chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2nd dose administered to patient from expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd dose administered to patient from expired vial) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-2021 at 10:15 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd dose administered to patient from expired vial). On 01-Sep-2021, EXPIRED PRODUCT ADMINISTERED (2nd dose administered to patient from expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided. The vaccine vial was on refrigerator from 25-Aug-2021 (8 days prior).   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Follow-up contains patient's demographics and product details.
Generalized erythematous maculopapular rash on the posterior torso and a few in the upper and lower extremities. None on palms or soles.
upset stomach; chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (upset stomach) and CHILLS (chills). At the time of the report, ABDOMINAL DISCOMFORT (upset stomach) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication use was provided by the reporter.  No treatment of events was reported.    This case was linked to US-MODERNATX, INC.-MOD-2021-036232 (E2B Linked Report). This case was linked to MOD21-045496, MOD21-045539 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-036232:
This spontaneous report as received from a dentist refers to a 75 year old male patient with macular degeneration, arteriosclerosis and high blood pressure. The patient's medical history included aortic stent insertion. In approximately 2013 reported as about two years ago, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number and expiry date were not reported). There was no concomitant medication provided. In approximately February 2015 reported as 3-4 weeks ago, the patient developed shingles of the eyes. The patient sought medical attention, went to see the physician and an ophthalmologist and was prescribed with unspecified eye drops for the shingles on an unspecified date. None laboratories studies were performed. The outcome of the shingles of the eyes was reported as not recovered at the time of the report. The relatedness between the shingles of the eyes and ZOSTAVAX was not provided. Additional information has been requested.
Left arm with erythema, warmth + swelling - vaccines given 8-6-08, signs and symptoms started 8-7-08. Motrin, Benadryl icepacks.
Patient's left arm was red and swollen. Area was about 5 inches in diameter. Patient took some TYLENOL for the pain. Area has improved a little bit from 10/3/18 to 10/4/18, but it was still red.
1/7/2022 Dx Cough  o Covid-19 Positive  Reason for Visit  presenting today for Cough (body aches, fatigue) and Covid-19 Positive   current episode started 2 days ago. Cough This is a new problem. The current episode started 2 days ago. The problem occurs every few minutes. The problem has not changed since onset.The cough is non-productive. There has been no fever. Associated symptoms include headaches, rhinorrhea, sore throat and myalgias. Pertinent negatives include no chest pain, no chills, no ear pain, no shortness of breath and no wheezing. She has tried nothing for the symptoms. She is not a smoker. Her past medical history is significant for asthma. Her past medical history does not include bronchitis or pneumonia. There were no sick contacts. She has received no recent medical care. Review of Systems  Constitutional: Positive for fatigue. Negative for activity change, chills and fever.  HENT: Positive for congestion, rhinorrhea and sore throat. Negative for ear pain and sinus pressure.   Respiratory: Positive for cough. Negative for shortness of breath and wheezing.   Cardiovascular: Negative for chest pain.  Gastrointestinal: Negative for abdominal pain, nausea and vomiting.  Musculoskeletal: Positive for myalgias.  Neurological: Positive for headaches.                      Medication Changes    Promethazine-DM 6.25-15 MG/5ML 5 mLs Oral Nightly PRN   Medication List  Visit Diagnoses    COVID-19    Cough   Problem List
Extreme fatigue suddenly  has been going on for months now  Have had all types of blood work done and there are no other underlying ailments
12/17/01 TC from Re; mother, states mother received flu shot on 11/30/2001. On the evening of 11/30 began symptoms of severe HA, nausea, vomiting temperature and extreme fatigue, was in bed all 12/1 and 12/2/01-felt better but tired and on 12/16 developed symptoms again severe HA, nausea, chills. Scheduled a physician appointment to have mother evaluated. 01/15/02 client stated went to ER x 1, diagnosis virus, saw another physician, diagnosis sinus infection, placed on Bactrim and nasal spray. He developed chest pain seeing cardiologist for a work-up.
Patient fell and had swelling and a large abrasion to the forehead, extending into the scalp. ED visit; Patient given tramadol for pain with a small prescription for this. Hospital admission for history of progressive left vulvar edema tenderness and febrile sensation.  Incision and drainage was performed with placement of a Word catheter. She was deemed to have achieved maximal benefit of inpatient therapy on the third postoperative day and discharged to home care on doxycycline. ED visit and hospital admission were separate and both within 6 weeks of receiving the COVID vaccine.
I woke up with a thickness/swelling upper left chest/arm, underarm and around to my back. The area is tender and hot to the touch. Feels like swollen lymph nodes.
itchy nose, similar to when she has anestesia and the  same reaction, hr=76bpm normal, only issue is itchy nose
Extreme stomach pain; Loss of appetite; Diarrhea; Muscle pain; Joint pain; Swelling at injection site; Bruising at injection site; This is a spontaneous report from a contactable healthcare professional, the patient. A 29-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the right arm on 24Mar2021 at 15:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included depression and ADHD both from unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included clonazepam (KLONOPIN), sertraline hydrochloride (ZOLOFT) , duloxetine hydrochloride (CYMBALTA) and cetirizine hydrochloride (ZYRTEC); all from unknown dates for unknown indications. The patient previously took amoxicillin and experienced a rash and itching. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Apr2021 at 15:00, the patient experienced extreme stomach pain, loss of appetite, diarrhea, muscle pain and joint pain, swelling and bruising at injection site. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme stomach pain, loss of appetite, diarrhea, muscle pain and joint pain, swelling and bruising at injection site was not recovered at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Intense entire arm and fingers pain, for at least two days, it is the 3rd day after the shot and in investigating '2nd dose necessary?' when I was so close to going to ED. Investigating I found '2nd dose usually more painful' which is horrifying -- I have had shingles twice.  I found two websites that mention intense pain which made me worry less. CDC is underplaying that some people may have intense pain -- here is a good way it was put: "The side effects are more intense than most have experienced from other vaccines, but usually go away on their own in two to three days." "While some people can have a very sore arm, fatigue and low-grade fever after the vaccine, most people who get Shingrix experience only mild side effects."
3Jan92 recvd 1 dose vax & 4JAN92 arm ached; 5JAN92 devel local erythema below inject site & down elbow w/itching & swelling; Seen 3 days later by PA;
Swelling, redness at site one day after vaccine administered. Knot under (L) arm two days after.
Pt came in for second dose of the monkeypox, attempted to give in the left lower forearm but no wheel appeared. Pt was then revaccinated in the right lower forearm where a wheel appeared
This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness in legs) and VACCINATION SITE PAIN (Injection site pain) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. No Medical History information was reported. On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness in legs) and VACCINATION SITE PAIN (Injection site pain). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness in legs) and VACCINATION SITE PAIN (Injection site pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication use was not provided. Treatment information included was not provided.
Vision loss roughly 2- 5minutes after injection, pt reported felling hot and had difficult hearing as well. pt stayed alert through entire episode. vision returned roughly 10-15 minutes after vaccine administration. at time of pt leaving pharmacy pt reported all symptoms were no longer present.
Hospitalization for worsening COVID symptoms after molnupiiravir on dates 7/5/22-7/7/22. Treated with no covid-related medications due to Heart failure exacerbation.
I almost instantly became ill.  Felt incredibly nauseous right away. Went home and laid down with fever and chills and extreme body aches for a number of days. Was bed ridden for about 3 days.  Also extreme migraines and flushing of entire body. Felt a general malaise for a few days after major symptoms had passed.  Developed Chronic Urticaria 3 months after vaccination and has continued to this day. I have gone to many allergists and doctors for this condition, had many tests, and it has been deemed that this condition HAD to be caused by the vaccination. No allergies found, no infections found.
Eye twitch in left eye bottom lid; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199), via an unspecified route of administration in the left arm on 08Mar2021 at 13:45 (at the age of 19-year-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN2613) via an unspecified route of administration in the left arm on 29Mar2021 at 13:45 (at the age of 19-year- old) as a single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included microgestin (MANUFACTURER UNKNOWN) for unknown indication. 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 COVID-19 vaccine. On 08Mar2021 at 13:45, patient experienced eye twitch in the left eye bottom lid all day and every day. It started the day, when patient got first dose. The patient did not receive any treatment for the reported event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event eyelid twitching was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Fever 100 - 101, local edema left thigh measured 13" acute redness 15 cm x 14 cm. Tender to touch. PT very fussy, mom administering Tylenol infant gets 4 hrs and pushing PO fluids.
Threw up twice in his sleep, trouble breathing and so lethargic we could barely wake him out of his vomit, he is an otherwise hard to get to sleep baby and his behavior was left field.
Health Department received a phone call on 6/3/2021 from community member stating she had an anaphylactic reaction after receiving her 1st dose of Pfizer on 2/26/21. Subject states 30 minutes after receiving the injection, she was at home alone when the roof of her mouth, nasal passages, and ear canals become extremely painful, 'as if they were burned', then they became, including her throat with difficulty breathing. She states she laid down on her side and was unable to get back up to call for help, and her symptoms resolved the next day. States she has a history of anaphylaxis, unknown to what. She followed up with her primary care provider shortly after and reported the event to CDC.
Pts mom called 90 mins after vaccine was given and said her daughter complained of a numb thumb immediately after the shot. She said it is getting better, but it is still numb. We told her that was not a usual reaction and recommended taking her to her pediatrician for follow up.
05/06/2021 that night my arm started hurting and got numb and heavy, I got really sleepy, got a headache thru the night it lasted, into 05/07/2021 I did not get out of bed at all and I do not remember most of that day, I did have aches, fever and nausea, it hurt to move, that latest well into the night into the next day 05/08/2021 I was able to do a bit more daily activities, but It was not easy I was still achy all over, fever, chills, nausea, dizziness.  05/09/2021 the fever was not as bad, a low-grade fever, headache, arm still hurt. It really took me several days to feel better, 05/11/2021 I still felt bad but went back to work. I couldn't go to the doctor till June 4th. On 09/17/2021 I got Fluconazole because I had sent pictures into my doctor that appeared to look like ringworm.  But went to see him on 09/23/2021 the rash did not go away, and I was still not feeling well, I showed him in person the sore on my face and the doctor stated it looked funny that some look like ring worm and some do not, like viral. He said just to keep an eye on it and the next weekend on 09/28/2021 I began feeling bad again with COVID-19 symptoms and tested positive for that on 09/28/2021.  The sores/rash started to begin changing a bit, so I treated them topically with Nystatin, but it was not working. The rash began to spread to other parts of my body. Nothing seemed to work on the rash. During the time in which I had COVID-19 my mouth was dry, and my tongue would shed. I went back to work on the 24th of Oct. I was there just three days, I called out of work on the 26th and on the 26th I went to urgent care, they looked at the sores, they decided they looked like MRSA and gave me Bactrim, that did not clear up the sores. On 11/01/2021 the sores had transformed, small spots. The doctor decided I possibly had Pityriasis Rosea, I was prescribed Prednisone 20mg a day for 5 days. It was not working; within just a few days the sores were spreading so I contacted my doctor again over the phone to ask for help but he did not want to take a sample since they may be contaminated. The doctor asked me to come in for bloodwork on 11/03/2021 but my doctor is on vacation now and I have gotten the results yet but have not been able to see him again yet.
Rash, itchiness, and swelling around injection site 8 days after first dose
Deep Vein Thrombosis,  Pulmonary Embolisms.  8 Dec 2022.
This spontaneous case, initially received on 19-Sep-2018 from other non-health professional (consumer), concerns a 36-year-old, adult, female pregnant patient. The patient had no maternal medical history relevant to pregnancy and paternal medical history (hereditary disease). The patient had 2 previous pregnancies and had a stillbirth/miscarriage. There was no birth defect or congenital anomaly occurred during any previous pregnancy. The patient's contraceptive method was not reported. The patient's medications taken prior to pregnancy and during pregnancy were not reported. The medications taken by father prior to conception were not reported. The patient's concomitant medications were not reported. The patient's last menstrual period (LMP) date was not reported. On 17-Sep-2018, at gestational age of 18-weeks (second trimester) the patient was administered with FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number and expiry date: not reported). No adverse events were reported in pregnant patient and fetus after the vaccination. There was no evidence of a defect or adverse finding from a prenatal test. The patient's estimated delivery date (EDD) was reported as 19-Feb-2019. The reporter assessed this case as non-serious.
The Patient's Mother noticed a small rash once they got home from the office. The rash continued to increase in size; patient inadvertently received a third dose of VAQTA; This spontaneous report was received from a medical assistant referring to a 6 years old female patient. The patient's concurrent condition included food (peanuts) allergy. Drug reactions/allergies included amoxicillin. The patient had no concomitant medications.  On 03-SEP-2019, the patient inadvertently received a third dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (unit not reported) (lot# reported as Z002507, expiration date: 04-APR-2020) intramuscularly for prophylaxis (extra dose administered) because the medical record was not showing that she had received it already. After the third dose had been given, reconciliation of the medical record showed 3 doses. Lot # Z002507 is an invalid lot number for hepatitis a vaccine, inactivated.  On the same day, the patient's mother noticed a small rash once they got home from the office. The rash continued to increase in size. On 04-SEP-2019, the patient was seen by her physician. The patient was advised to be watched and go to urgent care if worsened or short of breath. No lab diagnostics/studies were performed. The mother did not report itching, hives or shortness of breath. Around 12-SEP-2019, the patient recovered from the event.   The causality assessment between hepatitis a vaccine, inactivated (VAQTA) and the event was not provided.
Severe dizziness, sweating, nausea, weakness, (one hour) pain both arms, and headache lasted all night.
I started off with congestion and a cough. My case was not severe at all. I reached out to my provider, and he prescribed PAXLOVID. I also have a lingering cough.
After receiving Tdap, VZV, MENACTRA (in this order), client immed. lost consciousness, color very pale, had posturing of upper extremities followed by shaking of arms and legs and foaming @ the mouth lasting < 5 seconds. No incontinence of urine or stool. Had not eaten before vaccines.
Vomiting, headache, stomach ache, and dizziness x 24 hours.
Chills; fever; muscle ache; headache; This is a spontaneous report from a non-contactable healthcare professional (patient). A 33-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 26Jan2021 10:45 at a single dose for COVID-19 immunization. The first dose was received on an unspecified date. The patient medical history was not reported. Patient was not pregnant at the time of vaccination. Concomitant medication included celecoxib (CELEXA).  The patient experienced chills, fever, muscle ache and headache on 26Jan2021 23:00. Outcome of the events was not recovered and no treatment was received for the events. Events were considered non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Initially, after the vaccination, I had a very sore arm, roll over in bed, it would hurt, fatigue. I felt like I was coming down with something, just like the similar symptoms as my second dose. The soreness went away, I still feel like I have some itchiness there in my arm. A week or ten days later I saw the doctor. I have a lot of congestion because of my allergies, my right ear began getting plugged, ear congestion. My right ear gets plugged so I did not think anything of it. The doctor said I had fluid in my right ear. I did not think it was related to the vaccine. The doctor prescribed prednisone 10 mg for four days, and to use my nasal spray morning and evening, I took Tylenol Sinus and Mucinex. I went back to the doctor because it was not getting better. We tried an antibiotic, but it upset my stomach and it did not help me anyways. I am still congested, my ear is still stuffed up, but my dizziness is not as bad, I am going to see my ENT next week. I am also going to see my allergist. I usually self treat my allergies, but when it gets this bad, I go see my doctor. My upper left shoulder is numb to touch and tingling. When I asked the doctor what is going on with my right arm. He tried to loosen everything up. It feels numb and weird, tingling. The tingling went away but the numbness has not gone away. The doctor said it's possible it is from the booster. Everything is brand new so I don't know. I do have my upper back that is pinched and tight. But I never had any problems with my left shoulder. The ear problem is not new, I don't know if it's an immune response. That's for someone else to figure out, not me.
Information has been received concerning a male physician who on 13-FEB-2009 was vaccinated with PNEUMOVAX vaccine 0.5ML (lot# 659922/1667U). Subsequently the physician experienced swollen lymph nodes and could hardly walk. Unspecified medical attention was sought. No further information is available.
Arm had a large bruise above and below injection site. Patient stated it was slightly painful above injection site. We advised patient to contact and be seen by a doctor.
Adverse event description: I had to have a check up related to hand surgery and when I went to get my check up for that my blood pressure was elevated to almost 140. The nurse double checked it and confirmed it was accurate. After my surgery, we had a new blood pressure machine and I started taking my blood pressure every day. The machine reflected that I had a missed heart beat. I decided to go see the heart doctor to find out why. I had a complete heart work up. He found that I have a little bit of a floppy valve that I did not have before. I am going back for a check up regarding this.