chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received dose 1 of the Pfizer vaccine and while in the waiting area, she experienced dizziness, nausea, and difficulty breathing with tingling in her throat. Her husband requested assistance. Onsite medical staff state patient?s arms and face turned red and she appeared to stop breathing, while they were speaking with her. Epinephrine was administered at 1319 and EMS was immediately.
constant sense of smelling smoke/ new smell developed in its place; This smell was so strong that at times, I could even taste it/ tastes like soured oil.; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) in the right arm on 18Mar2021 at 04:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) in the left arm on 08Apr2021 at 16:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included clogged, full-feeling ear for which the treatment was ongoing. The patient had no allergies to medications, food, or other products. Concomitant medications included guaifenesin (MUCINEX), allergy pills (MANUFACTURER UNKNOWN), nose spray (MANUFACTURER UNKNOWN) and nasal saline rinse (MANUFACTURER UNKNOWN), for indication of clogged ear from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Mar2021, after the first vaccination, the patient developed a constant sense of smelling smoke. The smell was so strong that at times, the patient could even taste it. This continued the entire 3 weeks until the second vaccine. On 09Apr2021, after the second vaccine, the smoke smell noticeably decreased, disappearing the second day after the second vaccine. But a new smell developed in its place; a smell that was more difficult to label. The patient described it as soured olive oil. This new smell was much more problematic, because everything she ate, tasted like soured oil. Like those who sell perfume had cleared their sense of smell with a sachet of coffee beans, the patient experimented the same and took a whiff of some ground coffee but it only smelled like a stronger version of the sour oil. She could taste nothing spicy nor savory. It all tasted like the dull, almost rancid taste of oil. Since there was no third vaccine to change her smell/taste, she wondered how long she should expect this condition to last. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events smell and taste alterations were not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Vaccine shot at 10:20 am Sunday.  Severe swelling of lips, face and around eyes at 6:00 pm on Monday.  Several days for swelling to go down.  Not anaphylaxis.  No swelling of tongue or throat.  No trouble breathing. Exactly the same reaction and time line after first shot, 2/14/2021.   I reported first event as well.
Seizure - prolonged >10 min < 12 hours after receiving PEDIARIX, Hib, PREVNAR, Rotavirus vaccine. Treated with VERSED, ATIVAN, Fosphenytoin EEG was negative.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (consumer). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 OMI BA.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 at 12:00 as dose 5 (booster), single (Lot number: GH9702) at the age of 66 years, in left arm for COVID-19 immunisation; BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: ER2613, Expiration Date: 31Jul2021), in left arm, on 27Apr2021 as dose 2, single (Lot number: EW0175), in left arm, on 10Nov2021 as dose 3 (booster), single (Lot number: FF2593), in left arm and on 05May2022 as dose 4 (booster), single (Lot number: FJ4989), in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Known allergies: All Narcotics" (unspecified if ongoing). Concomitant medications included: SYNTHROID, start date: Jan2008; FISH OIL, start date: 10Oct2022, stop date: 18Nov2022; B12 [CYANOCOBALAMIN]; MAGNESIUM CALCIUM; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; ASPIRIN BAYER; TURMERIC [CURCUMA LONGA]. Past drug history included: Juniper, reaction: "Known allergies: Juniper". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Nov2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Nov2022) Positive, notes: A very faint line; (Nov2022) Unknown result, notes: Tested three days in a row; (17Nov2022) Positive, notes: A bright pink line. Therapeutic measures were taken as a result of vaccination failure, COVID-19.  Clinical course: The patient first tested positive for COVID on 07Nov2022 (a very faint line) and received the Paxlovid the same day. She completed the five-day course on 11Nov2022. She then tested three days in a row. But then on 16Nov2022, she began to sneeze and has a runny nose. She tested again on 17Nov2022 as the sneezing got worse and a small cough began; she tested positive again, a bright pink line this time. At the time of reporting, the sneezing and coughing were slightly worse.
COVID-19/symptoms returned and tested positive for covid again; Interchange of vaccine products; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19/symptoms returned and tested positive for covid again) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer / BioNTech (Dose Number: 1 Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion Location of injection: Arm Left.) on 31-Mar-2021 and Pfizer / BioNTech (Dose Number: 2 Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion Location of injection: Arm Left.) on 21-Apr-2021. Past adverse reactions to the above products included No adverse reaction with Pfizer / BioNTech and Pfizer / BioNTech. Concurrent medical conditions included Postural orthostatic tachycardia syndrome (postural tachycardia) and Drug allergy. Concomitant products included PROPRANOLOL for an unknown indication.    On 21-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19/symptoms returned and tested positive for covid again) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 10-May-2022 to 14-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19/symptoms returned and tested positive for covid again) had not resolved and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.            It was reported that after Paxlovid treatment patient tested covid negative on days 5, 6, 7, 8. On day 10 symptoms returned and tested positive for covid again. Currently day 14 and still positive.  Company comment: This is a spontaneous case reported by a consumer. A patient of an unknown age and gender, previously vaccinated with 2 doses of Pfizer, experienced non serious event of COVID-19 (AESI) after receiving mRNA-1273 vaccine, reported as the third dose of the COVID-19 vaccination schedule. Onset date of the event was not provided. Patient was treated with Paxlovid with negative tests on days 5, 6, 7, 8; on day 10 symptoms returned and tested positive again. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a consumer. A patient of an unknown age and gender, previously vaccinated with 2 doses of Pfizer, experienced non serious event of COVID-19 (AESI) after receiving mRNA-1273 vaccine, reported as the third dose of the COVID-19 vaccination schedule. Onset date of the event was not provided. Patient was treated with Paxlovid with negative tests on days 5, 6, 7, 8; on day 10 symptoms returned and tested positive again. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Adverse event: alteration of ovulation and menstrual cycle. I have a very regular cycle that I track very closely with over 2 years of basal body temperature and cervical mucus data. Based on this carefully tracked data, I ovulate around cycle day 16-17 and have a menstrual period that lasts 2-4 days. After receiving the first shot of Moderna on the 11th day of my cycle, I continued to have low and erratic temperatures for 2 weeks. I did not observe any of the typical signs of ovulation.  I took a pregnancy test which was negative. My menstrual bleed was also ~10 days delayed, and lasted for about 7-8 days which is over twice the usual length of my natural menstrual bleeds. The bleed was generally the same flow (moderate) as my normal bleed, but lasted much longer.
Pain radiating down my arm and my upper whole right side of my body and in my head and then it went numb; About two minutes later, it tingled and I also had tingling on my face and around my lips; Pain radiating down my arm and my upper whole right side of my body and in my head and then it went numb; About two minutes later, it tingled and I also had tingling on my face and around my lips; Pain radiating down my arm and my upper whole right side of my body and in my head and then it went numb; About two minutes later, it tingled and I also had tingling on my face and around my lips; Pain radiating down my arm and my upper whole right side of my body and in my head and then it went numb; About two minutes later, it tingled and I also had tingling on my face and around my lips; Pain radiating down my arm and my upper whole right side of my body and in my head and then it went numb; About two minutes later, it tingled and I also had tingling on my face and around my lips; This is a spontaneous report from a contactable consumer or other non hcp (patient, self-reporting).    A 59-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: ER8732 and expiration dates were not reported), via an unspecified route of administration in arm left on 25Mar2021 as first dose, single for COVID-19 immunisation. The patient was also taking diphenhydramine hydrochloride (BENADRYL), via an unspecified route of administration from an unspecified date for an unspecified indication and epinephrine (EPINEPHRINE), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included Thyroid, High Blood Pressure and patient previously took benadryl for drug hypersensitivity and experienced drug hypersensitivity, epinephrine [epinephrine hydrochloride] for drug hypersensitivity and experienced drug hypersensitivity. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) 5 ug taken for an unspecified indication, from an unspecified date. The patient reported that she was calling to report an adverse reaction to first shot and she got the shot and about ten minutes after got the shot, she had a pain radiating down her arm and upper whole right side of the body and in her head and then it went numb and then about two minutes later, it tingled and she also had tingling on face and around her lips on 25Mar2021. The outcome of the event was recovering. Reason of delay: Daily spike of incoming calls due to COVID19 vaccine.  No follow-up attempts are possible. No further information is expected.
she is over the 1 month period; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (she is over the 1 month period) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (she is over the 1 month period). At the time of the report, OFF LABEL USE (she is over the 1 month period) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No concomitant medications were reported. No treatment related information has been reported.
Allergic reaction started  after 15 hours and worsen. hives all over her body, trunk and back. no signs of anaphylaxis.
02:30   Patient received the first dose of moderna. Patient started to feel light headed and mild rash/ redness to her shoulders.  02:40 MD at the bedside. Patient still light headed and her rash has now spread to her anterior neck and chest.  Patient taken to another building. Patient was able to ambulate. No shortness of breath, no stridor, not itchiness  02:42 Benadryl l 25 mg PO given as per MD orders  BP 155/87 HR 122 RR 20 SpO2 100 RA. Water provided and well tolerated  02: 45 Patient laying in bed, resting comfortably/  02:58 Rash is gone, no redness seen.  BP 145/77 HR 103 RR 20 SPO2 99
15-20 minutes after the injection, I started feeling a tightness in back of my throat; I broke out in cold sweat. I started getting dizzy and very whoozy. I felt my vision starting to close in. I thought I was going to pass out. I got the attention of the person across me to get an attendant and they brought me a chair with wheels. Two people got me up (and I'm not a big person) - they were worried I was going down and I was taken to exam room. They said I was white as a sheet. She checked my eyes and throat a few times and checked my blood pressure. It was lower than normal but she didn't seem really concerned about it - 104 over 60 something which is low for me. She gave me water to sip. She gave me very cold compresses to put on my forehead. They watched me pretty good. She had the epi-pen ready. She watched me and I sat in there and nurse came in a quite a few times to check me for about an hour. About an hour later the tightness went away and I started feeling myself again. We went home. I went to sleep. I woke up at night to go to bathroom and I was still a little woozy but I didn't fall. Next day, I just didn't feel well. My left arm was starting to hurt - was no swelling; it was a little red at injection site. It hurt just a little. I was woozy. My eyes couldn't focus as well. I felt out of it. I drank a lot of water and took a nap.  Yesterday, I felt pretty decent but still woozy somewhat. I tried to run errands with my husband  - just wasn't quite right. Today, much better but I'm not quite myself yet. Just a little wooziness - weird feeling. Yesterday, I did feel a soreness in the back of my right calf muscle. It wasn't warm to the touch or swollen. I don't have it anymore, it went away.  It could have been a muscle thing from the first day of the vaccine when I got home and I got up and almost fell down. I do still have some achiness in joints. Especially in my knees - which isn't normal because they are replaced.
He got the vaccine, and his arm was sore.  Before his arm got sore a few hours after that suddenly it was harder and harder to breath.  He was trying to lie down and go to sleep and couldn't breath, and progressively it got worse.  He did check his pulse and other VS and they were not unusual.   Yesterday it was worse, tingling in his hands and felt like they were asleep.  He was about to go to the ER and was out of breath while lying down and trying to rest.  Today, 5/4/21 his symptoms have totally subsided.  He took  tablets for your immune system.  Did not have any chills or anything else other than the arm pain and the shortness of breath.
Case number PHEH2013US018981 is an initial spontaneous report received from a nurse on 05 Sep 2013, with a follow up received on 10 Oct 2013. This report refers to a 17-year-old female patient. Her medical history and concomitant medication were not reported. Her vaccination history included administration of meningococcal vaccine (manufacturer and batch number unknown) on 19 Jun 2008, which she was well tolerated. She was further vaccinated with MENVEO (batch number: A11077, expiry date: 30 Apr 2013) in the right deltoid at a dose of 0.5 ml intramuscularly on 18 Jul 2013 at 01:00 pm. It was reported that MENVEO which reached 31 Fahrenheit for 3 days was subsequently administered to the patient. No adverse event was reported following these medication errors. Follow up received from a nurse on 10 Oct 2013: Updated patient demographics, vaccination history, site and time of vaccination.
Cellulitis; bruise red; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE CELLULITIS (Cellulitis) and CONTUSION (bruise red) in a 76-year-old patient of an unknown gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE CELLULITIS (Cellulitis) and CONTUSION (bruise red). At the time of the report, VACCINATION SITE CELLULITIS (Cellulitis) and CONTUSION (bruise red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment information provided
Redness, swelling, induration 4x4 in right thigh site of DTaP administration 24 hours after the vaccine was given.
Caller is 28 weeks pregnant and was given GARDASIL 9 by mistake; Caller is 28 weeks pregnant and was given GARDASIL 9 by mistake, Caller stated the nurse was supposed to give her a flu shot; No additional AE/PQC was reported.; This spontaneous prospective pregnancy report was received from a unknown age female consumer referring to herself. The patient's pertinent concurrent conditions, medical history and concomitant medications were not provided.  On an unknown date in October 2020, the 28 weeks pregnant patient was mistakenly vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) as prophylaxis instead of influenza virus vaccine (unspecified)(reported as flu shot) (for both vaccines, concentrations number of administered dose, vaccination scheme frequencies, anatomical locations and routes of administration, lot numbers and expiration dates were not reported) (exposure during pregnancy and wrong product administered). No adverse events were reported. The patient's last menstrual period (LMP) was approximately on 23-MAR-2020 and the estimated due date (EDD) of 28-DEC-2020. The pregnancy outcome was pending.
Suspect that patient received the correct age group vaccine (5-11 years COVID PFR BIV), but the vaccine ordered and documented was the wrong age group. This may be the case, as vaccines are verified by another healthcare professional before administering to the patient.
Shortness of breath, severe chest pain, debilitating pain with inability to take deep breaths, visit to ER - all tests came back negative and patient was sent home. continued to experience bouts of severe pain in the chest, left side rib cage, back left shoulder for two weeks, dry cough appeared on day 3 and developed into a severe cough, sleep disrupted, acute symptoms subsided after two weeks, and breathing returned to normal after one month. Use of ibuprofen helped relieve the pain.
Injection was given in the left joint area of the shoulder. Woke up the next morning experiencing sharp pains in the shoulder joint and running down the muscle to the elbow. It is more painful to lift my arm up and when I don't move it at all. Today is October 5 and I am still experiencing the same kind of pain.The pain still as severe as it was the day after I received the shot.
ABOUT 3 HOURS AFTER ADMINISTRATION, PATIENTS ARM HAD SEVERE SWELLING, TENDERNESS, REDNESS AROUND INJECTION SITE. HAD TO GO TO THE EMERGENCY ROOM AT 3AM WITH 104 DEG FEVER, INTENSE PAIN AND SWELLING, WAS ADMITTED TO THE HOSPITAL FOR 2 DAYS. DUE TO COMPRISED IMMUNE SYSTEM, PATIENT ENDED UP GETTING PNEUMONIA AND HAD TO BE HOSPITALIZED AGAIN.
Caller reported that the first dose just swelled her arm; There was pain; It turned red at the injection site that last 6 days and then that went away.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Apr2021 08:40 (Lot number: EP7334) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (ongoing), notes: Had for about 6-7 years.; "Arthritis" (ongoing), notes: She has had for years, started when she was little.; "overweight" (ongoing), notes: She is borderline due being overweight, if she lost weight it would probably go away. Family history included: "Rheumatic fever" (unspecified if ongoing), notes: dad; "high blood pressure" (unspecified if ongoing), notes: dad. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset Apr2021, outcome "unknown", described as "Caller reported that the first dose just swelled her arm"; PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "There was pain"; VACCINATION SITE ERYTHEMA (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "It turned red at the injection site that last 6 days and then that went away.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of peripheral swelling, pain in extremity, vaccination site erythema.  Additional Information: History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none, Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Clinical Course: The first shot was on 02Apr2021, Lot: EP7334, at 8:40am. It was noted that with the first shot, just swelled her arm and there was pain and it turned red at the injection site that last 6 days and then that went away. She took Tylenol and hot water in the shower to treat this event.  No follow-up attempts are possible. No further information is expected.
It was reported that a female patient (2 of 3) received a Fluzone SV vaccination. Reportedly the patient developed a reaction of warmth, erythematous area around the injection site for 24 + hours, measuring greater than 5cm and up to 10cm. Further information is required. From additional correspondence received on 03/06/2001, it was reported that the patient recovered from this experience. Additional vaccine, patient, vaccine administrator and responsible physician information were provided.