chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt tired; nausea; headache; short of breath; rapid/shallow breathing; rapid/shallow breathing; fast heart rate (100 bpm); low grade fever; felt very weak; pleuralpericardial effusion; pleuralpericardial effusion; This is a spontaneous report from a contactable consumer. A non-pregnant 78-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm on 16Jan2021 10:30 at a single dose for COVID-19 immunization.  Medical history included allergic to opioids, allergy to fish, cirrhosis with portal hypertension, parkinsonism, heart blockage, type 2 diabetes, depression, early dementia.  The patient previously took morphine and experienced drug hypersensitivity.  There was unspecified concomitant medication.  The patient previously took morphine (MANUFACTURER UNKNOWN) and experienced allergic to morphine.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient experienced felt tired, nausea, headache, short of breath, rapid/shallow breathing, fast heart rate (100 bpm), low grade fever, felt very weak, pleuralpericardial effusion on 16Jan2021.  All the events were reported with the seriousness criteria of disability, hospitalization and being life-threatening.  The patient was hospitalized for the events for 4 days.  After the injection, from 0 to 24 hours the patient felt tired, had nausea, a headache, short of breath then at about 24 hours post injection developed rapid/shallow breathing, fast heart rate (100 bpm) low grade fever and felt very weak. The patent was taken to the emergency room (ER) at 30 hours post injection and it was determined (Xray, CTA & EKG) that she had a pleuralpericardial effusion. She was flown by air life to another ER for treatment.  The patient underwent lab tests and procedures on 16Jan2021 which included angiogram (CTA): had a pleuralpericardial effusion; body temperature: low grade fever; electrocardiogram (EKG): had a pleuralpericardial effusion; heart rate: 100 beats per minute (bpm); X-ray: had a pleuralpericardial effusion.  The patient had a rapid nasal swab on 17Jan2021 which was negative.  Therapeutic measures were taken as a result of the events and included unspecified medications & oxygen therapy.  The outcome of the events was recovering.    The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
CENTRAL RETINAL VEIN OCCLUSION RESULTING IN LOSS OF SIGHT TO RIGHT EYE  I WAS ON COMPUTER AND HAD BRIGHT FLASHES OF LIGHTS THE LOST VISION IN THE EYE ABOUT 2 1/2 HOURS AFTER RECIEVING VACCINE. CRVO IS RARE IN MY AGE WITH NO HEALTH PROBLEMS. SAW ER DOCTOR THAT NIGHT THEN OPTHAMOLOGIST THE NEXT MORNING WHO DIAGNOSED ME. I AM CURREENTLY PRESCRIBED A BABY ASPIRIN AND WILL HAVE TO GET INJECTIONS IN MY EYE WHEN MACULAR EDEMA OCCURS, AN EXPECTED OCCURRENCE WITH A BLOOD CLOT IN THE RETINAL VEIN
A measles like rash that began in the groin eight days after injection and then slowly spread to torso, then arms, and then legs down to the knees.  Rash continues to spread to time of this filing, which is one week after symptoms appeared.
Narrative:  COVID infection following completion of COVID vaccine series 02/04/21 COVID vaccine dose #1 02/10/21 COVID vaccine dose #2 02/23/21 Pt reports falling 3 times in the past week, legs give out after walking a short distance, pcp offered physical therapy and attributed to neuropathy and back pain 07/22/21 Pt received COVID test for pre-procedure; COVID positive 07/23/21 Pt reports Chills, Cough, Fatigue, Headache, muscle pain (Myalgias), Runny nose (Rhinorrhea), temp 99.2 07/24/21 Pt reports fatigue, myalgia, no fever 07/25/21 Pt reports improving fatigue and myalgia, a little congestion 07/26/21 Pt reports improvement, quarantine end 8/2/21
Systemic itching all over the body; This non-serious case was reported by a consumer via call center representative and described the occurrence of generalized pruritus in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25-MAY-2023, the patient received the 1st dose of Shingrix (right arm). In MAY-2023, 2 days after receiving Shingrix, the patient experienced generalized pruritus (Verbatim: Systemic itching all over the body). The outcome of the generalized pruritus was not resolved.   It was unknown if the reporter considered the generalized pruritus to be related to Shingrix.     It was unknown if the company considered the generalized pruritus to be related to Shingrix.   Additional Information: GSK receipt date: 21-JUN-2023 The reporter was the patient who stated that he received dose of Shingrix and then 2-3 days later developed what he called a systemic inching all over the body, with no rash. No other symptoms reported. Doctor was not aware of this event yet.  Consented to follow up.
pt came in and stated he was here for his 2nd covid shot. immunizing intern looked at his vaccine record card and thought it stated he received dose 1 on 4-1-21. after administration it was determined that pt actually received dose 1 on 4-21-21. observed pt for longer time. pt stated he felt fine with no issues and even said it was his mistake he came in today bc he had it in his mind that his 2nd dose was due on 5-5-21
(Moderna) Vaccine was given beyond the refrigeration use; (Moderna) Vaccine was given beyond the refrigeration use; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED ((Moderna) Vaccine was given beyond the refrigeration use) and PRODUCT STORAGE ERROR ((Moderna) Vaccine was given beyond the refrigeration use) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED ((Moderna) Vaccine was given beyond the refrigeration use). On an unknown date, the patient experienced PRODUCT STORAGE ERROR ((Moderna) Vaccine was given beyond the refrigeration use). At the time of the report, EXPIRED PRODUCT ADMINISTERED ((Moderna) Vaccine was given beyond the refrigeration use) and PRODUCT STORAGE ERROR ((Moderna) Vaccine was given beyond the refrigeration use) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. The vial was initially stored in the refrigerator on 02-Jun-2022. The vial does not undergo any temperature excursions. No treatment medications was reported.
Woke up the following morning and neck felt sore. Lymph nodes enlarged throughout the day. After several days, the lymph node became really enlarged and pt couldn't move neck. Dr. prescribed meloxicam for symptoms. Pt also utilized Tylenol and lidocaine patches. Has been several weeks and the pain and swelling hasn't gone down.
Red, sore, painful, and swollen arm that extends from deltoid to elbow.  Started 2 hours after injection.
I had tinnitus in my right ear for at least 9 days. I still have tinnitus right now but am receiving steroids to alleviate the pain, which is working. Initially, I experienced a little hearing loss as well. It sounded like everyone I spoke with had a cold, like their voices were muddled, or they were congested. Lastly, any high-pierced noise was jarring, like sirens or the timer on our oven. As of now 9 days later, I only hear ringing and the pain with loud noises is gone.
Within 5 minutes of administration, patient felt dizzy, lightheaded, and flushed. She sat down for a few minutes but then "seized up" with her arms in clenched position and vision fixated on a point on the wall. She snapped out of it but then slurred speech for 10-15 seconds until she went back to normal. Then she felt hot and vomited. EMS took her to hospital and the next day patient said she was feeling better. Hospital could not determine cause and she is following up with her PCP.
Initial misuse report received from a nurse on 14-October-2013. The 4-months-old patient had received FLUZONE 0.25 ml. No adverse event was reported. List of documents held by sender: none.
Approx. 14 hrs after immunizations were adm. mother states she noted hives on elbows which disappeared and post a while, reappeared on another site (L cheeck, L arm, and L wrist) per her put MD's orders, she gave infant 3/4 tsp. Benadryl q 6 hrs. Hives cont. to appear and disappear x 2 days.
Headache, Myalgia,  stated also experienced fatigue and on 1/12 developed abd pain,  seen in ED and was told not sure if related to covid vaccine or not, abd us pending Narrative:  employee relayed abd discomfort and ED visit on  1/12/2021 - however she was told it wasnt clear if symptoms related to covid vaccine or not
We had received the first dose of the cervical cancer vaccine a few months before the second dose on 10/10/2011.  My daughter complained that the first dose was very painful and caused tingling in her feet and hands.  She said she could actually feel the medication run through her and burn as it went through.  We began to see some issues with her ability to eat and diarrhea after the first dose.  Our life completely changed right after the second dose on October 10th.  Her ability to eat worsened and her diarrhea did not go away.  After many tests she has now been diagnosed with an immune disorder that she never had before the vaccine and we do not have any family history of, Crohns.  She still has cramps to this day in her feet and hands.  I will never let anyone I know take this vaccine it has destroyed my daughters life at a very young age.  I am confused as to why this vaccine is being pushed so hard.  Every time I went to doctors it was peddled to me as being very safe.  I now know this vaccine is very unsafe and it was not given enough time in trials with children my daughters age.  It is time to prevent this from happening to anymore children.
Atypical ringing in ear, tinitus-like symptoms not previously present.  Specific to left ear only.
I experienced fainting while attending my prayer meeting and thought I had to go to the bathroom (vomiting/incontinence./could not get up) and an Ambulance was called to take me to the hospital and administered an IV to stop my vomiting feeling that I was experiencing. At the hospital, I was administered a COVID test and the kept me at the hospital to watch me overnight. I went to see a GI doctor and he did an coloscopy and an endoscopy. My symptoms subsided and I am continuing to take the medication that was previously prescribed for me.
Patient arrived at observation area around 12:15 pm. Complained of nausea and vomited about 25 ml. Patient later complained of chest pain. Vital signs was initiated by RN in observation area. HR 130, R: 18, BP: 200/120, O2: 99%
Information has been received from a 64 year old non-pregnant female patient referring to herself. The patient had no concomitant medication, drug reactions/allergies and pertinent medical history. On 14-NOV-2018, the patient received a dose of PNEUMOVAX 23 (intramuscular, lot# was R018136, expiration date was 10-JUL-2020; strength was not reported) for prophylaxis. The patient reported that a few hours later, she took 2 TYLENOL EXTRA STRENGTH (lot number and expiration date were unknown by reporter). The patient reported that later in the day, she began to feel arm pain at the injection site, and achy all over. She began to feel chills and temperature spiked to 102.3 Fahrenheit (F) degree. She took 2 additional TYLENOL EXTRA STRENGTH. On 15-NOV-2018, she called physician to report that she experienced the adverse effects, with no report of a response by the physician. On 15-NOV-2018, she began to feel better. Treatment was given for the events. No lab test was performed. The outcome of the events was reported as recovering. The causality between the events and PNEUMOVAX 23 was not reported.
p/vax pt entire thigh was swollen & red 93x4 inch area) w/in 24hr p/vax & lasted 48 to 72hr;
This spontaneous report as received from an office manager refers to a patient of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 08-AUG-2016 the patient was vaccinated with improperly stored M-M-R II (dosing details were not reported) (lot # M004899 expiry date: 27-JAN-2018). No adverse effects were reported. There was no product quality complaint involved. This is one of the two reports from the same reporter. Additional information has been requested.
she says her first shot hurt but not that bad; fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 01Apr2021 (Lot number: ER8732) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diverticulitis" (unspecified if ongoing), notes: Verbatim: Diverticulitis, Additional Information for Other Conditions: Caller says she has had this many years. There were no concomitant medications. The following information was reported: PAIN (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "she says her first shot hurt but not that bad"; PYREXIA (non-serious) with onset Apr2021, outcome "unknown", described as "fever". The event "she says her first shot hurt but not that bad" was evaluated at the physician office visit.  No follow-up attempts are possible. No further information is expected.
signficant left shoulder/upper arm erythema, induration, swelling and limited ROM starting after injection. Limited ROM is persisting
a 7 month old patient was inadvertently administered a Bexsero dose on 5/19/2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old female patient who received Men B NVS (Bexsero) (batch number 25DB5, expiry date 31-JUL-2025) for prophylaxis.   On 19-MAY-2023, the patient received Bexsero (left thigh). On 19-MAY-2023, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: a 7 month old patient was inadvertently administered a Bexsero dose on 5/19/2023). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 31-MAY-2023 Medical Assistant called to inquire that, what to look for in the patient? The reporter did not consent to follow-up. The patient was inadvertently administered a Bexsero dose at inappropriate age, which led to inappropriate age at vaccine administration.
Moderna COVID-19 Vaccine EUA  20-30 minutes after injection I felt faint and dizzy. Dizziness has yet to subside and have multiple times felt like I would faint. Room spins if I lay down or close my eyes.
about 45min after injection time, my lips started to tingle and my throat was scratchy. the muscles in my anterior neck and upper back felt acutely tight. I did not have any trouble breathing. the scratchy throat and muscle tightness lasted about 10 min. the lip tingling lasted about 20 minutes.  after those symptoms resolved, I started to feel flu-like and fatigued/diffusely achy.  those myalgia/fatigue symptoms lasted 5  hours. I never had a rash. I never had trouble breathing. I was back to normal about 6 hours after injection--other than an expected sore injection site.
swelling of cyst behind right ear; swelling of cyst; This case was reported by a consumer via call center representative and described the occurrence of cyst in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cyst (cyst behind right ear).   On 18th May 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 28th May 2020, 10 days after receiving Shingrix, the patient experienced cyst and condition aggravated. On an unknown date, the outcome of the cyst was not recovered/not resolved and the outcome of the condition aggravated was unknown.   It was unknown if the reporter considered the cyst and condition aggravated to be related to Shingrix.  Additional case details were reported as follows: The patient reported had a longtime cyst behind her right ear and after the 2nd dose of Shingrix the patient had experienced swelling of cyst behind right ear. The patient planned to follow-up with her physician on an unknown date.  The reporter consented to follow up.
This case involved a cluster of 4 patients (a mother and her 3 sons). This case represents one of the 4 patients (7-year-old son). The other 3 patients are captured in case numbers 2012-09093, 09094, and 09096. Initial report received from a company representative who provided a link to a non-scientific news report on 26 September 2012. On the same date, another company representative provided additional information obtained from an internet source that is maintained by the patient and her husband. This case involved a 7-year-old male patient, who had received a pertussis vaccine (manufacturer, date, route, site of administration not reported) and later developed whooping cough. The patient's 4-year-old brother was the first in the family to develop a cough. Because the patient's sister was undergoing chemotherapy, the patient went away for a family vacation with his mother and 2 brothers to avoid the risk of his sister getting sick. All of them quickly came down with nagging coughs that wouldn't go away and seemed to be getting worse. After approximately 2 weeks, the 4-year-old brother experienced a cough where he was gasping for breath during coughs, and he would turn blue, vomit, and dry heave. The next day, the family presented to the pediatrician and asked for a Pertussis test (unspecified). The 4-year-old brother was diagnosed with pertussis and the whole family was treated with antibiotics (unspecified). According to the blog posting on 14 September 2012, the patient was "doing great" while his mother and 9-year-old brother were reported to have a lesser, but still nasty, cough. The patient and his 9-year-old brother were up-to-date on their vaccines. However, the mother had not received the recommended booster shot for pertussis and his 4-year-old brother was lacking one dose of pertussis vaccine because of his age and vaccine schedule. Outcome was not reported. Documents held by sender: None.
Pt was hospitalized with Covid 19 Dose #1 Moderna given 3/12/2021 Lot # 031A21A
Heart racing happened several times the day of and a few days following. Reported to Dr. he advised not getting second shot.
Patient's opposite arm became red and splotchy within ten minutes and his face started to get red.  I gave him 10ml of benadryl and had them stay for another 10 minutes for observation.  Recommended to continue the benadryl at home if needed.
Shortly after injection area became red, swollen and tender. The redness and swelling continued to expand. Area was warm to touch. Upon exam on 07/27/18 the left upper arm had a clearly demarcated, erythematous and warm rash along the entire bicep area extending posteriorly, no streaking.
The onset of atrial fibrillation, something I had never experienced before.  Rapid and unsteady heartbeat.  About a month later, following the flu vaccine, I experienced it again.
Partial seizure, numbness on one side of body,  tremors, difficulty breathing, unable to talk, 5 minutes to complete recovery, another seizure the following night and again the next.
I got one vaccine just over 2 years ago, then I couldn't afford the second dose; This case was reported by a consumer via  interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose over 2 years before the date of reporting).   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 details were reported as follows: The case was self reported by the patient. The age at vaccination was not applicable for this report. The reporter reported that they got one Shingrix vaccine just over 2 years before the date of reporting, then they lost their health insurance and amp. The patient could not afford the second dose. Till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination. The patient now had insurance again and wanted to be fully vaccinated. The patient asked if he/she should get one more shot or two. Follow up would not be possible as contact details were not provided.
Parents noticed a rash on the child on 12/23/09 and brought her in for an office visit. She was afebrile @ 97.5, ENT was WNL, heart rate regular, lungs clear & equal. Child was alert & awake. Rash was noted to trunk, arms, legs, face, & top of hands (maculopapular). Tx plan was supportive care & parents were advised to seek further medical attention if the child had a fever or became ill.
Pt developed a fever in the first 24 hrs. after administration on 6/29/12 & fever continued for 5 days (probably not related at all.
Initial information received on 09-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves five patients (from 27 to 64 years of age) who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (lot: UJ023AB) instead of FLUZONE QUADRIVALENT on 28-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration, wrong vaccine administered and overdose. No adverse event was reported. The doctor was not involved in the cases; so it was suggested to remove his name from the report. 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. Additional information was received on 09-Oct-2018 by  "the same reporter".