chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse referring to a 9-month old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not provided. On an unknown date, the patient was vaccinated with improperly stored doses of ROTATEQ, orally, lot # N021308, expiration date 05-MAR-2019 (strength, dose, frequency and anatomical location were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. There was no adverse effect reported. The administered doses of vaccine experienced a temperature excursion of 9 to 25 (8.6) degrees Celsius for 16 minutes. Data logger was involved. There were no previous excursions reported. This report was not associated with a product quality complaint. This is one of several reports with the same reporter.
Pregnant (24 weeks, 6 days at time of vaccination; EDD is 6/23/2021).  I reported on the v-safe's daily check-in that one day I was totally exhausted and had to take a nap. I slept for about 2 hours. The exhaustion was akin to the first semester of pregnancy exhaustion when you can barely stay awake. I was fine after. The exhaustion was significant enough that I could not focus on work, so I decided to nap. On the v-safe reporting, I indicated that this "interferred with my daily work" or whatever that category of assessing the impact is. The agency staff who reached out to me after for details asked that I fill out this form and submit it. I do not remember the exact date of the exhaustion but, if possible to match my v-safe checklist with this report, it is available there. I believe it was 3/16.
Vaccine administered 9/8/14. On 9/13/14 woke at 4 AM with chills. At 8 AM temp of 99.9 and headache. Took 400 mg MOTRIN. At 2 PM began chills. At 4 PM temp of 103.5. No other symptoms. At 10 PM fever subsided.
SHOT  WAS EXTREMELY PAINFUL. PAIN IN SHOULDER LASTED FOR  FOUR  DAYS. APPLIED ICE TO SHOULDER , TWO TO THREE TIMES  A DAY, FOR A TOTAL OF FOUR DAYS .  WITH SECOND SHOT, ABSOLUTELY NO  PROBLEMS!
he had also his booster shot summer or early fall. Caller mentioned that he's having seizures; booster; seizures got worse; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Oct2021 (Lot number: 301458A, Expiration Date: 30Nov2021) at the age of 68 years as dose 3 (booster), 0.3 ml single for covid-19 immunisation. Relevant medical history included: "ryders syndrome" (unspecified if ongoing); "AVM (Arteriovenous malformation)" (unspecified if ongoing), notes: Diagnosed a couple of decades ago or at least 10 years ago. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1), administration date: 28Jan2021, when the patient was 67 years old, for COVID-19 Immunization; Bnt162b2 (dose 2), administration date: 26Feb2021, when the patient was 67 years old, for COVID-19 Immunization. The patient received his first dose on 28Jan2021 and second dose on 26Feb2021. The patient also received the booster dose but the day indicated in his vaccination card is incorrect, but he received it in the late summer or early fall. The patient was asking if there are any side effects related to AVMs because he has been having seizures on 29Oct2021 since he had the booster dose. The seizures got worse and then he started medication and they have improved. Vaccination Facility Type was Grocery store. Vaccine Administered at Facility was No. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. The AEs require a visit to Emergency Room twice but the caller was never admitted to the hospital. Prior Vaccinations (within 4 weeks) was None. The outcome of seizures and seizures got worse was recovering, of other event was unknown.
Around 8-9 PM on 2/26 I began to experience tachycardia and could feel my heart racing.  I went to bed hoping to sleep, but my sleep was restless. I checked my blood pressure around 3:30 AM on the 27th and it was 124/70 Pulse 113. At that point I decided to wait until the morning to contact my doctor rather than go to the hospital.  I got up around 8 AM and my pulse was still fast, but had slowed down from the night before.  By around 9:30 AM my heart rate had normalized.  I did not go to the hospital or call my doctor as I believed things had subsided.
Pt reports mild fatigue in days after vaccination (her booster dose) but awoke with heart "pounding" 4 days after vaccination and feels that this is an adverse reaction to the vaccination and requests event be reported. Symptoms resolved spontaneously and not evident at time of evaluation
101 fever, severe body aches and headache, huge painful swollen lymph nodes under left armpit which received the shot
shortness of breath; light congestion; loss of appetite; cough; fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), NASAL CONGESTION (light congestion), DECREASED APPETITE (loss of appetite), COUGH (cough) and FATIGUE (fatigue) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced DYSPNOEA (shortness of breath), NASAL CONGESTION (light congestion), DECREASED APPETITE (loss of appetite), COUGH (cough), FATIGUE (fatigue) and CHILLS (chills). At the time of the report, DYSPNOEA (shortness of breath), NASAL CONGESTION (light congestion), DECREASED APPETITE (loss of appetite), COUGH (cough), FATIGUE (fatigue) and CHILLS (chills) outcome was unknown. Not Provided
Nightmare; Panic attack; Anxiety; pain at the injection site; swollen arm; This spontaneous report was received from a consumer which refers to a 68-year-old female Nurse patient who received the Moderna COVID-19 vaccine and experienced arm swelling and pain at the injection site, a nightmare, panic attack and anxiety.  The patient's medical history was not provided. Concomitant medications were not reported.   On 03 JAN 2021, prior to the onset of the symptoms, the patient received her first of two planned doses of mRNA-1273 intramuscularly (Lot number: not provided).   The patient had the first Moderna COVID-19 Vaccine on 03 JAN 2021 and reported, experienced swollen arm and pain at the injection site. On 04 JAN 2021 she experienced a nightmare, panic attack and anxiety. All symptoms are ongoing. The patient was advised to follow-up with her healthcare provider for decisions on symptoms management.  The action taken for Moderna COVID-19 Vaccine was not reported.   The outcome of the events, swollen arm and pain at the injection site, nightmare, panic attack and anxiety was not reported.; Reporter's Comments: This case concerns a 68-year-old female who experienced NS events of unexpected nightmare, panic attack, anxiety and expected injection site pain, injection site swelling.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Started vomiting on 8/19/11 at approximately 4:30pm until late that night. No vomiting Saturday or Sunday and feeling fine on Monday.
First was biontech and then i got the Moderna for second; First was biontech and then i got the Moderna for second; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 IMMUNISATION (First was biontech and then i got the Moderna for second), INTERCHANGE OF VACCINE PRODUCTS (First was biontech and then i got the Moderna for second) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 IMMUNISATION (First was biontech and then i got the Moderna for second), INTERCHANGE OF VACCINE PRODUCTS (First was biontech and then i got the Moderna for second) and NO ADVERSE EVENT (No adverse event). At the time of the report, COVID-19 IMMUNISATION (First was biontech and then i got the Moderna for second), INTERCHANGE OF VACCINE PRODUCTS (First was biontech and then i got the Moderna for second) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant medications were not reported.  No treatment information was provided by the reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  HCP reported that there was a confusion between the expiration date printed in the carton and the expiration date when the quick response (QR) code scanned. On 18-Oct- 2021, vial was stored in the refrigerator. No temperature excursions were noted. No adverse events were noted.  No treatment information was provided.
Breakthrough case admission after 4 vaccines Moderna 3/9/21 Lot# 023M20A;  MOderna 4/8/21 Lot# 018B21A;  Moderna 11/4/21 Lot# 039F21A;  Moderna 12/21/22 Lot# AS7170B
1325 Patient became dizzy and reported a headache with nausea VS stable 1345 After Benadryl 25mg, Tylenol 1000mg and Zofran 4mg patient reports improving symptoms. VS remain stable 1415 VS remain stable patient reports good resolution of HA and nausea, some dizziness remains, no nystagmus 1430 Patient discharged to home with family
Swollen, red area about 2-2 1/2 inches wide by about 4 inches long extending from injection site. This occurred about a day after the shot. It occurred below injection site. I had slight pain on arm for several evenings. The redness and swelling were all gone on. I just waited for the symptoms to go away. The redness, swelling and any pain were all gone on 08/26/2018.
reports rash chest, R armpit down to buttocks and thighs. Itchy and irritating when sweating at work.
Pt recv vax 7/23/98 in right deltoid region. pos rash noted on arm 7/28/98. + pruritus at site, + erythema, - edema, - pain
12 hours after booster, I started to have severe chills (to the point of shivering), body aches, nausea, fever (up to 102°), skin sensitivity/pain to the touch, and sometimes hot flashes. I also have a slight headache, joint pain, injection site stiffness and a little itchiness too.   Please note I?m also currently menstruating, so some side effects may or may not be exacerbated by this.   I received the vaccine less than 24 hours ago, so many of these AES are still lingering.
Within 15 minutes of receiving the vaccine, the patient described feeling prickly sensation and pruritus around mouth and labial region. She also noted within 20 minutes of receiving the vaccine that her tongue felt larger than normal.  50 mg Diphenydramine (BENADRYL) was administered within 5 minutes of symptom report, patient noted she was feeling less, itchy, her tongue still felt larger than normal. Patient was able to swallow the two caplets without any difficulty and a visual exam of her mouth, tongue and pharynx at time of symptom report and before leaving the clinic was normal with no enlargement noticed.   ER precautions reviewed and the patient was encouraged to call clinic immediately for any concerns, worsening or non-improvement  Patient was advised to take Diphenhydramine (BENADRYL) 50 mg in about 5-6 hours. The patient was called at home around 8 PM , she still felt some residual symptoms and agreed to take Diphenhydramine 50 mg (second dose). She is also advised to take Allegra (Fexofenadrine) 180 mg daily for 14 days.  Patient referred to an allergist for advice on whether or not to receive Moderna #2 due four weeks follwoing initial dose.
five employees in a nursing home have gotten the first dose of the vaccine, and then tested positive for COVID; five employees in a nursing home have gotten the first dose of the vaccine, and then tested positive for COVID; she had felt weird; This is a spontaneous report from a contactable nurse. This nurse reported similar events for five patients. This is the fifth of five reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The nurse reported on behalf of her sister (patient). It was reported that the patient called right before Christmas and she had gotten the Pfizer COVID Vaccine. She reported that she had felt weird and had side effects to the vaccine. The patient works in a nursing home type thing, and she said she has had people who have gotten the first dose of the vaccine, and then tested positive for COVID. The patient called to ask the reporter if they should still get the second dose. The only other details that her sister (patient) provided her was that this has happened with several people; 5 employees and several or 9 patients. She is unsure if she said several patients or 9 patients, but there were 5 employees. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021021881 Same reporter/ drug/ event for different patients.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 25-NOV-2014 the patient was vaccinated with a dose of ROTATEQ (oral dose, frequency, lot number and expiration date were not reported) which had undergone temperature excursions. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Info has been received from a registered nurse concerning a pt who was vaccinated for the 1st time with a dose of pneumococcal vaccine 23 polyvalent (Lot #641532/1353L). Concomitant therapy included "some type of allergy medicine" including loratoadine (CLARITIN), cetirizine hydrochloride (ZYRTEC) or fluticasone propionate (FLONASE). Subsequently the pt experienced a lot of pain in the axilla (injection was given in the deltoid). The pt sought unspecified medical attention. Additional info has been requested.
Pain at vaccination site. Started 11/8/15. Shot was given 9/30/15. Off and on ache, pain since that date.
Maculopapular rash involving entire trunk front and back,  neck,  and arms.
Pt states he received flu shot at approx. 10:00 a.m. today (10/26/07).  Started having mild nausea and lightheadedness/dizziness at approx. 12:15 p.m.  Was advised dizziness was considered a severe reaction and was advised to be seen at Emergency Room.  Pt states he was not going to go to the Emergency Room; that he was instead going to go play golf and would seek medical attention if symptoms worsened or persisted to 10/27/07.
Pt felt faint after receiving the vaccines, c/o blacking out & pain behind ears.  Pt very pale & skin clammy.  Laid down on floor with feet elevated.  Pt alert, mom & brother with pt.  B/P checked & pulse.  B/P on the low side.  Pulse strong, steady.  5-10 min. pt says feeling better, sat back on chair, skin dry, color to face.  Allowed to go w/ family to area where pts being watched for 15 - 30 min. after vaccines. 10 min later, pt states she is backing out again & begins to faint.  In private area laid down with feet elevated.  Mom wants to call ambulance.  911 called, one of our team, paramedic, spoke with operator.  Paramedics came, assessed pt and took to ER
Pt. received his 2nd Covid vaccine (Pfizer) at 8:23 am he then lost consciousness two times with a low b/p and HR. This happened immediately after receiving the vaccine.
This is in follow-up to report(s) previously submitted on 8/14/2008. Information has been received from a registered nurse (RN) concerning herself who on an unspecified date had some ROTATEQ splashed into her eye when the baby spit out some of the vaccine. She felt little sting in her eye when she was splashed. Additional information has been requested. Follow up information has been received from the R.N. who was an approximately 53 year old female with hypertension and an allergy to penicillin reported that in a morning of an unspecified date as she was administered the ROTATEQ (lot #65741/1052U) to a 2 month old infant it coughed splashing the ROTATEQ into the corner of the left eye. There was a little sting to the left eye. She called for instructions. She washed the eye out for 30 minutes. No ill effects were reported. She had no problems since. It was reported that the nurse recovered from the sting in the left eye. Additional information is not expected.
Sudden onset of tinnitus in my left ear 2 days after shot. Ongoing buzzing that has never happened before and is almost constant and affecting quality of life. Mild headache after vaccine want away before tinnitus started about 36-48 hours after shot. It has now been going on for 5 days.
Narrative: Per 10/31/22 Specialty Clinic Nurse Note, Patient presents to Podiatry Clinic appt for evaluation for gangrenous right third toe and decubitus bilateral heel ulcerations. Patient transfers via wheel chair pushed by wife who is accompanying patient at this appt. Patient is alert and oriented x3, able to verbalize needs, and VSS. Patient and wife agreed to have the flu vaccine at this time. Fluad vaccine was administered to left deltoid. Approximately 5 minutes after vaccination was received, the patient slumped his head backward loosing consciousness in wheel chair. Code Blue was called over head and he was taken to triage room for evaluation by code blue provider. EKG done, and facility police notified. He was taken to hospital via ambulance and wife  was to meet them there. Per 10/31/22 Cardiology Follow-Up Note, 82-year-old patient with history of heart transplant due to severe cardiomyopathy, a stage III chronic kidney disease, type 2 diabetes mellitus, essential hypertension and previous history of pulmonary embolism. He was given an IM INFLUENZA VIS vaccine to the left deltoid and within 5 minutes of the injection had an episode of unresponsiveness. When evaluated in the triage room, he was only responding to deep stimuli but within minutes he was following commands . He has generalized weakness but not of ipsilateral weakness and was alert in time and space. Episode of unresponsiveness : Needs to consider TIA unlikely to represent an allergic reaction to the flue vaccine but still needs to be consider. Vomiting could be one of the side effect of the flu Vaccine . Per staff, nausea and vomiting are documented as ADRs to the influenza vaccine and syncope is a documented postmarketing ADR. While multiple postmarketing neurologic  ADRs have been reported, disorientation was not one of them.
Shot for shingles received afternoon of 11-5-12. Morning of 11-7 noted pain and swelling at site of injection. Seen in clinic afternoon of 11-7-12. Red, very sore to touch measuring 40 x 50 mm. Was up middle of the night with headache. Took ibuprofen at that time.
Myalgia, neck stiffness; weakness of lower extremities; pain at injection site  Narrative: Per nursing report: "presented this morning [5/6] with complaints of body aches, stiff neck and bilateral weakness in lower extremities, also state pain in left arm were he received his injection for his 2nd Moderna shot 5/5/2022. Employee states similar symptoms after 1st Moderna shot."
PERSISTENT RINGING IN EARS, TINNITUS (debilitating, extremely loud)
This spontaneous report was received from a physician refers to an unspecified number of patients of unknown age and gender. The physician reported that on unspecified dates, an unspecified number of patients may have received improperly stored MMR II (lot number, expiry not reported) that were exposed to 36F for 13 hours. The physician was unable to provide any additional information or details about whether or not patients received this improperly stored MMR II. Additional information has been requested.
large red area lt arm-started 3APR97 hot to touch on 4APR97 red area from elbow to shoulder;around & underneath arm-area swollen firm w/small blisters forming in half circle mid elevated arm hot to touch;c/o pain in area;
About 30 minutes after receiving the injection, the Left half of my face went numb/tingly; pupils were different sizes (Left pupil was dilated). This lasted for approximately 1 hour and then slowly went away.
8 days after receiving the vaccine I developed shortness of breath & rapid hard heartbeat. Symptoms have lessened but are not totally gone. Hoping it doesn't happen again after my 2nd shot.
Hearing loss; This is a spontaneous report from a contactable consumer (patient). A 31-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0187; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 28May2021 at 16:30 as single dose for COVID-19 immunization at Pharmacy or Drug Store. The patients medical history and concomitant medications were not reported. Patient did not have covid prior vaccination. Patient did not receive any other vaccine in four weeks prior to the COVID vaccine nor any other medications received within 2 weeks of vaccination. On 07Jun2021 at 07:00 the patient experienced hearing loss. No treatment was received for adverse event (AE). Patient had not tested for COVID-19 post the vaccination. The outcome of event was not recovered.  Information on the lot/ batch number has been requested.