chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Menveo reconstituted with wrong diluent; Wrong reconstituted Menveo administered; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number amva6564a, expiry date 1st January 2023) for prophylaxis.   On 18th July 2022, the patient received Menveo. On 18th July 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 19-JUL-2022 Reporter's Comment: The reporter was medical assistant. The reporter reported that, a patient received a Menveo vaccine that was reconstituted with the wrong diluent inadvertently. The reporter consented to follow up. Additional Supportive Information: The reporter reported that, a patient received a Menveo vaccine that was reconstituted with the wrong diluent inadvertently, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
severe chills 7hrs p/vax & chills lasted about 2hrs followed by fever up to 103 which subsided during the noc; rxn lasted about 24hrs;
This spontaneous report was received from a health care worker regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 17-DEC-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route were not reported, lot # L013429, expiration date 21-JUL-2017). There was no adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Minor body aches started about 12 hours from injection and continued for about 12 hours.
My Period started 1.5 weeks early & was much heavier than usual. I am always regular and this was a surprise because I always have my period in same increments every month and this was way off. After talking with a family member that also had the vaccine, she confirmed same thing happen to her after the vaccine. Was surprised that the vaccine could potentially impact hormones and menstrual cycles.
Tender L-sided supraclavicular lymphadenopathy lasting 3 weeks and slowly fading away during this time.
pt recv vax JUL94 & pt exp heart racing & red face & flushed;tx w/DPH & recovered; stopped the series @ that time;
It wasn't bad maybe 24hr. We had been at a meeting then my son had symptoms and then I had it the next day. I called urgent care and they gave me PAXLOVID and I started it the next day, or that night. Then by the next night I was feeling a lot better. I was still achy and tired, I was using my inhaler a lot but it wasn't serious.
face became entirely swollen - no breathing problems; eyes itching; itching spread to body - no rash; eyes itching; itching spread to body - no rash; This is a spontaneous report from a contactable consumer (Patient). A 73-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9264, expiration date was not reported) via an unspecified route of administration administered in Arm Right on 28Jan2021 at 15:00 pm, as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient had no known allergies and had not received COVID prior vaccination and had not tested positive for COVID post vaccination. Patient had not received any other vaccine in four weeks. Caller stated that after receiving the first dose of vaccine on 28Jan2021 at 15:45 pm the patient experienced eyes itching; itching spread to body - no rash; face became entirely swollen - no breathing problems. Benadryl was given as therapeutic measures to treat the events. Outcome of all events was recovered.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Patient reports he felt dizzy on Day 2 to the point of losing balance. On day 3 he was still, feeling dizzy, blacked out, hit his head on concrete, and got a concussion. After that he continued to have dizziness, nausea, vomiting. Continued for at least 7 days. Still has some mild sporadic dizziness.
Patient felt dizzy during observation time. Vital signs were measured B/P 110/70, P: 86, 100% Dextrose Saturation: 105. Asian patient from home. The waiting time was extended by 20 minutes, and it was relieved. Patient leaves alert in time, place and person.
pt recvd vax 14JAN93 & it was noted that pt was pregnant; pt had not been hospitalized; pt was proceeding w/pregnancy; LMP 27DEC92; pt exp inc BP during pregnancy & on 15JUL93 had a C-section baby was delivered @ 28 3/7 wks;
I could not sleep on my right side due to uncomfortable; after received the dosage I started experiencing chills; muscle pain; joint pain; headache; extremely tired.; Discomfort on the injection site pain.; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of bnt162b2 (Pfizer Covid-19 vaccine, solution for injection, Lot number: EW0153, Expiry date: unknown), via an unspecified route in the right arm on 21Apr2021, as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (Pfizer Covid-19 vaccine, solution for injection, Lot number: unknown) as a single dose for covid-19 immunization. On 21Apr2021, couple of hours after second dose of Pfizer vaccine patient started experiencing chills, muscle pain, joint pain, headache and extremely tired. Patient was still experiencing these things now and discomfort on the injection site pain. Patient would not call it same but in my bed last night could not sleep on right side due to uncomfortable. So patient was wondering was it okay if take Tylenol or Ibuprofen or aspirin or something for the discomfort patient was feeling? The clinical outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
c/o itching & tingling sensation immediately p/vax was given; devel rash upper extremities; DPH given;
The adult was given the MMRV formulation that is licensed only through 12 years of age.
A healthcare professional reported that a 77 year old female received Pnu-Imune 23 on 4/25/01 and subsequently, developed an injection site reaction characterized by "severe" swelling, redness and pain from her shoulder to her fingertips for several days. The pt was treated with applications of warm compresses. This is 1 of 2 pts from this facility who experienced this event following receipt of Pnu-Imune 23 (lot 475387).
Narrative: Admission: 9/7/2021 Discharge: 9/17/2021 Acute Adult-Onset Still's Flare/Macrophage Activation Syndrome Diagnosis: 36yo female with h/o Adult Onset Still's disease (on Actemra every 2 weeks) and anxiety presented to the Emergency Dept 9/7/2021 with complaints of SOB. Patient stated that on 8/27/2021 she got the third (booster) dose of Pfizer COVID vaccine (2 previous Pfizer vaccinations were on 1/26/2021 and 2/16/2021 . Following this, she developed a productive cough and SOB and her symptoms got progressively worse. She endorsed significant SOB and chest pressure. She said it felt like something is sitting on her chest. She noted pain with inspiration. She endorsed productive cough of green sputum as well as fever up to 102 at home. Around the same time her son's teacher tested + for COVID, but she (the patient) had had 2 negative COVID tests in the past week. She was seen in the ED the previous day for these symptoms and was noted to have a pneumonia on CXR. She was started on Augmentin and given an albuterol inhaler. She says the inhaler helped a little, but the SOB and chest pressure got so bad today she had to come back to the ED on 9/7/2021. She denied vision changes, n/v, arm numbness/tingling, abdominal pain, diarrhea/constipation, dysuria, hematuria. She was admitted to the intensive care unit. On review of story and lack of risk factors, picture seemed more consistent with myocarditis; thought was secondary to the vaccine vs Still's dz. Rheumatology was consulted and believed vaccine was more likely etiology/higher on ddx, and requested Still's/MAS labs to trend. TTE was obtained with no evidence of myocarditis. MRI was not obtained as pt clinically was improving. Troponins rapidly downtrended. Pt was deemed stable for floor transfer on 9/9, with plan to c/w abx for LUL CAP/Otitis Media and obtain recs from rheum regarding new onset abd rash concerning for Still's flare on 9/9/21. Suspected Still's flare due to pulmonary infiltrate, type 2 NSTEMI, characteristic rashes and fever after 4 days of antibiotic treatment for CAP. There is concern for reactivation of Still's after COVID booster as well as Macrophage Activation Syndrome. Patient had improvement of her symptoms with Anakinra (started 9/13) and predisone (started on 9/10) with eventual downtrend of inflammatory markers. There was some initial concern for Acute generalized exanthematous pustulosis (AGEP) given concomitant abx treatment with Rocephin. However skin cx per derm showed coag neg staph and rash persisted despite d/c of abx. Thus rash was considered to be Still's related. The patient was discharged to home in stable condition.
afebrile seizures; breath holding spell; Initial information received on 15-Jul-2022 regarding an unsolicited valid serious case received from a physician.This is a courtesy case received from partner Pfizer (GPE).   This case involves 6 months old child with unknown  gender who experienced afebrile seizures and breath holding spell while receiving vaccine Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a 2 doses of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine(lot number not reported) at an unknown dose via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date (latency: unknown),the patient developed a serious events of afebrile seizures (seizure) and breath holding spell (breath holding) following the administration of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine  Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the events (breath holding spell, afebrile seizures).  At time of reporting, the outcome was Not Recovered / Not Resolved for both events; Sender's Comments: Sanofi company comment dated 21-Jul-2022: This case involves 6 months old child patient with unknown gender who was vaccinated with Pentacel (vero) and experienced afebrile seizures and breath holding spell . The time to onset is unknown with the role of the vaccine. The clinical course was not provided. Furthermore, information regarding condition at the time of vaccination, the role of medical history, concomitants, and laboratory data excluding other predisposing etiologies would be needed for a complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
PRESENTING PROBLEM: RSV (acute bronchiolitis due to respiratory syncytial virus) [J21.0] Hypoxia [R09.02] Acute on chronic congestive heart failure, unspecified heart failure type (HCC) [I50.9] COVID-19 [U07.1] Acute respiratory failure with hypoxia (HCC) [J96.01]   HOSPITAL COURSE: Patient is a 64 y.o. male with past medical history significant for combined heart failure, essential hypertension, diabetes type 2, dyslipidemia, coronary artery disease, carotid stenosis bilaterally status post left carotid stent in October presented with progressive shortness of breath.  Patient takes Lasix 40 mg as needed . Does not follow a fluid and sodium restriction although recommended to follow 2 L fluid restriction by cardiologist.  States he drinks a lot of fluids throughout the day.  Was following a strict diabetic diet and monitoring sugars closely in anticipation his left carotid stent back in October.  Since the stent he has not been taking medications and following his sugars closely.  Plan for right carotid stent 12/27.      In the emergency department hypoxic to 79, respiratory rate 35.  Labs notable for potassium 5.4, creatinine 1.53, glucose 176, calcium 8.5, alk-phos 132, BNP 2400, VBG pH 7.3, pCO2 57. COVID and RSV positive.  Patient was started on BiPAP.  Given 10 mg IV dexamethasone, total of 80 mg IV Lasix.  Patient transitioned to high-flow nasal cannula.  I-STAT VBG without improvement placed back on BiPAP.  Patient admitted to the Internal Medicine Service has a CC2 further management of hypoxia.    He was quickly weaned off of Bipap and weaned down to 2L. He was started on dexamethasone daily for COVID 19 infection. Received Duonebs and guafenesin. Oral lasix 40 mg BID for diuresis was ordered with good response and patient down to room air quickly. Patient was started on heparin gtt for elevated troponins on admission. Cardiology consulted. Heparin gtt discontinued as troponin elevation was likely 2/2 to hypoxia and viral illness. 2D ECHO showed decreased EF to 35% compared to 49% previously. Cardiology recommending repeat echo in 3 months when removed from acute illness, they will call to schedule follow up. Patient feeling nearly back to baseline and ambulated maintaining oxygen saturation > 90%. Patient discharged in stable condition with no new complaints.
Left ear began ringing/whooshing on 4/13 followed by right ear the next day. On 4/15 I experienced a bout of dizziness/vertigo 4:15-6 p.m. I awoke on 4/18 at 6 a.m. and experienced a much worse episode of vertigo for approximately two hours. Afterwards, both ears and vertigo have cleared up. I reported an episode of "COVID Arm" last week, but wasn't sure if ear/vertigo were also a side effect, but have since seen a minor number of others have experienced this as well. I do have seasonal allergies, but typically ears and balance are not impacted.
Patient called office and complained of small itchy blisters all over body starting yesterday 6/9/19.  Patient said that he felt otherwise fine, just the itchiness of the bumps.  No complaints of fatigue, fever, or malaise.  Dr. advised patient to take Benadryl tonight to see if any improvement, to call office in the morning if not any better or doing worse.
Information has been received from the mother of an 11 year old male with no medical history and no allergies who on 4/2/02 was vaccinated with a second dose of hepatitis B virus vaccine. There was no concomitant medication. Three weeks later, on approximately 4/23/02, the patient developed acute and chronic migraine headaches. He was given topiramate and ergotamine tartrate which did not help. In July 2002, the patient went to the emergency room and was given dexamethasone, ketorolac tromethamine IV, and promethazine HCl. From August 2002 to April 2003 he was given these drugs IV two to three times per week. On 2/17/03 and on 4/22/03 he was hospitalized. In April 2003 he was switched to nortriptyline HCl. Subsequently, he finally recovered. The mother reported that her son missed 43 days of school and that both his parents lost their jobs because of the time needed for his medical care. No product quality complaint was involved. Acute and chronic migraine headaches were considered to be disabling. Additional information has been requested.
The vaccination site just called & cancelled both our 13Mar2021 appointments; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The vaccination site just called & cancelled both our 13Mar2021 appointments) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No past medical history was reported.     On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The vaccination site just called & cancelled both our 13Mar2021 appointments). On 10-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The vaccination site just called & cancelled both our 13Mar2021 appointments) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow-up received on 21-JUN-2021 and contains no new information. Reporter declined any further follow-up.
On 11/23/99, pt. had classical shingles involving left back, left chest and patches down left arm.
Difficulty breathing, fast heart rate, hard time speaking within 17 minutes of vaccination.  Was given oxygen at location and epi injection during EMT transport to Hospital ER. was given steroids, benadryl. After discharged from ER, continued to have headaches, nausea, site soreness for 1 week.
Pain in left upper arm @ 7/10 with tenderness in lymph area, "brain fog", fatigue, dizziness
Diarrhea (for 3 weeks!), Arm pain, neck and back pain, fatigue - missed work the day after vaccine.
pt recv vax; persistent screaming for 4 hr w/ irritability that lasted for 4-5 days ending w/ diarrhea; pt seen in hosp;
On January 18, 2021, I received my first moderna vaccine.   On Tuesday, I noticed a rash starting where I got my shot.  I was a bit black and blue on my after the shot.  The rash actually woke me up in the night because it was itching.  It isn't itching now, but it seems to be getting bigger.    I have contacted the doctor virtually.  Doctor said to keep an eye on the rash.  Took Benadryl to ease itching.
Localized reaction, warm and red.  Non tender to touch.  Able to walk without difficulty in area of DTAP shot.
started having night sweats; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 13Sep2021 (Lot number: Fc3184) at the age of 68 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Backache" (unspecified if ongoing); "Migraine headache" (unspecified if ongoing); "postmenopausal" (unspecified if ongoing), notes: I am 18 years postmenopausal so, they are not related to menopause. Concomitant medication(s) included: ZOLOFT; TRAZODONE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: Bnt162b2 (prev dose product: COVID 19, prev dose brand: Pfizer , prev dose brand unknown: False , prev dose lot number: #Fc3183, prev dose lot unknown: False, prev dose administration date: 23Aug2021, prev dose dose number: 1), administration date: 23Aug2021, when the patient was 68 years old, for Covid-19 immunization. The following information was reported: NIGHT SWEATS (non-serious) with onset 30Oct2021 02:00, outcome "not recovered", described as "started having night sweats". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of night sweats.  Additional Information: Facility type vaccine was Pharmacy or Drug Store. If other vaccine in four weeks was no. Other medications in two weeks: Zoloft, Trazadone, Zyrtec. About a month after the second vaccine I started having night sweats. I am 18 years postmenopausal so they are not related to menopause. I did have occasional night sweats during menopause but the night sweats now occur every night. If covid prior vaccination was no. If covid tested post vaccination was yes.  Follow-up attempts are completed. No further information is expected.
Received Expired Dose of Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medications were not reported.  The treatment information was not provided.
Passed out and fell on the bathroom floor; didn't feel well; Passed out and fell on the bathroom floor; Nauseated; Arm was sore; A spontaneous report was received from a consumer concerning a 68-years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) experienced arm was sore, nauseated, didn't feel well, passed out and fell on the bathroom floor.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 12 Feb 2021, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 13 Feb 2021, the patient experienced sore arm, not feeling well, nausea, passed out and fell on the bathroom floor. Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events arm was sore, nauseated, didn't feel well, passed out and fell on the bathroom floor were unknown.; Reporter's Comments: This case concerns a 68-year-old female who experienced serious unexpected events of Loss of consciousness, along with nonserious unexpected malaise and fall and NS expected vaccination site pain and nausea.  The events occurred 2 days after the first dose of mRNA-1273. Treatment not reported. Event outcome unknown.  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.
pt recvd vax & exp arthralgia, arthritis, fatigue, h/a & nausea; pt indicated exp shoulder pain & stiffness lasting 3-4 days; lt arm hurt; exp pain/tightness;
Onset general malaise w/t100.4, sore throat productive cough;dx by MD w/bronchitis; given Ceftin x 10 days;
headache, fever, shortness of breath, sinus congestion, productive cough, sore throat, ear pain. starting on 1/9/22
This is per pt report at follow up visit at primary care clinic. Within 3 min of injection began to experience itchy throat, sensation of throat closing, difficulty breathing. 911 called. Within 10 min she states she developed rash, palpitations, rigors and nausea, low BP. Was given epinephrine and benadryl and transferred to hospital. In ED received more medications and was monitored for 4 hours and send home on oral prednisone and given 2 epi pens. Today is day 5 after reactions and she reports rash/itch improved significantly, she was feeling weak and disorientated at times but this has resolved. Still has a sensation that her body is shaking form the inside but she is not shaking externally.