190 has been nullified and re-entered under this new manufacturer report number 202300237421.  This is a spontaneous report from a contactable consumer. A patient (no qualifiers provided) received BNT162B2 (COMIRNATY) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient had clot in the leg. Outcome of the event was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.  Follow-up (10Oct2022): Follow-up attempts are completed. No further information is expected.  Amendment: This follow up report is being submitted to amend previously reported information: patient's information (name, address details, gender) were removed and patient initials was updated to unknown.  Follow-up (30Jun2023): This is a follow-up report to notify that the case 202101559190 and case 202300237421 are duplicates.  All subsequent follow-up information will be reported under Manufacturer report number 202300237421.
States she felt soreness in her arm from the shot around 3 pm however late night around 1am 12/23/2016 she started to feel hot and achy, experienced chills and a headache and had a fever of 101. Upon waking up around 7am this morning, she states her fever broke. She reported the event to me today at 2pm after most of her symptoms resolved and after taking her temperature at 2:10pm, her temperature is now 97.8. She states she still feels a little weak and achy today.
cellulitis at site of injection with evidence of streaking/lymphangitis towards the right axilla
Friday afternoon I started getting a rash on my inner thighs from my groin to my knee.  It spread rapidly o my thighs, then the underneath side of my arms, my feet and ankles, and my hands. The rash itches and is prickly. My face is flush and my eyes are itchy. It has been four days. The rash has finally quit spreading. I have bruises mixed in with the rash. I finally got an in-person appointment with a doctor tomorrow.
This non-serious initial spontaneous case, was received from a Pharmacist on 06-Nov-2017, concerning a 33-year-old, adult female patient. On 31-Oct-2017, the patient was administered with FLUCELVAX QIV (dose:0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 195243, expiry date: Jun-2018). On 01-Nov-2017, after 1 day of vaccination, the patient experienced burning while urination and swelling on one side of her labia. It was reported that, the patient used unspecified medications (not antibiotics) for urinary pain. At the time of this report, the outcome of events was not recovered (still ongoing) and not sure of her recovery (as reported). The reporter assessed the case as non-serious and causality as related to the suspect vaccine. Follow-up report received on 28-Nov-2017: It was reported that, the patient was using unspecified medications (not antibiotics) for urinary pain and not sure of her recovery. Amended narrative accordingly.
For about 36 hours after vaccine - I started getting headaches and I never get them. I had backaches and my legs were hurting too. My blood pressure was elevated as well. And that was not going away either. I went to doctor. My headaches have decreased. But for the last two to three days I have been getting chest pains. I have called the doctor this morning and I'm waiting to call me back.  It's not ongoing pain - just every now and then - I'm not sure what it is.
pt states that she had some common symptoms but the 2nd night she developed a terrible stomach ache and pain in her left side.  She had pain in both breast which this symptom is about 80 % gone at this point.  She feels like this may have been swelling of her lymph nodes.  She also got a ringing and pressure in the right ear along with pain down the neck.  The ringing and pressure got worse so she went to the ENT Dr.  on 3/3/21 which prescribed her a steroid for inflammation.  She did not take the steroids but treated her pain w/ Advil for about 5 days.  This helped w/ the pain around the ear and in the neck.  She went for a hearing test on 3/17/2021.  Test was normal.  She was diagnosed w/ Tinnitus.  Pt is  still having constant noise like a buzzing in both ears.  Doctor has advised to get the 2nd Covid dose and if she has any problems to take the steroids that he prescribed.
Expired vaccine given to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 500E21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not reported. Treatment details not provided. The vials expired on 8-OCT-2021 and were left in the refrigerator past that date.
4 hours after injection, rapid heart rate, cardiac palpitations (subsided) 2 days later severe night sweats (after 4 weeks still having severe night sweats) 6 days later, oral mouth ulcers, facial swelling (after 4 weeks still have oral ulcers, facial swelling (has gone down but still evident))
Tingling in her Tongue; Burning Sensation on the Lips and Mouth; Sore Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Tingling in her Tongue), BURNING SENSATION (Burning Sensation on the Lips and Mouth) and INJECTION SITE PAIN (Sore Injection Site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021 at 10:42 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced PARAESTHESIA ORAL (Tingling in her Tongue), BURNING SENSATION (Burning Sensation on the Lips and Mouth) and INJECTION SITE PAIN (Sore Injection Site). On 21-Apr-2021, PARAESTHESIA ORAL (Tingling in her Tongue) and BURNING SENSATION (Burning Sensation on the Lips and Mouth) had resolved. At the time of the report, INJECTION SITE PAIN (Sore Injection Site) had not resolved. Not Provided          No relevant concomitant medication was reported. Treatment information was not provided.
Six weeks after getting the third dose of the vaccine I started to experience right back pain for five weeks. The pain was in my left lower back Sacral area. The pain was worse with walking. The pain was not there when I was laying down or sitting in a certain position. I did Physical Therapy and it resolved suddenly. The next day I woke up with the same pain on my right side. It was a similar pain, but it was constant. I still have pain on the right side now and it has been two weeks. I am doing Physical Therapy weekly now. My X-Ray was normal, and I have not had this pain before. I did have back pain 11 years ago.
Narrative:  Pt had received vaccines on 1/7/2021 & 2/4/2021. Pt died of stage 4 SCC Lung Cancer during inpatient hospice care on 6/1012021. Appears covid vaccines were unrelated to patient's death.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: PATIENT HAD HISTORY OF VASOVAGAL SYNCOPE -Medium, Systemic: Nausea-Medium, Systemic: Weakness-Medium, Additional Details: PATIENT FAINTED AFTER RECIEVING HER 1ST DOSE OF MODERNA VACCINE. PATIENT'S MOTHER WAS WITH HER AND NOTIFIED US THAT PATIENT HAS A HISTORY OF VASOVAGAL EPISODES AFTER GETTING VACCINATION. PATIENT REFUSED FOR US TO CALL 911 AND AFTER LAYING ON THE FLOOR FOR 40 MIN LEFT THE PHARMACY WITH HER MOM. SHE WAS GIVEN WATER AND APPLE JUICE AND HER BLOOD PRESSURE WAS CHECKED 110/86.
Information has been received from a county health registered nurse concerning a 6 year old patient who on 30-AUG-2001 was vaccinated with VARIVAX (Oka/Merck).  On 23-MAR-2007 the patient developed varicella < 50 lesions.  The nurse reported that an outbreak of varicella had taken place in the local school district in April 2007, and this student was identified during the county health investigation.  An immunization clinic was conducted in the school where students received a second dose of VARIVAX (Oka/Merck).  This is one of 28 reports received from the same source.  No further information is available.
Regular menstral cycle started 10/1/2021 ended normally by 10/5/2021. Regular is light for most days and heavy 1 day in the middle. Restarted 10/7/2021 heavy everyday for 7 days until 10/15/2021.
Headache, chills, diarrhea, muscle soreness, soreness under right arm, redness.
10/3 very tired and had rash, 10/4 - increasing SOB - cough worked only 3 hrs had to go home - saw PCP - placed on antibiotics - no better so returned saw Dr placed on steroids and another antibiotic - felt a little better. After steroid finished started with SOB again - went to ER - Dr - IV meds, CT scan chest, nebulizer tx. Back to PCP for follow up sent to pulmonologist - O2 and oral steroids follow up.
About a month after the second shot I experienced shortness of breath, I retained fluid in legs, stomach, and chest, went to hospital several times for treatment in the months after. In November 2021 I went in to hospital for a Right Heart catheterization. Dr then diagnosed me with congestive heart faliure due to all of the fluid around my heart.
Severe headache, unable to lift arm, redness, swelling, itchy, large diameter of swelling and redness. Sensitive to touch, bruised
We gave him his 2nd pfizer COVID vaccine (got 1st somewhere else on 4-9-21).  Began experience bilateral tinnitus Sunday morning around 4am
This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. There was no concomitant medication. Information about concurrent conditions and medical history was not provided. On 25-APR-2017 at 10:00 am, the last recorded temperature of the vaccines was 4 Celsius degree. On the same day at unspecified time, the ROTATEQ were discovered out of temperature range (refrigerator temperature was 12.7 Celsius degree). The vaccines were not moved to a working refrigerator post the event. It was also reported that the vaccines experienced a temperature excursion during 1 hour 17 minutes. No previous temperature excursion was reported. A data logger issue was involved. On 22-MAY-2017, the patient was vaccinated with improperly stored doses of ROTATEQ (lot number M039067 with expiration date of 18-APR-2018; strength and dose were unknown; location was also reported as "2", dose number was also reported as "0"; Vaccines for Children Program (VFC) stock) orally for prophylaxis. The nurse sated that they would monitor every 30 minutes to insure temperature with range. It was confirmed the vaccines were OK to use. There was no adverse event reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA014144:
Initial report was received on 25 October 2011 from a health care professional. A cluster of unidentified patients had received a 0.5 mL injection of FLUZONE (lot numbers, routes, sites and dates of administration not reported) and an unspecified amount of time later, reports were made of local reaction of redness, slightly raised and warm to touch. One patient had increased redness measuring 40 mm by 50 mm in size two and three quarter inches below injection site and one patient within two hours of immunization experienced a thick tongue and shortness of breath. The patient was evaluated in the ED (emergency department), treated, release and was advised not to receive another influenza vaccine in the future. No further information was available at the time of the report. The patient's outcomes were not reported. The reporter for this case is the same as for case 2011-10408. Documents held by sender: none.
Nasal congestion and Bilateral lungs infiltrate - Transferred to hospital on 2/6/2021
Shortness of breath; Body aches; Pain; Headache; Nausea; Muscle pain; injection site pain; fever; feeling unwell; swelling of throat; weakness.; This is a spontaneous report from a contactable consumer.  A male patient of 62 years age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE LOT number UNKNOWN) On 21Mar2021 16:30 via an unspecified route of administration, on the left arm as a single first dose (at the age of 62 years) for Covid-19 immunization. Patients medical history reports bronchitis, COPD, asthma and oral cancer from 8/01 and operation/recovery/radiation till 11/01. The patient reports allergy to penicillin, nuts. Prior to vaccination patient has was not diagnosed with COVID-19. Since vaccination patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received doxycycline(UNKNOWN MANUFACTURER), metronidazole(UNKNOWN MANUFACTURER), guaifenesin(UNKNOWN MANUFACTURER), aspirin(UNKNOWN MANUFACTURER) within 2 weeks of vaccination. On 22Mar2021 patient reports to have shortness of breath, body aches & pain, headache, nausea/threw-up, muscle pain, injection site pain, fever, feeling unwell, swelling of throat, weakness. The patient also reports to have a compromised immune system due to oral cancer. No treatment was taken as a result of the events  shortness of breath, body aches & pain, headache, nausea/threw-up, muscle pain, injection site pain, fever, feeling unwell, swelling of throat, weakness. 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 shortness of breath, body aches & pain, headache, nausea/threw-up, muscle pain, injection site pain, fever, feeling unwell, swelling of throat, weakness was recovering.   No follow-up attempts are possible; information about lot number cannot be obtained.
This spontaneous report as received from a pharmacist refers to a 72 years old male patient with eczema and no drug reactions or allergies. The patient was vaccinated SC. with a dose of 0.65 ml ZOSTAVAX on 21-SEP-2012. Other suspect therapies included Influenza Virus Vaccine (manufacturer unknown) on 21-SEP-2012. No concomitant medications were reported. The pharmacist stated that patient was having exacerbation of eczema now. The patient was prescribed prednisone for the exacerbation of eczema. The outcome of exacerbation of eczema was unknown. The patient had sought unspecified medical attention. Additional information has been requested.
Patient noted to have localized redness and swelling on left thigh on 6/7/01. Patient advised treatment with warm compresses and massage to area.
3cm circular raised erythematous welt. Normal shot. 3cm circular raised warm erythema.
The patient got the symptoms and also got guillian barre in some instances; Initial information was received on 23-Oct-2020 regarding an unsolicited valid serious social media case from a consumer via social media.    This case involves a patient who got the symptoms and got Guillian Barre in some instances (Guillain-Barre syndrome), while he/she received vaccine INFLUENZA VACCINE.  Medical history, past medical treatments, vaccinations, concomitant medication 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 and expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious gullain-barre (Guillain-Barre syndrome), unknown latency following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Laboratory data was not reported.  It was not reported if the patient received any corrective treatment or not.  The outcome of the event was unknown at the time of reporting.  Batch number has been requested for suspect product for this case.; Sender's Comments: This poorly documented social media case concerns a patient with unknown demography who got Guillain-Barre syndrome after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is unknown. The patient's medical history, medical condition at time of vaccination, concomitant medication and lab test ruling out alternate etiologies were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
Patient Reported in September (9.16.21 / 9.17.21) at PCP appointment:  Continued Left Arm Pain since 2nd COVID vaccine.  1. Chronic left shoulder pain 2. Pain of left deltoid - Persistent left deltoid pain following his second dose of COVID-19 vaccination (last dose 9 months ago in January) - Exam is reassuring and benign; really impossible for me to say that this is definitively due to the vaccine. He certainly has mild muscular tension to this area, though I do not appreciate any hematoma or fluid collection. It sounds like he did not have complications immediately following his second dose.  - Encouraged he continue exploring options through Employee Health - Consider US to rule out any soft tissue injury though I feel this would be low-yield - PT course would have high probability of success in my opinion though can hold off for now - He will let me know how he wants to proceed
Information has been received from a RN concerning a 42 year old female with migraines and a history of a positive PPD and cardiac problems in 1999, who on 01/11/04 was vaccinated with a dose of MMRII (Lot # 645907/0511N). Concomitant therapy included isoniazid, progesterone and Axert. On 01/19/04 the pt developed joint soreness, cough and fatigue. On 01/26/04 she visited her physician and had a chest x-ray and flu screening (no results reported). On 01/28/2004 the pt returned to the physician experiencing myalgia, fever of 103F, arthralgia and cough. The physician prescribed fluids, rest and ibuprofen. On 01/29/04 the pt called the physician's office and reported a rash on her chest, face, arms and tingling of her skin from head to toe. She no longer had a fever. At the time of this report, the pt had not recovered. Follow up information from the RN indicated that the pt's condition had improved. At the time of this report, the pt was "still a little sluggish, not so painful." The pt was able to move more freely, there was no itch and the rash had resolved. It was noted that the pt was newly diagnosed with type II diabetes, considered by the reporter to be not related to the other events. The pt was started on metformin 250mg BID. The reporter stated that there was no additional information. Additional information is not expected.
Information has been received from a registered nurse concerning a patient who on 09-JAN-2009 was vaccinated with the first dose of ROTATEQ (lot number and route not reported).  On 26-MAR-2009 the patient was in the office to receive the 2nd dose.  No adverse effect reported.  Additional information has been requested.
"hurt right away" administered SQ. Saturday had red welt about the size of a half dollar. Sunday much bigger, very tender, rash. Lasted 3-4 days and continued to be itchy for 6 days.