chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient presents with Stroke symptoms.  Started at 7:30 p.m. tonight.  Per EMS patient was in the kitchen and was staring at the refrigerator, told her husband that she did not feel well and that her left arm hurt.  Husband lowered her down to the floor.  When EMS got there per report she had a right facial droop and left arm and left leg weakness with slurred speech.  Patient is on baby aspirin.  Blood pressure for EMS was 221/151, glc 105.  Arrives as a stroke alert..  The onset was 7:30 p.m. tonight. Stroke, Afib, COVID 19 incidental finding
I have had recurrent dizziness that is not cardiac in origin. From the visit to the ER on March 27, 2021 I was told it was a post-viral syndrome syncope, but the dizziness continues to this day. I also have tried taking meclizine (no change insymptoms), received a 500mL bolus (no change), and have started taking anti-allergy medication (Allegra 180mg; no change).
Sterile diluent used for sub q vaccine and conjugate compound 135 liquid men cyw used for sub q vaccine. not sure which diluent was used with what sub q vaccine.
approx 1030Am 3DEC97 pt devel nausea, stomach pain, sore arm;school reported to parent t101.8 w/ c/o h/a, nausea medicated w/APAP;next day temp 99;painful lt arm;
Number of patients affected: 10-24. Pfizer adult vial removed from freezer on 10/28-BUD of 11/29. Vaccines administered to patients on 11/30-12/2 prior to being noticed. Attempted to submit info to Pfizer for additional stability information. Pfizer inbox full and unable to accept messages after attempting x3 days including multiple calls regarding the issue. Based on available information, determined revaccinate for these patients is appropriate. Patients will be contacted and revaccinated.
Within 12 hours after receiving dose #3 of the COVID vaccine, the patient reports sharp pain in ear/jaw/neck and knee and toes. The patient also reports body aches and chills/fevers 100.4. The patient took her BP (192/117) and messaged her PCP and rested at home. Patient took her own benazepril 40mg and hydrochlorothiazide 12.5mg. On 10/13, the patient went to Urgent Care per MD instructions and was taken by ambulance from urgent care to Hospital as EKG showed inverted T waves in urgent care and patient reported onset of chest pain. She was given nitroglycerin 0.4mg SL x 1 and aspirin 81mg x 4 by ambulance. She was treated and discharged on 10/15. She rested at home and on 10/16, the chest pain returned and new onset shortness of breath. She drives to a facility. A CT chest showed a tiny nonocclusive pulmonary embolism in a left upper lobe segmental pulmonary artery. CT abd/pelvis showed no DVT. Ultrasound doppler negative for DVTs. CT angiogram is performed and coronary arteries are clear. Troponins are negative. She was treated with Eliquis 10mg BID (10/17-10/23) and then 5mg BID x 3 months. She is discharged on 10/19/21.
I felt chills, severe muscle and joint aches, tiredness, general malaise , for 2 days
PAIN; REDNESS; BONE ACHES; STOMACH PAIN; ASTHMA (BREATHING DIFFICULTY); VERTIGO; LEFT FOOT INFLAMMATION (AS BIG AS A SOCCER BALL); KEPT ON SLEEPING; SEVERE DEEP PAIN IN THE LEFT FOOT; CHILLS/ SHIVERS; JOINT ACHES; HEADACHE; NAUSEA; MUSCLE PAIN; DIARRHEA; GENERAL WEAKNESS; FEVER; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. 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: Unknown) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-MAR-2021, the patient experienced severe deep pain in the left foot. On 14-MAR-2021, the patient experienced pain. On 14-MAR-2021, the patient experienced redness. On 14-MAR-2021, the patient experienced bone aches. On 14-MAR-2021, the patient experienced stomach pain. On 14-MAR-2021, the patient experienced asthma (breathing difficulty). On 14-MAR-2021, the patient experienced vertigo. On 14-MAR-2021, the patient experienced left foot inflammation (as big as a soccer ball). On 14-MAR-2021, the patient experienced kept on sleeping. On 14-MAR-2021, the patient experienced chills/ shivers. On 14-MAR-2021, the patient experienced joint aches. On 14-MAR-2021, the patient experienced headache. On 14-MAR-2021, the patient experienced nausea. On 14-MAR-2021, the patient experienced muscle pain. On 14-MAR-2021, the patient experienced diarrhea. On 14-MAR-2021, the patient experienced general weakness. On 14-MAR-2021, the patient experienced fever. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left foot inflammation (as big as a soccer ball) on 15-MAR-2021, and the outcome of pain, redness, fever, nausea, bone aches, headache, joint aches, muscle pain, chills/ shivers, stomach pain, diarrhea, asthma (breathing difficulty), vertigo, general weakness, severe deep pain in the left foot and kept on sleeping was not reported. This report was non-serious.
Severe case of hives; This case was reported by a consumer via call center representative and described the occurrence of hives in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th March 2022, the patient received the 1st dose of Shingrix. On 12th April 2022, 23 days after receiving Shingrix, the patient experienced hives. On an unknown date, the outcome of the hives was not recovered/not resolved.   It was unknown if the reporter considered the hives to be related to Shingrix.     Additional Information: GSK Receipt Date: 13-APR-2022 Reporter's Comments: The patient called and reported that she had first dose of Shingrix and developed a severe case of hives. The reporter consented to follow up.
p/vax pt exp severe cellulitis of lt shoulder area & was hosp;pt hosp for 5 days & treated w/IV ATB;60 day follow-up states the pt has recovered.
Case number PHEH2015US025162 is an initial spontaneous report received from a pharmacist on 30 Nov 2015. This report refers to a 60 year old male patient. Medical history and concomitant medications were not reported. His vaccination history included administration of FLUVIRIN (batch number: not reported) last year with no problems. The patient was vaccinated with FLUVIRIN (batch number: 158303) intramuscularly into left arm on 29 Nov 2015. On 30 Nov 2015, the patient experienced itchy rash on right arm between elbow and wrist. The pharmacist reported it as eczema type rash. The patient had no big hives. The outcome of the events was reported was unknown. Seriousness and causality of the events was not reported.
Temp. Imbalance Chills, Nausea , fatigue, foul diarrhea (like when I had COVID in July)  low grade elevated temp.
SHARP PAINS CONSUMING IN HER LUNGS AND HEART LIKE; INTRACRANIAL PRESSURE/ CONSTANT HEAD PRESSURE; UNABLE TO SLEEP; TEETH PAIN; BONE PAIN; TINNITUS; PALMS, LIPS AND FACE TURNED BLUE; THOUGHT SHE WAS GOING TO DIE; SHARP PAINS CONSUMING HER BODY/BODY PAIN/ ACHES/ UNBEARABLE PAIN; CHILLS; JOINT PAIN; TIRED; MUSCLE PAIN; BODY FEVER; SORENESS AT INJECTION SITE; HEAD EXPLODING; This spontaneous report received from a patient concerned a 48 year old female. 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: 1805018, expiry: UNKNOWN) dose was not reported, administered on right deltoid muscle on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced sharp pains consuming in her lungs and heart like. On 2021, the subject experienced intracranial pressure/ constant head pressure. On 2021, the subject experienced unable to sleep. On 2021, the subject experienced teeth pain. On 2021, the subject experienced bone pain. On 2021, the subject experienced tinnitus. On 2021, the subject experienced palms, lips and face turned blue. On 2021, the subject experienced thought she was going to die. On 2021, the subject experienced sharp pains consuming her body/body pain/ aches/ unbearable pain. On 2021, the subject experienced chills. On 2021, the subject experienced joint pain. On 2021, the subject experienced tired. On 2021, the subject experienced muscle pain. On 2021, the subject experienced body fever. On 2021, the subject experienced soreness at injection site. On 2021, the subject experienced head exploding. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the soreness at injection site, chills, tired, muscle pain, joint pain, body fever, unable to sleep, sharp pains consuming in her lungs and heart like, tinnitus, teeth pain, bone pain, intracranial pressure/ constant head pressure, palms, lips and face turned blue, head exploding, sharp pains consuming her body/body pain/ aches/ unbearable pain and thought she was going to die was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
REDNESS, SWELLING ABOUT 1 1/2 X 3 INCHES, ITCHING, HARDNESS IN THE CENTER, TENDERNESS.
Just a slightlly sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Just a slightlly sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Just a slightlly sore arm). At the time of the report, PAIN IN EXTREMITY (Just a slightlly sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Both Pfizer shots, just a slightly sore arm after. However, a good friend had fever, chills, headaches, and body aches for three days after her second shot. 4 closest blood relatives, brother who had Moderna and niece and 2 nephews with both Pfizer had the same results that reporter had.  No concomitant medications were reported. No treatment medications were reported.  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.
Died with a blood clot in her brain; This spontaneous case was reported by a consumer and describes the occurrence of CEREBRAL THROMBOSIS (Died with a blood clot in her brain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBRAL THROMBOSIS (Died with a blood clot in her brain) (seriousness criteria death and medically significant). The reported cause of death was died with a blood clot in her brain. It is unknown if an autopsy was performed.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.  Company Comment: Very limited information on this fatal case. However, based on the current available information and  assumed temporal association between the use of the unspecified Moderna Vaccine product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Very limited information on this fatal case. However, based on the current available information and  assumed temporal association between the use of the unspecified Moderna Vaccine product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Died with a blood clot in her brain
fever, chills, body aches, shortness of breath, chest pain, cough, headache, dizzy, pelvic pain, weak and tired everyday.  Seen in  ED twice in October, 10 Doctor visits in the last 25 days. Still experiencing shortness of breath, chest pressure, weakness, dizzy spells. Given prednisone, rescue inhaler, z-pak, steroid inhaler, cough syrup. No  relief as of 10/22.
Fever. Chills. Body Aches. All lasted several hours. We?re subsided by morning. Took Tylenol at bedtime.
Pt came to facility from long term care and currently on hospice. Pt has hemoptysis and has a pulse ox of 88% on RA. Facility has multiple residents with COVID-19 and pt was found to also be COVID-19 positive.
Swelling, pain, slight erythema and large area of induration at immunization site on right arm.
This spontaneous report was received from an approximately 84 year old female consumer referring to herself. Concurrent conditions included heart problems. She refused to provide concomitant medications. On an unspecified date, the patient received ZOSTAVAX subcutaneously to prevent shingles (lot number not provided). On an unspecified date, the patient experienced bumps on her head. She spent time at a hospital for an unspecified amount of time. No labs or diagnostics were performed. The patient stated that she might be allergic to unspecified ingredients in ZOSTAVAX. The patient's status was not recovered. The patient stated she "wanted her name to be put down for a class action suit". Additional information is not expected. The patient did not provide contact information.
I had chills and kidney pains.  These symptoms lasted for about 24 hours.  I went to an urgent care about this.  They did a urine sample, that I had UTI.
Pt experienced a rash at site of injection, subsequent eczema on hands and upper body.
ADVERSE EVENT NOS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported 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 an unspecified date, the patient experienced adverse event nos. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse event nos was not reported. This report was non-serious.
I believe my vaccine was administered by a new nursing student. She was nervous. I looked away while she gave me the shot and when she injected, I felt "lightning" out my left finger tips. I figured she may have knocked a nerve. My shoulder was sore but I did not have a point of reference to know if it was more than I should expect. My second COVID-19 injection was uneventful. 11 months later, my shoulder still hurts in upper area of my deltoid muscle. I have  deceased range of motion in my left shoulder. I cannot put on a jacket or backpack without pain in that shoulder.
8/21/19 - Pt returned to clinic for 11:00AM. evaluation of Rt Arm, sx of local reaction: Rt arm red, swollen, warm with vesicular reaction. Dr. sent Pt to ED to Rule out infection vs necrotizing fasciitis. 8/26/19. Pt returned to Clinic follow up ED visit. Treated for Local skin infection with cephalexin antibiotics. Rt arm improved.
Metallic taste in mouth; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6201) via an unspecified route of administration in the left arm on 10Mar2021 at 10:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient medical history included endometriosis from unknown date. The patient had allergy to corn and nickel. Concomitant medications included spironolactone (MANUFACTURER UNKNOWN) from unknow date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 10Mar2021 minutes after vaccine at 10:15, the patient experienced metallic taste in mouth. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event metallic taste in mouth was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild
Facial, lip, and neck numbness of the side of the body where injection was received (left). Numbness, tingling, and Pins and needles. Has occurred 4 times since receiving second dose and lasted for an hour or more each time. Starts with an initial sensation of numbness before growing in intensity and spreading across the left side of the face
Fatigue, sore throat, coughing, hoarseness, itchy eyelids, extreme headache, congestion, inside of mouth felt like hives were breaking out, big puffy eyelids. Called pharmacy where shot was given to inquire about taking some Benadryl. They advised Tylenol and okay to take Benadryl. Symptoms were bad enough to consider going to Urgent Care, something I would need to be pretty sick to do. I was starting to get worried about being able to breathe. Severe symptoms lasted about 7 hours. Giant eyelids about 24 hrs.
p/vax pt exp swelling in arm from the deltoid to wrist;pt sought unspecified medical attention;
he went to the dentist and the dentist would want to do an implant surgery; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Apr2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: DENTAL IMPLANTATION (non-serious), outcome "unknown", described as "he went to the dentist and the dentist would want to do an implant surgery". The events "he went to the dentist and the dentist would want to do an implant surgery" required physician office visit.  Additional information: The reporter's husband just took the COVID-19 bivalent Vaccine yesterday and today he went to the dentist and the dentist would wanted to do an implant surgery; she would wanted to know if it was ok for him to have the procedure with the dentist.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Janssen vaccine vial punctured at 0833 and syringes drawn, BUD time 1433. Patient arrived at 1432 and was given injection at 1442, 9 minutes past BUD time. No adverse reaction or treatment necessary.
Made oatmeal at 10:00 a.m. on 03/27/2021 and ran to the bathroom and vomited violently. Body temp.is 99.5
About 2 days after receiving the vaccine, I started to experience severe neck pain. I noticed there was a headache that went along with it. It wasn't a bad headache, but I don't normally have headaches, so I noticed it. It was difficult to lift my head. I kept experiencing pain and it wouldn't go away. I took TYLENOL, and it helped, but I could still feel the pain. I decided to call the pharmacist on 12/03/2022 and he said that it could be a result of the vaccine. I called my doctor on 12/07/2022 to ask if anyone had reported this type of problem. I went into the office on 12/08/2022. I wasn't given any prescriptions from the doctor, but the pain started to get better over the next couple of days. They did perform an EKG because I was experiencing a little pain in my chest. On 12/13/2022, I started to feel a tingling and numbness in the left side of my face, mouth and arm. I went to the ER, because I thought I may have been experiencing a stroke. While there, they ruled out a stroke by performing multiple scans. My blood pressure was 189/91. I was told to start taking a low dose aspirin. I was discharged and told to follow up with my physician. I had a tele-health appointment on 12/15/2022, and my doctor said that I may have started to experience Bell's Palsy post vaccine. While talking to my doctor, I started to experience the numbness in my face and ringing in my ears. My physician prescribed me prednisone as a preventative, in case I wake up and my face happens to be drooping. I asked my doctor about the low dose aspirin and she told me that I could take one every other day. I have a follow up on 12/29/2022 to check my blood pressure. My doctor did increase the dosage of the HCTZ.
Day 1: Evening after administration, swelling and redness through left upper arm. Trouble sleeping. Pt took ibuprofen and put ice on area. Day 2: Swelling, pain, redness, fever, blood glucose levels spiked, site painful to touch. Day 3: Redness spread across upper arm to inner arm and elbow area. Pain continued. Day 4: Office appointment for antibiotic and prednisone. Pt reported slight reduction of swelling but still pain.
Pt had fever 103-104 for 7 days followed by a diffuse mobilization rash. No other complication.
Rash started to develop after approx 38 from receiving the second shot. Rash was similar to poison ivy and appeared on upper inside of both thighs, worse on left thigh. Rash slowly spread down inside of both legs over a couple hours and also on left shoulder and itchy.  Rash was gone after approx 10 hours.