chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Febrile seizure- CT Scan-neg; LP-neg; Had BOM @ time; tx BOM on 20FEB92 & 9MAR92;
Felt pain upon vaccine administration to left upper arm. Noticed difficulty lifting arm within 30 minutes of vaccine administration.
heaviness in the arm at the injection site/ left arm is in pain; heaviness in the arm at the injection site/ left arm is in pain; This is a spontaneous report from a contactable nurse reported for herself. A 34-year-old female received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK9230 and expiration date: Apr2021), via an unspecified route of administration on left arm on 04Jan2021 at 7:40am at single dose for covid-19 immunisation. The patient medical history included food allergy from 29Jan2020 and ongoing, reported as allergic to avocado, banana, beef, cantaloupe, cashews, chicken, coconut, coffee mix, corn, cucumber, egg, fish mix, green pea, milk, onion, olive, peach, pecan, potato, rice, shrimp, strawberry, watermelon. The patient concomitant medications reported as none. The patient is a registered nurse reporting she got her Pfizer Covid vaccine shot yesterday 04Jan2021 at 7:40 am, she had heaviness in the arm at the injection site on 04Jan2021, clarifies her left arm, she already took Tylenol yesterday. When she woke up this morning, left arm is in pain, the pain will not go away it has been 24 hours. She took her temperature and it is 98.1 F. She does have a lot of food allergies. She attempted to treat the arm pain with acetaminophen, 500mg (expiration Dec2022, purhased from store, Manufacturer is unknown, states it is the generic, LOT P142171). The reporter considered the event as non serious. The outcome of the event was not recovered.  .
In patient's words "My arm started hurting after the shot, but the pain continued to get much worse and then the pain plateaued at about 1.5 weeks. My range of motion has been extremely limited the last 6 weeks and it has been difficult to perform even the most simple task. I have received care from my primary care physician, x-rays, orthopedic, and am scheduled for physical therapy and a future MRI."
Had lip swelling from the Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Had lip swelling from the Moderna Covid-19 vaccine) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIP SWELLING (Had lip swelling from the Moderna Covid-19 vaccine). At the time of the report, LIP SWELLING (Had lip swelling from the Moderna Covid-19 vaccine) outcome was unknown.      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.
The pt experienced a swollen left leg which was red and hot and greater than the size of a fifty cent piece. Treated with cool compressed to the site, Tylenol and Duricef.
I first felt tired a few hours after the vaccine.  By evening, I had chills, fever, body aches , nausea and a terrible headache.  By morning everything was gone except for fatigue and headache.  Everything was gone a day and a half after the vaccine.
Chills, Fever, Body Aches, Fatigue, Headache, Nausea,  Slight chills started about 4 hrs after vaccine. More intense symptoms hit overnight (starting around 11PM) and lasted throughout the following day (3/27).  Nausea abated in the AM after eating a small piece of bread and taking Advil. Chills, body aches and fatigue were the most acute symptoms. Felt 90% better morning of 3/28 - just a slight headache and a bit of fatigue that day.
Transient pleuritic pain -- about 3 incidents lasting about 1/2 hour each, day following vaccination. Minor headache a few hours after vaccination. Mild abdominal discomfort off and on for a couple of days. Soreness in the arm at site of injection -- not unexpected.  Resolved after three days.
She stated she felt dizzy while standing waiting to check out, then she passed out and slid herself along the wall while I caught her before she fell. Her face was pale and her lips were blue tinged and she was not responsive for about 10 seconds. Feet were elevated and shortly after she came too, kind of groggy though. Juice was given, she drank it without difficulty and stated she felt better, but had a bad headache and nauseous and stomachache. Did come home shortly after, no complaints of dizziness or feeling of passing out, but a lot of pain and lots of swelling at the injection site.
a week after vaccine Thur Jan 1 quarter sized red slightly raised round area developed on Right upper arm . grew for next 3 days to entire upper arm . warm to touch . Went away on it's own Sunday Jan 3 in the late afternoon
Urticaria all over body. Started on arms, then hands, back, legs, feet and neck. Very itching. Injection site large red area, hot to touch and itchy. Started about 28 hours after 2nd injection. Used Zyrtec during the day and Benadryl at night to sleep.
inadvertently administered frozen vaccine / frozen temp ranging -8.2 to -13.4 C for 7 hrs; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 5-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) for prophylaxis and flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th May 2021, the patient received Kinrix, Kinrix Pre-Filled Syringe Device, FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device. On 6th May 2021, unknown after receiving Kinrix, Kinrix Pre-Filled Syringe Device, FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. The action taken with Flulaval Tetra Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details was reported as follows: The patient was administered with frozen vaccine Kinrix and FluLaval Quadrivalent  which was kept on temperature ranging from-8.2 to -13.4 C for 7 hours, which led to incorrect storage of drug. The mobile cooler went too cold. The reporter wanted to know, if the patients can be revaccinated. The vaccine details were available. The reporter consented to follow up. This case is one of the several cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021100521:same reporter US-GLAXOSMITHKLINE-US2021100518:same reporter US-GLAXOSMITHKLINE-US2021100514:same reporter US-GLAXOSMITHKLINE-US2021100519:same reporter US-GLAXOSMITHKLINE-US2021100517:same reporter US-GLAXOSMITHKLINE-US2021100510:same reporter
A couple months after my vaccination with the second dose, I began to experience my field of vision being blurred and did not associate them with a migraine at the time. Then it began more frequent and the doctor wanted me to log when I would get these. This gave me a dizziness as well extremely bad. Propranolol was given to help offset these migraines and dizziness spells. Symptoms began to decrease after taking the medication however I am still experiencing migraines. but no other symptoms. Moderna Booster: 10/29/2021: Lot : 048C21A : No effect on symptoms.
Site: Pain at Injection Site-Severe, Additional Details: Patient still experiences pain at the injection site and throughout her left arm. She has limited mobility and cannot lift her arm to the same extent as prior to the vaccination. She also experiences pain with any movement involving her left arm.
This spontaneous report as received from a female patient of unknown age reporting herself. There was no information about the patient's concurrent conditions, allergies or reactions, medical history or concomitant medications. On an unknown date, the patient was vaccinated with the second dose of PNEUMOVAX 23, for prophylaxis (dose, frequency, route of administration, lot number and expiration date were not reported). On an unspecified date, after receiving her second dose, her shoulder down to her elbow was swollen, red, and sore. In addition,  patient's arm was "two times larger than normal" (Inflammation localized). Consequently, she visited her pharmacy where she was recommended and received treatment with acetaminophen (TYLENOL), ibuprofen (MOTRIN), and diphenhydramine (BENADRYL). The patient also mentioned that she would have to miss work an unspecified day (reported as today) with the pain. No product quality complaint was involved. The outcome of the events and the causal relationship between the events and therapy with PNEUMOVAX 23 were not reported.
Provider discharge summary "Per HPI, a 20 YO female with h/o asthma presenting to the ED for evaluation of shortness of breath.   Pt states she developed shortness of breath with associated productive cough which progressively worsened over time. She was unable to get any sleep last night due to her symptoms. She also complains of pleuritic chest pain worse with cough.Trial of rescue inhaler and nebulizer treatment without improvement in symptoms. She was seen in the ED on 1/1 for similar symptoms, tested positive for COVID, discharged home on short course of prednisone at that time which she completed. She has had multiple ER visits due to asthma exacerbation and 2 hospitalizations in the past year.    In the ED, pt is tachycardic though able to maintain adequate saturation on RA. Low grade temp of 100.1F on admission. Lab work significant for WBC 17.8, Na 132, procal 0.27, D-dimer 770. CTA chest showed mixed solid and groundglass opacities, mildly enlarged mediastinal and hilar lymph nodes. Negative for PE.    Hospital Course: Asthma exacerbation: possibly related to residual COVID-19 URI, though superimposed bacterial pneumonia cannot be ruled out with presence of low-grade temp, leukocytosis, borderline procalcitonin. Tachycardia likely related to serial breathing tx. Pt received serial nebulizer tx, steroids, Mg in the ED. Patient was admitted to the hospital and started on scheduled inhaler treatments along with steroid therapy. Patient was also started on empiric abx for leukocytosis and mildly elevated procalcitonin with eventual improvement in symptoms. Pt discharged on remainder course of steroids/antibiotics to complete 5 day course of therapy. "
No additional adverse effect reported; A dose of improperly stored Varivax administered to patient; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. Information regarding the patient's concurrent condition, medical history, drug reactions/allergies and concomitant medications were not provided. On 04-JAN-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection (strength, dose #, schedule, route of administration were not reported) lot # S002735 expiration date reported as 28-JAN-2021 for prophylaxis (product storage error) reconstituted with properly stored sterile diluent. No additional adverse effects reported. The vaccine underwent temperature excursion of 16.9 Fahrenheit for a duration of 8 hours and 38 minutes. There were no previous temperature excursions. Digital data logger was involved. No product quality complaint.
This case was reported by a consumer and described the occurrence of allergic reaction in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. Concurrent medical conditions included milk allergy. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient had a strong allergic reaction to the vaccine. The patient was trying to sleuth out what in the vaccine she had reacted to, as found this study which listed lactose as a stabilizer. The patient wanted to know what to do about follow up/booster shot. The patient  was exactly the cohort that was urged to get this vaccine. The patient wanted know could she get this SHINGRIX booster minus the lactose. The patient wanted to know why would you include one of the top 8 allergens in a vaccine as 15 million  to one or more of these. This case was linked to the case US2018GSK124082, reported by the same reporter.
Patient experiencing upper back stiffness/mild pain and right lower gum pain during dental flossing.
Rashes, swelling, itching, hives   Had to go to the urgent care. Received steroid, antihistamines via IV
This solicited report was received from a physician regarding a 11 year old female patient as part of a market research program. The patient was a healthy child. There were no concurrent conditions or concomitant medications reported. On an unspecified date in March 2016 the patient was vaccinated first dose of with GARDASIL 9. After the vaccination, on an unspecified date in March 2016, the patient looked pale, was sweating and had to lay down. She went to the bathroom, felt sick and threw up. No tests were done to diagnose the events. The subject recovered with sequelae from the events on the same day. The action taken with the GARDASIL 9 was reported as discontinued due to the events (however it was also reported that second dose was on an unspecified date in May 2016). The reporting physician considered the events (pale, sweating, felt sick and threw up) to be related to GARDASIL 9. Additional information has been requested.
vertigo; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Apr2021 11:45 (Batch/Lot number: unknown) at the age of 34 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "preeclampsia while pregnant" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN B COMPLEX; PROBIOTICS. Vaccination history included: Bnt162b2 (After first shot: instant vertigo and nausea which last approximately 5 hours. Product: COVID 19, brand: Pfizer, lot unknown: True, lot unknown reason: Not available/provided to reporter at the time of report completion, administration date: 25Mar2021, administration time: 11:45 AM, dose number: 1, vaccine location: Right arm), administration date: 25Mar2021, when the patient was 34 years old, for COVID-19 Immunization, reaction(s): "instant vertigo", "nausea". The following information was reported: VERTIGO (non-serious) with onset 18Apr2021 07:00, outcome "not recovered", described as "vertigo"; NAUSEA (non-serious) with onset 18Apr2021 07:00, outcome "not recovered", described as "nausea". The events "vertigo" and "nausea" were evaluated at the physician office visit. Therapeutic measures were taken as a result of vertigo, nausea.  Additional information: Facility type vaccine was Pharmacy or Drug Store. No other vaccine in four weeks. Other medications in two weeks included Birth control. After first shot had instant vertigo and nausea which lasted approximately for 5 hours. After second shot vertigo and nausea set in approximately 1.5 hours after shot. Have had constant vertigo since (a little over 3 weeks right now). Treatment received included Allergy meds, medrol pack and physical therapy. There was no Covid prior vaccination. Covid test was not performed post vaccination. The patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
psoriatic arthritis flare; Uveitis was a lot better but not fully healed on humira; Fever; achy body; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4253187-00 (Agency).  A 71 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Aug2021 (Batch/Lot number: unknown) at the age of 70 years as dose 3 (booster), single, intramuscular, administration date 01Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 04Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for psoriatic arthropathy. The patient's relevant medical history was not reported. Concomitant medication(s) included: METHOTREXATE. The following information was reported: PSORIATIC ARTHROPATHY (medically significant), outcome "recovered", described as "psoriatic arthritis flare"; THERAPEUTIC PRODUCT EFFECT INCOMPLETE (non-serious), outcome "recovering", described as "Uveitis was a lot better but not fully healed on humira"; PYREXIA (non-serious), outcome "recovered", described as "Fever"; PAIN (non-serious), outcome "recovered", described as "achy body". The action taken for adalimumab was unknown. Clinical course was reported as, the patient had events of non-serious uveitis was a lot better but not fully healed on HUMIRA, psoriatic arthritis flare, fever and achy body with HUMIRA (ADALIMUMAB). PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for HUMIRA(ADALIMUMAB); The reporter's causality for the event(s) of uveitis was a lot better but not fully healed on HUMIRA, psoriatic arthritis flare, fever and achy body was not provided. Causality as per reporter (Drug/Vaccine) for all the events were probable.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided the causal association of the events with the suspect product BNT162B2 cannot be excluded.
11/14/21   onset seizure. HAD TDAP VACCINE 8/23/2016
This case was reported by a non-health professional and described the occurrence of painful rash in a 74-year-old female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 4 days after receiving SHINGRIX, the patient experienced painful rash. On an unknown date, the outcome of the painful rash was not recovered/not resolved. It was unknown if the reporter considered the painful rash to be related to SHINGRIX. Additional information was reported as follows: The patient experienced painful rash around the torso, after vaccination with SHINGRIX. The patient experienced the event painful rash continuing for a period of 3 days and till the date of reporting was not resolved. The patient had informed this to the pharmacist and the doctor.
Irritability, Intense pain for 10 days, fevers for 5 days, rashes, not sleeping much at night for over a week. Lethargy, baby did not want to be put down for 10 days.
MMR, Varicella, PREVNAR and Flu ordered. PROQUAD given instead of MMR. Patient did not have signs of adverse reaction at time of visit. Notified mother and provider of incident. Called to follow up with mother 10/8/18 and she stated pt and his twin brother were fussy 10/5 & 10/6, but are now acting well. Denies fever, fussiness, redness or swelling at vaccine administration sites.
Dizzy; short of breath; low blood pressure; heart palpitations; arrhythmia for 3 days
Patient was to receive Pfizer Bivalent vaccine, patient received Pfizer 6mo - 5yr
chills; aching; like a bad flu; his left testicle swollen; his left is painful when you touch it; nausea; he had fever; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), PYREXIA (he had fever), CHILLS (chills), PAIN (aching) and INFLUENZA LIKE ILLNESS (like a bad flu) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced NAUSEA (nausea), PYREXIA (he had fever), PAIN (aching), INFLUENZA LIKE ILLNESS (like a bad flu), TESTICULAR SWELLING (his left testicle swollen) and TESTICULAR PAIN (his left is painful when you touch it). On an unknown date, the patient experienced CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 09-Mar-2021, NAUSEA (nausea), PYREXIA (he had fever), PAIN (aching), INFLUENZA LIKE ILLNESS (like a bad flu) and TESTICULAR SWELLING (his left testicle swollen) outcome was unknown. At the time of the report, CHILLS (chills) and TESTICULAR PAIN (his left is painful when you touch it) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        no concomitant medication provided
This spontaneous report was received from a physician refers to an unspecified number of patients of an unknown age and gender. The patients relevant medical history, concurrent condition and concomitant medication were not reported. On unknown dates, the patients were vaccinated with unspecified improperly stored doses (at a temperature of 10 degrees Fahrenheit (F) for 1 hour) PROQUAD for prophylaxis  (lot # M029595 and expiration date of 10-DEC-2017) (strength, dosage schedule, anatomical location and route were not reported). No adverse effects were provided.  No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. As of 16-DEC-2016, all telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. ; Sender's Comments: US-009507513-1610USA010337: US-009507513-1610USA010777:, MERCK 1610USA010778:Mfr number
I was tired that night after vaccine, but the next morning it was really painful and I had a red swollen bump that was an inch and a half on arm. On the 23rd It had gotten 3 inches in diameter and it was still painful, red, swollen, and itchy. I called the Doctor that morning to check and they called me back and said they had seen that in other people and to just add an extra zyrtec. On the 24th, it was 5 inches in diameter and still red, painful, swollen, and itchy. Saturday it was the same, and by the 26th it started to go down a little bit and wasn't quite as red or painful but it did still itch quite a bite. Today there's a little bump but only a little redness and a little itchy.