chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse referring to unspecified number of patients of unknown age and gender. On unknown dates since 01-OCT-2015, the patients were vaccinated with improperly stored MMR II (lot # K006141, expiration date 29-APR-2016) (dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
On 01/04/2022, patient presented to Center for a Pfizer booster. Patient?s first dose of Pfizer was on 5/15/2021 and second dose was on 06/05/2021. At 1300, patient was vaccinated with Pfizer as a booster dose (Lot # FL3197 exp 1-21-22). According to DOB, patient is 15 years old. At the time of vaccination, minors age 12-15 were not yet been approved for Pfizer booster shots. Patient would have been eligible on 03/13/2022 based on CDC guidance for vaccination date. Patient did not have any adverse reactions during observation period.
Weakness, slightly improved now; Episode of dizziness; Injection site pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16-MAR-2023, the patient received the 2nd dose of Shingrix (intramuscular, unknown arm). On 16-MAR-2023, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: Injection site pain). On 17-MAR-2023, the patient experienced weakness (Verbatim: Weakness, slightly improved now) and dizziness (Verbatim: Episode of dizziness). On 17-MAR-2023, the outcome of the dizziness was recovered/resolved. The outcome of the injection site pain was not recovered/not resolved and the outcome of the weakness was recovering/resolving.   It was unknown if the reporter considered the injection site pain, weakness and dizziness to be related to Shingrix.   It was unknown if the company considered the injection site pain, weakness and dizziness to be related to Shingrix.   Additional Information: GSK Receipt Date:17-MAR-2023 The reporter was the patient.  He received his Shingrix dose the day before reporting and experienced injection site arm pain.  At the time of reporting, about 10 hours after the injection, he experienced weakness and the weakness was slightly improved now.  He also had one episode of dizziness one day after receiving Shingrix. Nothing else was reported.  The reporter did not consent to follow-up.
patient reports no drug allergies. patient called on 8/3/09 to report the following side effects after administration of vaccine: raised whelps and itching at site of injection
I got sick with Corona Virus; I was not feeling good; I got sick with Corona Virus; I was not feeling good; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown (booster), single (Batch/Lot number: unknown) and (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 06Jun2022, outcome "unknown" and all described as "I got sick with Corona Virus; I was not feeling good". The event "i got sick with corona virus; i was not feeling good" required physician office visit. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Report was not related to a study or programme. NDC and UPC number of COVID-19 Vaccine was Unknown. Consumer stated, "I am 53 (years) old, I had the Booster shot (Pfizer COVID-19 Vaccine), I have everything and now on 06Jun, I got sick with Corona Virus so, I was not feeling good, I called the doctor and he prescribed me this Paxlovid for COVID and I don't know how that, I would call COVID pills (Paxlovid)."When probed to clarify if consumer wants any information about Paxlovid: Consumer stated, "Yes exactly. Now since I took two dose like in the morning and in the night. I had a hives and stomach pain and Diarrhea at the timing of pain, a Diarrhea. Now I still have those symptoms like I would say a month." Consumer was informed about the role of Pfizer Drug Safety and Pfizer Medical Information for the concern. In response Consumer stated, "Yes because I felt, like I went to do my Endoscopy, I did it, I went to the Emergency room, okay can I have the number (MI Department)." When paraphrased the Booster shot as Pfizer COVID-19 Vaccine and concern: Consumer stated, "I had, I still have the stomach problem and now the Booster (Pfizer COVID-19 Vaccine) shot I got it. I was almost a year ago." When probed for further probing to file the safety report: Consumer stated, "No, it's okay, I am going to call them."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Throughout thy day on October 2, my pulse rate was getting in the 120's for long periods of time. It would sometimes go down to around 1 10 but it never got down to normal. I had some lorazepam for anxiety that I had not taken in monrhs so I took one pill and it brought my pulse rate dowm to the upper 70's to low 80's. I feel like since I received the Pfizer Booster shot yesterday, it is probably related to that.
strep pneumonia bacteremia;pneumonia 23JAN96 on top of COPD;shaking chills,rt sided,chest pain,weak,diaphoretic,febrile (104),SOB-rt upper lobe infiltrate
pt recvd vax & exp nausea, h/a, & fever 100.2 @ 8PM 14FEB93; cont nausea & h/a;
Information has been received from a physician concerning a 21 year old female patient with a history of other unspecified sexually transmitted diseases (STDs) who on an unspecified date was vaccinated with a 0.5 ml dose of GARDASIL (route and lot # not reported). The physician reported that 2 weeks after getting her first dose of GARDASIL, the patient had an outbreak of genital warts. The patient had sought unspecified medical attention. No treatment was given for the event. Vaccination with GARDASIL had not reintroduced. At the time of the report, the patient's outcome was unknown. Follow up information has been received from the vaccine administering health professional refers to the female student patient. The patient was vaccinated with the first dose of 0.5 ml GARDASIL (lot #672193/1524AA) intramuscular at left deltoid on 12-APR-2012. No other co-suspects were reported. Concomitant medications included LEVORA and dicyclomine hydrochloride. Approximately on 26-APR-2012, two weeks after onset of therapy, the patient had outbreak of condyloma acuminatum. Patient thought outbreak was caused by the GARDASIL. Patient was reassured that it is not likely, but reporter would discuss it further with the Merck representative. The outcome of condyloma acuminatum was unknown. The patient did not sought medical attention. Additional information is not expected.
Booster shot. Receive phizer dose 1 and 2. 5 days after booster had abdominal cramping and spotting even though I had a hysterectomy in August 2020. It lasted about 5 days. I saw my Gyno's NP on 12/15/21. They found no reason for the cramping & spotting and referred me to my hysterectomy surgeon. I am awaiting an appointment with him.
5 days after vaccine--severe vertigo. Nausea. Room spinning for 3 days with any movement. Dizziness with any movement has persisted for 2 weeks.
Fully vaccinated for Covid19 Pfizer 03/09/2021-04/02/2021
COUGH; POSSIBLE SHORTNESS OF BREATH; HEADACHES BACK OF HEAD TO EYES; FEVER; NAUSEA; LETHARGY; GENERALIZED ACHING; WEAKNESS; CHILLS; This spontaneous report received from a consumer concerned a 37 year old female. The patient's weight was 145.6 pounds, and height was 63 inches. The patient's concurrent conditions included hypothyroidism, allergy to egg, sulfa allergy, no alcohol use, and non smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included levothyroxine for hypothyroidism.  On 06-APR-2021, the subject experienced lethargy. On 06-APR-2021, the subject experienced generalized aching. On 06-APR-2021, the subject experienced weakness. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced fever. On 06-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced headaches back of head to eyes. On an unspecified date, the subject experienced cough, and possible shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from generalized aching, chills, fever, and nausea on 07-APR-2021, had not recovered from lethargy, weakness, and headaches back of head to eyes, and the outcome of cough and possible shortness of breath was not reported. This report was non-serious.
Patient describes a burning sensation from elbow to wrist, numbness and tingling from elbow to shoulder and slight numbness/coldness in right hand.
Patient was on our schedule today for Covid vaccination. Patient received a flu vaccination by mistake today. Patient already received a flu vaccination on 11/2/2023 I did not realize error until I went to document in patient's chart. Office manager notified immediately. Patient's PCP and the Supervising physician both notified. I called and spoke with patient. Patient was ok and asked to be scheduled for covid vaccination.
Pt had a Vasovagal syncope response and was directed to the ground, pt lost consciousness, airway was intact and patient was breathing appropriately, blood pressure was 92/44 mmHg while lying down, heart rate was 77, pt given about 4 fluid ounces of orange juice and felt better. Pt recovered quickly and walked out of the pharmacy with her mom after waiting about 15 minutes.
Positive COVID test on 11/14/22 (first symptoms 11/12/22)
Congestive Heart failure diagnosed recently. Began with pain and tightness in chest that I thought was stress/anxiety within 1 week of 1st vaccine.  Progressed to recent diagnosis of Ejection fraction 30. Also experienced a sharp decline in hormones and diagnosis of complications r/t Menopause.
-Got Immun. (flu) on 9/20. On Saturday 9/21 felt very ill - shaking, headaches, body aches, felt flushed. Still doesn't feel well. - Took temp Wed 9/25 - 91.1 degrees F - Lives with brother who currently has bronchitis.
Low grade temp 99.2 and general aches. Site warm to touch, put ice on it.
Chills, Fever 103.5, Headache, Heart Racing, Extremely tired.  Fever slowly went down overnight. After fever went down I developed stuffy nose and headache that is still present 3 days after injection.
Patient awoke to stomach cramping & diarrhea the morning after the shot. This continued during the day. She called in on the 17th but reported her symptoms were "much better". Advised her to call  MD Monday if she did not continue to improve.
This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. No information regarding concurrent conditions and medical history was reported. On 23-JUN-2015 (two weeks ago), the patients were vaccinated with first dose of GARDASIL (unknown strength, route and dose). The patients were administered second dose of GARDASIL was administered second dose of GARDASIL was administered today, on 07-JUL-2015. No adverse effects were reported. The outcome of the event was unknown. There was no product quality complaint involved. Additional information is not expected as the reporter did not provide consent for further contact.
Chills - Fever (100 degrees) - Weak/Tired  Symptoms lasted 8-10 hours
I thought I was vaccinated,  I am a flight attendant. I felt sick when I landed. On Tuesday I was in  I woke up really sweaty and had night sweats. While flying i had diarrhea and felt really sick. I didn't think I  had Covid since I was vaccination. I continued to work spreading Covid and on Tuesday morning I had a cold. On Wednesday night I had breathing difficulty, got myself vomiting, was vomiting foam. I went to ER where they did a Covid test. I was told I had Covid. They put me prednisone, prescribed a z-pack. I then had diarrhea, difficulty breathing and I am so angry because I got really sick.  It was coughing for an entire dark dog cough for a whole month. I also took Mucinex severe cough syrup which helped me get my symptoms down.   At this time, I feel like I am recovered. On may 10,2021 I stopped coughing.
red, raised blotches below inject site approx 25mm no tx-told mom to keep area clean & dry & to observe
Roughly 12-14hrs after shot I experienced a very painful headache , full body aches with muscle and pain all over (head to toe), fever was 101-102, chills, dry mouth and my throat was swollen (hurt to take ibuprofen). About 7-8hrs after symptoms began I had diarrhea and was nauseous. 24hrs after symptoms began, they were gone and I felt fine.
dizziness; increased heart rate; increased blood pressure; flushed; weakness; shakiness; lethargy; chilled; in particular hands were very cold; pale color; slurred speech; mental fog; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 25-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EL3249), via an unspecified route of administration at site of right arm on 20Jan2021 09:30 at single dose for COVID-19 immunization. Medical history reported as none. Concomitant medication included vitamin D3 and iron (SLOW RELEASE IRON) and daily multivitamin. Within minutes of receiving the dose on 20Jan2021 at 09:45 AM, dizziness, increased heart rate, increased blood pressure, flushed, weakness, and shakiness. About an hour after receiving the dose on 20Jan2021, lethargy, chilled, in particular hands were very cold, pale color, mental fog, and slurred speech. The patient did not receive any treatment from events. The outcome of events was recovered in Jan2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The reported temporary mental fog/mental impairment was likely related to first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship and clinical course of the events. 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 Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Severe Chills and shaking, fever of 103, Feeling exhausted and unable to perform normal activities for at least 12 hours
The patient came in for routine physical and his second varicella vaccine. He received the physical and vaccine and left the office. He returned to the office approximately 10-15 minutes after leaving with initial complaints of sore throat and his stomach "feeling bad". Per mom, he was vomiting but what was actually witnessed in the office was more like spitting up of phlegm and looking as though he wanted to vomit. He was crying and very agitated. Aprroximately 10 minutes later he developed swelling of his right eye (hives).  he was then sent to the ER where he was given oral and IV steroids and observed for 4-5 hours.  His symptoms subsided completely and he was sent home on a few days of oral steroids.  He has been fine since.
ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE 4/19/2023 DM 2 W HYPOGLYCEMIA
He had the shingles shot. Got blisters on left foot which broke open and spread all the top layer of flesh came off. Looked like a burn. Bad infection, can't walk on. Dr's don't know what to do. Haven't really done anything yet. May have to amputate foot.
Beginning Aug 24 at 8:30pm I started experiencing chest pain, chest tightness and cramping. Shortness of breath, lightheaded sensation  and dizziness.
The pharmacist giving vaccines gave this patient 0.3ml of undiluted vaccine. She had no symptoms other than a sore arm when we followed up the next day.
Starting on 08/03/2021 (day three) rash down both arms and on chest. Heart palpitations with some chest pain lasting about three days.
24 hours after injection, swelling at the site. 48 hours after injection urticaria to face and extremeties but no wheezing or respiratory distress. Pt currently on steroid therapy.
pt recvd vax;saturday in am,unable to speak, congested,glands swollen & woke up in am w/ eyes red & draining & very hoarse;
Sore arm Major Fatigue began 24 hours after injection, was gone by the next day
2nd vaccine 4-16-2021 Pfizer ER8731, developed hard 1 inch hard lump on left arm. Lump was tender to touch and light pink. Today 4/21/2021, vaccine 1 inch lump is still on left arm, no longer tender or pink.
Information has been received from a physician concerning a 65 year old female patient with drug reactions/allergies to DEMEROL, penicillin and "sulphure" and no pertinent medical history, no smoking, no alcohol, no drug use, who on 11-APR-2012 was vaccinated with a single dose of ZOSTAVAX (Merck) subcutaneously (dose not reported) (lot number 672428/1599AA). The physician reported that medical status prior was good health and on 11-APR-2012 no immediate reaction in the 20 minutes of office wait period after shot. On approximately 16-APR-2012 (around 5th day after shot) the patient began to have bone and muscle aches and still continued to experienced this. The patient experienced dizziness, queasy stomach and 2 or 3 bouts of diarrhea, have experienced 6-7 active chicken pox on body and felt "as if was sick with knees and cannot shake". Blood pressure was 147 on 90. The treatment was given for an AE: TEVA tablets 500mg, 5 x day x 7 days orally from 10-MAY-2012 to 15-MAY-2012 (lot number 35202142 X, exp: December 2012). Treatment therapy patient stopped 2 days earlier due to "zoster upset". It has been reported that bone and muscle aches still persisted. The outcome of the other events was unknown at the time of the report. The physician considered all events to be other important medical events. Additional information has been requested.
it was rpt from nurse concerning pt who was vax & devel diarrhea which lasted for 1 week;
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild
Right thigh red and swollen the evenings that patient got vaccinated and next morning pt had fever and convulsions, pt was seen at ER and diagnosed with febrile seizures.
she began to feel chills, was very cold, couldn't get warm; Hard time breathing; Felt as if I actually had Covid; swollen lymph nodes (left side), under the arm pit, it was very painful; still feeling fatigue; Swollen lymph nodes (left side), under the arm pit, very painful, close to breast; Chills; Arm swollen at injection site area covered size of her hand; Body aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (she began to feel chills, was very cold, couldn't get warm), DYSPNOEA (Hard time breathing), MALAISE (Felt as if I actually had Covid), LYMPH NODE PAIN (swollen lymph nodes (left side), under the arm pit, it was very painful) and FATIGUE (still feeling fatigue) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Iron deficiency. Concomitant products included ATENOLOL, CHLORTALIDONE (ATENOLOL AND CHLORTHALIDONE) for an unknown indication.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramedullar) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING COLD (she began to feel chills, was very cold, couldn't get warm), DYSPNOEA (Hard time breathing), MALAISE (Felt as if I actually had Covid), LYMPH NODE PAIN (swollen lymph nodes (left side), under the arm pit, it was very painful), FATIGUE (still feeling fatigue), LYMPHADENOPATHY (Swollen lymph nodes (left side), under the arm pit, very painful, close to breast), CHILLS (Chills), VACCINATION SITE SWELLING (Arm swollen at injection site area covered size of her hand), MYALGIA (Body aches) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, FEELING COLD (she began to feel chills, was very cold, couldn't get warm), DYSPNOEA (Hard time breathing), MALAISE (Felt as if I actually had Covid), LYMPH NODE PAIN (swollen lymph nodes (left side), under the arm pit, it was very painful), FATIGUE (still feeling fatigue), LYMPHADENOPATHY (Swollen lymph nodes (left side), under the arm pit, very painful, close to breast), CHILLS (Chills), VACCINATION SITE SWELLING (Arm swollen at injection site area covered size of her hand), MYALGIA (Body aches) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramedullar), the reporter did not provide any causality assessments.
PATIENT GIVEN A SYRINGE THAT PASSED THE 6 HOUR WINDOW IN THE REFRIGERATOR; This spontaneous report received from a health care professional 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 not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced subject given a syringe that passed the 6 hour window in the refrigerator. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of patient given a syringe that passed the 6 hour window in the refrigerator was not reported. This report was non-serious.
(From ER report) Patient presented to emergency room with marked swelling of right deltoid area (1cm from top to bottom and 9 cm semi-circumferentially). Able to move arm, slightly tender with redness and warmth. No systemic symptoms, neurologic and respiratory symptoms with in normal limits. Given prednisolone 15 mg orally for 1 week, tapering dose and Keflex 250mg orally for 1 week. Emergency room recommended ibuprofen and warm compress. Mom reported improvement by the following day.
On 25 April I woke up and felt fine and then at 10:30 am I started to feel weak. I had fever and chills and couldn't get out of the bed until 4:00pm that day. I was dizzy and drove to the hospital. They did blood work and did two Covid 19 tests. They released me and the next day I developed Heavy pains. On 27 April I woke up and went back to the  hospital. They said I had elevated enzyme levels when they drew blood and they started three iv?s. They said I was having a non emergency heart attack. They had me transferred  by ambulance to the another Hospital. They drew more blood and did elf?s and ultra sounds. The next day they said they were going  to put a stint in my heart. The next day I was prepped for the procedure and they went in and said my heart didn?t need it. The surgeon said I had Myocarditis and at 7:00 pm that night I was released.  My nose broke out with acne bumps and it feels like I have a chest cold and cough.