chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I got home at 5 am from getting the shot, and laid down, I woke up at 9 am for a 10 am meeting with left arm soreness at the site of the injection.  I then developed body chills, ackey sore muscles Back, chest, arms and a really nagging headache. I was very groggy. Saturday, I was a mess,  I bundled up with an electric blanket to stay warm.  I slept most of the day. The symptoms lasted until Sunday (Easter) around noon, when I started to feel normal again
I began to breakout in hives on several soft tissue areas of my body and had angioedema in my lips  approximately 36 hours post injection.
Error: unauthorized age group (11-year-old, Pfizer EUA approved only for children 12 years and older. Parent signed consent form with incorrect DOB indicating age greater than 12 years). Event discovered and forwarded for reporting. Signs and symptoms: None known. Diagnosis and treatment: None known. Outcome: No adverse reaction reported.
pt recv vax 22DEC97 & 30DEC97 pt devel a rash consisting of two dots on the face, & one on the leg;pt also felt warm (no fever);
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 22-MAR-2018, the patient was vaccinated with one dose of improperly stored ROTATEQ (lot: N004812, expiry date: 04-OCT-2018). No adverse effects reported. The vaccine was exposed to 9°C to 25°C for 30 minutes. There was no previous temperature excursions. The call was because of a digital data logger.
He presented to the emergency department for evaluation of worsening hypoxia in the setting of known COVID infection and was found to have acute hypoxic respiratory failure for which he is being admitted for further evaluation and treatment. o Dexamethasone 6 mg x 10 days or until hospital discharge, started on 11/19/21 o Remdesivir x 5 days or until hospital discharge, started on 11/19/21
Fever (105), headache, nausea, shooting pain in abdomen, pain in arm, swelling in tongue, and weakness.  It took three days to recover.
After Tdap admin, pt developed immediate significant shoulder arm pain/swelling redness seen today for follow up imaging shows tendon tear NSAIDS rest.
OFF LABEL USE. PATIENT HAD RECEIVED THE 1ST DOSE MODERNA AT THE PHARMACY IN APRIL. DAD (CAREGIVER) HAD SAID THEY HAD MISSED THE 2ND DOSE DUE TO ILLNESS AND THEY WERE ADVISED BY THEIR PROVIDER TO GET THE JOHNSON AND JOHNSON.
Pt. reported having GI symptoms such as nausea and vomiting for 2 days that started on 01/22/21. She also had reported taking a pain medication on an empty stomach prior to having GI symptoms.
I received the 3rd shot of my rabies vaccine in the Er at approximately 5:30pm. There was significant bleeding from the insertion point in my upper left arm. I almost instantly felt soreness and pain that typically came on slightly later. At around 12:30am, I awoke extremely nauseous. This continued for about three hours, but never led to vomiting. I had no fever. At various points the following day, I felt the waves of nausea return. By the third day after the shot, the nausea subsided. I have a large bruise at the insertion point and slight swelling.  For the first two doses, I believe I received the same vaccine (RabAvert) - the nurse injecting the vaccine said they ran out one and that they used Imovax instead. Or perhaps it was the reverse...I am not sure.
have sensitivity in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization complete; Manufacturer unknown.), for COVID-19 Immunization. The following information was reported: SENSORY DISTURBANCE (non-serious), outcome "unknown", described as "have sensitivity in the arm".  Additional information: Patient received one Booster months ago by Pfizer and had sensitivity in the arm.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a physician refers to a patient of unknown age who on an unspecified date was vaccinated with a dose of GARDASIL (lot #, dose and site of administration were not provided). No other co-suspects were reported. On an unknown date, the patient experienced unspecified adverse event after the patient received GARDASIL. No treatment information was reported. At the time of the report, the patient's outcome was not reported. Additional information has been requested.
This case was reported by a nurse via sales rep and described the occurrence of pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain, nausea, chills and diarrhea. On an unknown date, the outcome of the pain, nausea, chills and diarrhea were recovered/resolved. It was unknown if the reporter considered the pain, nausea, chills and diarrhea to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the nurse for herself. The age at the vaccination was not reported. The patient presented pain, waves of nausea, chills and some diarrhea. All reactions resolved within 4 days. The reporter agreed to be contacted for follow up.
Chief Complaint  pt in ENDO to get MAB- sudden onset of not feeling well, diaphoretic and almost passed out per endo staff. Denies pain or any other symptoms. hx of chronic afib- per ENDO pt had a run of 16 PVC's while on monitor  History of Present Illness  Very pleasant 69-year-old gentleman presents to the emergency room upon referral from outpatient infusion.  He became ill with some body aches headache cough and hiccups starting on Monday.  He got tested for and was diagnosed with Covid on Wednesday at orchard drug, and had been referred to get monoclonal antibody infusion.  As he was preparing for that, he was being monitored on telemetry and was noted to have some nausea and lightheadedness that corresponded with 16 beats of a wide-complex tachycardia.  He was mildly symptomatic with this, it self resolved.  Because of this the process stopped and he was referred to the emergency room for further evaluation.  I have been informed that Dr, has seen him and recommended admission for observation close monitoring.   He does have a history of paroxysmal atrial fibrillation and follows with electrophysiology Dr..   With known recent diagnosis of Covid on Wednesday, administering Regeneron here today  Not repeating test today
swelling in L axilla hair loss swelling under L breast hives (happened after eating eggs, but never had any history of egg allergy in the past)
p/vax mom noted pt had T101;Ibuprofen given fever decreased;did not give Ibuprofen throughout the noc;fever noted again 8/11/99;began fever meds q 6hr also had cough & congestion 8/10/99;no cough/congestion on 8/11/99;MD felt fever d/t vax;
9 days after vaccine large red, swollen and itchy are on left deltoid area. 10 days later red area much larger and itchy. 12 days later hives on left arm and back torso. Still itchy
pt recvd vax 24OCT 3PM & 1-1 1/2 hrs later started changing color (white-purple) & went limp & unarousable for 15mins;pt spontaneously returned to nl & parents brought pt to clinic
Swelling - edema of Lt upper deltoid. Improved in 48-72h. Followed by acute urticaria. Treatment - BENADRYL po.
w/in 2min of vax hive @ site;some sneezing & nasal congestion  p/10min;given DPh resolved p/1hr or so;
pt recvd vax; 48 hrs later, sore at inject site w/ shooting numbness tingling down arm intermittently at 1st; now,1wk later,numbness & tingling remain & "is almost constant",c/o thumb "being on the verge of numb;
6 yellow vesicles on right eyelid. Meds: Famvir.
Right after vaccine had rough patch of skin 2 inches below vx site- may be reaction to glove. 26 hours after vx experienced extreme lethargy, chills, temp rise to 99.3, mild congestion/cough that continued until 2/13/2021. Was out of breath/lightheaded if holding anything over 10lbs. Sleeping or spending 12-24 hrs in bed at a time.
portal vein thrombosis; This is a spontaneous report received from a contactable physician. A 68-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Jan2021 (Batch/Lot number was not reported) as unknown single for covid-19 immunisation. Medical history included on hormone replacement therapy (HRT). No known allergies. The patient's concomitant medications were not reported. The patient experienced portal vein thrombosis (seriousness criteria: medically significant) on an unspecified date. The adverse event resulted in doctor or other healthcare professional office/clinic visit. AE treatment including lovenox. No covid prior vaccination. Unknown if covid tested post vaccination. The event outcome was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of portal vein thrombosis due to temporal relationship.  Case will be re-assessed upon the additional information provided. 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.
Loss of muscular control of right arm possibly Parsonage-Turner Syndrome.   Diagnosis incomplete but continuing.
Sweating and Dizziness. Hx of vertigo (last episode 48 hrs ago). Apple juice (120mls), water, crackers given at 1735 (pt unable to recall last meal). At 1745, pt feeling better. Stable and released.
Patient had initial redness at injection site for 2 days after vaccinations administered, but resolved. Redness an swelling to injection site returned 10 days later.
On 11/15/06, patient developed rash consistent with erythema multiforme. Has been treated with Benadryl, Zyrtec and Atarax.
~4 hr later severe pain and swelling at site of reaction and over a 24hr period pain radiated to part of the shoulder and into both arms. Difficulty sleeping due to pain. Extreme warmth of the arm. Patient  on heavy anti-inflammatory.  VERY severe nausea continued for about 29 hrs.   At 48h pain has abated somewhat but arm is still swollen and painful.  Nausea decreased significantly.
Patient complained of feeling flush, "head rush", and scratchy throat, and a "funny feeling". No shortness of breath or itching.
Ever since I got the 2nd dose, I feel a heaviness in my womb area, and it does not match with any part of the menstrual or ovulating cycle.  What worries me the most is that, besides activating wild Urticaria bursts, at night my arms, legs and whole body goes numb, as if I was about to pass out. My breath fades away and it feels like I have no control over my body. The heart rate increases and when I finally am able to breathe again, my whole body jolts out of the bed, feeling like I almost died. I see flashing lights, colorful dots, head feels heavy, and also experiment a loud whistle sound before my ears clog. The exact area where I got the second shot starts "palpitating". I didn't experiment any of these before. I am terrified of getting a third shot because of these symptoms that started since June.  I'm just scared it might get worse over time. The only thing that calmed down was the Urticaria with Aveno Psoryasis oat lotion, but the other things keep on happening.
PT RECEIVED THE VACCINE AFTER COMPLETING THE SCREENING QUESTIONNAIRE AND CONSENT FORM. PT THEN WALKED AROUND IN THE STORE AFTER RECEIVING THE VACCINE AND ENDED UP FAINTING. THIS OCCURRED WITHIN 10 MINUTES OF RECEIVING VACCINATION.
COVID-19; COVID-19; Moderna Vaccine dose 4 and Pfizer vaccine dose 5; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 71 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 05May2022 as dose 4 (booster), single (Lot number: 056M21A), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing), notes: diabetes, controlled by medication; "high blood pressure" (unspecified if ongoing), notes: high blood pressure controlled by medication. Concomitant medication(s) included: LEVOTHYROXINE, start date: Jan2019; LOSARTAN, start date: Jan2019; FAMOTIDINE, start date: Jan2019; ROSUVASTATIN, start date: Jan2019, stop date: 10Dec2022. Past drug history included: Lisinopril, reaction(s): "known allergies lisinopril", notes: known allergies lisinopril. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 05Oct2022, outcome "unknown", described as "Moderna Vaccine dose 4 and Pfizer vaccine dose 5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive, notes: still slight positive line on home COVID test; (19Dec2022) Negative, notes: Negative COVID home test on morning of 19Dec2022; (21Dec2022) Positive, notes: positive on home COVID test that evening. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Started 5-day dose of Paxlovid in evening of 11Dec2022, finished it morning of 16Dec2022. Negative COVID home test on morning of 19Dec2022. Developed repeat of initial COVID symptoms in afternoon of 21Dec2022, tested positive on home COVID test that evening. Doctor recommended no further meds, COVID symptoms currently thru 27Dec2022, still slight positive line on home COVID test. Have lost sense of smell and taste.  No follow-up attempts are possible. No further information is expected.
The night of the vaccine I started experiencing joint pain, but then severe brain fog. I literally did not know how to get home from work.I had to pull over and plan my route. This was a route I took daily. I continued to experience the brain fog and joint pain, coupled with extreme exhaustion for the next several days. I couldn't remember how to work basic equipment at work, nor how to get to very familiar destinations. The following Monday I was at work and began to feel very shaky and light headed and started getting numbness and tingling in my arms and hands.  Extreme exhaustion came over me. I went home and just went to bed. I was awakened with severe heart pounding and an irregular heart rhythm, while still having the numbness and tingling. I contacted my dr. I just continued to hydrate and take aspirin and tylenol and sleep. My doctor encouraged me to report my symptoms to VAERS. I have since continued to have irregular heart rhythms . I also was exhausted for about 7 weeks post vaccine.
given a dose of Shingrix / but was 48 years old; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 48-year-old male patient who received Herpes zoster (Shingrix) (batch number 39KB3, expiry date 1st April 2022) for prophylaxis.   On 8th April 2021, the patient received Shingrix. On 8th April 2021, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: The reporter called for information regarding the administration of the complete dosing schedule of Shingrix to the patient that was given a dose of Shingrix but was 48 years old, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
She administered Moderna COVID19 Vaccine to three sixteen years old individuals; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (She administered Moderna COVID19 Vaccine to three sixteen years old individuals) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (She administered Moderna COVID19 Vaccine to three sixteen years old individuals). On 09-Jun-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (She administered Moderna COVID19 Vaccine to three sixteen years old individuals) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Doctor confirmed that she administered Moderna COVID19 Vaccine to  three sixteen years old individuals on 09June2021.  Concomitant product use was not reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow-up received: Ethnicity updated and Reporter added.
Migraines; COVID; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (COVID) and MIGRAINE (Migraines) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2020. Concurrent medical conditions included Migraine. Concomitant products included RIZATRIPTAN BENZOATE (MAXALT) for Migraine.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced COVID-19 (COVID). On an unknown date, the patient experienced MIGRAINE (Migraines). At the time of the report, COVID-19 (COVID) and MIGRAINE (Migraines) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, SARS-CoV-2 antibody test: positive (Positive) Positive.     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.
This spontaneous report was received from a licensed practical nurse and refers to an unknown number of unspecified patients of unknown age and gender. There was no information about the patients' concomitant therapies, medical histories and drug reactions or allergies provided. On 18-APR-2017, the patients were vaccinated with improperly stored doses of M-M-R II lot# reported as M00166, expiry date: 08-MAR-2018 (dose and route of administration were not provided). Sterile diluent (STERILE DILUENT) (lot #, expiry date were not provided) used to reconstitute improperly stored doses of M-M-R II was stored properly. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion with temperature between 47 degrees Fahrenheit to 77 degrees Fahrenheit for 2 hours. Data logger was used to capture temperature excursions. There were no previous temperature excursions. No Product Quality Complaint (PQC) was involved. Lot number M00166 is an invalid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA000206: US-009507513-1705USA000207: US-009507513-1705USA000205:
This spontaneous report was received from a licensed practical nurse and refers to multiple patients of unknown age and gender. Information regarding medical history and concurrent conditions were not provided. The licensed practical nurse noted that on multiple unspecified dates, patients were vaccinated with improperly stored vaccine (temperature of 62.2 degrees F, time frame of 3.75 hours) of PNEUMOVAX 23 single dose vials, lot # L019836 with expiration date 24-MAR-2017 (dose and route were not reported). No known adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Lower extremity swelling, leg pain, burning in the ankle, chest pain, shortness of breath, shoulder blade pain
Patient who is 11 years old came to receive his second dose of Pfizer on 4/22/22. Patient received a Pfizer dose that is for ages 12 and up instead of receiving the Pfizer for 5-11 years old. No adverse reactions reported during the observation time after being  vaccinated.
Nausea, aches, fatigue, chills, night sweats, then on 11/15/2016, localized reaction: redness and swelling (5" diameter) hot.
Breakthrough case: I developed symptoms for COVID-19 on 08/29/2021. My symptoms included muscle aches, debilitating headache, body aches, coughing, nausea, diarrhea, and runny nose. I received the monoclonal antibodies treatment from my doctor. However, I am still experiencing fatigue.
Inadvertently given Pfizer peds dose instead of pfizer 12 and older.
Pseudoaneurysm of femoral artery. Hospital Admission. This visit was within 6 weeks of receiving the COVID vaccine.
Initial and follow-up information has been received from a registered nurse, concerning a patient of unknown age and gender, who on 09-AUG-2013, was vaccinated with a dose of VARIVAX (Merck), 0.5 ml, subcutaneously (lot # reported as J003225, exp: 15-MAR-2015), which was improperly stored. The nurse reported that VARIVAX (Merck) was exposed to a temperature of 10F for 264 hours from 06-AUG-2013 to 16-AUG-2013. The nurse reported that the overall average temperature for the VARIVAX (Merck) did not remain between -58F and 5F. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Developed  a rash on the skin of the left arm early Saturday morning and doctor prescribed prednisone and benadryl for six days.
Jaundice, abdominal pain, body aches. headache,nausea - started 1/24/21. HGB 6.8, low haptoglobin  Pt has a had a history of hereditary stomatocytosis.  When the patient had the shingles vaccine 5/2019,he had a similar reaction.   Pt is requiring IV pain medications.