chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cellulitis; Arm swell up; Arm turn red; Sore; Fever; Felt run down; This case was reported by a consumer and described the occurrence of cellulitis in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2019-2020 season at an unknown dose. On an unknown date, unknown after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced cellulitis (serious criteria GSK medically significant), swelling arm, erythema, pain in arm, fever and feeling unwell. The patient was treated with antibiotics nos. On an unknown date, the outcome of the cellulitis, swelling arm, erythema, pain in arm, fever and feeling unwell were unknown.   It was unknown if the reporter considered the cellulitis, swelling arm, erythema, pain in arm, fever and feeling unwell to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Fluarix Quadrivalent 2019-2020 season and his arm swell up, turn red, sore, fever, cellulitis and was felt down. On Friday and Saturday, the patient was in bed. The physician prescribed antibiotics for 10 days. The reporter consented to follow up.
Patient received the flu vaccine on 10/31/2001. That evening, she experienced a fever and a  sore arm. The sore throat, which the patient had prior to the vaccination, became more swollen. By the next day, the arm where the injection was given had developed a swollen, hard , itchy knot. The day of this report, 11/01/2001, the site is hot to touch, itchy, sore, swollen, and the size of a golf ball.
Patient received Moderna COVID vaccine on 3/27/21 and 4/24/21. Patient states that she had a large gathering of family and friends on 7/4/21.  Since then some people at the gathering had developed mild fevers and cough.  Most however doing fine and have no acute symptoms.  Patient however states that beginning 7/10/21, she began to have horrible asthma exacerbation, patient on prednisone 10 mg daily at this time but states she took 40 mg of prednisone secondary to concern for asthma exacerbation. On 7/11/21, patient again took 40 mg of prednisone, multiple rounds of her beta agonist without symptom relief.  Patient noted that her home oxygen saturations on home pulse oximeter 85%.  Patient is brought to ED for evaluation and eventually admitted. On 7/12/21, patient had respiratory decompensation failing HFNC and BiPAP, O2 desaturation in the 60's, and was extremely short of breath.  FiO2  was increased to 100% without recovery. Patient was intubated and transferred to CCU on 7/12/21. This event is being reported due to COVID cases resulting in hospitalization even though patient was fully vaccinated.
Child was given DTAP and IPV in right arm.  Localized swelling and erythema from shoulder to forearm (approv 10 inches).  Patient complains of tenderness in shoulder area.
Breakthrough case admission after 4 vaccines: Moderna 3/1/21 Lot# 024M20A;  Moderna 3/29/21 Lot# 032M20A;  Moderna 11/5/21 Lot# 039F21A;  Moderna 5/20/22 Lot# 054A22A.
still experiencing ache in her arm/ very sore arm for 2-3 days, very sore arm for 2-3 days, with a dull ache for a week; chills; felt 'achy'; headache; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer-sponsored program. An 81-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number and expiration date not reported), via an unspecified route of administration on 26Feb2021 (at an unspecified age) at 1st dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that she had her first dose of the vaccine last 26Feb2021, and was still experiencing ache in her arm, which started on an unspecified date. On 17Mar2021, it was reported that the patient was scheduled to receive her second dose this Friday, 19Mar2021. On an unspecified date, after her first dose, the patient experienced very sore arm for 2 to 3 days with a dull ache for a week, headache for 24 hours, chills, and the patient felt 'achy'. Outcome of the events pain in arm and headache was recovered on an unspecified date, and for other events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history was not provided. On 06-FEB-2015, the patient was inadvertently subcutaneously administered a dose of M-M-R II (albumin status and lot# were not reported), which expired on 18-OCT-2014. No adverse effects were reported. Additional information has been requested.
Constant headache; Severe neck pain; This is a spontaneous report from a contactable healthcare professional, the patient. A 43-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN9269), via intramuscular route in the left arm on 09Mar2021 at 12:30 (at the age of 43-years-old), as a single dose for COVID-19 immunisation. Medical history included anxiety and depression. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included fluoxetine (MANAFACTURER UNKNOWN) 40 mg for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL9269), via intramuscular route in the left arm on 15Feb2021 at 12:00 (at the age of 43-years-old), as a single dose for COVID-19 immunisation. Since the vaccination, the patient had not been tested for COVID-19. On 10Mar2021, the patient experienced constant headache and severe neck pain that moves for over a week. The patient did not receive any treatment for the reported events. The clinical outcome of the events head ache and neck pain was not recovered.  No follow-up attempts are needed. No further information is expected.
Severe abdominal pain starting the day after the 2nd dose of Moderna.  Continuously severe abdominal pain for months.  Sought care from a gastroenterologist now have a diagnosis of gastric stenosis.  I have had 2 dilations since my 2nd vaccine.  I have another dilation scheduled next month in February 2022.
Red hive like rash and felt hot.  She was also feeling dizzy    Epinephrine given  IM   After 5 minutes, her symptoms returned and another Epinephrine given IM
Redness, induration at injection site of (R) deltoid from pneumococcal vaccine. Redness around upper arm.
Received H1N1 vaccination - difficulty breathing; felt swollen and was light headed. 0.5 ml epinephrine administered. EMS activated - refused transport to ER - went to see primary physician.
limp pale spell in afternoon 8/30/99;recv Prosoybee formula as a trial had been on Nutraminogen;
Severe abdominal pain and diarrhea with nausea Redness and swelling (looks like a bee sting) at injection site with soreness in arm injected
This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 28-JAN-2016, the patient was vaccinated with a dose of ROTATEQ (lot # L013192 and expiration date January 2017, oral), which was exposed to temperatures outside of the recommended range. There were no concomitant medications provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Healthcare Facility consulted with the Dept. of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare is working with the Facility on a compliance improvement plan and has been reinstated vaccination privileges.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date in 2014, the patient was vaccinated with a dose of ZOSTAVAX, (dose, route of administration, anatomical location, lot # and expiration date were not reported) for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster (onset date was not provided). On or about 29-AUG-2016, the patient was treated by a physician for a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter determined the events to be related to the ZOSTAVAX.
Patient felt bilateral arms shaky, feels warm.  No SOB or CP.  VS at 10:40am 145/90 P95 o2sat 97. Feels a little anxious due to symptoms showing.  Talked to her for another 5 mins and retook vitals at 11:00am 143/86 P94 o2sat100. She says she feels better, and feels safe to leave on her own.
Patient reported signs and symptoms of nausea including vomiting (every 15 minutes for a while), vertigo and dizziness, loss of appetite. Patient reports that he is rarely sick and believes that this could be due to the flu shot he received the day before. Patient had to miss a day of work - has not missed a day in a very long time.
Late last night, on top of feeling achy, itchy and tired, my arm started itching at the injection site. There was some pain, the area was raised and swollen and hot to the touch. For the past couple days, my armpits, groin and breasts were tender also. After I noticed the rash, I checked and my left armpit (injection arm) was considerably more swollen and tender than the right. Took two benadryl and went to sleep. Woke up and the red tenderness was all still there. I took one more benadryl and it has not spread.  Unfortunately it hasn't gone down much, either.
11/20/22 I was hearing a whooshing sound in my left ear, like your heartbeat. I went to see an ENT, had testing and had an appointment already scheduled with a Neurologist who did more testing. I had an MRI of the brain, MRA and MRI of the neck, Ultrasound of the Carotid and found an aneurysm. My diagnosis was a dissecting aneurysm of the left cervical ICA just below the base of the skull, 10mm x 7mm. After the results, my brother-in-law who is a Neurologist told me to go the ER. I ended up testing positive for COVID on 12/11/22. On 12/16/22 I went to the ER and spent 3 days in the hospital. The same tests were run, MRI and MRA and confirmed the diagnosis. They determined it was acute rather than chronic. I was started on PLAVIX and aspirin and sent home. I have continued to have testing and have an appointment with the Neurologist this week. I did have a follow up MRI that showed no change.
Patient received additional dose (0.5mL)vs. booster dose(0.25mL); patient experiencing weakness, vomiting, arm soreness
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 05-APR-2018, the patient was vaccinated with GARDASIL 9 lot number N021475 with expiration date on 31-JAN-2020 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion in the range between 32°F up to 35°F for 270 minutes and 47°F to 77°F for 75 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1805USA003078:
Redness, swelling, tightness at injection site (left arm) and low grade fever.
Received the first Moderna vaccine at age 17; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received the first Moderna vaccine at age 17) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received the first Moderna vaccine at age 17). On 27-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received the first Moderna vaccine at age 17) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment related information has been reported.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old) for mRNA-1273 (lot number 019A21A) with no associated AEs reported.
Headaches started 01/08/2021 and would come and go during the day.  The last two days not as much.
It started with a tickle in my throat the next day I had a runny nose with clear discharge headache no body aches slight aches no fever but needed sleep for three days straight.
grandma reports on return to clinic that p/last inj w/in 30min child had blisters all over & T105;took to PCP-MD said it was because too many immun were given @ once or pt was allerg to shots;
Patient presented with cellulitis of right arm associated with swelling and axillary lymphadeopathy.  Patient reported fever, chills at home.
I had to miss work because I felt sick. A rash developed on my neck, face, and jawline and to the back of my neck. I took Benadryl, and I called the tele doc. I sent pictures. The doctor said this looked odd. He wrote me a script for a cream I used for a month. He diagnosed it seborrheic dermatitis . Since then this rash pops up every so often even now.
This spontaneous report as received from patient's grandmother refers to her grandson who was a 16 year old male patient. Patient received his first dose of injection of GARDASIL (strength, formulation, Lot#, route and duration were unspecified) last month (August 2013) and before getting 2nd injection of GARDASIL (strength, formulation, Lot#, route and duration were unspecified) today (23-SEP-2013) he felt nauseated, however he went through physical activity at school without eating then was taken in to get injection and was feeling nauseated. He could not feel his legs and could barely hear and vision was blurry after receiving the 2nd injection of GARDASIL. Patient did not seek medical attention. Therapy was continued. No treatment was given for the events. The outcome was unknown. Upon internal review, barely hear was considered as other medical significant event. Additional information has been requested.
3 to 4 inch redness at site of injection, with some blistering, told to take BENADRYL at that time 5 months later- have had weakness in legs and feet, flu like symptoms for 2-3 day periods of time, now have pain in the upper right side under rib area.
2 days post vaccine, patient noticed that she was feeling very nauseous, followed by severe itching on day 5 post dose #2. Patient became jaundice and sought medical evaluation.
I had to go to the emergency room, high d-dimer (.95), elevated Pro B Type Natriuretic Peptide (152 pg/mL) ---Days 1-2 (12-22hrs post-vaccine) were horrific - fever, body aches, extreme pain everywhere, my eyes hurt so bad I thought I'd lose my vision, I was in so much pain that I couldn't talk to ask for help. Saying they were flu-like symptoms is a euphemism. ---Days 2-9 I was weak and shaky on my legs, easily winded (e.g. breathing hard when doing laundry). Fever returned off and on. ---Days 4-13 It felt like someone was sitting on my chest. ---Day 10 I had a blood draw per my doctors request. ---Day 12 Blood draw results showed high d-dimer, and my doctor told me I need to go to the ER for a ct scan to look for blood clots. ---Day 12 Went to Emergency Department - ct scan showed no clots, but elevated Pro B Type Natriuretic Peptide ---Day 15 Finally started feeling better, but still winded easily, fatigued, dizziness, heart palpitations
I went to local facility to get my birth control refilled and they said they couldn't give it to me because my blood pressure was dangerously high. They advised me to go to the ER. I waited a couple days to see if anything changed, but it got worse, so I went to the ER.
Patient C/o throat itching, flushing, and warmth to R ear.  Water and PO liquid Benadryl given with improvement. Disposition to home.
patient called today to report that she began yesterday 4-18-21 with nausea, vomiting, little diarrhea, fever, body/muscle aches and a red face. we told her to take tylenol for fever and to drink plenty of fluids/electrolytes. called her later today and her fever has gone away but she continues with nausea vomiting and diarrhea. reiterated the importance of staying hydrated and if she got worse to see her doctor.  pt did state she had covid back in september (2020).
Approximately 10 minutes after pt received the flu shot he had a "sunburn" type facial look, swelling of feet but no throat or tongue swelling or difficulty breathing.
Red, swollen upper arm, Painful, itchy, chills, tired, sore joints, headaches.
12/07/21 presents to ED for "fatigue, cough and fever". "PMH of obesity"
On the day of the vaccination, 11/20/2021, 6 hours after the injection, I was laying on the couch I started to feel rapid heart rate. My resting heart rate went from 80 up to 120 and went down to 80 over the course of an hour or 2. I have had history of rapid heart rate and I called my doctor, via telehealth, he said since my heart rate went down after an hour he did not feel I needed further examination or test.
Chills, fever (100), Fatigue, Muscle and Joint pain, Sore arm at the injection site.
hives; both biceps, chest, torso and both legs; This spontaneous case was reported by a non-health professional and describes the occurrence of URTICARIA (hives; both biceps, chest, torso and both legs) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 09-Apr-2021, the patient experienced URTICARIA (hives; both biceps, chest, torso and both legs). On 11-Apr-2021, URTICARIA (hives; both biceps, chest, torso and both legs) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       .   Reporter did not allow further contact
This case was reported by a consumer via call center representative and described the occurrence of therapeutic response decreased in a 73-year-old male patient who received Hepatitis B vaccine for prophylaxis. The patient's past medical history included non-Hodgkin's lymphoma (in chest, and he had chemo and radiation that). Previously administered products included Diovan with an associated reaction of rhabdomyolysis (rhabdomyolysis also caused by statins). Concurrent medical conditions included heart disease, unspecified (from radiation treatment), cardiac pacemaker insertion, tachycardia and drug hypersensitivity (very sensitive to medications). On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased was unknown. It was unknown if the reporter considered the therapeutic response decreased to be related to Hepatitis B vaccine. Additional details were provided as follows: The age at vaccination was not reported. In 2008, the patient received hepatitis B vaccination. The patient's antibody titers were low so, the patient was receiving another round of vaccine. For tolerance for 1st dose and 2nd dose of Engerix B adult, refer cases US2018133497 and US2018GSK135695 respectively. Lab Comments: On an unknown date, the lab test was performed.
Vaccine expired on 12-Feb-2023/removed from freezer to thaw on 20-Mar-2023; No adverse event; Dose administered after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (Vaccine expired on 12-Feb-2023/removed from freezer to thaw on 20-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Mar-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 20-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 12-Feb-2023/removed from freezer to thaw on 20-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (Vaccine expired on 12-Feb-2023/removed from freezer to thaw on 20-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Vaccine expired on 12-Feb-2023/removed from freezer to thaw on 20-Mar-2023).    No concomitant medications was reported.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patients had shots around 8:30 in morning. No side effects have been reported. The vial did not undergone any temperature excursions. Level 5 incarcerated inmates. Reporter says they will monitor the inmates.   No treatment medications was reported.  This case contains information for the 1 of 3 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-716277, US-MODERNATX, INC.-MOD-2023-716279 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716279:Patient 3 out of 3 Patients US-MODERNATX, INC.-MOD-2023-716277:Patient 2 out of 3 Patients
Chills, rigors & low-grade fever, lasted about 24 hrs.  Took Tylenol & Ibuprofen for symptom relief.  Developed irregular shaped red spots on hands & feet.  They come & go, sometimes they itch or hurt.  These spots come & go most days since receiving the vaccination.  When they itch, rub Benadryl cream which stop the itching.