chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dark circles under eyes; eyelids appeared purple; eyes look puffy; eyes look swollen; skin appears yellowish; This case was reported by a consumer via call center representative and described the occurrence of dark circles under eyes in a male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 26th January 2022 18:00, the patient received Boostrix (intramuscular) .5 ml. In January 2022, less than a day after receiving Boostrix, the patient experienced dark circles under eyes, skin discoloration, puffy eyes, swelling of eyelid and yellow skin. On an unknown date, the outcome of the dark circles under eyes, skin discoloration, puffy eyes, swelling of eyelid and yellow skin were not recovered/not resolved.   It was unknown if the reporter considered the dark circles under eyes, skin discoloration, puffy eyes, swelling of eyelid and yellow skin to be related to Boostrix.  Additional details were provided as follows: The case was reported by patient himself. The patient received a dose of Boostrix into his left arm  around 6pm at his pharmacy.  Last night after receiving the dose, the patient developed dark circles under his eyes and that his eyelids appeared to turn purple in color.  In morning of the day of reporting, patient's eyes look swollen and puffy and that looked like patient was in a car accident or beat up, and that his skin appears to be yellowish.  The reporter did not provide the lot or expiration date of the vaccine given. The patient was contacting his health care professional(Hcp). The reporter consented to follow up with hcp.
2-3mins p/vax pt devel red blotchy rash on upper neck & trunk;mom states pt became limp for an instant;no wheezing or resp distress noted;sl red rash @ hib site lt leg;
Day 5 after shot, little itchy rash around injection site; This is a spontaneous report from a contactable consumer (patient). A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9264, Expiration date: Unknown), via an unspecified route of administration, administered in right arm on 04Feb2021 at 03:00 (at the age of 76-years-old) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included alendronate sodium (ALENDRONATE). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3249, Expiration date: Unknown), via an unspecified route of administration, administered in right arm on 14Jan2021 03:00 (at the age of 76-years-old) as dose 1, single for covid-19 immunisation in other facility. On 09Feb2021 at 08:00, day 5 after shot the patient experienced little itchy rash around injection site. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of the event with self-hemp oil topical, and allergy pill. The outcome of the event was recovering.  Follow-up attempts are completed. No further information is expected.
On 3/12 I developed a rash at the vaccine site along with a lump. It is very itchy and hot. As of today 3/16 I still have the rash and itchy but the lump is gone.
9:45AM Patient pale; diaphoretic, unresponsive x 10 sec O: BP 80 palpable, P 70 irregular O2 99% 9:50AM pt admits to no food intake; feels nausea A/P hypotensive - gave H2O, check BP, called ambulance RN and EMT with patient; elevated legs 9:55A BP 110/60 - transported to hospital; wife present
Pt called 10/29 in AM states think she had a rxn. T 99.9 night of 1/28. 98.8 in am 10/29 states headache, cough, running nose.
No additional adverse effects were reported; One patient received improperly stored PROQUAD, on 2/6/2020; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies, and concomitant therapies were not provided.  On 06-FEB-2020 (also reported on 10-FEB-2020 it was identified), the patient was vaccinated with an improperly stored dose (product storage error) of measles, mumps, rubella and varicella (oka-Merck) virus vaccine live (PROQUAD) 0.5 milliliter (ml), once for prophylaxis (strength, route of administration, and anatomical location were not reported) (lot number S030208 had been verified to be a valid number; expiration date was reported as 25-MAR-2020 and upon internal validation established as 25-MAR-2021). It was reported the use of properly stored sterile diluent (DILUENT MRK). It was reported the temperature storage range was at 47 degrees Fahrenheit (F) to 77 degrees F (9 degree Celsius (C) to 25 degrees C) (8.7 C) for a time frame of 2 hours. It was reported that no had previous temperature excursion. It was reported that the call was due to a data logger. No adverse effects were reported.
an injection was done in the glutinous muscle; A spontaneous report was received from a nurse concerning a female patient of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced inappropriate route of vaccination that was at glutinious muscle instead of deltoid muscle  The patient's medical history is not provided.  On 19 Mar 2021  prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown)  in the glutinous muscle for prophylaxis of COVID-19 infection.   On 19 Mar 2021, prior to receiving mRNA-1273, HCP called asking for alternative injection site location, after speaking to her she stated that an injection was done in glutinous muscle.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event was considered as unknown.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 (lot # unknown) with no associated AEs reported.
nurse first injected her with air, and then the nurse injected her  subcutaneous tissue; nurse first injected her with air, and then the nurse injected her  subcutaneous tissue; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (nurse first injected her with air, and then the nurse injected her  subcutaneous tissue) and PRODUCT ADMINISTRATION ERROR (nurse first injected her with air, and then the nurse injected her  subcutaneous tissue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (nurse first injected her with air, and then the nurse injected her  subcutaneous tissue) and PRODUCT ADMINISTRATION ERROR (nurse first injected her with air, and then the nurse injected her  subcutaneous tissue). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (nurse first injected her with air, and then the nurse injected her  subcutaneous tissue) and PRODUCT ADMINISTRATION ERROR (nurse first injected her with air, and then the nurse injected her  subcutaneous tissue) had resolved.     The nurse first injected her with air, and then the nurse injected her subcutaneous tissue. No concomitant and treatment medications were reported.
Patient was fine the day of the immunization. That night patient ran fever of 101* but otherwise was fine.  Pt went to daycare on the day of 04/19/2011 where she was fine to begin with.  At around 9:30am patient had a diaper change and stood up afterwards and walk and then began to stumble and fell down. Daycare worker stated her eyes were rolled back in her head and she had temp of 102.6*.  Daycare called 911 and patient was transported to ER where she was diagnosed with a febrile seizure.
GARDASIL administered 12/22/08, within hours patient noticed "tremors" (looks like she is having chills). Family and friends noticed episodes too. Episodes are less frequent but still occurring.  1/12/09 Receied PCP medical records of 10/16/08-1/6/2009. FINAL DX: tremors Records reveal patient experienced intermittent bilateral tremors of arms, hands & fingers since 12/22 w/decreasing intensity & duration.  No tx rendered & patient was to RTC if worsened.
A report from a literature source concerns an 11 year old female who received FLUMIST. The patient developed fever, cough, rhinorrhea, myalgia, and mild hypotension requiring hospitalization 12 days after LAIV receipt. Viral culture of a nasal swab had isolated the vaccine strain of influenza A virus on day 3 after vaccination but not on day 7. A nasal wash collected on day 13 at the time of onset of the symptoms was negative for influenza by DFA and culture, but influenza A virus was detectable by PCR. Insufficient RNA quantities prohibited further characterization. She was treated with antimicrobials and oseltamivir but remained febrile after 5 days of therapy. Multiple pulmonary nodules consistent with fungal infection were identified by computerized chest tomography on day 9 of hospitalization, and antifungal therapy was begun, fever resolved, and she was discharged from the hospital on day 11. The clinical impression at the time was probable fungal pneumonia. The event was judged to be possibly related to vaccination. Assessment of serious criteria of report: Hospitalization.
Local reaction (R) arm, red, swollen & itchy. Slight fever x2 days. Tx: Ice, TYLENOL and BENADRYL. F/u in office PRN.
Stroke two days after vaccination, CVA hemorrhage, aneurysm (hospitalized ICU 08 January 2021, currently requires daily physical therapy and has walker to ambulate).
This spontaneous report was received from a licensed practical nurse, and refers to an unspecified numbers of patient of unknown age and gender. On unspecified dates since 01-MAR-2015, the unspecified number of patients were vaccinated with an improperly stored dose of PROQUAD (Merck) lot # K018143; expiration date on 10-APR-2015 and Lot # L005297; expiration date on 17-AUG-2016 (strength, dose #, dose, anatomical location and route of administration were not provided). There was not concomitant medication reported. No adverse effects were reported. There was not a product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with VARIVAX (lot# and expiration date not provided) (dose not reported). On an unknown date the patient received dose of VARIVAX that was exposed to temperature above the recommended temperature range. No adverse effect was reported. This is one of several reports from the same reporter (Same Reporter Link: MARRS#1405USA014687, MARRS#1405USA015420, MARRS#1405USA015421, MARRS#1405USA015423). Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a patient of unknown gender and age. The patient was vaccinated with lot# (669467/0005AA) M-M-R II on an unknown date in 2012, subsequent to 08-OCT-2012. Route of administration was not provided. No other co-suspects were reported. No concomitant medications were reported. Prior to administration of the vaccine M-M-R II, the vaccine had been exposed to storage at 47 degrees Fahrenheit for 12 hours. No adverse event was reported. Additional information has been requested.
This case was reported by a nurse via call center representative and described the occurrence of myalgia in a 53-year-old female patient who received SHINGRIX for prophylaxis. On 24th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 24th December 2018, several hours after receiving SHINGRIX, the patient experienced myalgia. On an unknown date, the outcome of the myalgia was recovered/resolved. It was unknown if the reporter considered the myalgia to be related to SHINGRIX. Additional details were reported as follows: Nurse reported that the patient received SHINGRIX at about 11:30 AM. That night of vaccination, the patient woke up in the middle of the night with severe myalgia and thought she was coming down with the flu. She did not get the flu and the myalgia resolved after less than 24 hours. The reporter consented to follow up.
Moderna COVID -19 Vaccine EUA  This was the second dose of the vaccine. I started to feel general malaise a few hours later. Upon waking around 7 am the morning of May 26, I felt very unwell and went back to bed. I woke at noon and began vomiting, although I had not eaten since the day before. For the next 30 hours I could not keep even a sip of water down. Position changes brought on stomach pain and vomiting. Symptoms began subsiding by evening of May 27. I felt ill enough to go to the ER on May 26 and was concerned about dehydration, but felt so poorly that I could only lay still and kept falling asleep. I am still experiencing mild gastrointestinal issues, with discomfort after eating and looser than normal bowel movements, increased flatulence and occasional bouts of diarrhea. Although I did not seek  medical attention or report sooner, I am now reporting this because unreported/undocumented/unknown data does not help in compiling information.
On the day following Prevnar dose 3, mother states he developed "a rash under the skin all over" and a fever of 102. Both lasted for 4 days. No erythema or swelling noted at injection site. Did not seek medical attention. Called MD's office, said rash may have been due to his "high" fevers.
Within 15 minutes of the injection, I felt numbness traveling from my left shoulder blade to the left side of my neck and face.  I immediately alerted the Medical assistant and the Physician assistant on-site and they told me to stay put and see if this will disappear.  As I sat another 15 minutes or so, the numbness traveled to the right side of my face and neck. By now, my whole head is numb.  I was very alarmed and the PA made a call to his supervisor, who advised me to go to the nearest Emergency room.  By the time I got to ER, this numbness disappeared (one hour from injection).  No further treatment was performed.
More than usual need to move my bowel. Looser than normal. Urge comes soon after eating. Up to three times a day.   Also have had very irritable gums. My gums are much healtier than average according to dentists I have visited. So, this is odd.
Moderna COVID-19 EUA  Chills Fever Sweats Body Aches Headache Neck Pain Tiredness Severe chest pain that lasted for 45 minutes.
Hospitalized 6/23/2021 with pericarditis - sudden onset of pleuritic L precordial pain that increased with supine position
Severe joint pain and swelling in fingers/hands, wrists, knees, ankles, toes.  Blood work, xrays of hands have been done, doctor ordered MRI of one hand waiting to get that scheduled.
Initial information received on 13-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2019SA071987 (same reporter). This case involves a six months old male patient who was vaccinated with a once dose of vaccine PENTACEL which had experienced a temperature excursion (lot C5574AA and Exp. Date 13-Oct-2019) via unknown route in the thigh vastus lateralis on 12-Mar-2019. The patient's medical history not reported and concomitant medications included HEPATITIS B VACCINE and FLUARIX for Immunization. It was an actual medication error case due to incorrect product storage. It was unknown whether the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Mother states "next am after shot in (R) leg pt limping and leg would give out and child would fall" no treatment took child to daycare and "when picked up that pm seemed to be fine".
Superficial blood clot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (Superficial blood clot) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced THROMBOSIS (Superficial blood clot) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Superficial blood clot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Apr-2021, Ultrasound scan: abnormal (abnormal) Ultrasound of left arm was done and determined a blood clot in that arm..         Patient went to the emergency room on 24 Apr 2021, approximately 7 pm. The patient was a healthy individual and used to do bike ride 11 miles per day with average speed 16mph. He did bike ride the evening of his second covid shot. No relevant concomitant medications were reported. Treatment information included anti-inflammatory medicine. Action taken with mRNA-1273 in response to the events was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Additional information was received on 26 Apr 2021. Added lab data and treatment; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
My cold became much worse and lasted several weeks. Sinus infection, congestion, cough and sore throat.  I tested positive for Covid on 04/26/2022. My symptoms were similar to the cold I had, at first I thought it was just a relapse of my cold but wasn't as bad! Each day after the initial onset it was better. I am almost symptom free now, 04/29/2022.
Shortly after vaccine, at home patient felt pain, developed edema and redness of right arm(upper). With range of motion -she had more severe pain. Took Tylenol and applied ice to area. This lasted through the next day Wednesday and some on Thursday. Friday (11-10-06), pain subsided to about 15%. Edema decreased. Has red blotches. Called home health nurse.
Pain when moving the arm. Area really warm. When closing fist I feel pain, numbness in the upper part of left arm.
Tinnitus in my left ear; mid fever; This is a spontaneous report from a contactable consumer or other non hcp (patient).    A 27-years-old (non-pregnant) female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported) as single dose via an unspecified route of administration, administered in Arm Left on 24Apr2021 as dose 2, single (at the age of 27-years-old) for covid-19 immunisation. Medical history reported as none (known allergies: not that I know of other medical history: not that I know of). The patient's concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported) via an unspecified route of administration in Arm Left on 03Apr2021 as dose 1, single (at the age of 27-years-old) for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not tested for COVID-19. On 25Apr2021, 1 days after vaccination the patient experienced tinnitus in her left ear, mild fever after the second shot of the Pfizer shot. events reported as serious Disability. as a resulted events patient visited physician office visit. patient did not received any treatment for events. she went to a hearing specialist and she said everything looks normal. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 20Jul2021. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt recv vax on 10/27/98; on 10/28/98 pt exp tiredness, hot/swollen/itchy/sore arm x3 day; itched 3rd day
stomach issues; anxiety; cannot breathe; panicking about not being able to breathe; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach issues), ANXIETY (anxiety), DYSPNOEA (cannot breathe) and PANIC REACTION (panicking about not being able to breathe) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (stomach issues), ANXIETY (anxiety), DYSPNOEA (cannot breathe) and PANIC REACTION (panicking about not being able to breathe). At the time of the report, ABDOMINAL DISCOMFORT (stomach issues), ANXIETY (anxiety), DYSPNOEA (cannot breathe) and PANIC REACTION (panicking about not being able to breathe) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-251573 (Patient Link).
UNABLE TO WALK; UNABLE TO GET OUT OF BED; BLURRED VISION; LEFT ARM PAIN; LEFT ARM WEAKNESS; FEVER; MUSCLE PAIN/ACHES; WEAKNESS; TIREDNESS; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's past medical history included ulcers in mouth due to medication, and concurrent conditions included psoriasis, psoriatic arthritis, high blood pressure, non alcohol user, and non smoker, and other pre-existing medical conditions included patient had no history of drug abuse or illicit drug use. The patient experienced drug allergy when treated with terbinafine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and batch number: 1808978 expiry: 28-JUL-2021) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. Concomitant medications included hydrocodone for pain, alprazolam, amlodipine, cyclobenzaprine, folic acid, hydrochlorothiazide, methotrexate, metoprolol succinate, secukinumab, sulfasalazine, and trazodone. On 24-MAR-2021, the subject experienced unable to walk. On 24-MAR-2021, the subject experienced unable to get out of bed. On 24-MAR-2021, the subject experienced blurred vision. On 24-MAR-2021, the subject experienced left arm pain. On 24-MAR-2021, the subject experienced left arm weakness. On 24-MAR-2021, the subject experienced fever. On 24-MAR-2021, the subject experienced muscle pain/aches. On 24-MAR-2021, the subject experienced weakness. On 24-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from unable to walk, unable to get out of bed, fever, muscle pain/aches, and weakness on 24-MAR-2021, and had not recovered from blurred vision, left arm pain, left arm weakness, and tiredness. This report was non-serious.