chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 13 year old female consumer who on 10-MAR-2008 was inadvertently vaccinated SQ with 0.65mL of zoster vaccine live (Oka/Merck) instead of varicella virus vaccine live (Oka/Merck) (MSD). Concomitant vaccinations included MENACTRA and GARDASIL (MSD). Subsequently, the nursing error was discovered the next day on 11-MAR-2008. Medical attention was sought in the office. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Follow up information from the medical assistant indicated she inadvertently picked up the wrong bottle as both the zoster vaccine live (Oka/Merck) and the varicella virus vaccine live (Oka/Merck) (MSD) were in the same location in the freezer. The medical assistant indicated that both are labeled clearly, it was human error. Follow-up information has been received from the medical assistant concerning this 13 year old white female with rhinitis allergy who on 10-MAR-2008 was inadvertently vaccinated SQ with 0.65mL of zoster vaccine live (Oka/Merck) instead of varicella virus vaccine live (Oka/Merck) (MSD). The medical assistant indicated that the patient has not experienced an adverse event thus far. Additional information is not expected.
Received first dose of moderna vaccine but it was administered 1 cm below the deltoid muscle; A spontaneous report was received from a physician concerning a female patient who was received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced received first dose of Moderna vaccine but it was administered 1 cm below the deltoid muscle.   The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 on an undisclosed date intramuscularly for prophylaxis of COVID-19 infection and experienced product administered at inappropriate site when the vaccine was administered one centimeter below the deltoid by a medical student.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the event, received first dose of Moderna vaccine but it was administered 1 cm below the deltoid muscle, was not provided.   The event, received first dose of Moderna vaccine but it was administered 1 cm below the deltoid muscle, was considered recovered/resolved.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273.  There were no reported adverse events associated with this case.
Patient received TD vaccine on 6/12/08 as a routine booster.  Later that day, the patient visited his cardiologist for an unrelated reason and was not in respiratory distress.  On 6/13/08 the patient visited his primary care physician for the rash and noted some discomfort associated with the rash.  Patient was given BENADRYL; no other symptoms observed.  Follow up received on 07/31/08: Patient recovered.
Pt recvd vax & devel radiculopathy & other sx following w/Hep B vax;
Patient accidentally received a 3rd COVID19 vaccine with Moderna. He originally received the Pfizer COVID19 vaccine on 2/24/21 and 3/17/21. Our office identified the error after the patient already received the third dose. Follow-up with patient was completed 3 days after the 3rd dose was given. Patient denied any adverse events from the vaccine and had no concerns. He confirmed the administration of the Pfizer vaccine in February/March and scheduled for another dose because he wanted the $100 gift card from his insurance. Our practice is implementing procedures to prevent this error in the future.
Information has been received from a physician concerning a 9 yr old male who on 08Jul97 was vaccinated with a dose of varicella virus vaccine live. On 05May05, the pt presented with a case of breakthrough varicella with less than 50 lesions and no fever. Unspecified medical attention was sought. The pt recovered on his own and no treatment was needed. A product quality complaint was not involved. Additional information has been requested.
Red and swollen right thigh. Diagnosis - cellulitis. Antibiotic - Cephalexin 125mg.
Approximately 11 hours after getting the vaccine, I woke up at 2:30 in the morning nauseous and extremely dizzy.  I had difficulty walking and stumbled and almost fell.  The symptoms continued through the following day (3/2) and lessened at around 4:00 on 3/2.  I remained generally dizzy when I would sit up or move and continued to experience nausea throughout 3/3.    I have significant fatigue and some tingling in my face.
pt woke up from sleep screaming; screamed approx for 3 hrs constantly; seen @ hosp ER;
13 year old patient became diaphoretic and lost consciousness. He immediately woke up and vitals were normal. Parent denies any previous health conditions or syncopal episodes.
Doctor said bilateral stroke causing loss of peripheral vision on right; Doctor said bilateral stroke causing loss of peripheral vision on right; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Lot number: EK9231), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sjogren's" (unspecified if ongoing). Concomitant medication(s) included: SYNTHYROID; VITAMIN D [COLECALCIFEROL]; FOLIC ACID. Vaccination history included: BNT162b2 (at 10:00, dose 1, in left arm, Lot number: EK9231), administration date: 06Jan2021, for COVID-19 immunisation. The patient had no known allergies. The following information was reported: CEREBROVASCULAR ACCIDENT (disability), VISUAL FIELD DEFECT (disability) all with onset 21Feb2021 at 12:00, outcome "recovered with sequelae" and all described as "Doctor said bilateral stroke causing loss of peripheral vision on right". The event "doctor said bilateral stroke causing loss of peripheral vision on right" required physician office visit.  Follow-up attempts are completed. No further information is expected.
I had heart palpitations and my heart started racing really fast. I was at work when it happened so I had to sit down to calm down. It took about 30 minutes for my heart rate to calm down. I felt uneasy afterwards so I went home. Two days prior to that when I woke up something similar happened and I shrugged it off. But that Friday it was much worse when it happened at work. I followed up with my primary doctor and I was sent to my cardiologist.
This spontaneous report was received from nurse referring to a 31 year old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date the patient was vaccinated with VARIVAX (doses, routes of administration, lot numbers and expiration dates were not reported) for chickenpox prophylaxis. On 05-JUN-2018, the patient had a VARIVAX/ZOSTER AG/IGG test performed and the results showed negative titre levels. No adverse effects reported. The outcome of varicella virus test negative was reported as not recovered. The causality between the event and the therapy with VARIVAX was not reported.
They got this shot and got shingles/suspected vaccination failure; shingles/ got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 28-Oct-2022 Reporter's comment: The case was received from the consumer via interactive digital media. The reporter stated that everyone he/she knew got this shot and got shingles. The reporter mentioned another hoax in his/her opinion and had been convinced to be an antivaxxer. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Patient reports she received her 1st Moderna covid 19 vaccine lot number 039K20A on 1/11/2021. Patient reports on 1/20/2021 she noted redness and itching to her arm at injection site. Patient reports the area is 4 inches in diameter and raised. She denies pain or fever. Patient advised to take antihistamine per Hospital policy and advised her to monitor redness and notify Hospital if it worsens or she develops red streaking or fever. Patient
COVID Vaccine Breakthrough Case  J&J Dose 9/1/21 (206A21A) COVID Positive 11/13/21  11/13/21: A 79-year-old obese female with past medical history of rheumatoid arthritis, fibromyalgia, hypertension, impaired fasting glucose, mixed hyperlipidemia, neuropathy, uterine prolapse and chronic hypoxic respiratory failure on 2 L oxygen at home is brought to ED by ambulance for increasing weakness and unable to move from her chair for the past few days.  EMS noted her to be hypoxic and route, increase her home oxygen from 2-6 L by NC.  Per medic patient was confused, but it resolved by the time she arrived in the ED.  patient complains of some cough with small amounts of mucoid sputum and shortness of breath but no chest pain or fever or chills.  States her husband is diagnosed with COVID about 10 days ago.  Denies vomiting or diarrhea or abdominal pain.   After reviewing the chart, she was seen as a telehealth visit on 11/09/2021 for cough, congestion and shortness of breath, was assumed to be COVID positive as her husband was positive and was already followed by the program.  She was seen by tele health this morning, as per the regarding she had a fever of 101° F yesterday, heart rate was jumping into 130s and advised her to go to the ED.   Upon arrival in the ED, her temp was 99.2° F, vital signs stable, pulse ox 93% on 2 L oxygen by NC.  Chest x-ray showed bilateral pulmonary infiltrates.  COVID-19 rapid antigen test is positive.  Blood work showed acute kidney injury with BUN of 72, creatinine of 1.79 with hyperkalemia potassium 6.7, pH of 7.25.  Troponin is 0.05.  EKG shows sinus rhythm, no acute ST changes, tall T-waves in the chest leads.  Urinalysis positive for leukocyte esterase.   She was treated for hyperkalemia with cocktail, was also given dexamethasone 6 mg IV in the ED.  Nephrology is consulted in the ED.  12/2/21: This patient with a history of rheumatoid arthritis and fibromyalgia was admitted on 11/13 with COVID-19 pneumonia and hypoxemic respiratory failure.  She has received a full course of Remdesivir and Actrema, and is still on IV steroids and Lasix.  She is very weak and needs 2 people to help her out of bed to the chair.  There has been occasional episodes of confusion and yelling out at night.  Patient is still requires OptiFlow at 50-70%. She is too weak to return home in too sick to go to a skilled nursing facility we have arranged for her to be transferred to an LTAC for continued therapy.  She does have a DNR status, but is still getting full medical treatment.
Thigh swelling 7cm X 9 1/2cm with redness and induration.
Pt received Boostrix vaccine for prevention of tetanus 06.27.14, returned to the ED 07.17.14 with signs/symptoms of tetanus: lock jaw, grinding teeth, abd spasms. Was transferred to Medical Center.
Patient complained of body aches and fatigue about 5 hours after innoculation.  No treatment indicated.
This spontaneous report as received from a pharmacist via company representative refers to a female patient in her early 70's. Medical history and current conditions were not reported. On approximately 2014 (reported as about two years ago), the patient was vaccinated with ZOSTAVAX, (1 dose, 0.65 ml, subcutaneously). Concomitant therapy was not reported. On approximately 2014, 10 days after vaccination, the patient experienced a shingles like rash. Patient sought medical attention. The outcome of the event was unknown. Causality assessment was not reported. Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of oral, ROTATEQ lot # K013868 with 27-MAY-2016 and lot # L008053 exp. 30-NOV-2016, (dose and route were not provided). This is one of several reports received from the same reporter. Additional information has been requested.
Dizziness, cotton mouth, headache, could not focus, swelling on arm the size of a quarter for about 3 days.
Moderate chest pain, especially when breathing. Tylenol helps mildly with the pain.
PATIENT BRIEFLY LOST CONSCIOUSNESS, WHEN CAME TO HE COULD NOT SEE AND HIS HEARING WAS MUFFLED.  HE THEN BECAME CLAMMY, COLD SWEAT AND NAUSEOUS
Systemic: Dizziness / Lightheadness-Mild, Systemic: Shakiness-Mild, Systemic: Tachycardia-Medium, Additional Details: Refer pt to ER due to tachycardia and anxiety.
had the shot and then got Shingles / suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient had the shot and then got Shingles. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
I think I had the stomach flu; now I think I had a reaction to the injection; This case was reported by a consumer via call center representative and described the occurrence of stomach flu in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 20th February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced stomach flu and adverse drug reaction. On an unknown date, the outcome of the stomach flu and adverse drug reaction were recovering/resolving.   It was unknown if the reporter considered the stomach flu and adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The patient reported that she thought she had stomach flu but now she thought she had a reaction to the injection. The patient asked how long did the side effects last and stated she was doing a little better in the afternoon of day of reporting.
called to observation area at 1020.  98/60 p 100.  stated felt shaky, tongue feels thick and not changing, skin warm, hands, face, neck mottled.  respirations not labored.  oriented.   rapid response called and arrived at 1025.  transported to ER per wc as stated throat getting tighter.
Pain at injection site, chin, neck, shoulder blades, and wrist. Rash/blisters appeared under arm; was treated with steroid cream.
pt recv vax OCT98 & 9OCT98 c/o back lt muscle soreness;19OCT98 every vertebra in back hurt. In retro-spect - May have been a co-Medicine and not a vaccine reaction
I felt like I had the flu about 6 hours after receiving the vaccine - achy muscles, headache, pain all over my body, queasy. There was a lot of pain in my arm, which was to be expected, but two days later the injection site is just as sensitive and is red (about 1 1/2" in diameter) and now my entire upper arm is very sore.
Afib heart event 2 day after injection requiring medication and electroconversion (100 joules)
Pt recvd Td/Immune globulin & became nauseated, diaphoretic, exp vertigo, BP dec 70/40, P60; BP 110/80, P70; pt left clinic w/neighbors @ 5PM;
Arm pain; Headache; Fatigue; Back pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administration date 02Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm pain"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; BACK PAIN (non-serious), outcome "unknown", described as "Back pain".  Additional information: Patient has been experiencing arm pain, headache, fatigue, and back pain for 5 days and is wondering if this is a normal reaction. Patient was concerned about getting the second dose of the vaccine because she is worried about worse side effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt recvd vax 5MAY92 & pt cried non stop since getting shots this AM; no fever using APAP; no obvious swelling etc @ inject site; advised to call MD; MD advised cont APAP & ice to site; Seen in ER about 9PM; t102, red ears & throat;
Information has been received from a physician assistant in her "late thirties" who on an unspecified date was vaccinated intramuscularly with the first dose of Gardisil vaccine (yeast). The physician assistant reported that she did not get her period the first month after the Gardisil vaccine. It was unknown if the patient sought unspecified medical attention. At the time of this report, the outcome of the events were unknown as " the patient was not due yet for her next menstrual cycle". Additional information has been requested.
A couple days earlier, I was sensitive to really harsh smells. At first, it was just a tickle in my lungs  - an irritation. It started on the Tuesday before the 6th but only occurred once that day and then on Thursday it happened again. On the 6th, after I got my tooth pulled, I was knowing that my chest was bothering me. The next day, I could tell for sure it was my chest. I had been on Hydrocodone with the pulled tooth and so I only got a fever to 99. I never got to 100.4. When I did have a fever, it could have been from the anesthesia. It was never higher than 99. I started coughing and hacking and was worried about irritation from where the tooth was pulled. Wednesday, the 11th, I went to get the Rapid test. They told me I didn't have COVID - but it wasn't a PCR. On the 18th of August I had my PET scan - I told her I was sick when I was there for the scan. I am still coughing  - still can feel it in my chest and I can feel pain in one of my lungs (I don't have the coughing fits (like I had before) that I was still having last week). Before Labor day, (1st or 2nd) my Primary physician put me on  Erythromycin and a cough medicine pill and it stopped some of the congestion but it didn't stop the cough. Instead of hacking a lot, it reduced it - it was a lot less. Still have a cough but have recovered quite a bit. The CT scan will show if I'm recovered. (October 11th).
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 11-MAR-2010, the patient was inoculated with ZOSTAVAX by a pharmacist as recommended for routine adult health maintenance and for the long-term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 08-APR-2016, the patient was treated by a physician for a vesicular outbreak which was diagnosed as shingles. As a direct and proximate result of the 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.
Initial unsolicited report received from a consumer via other company (Pfizer) (Manufacturer Report Number: 2016219272) on 21 April 2016. This case involves a patient (age and gender not reported) who was vaccinated with a dose of DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED) (DPT shot) (batch number, route and site of administration not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had experienced autism. Laboratory data and corrective treatment were not reported. The outcome of event was not reported. Upon internal review the case was considered as serious because of important medical event autism. List of documents held by sender: none.; Sender's Comments: This is poorly documented case received from consumer where autism is reported after receiving DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED). Manufacturer of the vaccine not provided. However, investigation results ruling out a concurrent condition and other etiologies would be helpful to further assess this case.
Pt vaccinate6d with DTP developed fever, extremely irritable, & refused to eat.
enlarged heart; chest pain; became sick; had trouble walking; had left arm pain; turn blue; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date, as single dose (Batch/Lot number was not reported) for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient became sick right after receiving the Pfizer Covid vaccine and within a week of vaccination had trouble walking, began to turn blue, had left arm pain and chest pain. The patient was taken to the hospital for all events and diagnosed with an enlarged heart. The outcome of all events was unknown. The case was reported as serious due to hospitalization condition.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.