chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received pediatric vaccine instead of Bivalent Booster; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received pediatric vaccine instead of Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in a 31-year-old male patient 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 WRONG PRODUCT ADMINISTERED (Received pediatric vaccine instead of Bivalent Booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received pediatric vaccine instead of Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Received pediatric vaccine instead of Bivalent Booster).    No concomitant medications were reported.  Reporter stated that in Oct-2022 they accidentally administered 2 patients, the Moderna Covid-19 vaccines for children 6 months to 5 years old instead of administering the Moderna Covid19 Bivalent booster. Reporter stated that on 07-Oct-2022 patient were mad because they were travelling.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Oct-2022: Live follow up received contains I narrative were updated.
Papular non-erythematous rash around injection sites, right & left hip with 3 days of injection at 4 months and 6 months.
Around 2pm mom called and said that the patient came to her pale, dizzy, clammy, "freezing," and legs were weak. Patient was told to take some Tylenol and take a warm bath. Patient temp was 99 degrees. Mom called again at 4pm and stated that patient now has a temp of 100.2 and is feeling hot. Can moves leg well but they still "feel funny". Encouraged her to elevate legs, increase fluid intake, give Tylenol every 4-6 hours. If symptoms get worse to go to the ER. Spoke to mother on 5/19/2020 and patient was doing much better. Symptoms had improved later in the evening on 5/18/2020.
Exacerbation of myasthenia gravis that had been stable for 10 years. Increasing weakness and respiratory difficulties within 72 hours of vaccination. Required intubation and mechanical ventilation which continues
devel red blotches p/MMR; given DPH; blotches resolved w/in 30 mins; no resp distress noted;
Bell's Palsy on the Left side; A Spontaneous report from was received from a Healthcare professional concerning a 64-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Bell's palsy on the left side of her face.    The patient's medical history was not provided. The patient's concomitant medication was not provided.    On 02 Mar 2021, the patient received  their first of two planned doses of mRNA-1273 (Lot number : unknown) intramuscular for prophylaxis of COVID-19 infection.  On 14 Mar 2021, the patient experienced Bell's palsy on the left side of her face. The event was considered medically significant.  Laboratory details was not provided. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the event was not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Flu vaccine 10-2-11. Joint pain in thumb & hip joint starting 10-16-11. Now ambulates with dysfunctional gait. Hip pain is now severe.
Dose was administered to patients after the 30 days use by date.; patient was administered frst dose moderna without 30 days refrigeration; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was administered to patients after the 30 days use by date.) and PRODUCT STORAGE ERROR (patient was administered frst dose moderna without 30 days refrigeration) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was administered to patients after the 30 days use by date.) and PRODUCT STORAGE ERROR (patient was administered frst dose moderna without 30 days refrigeration). On 20-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Dose was administered to patients after the 30 days use by date.) and PRODUCT STORAGE ERROR (patient was administered frst dose moderna without 30 days refrigeration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment drugs were provided. Nurse stated that patient received the 1st dose of the Moderna COVID 19 vaccine on 20SEPT2021 between 8:10-9:10am. The dose was administered to patients after the 30 days use by date.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Follow up received on 23-Sep-2021 contains significant information, added reporter information and added an event or incorrect product storage.
I am bleeding heavily because I am getting blood clots and stuff like that; I am bleeding heavily because I am getting blood clots and stuff like that; Right side of face, my tongue inside is very swollen and irritated; Lot of pain in my joints and in my bones; Right side of face, my tongue inside is very swollen and irritated; Right side of face, my tongue inside is very swollen and irritated; Lot of pain in my joints and in my bones; This is a spontaneous report from a contactable consumer (patient)   A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Lot number FN6200) as SINGLE DOSE for covid-19 immunisation; axitinib (INLYTA), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 2 DF, 1x/day (two pills a day ) for renal cancer; pembrolizumab (KEYTRUDA), route of administration, start and stop date, batch/lot number and dose were not reported for renal cancer; zoledronic acid (ZOMETA), route of administration, start and stop date, batch/lot number and dose were not reported for bone disorder  . The patient received the first dose of BNT162B2 on unknown date (Lot number CL9265).  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient stated "I got a clear cell renal cancer. And I am taking a combination Inlyta okay which is your drug and Keytruda and I also have also taken Zometa that is for the bones and I have had two Pfizer Vaccines (Unspecified Vaccines) for it.I am getting terrible side effects from either the Inlyta or the Keytruda. I am bleeding very heavily and the right side of face, my tongue inside is very swollen and irritated. I am getting a lot of pain in my joints and in my bones. I am bleeding heavily because I am getting blood clots and stuff like that. I just wonder if there is anything that I have been taking Inlyta two pills a day and I have taken probably 80 pills from the start. So, if there is anything to mitigate what's going on. The action taken with axitinib , and pzoledronic acid embolizumab was unknown.".The outcome of the event was unknown
High fever 101.8 possibly higher. Severe back pain. Muscle aches more severe than any shot she's had. Extreme swelling at injection site. Never happened before. Back issue most alarming.
Fever/Chills/Fatigue/Redness & Swelling (Covid Arm) at injection site.    Day 3, only Redness & Swelling remain.
48 hours post injection with the development of injection site erythema, edema, and pain. ?Softball sized?
FLUZONE QUADRIVALENT was given to 2 months old patient/ no adverse event; Initial information received on 16-Nov-2021 regarding an unsolicited valid non-serious case from other healthcare professional and non-healthcare professional via Media information (under the reference 00859792).  This case involves a 2 months old male patient (date of birth: 15-SEP-2021) who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (product administered to patient of inappropriate age).  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR), DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL) and ROTAVIRUS VACCINE for prophylactic vaccination.  On 15-Nov-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (total, solution for injection in pre-filled syringe, lot number: UJ775AA and expiry date: 30-JUN-2022) via an intramuscular route in the left thigh for prophylactic vaccination.  It was an actual medication error due to inappropriate age at vaccine administration (same day).  It was reported "The Fluzone Quadrivalent was given to the wrong patient, it was supposed to be given to his sibling."   At time of reporting, it was unknown whether the patient had any adverse event or not and the outcome was unknown for the reported event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient received the vaccine at day 15 instead of day 21. No Adverse effects noted at the time of the vaccine. Patient needs 3rd dose to be consider fully vaccinated.
Period cycle is lasting more than 8 days without relief or a reduction of intensity.  This is abnormal and hasn?t changed within the last 24 hours
Received vaccination on what would have been last day of menstral cycle.  24 hours after shot started cycle again but 30x worse ended up in the er and they said I should report to cdc as they are unsure if the shot is related but they had seen others with same issues.
Patient presented saying that she had experience a red rash spanning a couple of inches from the injection site.  She also complained of flu like symptoms, fatigue, stomach issues and nausea.  She complained of extreme soreness in both arms.  She said she wasn't able to do much on the 26th as she felt so bad.  Today she felt better but not 100% and she still had the rash.  She is going to monitor her symptoms and notify a medical professional if it does not continue to improve
Pt rec'd FLUVIRIN; 3-5 days later, all of LUPUS sx increased (to include renal cardiac, CNS & arthritis), sx remained x 5-7 days, then tapered; pt was in contact w/MD after 5-6 days after vaccine. MD directed pt to increase MTX - prednisone to control sx. Sx still present, but not as severe - worst flair since pt was on DM agent.
Started feeling numb and tingling pin prick sensation on all fingers on both hands, and both feet continuously since the onset of symptom a day after vaccination. It has not changed (worse or better) remains about the same for past two days.Feeling weak on both leg muscles compared to before receiving shot. Climbing down stairs and walk feel different, weak. Stairs down knees unlocks. Stairs up is ok. But, able to keep balance so far. At the time of vaccine shot 3, unlike dose 1 and 2, jab felt sharp, felt brief tingling at back of the head on the side where shot was jabbed. Left arm below jabbed location near elbow inside pains when stretching arm up.
Chills, fever, aching everywhere, increased sharp pains in joints, headache, sensitive skin, and finally, 30 hours later, ringing in ear.
Tingling and numbness toes, cheeks and hands 16 minutes after vaccination and it lasted for 2 minutes
Emergency room 9/17/10 for fever of 102 very itchy and skin turned bright red. ER MD prescribed oral steroids.
Pfizer Dose 1 2/12/21 (EN5318) Pfizer Dose 2 3/11/21 (EL9266) COVID Positive 2/14/22  2/14/22: Patient is a 67-year-old male with history of HTN, HLD, NIDDM, CKD(IV), and chronic blood loss anemia. Patient has had recurrent GI bleeding with negative upper GI endoscopy and colonoscopy as recently as 9/1/2021.  He follows with hematology for chronic iron deficiency anemia and leukopenia.  He presented to the emergency department today with complaints of chest pain and shortness of breath.  He was found to have a hemoglobin of 7.9.  Also had FOBT positive.  GI was consulted from ED and recommended treating him with 1 unit of PRBCs and discharging him home to complete his OP workup.  The patient was noted to have several antibodies on his type and screen, and blood will likely not be ready tonight. Patient will be admitted for observation, receive his blood transfusion, and likely discharge home in a.m..   ED reported the patient was 79% on room air on arrival to the ED.  They placed him on 2L of supplemental oxygen.  On my exam, the patient dropped no lower than 92% on room air, this even with holding a conversation.  He denies any shortness of breath or chest pain currently.  Reports that the symptoms that brought him into the ED have completely resolved.  His vitals have been stable in the ED.  His CXR showed no acute cardiopulmonary processes.  Creatinine is elevated at 2.47, but the patient does have a history of CKD(IV) and is at baseline.  On recent Hematology notes, patient is noted to be quite iron deficient, but does not tolerate oral iron therapy due to significant constipation. He receives IV iron supplementation at times.  Will give him Venofer while admitted.  2/17/22: Patient is a 67-year-old male with history of HTN, HLD, NIDDM, CKD(IV), and chronic blood loss anemia with recurrent GI bleeding.  Has had negative upper GI endoscopy and colonoscopy as recently as 9/1/2021.  He follows with hematology for chronic iron deficiency anemia and leukopenia.  Patient was admitted on 2/14/2022 with acute on chronic blood loss anemia and positive fecal occult blood test.  GI was consulted from the ED, and they recommended transfusing the patient with 1 unit PRBCs and discharging him home to complete his outpatient follow-up. Unfortunately, the patient had several antibodies on his screening, and had to be admitted for blood transfusion. As the patient was being admitted, he was screened for COVID-19.  His screening test came back positive.  The patient's chest x-ray showed no pneumonia.  He was admitted, received 1 unit PRBC, then demonstrated some mild hypotension.  This resolved with fluid resuscitation.  The patient today reports that he is feeling well.  He denies shortness of breath at rest, dyspnea on exertion, chest pain, palpitations.  He did have a home oxygen walk which showed that he needs 1L of oxygen with activity, but requires no oxygen at rest.  Physical therapy evaluated the patient and felt that he would benefit from VNA.  He will be discharged home today with VNA for nursing and physical therapy.
Pt broke out of rash; and itching left ear inflamed lesions, flushing noted. Benadryl 50 mg  96  given, Benadryl given.
Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the Health Agency and Health Clinic that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of HA/HC. The regulatory authority website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
Two days after getting the Moderna booster, patient developed a red, itchy quarter-sized spot on her left deltoid. She is still pretty uncomfortable two months later. She decided it needed to be reported.
Swelling and redness at injection site. Extreme soreness at injection site, nausea, headache.
Red Swollen area approximately 4.5 x 3.5 in size. Warm compresses to area. No other treatment.
Myocarditis; Sick; Fever of 102-103 degrees F; Felt like she had pressure in her chest; Palpitations; Very fatigued; Shortness of breath; Cold chills; This spontaneous case was reported by an other health care professional and describes the occurrence of MYOCARDITIS (Myocarditis) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Family history included Breast cancer since an unknown date.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced ILLNESS (Sick), PYREXIA (Fever of 102-103 degrees F) and CHEST DISCOMFORT (Felt like she had pressure in her chest). In February 2021, the patient experienced DYSPNOEA (Shortness of breath), CHILLS (Cold chills), PALPITATIONS (Palpitations) and FATIGUE (Very fatigued). On an unknown date, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant) and STRESS (Stress). In February 2021, CHILLS (Cold chills) had resolved. On 17-Feb-2021, PYREXIA (Fever of 102-103 degrees F) had resolved. On 28-Feb-2021, ILLNESS (Sick) had resolved. At the time of the report, MYOCARDITIS (Myocarditis), DYSPNOEA (Shortness of breath), CHEST DISCOMFORT (Felt like she had pressure in her chest), PALPITATIONS (Palpitations), FATIGUE (Very fatigued) and STRESS (Stress) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Body temperature: high (High) Fever of 102-103 degrees F. In July 2021, Electrocardiogram abnormal: abnormal (abnormal) abnormal electrocardiogram. On an unknown date, Echocardiogram: abnormal (abnormal) diagnosed with myocarditis. On an unknown date, Electrocardiogram ambulatory: abnormal (abnormal) diagnosed with myocarditis.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  About 3-4 weeks ago the patient wanted to be checked out before she went for a magnetic resonance imaging for possible breast cancer. The patient did not get any medication for the myocarditis. Patient was not going to get a booster.  Treatment information was not provided.; 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.
Rash (petechiae), redness, warmth in area starting on injection site and going down to the middle of the forearm. Headache resolved with ADVIL.
Pt developed Gullain-Barre Synd. characterized as ascending myopathy, myalgia & automic neuropathy, with bradycardia & flushing. Pt was hospitalized.
Woke up at 6am the morning of 4/24 with chest pains and shortness of breath. Two days earlier I walked/ran 5 miles and on 4/24, I could barely walk up our stairs in our house due to tight chest and shortness of breath. I let it go for a few hours thinking it would go away but it didn't. I was worried I was having a heart attack so I went to the ER. They did several tests including a chest X-ray, Endo cardiogram, blood work. They couldn?t find anything wrong however I had a elevated pulse rate in the 120s and remained high the entire four hours I was there.
Small mass like /swollen/left axilla, tender at the touch /1 (1-10) pain.
13DEC 2 wks p/vax pt devel fever up to 103 w/ n,v, cough, non prod, +rash chest-maculopap, faintly erythematous, also on back & neck; then devel dec WBC=2.2 15DEC94 & also transient encephalitis 16DEC94;
She got her vaccine, just a little soreness in the arm at first.  The 2nd day started getting stiff, difficulty moving.  Then 2 days later she started feeling very nauseous, like she wanted to throw up but didn't.  Had this feeling all the time.  Almost like vertigo, dizziness that was really bad.  She could not lay down because the room would spin no matter what she did.  She would have to hold onto things as she felt like she was going to fall over.  For a couple of days she felt like she possibly was having a panic attack, her heart was beating faster, fogginess and light headedness.  Really strange as it was hard to describe, and was having trouble hearing as her head was so cloudy/foggy.  The strangest thing she has ever encountered.  She's glad it's all over.  This reaction lasted for a long time, was concerned and was thinking of going to the ER as she was afraid to due to the dizzy spells.  Described it as putting a marble in a jar and spinning the jar.  She does not feel the same the way she was before the vaccine.  She does not get the dizziness anymore but sometimes has the light headedness and fogginess.  Says it lasted for almost a month.   The nausea went away, no more dizzy spells, and will have a quick spell and then it disappears.  The only thing that she still feels once in a while is a little fogginess.   Did not seek medical attention, listened to neighbor who told her to give it time and that she would get over it.
Onset of fever, reached 104 degress by 4 pm.  Went to Emergency Room due to high fever. Given Tylenol and IV Fluids for 4-5 hours and released.
Swelling in arm just below and to the right of injection site. Swelling is very red/warm to the touch. The area has remained the same since 1/7/21 and has not increased or decreased in size. However the itch/burn feeling continues to increase daily. I do not plan to seek medical attention for this side effect unless the swelling is still present by dose #2. Im showing no other negative symptoms.
Patient said  she developed a fever of about 100 degrees F later that evening which lasted for about 36 hours.  She said her arm and shoulder started hurting a few hours after getting the vaccine.  She said the next day the pain was in her shoulder and back and it hurt  to take a breath.  She took Advil and Tylenol which helped relieve the pain.  She is still having pain 3 days after getting the vaccine.