chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Covid 19 positive; confusion; weakness; cough; fever; body aches; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of COVID-19 (Covid 19 positive), CONFUSIONAL STATE (confusion), ASTHENIA (weakness), COUGH (cough), PYREXIA (fever) and MYALGIA (body aches) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced COVID-19 (Covid 19 positive) (seriousness criterion hospitalization), CONFUSIONAL STATE (confusion) (seriousness criterion hospitalization), ASTHENIA (weakness) (seriousness criterion hospitalization), COUGH (cough) (seriousness criterion hospitalization), PYREXIA (fever) (seriousness criterion hospitalization) and MYALGIA (body aches) (seriousness criterion hospitalization). The patient was hospitalized on 14-Mar-2021 due to ASTHENIA, CONFUSIONAL STATE, COUGH, COVID-19, MYALGIA and PYREXIA. At the time of the report, COVID-19 (Covid 19 positive), CONFUSIONAL STATE (confusion), ASTHENIA (weakness), COUGH (cough), PYREXIA (fever) and MYALGIA (body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, SARS-CoV-2 test positive: positive (Positive) Positive.     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.   Treatment information not reported. No concomitant medications reported.  Company Comment - Based on the mechanism of action of mRNA-1273, the event is assessed as unlikely related to mRNA-1273. However, the events of confusional state, asthenia, cough, pyrexia, and myalgia maybe related to COVID infection. Further information has been requested.; Sender's Comments: Based on the mechanism of action of mRNA-1273, the event is assessed as unlikely related to mRNA-1273. However, the events of confusional state, asthenia, cough, pyrexia, and myalgia maybe related to COVID infection. Further information has been requested.
pt states that a couple of hour after taking the 2nd shringrix dose he started have severe pain in his right leg.  He says the muscles hurt to the bone in his right leg.  He also has other body aches and pains as well as a headache.  He went to bed but once he laid down he was not able to raise his body to get up and thought he was going to have to call an ambulance.  The next morning he was able to get up.  His tastebuds are off and states nothing he puts in his mouth taste good.  He does feel like he is somewhat improving.
belief they are in the early stages of a shingles; belief they are in the early stages of a shingles; Itching; receiving first dose in November of 2019 and second dose in 2021, due to COVID; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingrix. In November 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pruritus and social problem. On an unknown date, the outcome of the vaccination failure, shingles, pruritus and social problem were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pruritus to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 7-July-2022 Reporter's Comment: The reporter was the patient. The patient received first dose in November of 2019 and second dose of Shingrix more than 6 months after the first dose, in 2021, due to COVID. The reporter reported that she belief that she was in the early stages of a Shingles outbreak. The patient was experiencing itching in the same area of previous Shingles outbreak. The reporter did not consent to follow-up. Additional supportive information: The patient received the 2nd dose more than 6 month after the 1st dose due to COVID, Social problem. This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation of shingles were unknown at the time of reporting.
heavy bleeding, large blood clots, spotting and two periods in the month following first moderna vaccine  ear hissing - tinnitus
received a dose that expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 67-year-old male patient who received HAB (Twinrix) (batch number x239d, expiry date 7th August 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th August 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 16th August 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-AUG-2022 Reporter's Comments: The nurse reported that a patient received a dose of Twinrix that was expired on 7th Aug 2022. The reporter consent to follow up. Additional Supportive Information: The patient received an expired dose of Twinrix, which led to expired vaccine used.
3 migraine events/aura & migraine switches sides; booster; Aura/aura & migraine switches sides; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 01Dec2021 20:00 (Lot number: 3303080) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "high bp" (unspecified if ongoing); "pmdd" (unspecified if ongoing); "migraine w/aura" (unspecified if ongoing); "mal de debarquement" (unspecified if ongoing); "migraines" (unspecified if ongoing), notes: I have been getting migraines for the past 19 years.; "penicillin" (unspecified if ongoing); "sulfa" (unspecified if ongoing); "nightshades" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; SERTRALINE; NORETHINDRONE [NORETHISTERONE]. Past drug history included: Erythromycin, reaction(s): "Reaction: Allergy"; Lanolin, reaction(s): "Reaction: Allergy"; Kaolin, reaction(s): "Reaction: Allergy". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0150, Location of injection: Arm Left), administration date: 15Apr2021, when the patient was 37 years old, for COVID-19 Immunization, reaction(s): "I got a migraine on day 2, 3 & 4."; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER2613, Location of injection: Arm Right), administration date: 23Mar2021, when the patient was 37 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021, outcome "unknown", described as "booster"; MIGRAINE (non-serious) with onset 03Dec2021 14:15, outcome "not recovered", described as "3 migraine events/aura & migraine switches sides"; AURA (non-serious) with onset Dec2021, outcome "not recovered", described as "Aura/aura & migraine switches sides". Therapeutic measures were not taken as a result of migraine, aura.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
her left arm is huge and a sack of fluid is hanging from her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A 79 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 (Lot number: EP6955) as dose 2, single for covid-19 immunisation. Relevant medical history included: "hypertension" (unspecified if ongoing). Concomitant medication(s) included: SPIRONOLACTONE taken for hypertension. Past drug history included: Lisinopril, reaction(s): "edema", notes: wound up at hospital over night with edema; Lisinopril, reaction(s): "couldn't breath", notes: wound up at hospital over night with couldn't breath. Vaccination history included: Bnt162b2 (1st Dose), for Covid-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset Mar2021, outcome "unknown", described as "her left arm is huge and a sack of fluid is hanging from her arm". Therapeutic measures were taken as a result of peripheral swelling.  Additional information: Patient said her left arm was huge and a sack of fluid was hanging from her arm. It looks like jelly, was out of shape and wobbles. She doesn't know if it was localized or has traveled to other parts of her body, specifically to her heart. She had a previous experience after taking lisinopril and wound up at hospital over night with edema and couldn't breathe. She took 100mg of spironolactone for hypertension. She contacted her hypertension doctor and her primary care physician and a message from her primary physician only said to take Tylenol.   No follow-up attempts are possible. No further information is expected.
Tingling and numbness in left hand and fingers, same arm as injection site. Began on Friday, February 5, 2021 at about 7pm,  approximately 35 - 40 min after injection. Arm at injection site iced 20 minutes on 40 minutes off each hour for 4 hours before bed. Tingling and numbness didn?t interrupt sleep, but adverse effect returned in the late morning of Saturday, February 6, 2021, increasing in intensity in the afternoon and remaining constant in the evening.  Doctor advised to continue icing. Doctor also advised to seek additional treatment if symptoms, constant tingling and numbness, didn?t relieve or got worse or other symptoms presented. Told to report a adverse effect here by doctor.
Facial and chest acne; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the right arm on 17Feb2021 at 15:00 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL8982) via an unspecified route of administration in the left arm on 27Jan2021 at 15:00 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. On 24Feb2021, the patient experienced facial and chest acne. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event facial and chest acne was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Shaking, cold, clammy, sweaty, headache. Gave BENADRYL and KENALOG in office to try to help. It didn't.
This spontaneous report was received from a pharmacist via a company representative concerning a 63 year old female patient. The patient's pertinent medical history and concurrent conditions were not provided. On 09-SEP-2015, the patient was vaccinated with a dose of ZOSTAVAX (Lot # L012475), 0.65 ml, subcutaneous. The pharmacist reported that the patient experienced an injection site rash on 10-SEP-2015 the day after receiving ZOSTAVAX injection. The rash was treated with BENADRYL and hydrocortisone cream. On 13-SEP-2015, the patient's condition worsened. The patient went to an unspecified urgent care center and was diagnosed with localized shingles (herpes zoster) and cellulitis. At the time of the report, the patient's outcome was unknown. Adidtional information has been requested.
20OCT-21OCT dull h/a; 23OCT diarrhea, achy all over, heavy feeling; 24OCT no appetite, heavy feeling, aching in muscles & joints; 25OCT missed work because still not feeling well; 26OCT stomach cramps; 27OCT no appetite sore throat;
Headache, severe chills, muscle aches, nausea, fatigue, injection site pain
On 11/08, I began having mid and low back pain, the body sensations (twinges all over), tingling in my feet and legs and hands.  After the second dose, I was prescribed Gabapentin.  I started taking that then and took it again with the symptoms from the 3rd dose.  The symptoms lasted until 11/22.  After the second dose, the symptoms continued until 03/21, longer and more extensive than after the 3rd dose.  I'm a bit anxious about taking the 4th dose, but think I will since the Covid cases are increasing.
Shortly after receiving the vaccine I experienced a warm sensation near my sternum. The sensation was internal and radiated from my left side to my sternum.  I also felt slightly dizzy, but it eventually resolved.  In the evening (7:00 pm) I felt fatigued and experienced headaches, body aches and pain in my left arm.  It was painful to move my left arm and difficult to put clothing on.  It is still painful today (12/18/20), but I'm managing it with Tylenol.
Muscle aches, joint pain, fatigue, mild nausea, slight nerve pain, ear pain, hot flashes, chills, redness at injection site, pain at injection site, swelling at injection site.  All symptoms started overnight from 3/10-3/11 and most were gone by noon on 3/12.
Horrible pain in my right arm where I received the shot, the pain spread to my shoulder, front and back of arm, down my arm to elbow, headaches, to my neck area, and elevated BP . It wakes me up every night.
heart racing, uncomfortable pulsating sensation in right leg for 3 days following vaccination. symptoms subsided after 3 days.
Impression: SIDS. This case was reported by a nurse and described an infant who died after receiving diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined for prophylaxis. The vaccine provider submitted a report directly to VAERS. The patient's past medical history included premature birth at 34 weeks' gestation; there had been no prenatal care. The medical history also included gastric reflux. Concurrent medications were not reported. On 7/21/03 the patient received an injection of Pediarix (lot 21881E9), as well as, other unspecified vaccines. Three days post immunization, on 7/26/03, the patient died. Cause of death was unknown. An autopsy was performed; the results were not available as of 8/13/03. Death certificate confirms the cause of death as SIDS.  - 10/16/2003 autopsy report rec'd.  COD confirmed as SIDS.
Woke in the middle of the night feeling like my heart was ?vibrating?/racing against my chest and some shortness of breath. Lasted about thirty seconds and resolved itself. Happened again for a couple of seconds a day later and resolved itself. Did not recur.
Dose 1: Pfizer 3/7/21 Dose 2: Pfizer 3/28/21 Booster: Pfizer 9/23/21
High fever; chills; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old male patient received the BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the arm right on an unknown date (at the age of 28-year-old) as a dose 2, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the right arm on an unknown date (at the age of 28-year-old) as a dose 1, single for COVID-19 immunisation. 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 have COVID-19 test. On an unknown date, the patient experienced high fever and chills, on and off for 20 hours 10 hours after receiving the vaccine. Lab data included body temperature of result high fever on an unknown date. The clinical outcome of the event high fever and chills was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient initial added in first name field.
On 4/18/21 at approximately 9:50am, client had just received her first dose of the Pizer vaccine (lot# EW0171 exp: 8/31/2021) at vaccination site. The client was sitting in the observation area after her vaccine when she started to feel very weak and lightheaded.  EMT went over to assist when the client stated she was not feeling well and then promptly fainted.  EMT called over to another nurse who helped bring the gravity chair over and assisted the client to lay down and started to take vital signs at 1000:  blood pressure (BP) 108/62; heart rate (HR) 71, oxygen saturation (02) 99%. Client was alert and oriented to place, time, location, and person throughout her 30 mins. observation. The client very shortly after lying down stated that she was feeling better. The client's airway was patent. She did lose consciousness momentarily. The client did not fall or strike her head on the ground. The client then stated that she has routinely had similar experiences while receiving shots in the past that have led to her fainting as well.  The client was monitored for 30 minutes after the initial syncope.  EMT took the following vitals at 1005: BP 110/64, HR 72, 02 99%; 1010: BP 112/68; HR 70, 02 99%; 1015 BP 116/68, HR 72, 02 99%, 1020: BP 116/68, HR 74, 02 99%; 1025: BP 116/68, HR 70, 02 99%: 1030: BP 116/68, HR 72, 02 98%. The client?s vitals quickly returned to normal range for the client. After the 30 minutes of monitoring the client stated that she felt fine. The client had arrived with friends who were able to assist the client by driving her vehicle for her to go home.  The client was instructed to seek medical assistance if any symptoms worsened throughout the day. The client left vaccination site around 1030 with a steady gait.
My period completely stopped immediately after the vaccine. I had no menstrual bleeding at all in the month of May or June 2021. Prior to the vaccine I was on a regular cycle for over 3 years with regular periods. At the beginning of July I started bleeding every day and it has continued now through December with no more than one day here or there of it stopping. In the last 15 days the bleeding has been heavier than I have ever bleed in my 40 years.  It has now been nearly 6 months that my body has been bleeding daily.....
This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender.  The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date(s), the patients were vaccinated with improperly stored doses of VARIVAX from lot # M010480 with expiry:01-MAR-2018, and M004329 with expiry: 26-JAN-2018, for prophylaxis (dose, route and anatomical location not reported). The vaccine lots had a temperature excursion of -13.6 degree Celsius for 3.5 hours. No adverse effects were reported. The vaccines had no previous temperature excursion. The temperature excursion was identified by data logger. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA001439:
Abnormal uterine bleeding. I take my OCP continuously and on time daily and never have periods or break through bleeding. I have been on OCP form 19 years and taking continuously for 10 with no issues until 8/16/21. I am having a full blown heavy period for now 3 days where I am bleeding through tampons within 4-6 hours.
Zero to no hearing in her left ear; Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (Zero to no hearing in her left ear) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hearing disability (Hearing issues, but not to the point of deafness/lost of hearing.) and Ear tube insertion.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced DEAFNESS UNILATERAL (Zero to no hearing in her left ear) (seriousness criterion medically significant) and VERTIGO (Vertigo). The patient was treated with PREDNISONE ongoing since an unknown date for Hearing loss, at an unspecified dose and frequency. At the time of the report, DEAFNESS UNILATERAL (Zero to no hearing in her left ear) and VERTIGO (Vertigo) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Acoustic stimulation tests: profound hearing loss (Positive) Profound hearing loss.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product used was provided by the reporter.  Around 22-Apr-2021, the patient started experiencing vertigo and went to the doctor. A hearing test was performed because she had zero to no hearing in her left ear. Hearing test indicated profound hearing loss. The doctor thinks the vaccine caused her hearing loss. They told her to get a COVID and antibody test because the virus might have caused the hearing loss. The patient had therapy for her ears and she regained her hearing back a little bit, but she will still have to get hearing aids.   Treatment information included prednisone and hearing aids.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  Company Comment   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow-up received on 17-Jun-2021 included no new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Given dose of vaccine that was diluted with the incorrect amount of diluent, .8 instead of 1.8 Pt observed for 30 mins, no problems