chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 50 years, 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 and concomitant medications were not reported. The patient had no known allergy.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 22Aug2023 to 27Aug2023,  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Pfizer vial was received and placed in clinic/refrigerator on 2/10/22. The NP entered expiration date 5/31/22 in system. 10-week expiration date was 4/21/22. Pfizer COVID-19 vaccine was administered to patient on 4/26/22. Lot # FK9895; vial exp date 9/2021; NDC.  Pfizer and CDC contacted for guidance for recommendations on revaccination.
About an hour later he was disoriented; headache; seizure; fever was over 103/temperature spiked so quickly; This is a spontaneous report from a contactable consumer. A 16-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in right arm on 16Apr2021 13:00 (Batch/Lot number was not reported) (at the age of 16-years-old) as a single dose for COVID-19 immunisation. Medical history included mental illness and autism from unspecified dates and unknown if ongoing. There were no concomitant medications. Patient previously took the first dose of BNT162B2, administered in right arm on Mar2021 (Lot number was unknown), at the age of 16 years old, for COVID-19 immunisation. There were no other vaccines in four weeks. Several hours after receiving the second dose of Pfizer Covid vaccine on 16Apr2021 20:00, the individual developed a headache and took ibuprofen (ADVIL) and water. About an hour later, he was disoriented and the parent (who was a nurse practitioner) asked him questions and he was having a hard time answering. Patient's fever was over 103 in the ambulance. He was tested for everything at the hospital and all was negative. It was determined to be an adverse reaction to the vaccine and what likely happened is his temperature spiked so quickly that he had a seizure. The events resulted in emergency room/department or urgent care. Treatment for other adverse events was unknown. There was no COVID prior vaccination and patient was not COVID tested post vaccination. The outcome of the events was recovering.  Information about lot/batch has been requested.
Approximately 12 hours after injection, patient experienced a rash that moved bilaterally to both arms and to trunk region. Rash was uncomfortable, painful and itchy. Use of OTC hydrocortisone and oral benadryl helped decrease the rash by afternoon the next day.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On 02-SEP-2016, the patient was vaccinated with a dose of VARIVAX (strength, dose and frequency were unknown; lot number was reported as L0404865 with expiration date 02-DEC-2017). VARIVAX was improperly reconstituted with "0.5 ml, from a separate, 10 ml single dose vial of Sterile Water for injection, for drug diluent use, manufactured by Hospira, lot # 54-152-DK with expiration date 01-JUN-2018" instead of the Merck supplied diluent. No adverse effect reported. This is one of the twelve reports that received from the same source. Additional information has been requested.
11 days after shot, I woke up in the middle of the night and my hearing was gone in left ear. Tested last Tuesday and compared to previous tests showed catastrophic hearing loss. Prescribed Prednisone. After 6 days, notice slight improvement in hearing but still not right.
Admitted at Hospital on 3/3/21 after having decreased level of consciousness and GI bleed in ER at another hospital. Found to have a midgut volvulus on CT scan. Underwent laparotomy, detorsion of midgut volvulus, LADD procedure.
Patient experienced dizziness and possible orthostatic hypotension before losing consciousness on the walk to the observation room. EMS was contacted and assessed the patient upon arrival. Blood pressure was approximately 90/60. EMS departed and the patient stayed at the facility. Observation time was extended to 1 hour and the patient was driven home by a third party.
losing hair; headache; High Fever; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (losing hair), HEADACHE (headache) and PYREXIA (High Fever) in a 33-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced ALOPECIA (losing hair), HEADACHE (headache) and PYREXIA (High Fever). At the time of the report, ALOPECIA (losing hair), HEADACHE (headache) and PYREXIA (High Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events, a causal relationship cannot be excluded.
Just a minute or two after the shot I felt all hot and flushed, my face and chest were bright red and then I had the feeling of a vice-like grip on my chest. The pharmacist told me to sit down and then the vice-like grip went to my low back and hurt so much I had to stand. Within another few minutes these symptoms disappeared. I have felt shaky ever since.
Severe lymphadenopathy L/posterior cervical nodes, tender R/testicle. Continues to have lymphadenopathy although less severe & continues to c/o R/testicular discomfort.
Information has been received from a Registered Nurse (R.N) concerning a 4 year old female who on 15-APR-2009 was vaccinated with a dose of VARIVAX (Merck) (lot # 663823/0221Y) through the Vaccines for Children program.  It was reported that the patient had injection site reaction.  The patient recovered.  This is one of several reports from the same source.  No further information is available.
On 12/19/03 and 02/19/04, pt received DTAP, IPV HIB AND PREVNAR vaccines.  By the evening after shot received leg with DTAP was red and swollen, including foot.  No rash up body.  No fever.  Pt did have aom on 12/19 and cold symptoms 02/?/04.  Otherwise healthy.  Shots were changed to opposite legs in February.  Reaction still in leg with DTAP.
Forgot to complete the regimen for Vivotif and did not take Vivotif after first two doses; A spontaneous report was received from a nurse on 26OCT2022. It described a 34-years-old male patient who "forgot to complete the regimen for Vivotif and did not take Vivotif after first two doses" (PT: Incomplete course of vaccination). The patient took the Vivotif capsule (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. On 15OCT2022, the patient received the first dose of Vivotif, followed by the second dose on 17OCT2022. However, the patient forgot to complete the regimen for Vivotif and did not take Vivotif after first two doses. Reportedly, the patient did not experience any side effects. The outcome of the reported event was not applicable.  Action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a patient forgot to complete the regimen for Vivotif and did not take Vivotif after first two doses (incomplete course of vaccination. Considering the nature of the event, the causality of incomplete course of vaccination is assessed as not applicable to Vivotif. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a patient forgot to complete the regimen for Vivotif and did not take Vivotif after first two doses (incomplete course of vaccination. Considering the nature of the event, the causality of incomplete course of vaccination is assessed as not applicable to Vivotif. The case is considered non-serious as per medical assessment.
SMALL AMOUNT OF MIST NOTICED WHEN VACCINE WAS INSERTED Not evaluated by me LVN NONE, WHEN VACCINE WAS INSERTED, A LITTLE AMOUNT OF MIST WAS NOTICED THAT SPRAYED OUT MADE MD and vaccine coordinate aware
Treatment of COVID-19; Treatment of COVID-19/Fatigue, congestion, and cold-like symptoms/feel like a bad head cold/bad headache and body aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Lot number: EL9264), in left arm, on 23Feb2021 as dose 2, single (Lot number: EN6201), in left arm and on 01Nov2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: XANAX, start date: 01Jan2020; VYVANSE, start date: 01Jan2020; LAMICTAL, start date: 01Jan2021; TRAZODONE, start date: 01Jan2020; PEPCID AC, start date: 01Jan2020; SINGULAIR, start date: 01Jan2020; FLONASE [FLUTICASONE PROPIONATE], start date: 01Jan2020. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Treatment of COVID-19"; COVID-19 (medically significant), outcome "unknown", described as "Treatment of COVID-19/Fatigue, congestion, and cold-like symptoms/feel like a bad head cold/bad headache and body aches". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Symptoms occurred 9 days after my first positive COVID test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Anti-viral details: brand: Paxlovid, start date: May2022 to: May2022, Indication: Treatment of COVID-19.
Patient presented with c/o fall the morning of admission while trying to get out of bed. The pt is alert and oriented x 3. Per history from dtr, the pt tested (+) for COVID infection 2 weeks ago and had a negative test last week, however, she tested (+) on NAAT today. She was attempting to lean forward and open the door to the bathroom when she fell forward from a sitting position. She did not lose consciousness or feel dizzy. There are no visible injuries to her face, head or other parts of anatomy on exam. She is on 3l/min with SpO2 100%. She does not have O2 at home and still smokes 3 cig/day. In ER, CT chest showed subacute lateral right fourth and fifth rib fractures and she tested positive for Covid-19.I D consult requested from and she was started on Decadron inview of oxygen requirements.  Pain controlled with medications and weaned off from Oxygen. PT recommended post-acute therapy PT and OT. She was discharged home with home health services.
Fever, Chills, Nausea - lasted approx. 6 hours Headache - lasted approx. 2.5 days
Narrative:  74yo male pt discharged from inpatient to home hospice with DISCHARGE DIAGNOSIS: Acute Renal Insufficiency, End Stage Renal Failure on 9/17/2021. Pt died at home in home hospice care on 9/19/2021. Pt had received covid vaccines on 2/14/201 & 3/14/2021. Death not related to vaccines.
ABOUT 4 MINS. AFTER IMMS. WE'RE GIVEN PT. LOOKED VERY WHITE AT THE FACE AND SHE REPORTED THAT SHE FELT FUNNY, WALKED TO HER MOTHER, AND THEN SHE FELL OUT WHILE IN HER MOTHER'S ARMS. SHE WAS OUT FOR ABOUT 2 SECONDS SHE CAME BACK RIGHT AWAY. I PLACED HER IN A CHAIR SHE REPORTED THAT SHE FELT FINE, PT. THEN WAS PLACED ON THE TABLE WITH HER MOTHER AT HER SIDE TO CALM DOWN, SHE DID GET A LITTLE EXCITED AFTER THE SYNCOPE EPISODE COOL CLOTH WAS APPLIED TO HER FOREHEAD SO THAT SHE FELL A LITTLE BETTER. DR. EXAMINED PATIENT AFTER EPISODE PATIENT WAS CLEARED BUT STILL HAD TO WAIT THE 15-20 MINS. STILL.
blacked out; Arm soreness; body aches; dizziness; nausea; chills and sweats; chills and sweats; headache; This is a spontaneous report from a non-contactable consumer (patient). A 37-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration, administered in the left arm on 28Apr2021 at 10:15 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included vortioxetine hydrobromide (TRINTELLIX) taken for an unspecified indication, start and stop date were not reported; levonorgestrel (MIRENA) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162b2 on 06Apr2021 at 10:00 AM (Lot Number: unknown) via an unspecified route of administration in the left arm for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 28Apr2021 at 21:00, the patient experienced blacked out, arm soreness, body aches, dizziness, nausea, chills and sweats, and headache.  The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on an unknown date post vaccination.  The patient had not recovered from the events, blacked out, arm soreness, body aches, dizziness, nausea, chills and sweats, and headache.    No follow-up attempts are possible; information about lot/batch number cannot been obtained
Report A0361249A describes a seizure in a female infant of unspecified age who received Infanrix. This report was received from the vaccinee's neighbor and has not been verified by a physician or other healthcare professional. Medical history, concurrent conditions, and concurrent medications were not specified. In June 2001 (exact date not known), the infant received her third injection of Infanrix. Approximately four hours post-immunization, the infant experienced a seizure. The infant was seen by a physician. Treatment and outcome of the event were not provided. Seizure is considered medically serious.
10/17/18 0930 AM: Developed right hand numbness, 1330: shortness of breath, chills, pain radiating from neck to tailbone along the spine and rapid heart rate. Evaluated at ED 10/17/2018 1635 and later admitted to Hospital. At that time experiencing intermintent  numbness and tingling, all 4 distal extremities.
passed out; black out; tense nerve feelings/nerve twitching; tense nerve feelings/nerve twitching; typical body aches or pain; This is a spontaneous report from a contactable consumer (patient). This 35- year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EN6208), via an unspecified route of administration, on 12Apr2021 at 09:30 am (at the age of 35-years-old) as a single dose for COVID-19 vaccination, in left arm. The facility where COVID-19 vaccine was administered was a hospital. No known allergies. Patient has no relevant medical history. States: I live a healthy lifestyle diet, exercise, proper rest. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 10:00 am, the patient stated: I passed out and or blacked out on my drive home from the hospital. I was careful to follow the 15minute wait period before I left the hospital and was ok at that point. I had tense nerve feelings came over me as it grew so strong, I was forced to try and get my car on an off ramp to leave the highway I was on. I thankfully did not get any real injuries to my body as I spun and landed on the side of the road in the grass area. However, this experience was horrifying to say the least. I had a delayed reaction to this vaccine, other than this one incident, I really only had the typical body aches or pain for 24 hours and a bit of nerve twitching. I will not mark this as a risk of death, because it was my driving a car that risked my safety not the vaccine, however, the vaccine did cause the black out. The clinical outcome of the events was recovered. The patient was not tested for COVID-19 after the vaccination.  Information about the Lot/batch number has been requested.
Hives all over her body. Complained of itched and pains all over her body.
shingles; Information has been received from a lawyer regarding a case in litigation, regarding a male patient of unknown age (the patient's concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant medications were not provided). On unknown date, in 2014 patient received a dose of Zoster Vaccine Live (ZOSTAVAX) (dosage, route, anatomical location, lot # and expiration date were not provided) for the long-term prevention of shingles and/or zoster-related conditions, at the pharmacy. Subsequently, after receiving the vaccine, on unknown date, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of patient's use of Zoster Vaccine Live (ZOSTAVAX) vaccine, the patient have and will continue suffering ongoing injuries, including but not limited to significant medical and related expenses as result of these injuries, losses and costs included care for hospitalization, physical care, monitoring, treatment, medications, and supplies, diminished capacity for the enjoyment of life, diminished quality of life, increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions. At the time of the report, the patient had not recovered from the event. The reporter considered the event to be related to Zoster Vaccine Live (ZOSTAVAX).
Pain, itching, swelling, warmth, erythema (width =3.25 in, length =5 in) at injection site. Pt has not used any home care treatments (ibuprofen, acetaminophen, ice-pack, hydrocortisone). Symptoms have not worsened or decreased since they first appeared.
No adverse effects reported; inadvertently received a dose of expired PNEUMOV AX 23; PNEUMOV AX 23 was also improperly stored prior to administration; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information on patient's pertinent medical history, concomitant medications and drug reaction or allergies was provided.  On 25-SEP-2019, the patient was inadvertently vaccinated with a dose of improperly stored and expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # N024385, expiration date 18-MAY-2019) 0.5 milliliter (route of administration was not provided) for prophylaxis. The vaccine underwent a temperature excursion of 9 to 25 Celsius degrees for 2 hours and 30 minutes. There was no previous temperature excursion. It was unknown if data logger was involved. No adverse effects were reported.
Muscle pain, swelling around injection site, rash. Overall muscle aches, tired, nausea, stomach pain, headache, chills (no fever present)
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age. The patient's medical history and current condition are not reported. It was reported that on 29-JUL-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (lot # J008443 and expiry date 9-JUL-2015) of dose 0.5 ml, subcutaneously that was improperly stored since an unspecified date. Also reported that no doses of improperly stored (Oka/Merck) VARIVAX were reported as administered on 28-JUL-2014. No adverse events are reported. Product quality complaint is not reported. The outcome of the event is unknown. Additional information has been requested.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Medium, Additional Details: Immediately after receiving vaccination patient fell forward onto the ground. EMT was called and arrived, he fainted a second time and may have had a seizure possibly where they decided to take him to the hospital and run some tests. Results are unknown
There was extreme pain in the injection site immediately. Twelve hours after the shot, I had terrible chills and flu like symptoms that lasted for several days. I then started getting strange pulsing in my legs that moved around and was more prominent at night. I was somewhat short of breath when exerting myself for about a month. Then I had pain that would travel throughout my legs and in my groin.  2 1/2 weeks later it was so bad that I went to the emergency room to be tested for blood clots, which were negative. The pain in my arm dissipated gradually, but 7 weeks later it still hurts enough to wake me up in the middle of the night. The pulsing in my legs has for the most part finally dissipated, but continues from time to time.
Pt received immunization at approx 10:15 am. Father found unresponsive @ approx 7:15 pm. 8/21/08-cause of death undetermined. pulmonary vascular congestion. petechiae of epicardium.
I initially developed a fever the night of the vaccination followed by chills and shivers.  This lasted about a day and a half.  Soon after the fever my arm started to ache and then it became almost immobile.  I could not initiate movement in that arm for about two days and the nerves were painful in that arm near where the shot was given for about four days.
45 minutes  after vaccine patient got dizzy and felt like he was about to faint. Felt nauseous and had to lie down. Then  he felt very hot but no fever. Three hours later he felt better but said he would have crashed a car if he had been driving..
Hospitalized 11/11/2021; COVID 19 positive 11/11/2021; Fully vaccinated plus booster  BRIEF OVERVIEW:   Discharge Provider: MD Primary Care Provider: DO Admission Date: 11/11/2021 Discharge Date: Nov 13, 2021  DETAILS OF HOSPITAL STAY:   PRESENTING PROBLEM: Hypoxia [R09.02] Chronic kidney disease, unspecified CKD stage [N18.9] Pneumonia due to COVID-19 virus [U07.1, J12.82] COVID-19 [U07.1]   HOSPITAL COURSE: Pt is a 55 yr old M with PMHx of NICMP s/p Bi Vent ICD, Chronic systolic CHF, Morbid Obesity, OSA on BiPAP at night, HTN, GERD, Full vaccinated against COVID with recent booster vaccine presented to ED on 11/11 after testing positive for COVID 19. Pt was exposed to his wife - who tested positive on 11/8. Patient noted that he was short of breath and hypoxic (on pulse ox at home) with activity.  Upon ED - eval, patient required 2L O2. Chest X ray concerning for mild pulmonary vascular and interstitial prominence - pulmonary edema vs underlying infection. Pt admitted for COVID-19 pneumonia - started on Decadron and Remdesivir. Right leg noted to be enlarged - US lower extremities negative for DVT.   patient responded rapidly to remdesivir and dexamethasone. he had a slight AKI for which he was encouraged to hydrate and instructed to hold his entresto for two days, he was also set up with a follow-up lab. when i saw him he was in good spirits with no objections to leaving, he was actually comfortable on room air (was supposed to be wearing his oxygen) though did have some DOE. patient seen by pulmonary rehab prior to discharge and sent out on dexamethasone as well. all questions and concerns addressed, all meds and follow-ups reviewed.