chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse concerning a female with allergy to nuts who on 06-JAN-2006 was vaccinated with the first dose of VAQTA (Lot # 651877/0706R), 0.5 ml IM. It was reported that the patient experienced vomiting and developed hives 2 hours after administration of VAQTA. The patient also ate mixed nuts before the adverse event. The patient was given BENADRYL immediately and ZYRTEC later. It was reported that the patient recovered from the event. Unspecified medical attention of office visit was sought. No product quality complaint. Lot check result for lot # 651877/0706R: A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center and was released. Additional information has been requested.
topical reaction/ rash; Initial information received on 08-Nov-2022 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 80 years old female patient who had topical reaction/ rash after receiving vaccine Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 08-Nov-2022, the patient received a dose of suspect Influenza Quadrival A-B high dose HV vaccine at a dose of 0.25 mL to 2 mL Total (1x) (strength, formulation, lot number and expiry date: not reported) via unknown route in unknown administration site as Immunisation.  On 08-Nov-2022, the patient developed a non-serious event of topical reaction/ rash (rash) (same day) following the administration of Influenza Quadrival A-B high dose HV vaccine.  No lab data was reported.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (topical reaction/ rash).  At time of reporting, the outcome was Unknown for the event topical reaction/ rash.; Sender's Comments:  01358051:
No adverse reactions noted,    Patient had Flu vaccine on 09/22/2023 and by mistake had a second dose on 10/06/2023.
pt recv vax 930AM & by 1PM had significant swelling & pain which pt felt was nl expectation;swelling cont & by the afternoon 3OCT98 had swelling from elbow to wrist w/inability to flex elbow;also had mild resp sx;seen in ER:
lower leg and ankles had redness and swelling; some pain. Worse on right leg.
Syncope leading to fall 24 hours post vaccine Deep venous thrombosis 2 weeks post vaccine
Tested positive for COVID-19 via PCR test; Tested positive for COVID-19 via PCR test; This is a spontaneous report from a contactable other healthcare professional. A 26-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: H3248) via intramuscular in left arm on 12Jan2021 at 6:00 pm as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included Bentyl, Zoloft and Sprintec. Historical vaccine included first dose of BNT162B2(lot number=EK9231, lot unknown=False, administration date=22Dec2020, administration time=06:00 PM, administrator route=Intramuscular, vaccine location=Left arm). On 03Jan21 and 01Mar2021, patient tested positive for COVID-19 via pcr test. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. Covid test type post vaccination=Nasal Swab covid test name post vaccination=PCR covid test date=01Mar2021 covid test result=Positive. Outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number could not be obtained. No further information is expected.
1) Severe pruritis with urticaria about one week after vaccination.  Started at site of injection, also had some  2)sense of choking and diaphretic on 10/24 office visit.  10/30 symptoms resolved.
Fever (tmax reported per 100.0; temp at clinic 100.9);  Rapid heartbeat; Chills, Fatigue, Dry mouth, loss of appetite, nausea
After patient awoke from daily nap, noted to have macular erythematous flat rash mostly on trunk, a little on extremities, diaper area also. No respiratory distress, no wheeze, no swelling of mucosal membranes, no scrotal swelling, no vomiting or diarrhea. Pulse ox was 97%.
A few minutes after the patient was vaccinated, she informed me that her eyes were starting to be blurry.  I asked her if this had just started of if she thought it was because she was crying.  I offered her some water and asked her to let me know if anything changes or gets worse.  While drinking her water she said that she thinks her throat was starting to swell.  I gave her benadryl and had the person I share an office with call the nurse practitioner in case the situation got worse.  While she was calling the NP I got the epi pen ready and offered to call the ambulance to get her emergency care right away.  Patient refused an ambulance and said her friend who was with her during her vaccination would take her to the ER.  I recommended to call the ambulance again for their safety.  The NP arrived and epinephrine was administered.  I offered to call the ambulance one more time, she refused again.  I told the patient's friend to get her to the nearest emergency room right away.  I called to check on her a few hours later and she said she is still being monitored and received more benadryl and epinephrine.
Fever up to 103, chills and shaking over the entire course of 3/17/21
Child received vaccination on 3-27-2009 and came in office with chickenpox on 4-8-09.
flu like symptoms after the 1st dose / same symptoms after the second dose / were more severe; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (received 1st dose on an unknown date and experienced flu lie symptoms. For the tolerance of 1st dose, refer linked case US2021010485).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's friend. The age at vaccination was not reported. After receiving Shingrix, the patient had flu like symptoms, and they were more severe than the after 1st dose. The reporter did not consent to follow-up. This was 1 of 3 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021010484:same reporter US-GLAXOSMITHKLINE-US2021010485:same patient, 1st dose
shortness of breath, foot swelling, chills, body aches, dry mouth, fatigue, wheezing, eye burning sensation, joint pain, Blood clots in lungs, prescribed Xarelto
The pt experienced allergic reaction, post vax, which was dx'd as cellulitis. Unspecified medical attention was sought and she was placed on therapy with Duricef for 1 week. The pharmacist reported that the pt discovered she was 6 weeks pregnant in the beginning of January. Her estimated date of delivery was 9/6/01. Upon internal review, cellulitis was determined to be an other important medical event. In follow up, the pharmacist reported that her sister delivered a healthy  baby boy at term with no problems noted. The infant wasborn on approximately 09/17/01 and is "doing well" Additional information is not expected.
"10 days ago on February 1st she received the first moderna vaccine. At the time her arm hurt badly for a few days, however yesterday she started to develop new redness and swelling and pain in her left shoulder. It feels much warmer than the surrounding area. The area is tender and hurts her to lift the arm. She has developed some new joint pain around her ankles. "
08/17/2018. Patient received vaccine and did well initially. Approximately 7-8 mins later, patient fell forward off the exam table saying that she wanted to lay down. Mom witnessed fall but was unable to catch her. She had LOC lasted 45-60 secs and awoke. She was oriented to time, place, and person. She appeared pale. Patient had struck forehead against the floor her left thigh hit the table. She has a small cut on the inside of her upper lip which stopped bleeding within a minute of applying pressure. She also c/o left thumb pain following her fall with some bruising and mild swelling evident prior to her leaving. She had FROM, no wrist pain, and no obvious deformity of thumb, however it is slightly TTP. She had swelling of her forehead which improved with cold compress here in the office. She reclined for approximately 10 mins. She drank Sprite and had 2 lollipops and 4-5 pieces of chocolate. Her color improved and she was able to sit up and eventually transfer to a wheelchair to return home. Notes: Following her incident, patient stated that she had not had anything to drink or eat that morning. She had also been in a golf tournament over the last few days and had been in the heat. Parents will continue to monitor her today and advised them to call if any issues arise. Parents were instructed to seek prompt care if develops recurrent vomiting, confusion, lethargy, irritability, or any abnormal behavior. Discussed cool compresses for site of injury- forehead, left thumb, left thigh, and a small cut on the inside of her upper lip. I followed up with family by phone at 330pm and per mom, she is feeling much better. Her 'shakiness' feeling improved after eating lunch and she has no vomiting or other symptoms. Advised mom that I am on call tonight if they need anything or she developed any signs/symptoms.
pt recv vax 11APR94 & 22APR94 pt devel an elevated temp & a gen rash; pt recovered; No further details were provided;
Anaphylaxis. Turned gray, diaphoretic, blurred vision, difficulty hearing. Blood pressure quickly dropped to 66/31. Perfusion was 5 seconds. Received EpiPen (0.3mg Epinephrine) x1. BP better but slow to return to baseline. To Emergency Room for 4 hours observation. While in ED, received IV Benadryl and IV Zofran. Condition improved by the end of 4 hour observation so discharged with an EpiPen.
Fever of 104.6F, myalgia, local erythema and warm on left buttock.
Mom states pt c/o right arm pain after immunization. Tylenol given with some relief, pain continued through the night. Pt awoke with a swollen deltoid area, warm to touch and erythema surrounding injection site approx 5" x 2 1/2". Pt also c/o having difficulty breathing x 1 1/2-2 hrs on and off and her throat was sore and clogged. Pt was able to swallow breakfast, ice applied, swelling reduced, no Benadryl given by mom prior to visit in office. At office visit, mild swelling and erythema 5x 2 1/2" tender, warm, difficult ROM in R arm, pain. Tx: Benadryl 96 hrs, ice prn, enc ROM call with increased s/s, SOB prn
11-28-18 - Red, itchy non-raised rash began on chest then moved to shoulders, arms and face. Went home around 2 pm and took Benadryl 50mg (25mg x 2 capsules) and applied OTC Bendryl cream to chest. Repeated both at bedtime. 11-29-18 - Rash still present but less prevalent. Benadryl  PO and cream continued.
Anaphylactic reaction; Initial information was received on 16-Nov-2021 regarding an unsolicited valid serious case received from a- Social Media via a consumer/non-health care professional.  This case involves a patient (unknown demographics) who had anaphylactic reaction after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious anaphylactic reaction (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, outcome of the event was unknown.  The reporter did not report the causality of event with suspect.  Information on batch number was requested for this case.; Sender's Comments: This case concerns a patient (unknown demographics) who had anaphylactic reaction after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. The time to onset is unknown. Additional information regarding patient's medical history, condition at the time of vaccination and laboratory data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Low grade fever, excessive sleepiness, muscle pain, fatigue, sharp intermittent 3-second pains in joints, hallucinations, and crying spell.
She also took the flu shot and bivalent shot on the same day; She also took the flu shot and bivalent shot on the same day; couldn't see; thought she was having a stroke; feeling like she was almost about to pass out; arm pain; Fever; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A 77-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 30Sep2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, manufacturer unknown), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 2022, outcome "recovering", described as "Fever"; PAIN IN EXTREMITY (non-serious) with onset 2022, outcome "unknown", described as "arm pain"; BLINDNESS (medically significant) with onset 2022, outcome "unknown", described as "couldn't see"; PRESYNCOPE (non-serious) with onset 2022, outcome "unknown", described as "feeling like she was almost about to pass out"; CEREBROVASCULAR ACCIDENT (medically significant) with onset 2022, outcome "unknown", described as "thought she was having a stroke"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 30Sep2022, outcome "unknown" and all described as "She also took the flu shot and bivalent shot on the same day". The reporter who is 77-year-old and got the Bivalent COVID-19 Vaccine on Friday (30Sep2022) and is reporting arm pain and couldn't get out of bed, couldn't see, and couldn't do anything. She was feeling like she was almost passing out when she woke up. She also took the flu shot and bivalent shot on the same day. The reporter was just reporting this and wasn't planning on getting all those shots but her doctor had the shots available and asked her if she wanted to receive the shots. She just wanted to let Pfizer know. Her husband was home with her and got her coffee and water as she knows she needs to hydrate herself. She felt better and had to go on an errand as her glasses broke and went to the glasses place. She got her glasses fixed and came home and developed a fever at night but the fever wasn't high. The next day she was better. When she couldn't get out of bed her husband thought she was having a stroke.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Left deltoid muscle pain, this pain has continued over two weeks and patient c/o increasing pain. No redness, swelling, or lump felt in muscle.
Second dose was received on February 13 and instantly when the needle went in, I started having instant pain that went right to the rotator cuff and the next morning I tried to raise my arm and it was sore in the joint. I?ve done heat, cold presses, Tylenol and everything to try to help the pain, the pain is bad.  I received my first dose in January and had the exact same reaction.
PATIENT DESCRIBES A LUMP UNDER HER ARMPIT OF THE LEFT ARM A DAY AFTER SHE RECEIVED THE SHOT, SHE REPORTS IT AS VERY PAINFUL AND HOT TO TOUCH
Patient presented to clinic to receive Jansen vaccine. Patient filled out our pre-vaccination checklist and checked "NO" to any previous vaccines. After completion of the vaccine, the vaccine was being placed into system. Upon looking into the patients system, it was noticed that the patient received two doses of Pfizer at Health System and two doses of Pfizer at another Hospital. The patient was questioned, he admits to receiving two doses at Health System, but denied at the other Hospital. Health System and the other Hospital notified, patient did in fact receive all five vaccines. Asked patient to wait for me to call the state or figure out that to do in this case; however, the patient left and would not answer his phone when I tried to reach him.
Developed double vision then blindness, slurred speech, ataxia, and now unable to swallow, move or follow commands. Has been hospitalized since 9/6/2017, MRI's and CT scans show some diffuse swelling, as well as Cranial Nerve involvement. Continues to remain hospitalized.
injection site, red, hot to touch, burning pain from injection site up to the neck area Narrative:
I have a history of previous parox. at. fibrillation but none for the last year.  A few hours after 2nd covid injection, along with  mild myalgias/prodromal sx., I went into atrial fib., with mild tach. but no other problems.  The arrythmia persisted for ~24 hr.s then converted back to sinus rhythm-- and fine since.  This event is more of an interesting observation than an "adverse event" but as the spike protein binds to ACE2 receptors, I thought the two events might be related and possibly of interest to you.
No other AE; ROTATEQ was administered to patients after the excursion occurred; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 29-OCT-2021, the patient was vaccinated with dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 time dose, lot # 1742081, expiration date 18-JUL-2022 (exact dose, route of administration, anatomical location were not reported) for prophylaxis.  Administered dose of vaccine has been stored in the temperature of 35.0 degrees Fahrenheit (°F), 35.1 F, 35.3 F, 35.2 F, 34.9 F for 53 minutes (cumulative). There were no previous temperature excursions reported. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA001754: US-009507513-2112USA001753: US-009507513-2112USA001755:
Within 5 hours I broke out in a rash all over my body, horrible piercing headache, became dizzy, became diaphoretic and feverish  , horrible muscle body aches hurt to the bone , left arm burned and could barely lift it . Felt very confused totally brain fog and extremely fatigued.  I took benadryl and tylenol.  I came home from work and went to bed and couldn't function until Friday.  I slept all of Thursday . By Saturday my rash subsided, I felt ok enough to function but haven't felt 100 % since.
Very fast heart beat and light chest pain. Went to Emergency Room and they diagnosed condition as heart palpitations.
Initial information has been received from a physician via field representative concerning a female patient with an unspecified age, pertinent medical history or drug reactions/allergies. On 03-JAN-2013, the patient was vaccinated with PNEUMOVAX23 (lot H018441) (dose was not reported). No other co-suspects were reported. No concomitant medications were reported. On 04-JAN-2013, the patient had significant "pain, swelling and soreness at the injection site and a lack of mobility. As a treatment, the patient received physical therapy. On an unspecified date, the patient recovered from the events. There was not laboratory test performed. The patient sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Pain in left arm that has increased; Numbness; Tingling; Feel tired; Lack of strength; Having neck tightness left sideseems to be affect; Fatigue; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 01Mar2021 at 13:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient previously took morphine (MANUFACTURER UNKNOWN) on unknown date for unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 03Mar2021 at 00:00 the patient experienced pain in left arm that had increased over time with numbness and tingling, felt tired and lack of strength also had neck tightness and left side seems to be affected, and also experienced fatigue and nausea. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were  not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain in left arm that had increased over time with numbness, tingling, felt tired and lack of strength also had neck tightness and left side seems to be affected, and also experienced fatigue and nausea was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
pt recv vax 8JAN98;returned to office 9JAN98 w/gen urticaria & erythema multiforme;inj site rt deltoid was indurated, erythematous & hot to touch 1 1/2-2";medial aspect lt foot moderately erythematous & edematous;there was no wheezing
Incorrectly reconstituted dose, not sure; Incorrectly reconstituted dose given; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA751A, expiry date 30-NOV-2023) for prophylaxis.   On 24-FEB-2023, the patient received Menveo. On 24-FEB-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Incorrectly reconstituted dose, not sure) and inappropriate dose of vaccine administered (Verbatim: Incorrectly reconstituted dose given). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 09-Mar-2023 A nurse supervisor reported that the patient might have received an incorrectly reconstituted dose of Menveo on 24 February 203. The healthcare professional found an extra dose of the liquid component so nurse was not sure if the dose was correctly or incorrectly reconstituted. The healthcare professional consented to follow up via email. The patient received a received an incorrectly reconstituted dose of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.