chrisvoncsefalvay/vaers-outcomes huggingface dataset:
serum sickness localized inflammation & redness, induration;lt neck pain, arm achy, whole body muscle aches, fever up to 102 on 18MAY by 19MAY temp gone, tired, weak;
Herpes simplex; This is a spontaneous report from a contactable other health professional (reported for herself). A 54-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 22Feb2021 16:00 (Batch/Lot number was not reported) at the age of 54 years old as single dose for covid-19 immunisation. Medical history included Encephalitis Herpes simplex; No Known allergies. Concomitant medications in two weeks included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); vitamins nos (MULTIVITAMIN [VITAMINS NOS]). Facility type vaccine other Public housing. No other vaccine in four weeks. The patient experienced Herpes simplex on 27Feb2021 07:00. No Treatment Received. No covid prior vaccination and no covid tested post vaccination. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Thi spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The healthcare worker reports that an improperly stored GARDASIL (lot #, expiry not reported) that was exposed to a temperature of 27F for 1 hour may have been administered. The healthcare worker did not have patient or physician details available at the time of the call since it was unknown to her whether or not the vaccine had been administered. No adverse effect reported. The healthcare worker also reported that the vaccine were stored as low as 33 F for up to 225 hours. This excursion was supported so there was no adverse event. This is 1 of several reports received from the same reporter. Additional information has been requested.
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 03-MAR-2012 at 11:30 ZOSTAVAX (Lot # 672476/1605AA) was exposed to -12 degrees C for an estimated total time out of range of 4 hours. On 15-MAR-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # 672476/1605AA, expiration date 13-JAN-2013) (dose and route of administration were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
Flu vaccine received on 1/30/08 here in the office at 430 pm - over the past 3 days pt c/o R arm swelling at site with redness 2-4 cm non-puritic bump.  Not allergic to eggs, has received flu imm before.  Tx Benadryl/50mg every 6-8 hours.  Contact us if no improvement.
Pfizer-BioNTech COVID-19 Vaccine: Emergency Department Visit 01/07/21: 47 y.o. female who presents with complaints of fever, rapid heart rate and body aches that began around 1 PM this afternoon.  Patient states that she received her second Covid vaccination yesterday and began developing symptoms today.  States she had a temperature of 102.  She is a nurse here in the rehabilitation center.  She denies any cough, sore throat, abdominal pain that is new, vomiting, diarrhea or bloody stools.  She has had no urinary symptoms.  She denies any leg swelling or pain.  No history of DVT or pulmonary embolism.  No recent travel, immobilizations, surgeries, bedrest or history of malignancy.  No hemoptysis.  Again, no cough.  Patient is taken no medications for the symptoms other than Tylenol which she states has not improved her symptoms. ROS negative. No pertinent history - Ovarian cyst, Spontaneous abortion, Uterine fibroid. She is given a liter normal saline 1 ibuprofen as she has allergies and side effects to multiple medications including pain medication and the patient did refuse any pain medications other than ibuprofen.  Symptoms are consistent with side effects of the Covid vaccine.  She does not appear ill appearing.  She has no fever at this time.  She does state that her symptoms are somewhat improved.  Chest x-ray and labs are otherwise unremarkable.  Encouraged the patient to get rest, drink plenty fluids and take ibuprofen and follow-up with her primary physician or return if symptoms worsen.  This is the patient's second dose of vaccine for Covid.
For 48 hours I experienced fever (between 101 and 102.4 degrees), severe body aches, chills and shaking, swollen red arm and weakness. I took Tylenol and used cool pack on arm and warm pack on low back.
being given Moderna vaccine instead of Covid-19 vaccine since no available supplies of Pfizer Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (being given Moderna vaccine instead of Covid-19 vaccine since no available supplies of Pfizer Covid-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 07-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (being given Moderna vaccine instead of Covid-19 vaccine since no available supplies of Pfizer Covid-19 vaccine). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (being given Moderna vaccine instead of Covid-19 vaccine since no available supplies of Pfizer Covid-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-073601 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD-2021-073601:
Employee states that she developed soreness to vaccine site but pain progressed and went to PCP who diagnosed her with (L) shoulder adhesive capsulitis. She attributes her (L) frozen shoulder from the flu vaccine as per her PCP. She was prescribed tramadol 50 mg BID PRN, Ibuprofen 800 mg Q 8 Hrs PRN x 4 days, PERCOCET 5-325 mg Q 6 hrs. PRN.
Following pneumoccal vaccine, pt developed red, swollen, painful left arm requiring ice packs and diphenhydramine. Developed fever (100.1F) x24 hours.
pt recv vax;devel elev AST of 62 U/L and inc LDH of 280 U/L.
Fever and chills day of vaccine, red arm starting and swelling starting 9/15/16.
Pain at site of injection, diarrhea, fatigue, headache, fever, brain fog
afebrile seizures; breath-holding spell; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 6-month-old patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose 2, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Prevnar 13 (Dose 1), for Immunization. The following information was reported: SEIZURE (medically significant), outcome "unknown", described as "afebrile seizures"; BREATH HOLDING (non-serious), outcome "unknown", described as "breath-holding spell".  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: A possibly contributory role of PREVNAR 13 in triggering the onset of afebrile seizures cannot be fully excluded, considering the temporal relationship and known adverse event profile of the suspect vaccine.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Approximately one week after she received her MMR, Hepatitiis B, and Varicella vaccinations on 2-01-18, she noticed red, raised circular lesions, approximately 2 mm in size started to appear on employee's body. These lesions starting on her arms, thighs, and legs. She denies any itching but describes them as "stinging or burning." They progressively got worse and spread to her arms and hands. Some of the lesions are scabbed over. Pateint was seen at ER on 3/23/18, which she was prescribed Prednisone. Patient called on 3/30 because she still has these lesions. On 3/30/18 patient was seen in clinic by provider, who ordered, During employee's  the following labs: Hepatitis B Surface Antibody, Qualitative/Quantitative, Serum Hepatitis B Surface Antigen, Serum Hepatitis C Antibody Screen with Reflex to HCV RNA by PCR, Serum. HIV-1 and HIV-2 Antigen and Antibody Evaluation, Serum The labs listed above were all resulted as negative, except HBsAb was positive. A dermatologist appointment was then made for 4/05/18, triamcinolone 0.1% cream was given to the patient so she can apply to the small red bumps when they initially present to try to abort them from turning into full-blown lesions and then the subsequent post inflammatory hyperpigmentation.  She can do this twice a day to the affected areas for up to a few days at a time. Diagnosis: reactive dermatitis.
After giving the booster vaccine to the patient, we found out that there is less than 6  months interval after  the second dose to the booster dose
Patient died of complications due to COIVD-19 illness, which was 4 months after receiving his second dose of vaccine. He was a breakthrough case that died with full vaccination status for COIVD-19. No one is indicating that the vaccine had anything to do with this persons' death.
This spontaneous report as received from a pharmacy technician refers to a female patient of unknown age. On an unknown date in 2014 (reported as sometimes in the last two months) the patient was vaccinated with PNEUMOVAX 23 (dose, strength not reported) (lot # K004148, exp. Date: 10-MAY-2014). The reporter stated that on an unknown date in 2014 the patient experienced swelling and redness on one whole side of the body. This patient was treated by her physician and given steroids and an antibiotic. The outcome of was swollen and red on one whole side of her body was unknown. The relatedness between events and PNEUMOVAX 23 was not reported. No Product Quality Complaint (PQC) reported. The reporter requested lot check and would like to return the remaining vaccines with this lot and get replacements depending on the results of the lot check. This is one of several reports from the same reporter (other MARRS # 1410USA001868). Additional information has been requested.
Low grade fever, Extreme fatigue, rash at injection site with a knot, upset stomach, cordination issues, & feeling off for 4 days
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 09-JUL-2018 the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # N030965 exp date 25-AUG-2019) (dose not reported) orally and an improperly stored dose of RECOMBIVAX HB (lot # R006746 exp date 09-NOV-2020) (dose and route not reported). There was a data logger issue reported. The temperature of excursion was 32°F up to 35°F (multiple excursions) for a time frame of 13 hours. No adverse effects were reported. This is one of several reports received from the same source.; Sender's Comments: US-009507513-1807USA010173: US-009507513-1807USA010174: US-009507513-1807USA010175: US-009507513-1807USA010176: US-009507513-1807USA010177: US-009507513-1807USA010178: US-009507513-1807USA004813:
HAD HEADACHE AND BODY ACHES THROUGHOUT THE NIGHT WHICH IMPROVED IN THE MORNING.
Increased heart rate during both rest and sleep. Chest pain. Arm pain on my right side. It was discovered I had nodules in my Thyroid. And a cyst in my left breast. Stiffness in my neck and back.
Initial unsolicited report received from a pharmacist on 28 December 2015. This case involves a 32-year-old female patient who was vaccinated with a dose of ADACEL (batch number: UI288AA, dose, dose in series, site of administration were not reported) intramuscularly on 08 November 2015. The patient's medical history and concomitant medications were not reported. On 08 November 2015, same day following the vaccination, the patient had developed sore arm, low grade fever, malaise/felt poorly and had headache (2 times). It was unaware whether the patient had medical care. Laboratory data and corrective treatment was not reported. The outcomes of the events were unknown. List of documents held by sender: none. Follow up information received from a pharmacist on 19 February 2016. No additional information provided.
Metallic taste filling mouth within first two minutes of injection, lasting for three hours.  Cold sweat and the feeling of possible fainting lasted ten minutes. Nausea occurred for 24 hours. Swelling of lymph node in the armpit of the left arm (non-injection) arm as well as a feeling of burning near the underside of the arm just above left elbow lasting 48 hours. When the metallic taste resolved, it was replaced by an indescribable taste lasting for two hours. Within 24 hours, a strong smell of "plastic" for two hours was replaced by the strong smell of "burnt toast/burning" for several hours.  The lymph node in the left arm still feels swollen but less so, and it six days past the injection date. Menstruation began a week early, which has not been off schedule for ten years, so it feels related. I hope this helps; feel free to reach out if you have additional questions.
Approx time frames:  3/10-3/17- soreness and lesions on toes, both feet 3/15-4/1- Purple flushing of toes, numbness, pins and needles 3/20-4/20- Extreme coldness of feet., so much so that it was waking me up at night.  3/22- podiatrist visit- diagnosis chilblains. Prescribed nitro-gel and 325mg aspirin 1x/day for one month took nitro-gel one night- very bad headache, continued aspirin 3/25- took warm bath, felt turbulence in blood vessels of ankle area, toes flushing purple and white. Seemed to improve condition somewhat. 3/29- Second Pfizer 4/4- 4/15- hives and itching all over body 4/12- 4/20 Edema on feet and ankles
Having dark urine, concentrated urine; Having dark urine, concentrated urine; This is a spontaneous report from a contactable consumer (patient). This male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Apr2021 as single dose for covid-19 immunisation. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) as single dose for covid-19 immunisation. On 19Apr2021 evening, the patient had been having dark urine, concentrated urine, no matter how much water drink. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Confirmed breakkthrough case   COVID-19 (Moderna) 1  03/10/2021 local Health Dept.  Moderna 044A21A   COVID-19 (Moderna) 2  04/07/2021 local Health Dept.  Moderna 040B21A   COVID-19 (Moderna) 3  03/10/2022 HCF Moderna 022J21A
Information has been received from a registered nurse concerning a male child who was vaccinated PO with a first 2 ml dose ROTATEQ vaccine live (human-bovine) after 12 weeks of age. No adverse affects. No other information. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
G47.33 OBSTRUCTIVE SLEEP APNEA 1/10/2023 ATRIAL FLUTTER, PAROXYSMAL
The morning after I received the shot in my right arm, I woke up and jumped out of bed to turn off my alarm. My right leg buckled and completely gave out. It felt like there was not a muscle or bone in the leg. I  melted down on top of my leg, twisting my ankle and my knee. I ended up with my knee twisted behind me as I hit the floor and my nightstand. I don't know if you would call it muscle fatigue or weakness, it felt like muscle paralysis, but it only lasted less than a minute before it was gone, however, the damage was already done. I hurt my knee very badly because I had no control over my leg muscles. I've never had anything like that happen before.
The date when the vials were stored in the fridge was 14Mar2023 and the dates of administration were 25Apr2023.; No adverse event; A dose of Moderna vaccine given beyond use by date. The BUD was 13 April 2023 and the vaccine was given 25 April 2023.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A dose of Moderna vaccine given beyond use by date. The BUD was 13 April 2023 and the vaccine was given 25 April 2023.), PRODUCT STORAGE ERROR (The date when the vials were stored in the fridge was 14Mar2023 and the dates of administration were 25Apr2023.) and NO ADVERSE EVENT (No adverse event) in a 30-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Apr-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 25-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (A dose of Moderna vaccine given beyond use by date. The BUD was 13 April 2023 and the vaccine was given 25 April 2023.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The date when the vials were stored in the fridge was 14Mar2023 and the dates of administration were 25Apr2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A dose of Moderna vaccine given beyond use by date. The BUD was 13 April 2023 and the vaccine was given 25 April 2023.), PRODUCT STORAGE ERROR (The date when the vials were stored in the fridge was 14Mar2023 and the dates of administration were 25Apr2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (A dose of Moderna vaccine given beyond use by date. The BUD was 13 April 2023 and the vaccine was given 25 April 2023.) and PRODUCT STORAGE ERROR (The date when the vials were stored in the fridge was 14Mar2023 and the dates of administration were 25Apr2023).    Concomitant Medication use information was not provided by reporter.  The patient took 3rd dose of Moderna vaccine on 26-Sep-2022 by IM route having batch lot number AS7163B.  A dose of Moderna vaccine was given beyond use by date. The BUD was 13-Apr-2023 and the vaccine was given 25-Apr-2023.  The date when the vials were stored in the fridge was on 14-Mar-2023.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721275 (Linked Report). This case was linked to MOD-2023-722089 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2023: No new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721275:Master Case
With in 5 minutes of receiving the vaccine, I started to feel light headed, dizziness, and faint. Then I felt a heat that traveled from the top of my head to me throughout my body. It caused my eyes, nose, ears, and throat to itch and burning. My eyes were itching and burning and I had an uncontrollable cough that I couldn?t control and had the feeling of my throat getting tight. I made it to get help from employee health nurse, I was given Benadryl po. And my vitals were checked. My blood pressure and heart rate was extremely elevated. The Benadryl didn?t help the coughing , so I was sent to the emergency room and given over Benadryl and steroids. The iv Benadryl was not effective so they gave my the iv steroid which helped some. I had to take  steroids for two weeks to keep form coughing. I also had to got to the emergency and doctors office due to recurring elevated blood pressure, headaches, dizziness, fatigue. I was put on blood pressure medication for 3 months.
I had cough, sore throat, and a running nose. I still have these symptoms and it has been a week today.  I have not been to the doctor about this.
Fever up to 101.3 orally starting within receiving Pediarix, Prevnar, and HIB.
On 5/8/18 patient had febrile seizure lasting 5-10 minutes. Parents took to Emergency Department. Only treatment was antipyretics.
Shoulder pain. Pt went to see prescriber and MD said it was possible tendonitis due to possible influenza vaccine administration into bursa.
Immediately after vaccination developed tingling in soft palate. Pale. sat for 15 minutes and symptoms remained and was given 25mg benedryl.
DIED; This spontaneous report received from a consumer concerned a female of unspecified age, race and ethnicity.   The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered on 23-DEC-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On 25-DEC-2021, 2 days after vaccination, the patient died.  On 25-DEC-2021, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220846104.; Sender's Comments: V0:20220848257-covid-19 vaccine ad26.cov2.s-Died. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Patient received Adacel in the left deltoid and then hit in the same arm by a baseball on 0619/2006. On 06/20/06, area was red, swollen, bruised and painful. Fever of 101 degrees on 06/21/06. Patient instructed to do Advil, ice and heat. If no better come back to physician office.
Fever. Diarrhea. Rash. Dyhydration. Nausea.
Severe Sepsis, positive for Covid-19 . Patient is fully vaccinated with Moderna vaccine