chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CARDIAC ARREST DURING ANESTHESIA FOR A SCHEDULED HEART SURGERY; ATRIAL FIBRILLATION; This spontaneous report received from a patient concerned a 70 year old White and Hispanic or Latino male. The patient's height, and weight were not reported. The patient's past medical history included general anesthesia.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: not reported) dose 1 total, administered on 06-MAR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 2021, the patient experienced atrial fibrillation. On 02-APR-2021,the patient went to the hospital for ablation of atrial fibrillation and experienced cardiac arrest during anesthesia for a scheduled heart surgery. Patient heart was stopped suddenly but cardiologist were able to revive patient .Patient had tested for Catheterization of heart ,CAT scan and stress test for heart prior 2-3 weeks before heart surgery. All the test were normal .On 02-APR-2021,After an event ,Patient was hospitalized for 5 days. The surgery for heart was pending.  On MAR-2021, Laboratory data included: CAT scan (NR: not provided) normal, Cardiac catheterization (NR: not provided) normal, and Stress test (NR: not provided) normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cardiac arrest during anesthesia for a scheduled heart surgery on APR-2021, and the outcome of atrial fibrillation was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0. 20210512607-COVID-19 VACCINE AD26.COV2.S-Cardiac arrest, Atrial fibrillation. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s)
2 y/o male. After receiving Hepatitis A IM 0.5ml injection the nurse noted that the patient was not breathing with his eyes rolled back and body had become very rigid, this lasted about 2 to 3 minutes, nurse sent a co-worker to get Dr. Patient eyes rolled to a normal position as his mother was calling his name, patient began to blink and then to cry. Physician spoke to parents and vital signs were repeat. Parents were asked to remain 15 minutes for further observation. Patient continue to cry with no further distress noted. Patient was referred to neurology for further evaluation.
EXPIRED VACCINE ADMINISTERED TO PATIENTS; This spontaneous report received from a pharmacist concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A and expiry: 21-SEP-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced expired vaccine administered to subjects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered to patients was not reported. This report was non-serious.
Following administration of Tdap, MENACTRA, HPV and a PPD placement, pt felt dizzy, nauseous, pallor and involuntary muscle twitching of legs, abdomen and arms. She lied down for about an hour, drank some Gatorade and ate some crackers. She attempted to meditate which seemed to help symptoms. Muscle spasms began to abate after about an hour and she was able to self-ambulate out of the office.
This case was reported by a nurse via call center representative and described the occurrence of injection site itching in a 63-year-old female patient who received SHINGRIX (batch number B327C, expiry date 4th July 2020). Concurrent medical conditions included hypercholesterolemia. Concomitant products included BOOSTRIX. On 17th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site itching, injection site erythema and injection site hives. On an unknown date, the outcome of the injection site itching, injection site erythema and injection site hives were recovered/resolved. The reporter considered the injection site itching, injection site erythema and injection site hives to be probably related to SHINGRIX. Additional details were provided as follows: The health care professional reported that the patient experienced an itchy red area and hives around the injection site on the left arm and hives also developed in this location. It took 2 to 3 weeks to resolve. The patient applied anti-itch cream to the area. Time to onset was not documented in the patient's chart. No further information was provided.
Cramping; Diarrhea; This is a spontaneous report from a contactable nurse (the patient). A 77-year-old, non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3249) via an unspecified route on left arm on 11Feb2021 at 14:00 (at age of 77-year-old at vaccination) as single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had medical history of hypertensive. Concomitant medications included hydrochlorothiazide, triamterene (DYAZIDE); biotin; glucosamine; metoprolol succinate (TOPROL XL); fish oil for unknown indications within 2 weeks prior to the COVID vaccine. The patient did not receive any other vaccination within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient previously took scopolamine [hyoscine butylbromide] and demerol and experienced drug allergy. On 18Feb2021 at 12:15 PM, the patient experienced cramping and diarrhea starting a week after first shot and lasting 2 weeks after second shot. Doctor or other healthcare professional office/clinic visit for the events. The events were treated with Imodium and Bentyl. The outcome of the events of cramping and diarrhea was recovered on an unknown date in 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/23/2023 HYPOXIA R09.02 HYPOXIA 4/20/2023 HYPOXIA
Developed 30%, Heart PVCs. Dr. performed a Cardiac Ablation. The problem was resolved but then recurred after 10 days.  Current condition, 30% of heartbeats are PVCs
Dizziness, slight vertigo, weakness. Checked patient's BP: 140/90, temp: 98.2 F, Pulse: 97. Advised patient to lay down (made her feel worse); sitting up was better for her. She also had a little candy and water from her employer. After 15 minutes she was escorted to the nearest clinic. The next day, I followed up with her and she says she was discharged from clinic with just needing some rest. They were unsure whether it's vertigo or if she may have the flu.
pt recvd 2nd dose of vax  on 18MAR92 & w/in 30 mins exp blurred vision & tightness in chest; felt uncomfortable & cold & clammy; tx Epi; pulse & BP 120 & 140/70; presented to ER & dx anaphylactic react;
Outer aspect entire upper arm painful, mildly swollen, 7x7 cm area of redness. Limited range of motion of upper extremity for 48 hours. Pruritus requiring diphenhydramine. No hives visible.
Patient developed a rash on her left arm above the site that extended up into her chest and neck area about 14 minutes after the vaccine was administered. Resolved within 25 minutes per father.
administered Shingrix to a patient 19 years of age; varicella vaccine was intended to be given; This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 19-year-old male patient who received Herpes zoster (Shingrix) (batch number 4n2ab, expiry date 10th February 2023) for prophylaxis.   On 30th August 2021, the patient received the 1st dose of Shingrix. On 30th August 2021, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The registered nurse informed that, during the day a nurse practitioner administered Shingrix to a patient 19 years of age when varicella vaccine was intended to be given, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter did not consent to follow up.
Headache, body aches, chills, nausea, diarrhea, no rash but itchy
Instantly after receiving my second dose, I started to experience nausea and vomiting. My blood pressure started to rise and my heart was beating so fast I felt like it was going to come out of my body. They had to open a vein and gave me Benadryl and other things. I was kind of out of it, so I'm not sure exactly what was given to me. They got me into a bed and gave me a lot of medications. Gradually I was able to start breathing. I had to calm myself by thinking about my breathing to normalize it. After everything was kind of back to normal, I was able to go home. I was not able to drive, so a family member took me home. At home, my daughter stayed with me. I started to have fever and chills and so I went into bed. My daughter is young and she was nervous for me. I received a phone call while in bed and I wasn't able to speak. My throat was killing me and I had a lymph node expanded under my left armpit. I took Tylenol and Advil and I was able to fall asleep. I sweat out the fever while in bed. I was in bed for about 48 hours trying to push through these reactions. The palpitations still happen and they did start back up more noticeably after my booster shot.
Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: PT FELT DIZZY AND WEAK, DENIES ANY PAIN AT THE INJECTION SITE OR REDNESS OR SWELLING.-Mild, Systemic: Weakness-Mild, Additional Details: PATIENT FELT DIZZY AFTER 5 MINUTES OF VACCINATION AND SHE ALMOST MADE HERSELF SLIDE DOWN THE FLOOR, NO HEAD INJURY, SHE REMAINED CONCIOUS FELT WEAK, HELPED HER TO SIT ON THE BED, WITHIN FEW SECONDS SHE FELT BETTER, HER VITAL SINS WERE STABLE BP -89/60 PULSE- 77 O2 SAT -98, SHE STATED SHE WAS GOO TO GO, FELT BETTER DENIES ANY DIZZINESS ABLE TO STAND UP BY HER SELF, PT FELT DIZZY AGAIN ON THE ENTRANCE BACK TO CLINIC, EMS ACTIVATED, VS STABLE BS -125 EMS EVALUATED HER AND SENT HER HOME.
This spontaneous report as received from a registered pharmacist refers to a patient of unknown age. On 18-NOV-2013, the patient was vaccinated with ZOSTAVAX (VIAL) (dose, route and lot number were not reported). No concomitant medications were reported. Approximately in November 2013, the patient experienced lower back pain, and "requires an epidural" for it on 22-NOV-2013. The outcome of lower back pain was reported as not recovered. Additional information has been requested.
sinus infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2), administration date 19Apr2021 (Batch/Lot number: unknown) 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: SINUSITIS (non-serious) with onset 06May2021, outcome "unknown", described as "sinus infection".  Additional information: Reporter stated that both he and his wife received their first PFizer Covid vaccine dose on 19Apr2021. They are due for their second dose of the vaccine soon. However, they both have sinus infections and were pressribed an antibiotic to take. The sinus infection started approx. 06May2021. He wants to know if he needs to wait to get the second dose of the vaccine. In response it was informed to reporter that Pfizer was unable to make treatment recommendations. Spoke from attached document CONS-COVID-19 vaccine-use of antivirals and antibiotics at vaccination (v1.0) and referred reporter to speak with HCP for treatment recommendations.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
severe headache started after few days of the second moderna shot  ended up in the hospital after few days of headache  MRI brain shows transverse sinus thrombosis  started on anticoagulation discharge home in 2 days on oral anticoagulation
Patient given the flumist and is over the age of 49.  No symptoms.  Patient notified, and will return to clinic to receive the flu injection.
Patient said she is unable to raise her arm after immunization. Onset unknown but reported the symptoms on 11/8/2016.
Culminated in myocardial infarction. Chest pains started next day and leg pains. By April 23, I had severe chest pains and had to see medical at work. On April 30, 2021 was at emergency department for heart attack symptoms. Was transferred for myocardial infarction. Test results show myocardial infarction, coronary spontaneous arterial dissection, and blood clot.
4 day history of sudden facial deviation to the right.  Not able to close her eye.  (Bell's Palsy).  Plan: Moisturize cornea.
Severe arthralgia and myalgia approx. 18 hours, post vax, with red, warm induration of 5" X 3".
Patient saw RN, for redness, warmth, and fevers since getting PCV 23 vaccine. First noticed redness and tenderness at site the following day after receiving vaccine in pharmacy along with fever. Redness progressively got worse. Patient took Tylenol. provider diagnosed her with allergic reaction and cellulitis and prescribed cephalexin 500mg.
PCV13 vaccine given to me May 22, 2015 on arm. Swelling disappear after 3 days. The redness is now spreading dowm to elbow. Antibiotics given May 22, 2015 by doctors office.
Shingles; other zoster related conditions; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of an unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about  05-APR-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, dose # and route not specified) for the long-term prevention of singles and zoster-related conditions. Subsequently on an unknown date, the patient was treated for singles and other zoster related conditions. As a direct and proximate result of the patient's receipt of zoster vaccine live (ZOSTAVAX), the patient continued suffer ongoing injuries including but not limited to mental and physical pain and suffering, medical care and treatment for these injuries; significant medical and related expenses as medical losses and costs included care for hospitalization, physical care, monitoring, treatment, medications and supplies, diminished capacity for the enjoyment of life, diminished quality of life, increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of singles was not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
sore left arm; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on (04Jun2021), this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from a Pfizer sponsored program. The reporter is the patient.  A 73-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 09Feb2021 18:00 (Lot number: EM9809) at the age of 72 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (ongoing), notes: 10 yrs ago; "Arthritis" (unspecified if ongoing). Concomitant medication(s) included: CELEBREX taken for arthritis (ongoing); LOSARTAN taken for blood pressure increased (ongoing); AMLODIPINE BESYLATE taken for blood pressure increased (ongoing).  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10Feb2021, outcome "unknown", described as "sore left arm".  Additional Information: Consumer stated, "I had my first COVID shot on the 09Feb. I am scheduled to have my second COVID shot on the 1st of March. I had a full hip replacement on the 18Feb. The Caller is asking about drug interaction with the covid vaccine he got his first shot on, 09Feb2021 and he is scheduled for his second dose next week, Monday, 01Mar2021. He took baby aspirin and he is asking if he should stop taking it until the second dose is given. He is also asking about the interaction of the COVID-19 vaccine with Oxycontin, Codeine, Tramadol, Tylenol. No prior vaccination (within 4 weeks). No relevant tests.  Follow-up (07Jul2021): Follow-up attempts are completed. No further information is expected.
got the latest strain of COVID/still battling symptoms; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (got the latest strain of COVID/still battling symptoms) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    In October 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In December 2022, the patient experienced COVID-19 (got the latest strain of COVID/still battling symptoms). At the time of the report, COVID-19 (got the latest strain of COVID/still battling symptoms) was resolving.            No concomitant medications were reported. It was reported two weeks ago patient and wife received the latest strain of COVID.  Both were boosted in October. But that booster did not save them and two weeks later patients were still battling symptoms, which was gradually diminishing with time and were not well yet. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-696394.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696394:Wife case
This case was reported by the daughter of a consumer and described the occurrence of multiple venous clots in a 65-year-old female subject who was vaccinated with Flu vaccine (GlaxoSmithKline), Pneumonia vaccine. A physician or other health care professional has not verified this report. On an unspecified date the subject received 1st dose of Flu vaccine (unknown GSK vaccine) and unspecified dose of Pneumonia vaccine (unknown). On the same date of vaccination with Flu vaccine and Pneumonia vaccine, the subject developed muscle pain. She became very ill and was hospitalized. It was discovered through muscle biopsy that the subjects veins were throwing clots everywhere. At the time of reporting, the subject was still hospitalised and myocitis was ruled out. Physicians were still not able to determine the cause of the subjects clotting disorder. At the time of reporting the events were unresolved.
12 hours later I had a full red body rash, red bumps, swollen hands, inflamed wrists, flu like symptoms, dizziness, nausea, headaches,  swollen tounge, extreme exhaustion, a feeling of being completely out of it, otherworldly.  I should have gone to the hospital but I have an extreme medical phobia so I stayed up and made sure my tounge didn't swell any further.  The next morning my tounge was normal ish, the red rash was gone and my hands and wrists were back to normal.  5 days later and I am still experiencing headaches, my throat feels sore and a little bit of a hard time swallowing, extreme exhaustion, dizziness, nausea, a feeling of being completely out of it, otherworldly.
After the 2nd dose, which was administered on November 24, I have had a constant headache and nasal/sinus issues. Last night, while working, my nose began to continuously leak a bloody mucus liquid.
Patient called 2 days later describing a local reaction with a knot on her arm. Rash the length of a finger and felt very hot to the touch. She put on ice and took some TYLENOL as comfort.
NAUSEA/VOMITING; TIGHTNESS IN CHEST EPISODE RESOLVED. CLIENT WAS MONITORED FOR 30 MINUTES.
LIGHT-HEADED; DIZZINESS; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the subject experienced light-headed. On APR-2021, the subject experienced dizziness. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from light-headed, dizziness, headache, and nausea. This report was non-serious.
Patient admitted to the hospital 2 days after receiving the COVID-19 vaccine following PEA arrest with ROSC.  Pernotes she was sitting on the couch at home when she suddenly became unresponsive. EMS was called and upon arrival patient was noted to be in PEA arrest.
Pt is a 36 y/o Caucasian Male who came for Covid-19 vaccine  At 0845am_ I called him in to the room and during the questions about allergies and reactions to medications: So, he expressed to me that he suffered from Anxiety and panic attacks sometimes and that he had not gotten vaccines since childhood. He also verbalized apprehension about the severe side effects of this vaccines. I talked to him for a while, reassured him that the vaccination process was painless. At around 0900am I gave him the Vaccine and Kept him sitting in my room after to closely observe him. I reviewed the possible severe and mild side effects before and after Vaccine. He verbalized understanding. At 0910_ I asked him how he was feeling, and he stated that? he didn?t feel well, that he felt weird and shaky.? I called for help and nurse came in talk to Pt for a couple minutes then I asked her to call RN. They both came in the room where Pt was sitting and after talking to him for a few minutes and trying to calm him down the RN notified the Provider NP @0915_NP came in the room to assess the Pt and told us to call 911.  @0920_ nurse  called 911 and gave reports of Pt condition, while we transferred Pt on to exam bed and plugged Vital-Sign machine. Pt continue to hyperventilate and check his own pulse in his Carotid area. B/P 138/85; Pulse 88; RR 22; PO2 100%. @925_ the Paramedics arrived and after giving them report they assessed Pt and tried to coach Pt to slow down his breathing pattern and  offered reassurance that his vital signs and Po2 was normal @ 100 % in Room air; And they also  offered to take him to the hospital, but Pt declined He stated ?I?ll be Ok? this happens before.  @940 Vital Signs at this time were- B/P 120/82; PR 80; PO2 100%; RR20. @950 Paramedics prepared to leave and help Pt to sit in waiting room chair. Pt sat in waiting area for 15 more minutes until he felt better and left to his home in stable condition.