chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nurse reported the patient was administered an improperly stored dose of PNEUMOVAX 23; This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 12-DEC-2019, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)(strength, route, dose, frequency, and anatomical location were unknown) with lot # S004548, and expiration date 12-AUG-202 for prophylaxis.  The administered dose of vaccine experienced the temperature excursion of 47.3 F degrees Fahrenheit for 20 minutes. There was a digital data logger invloved, but there was no previous temperature excursion. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S004548; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
This spontaneous report as received from a licensed vocational nurse refers to an unknown number of patients of unknown age and gender. The patients medical history and concurrent conditions were not provided. On unknown dates since 23-JAN-2015, the patients were vaccinated with doses of PNEUMOVAX 23, intramuscularly (lot # and expiration dates were not provided). Concomitant medication information was not provided. On unknown dates since 23-JAN-2015, the patients had been administered PNEUNOVAX 23 which underwent supported temperature excursions. No adverse effects were reported. It was unknown if the patient sought medical attention. At the time of the report, the patients status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Injection site redness; Bedridden; Fever; Myalgia; Diarrhea; Nausea; Feeling miserable; Unable to work. In bed all day; This case was reported by a physician via call center representative and described the occurrence of fever in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of erythema (1st dose received and experienced local redness and swelling, refer case US2020AMR024726).   On 9th February 2020, the patient received the 2nd dose of Shingrix. On 9th February 2020, couple of hours after receiving Shingrix, the patient experienced fever, myalgia, diarrhea, nausea, feeling miserable, activities of daily living impaired and bedridden. On an unknown date, the patient experienced injection site erythema. On an unknown date, the outcome of the fever, myalgia, diarrhea, nausea, feeling miserable and activities of daily living impaired were recovering/resolving and the outcome of the injection site erythema was recovered/resolved and the outcome of the bedridden was unknown.   It was unknown if the reporter considered the fever, myalgia, diarrhea, nausea, feeling miserable, activities of daily living impaired, injection site erythema and bedridden to be related to Shingrix.  Additional information was provided as follows: The physician was also the reporter. The patient experienced fever, myalgia, diarrhea, nausea, feeling miserable, could not work and was in bed all day few hours later receiving vaccine. Less than a week after receiving vaccine, the patient experienced injection site redness. On 11th February 2020, the patient felt a little better. The reporter consented to follow up. The physician wanted to be contacted by safety to discuss further. The outcome of the events were reported in source document as fatal, however it was reported as recovering and resolving in database. The outcome of the event  injection site redness was reported in source document as recovered and resolved with sequel, however it was reported as recovered and resolved in database.
After 6 Vaccines he felt like he was going to die. He laid on the ground for a week in severe head pain sweating and not able to move. Then from there it was 8 months of hell. He was sick constantly with a fever, vomiting, ear infection, it was non stop. He had leg pain and was having trouble breathing when he moved around too much. Its been two yrs almost and we have been in and out of the ER a handful of times with breathing problems. His body still hurts. He blacks out every day. He is in pain, He had chronic fatigue syndrome, his chest is now growing strange. His gut is destroyed and he has allergies. We have been seeing drs for about the last 6 months and they have no idea what is going on?
This spontaneous report as received from a clinical coordinator (who is also a registered nurse) refers to a patient of unknown age. The patient's medical history and current conditions are not reported. It was reported that the patient received an expired dose of MMR II (lot # H01467 and expiry date 3-AUG-2014) on 11-AUG-2011. Other co-suspects and concomitant medications are not reported. No symptoms reported. Product quality complaint was not reported. The outcome of the event is unknown. Additional information has been requested.
8/19/04 OV for meningococcal menigitis vaccine prior to college residence hall admission.  Counseled regarding hepatitis.  Elected to initiate series of combination hepatitis A/B as well as meningococcal menigitis vaccine.  Tolerated injections well.  At 9:15 reported treatment in hospital emergency room for "swollen tongue" that began around 8:15pm while eating corn chips with dinner.  Father stated that a chip hit the tongue "ring" the jewelry moved resulting in extreme pain, swelling began immediately, forced the removal of the tongue stud and partially obstructed her airway.  Transported to nearest hospital by parents.  ER MD diagnosed "reaction to shots."  Treatment included steroid injection and oral steroids for administration of next several days for reation to "shots" referred to PCP, ER MD instructed her not to reprot to college on 8/20/04.  Client was dischared from the ER and then "went out" with friends.  8/20/04 reported "doing fine" by both parents; instructed to follow-up with ear, nose and throat MD The ENT MD said he couldn't know which event, if event was the cause.
The patient reported feeling week and falling in her home the evening of the vaccination.  Her granddaughter took her to the ER to be evaluated
have become very tender/sensitive to touch.; I noticed my submandibular, superficial cervical and tonsillar lymph nodes began to swell; Severe body, joint and muscle aches/pain; Severe body, joint and muscle aches/pain; Severe body, joint and muscle aches/pain; malaise.; This is a spontaneous report from a contactable other hcp (patient).   A 31-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: ER8734) via intramuscularly, administered in left arm on 19Apr2021 18:30 (age at vaccination 31 years) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hypothyroidism, polycystic ovarian syndrome (PCOS) and known allergies: Sulfa antibiotics. Concomitant medications in two weeks included levothyroxine, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and metformin taken for unspecified indication from an unknown date. The patient previously received first dose of bnt162b2 (Solution for injection, Batch/Lot Number: EN6203) via intramuscularly, administered in left arm on 05Mar2021 15:15 (at the age of 31 years) as DOSE 1, SINGLE for covid-19 immunisation and experienced severe headache 30 minutes after initial injection. Patient had not received any other vaccine within 4 weeks. Patient was not pregnant at time of vaccination. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. It was reported that 24 hours after 2nd injection on 20Apr2021 at 18:30 the patient experienced severe body, joint and muscle aches/pain and overall malaise. The patient reported that she was on day 7 after injection and still experiencing those symptoms. On 24Apr2021 on day 5 after injection the patient noticed her submandibular, superficial cervical and tonsillar lymph nodes began to swell and at 18:30 it become very tender/sensitive to touch. It was further reported that on day 7 after injection and still experiencing all of these side effects without relief in sight. The patient was received NSAIDs as a treatment to help with total body discomfort. Outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Incorrect reconstitution of vial.  0.8 mg of saline diluent to complete vial instead of 1.8 as directed.  No symptoms, no adverse effects Patient received correct 0.3ml dose  concentration of vaccine in dose is higher due to incorrect reconstitution.  Parent notified and informed to contact the clinic directly if any symptoms occur.   Also informed to go to ER if life threatening symptoms occur.  None have occurred at this time.
Started with heavy periods lasting 7 days along with vomiting for the first 3 days of menstrual cycle about 2-3 weeks after the vaccine
I had my vaccination on 01/30/2022. A couple of weeks later in 02/2022 I started to experience dizziness and bad headache. I started to have a rash located on my abdomen and down my lower extremities and inner thighs. My doctor put me on a steroid cream that did end up making it worse. I had the headache for a couple of months. I had the dizziness for a couple of weeks. The rash lasted for about 6 months and started to blister. I did go to the emergency room for further evaluation in 08/2022. They prescribed me an ointment for the rash and blisters which reduced the itching and blisters.
Guillain-Barre syndrome; This is a spontaneous case, initially received from other health professional (nurse), via Merck, to Agency (reference number: SEQ20-00612) on 12-Feb-2020, concerning a male patient of unspecified age. At the time of this report the patient was 66-year-old.  The patient did not have any medical history.  The patient's historical medications included unspecified influenza vaccine and unspecified sulfa drug due to which the patient experienced unspecified adverse events. The patient's concomitant medications were not provided.  On an unspecified date in 2018, the patient was administered unspecified seasonal flu vaccine [influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number and expiration date: not reported] for an unknown indication.   On an unspecified date in 2018, at unknown amount of time after vaccination, the patient experienced Guillain-Barre syndrome. It was reported that the patient did not receive any corrective treatment for the event.  At the time of this report, the outcome of the event was not reported.  Per company, the event of Guillain-Barre syndrome was considered as serious due to criterion of medical significance.  The reporter did not provide causality assessment to unspecified seasonal flu vaccine.  The case is linked to the case 202001703 due to the same reporter.  Company comment: The patient experienced Guillain-Barre syndrome after vaccination with the suspect product, unspecified flu vaccine. Chronology is plausible. No medical history, concomitant medications and diagnostic findings were provided.  Considering all the above mentioned, causality between suspect product and the event is assessed as related.; Sender's Comments: The patient experienced Guillain-Barre syndrome after vaccination with the suspect product, unspecified flu vaccine. Chronology is plausible. No medical history, concomitant medications and diagnostic findings were provided.  Considering all the above mentioned, causality between suspect product and the event is assessed as related.
Chills; Vomiting; Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (Lot number: ER2613) at the age of 66 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose, single), for COVID-19 IMMUNIZATION. The following information was reported: CHILLS (non-serious) with onset 19Mar2021, outcome "recovered" (2021), described as "Chills"; VOMITING (non-serious) with onset 19Mar2021, outcome "recovered" (2021), described as "Vomiting"; DIARRHOEA (non-serious) with onset 19Mar2021, outcome "recovered" (2021), described as "Diarrhea". Therapeutic measures were not taken as a result of chills, vomiting, diarrhoea.  Additional Information: Patient calling because patient got the second vaccination and this is from Pfizer and last night patient experienced some symptoms, chills, vomiting and diarrhea so is everything okay.  No follow-up attempts are possible. No further information is expected.
One week after vaccine I developed a lump, redness, and itching on vaccination site. This lasted 3 days before the lump went away. Redness continued. After a few days there was a bruise around injection site and red ring around that. This is still on my arm, but not as red
hx per mom, pt fussy during day, acting as not feeling well becoming less active as day progressed; APAP & advil were given intermittently through the day; t105; MD was called;
received Moderna COVID-19 vaccine on 2/21/21 and 3/20/2021 7/4/21: 75 y/o male with PMHx of emphysema, BPH, and recurrent UTI who presented to the emergency department via EMS due to concerns from family that patient appeared to have worsening dyspnea over the past 3 days. Workup in ED revealed positive COVID-19 status, WBC 12.9, BNP 4900, and CXR with infiltrates consistent with possible pneumonia. continued as inpatient: azithromycin and ceftriaxone prescriptions that were started on 7/3. Has COVID-19 viral pneumonia, acute respiratory failure with hypoxia, hypercarbia, hyponatremia, hyperkalemia, acute kidney injury, and sever sepsis. 7/5: patient admitted to the ICU. on BiPAP support. started remdesivir.
Swollen axillary lymph node in L arm where I received my vaccine dose; headache; fatigue; Moderate Myalgia; This is a spontaneous report from a contactable consumer (patient). A 33-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration, administered in left arm on 23Feb2021 10:15 (at the age of 33-years-old) as dose 2, single for covid-19 immunization at workplace clinic. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration, administered in left arm on 04Feb2021 11:30 as dose 1, single for covid-19 immunization. The patient previously took amoxicillin and experienced known allergies to amoxicillin. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine with in four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that on 24Feb2021 02:30am the patient experienced moderate myalgia, headache, fatigue and on 25Feb2021 08:00am the patient experienced swollen axillary lymph node in L arm where she received her vaccine dose. No treatment was received for the adverse events. The outcome of the events moderate myalgia, headache, fatigue was recovering and outcome of the event swollen axillary lymph node in L arm where she received her vaccine dose was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
"After 10 minutes of getting the vaccine, patient c/o of throat scratchiness and lip tingling. No c/o of shortness of breath, chest heaviness or generalized urticaria. 25mg of Benadryl PO given. Throat scratchiness resolved in 20 minutes, but continued to have lip tingling. An additional 25mg of Benadryl given. Lip tingling resolved in 10 minutes Recommended that she speak   with her PCP about receiving the second vaccine.
Third dose of Pfizer 6m - 4yr vaccine was given 4 weeks after second dose, no adverse reactions occurred
3 days p/vax pt devel redness & swelling @ inj site;this is 1 of 12 pt fromt hi site to have an adverse exp p/vax w/lot# 4968181;
Both arms began feeling heavy, weak, clumsy 2 days after my 1st dose.  Kept up and got more pronounced throughout week and started feeling burning sensations in both arms through Feb 15th. Self referred to Neurology on Feb. 16th.  Feb 17th, began to feel worse, spreading to both legs feeling weak, burning sensation, fatigue, and began feeling VERY foggy brained.  Have been sleeping a lot, but legs and arms go from burning sensations, weakness, to cold sensations, and achy right leg thigh muscle, to this moment.  Brain fog and fatigue seem worst in morning.
Shortness of breath and rapid heart rate. 09/11/2015 7:00 AM Area where I received the injection is red, swollen, hot and tender to the touch.  Stopped at Dr. office at 9:00 AM for her to look at it.  Prescribed antibotic.
Slight itching under watch band, then rash spreading up arm by afternoon, systemic rash on thighs, abdomen, arms, and legs by the next morning. Noticed itching on tongue and in mouth by next noon.
her arm was red, swollen, and growing; her arm was red, swollen, and growing; She had numbness in parts of the ear and is now able to feel parts of the ear, but she is not sure if the numbness will go away; Caller mentioned that she can feel her ear "closing up" and by Saturday-Sunday had lost hearing on the right ear; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. A 68-year-old female patient received her 1st bnt162b2 (Pfizer-Biontech Covid-19 Vaccine; Batch/lot number: EK9231) single dose on 22Jan2021 10:45 AM at right arm for COVID-19 immunization. Medical history included COVID on 05Nov2020 but was mild only and she was not hospitalized; No medications aside from over-the-counter drugs. The patient was given a Z-pack and vitamin C and immune stuff like Zinc. Concomitant drugs included high blood pressure medication. Around 6:00 PM on 22Jan2021, the patient can feel her ear "closing up" and by Saturday-Sunday had lost hearing on the right ear - the same side of her arm she received the vaccine. The patient stated it was better on 25Jan2021 but still not 100 percent. The patient tried calling the emergency room and has read up and no one can give her any answers. She made an appointment this morning with her doctor to see what was going on, states not being able to hear messes with her equilibrium. The patient was supposed to have another dose on 12Feb2021 and wanted to know if she should. The patient currently still had partial hearing loss and was prescribed a Prednisone that she took for 5 days. Her arm did not hurt Friday through Sunday, however, on Monday, her arm was red, swollen, and growing. She was able to get partial hearing back after taking Prednisone. She had numbness in parts of the ear and was now able to feel parts of the ear, but she was not sure if the numbness will go away. The outcome of hearing loss was resolving, of other events was unknown.
ED to hospital. Admission: Current 10/30/2021 - present (5 days) in hospital. Acute respiratory failure with hypoxia. Hospitalist attestation: This is 89-year-old female, with past medical history of atrial fibrillation on Eliquis, diabetes mellitus, hypothyroidism, dementia and hypertension presented to ER with altered mental status and hypoxia. Patient was with her daughter last evening, while at the dinner table she slumped over the side of the chair and became unconscious. During that unresponsiveness she also had choking and gagging episode. Patient taken to the nearest fire station. Over there, her oxygen saturation was in 50s. She was bradycardic as well. EMS gave 1mg of atropine.
Red, itchy spots around the injection site but not the circle shape as in Covid arm. Mostly it is just a rash about the size of a golf ball or a bit larger.  It showed up about 8-9 days after injection.  I have been putting cortisone 10 cream on it for the itching and it helps some but not completely.
SUSPECTED COVID-19; This spontaneous report received from a patient concerned a 47 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriatic arthritis, and moderate to severe hidradenitis suppurativa, and other pre-existing medical conditions included: There was no reported medical history. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number: 4571858 expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-APR-2021 for covid-19 prophylaxis. Duration of drug administration was 1 days. Age at time of vaccination 45 years old. No concomitant medications were reported. Non-company suspect drugs included: adalimumab (solution for injection, subcutaneous, batch number: 1165521 expiry: UNKNOWN) dose, frequency, and therapy dates were not reported for psoriatic arthritis, and moderate to severe hidradenitis suppurativa. On an unspecified date, the patient experienced suspected covid-19 (covid symptoms) (Dose number in series 1). The patient received two doses of Pfizer BioNTech COVID-19 vaccine (Dose number in series 2) (form of admin, intramuscular, batch number: 4782537 expiry: UNKNOWN) dose was not reported, administered on 29-OCT-2021 and second dose on 10-SEP-2022 for covid-19 vaccination. Duration of drug administration was 1 days. It was unknown whether patient had any adverse events post two doses of Pfizer BioNTech COVID-19 vaccine (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from suspected covid-19. This report was non-serious.