chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immediately after the RN administered the Tdap vaccination today at the Health Dept., my son complained of "stinging of eyes", and a moment later complained of "dizziness", "blurred vision", and subsequently collapsed. I immediately held him and took him in my arms, and prevented free fall to the ground. My wife immediately notified the front desk receptionist at the clinic, and the RN who administered the Tdap Vaccine responded, and other clinic staff. Later ARNP on duty also joined. A serial BP and pulse reading were recorded, as my son regained consciousness, we were advised by the the RN and ARNP on duty that the incident report will be filed the same day, and I was advised to file report to the VAERS.
pt recvd vax; pt devel a fever of 103 for 12 hrs & felt generally unwell for 24 hrs;
Information has been received from a RN concerning a male who a week ago was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (0.5ml) (lot651332/1049P), SC. Subsequently, the pt experienced warm, red, swollen local reaction. The pt's primary physician was contacted and suggested application of ice and to continue monitoring the pt. It took approx four days for the symptoms to resolve. The pt recovered. There were no relevant diagnostic or laboratory tests performed. The nurse requested a lot check. The records of testing prior to release of this lot in question have been rechecked and found to be satisfactory. The lot met the requirements and was released by the regulatory agency.  Additional information has been requested.
I received my Covid booster shot (L deltoid) and my flu shot (R deltoid) at the same time around 0730 after my shift ended at the hospital.  I began having symptoms around 0750. Hives began on my both of my arms, and spread to my chest. I became very itchy all over, and my face and neck became very flushed. I also experienced heart palpitations. I did not go to a hospital immediately. I called the nurse hotline and the nurse advised me to not drive myself to the hospital, so she sent an ambulance to my residence instead. They took my vitals, and my BP was 140/90 and my SPO2 on room air was 99%. I declined going to the hospital, so I took a hot/cold shower, used topical steroid cream, and took 2 claritins. There were no residual issues after I went to sleep that morning.
Approx 15 mins afer injection, patient reported feeling hot, then cold, alternatley had facial flushing c/o dizziness.  Assisted into relining position.  Vital signs WNL.  Observed for 1 hour.  Pt recovered.
I had mild symptoms, tired, aches and headache. I took Tylenol. I started having flank pain around May 20th. I sat down but the pain became worse and I became nauseous. I was screaming in pain. I went to the hospital and was told I have a renal infarct. I have no history of clotting or underlying health conditions. They did some tests that showed a blood clot on my renal artery which blocked blood flow to my kidney causing the kidney pain. I was given medication to dissolve the blood clot. I was put on heparin and sent home on Eloquist. I was home but still feeling sick. I still was having kidney pain and saw my primary doctor. I went back to hospital and at that time the did another CT scan and hospitalized me because the blood clot broke apart and damaged more of my kidney. I was in the hospital for one day on observation.
Patient called pharmacy complaining of soreness in right shoulder from pneumonia shot. They said the arm was so sore he could not lift it to eat. I told the patient to go to the ER. Pt said ER doctor thought that a nerve may have been hit. Pt was not admitted.
Narrative:  Patient hospitalized an a hospital d/t pneumonia (COVID negative) while recovering from his pneumonia the patient unfortunately suffered a PE a cardiac arrest and under went to cardiopulmonary resuscitation; Patient did have a spontaneous return of circulation and had to be started on pressors, intubated and started on mechanical ventilation. Unfortunately, he had worsening pneumonia with fevers likely secondary to aspiration during his cardiac arrest and subsequently passed away under hospice/comfort measures. Per chart review, this patients cause of death was not likely attributable to the COVID-19 vaccine
no adverse event; Expiration date per the vial expiration checker: 14May2023HCP stated that they have administered the vaccines to 2 patients yesterday; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expiration date per the vial expiration checker: 14May2023HCP stated that they have administered the vaccines to 2 patients yesterday) and NO ADVERSE EVENT (no adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS1417B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Aug-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Aug-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expiration date per the vial expiration checker: 14May2023HCP stated that they have administered the vaccines to 2 patients yesterday). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expiration date per the vial expiration checker: 14May2023HCP stated that they have administered the vaccines to 2 patients yesterday) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expiration date per the vial expiration checker: 14May2023HCP stated that they have administered the vaccines to 2 patients yesterday).    Patient age group was reported as infant. Patients administered were from ages 6 months and above. Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-737863 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737863:Patient 2
Rash on chest, mucus in chest made popping and crackling noise, running noise, sneezing, diarrhea, wheezing,  As advised by my allergist due to my reaction to my first shot, I began taking 50 mg of Benedryl beginning 24 hours before my injection and had to continue for another 24 hours to maintain my symptoms.
within 5-10 minutes of shot, arm hurt and was sore like I got punched and a bit heavy (very similar to first shot). However, by evening, my arm ached and hurt to move; I began having headaches, felt nauseous, went to bed early. All through the night, full body aches bad enough to not get sleep because I could not get comfortable legs really ached and hurt, headache and stomach ache through the night. Next day, felt fluish, out of it, fatigue, sick, sore all over, arm so sore could not lift up without strong pain. Red rash beginning on left arm around injection site. Rash got worse--covered 7-8' in length on arm and when I touched the rash bumps/blisters it sent more pain in arm. These symptoms persisted for about 3 days and the rash did not go away until following week.
Patient presented to the health department to get updated immunizations for school.  The nurse that she saw was RN at Health Department.  The nurse did not do the screening checklist for contraindications to vaccines, which resulted in not asking if the patient was pregnant.  The patient was actually 16 weeks pregnant with a due date of 02/11/2020.  On 08/23/2019, the patient was counseled and advised to see her OB/GYN as soon as possible.  She was instructed to take of copy of the vaccines that were given to her doctor
This case describes the occurrence of cellulitis in a female pt who received Infanrix for prophylaxis. On 5/24/04, the pt received the 1st dose of Infanrix. Later that same day, she developed cellulitis requiring treatment with unspecified antibiotics. The cellulitis resolved (outcome date not specified). The reporting nurse administered the vaccine. Comment: Cellulitis is considered medically serious.
No adverse event; They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30 day beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30 day beyond use date.) and NO ADVERSE EVENT (No adverse event) in a 61-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 042J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Feb-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 23-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30 day beyond use date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30 day beyond use date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30 day beyond use date.).    No concomitant medications were provided. Lot 042J21A should have been reported with a BUD of 17-Feb-2022. No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live follow up received with Updated narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:MASTER CASE
This not a patient of our clinic. When called to confirm his second dose vaccine, is when we learned patient is deceased. Unable to reach anyone regarding date of death.
Flu like symptoms including body aches and 100+ degree fever lasting for two days.  Body aches subsided except for joint pain, now diagnosed as Rheumatoid Arthritis.
Friday patient experienced feeling fatigued and disoriented, Friday she reports muscle aches and headaches and Saturday patient reports feeling headaches and even more fatigue along with a sore throat on Saturday
pt recv vax 11AUG97 lt deltoid became red, swelled hot & painful starting w/in 1hr;pt notified clinic 12AUG97 & APAP, DPH & ice PRN ordered;to see MD if worsened 13AUG97;added short course pred & atarax;
Pt and mother reports pt awoke at 3:00 AM morning after vaccination w/ MENACTRA. Fever of 102.7 and redness and severe swelling of injection site. Pt and mother report site swollen 4-5 inches in diameter. MOTRIN 600mg by mouth administered. Visit to RN at Health dept at 1 pm on 10/6/15 advised pt to continue ice packs to area, continue alternating TYLENOL and MOTRIN every 4 hours and give patient BENADRYL for itching. Called pt at 3:30 - per mother patient resting w/ slight improvement.
06/12/2021 8pm- ringing in ears that didn't last long and tiredness and slight itching at elbow of same arm as shot 10pm- chills  06/13/2021 1:30pm- while peeing ears proceeded to ring and back had back aching feeling, called husband while sitting on floor propped up on bathroom sink cabinet. At which point my body when limp and my husband said I was rocking my head back and fourth with my eyes open but looking off to the side. When I came to for a second I was soaked in sweat just to pass out/black out again at which he said my head slumped off to one side while my eyes looked the other way.  I was also making snoring type sounds. The second time I awoke I was even more soaked. I also kept feeling the need to vomit but didn't. Helped me to the toilet to go #2 because I couldn't hold myself up. After which I finally started to feel better.  This didn't feel like the normal passing out I've done before after peeing in the middle of the night. It was 10xs worse.
Patient reported metallic taste in mouth, slight tightness in upper chest.  Observed chest tightness deceased over 20 min.  Metallic taste almost gone.  30 min. almost all gone.  Benadryl 50 mg. given at 25 min.  condition improved.  Instructions given to patient re-symptoms worsen, S.O.B, etc, husband driving patient home.
Headache, Nausea, Chills, Muscle aches at lower back and legs. Took 1 dose Ibuprofen approximately 2 hours after symptom onset. Muscle aches and headache subsided with ibuprofen. Symptoms continued 2 days after vaccination.
within a day the irritable bowel syndrome came back, no longer mild and I am still suffering from it; After the second shot I immediately had paresthesia in my feet which eventually went away; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 08Apr2021 13:00 (Lot number: EW0151) at the age of 48 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Lot: EP7534, Time: 01:15PM, Anatomical location: Right arm), administration date: 17Mar2021, when the patient was 48 years old, for COVID-19 immunization, reaction(s): "Paresthesia in my legs", "had mild irritable bowel syndrome". The following information was reported: IRRITABLE BOWEL SYNDROME (non-serious) with onset Apr2021, outcome "not recovered", described as "within a day the irritable bowel syndrome came back, no longer mild and I am still suffering from it"; PARAESTHESIA (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "After the second shot I immediately had paresthesia in my feet which eventually went away". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Mar2021) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of irritable bowel syndrome, paraesthesia.  Additional information: Other vaccine in four weeks and other medications in two weeks were no. After the second shot, immediately had paresthesia in feet which eventually went away. Unfortunately, within a day the irritable bowel syndrome came back, no longer mild, and still suffering from it. There was no way will risk getting a booster shot in a year. She can't imagine any worse. There was no treatment for IBS or paresthesia. No COVID prior vaccination. The patient tested COVID positive post vaccination. No known allergies and no other medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination.  No follow-up attempts are possible. No further information is expected.  Follow-Up (22Jul2021): Follow-up attempts are completed. No further information is expected.
The patient left pharmacy area after getting immunization. She came back a few minutes later stating she didn't feel good and her face was red. We went out and had her sit down. She said she just felt hot and "not right".  We gave her some water to drink and ice packs and took her bp and pulse which were normal. We asked her if she would like us to call 911. She said yes just to be safe. The emergency worker came and took over. She was feeling better, but they went ahead and took her in the ambulance.
Strong headache, vomiting, dizziness, general body ache and discomfort.
Vertigo, was prescribed Meclizine. At this time, still having symptoms, but less severe.
the stopper flew off side ways and cracked the screws/syringe where the needle would connect; the stopper flew off side ways and cracked the screws/syringe where the needle would connect; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown, single (Lot number: HG9498, Expiration Date: 31Jan2024) for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE ISSUE (non-serious), DEVICE BREAKAGE (non-serious), outcome "unknown" and all described as "the stopper flew off side ways and cracked the screws/syringe where the needle would connect".  Additional information: when removing the gray stopper (in order to attach a needle for injection), the pressure forces the stopper with strong force in 2 cases, the stopper flew off side ways and cracked the screws/syringe where the needle would connect for Pfizer-Biontech Covid-19 Vaccine Injectable (Combo)  The reporter considered "the stopper flew off side ways and cracked the screws/syringe where the needle would connect" not related to bnt162b2 omi xbb.1.5. Causality for "the stopper flew off side ways and cracked the screws/syringe where the needle would connect" was determined associated to device constituent of bnt162b2 omi xbb.1.5 (malfunction).  The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300177003 Same reporter/drug/AE, different patient;
Headache; Chills; Fever; Back pain; Fatigue; Sore arm; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0196) via an unspecified route of administration in the left arm on 26Jun2021 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included COVID-19 and back surgery on an unknown date in 2013. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included birth control (unspecified), multi-vitamin (unspecified), probiotic (unspecified) and calcium (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Jun2021, the patient experienced headache, chills, fever, back pain, fatigue and sore arm. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, chills, fever, back pain, fatigue and sore arm was resolved on an unknown date in 2021 at the time of this report.   No follow-up attempts are possible. No further information is expected.
Information has been received from a physician regarding a patient of unknown age and gender. The patient's medical history, drug allergies or allergies were not provided. On 28-JUL-2014, the patient was vaccinated with a dose of VARIVAX (Merck), (0.5 ml, subcutaneous, Lot number reported as J012816, expiration date not reported), that had been improperly stored. No adverse effects reported. Additional information is not expected.
pt recv vax 19JUL95 & on 25NOV97 pt devel a lesions compatible w/chickenpox;pt recovered;
Pain and tingling immediately and thereafter.  Weakness in arm.  Doctor  thinks a nerve was hit with the vaccination needle.
Pt. stated that the next day. After the shot in the late afternoon she started itching on her right arm in the area of the shot. States noted a rash with a 4x4 cm knot. States area was hot to touch. Instructed to go to MD since was also going to go visit her brother who has cancer and getting radiation tx. Placed on antibiotic and anti itch cream.
FACIAL PARALYSIS; RASH AROUND HER EARS; This spontaneous report received from a pharmacist concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, 1 total administered on 17-MAR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  The pharmacist reported that on an unspecified date patient got some facial paralysis, rash around ears. Pharmacist need to get more information about the patient. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the facial paralysis and rash around her ears was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210409588-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Facial paralysis. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Received both doses of the Pfizer covid vaccine early on and they all got covid 19; Received both doses of the Pfizer covid vaccine early on and they all got covid 19; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 5 patients. This is the second of five reports.   An elderly patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose, 2nd dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received both doses of the Pfizer covid vaccine early on and the patient got COVID 19 on an unspecified date. The outcome of the event was unknown.   The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : PFIZER INC-202101133918 Same Reporter/Drug/AE, Different Patient