chrisvoncsefalvay/vaers-outcomes huggingface dataset:
medication error due to dosing schedule not being followed from the PI for unvaccinated adults; first dose was given on 01AUG2022; plans to order and administer second dose with no reported adverse event; Initial information received on 31-Jan-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves an unknown age male patient who had medication error due to dosing schedule not being followed from the pi for unvaccinated adults; first dose was given on 01aug2022; plans to order and administer second dose with no reported adverse event after receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 01-Aug-2022, the patient received a dose 1 of suspect IPV (VERO) suspension for injection (lot number, dosage, expiry date, strength not reported) via unknown route in unknown administration site as immunization.  On an unknown date the patient had medication error due to dosing schedule not being followed from the pi for unvaccinated adults; first dose was given on 01aug2022; plans to order and administer second dose with no reported adverse event (inappropriate schedule of product administration) (unknown latency)   Caller reported he had not been vaccinated for IPOL and in 2020 he heard an infectious disease doctor discussing that the IPOL vaccine may give some protection against the Coronavirus, so he placed an order with plans to vaccinate himself but prior to administering he was informed that it was only the oral POLIO vaccine, so he did not administer. He later, on 01AUG2022, went to the health department and was administered his first IPOL vaccination. Caller reports he plans to order and administer second dose to himself as the cost was so high for his first dose  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Adverse effect of other vaccines and biological substances, initial encounter on 2021-12-15.
This spontaneous report as received from a physician refers to a 64 year old male patient. On 09-MAY-2013 the patient was vaccinated with a 0.65ml dose of ZOSTAVAX (lot number not reported) subcutaneously. The patient experienced a dramatic rise in his creatine phosphokinase(CPK) after being administered ZOSTAVAX. On 17-MAY-2013 the patient began to feel very ill. Ill was enough to go to hospital to be evaluated. The patient spent 3 days in the hospital receiving supportive care which included intravenous fluids and serial laboratory studies, specifically creatine phosphokinase(CPK). Initially the patient's CPK rose dramatically and over the course of the patient's 3 day hospital stay, the CPK's returned to normal levels. The outcome of feel very ill was reported as recovering. Additional information has been requested.
Itchy rash throughout trunk of body from neck to groin; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 at 10:45 as dose 4 (booster), single (Lot number: GJ5342) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Childhood asthma" (unspecified if ongoing), notes: Other medical history: Childhood asthma; "Known allergies: Sulfa drugs" (unspecified if ongoing), notes: Known allergies: Sulfa drugs; "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin. Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation, on 16Sep2022 as dose number unknown, single; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EN6205), administration date: 10Mar2021, when the patient was 37-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EN6206), administration date: 21Mar2021, when the patient was 37-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 3, Batch/Lot No: Fj8757), administration date: 20Nov2021, when the patient was 37-year-old, for Covid-19 immunization.  The following information was reported: RASH PRURITIC (non-serious) with onset 30Sep2022 at 07:00, outcome "not recovered", described as "Itchy rash throughout trunk of body from neck to groin". Therapeutic measures were taken as a result of rash pruritic, Benedryl was taken.  Additional Information: It was reported that, the patient had covid prior to vaccination. Also reported that, patient was not tested covid post vaccination.  No follow-up attempts are possible. No further information is expected.
doses administered past the published expiry date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided. The doses were administered on 12-OCT-2021, past the published expiry date(??-JUL-2021). The vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not underwent any temperature excursions.   This case was linked to MOD-2021-351062 (Patient Link).
Dizziness, Myalgia, Arthralgia & NauseaVomiting Narrative:
Patient presented with shortness of breath, feeling weak, headache, and clammy. Patient was immediately placed on 2L of oxygen by nasal cannula. Vitals were taken, blood glucose level checked (98), and provider monitored and examined the patient. After 5 minutes vitals were performed with the provider present throughout the reaction and patient stated she felt better. Oxygen sat was 98 and patient denied any of the previously reported symptoms. Patient was called on 10/15/2018 to follow up and per the child's mother the patient ran fevers all weekend which she treated with MOTRIN and TYLENOL and has a cough. Patient is schedule to see the provider today at 2:15 PM.
Information has been received from a registered nurse concerning a 13 year old female who on approximately 11/28/03, last week was vaccinated with a first dose of varicella virus vaccine live and in December 2003, now has approximately 24 varicella-like lesions on her body. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 01-NOV-2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (lot number, dose and route not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. During 2016, the patient was treated by a physician for a severe vesicular outbreak, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
Morning after receiving the shot I felt nauseous and dizzy at first.  Walked outside to let my dog out and felt very light headed and weak.  I could breathe, but not getting oxygen.  I laid down on the sidewalk expecting for things to improve and they did not.  I felt tingling all over and was having trouble maintaining consciousness and could not function nor speak correctly.  Neighbors gathered around as I was struggling and called paramedics.  I apparently tried to stand up and passed out causing my jeans to rip and a good bit of blood from my knees where I fell.  (Feedback from neighbors was that they thought they were watching me die and this is also how it seemed to me).  Not sure how long I was unconscious for, but I did regain consciousness at some point.  Very slowly I started to regain oxygen and the effects started to subside, but took a full day before I felt like standing was safe.  Paramedics never came.
Information has been received from a pharmacist referring to a 80 years old female patient. The patient's medical history was not reported. The patient was allergic to tetracycline. Concomitant therapies included blood pressure medicines (names unspecified). On 29-JUL-2016, the patient was vaccinated with ZOSTAVAX (lot # M001745, expiration date 07-APR-2017, dose not reported) subcutaneously in right arm. In 2016 (reported as "after receiving ZOSTAVAX"), the patient experienced sore arm. The soreness was not just around injection site but her entire arm was sore. The patient had been experiencing soreness in her arm for more than a week. The patient did not seek medical attention and no treatment was given for the event. No laboratory test was performed. The outcome of the events was reported as not recovered. The causality between ZOSTAVAX and the events was not provided. Additional information has been requested.
Lingering pain in my back and right leg. Constant tingling in my fingers and feet. Itching at the bottom of my feet.
pt recvd vax 26OCT95-numbness & tingling of fingers & feet started on 13NOV95 progressed to paralysis on 20NOV95;no hx of viral infect;GBS
TOOK THE FIRST DOSE OF VIVOTIF IMMEDIATELY AFTER EATING; A spontaneous case report was received from a caregiver on 19-Feb-2019 for two consumers.  Based on the information obtained from the caregiver, two individual case safety reports PVX201902-000134 (PVX2019-457; husband) and PVX201902-000135 (PVX2019-458, daughter) were created and cross-linked in the database.  The report describes a 15-year-old female consumer who "took the first dose of Vivotif immediately after eating". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.   It was reported that the consumer took the first dose of Vivotif immediately after eating on 19-Feb-2019.  The action taken with Vivotif with respect to the event "took the first dose of Vivotif immediately after eating" was not applicable.  The clinical outcome of the event "took the first dose of Vivotif immediately after eating" was unknown.  Company's Comment: The causality of the event "took the first dose of Vivotif immediately after eating" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took the first dose of Vivotif immediately after eating" was considered as not applicable US-PaxVax Berna GmbH-PVX201902-000134:
FEW LITTLE PAIN IN ARM; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced few little pain in arm. The action taken with covid-19 vaccine  was not applicable. The outcome of few little pain in arm was not reported. This report was non-serious. This case was linked to 20210503720 as reported by the same reporter.
Emely received her primary COVID vaccines at age 11yr, she came in today for her booster and the pediatric (orange) 0.2ml was given.  Where she should have received the 12yr COVID vaccine.
Ear Sense of Fullness/Ear Blockage; Feels like Mild Tinnitus; Diminished Sense of Hearing; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISCOMFORT (Ear Sense of Fullness/Ear Blockage), PAIN IN EXTREMITY (Sore arm), TINNITUS (Feels like Mild Tinnitus) and HYPOACUSIS (Diminished Sense of Hearing) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 09-Mar-2021, the patient experienced EAR DISCOMFORT (Ear Sense of Fullness/Ear Blockage), TINNITUS (Feels like Mild Tinnitus) and HYPOACUSIS (Diminished Sense of Hearing). On 07-Mar-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, EAR DISCOMFORT (Ear Sense of Fullness/Ear Blockage), TINNITUS (Feels like Mild Tinnitus) and HYPOACUSIS (Diminished Sense of Hearing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was not provided with any concomitant medication.  No Treatment was reported.
Parents lied about age of child in order for her to be vaccinated. They gave the date of date, she would have been under the age of 12 at that time.  She was given the Pfizer 12+ dose.  Child is now under service and returned for the seconded dose. That is when we were informed of the incorrect information given previously. Child was vaccinated with the Pfizer 5-11 dose on 2/7/2022.
No additional AE; improperly stored PROQUAD; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.     On 28-AUG-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) 1 dosage form, lot number T015598, expiration date 02-NOV-2021 (route of administration was not provided) for prophylaxis. No additional adverse events were reported.  The vaccine had a temperature excursion of 20.5 degrees Farhrenheit (°F) for 1 hour and 54 minutes. The previous temperature excursion was between 6°F and 14°F, with an average of 12.3°F for 23 hours. The call was due to digital data logger.
Around 10:30pm had symptoms of fever and chills.  In the morning had symptoms of chills, headache, increased heart rate, and slight nausea. On 1/1/2020 around 11:30am had slight swelling and tenderness on the left side of the neck right above the clavicle bone.  Decrease of symptoms starting the morning of 1/1/2020.
Patient had local swelling after infection at site of injection. No discoloring, fever, or pain. Swelling seemed to improve with increased circulation of arm. Patient returned to pharmacy 5 days later with large bruising at site of injection and towards elbow. After 7 days patient visited doctor and PCP found bruise non-threatening, but ran some platelet tests to be certain.
Fever and body aches started 12/10/16. Continued body aches with purpura over the weekend and he made an appt in our office 12/15/16 and we sent him to the ER. Acute ITP.
Patient presents extense red and hot area in right arm. MD gave LEVAQUIN 750mg per 7 days. Patient is well (follow up call 11/30/15). The symptoms persist for 7 days. She finish today 11/30/15 the antibiotic and the arm is normal.
Patient had a syncopal episode within 15 minutes of receiving the vaccine.  He recovered, then had a second episode.  EMT stated pulse was weak.  Patient was transported by EMS to the ER.
It wasn't a specific event, I went to the doctor for my annual physical checkup. she did bloodwork and said my iron was low. She had me take a more specific blood test and sent me for iron infusion and referred me to a hematologist. The hematologist said that I had anemia due to chronic kidney disease.  I have a colonoscopy scheduled for next week to see if I have bleeding in the colon.
Weakness started after 1st shot on 2/12 but it was not bad.  Doctors thought initially maybe myasthenia graves, especially given closing of right eye.  After 2nd shot, woken in middle of night with terrible sensation up and down spine, and trouble breathing.  trouble getting out of bed and terrible weakness in legs.
3days post vax developed vomiting & diarrhea which lasted on & off for 1wk; had fluid in ears when had immun; 8MAR91 had 1 sz which lasted 1-2min; To ER; recently treated for bronchitis & ear infect; Further pertussis vax is contraindicated
DOSE WAS GIVEN TOO EARLY.  PT RECEIVED 1ST DOSE ON 6/21/21.  IT HAS ONLY BEEN 18 DAYS INSTEAD OF THE MINIMUM REQUIRED 24 DAYS.  PT HAS NO PROBLEMS, JUST A VACCINE ERROR ON MY PART
Patient was given Tdap, HPV, Meningococall vaccines. After the vaccines where given patient was instructed to sit on the table for 5min before raising. Patient did as instructed. Once the patient stood she was instructed to stand for a few minute because her color was pale. Patient denies any light-headedness or dizziness. Patient and guardian walked to the front counter. Once the patient was standing at the front desk she told her guardian that she felt funny. Guardian started to walk the patient back to the nurses desk and the patient passed out. The guardian slide the patient down the wall calling for help so the patient would not hit her head. The nurses came over to the patient she had come to. We gave her juice and a cool rage. Patient was helped off the ground and placed in a chair. Once in the chair patient denies any dizziness or light headedness. We had the patient sit for about 30-45 minute before leaving the clinic.
As of 2/21/2020 patient reports tendon popping sensation and pain in left shoulder area since receiving flu shot on December, 18 2019 (approximately 2 months now) and inquired as to whether this could be caused by flu shot. Patient had not previously reached out to us regarding any problems she was having since receiving the vaccine. Advised patient that this is not an expected reaction and that she should follow up with primary care dr to rule out other causes. and that I would file an adverse reaction report on her behalf.
Vomiting at 12:20 pm, 1:15 pm, 1:30 pm and 1:45 pm. diarrhea at 12:20 pm , and 2:00 pm.
Headache, Diarrhea, FATIGUE AND MUSCLE ACHES Narrative:
slight fever; Chill; severe sore muscle and joints; severe sore muscle and joints; super achy; felt like I had been run over by a truck; flu like symptoms; fatigue; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6205), via an unspecified route of administration in the left arm on 05Mar2021 at 10:54, dose 2, single for COVID-19 immunisation. Medical history included ongoing birth control. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI FE 1.5/30). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9267) administered via an unspecified route of administration in the left arm on 12Feb2021 at 10:54, dose 1, single for COVID-19 immunisation and experienced soreness at injection site, lymph nodes left arm pit very sore, fatigue, red swollen injection site, swollen under left arm lymph nodes, sore arm, muscle + joints, lymph nodes left arm pit very sore. The patient did not receive other vaccines prior to COVID-19 vaccine. On 06Mar2021, the patient experienced fatigue, flu like symptoms. On 06Mar2021 at 02:00, the patient woke up in the morning and felt like she had been run over by a truck, super achy, severe muscle, joints, slight fever chills which lasted for 2 days. The patient took Ibuprofen and Advil for the events. The events were reported as non-serious. The outcome of the events fatigue and flu like symptoms recovered on an unspecified date and the outcome of other events was recovered on 08Mar2021.  No follow-up attempts are possible; No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021195717 Same reporter/patient /product, different dose and similar events
This spontaneous report was received from a 62 year old female patient referring to herself. The patient's concurrent conditions included diabetes, colorectal cancer, enlarged heart, fatty liver disease, neuropathy, back pain, and allergic reactions to Ibuprofen, VALIUM, Aspirin, Penicillin, Sulfa, Cephalexin, Tetracycline and other unspecified medications. The patient's medical history included several unspecified surgeries. On 12-NOV-2015, the patient was vaccinated with ZOSTAVAX, subcutaneously (dose, lot number and expiry date were not reported). Concomitant therapies included TOPAMAX, PROTONIX, an unspecified hypertension medication and other unspecified medications. On approximately 07-JUN-2016 (reported as "Two weeks ago today"), a little red spot appeared on the patient's stomach which she originally thought was just a painful bug bite. The patient said that over time, the red spot began to blister and she then began to experience a painful burning sensation. It was reported that the red spots spread across her stomach to her side and back. The patient also reported that she experienced nerve damage and, as a result, she would experience pain for the rest of her life. the patient visited the nurse practitioner and a treatment with an unspecified antibiotic was given. No laboratory diagnostic studies were performed. No product quality complain (PQC) was involved. At the time of reporting, the outcome of the events was reported as not recovered. The reporter did not provide a causality assessment between the events and the ZOSTAVAX. Upon internal review, the event nerve damage which would result in pain for the rest of the patient's life was considered as disabling. Additional information has been requested.