chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received on 26-MAY-2017 from a lawyer and a female patient of unknown age regarding a case in litigation. The patient was inoculated with ZOSTAVAX (dose. route, lot number and expiration date were not reported) on or about 15-DEC-2011 at a pharmacy as prescribed by a physician and recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 19-DEC-2014, the patient was treated by a nurse practitioner for a vesicular outbreak that was diagnosed as severe shingles. On or about 26-JAN-2015, the patient was treated by a physician for ongoing symptoms of shingles and chronic nerve pain. The patient was then diagnosed with post herpetic neuralgia. The patient was prescribed valacyclovir, gabapentin, and hydrocodone-acetaminophen for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
At 2:50 patient reported feeling dizzy and felt like she was going to "pass out" BP taken- 111/75, HR- 107, POX 98%.  Patient was asked by RN to remove sweater and mask. Patient reported feeling better, however feeling a little dizzy and nauseated. Patient denied swellings of tongue, chest tightness.  Patient asked for water and was given water. Patient sat in the chair for a few minutes and refused to lay down, patient reported feeling better after having water and reported feeling this before. Patient reported feeling better , vitals retaken  BP-114/75, HR-77, PT reported feeling much better and wanted to go home to eat as she did not eat lunch. Patient refused to stay longer and reported "I just want to go home to eat". Patient was called at home at 03:47 and asked how she was feeling. Patient reported feeling much better and was now home and about to have something to eat. Patient was advised to
03/15/2021: Presented to the emergency department with left flank pain. The patient was admitted with an obstructing kidney stone with associated hydronephrosis. The patient had a ureteral stent placed and discharged the next day with outpatient follow up.
Fever developed in the morning and progressively got worse. It went down to 101 then increased to 103, when he had a seizure. Paramedics required transport via ambulance.
At around 10:50 on 08/30/18 Patient had an abnormal reaction 2-3 minutes after receiving the vaccine. Patient slowly slumped over and slowly brought himself to the ground. RN called for help and Code Blue called. Patient appeared pale, and felt cold and clammy; reports feeling nauseous. No LOC noted; Patient did not hit his head or any other body part. VS.: 95/69; 55; 99%; resp 21. Pads placed on Patient for monitoring. Monitor showed NSR; Patient was A&O throughout the entire event and stated that he has had a similar reaction in the past after getting an injection. Code team arrived and assumed control of situation. Patient transported to the emergency room.
Fever and rash, seen by MD on  4/25/19 advised .  hydrate, continue with tylenol. if rash, worsens, spreads, fever >100.4-104, koplik spots. Inform to call/head to ER.
Shot was administered at appx. 3:30 pm and about 15 mins. after I was nauseated, throwing up, hives, weak and dizzy.  Later that evening, I was horse and rapid heart rate.  My throat started swelling and the EMTs were called after 10:00 pm and I was transported to Medical Center.  I was seen by Dr.  I was given an IV of steroids, Benedryl drew blood and was told that I had a bad reaction to the flu shot.  I am still taking steroids, Methyiprednisolone and Hydroxyzpam.
Note: the injection was given near the top of my shoulder. At the time of the injection, I felt a strange nerve pain that I hadn't felt before with a vaccine or an injection.  About 2hrs post vaccine, my arm had a rubbery/dull pain sensation. About 4hrs post vaccine, my shoulder felt very weak and there was significant pain. The pain and weakness increased by the next day. Day 1-4 post vaccine, 8-9 out of 10 pain when moving or attempting to move my arm.  It's been 2 wks post vaccine, and my shoulder, although less weak, still hurts (~3-6 out of 10 depending on time of day and activity) and is still weak (perhaps 50-70% of normal).
PAIN TINGLING AND BURNING IN LEFT ARM DISTAL FROM ELBOW TO FINGERS ON THE LATERAL ASPECT. COMES AND GOES. YESTERDAY THERE WAS PAIN AND TINGLING IN HER RIGHT LEG FROM KNEES TO TOES MORE MEDIALLY. IT IS NOT CONTINUOUS OR "SEVERE". SHE WILL BE SEEN BY A NEUROLOGIST. IT IS TOO EARLY FOR ME TO PREDICT A COURSE OR EVEN KNOW FOR SURE IF THIS IS DUE TO THE VACCINE.
Tested positive 06Jun2022; Tested positive 06Jun2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 16Mar2021 at 10:00 as dose 1, single (Lot number: Ep7534), in left arm, on 06Apr2021 as dose 2, single (Lot number: ER8743), in left arm and on 25Dec2021 as dose 3 (booster), single (Lot number: FD7218) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Smoke" (unspecified if ongoing). There were no concomitant medications. Patient did not had allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Jun2022, outcome "unknown" and all described as "Tested positive 01Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jun2022) positive; (07Jun2022) Negative; (14Jun2022) positive, notes: worse symptoms; (19Jun2022) positive, notes: still. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Dose was given high (into the shoulder).  The patient says they couldn't move there arm for a day and were in a fair amount of pain initially.  As of 7/6/20 the patient's shoulder pain is significantly less and patient says that her discomfort has improved daily since the incident, but it still bothers her some.
Swelling, redness, pain of the entire left arm, mild fever. There was some itching for the first few hrs. The swelling diminished gradually, took 5 days to go away.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Tha patient's medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, the patient received a dose of VARIVAX, intramuscularly for prophylaxis; lot # was reported as N027699, expiration date 09-JUN-2019 (dose, strength, and frequency were unknown).  The patient also received a dose of M-M-R II for prophylaxis; lot # N013279, and expiration date 28-APR-2019 (dose, strength, and frequency were unknown). Both vaccines were administered intramuscularly instead of the recommended subcutaneous route on different unspecified dates. No adverse events were reported.
Runny nose after 2nd dose; Sore arm after 2nd dose; Headache after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose after 2nd dose), PAIN IN EXTREMITY (Sore arm after 2nd dose) and HEADACHE (Headache after 2nd dose) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (Runny nose after 2nd dose), PAIN IN EXTREMITY (Sore arm after 2nd dose) and HEADACHE (Headache after 2nd dose). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, RHINORRHOEA (Runny nose after 2nd dose), PAIN IN EXTREMITY (Sore arm after 2nd dose) and HEADACHE (Headache after 2nd dose) had resolved.            No concomitant medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.     Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Outcome of events were updated.
This spontaneous report was received from a female patient who was over the age of 60 concerning to herself. The patient's concurrent conditions included penicillin and codeine allergy. There was no pertinent medical history. On 01-MAR-2016, the patient was vaccinated with a dose of PNEUMOVAX 23, (Lot # not reported), 0.5 ml, intramuscularly. There were no concomitant medications. On 01-MAR-2016, the patient developed a hard lump at the injection site as well as soreness. She started that the next day, on 02-MAR-2016, she developed a red ring around the injection site. On 04-MAR-2016, the red ring around the injection site was larger. The patient did not receive treatment for the events and there were no laboratory diagnostic tests performed. The patient did not seek medical attention. At the time of the report the outcome of the injection site mass, injection site induration, injection site erythema and injection site pain was not recovered. Additional information is not expected as there was no permission to contact the physician.
no additional AEs; 12 year old recevied both Varivax with an expiration date of 10/23/2020 and MMR II with an expiration date of 10/14/2020; This spontaneous report was received from a medical assistant and refers to a 12-year-old patient. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 28-JAN-2021, the patient was vaccinated with expired dose of varicella virus vaccine live (oka/merck)(VARIVAX), in dose 0.5 milliliter, expiration date: 23-OCT-2020. On the same day, the patient was also vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) in dose 0.5 milliliter, expiration date: 14-OCT-2020. Dose numbers, lot #, routes of administration and anatomical locations of aforementioned vaccines were not reported, both vaccines were used for prophylaxis. No temperature excursions of vaccines were reported. Both vaccines were supported by Post Expiry Memo Vaccines and Biologic's Administered information. The reporter declined to provide information on 12 year old at this time. No additional adverse events were reported.
OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient via company concerned a 48 year old female of an unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient had previously received 2 doses of covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, intramuscular, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total (1 in 1 once), first dose administered on an unspecified date and second dose administered on 15-MAR-2021 for covid-19 prophylaxis which was Off label dosing frequency (Off label use) (Dose number in series: 1). At the same time the patient had treated with upadacitinib (Rinvoq). On an unspecified date, the patient experienced 103.4 (unspecified unit) of fever and had covid-19 (Dose number in series: 1). Laboratory data (dates unspecified) included: Body temperature 103.4. The patient received treatment with OTC medication and C-Pac antibiotics (Unspecified). The outcome of the covid-19 and off label dosing frequency was not reported. The patient had received covid-19 vaccine ad26.cov2.s (Dose number in series: 2) (suspension for injection, intramuscular, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 total (1 in 1 once) administered on an unspecified date for covid-19 prophylaxis as first booster dose. It was unknown whether patient had any adverse events following vaccination covid-19 vaccine ad26.cov2.s (Dose number in series: 2). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 3) (suspension for injection, intramuscular, batch number: Unknown and expiry: Unknown) dose was not reported, administered on 03-JAN-2022 for covid-19 prophylaxis as a second booster which was an off label dosing frequency (Off label use) (Dose number in series: 3). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 48 years old. No concomitant medications were reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of off label dosing frequency was not reported. This report was non-serious. This case, involving the same patient is linked to 20220925988.
Arm soreness and fever of 100.6 within a few hours Subsequently developed Shortness of Breath at rest, tachycardia at 130s-140s, 'pressure' like sensation across chest area. Became worse over next 6 hours, remained constant for 2 days and improved on 3rd day. Patient did not seek medical care.
Moderna COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccine on 1/14/2021 and 2/10/2021. Presented to ED on 1/25/22 SOB onset 1/21. Admitted for acute on chronic resp failure, multifactorial 2/2 severe Covid19 infx and acute CHF c/b underlying pulmonary fibrosis, COPD. CXR: Worsening airspace opacities compared to CXR 12/21/2021. Recently NSTEMI with multivessel CAD. During admission continued to decline and have difficulty breathing. Pt was transitioned to comfort care/ DNR. Treated with prednisone, remdesivir, and decadron. Pt expired 02/09/22.
Hospital Course: The patient is a 40-year-old female who presented on the 8th to the emergency room with complaint of influenza type symptoms hurting all over. The patient was febrile at the time of admission and family members had been positive for influenza. The patient had also been on antibiotic for urinary tract infection that was prescribed earlier in the week. The patient was experiencing body aches, fever, fatigue, diarrhea, congestion all consistent with influenza running through the family. The patient unfortunately had 15 or so loose stools during short period of time. The patient is exhibiting a rash to entire upper body, redness across her skin which broke out on earlier in the day. The patient was started on IV fluids, was pan cultured. The patient's blood cultures were negative. The patient's urine cultures, however, confirmed urinary tract infection of E. coli. During the rehydrating process, the patient was noted to have a nice improvement in her hemoglobins. White counts were normal to the majority of the hospital stay. The patient's exam, however, demonstrated some congestive cough that led to a follow-up chest x-ray and that chest x-ray showed a new left-sided pneumonia, which may have been present at the time of admission is not well demonstrated on x-ray. However, it was noted that the patient received a PNEUMOVAX 23 pneumonia vaccination the day prior to onset. Given the urinary tract infection culture results and the chest x-ray, it was felt that antibiotic was necessary given her significant allergies. She was placed on aztreonam. The patient's red skin symptoms continued to get worse despite no prior exposure to antibiotics at least aztreonam. The patient's aztreonam was held. Urine output was reported to be minimal and follow-up labs on the 15th demonstrated the patient to be acidotic elevated white count, elevated lactic acid, all concerning for sepsis. The patient case was discussed with Dr. who given the abrupt change in the patient's overall kidney function and the large bump in the white count will be better served in a tertiary center. The case was discussed with the intensive this at facility and the patient is being transferred to the ICU there. An ABG done earlier in the morning demonstrated again the patient to be acidotic. Oxygen was started just prior to that due to diminished pulse Ox level. The patient's labs and vitals were stable prior to admission. Oxygen sats were 91% on 40% Venti but she was afebrile pulse 93, respiratory rate of 25, blood pressure 115/64 on just 150 cc an hour IV fluids. The patient is a very difficult IV stick. She has had history of developing thromboses in the extremities due to this factor 5 condition that she has and as a result central lines have not been used since that period of time. The patient has had some of her follow up care specifically Cardiology at another location. Further records could be provided if needed. The patient was transferred in stable condition. We will follow post discharge.
pre surgical procedure (splenectomy) vaccines sore arm w/swelling & redness (rt) fever (no recorded);
Dizziness after injection (assumed due to lack of food prior to). Intense severe dizziness 24 hours after injection and continuous up to 48 hours post injection . Severe headache 24 hours after injection. Sore throat 36 hours after injection and continuous
Child received vaccines during pregnant state on 9/19/14, 10/20/14 and 12/19/14. We were notified of this today on 5/8/15, when she came in to receive immunizations due. Stated she was not aware of pregnant state until 7+ months into it. Reports her baby was born on 4/5/15 and both her and baby are well. States babys dr is aware she received vaccines while pregnant. Reports baby is healthy with zero problems noted at birth or now. At time of immunizations received on 12/19/14, client would have been about 4 months pregnant.
Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history.   In 2014, the patient was vaccinated with a dose of the zoster vaccine live (ZOSTAVAX) (lot number, expiration date, anatomical location and administration route were not reported) at a clinic, for the long-term prevention of shingles and/or zoster-related conditions. On an unspecified date, subsequent to the patient's zoster vaccine live (ZOSTAVAX inoculation, patient was treated by a physician for shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care - for hospitalization (on unknown dates), physician care, monitoring, treatment, medications, and supplies. By the time of the report, the patient did not recover from shingles. The event was considered to be related to zoster vaccine live (ZOSTAVAX).
Arm paralysis for 2 days that has gone away. She now has hives that are working down her shoulder. Only complaint currently is it feels like it's crawling. Recommended ice and to call Dr if symptoms didn't improve.
About 2 hours after I received my 1st vaccine I developed hives on my forehead,face, neck at my hairline, arms and trunk
Face itchy.  Throat difficulty clearing throat.  Stuffy nose.  Rash on face.
Patient presented to pharmacy with complaint of a reaction at site of injection. Her right arm was red and swollen and she complained that it was sore. She stated she was dizzy but that did not begin right away. Patient was advised to follow up with PCP if it doesn't get better and to apply ice on it. She did not have any other symptoms.
Blotchy skin from chest; full rash on torso and back from hips up to chest/slight rash on thighs/rash on back of knees and legs/Looks like a drug rash; Noticed being a bit itchy that evening; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EH9899) via an unspecified route of administration at the left arm on 15Dec2020 16:00 at a single dose for covid-19 immunisation. Medical history included Iga nephropathy from an unknown date. Concomitant medication included lisinopril. On 15Dec2020, the patient noticed being a bit itchy before going to bed. On 16Dec2020 18:00, the patient noticed blotchy skin from chest up, full rash on torso and back from hips up to chest. The patient also noticed slight rash on thighs and more rash on back of knees and legs by 18Dec2020; looked like drug rash. The patient had no shortness of breath, fever, swelling, etc. The events were reported as non-serious and no treatment was given. Outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
day 1: (MON 9/12) Went to bed and woke in the night  with hard stomach cramps - high, not low -  day 2: (TUES 9/13) same with addition of fever - max 100.2 day 3: (WED 9/14) cramping less frequent, still hard, continued fever - spoke to on-call dr late afternoon, made plan to come in next day day 4: (THURS 9/15) cramping less and less frequent, no fever, but addition of diarrhea  days 5-7 (FRI 9/16 - SUN 9/18) continued mild cramping - no fever or diarrhea
Red circle about 4? in diameter developed around injection site approximately 10 days after shot.    It is warm and itchy but not bumpy
vomited; could not see, walk and having trouble at every level thought I would die never allowed me to see a Dr. she did nothing did they KILL ME OR POISON; could not see, walk and having trouble at every level; MYOCARDITIS; LUNGS AND HEART FAILING; LUNGS AND HEART FAILING; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on Mar2021 10:30 AM (Batch/Lot Number: ER8727) as DOSE 1, SINGLE for covid-19 immunisation. Facility type vaccine was hospital. Medical history included Allergies to little milk (Known allergies: Some food the patient think they don't test you here. when little milk), sinus, concussion, trigeminal neuralgia, had covid prior vaccination. No other vaccine in four weeks. Other medications in two weeks: take low dose of Nuerontinin. Concomitant medication included gabapentin (NEURONTIN). The patient previously took Sulphur and experienced allergy, motrin experienced allergy, penicillin and experienced allergy. The reported event started on 26Mar2021 10:00 AM, the course was reported as that nurse laughed I did nothing while I vomited, could not see, walk and having trouble at every level thought I would die never allowed me to see a Dr. she did nothing did they kill me or poison me. I am sick...getting worse...I have myocarditis now and lungs and heart failing...going to lose my job my health care everything cause you all lied you are liars. I asked what was in it I did not want it but from media pressure and my job got it. now I am about to die and lose everything I worked for cdc is liars and Dr. you all a bunch of liars killed me or it will. AE resulted in: [Doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event), Disability or permanent damage]. Treatment received and was reported as medical clinic did it said. The event outcome was not recovered. No covid tested post vaccination.  Follow-up (11Aug2021): Follow-up attempts are completed. No further information is expected.