chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient \(DOB: 01/28/2002) is a 19-year-old, female. Alert, oriented X4, clear speech, able to answer to questions. No known medical conditions. No history of allergies. At 12:52 pm, the patient received her second dose of Pfizer (lot number EW0182, expires on 08/2021) on left deltoid. Patient walked with a steady, balanced gait to EMT observation area. At 1:55 pm, patient notified EMT  that she was feeling dizzy and lightheaded. EMT M assisted patient to anti-gravity chair. Patient remained A&Ox4 and talking to EMT . Lead RN was notified of reaction. RN  requested vitals Q5 minutes for 30 minutes. At 1:00 pm: BP of 130/82, HR 93, SPO2 99%. At 1:05 pm: BP of 140/88, HR 88, SPO2 99%, 24 RR. Patient consumed 8 oz of apple juice and is feeling ?more calm?. At 1:10 pm: BP of 122/81, HR 54, SPO2 99%, 16 RR. At 1:15 pm: BP of 125/77, HR 64, SPO2 99%, 12 RR. At 1:17 pm, patient was transferred to sitting position. At 1:20 pm: BP of 156/97, HR 89, SPO2 99%, 17 RR. At 1:25 pm: BP of 143/92, HR 78, SPO2 95%, 17 RR. At 1:30 pm: BP of 120/84, HR 77, SPO2 99%, 13 RR. Patient states she is "feeling better" and requested to leave facility. Patient was A&Ox4 with no reports of dizziness and lightheadedness. Lead RN provided patient with education concerning when to call , including worsening of symptoms and trouble breathing. Patient was instructed to follow up with PCP. At 1:31 pm, patient stood up from chair, denied lightheadedness and dizziness. Patient walked to car with steady, balanced gait. Patient's father drove patient home.
Large red circle/welt - about 2.5 inches in diameter appeared around the injection site about 10 days after the initial shot. Slightly warm to the touch with mild itching.
Narrative:  Hospitalization: Fully COVID vaccinated, admitted 5/11/22 for geri-psych placement incidentally COVID positive on 5/21/22
herpes zoster; Pain in the lower right chest upon coughing or sneezing intermittent stabbing pain on the right, midback; Pain in the lower right chest upon coughing or sneezing intermittent stabbing pain on the right, midback; Information has been received regarding a case in litigation from a lawyer and the pt on 01-SEP-2020, referring to a male pt of unknown age. The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 17-MAR-2008, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot# and route unknown) for routine health maintenance and prevention of shingles (herpes zoster). The pt suffered the following injuries as a result of the zoster vaccine live (ZOSTAVAX) vaccine: pain in the lower right chest upon coughing (cough) or sneezing and intermittent stabbing pain on the right, midback and was diagnosed with herpes zoster; symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX) vaccine and seriousness of his conditions. The outcome of cough, sneezing and Herpes zoster was reported as not revolved. The causality assessment between cough, sneezing and Herpes Zoster with zoster vaccine live (ZOSTAVAX) was reported as related.  Cough, sneezing and herpes Zoster were considered disabling events.
was paralyzed from the neck down; Information has been received from a health business professional (HBP) via a merck employee referring to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were unknown.  On an unknown date, the patient got hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, frequency, lot # and expiration date were unknown) for prophylaxis.  On an unknown date, the patient was paralyzed from the neck down. The outcome of the event was unknown. The causality between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, paralyzed from the neck down was determined to be medically significant.
This spontaneous report as received from a medical assistant refers to a 16-year-old male patient. No concurrent conditions or medical history were provided. On 08-AUG-2016, the patient was vaccinated with a dose of PROQUAD, subcutaneously (strength, does, lot# and expiry date were unspecified). No concomitant medications were reported. No adverse effects were reported. Additional has been requested.
This case was reported by a other health professional via sales rep and described the occurrence of maculopapular rash in a 61-year-old male patient who received SHINGRIX for prophylaxis. On 1st April 2019, the patient received the 1st dose of SHINGRIX. On 3rd April 2019, 2 days after receiving SHINGRIX, the patient experienced maculopapular rash. On an unknown date, the outcome of the maculopapular rash was unknown. It was unknown if the reporter considered the maculopapular rash to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not provided, but it could be 60 or 61 years. The patient developed a maculopapular rash in the flank/hip area (not at the injection site).
new lot / was administered / asking to know if they could continue using that lot of vaccines; 3 out of 18 patients fainted; This case was reported by a nurse via call center representative and described the occurrence of fainting in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. This case was associated with a product complaint.   In August 2021, the patient received Menveo. In August 2021, less than a week after receiving Menveo, the patient experienced fainting (serious criteria GSK medically significant). On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the fainting and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the fainting to be related to Menveo.  Additional details were provided as follows: The age at vaccination was not reported. The reporter called to report, a new lot of Menveo was administered to 18 patients since 2nd August 2021. The patient fainted after receiving the Menveo vaccine.  The health care professional called on behalf of a nurse manager who was asking to know if they could continue using that lot of vaccines.  The health care professional who made the call did not have any patient's demographics information nor vaccine information. Follow-up was not asked because the health care professional who reported the event did not have any information. On 5th August 2021, call back to nurse manager, but she was not available.  As per the judgment there has to be a PQC associated, for that the health care professional was transferred to the Agency, but not sure if they collected it, because the agent said it was not, and afterwards she took the call. The data in health care professional detail was from the nurse manager who has all the information on the event. This case was 1 of 3 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR167724:Same reporter US-GLAXOSMITHKLINE-US2021AMR167723:Same reporter
Loss of appetite, feeling feverish, loss of balance, fatigue, muscle aches, diarrhea next morning, pain at injection site.
arm pain; felling achy; had a little bit of pain under their armpit; received a third full dose instead of a booster dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), PAIN (felling achy), AXILLARY PAIN (had a little bit of pain under their armpit) and ACCIDENTAL OVERDOSE (received a third full dose instead of a booster dose) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041J21A, 001B21A and 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to epinephrine), Thyroid disorder (Thyroid condition) and Mitral valve prolapse (Heart condition).   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 23-Dec-2021, the patient experienced ACCIDENTAL OVERDOSE (received a third full dose instead of a booster dose). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain), PAIN (felling achy) and AXILLARY PAIN (had a little bit of pain under their armpit). On 23-Dec-2021, ACCIDENTAL OVERDOSE (received a third full dose instead of a booster dose) had resolved. At the time of the report, PAIN IN EXTREMITY (arm pain), PAIN (felling achy) and AXILLARY PAIN (had a little bit of pain under their armpit) outcome was unknown.            No concomitant medications were reported. No treatment information was reported.  It was reported that the patient had not been working because they were hurt but clarified that was regarding something that had been going on for years. The patient took a spike protein test that showed a level of 1.78 or 1.76 after 8.5 months from  the second dose.   This case was linked to MOD-2021-428522 (Patient Link).
After the 2nd dose I started experiencing atrial fibrillation almost everyday. Before receiving the vaccine, it was only 2 or 3 times a year. Based on this my cardiologist changed my prescription, and I am now scheduled to have a heart ablation procedure for the atrial fibrillation. While I was waiting to have the procedure, I had a major cerebral stroke due to a blood clot. I was hospitalized for a week. I am now awaiting the surgery for the atrial fibrillation.
This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received the vaccination after a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (the vial undergo any temperature excursion) and NO ADVERSE EVENT (No Adverse Event) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received the vaccination after a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (the vial undergo any temperature excursion) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received the vaccination after a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (the vial undergo any temperature excursion) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient received the vaccination after a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (the vial undergo any temperature excursion).    No concomitant medications were reported.   The facility had a temperature excursion in the freezer. They had an inspection and saw that their DDL was not recording the temperatures.At the time of the excursion, the vaccine was in frozen storage. The vaccines were in unbroken cartons with vial size of 2.5 ml and 5.5 ml. Because only manual recording was done twice a day, the maximum and minimum temperatures reached by the vials were unknown.The excursion duration was unknown. The vaccine was returned to the freezer.  The visual inspection showed the vaccine state as still frozen.The vial underwent temperature excursion for the first time.  No treatment information was provided by the reporter.
a little bit of a lighter rash; it felt like there was a lump underneath; This spontaneous case was reported by a consumer and describes the occurrence of RASH (a little bit of a lighter rash) and VACCINATION SITE SWELLING (it felt like there was a lump underneath) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced RASH (a little bit of a lighter rash) and VACCINATION SITE SWELLING (it felt like there was a lump underneath). At the time of the report, RASH (a little bit of a lighter rash) and VACCINATION SITE SWELLING (it felt like there was a lump underneath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment details included a quarter of a Benadryl and probably a little of Cortisone cream.    Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
His arm is cold from his elbow to his shoulder from where he got the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 14 year-old male patient received bnt162b2 (BNT162B2), administered in deltoid left (Lot number: FA6780) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE COLDNESS (non-serious), outcome "unknown", described as "His arm is cold from his elbow to his shoulder from where he got the shot". Therapeutic measures were not taken as a result of vaccination site coldness. No follow-up attempts are possible. No further information is expected.  Follow-Up (18Aug2021): Follow-up attempts are completed. No further information is expected.
Leg Cram; sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and MUSCLE SPASMS (Leg Cram) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     Concomitant products included WARFARIN, ALLOPURINOL, LEVOTHYROXINE and LISINOPRIL for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 05-Mar-2021, the patient experienced MUSCLE SPASMS (Leg Cram). On 05-Mar-2021, MUSCLE SPASMS (Leg Cram) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
On Dec. 07, 2010, I received the immunization injection of ZOSTAVAX vial at the pharmacy order by dr. I feel that it activated 2 dormant viruses in my system-chickenpox & papillomavirus, Unsightly skin lesions appeared within days of the injection basically following the same path that the shingles usually follows (mid section around to the back). Nothing has helped to get rid of it. I am now trying occlusion using duct tape.
Information has been received from a consumer concerning her 19 year old son with penicillin allergy and no other pertinent medical history who on 29-DEC-2010, was vaccinated with the first dose of GARDASIL (lot number, dose and site of administration not reported). The consumer reported that her son never received the second or third dose due to illness not related to GARDASIL. The consumer mentioned that her son's physician did not want to administer any vaccine until he was better. At the time of the report, the patient outcome was unknown. Additional information has been requested.
redness at injection site; swelling at injection site; itchy at injection site; A spontaneous case report was received from a Consumer/Non-Health Professional on 20-JAN-2021, concerning an 80 year old, female patient who received Moderna COVID-19 Vaccine and experienced redness at injection site, swelling at injection site and itch at injection site.  On 11-JAN-2021, the patient received her first of the two planned doses of mRNA-1273 (batch number: 012220A), in the left arm for the prophylaxis COVID-19 infection.   On an unknown date, a week after vaccination, the patient experienced redness at injection site, swelling at injection site and itch at injection site.  The patients past medical history included: No adverse event.  The patient did not experience any serious criteria.  Patient gave consent for follow up.  No relevant laboratory tests and results were provided.   The action taken for Moderna COVID-19 Vaccine was Unknown. No information was provided on treatment given.  No concomitant medications were reported.  The outcome of the events, redness at injection site, swelling at injection site and itch at injection site was Unknown.  Additional information reported was: Patient received her vaccine in one state but spends winters in another state trying to get on a list in second state for 2nd dose due 08-FEB-2021.
Information has been received from the authors, in a literature published and reported that invasive pneumococcal disease (IPD) results in an estimated 5000 deaths annually. Reduction in morbidity and mortality associated with IPD in vaccinated patients, has led the ACIP to recommended routine vaccination in high-risk patients, Hospitalization provides an opportunity for immunization, thus agency had previously recommended screening every admitted patient for immunization. Most of locals hospitals have incorporated a pneumococcal immunization policy into the admission process. Although intended to be beneficial, it may result in immunization of patients not meeting stated ACIP criteria, or unwarranted repeat immunizations with studies suggesting that such practices may actually decrease immunity and thus be conterproductive. In an attempt to identify those patients not meeting ACIP immunization criteria but vaccinated anyway to meet hospital's vaccination protocol, the authors retrospectively reviewed tthe records of 661 patients admitted to the hospital and reported that on an unspecified date 53 elderly patients, were vaccinated with PNEUMOVAX 23 (manufacturer unknown) (dosage, strength, lot # and expiration date were not reported) more than once. The authors also reported that they suspected the actual number of elderly patient revaccinated was higher as a lot of them could not recall previous vaccination and were thus vaccination again. This is one of several reports received from the same reporter. (MARRS # 1505USA000357). A copy of the published article is attached as further documentation of the patient's experience. Additional information has been requested.
Since my last v-safe check-in, I had a bad stomach flu twice (once in April and once in May). Both were after exposure to families with similar symptoms. Symptoms were fatigue, nausea/loss of appetite, diarrhea, vomiting. The worst part lasted a day or two but I was tired and run down for about a week. The time I got sick in May, I also got a headache that has not gone away since.
This spontaneous report was received from a pharmacist via company representative and refers to unspecified number of patients. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with ZOSTAVAX, 1 dose, (dosing details not provided) for prevention of shingles. Subsequently, on an unknown date (s), the patients developed shingles. The patients sought medical attention. Outcome of the event and causality were not reported. No product quality complaint (PQC) involved. Additional information has been requested.
Pt vaccinated with MMR/DPT/OPV/Tine test had tonic-clonic seizures (X4) beginning 3:00 am to 7:30 am on 7SEP90. Max. T 101.8 per parents. @ ER T 101.7. Longest seizure about 2 min.
Immediately after vaccine I had a bad headache which was cleared up with Ibuprofen. Then 12 Hours after vaccine my arm became VERY sore, took my ibuprofen and alternated with Acetaminophen.  Then my face became very flushed (I used ice packs) and I got a mild sore throat. That night I had difficulty sleeping. I kept waking up with terrible body aches. About 24 hours after the vaccine I just had fatigue, mild fever, and chills. I slept on and off throughout the day and then started to feel better. But at about 32 hours post vaccine I started to feel worse. My headache and sore arm came back and I became very light headed and dizzy.
area-edema, red, hot to touch;told ice to area-ibuprofen;
Information has been received from a nurse concerning a 17 year old female patient who in approximately January 2009 (reported as about 3 months ago), was vaccinated with the second dose of GARDASIL (Lot number not reported). After getting the second dose, the patient fainted. On an unspecified date, the patient recovered. On an unspecified date the patient received the first dose of GARDASIL and did not experience any adverse event. Follow-up information has been received from a registered nurse concerning a 24 year old female patient (previously reported as 17 years old) with anxiety "when labs are drawn or when she receives an injection", who on an unspecified date was vaccinated with 0.5 ml of the first dose of GARDASIL (Lot number 660620/0571X), intramuscularly in the deltoid muscle. The patient had a vasovagal response after she received the first dose (not after the second dose as previously reported). The patient had recovered. The patient had received the second dose of GARDASIL (date not reported). Additional information has been requested.