chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash on left arm is gone now; arm achy at injection site; coughing up old mucus; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 02Feb2021 as SINGLE DOSE for covid-19 immunisation. Medical history included rash and patient states that her whole life she had asthma and allergies, had hypereosinophilia syndrome, and year round allergies, normally her lungs are pretty congested, sinuses are normally they are swollen shut, normally her eyes have a lot of discharge and are watery and they are not watering, her lungs are clear and her sinuses are clear. The patient's concomitant medications were not reported. The patient experienced rash on left arm is gone now on 03Feb2021, coughing up old mucus on 02Feb2021, arm achy at injection site on 03Feb2021. Patient knows she read that there is an RNA teacher cell is what she calls it and wants to know it, it taught her body to not fight the other stuff. Has this been reported before. Other thing that happened, got vaccine yesterday around lunch, both last night when she came home and early this morning, was coughing up little nodules of mucus. States another thing that is interesting, yesterday when she got the injection, she asked to have it in the right because she had a rash on her left arm and today it is gone. Only thing she got was arm at injection site was a little achy. started this morning. States that she remembers hearing in clinical trials they did not test the vaccine on pregnant people or people with allergies so she thought they would like to hear from someone with severe allergies.   Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
After 3rd dose the next day had chills and fever 100.9 for about 6 hours and felt like the flu for next 2 days. Took 4th dose per CDC phone call.
Hospitalization: 10/21/22 - 10/26/22.  Presentation to the ED: worsening SOB and generalized weakness.  COVID + date: 10/21/22. Treatment: remdesivir, steroids, LMWH  and antibiotics.  Discharge to: HOME W/ HOME HEALTHCARE SERVICES.
pt  went to the hospital  complaint  about  chest tightness , joint pain , red cheeks , rash , headache and heart palpitation ,  As per pt she  received benadryl shots   since  she cannot take  any steroid and was  stabilized and was  discharged  to home  and she  feeling  better
passed away; very sick; Fatigue; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (passed away) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In September 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced ILLNESS (very sick) and FATIGUE (Fatigue). The patient died in October 2021. The cause of death was not reported. An autopsy was not performed. At the time of death, ILLNESS (very sick) and FATIGUE (Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.  Company Comment: This is a spontaneous case concerning a 90-year-old, male patient with no reported medical history, who experienced the serious (due to medically significant and fatal) unexpected event of Death among other non-serious events. The event Death occurred on the following month after the first dose of mRNA-1273 vaccine. The cause of death, accurate date of death and circumstances leading to death were not provided. An autopsy was not performed. The patient also experienced non-serious events of lllness and Fatigue. The outcome of the event was reported as fatal. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Reported Cause(s) of Death: passed away
Burn; This is a spontaneous report from a contactable consumer(patient).  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 18Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization.  The patient medical history and concomitant medications were not reported.  He got his first dose on 18Mar2021 and got a burn last week in Apr2021, and was prescribed with antibiotics for the next 7 days and he was scheduled to receive the 2nd dose on Thursday, and wanted to know if the antibiotic would affect the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
PATIENT STATED THAT STARTING THE DAY AFTER VACCINATION (11/17/22) THAT SHE STARTED TO HAVE PAIN AND REDNESS AROUND INJECTION SITE. PATIENT STATED THAT PAIN WORSENED OVERNIGHT AND THAT SHE HAD TROUBLE SLEEPING DUE TO PAIN. WHEN PATIENT PRESENTED TO THE PHARMACY PHARMACIST WAS ABLE TO OBSERVE THAT REDNESS WAS 5-6 CM AROUND AND OVAL SHAPED (ELONGATED UP AND DOWN ARM).
Child's arm began to break out in small red bumps which turned into red whelps from child's shoulder to the elbow. Very itchy, no shortness of breath, no fever.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with first dose GARDASIL on 16-JUN-2008 (lot # and route were unspecified). It was reported that the patient received the second dose of GARDASIL late on 13-AUG-2012 (lot # and route were unspecified). The patient was not experiencing any known symptoms. No other information were provided. Additional information has been requested.
After waiting 30 minutes, I left the site.  Felt short of breath, but attributed that to the stress of getting the shot-I don?t like needles and the person who administered it was not nice.  I left work early, went home, took a nap and when I woke up, my heart was racing, and it wasn?t like it does after exercise
Have had the vaccine and shingles four times/Suspected vaccination failure; Had shingles four times; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Have had the vaccine and shingles four times/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Had shingles four times). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   Additional Information: GSK receipt date: 31-MAR-2023 The case  was received from the patient via interactive digital media. The patient had the vaccine and got shingles four times This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
This spontaneous report was received from a registered nurse concerning a current 18 year old male patient who received the third dose of RECOMBIVAX HB before 24 weeks of age (route was not provided). Nurse stated that the local county health department would not accept the third dose since it was administered to the patient before 24 weeks of age. No adverse events were reported. Additional information has been requested.
Rec'd 1st & 2nd dose according to 0, 1 mo schedule w/each dose w/in 24 hrs post vax, experienced "severe joint pain in every joint in body". Each time, the condition lasted 24 hrs & resolved, w/out tx;
Fever; patient's temperature was checked and recorded to be at 101.5; pain; I gave her the shot; This is a spontaneous report from a contactable consumer (parent). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number: unknown; Expiration date: unknown) as 2nd dose, single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 on an unspecified date as 1st dose, single dose for COVID-19 immunisation. On an unspecified date, the patient experienced fever and pain. The reporter stated that he/she gave the patient the shot and the patient got her 2nd shot yesterday at 4:00 pm. The reporter was asking if paracetamol (TYLENOL) can be given to the patient or if he/she should call a doctor. On an unspecified date, the patient's temperature was checked and recorded to be at 101.5. The outcome of the reported events was unknown.  No follow up attempts are possible. Information about lot/batch number cannot be obtained.
This is an instance of breakthrough COVID-19 disease after which death occurred. The individual was vaccinated with the Pfizer product on 01/04/2021 and 01/25/2021. They tested positive for COVID-19 three times on 09/30/2021 at the nursing home at which they were a resident. They had encounters at a hospital on 09/29/2021, 09/30/2021, 10/03/2021, 10/04/2021, 10/07/2021, 10/08/2021, 10/11/2021, and 10/19/2021 but it doesn't seem that any of these resulted in a hospital admission. The encounter on 10/11/2021 admit/discharge times are about 10 hours apart. The individual died on 10/22/2021.
7-20 GARDASIL 9 administered in left arm. Large local reaction (itchy, red, warm, few hives) in office. Received ZYRTEC in office. Improved in afternoon. Over night developed headache and temp 100.8. 7-21 Seen in office, clinically well, no hives, diffuse warm erythematous skin 10x13cm. No hives, non-tender, no evidence of infection.
This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EM9809) via an unspecified route of administration, administered in left arm on 04Mar2021 at 10:45 (age at vaccination was 32-year-old), as dose 2, single for COVID-19 immunization. The patient's medical history included some SVT (supraventricular tachycardia) in heart. The patient's concomitant medications (within 2 weeks) were reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The facility type where the vaccine was administered was reported as doctor's office/urgent care. The patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: PAA156051) via an unspecified route of administration, administered in left arm on 10Feb2021 at 13:30 (age at vaccination was 32-year-old), as dose 1, single for COVID-19 immunization and experienced slight metallic taste and became energetic over the next two days. On 04Mar2021, the patient experienced super hot / increased heat / extremely hot, back pain, increased heat and sweating, headache, chills / strong waves of chills / cold chills, left side of face feeling weird, fever/ 99.3 fever with shakes / from 99.5 to 101.6 in exactly 20 minutes / 101.6 to about 103 in 34 minutes / fever fluctuated between 101.3 to 102.7, muscle aches, joint aches, and increased heart rate (120 bpm resting). It was reported that the patient experienced super hot for 10 minutes on 11:30 (hour 1) and hour 4; major back pain, hot but no fever on hour 8; back pain with increased heat and sweating on hour 9; trace headache, chills and left side of face feeling weird but nothing physically noticeable on hour 10; patient was the same (but not as much), with fever, headache (feeling), muscle aches and joint aches on hour 11; more and more strong waves of chills, increased heart rate (120bpm resting), no headache while back pain and aches continue on hour 12; extremely hot with super cold chills, and 99.3 fever with shakes on hour 13; and on hour 14, the patient went from 99.5 to 101.6 in exactly 20 minutes and in the same hour the patient went from 101.6 to about 103 in 34 minutes. It was reported that between hour 15 and 18, the patient's fever fluctuated between 101.3 to 102.7. The patient underwent lab tests and procedures which included body temperature of 99.3 (fever; hour 13), 99.5 (hour 14), 101.6 (hour 14; changed in exactly in 20 minutes), 103 (hour 14; changed in 34 minutes), 101.3 (between hour 15 and 18 fever fluctuated), and 102.7 (between hour 15 and 18 fever fluctuated); all on 04Mar2021; and heart rate of 105 bpm (normal rest rate) on an unspecified date and 120 bpm (resting; increased; hour 12) on 04Mar2021. There was no therapeutic measures were taken as a result of the events. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
This case was reported by a pharmacist via call center representative and described the occurrence of sleep loss in a 64-year-old female patient who received SHINGRIX. Previously administered products included ZOSTAVAX (On an unknown date, the patient received ZOSTAVAX). On 23rd May 2018 13:30, patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 23rd May 2018, several hours after receiving SHINGRIX, the patient experienced sleep loss, chills, muscle pain, feeling hot and injection site pain. On an unknown date, the patient experienced incorrect product storage. On an unknown date, the outcome of the sleep loss, injection site pain and incorrect product storage were unknown and the outcome of the chills and feeling hot were not recovered/not resolved and the outcome of the muscle pain was recovering/resolving. The reporter considered the sleep loss, chills, muscle pain, feeling hot and injection site pain to be related to SHINGRIX. Additional information was reported as follows: The pharmacist herself was the patient who reported the case. The patient received the vaccine on the left arm. The nurse indicated at the time of injection, that the vaccine had been frozen. This led to incorrect storage of drug. The lot number and expiry date for SHINGRIX were unknown. The patient started to feel achy all over the last night, before the date of reporting. It worsened over time but was a little better on the date of reporting. She also felt feverish even though she did not take her temperature. The pain in her arm woke her up several times during the night and she experienced chills so she didn't sleep well. The site of the injection was very sore and tender. It hurted to lifted her arm up. The patient's call was transferred to Medical Investigation to see if she needed to be revaccinated.
Pfizer 3/26/21, 4/16/21. Positive on 2/12/22
Reported near syncope, dizziness x few minutes. Sat + drank some water & resolved
Janssen COVID-19 Vaccine EUA slight rash (red skin) on back of both hands and slight headache; both faded after a couple of hours
Was given Varicella vaccine on 02/27/11. Started feeling sick the day after the injection with sore throat, was congested, stuffy nose and hard to breathe. Started around 3pm in the afternoon. Injection site is red and painful to touch.
Widespread body aches (especially in the injection arm and various joints), diarrhea, tiredness, nausea, dizziness,  shortness of breath, all starting on the evening of 2/27/21 and worsening  2/28 - 3/1 (at the submission of this report). Slight fever of 98.9 on 2/27 and  99.8 2/28 - 3/1.
vaccine was given and child started to itch leg  within 5 minutes of giving vaccine.  We looked at the site and multiple hives were noticed. 2.5ml/6.5mg of Benadryl were given.  Itching and hives started to diminish within 10 minutes.  Gave instructions  for severe reaction at home and mild instructions.
This spontaneous report as received from a medical assistant refers to a 6-month-old patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 20-APR-2017, the six month old patient was vaccinated with the first dose of ROTATEQ (orally; dose, lot# and expiration date were not provided), instead of "being administered their first dose of ROTATEQ between six and twelve weeks". No adverse effects were reported. Additional information has been requested.
I had sore throat, cough, and muscle aches. The muscle aches only lasted a day. Then, I just had a cough and congestion. When I noticed the symptoms, I went to urgent care. They tested me for COVID-19. The result was positive. They prescribed PAXLOIVD. I took three pills in the morning and three pills in the evening for five days. I isolated for five days and limited my contact with the public for a full 10 days. My symptoms resolved after the first five days. I also took acetaminophen and a medication like DAYQUIL and NYQUIL.
Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Nausea-Mild
Pt. said flu shot hurt during administration. Over 3 weeks later she said it still hurts and hurts when she lifts her arm up. (reported to pharmacy 9/22/17).
On 06/24/2022 I started experiencing a longer span of headaches since receiving the Covid-19 vaccine.
Received vaccine on Monday by Wed afternoon lower abdominal cramping and feeling very unwell.  By Wed evening had chills and low grade fever 99.4.  Called out of work Thursday.  Felt terrible.  Thursday morning lower abdominal cramping consistent and pain scale between 4-5 with occasional spikes to 8.  Also felt terrible.  Had body aches, could only lay on couch.   Called my gastroenterologist.  Office returned call late afternoon and stated probably from vaccine and if it worsens or fever to call primary and to fill out VAERS form.  Thursday evening had temp of 100.4 and started with a cough where it felt I couldn't take deep breaths.  Only lasted a few hours.  Abdominal pain persisted.  Friday morning woke up and now have headache, but abdominal pain is now down to a 2 and I feel achy, but feeling a bit better.  Had to call out of work still too sick to go in.  No cough.  No fever.  Since I was feeling better my hope was since it was vaccine related that I would wake on Saturday and be totally fine, unfortunately, not the case.  Saturday morning abdominal pain same at a 2 and headache was on and off through the day into the night.  Still pretty much rested all day into the night.  Sunday morning much better.  Headache gone and abdominal pain down to a 1 and sometimes just vague.   Although I'm feeling better my head feels out of sorts, kind of like my brain can't keep up with my eyes?  And new symptoms? right ear crackling and teeth on right side feel sensitive also,  pain under left armpit.  It's tender and lasts through the day.  Monday still feeling a bit lightheaded and fatigued and armpit pain still there but not worse and feel able to go to work to see if I can.  Tooth sensitivity also still there but ear pain gone.  Called primary doctor she suggests getting Covid test and have appointment for phone conference for Tuesday with doctor, also had  Covid test today at work  (was Covid tested last Monday also for work and negative) into Monday night head is still feeling "off".  Tuesday armpit pain still same and dizzy head feeling same, mild abdominal pain comes and goes - Not bad enough to stop daily activity.  Spoke with primary doctor and she said side effects could possibly last this long and let her know when yesterday's Covid test comes in.........
Morning after, patient experienced fever, body aches, and fatigue that lasted approx 48 hours.
pain near the scapula; Less than several hours of getting the booster, a person has three lumps near the site of injection; Two near shoulder and one on armpit; This spontaneous case was reported by an other health care professional and describes the occurrence of MUSCULOSKELETAL PAIN (pain near the scapula), VACCINATION SITE MASS (Less than several hours of getting the booster, a person has three lumps near the site of injection) and AXILLARY MASS (Two near shoulder and one on armpit) in a  patient of an unknown age and 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL PAIN (pain near the scapula), VACCINATION SITE MASS (Less than several hours of getting the booster, a person has three lumps near the site of injection) and AXILLARY MASS (Two near shoulder and one on armpit). At the time of the report, MUSCULOSKELETAL PAIN (pain near the scapula), VACCINATION SITE MASS (Less than several hours of getting the booster, a person has three lumps near the site of injection) and AXILLARY MASS (Two near shoulder and one on armpit) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication.   Reporter stated that a patient experienced 3 lumps near the site of injection of which one was on patient's armpit and two being near the patient's shoulder after less than several hours of receiving the booster dose. Reporter also stated that the patient experienced pain near the scapula and queries whether it was normal as the reporter have also experienced similar reactions and lump near the armpit.  treatment information was reported.
Within 1 hour after 2nd dose of COVID vaccine had a strange sensation in R eye socket, but initially didn't think much of it. Then over next few hours, began having spreading Right sided face numbness, back of head, neck. Denies difficulty speaking or swallowing. Presented to ER. Resolved after a few hours. CT head unremarkable. Later that evening, severe chills, headache, arm soreness, fatigue. Fatigue persisting  6 days later.