chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in an 83-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021 at 11:29 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 04-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.   This case was linked to MOD-2021-405476 (Patient Link).
History of Reaction To MMR 15 years ago while in Navy. Had a reaction after 2nd MMR. It resolved hours later. Patient described swelling around left eye that was treated with benadryl with no complications afterward. Prophylaxis Benadryl 25mg and Pepcid  20mg given at this time and instructed to take Benadryl q6 hours and second dose of pepcid on 8 hours. Patient was discharged home
approx. 15 min after vaccination patient started experiencing mild chest pain, redness of sclera and tachypnea along with a small rash on (L) upper chest area.
This initial spontaneous case, was received on 30-Oct-2017, from a consumer, concerning a 26-year-old adult female pregnant patient of 9 weeks. The patient's medical history, concomitant medications were not reported. The patient's last menstrual period (LMP) was reported as 27-Aug-2017. On an unspecified date in 2017 (reported as 5 weeks ago), was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number:195239, expiry date: Mar-2018). It was reported that, 9 weeks pregnant patient (first pregnancy) was administered with vaccine (explicitly coded as vaccine exposure during pregnancy) and had no adverse event. The EDD (estimated date of delivery) was reported as 02-Jun-2018. The reporter assessed as event as non-serious.
The pt experienced a rash. Petechiae was noted. Platelets were less than 1,000. Bone marrow consistent with ITP. Admitted of IVIG.
Hospitalized 1.8.22;  COVID positive 1.6.22 and 1.9.22;  Fully Vaccinated Admission Date: 1/8/2022 Discharge Date: Jan 11, 2022 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Chest pain, unspecified type  COVID-19  HOSPITAL COURSE: Patient is a 52 year old woman with PMHx of cocaine abuse, CAD, NICM s/p ICD, DM2, CKD. Currently living in rehab facility and has abstained from cocaine since early December. She presented with chest pain and shortness of breath. She also had a reported positive rapid / antigen test at her facility, though she reports she never saw these results with her own eyes. She was admitted with elevated troponins. Repeat COVID swab was positive but patient remained asymptomatic Patient developed non specific neuro symptoms of L side paratsthesias and R gaxe palsy. Symptoms resolved. CT Head, Brain MRI. Orbit MRI were all benign  CP and troponins increased while inpatient. Cardiology diagnosed her with NSTEMI type 1 and added Plavix and Entresto to her meds. Heart cath was not pursued since she had a recent cath. 1/11/2021 Pt S+E. Alert. NAD, VSS on RA. No CP. Wants to go home. Stable at diascharge. Patient in agreement with instructions to follow up with cardiology as outpatient
(Reported to nurse by parent via phone) Pt was emotional and cried at school 9/9/19 afternoon. Woke suddenly at 10:30 pm screaming, crying, shaking. Body went stiff the patient urinated on self. Episode lased approximately 2 minutes, but patient Remained disoriented an additional 8 mins. Pt then went to sleep, no further incidents Remainder of the night. Pt awoke 9/10/19 a.m. at normal time, acting normally, no recollection of event.
Information has been received from a physician concerning a 5 year old male who on 9/24/98 was vaccinated with a dose of varicella virus vaccine live (lot # 626399/0654H). The patient's mother called the physician's office and reported that the patient developed breakthrough varicella. The patient had more than 50 lesions and a temperature of 98 degrees F. The patient was exposed to a child with chicken pox at school. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
My menstruation period was regular but since early Nov, it was suddenly 10 days delayed and now it is 2 weeks early.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider(s) recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 17-SEP-2014, a healthcare provider, at a medical office, administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In SEPTEMBER 2015, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.
Lightheadedness, nausea (no vomiting), anxious. She has a history of anxiety with needle injections.    She laid down on the floor (voluntary, no syncope, no mental status changes), when taken to private section of the Center via EMS stretcher.  Symptoms lasted 20 minutes, then resolved on their own.
Fever, Chills, muscle ache, joint pain, headache, fatigue, arm swollen
very sour stomach; feels like vomiting; A spontaneous report was received from a consumer concerning a 85-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events very sour stomach and feels like vomiting.  The patient's medical history include, she is a diabetic and had a pacemaker.   No relevant concomitant medications were reported. patient and her daughter called to report that,on 29 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  On 1 Feb 2021, the patient experienced the events,very sour stomach and still ongoing and she feels like vomiting but is holding it back vaccine sour stomach. she did not receive card with information at vaccination site  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, very sour stomach and feels like vomiting were unknown.
Patient contracted COVID after being fully vaccinated. Presented to the ER for CVA previously was sick with fatigue
12:30 pm injection given to left arm, after 10 minutes of waiting a sudden warm sensation began from left arm traveling across chest to right arm, up my neck and inside throat to my face and head. I found this sensation to be strange and describe the feeling similar to receiving contrast for CT scan and when administered you can feel the warm sensation as it travels through out your body. My vision became a bit blurry I tried to remain calm and asked others in the room if they experience similar symptoms in which no one had. I stood up and walked across the room to get some water. I had an unsettling feeling and coached myself to remain calm. I drank 2 cups of cold water and sat down. After about 5 minutes the hot flush went away. I decided to stay longer than the 15 minute observation time that I was told to do. After 30 minutes from injection I felt okay to leave.
Patient started experiencing dizziness and nausea approximately 5-10 minutes after administration of Moderna booster dose.  Patient BP was taken, and systolic BP and heart rate was elevated above patient?s normal baseline.  Patient then started to complain of headache and numbness in lips.  Retested BP/HR and was still elevated.  Administer patient 2 tablets of OTC acetaminophen and called EMS.  Ambulance came and observed patient retested vitals where BP & HR were still elevated.  Patient later complained of right leg numbness.  Patient taken to local HCF ER by ambulance
I had my 2 shots last year and I now have shingles/ Suspected vaccination failure; I have it now, painful; I have it now- painful; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient received 2 shots of shingles vaccine last year and at the time of reporting had shingles. The shingles were painful. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were not provided.
Patient reports allergic reaction to Dupixent about 2 weeks after receiving second dose of Pfizer COVID vaccine. Patient reported symptoms of rash all over body, itchiness, tiredness, and eyelids hurting. Patient went to ER and is following up with her doctor and getting second opinion.
Information has been received from a registered nurse concerning an adolescent female (age not reported) who on an unspecified date was vaccinated with the first dose of HPV vaccine (yeast). Subsequently, the patient passed out or was unconscious (date unknown). It was reported that the vaccination was "somewhat painful". The patient sought unspecified medical attention.  At the time of this report, the patient had recovered from the event (date unknown). The nurse reported that there were a total of 4 cases of adolescent females that passed out or were unconscious after receiving the first dose of HPV vaccine (yeast) out of 130 total doses administered by the office.  Additional information has been requested.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age. The patient's medical history was not reported. The reporter stated that on 16-MAY-2016, the patient was inadvertently administered an expired dose of PNEUMOVAX 23 lot number K020215, expiration date 15-MAY-2016 (dose, route and site of administration not reported). No adverse effects reported. Additional information has been requested.
Cherry color pin point papules, VS Q 4 x 24, O2 sats.
2 rashes to left arm first 1.5  by 2 inches 2nd lower down 3 x3 inches after 1st dose  warm firm itchy. used benadryl went away 2 days later then returned on 2/12 1 rash 3.5 by 4 inches not warm of firm but itchy again using benadryl  rash still present not itchy and now pink in color.
Vomited; Soreness at the injection site; A spontaneous report (United States) was received from a healthcare professional concerning a 76-years-old  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events soreness at the injection site, vomited.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 3 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013M20A) unknown route in the left arm for prophylaxis of COVID-19 infection.  On 3 Feb 2021, the patient experienced the event(s) soreness at the injection site,On 4 Feb 2021, the patient experienced the event(s) vomited.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  On 3 Feb 2021 the outcome of event(s), soreness at the injection site was resolved. The outcome of event(s), vomited was unknown.
No additional AE reported; Student medical assistant reports that a 12 month old patient was accidently administered both VARIVAX and PROQUAD on Jun 22. 2022.; This spontaneous report has been received from a student medical assistant concerning a 12-month-old patient of unknown gender. The concomitant medications, medical history, drug reactions or allergies, and concurrent conditions were not reported.  On 22-JUN-2022, the patient was accidently administered both measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) lot # U030590, expiration date 29-MAR-2023 (strength, dose, route of administration and anatomical location were not provided) and varicella virus vaccine live (oka/merck) (VARIVAX) lot # U028164, expiration date 09-SEP-2023 (strength, dose, route of administration and anatomical location were not provided) for prophylaxis (accidental overdose). No further information was provided. Healthcare professional (HCP) provided consent to be followed up with, and stated if she was not there, could talk to anyone at the doctors' office. No additional adverse event (AE) was reported. No product quality complaints (PQC) was reported.
Consumer answered "Yes" when the ChatBot asked if they had received the Moderna COVID-19 Vaccine and experienced a side effect.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Consumer answered "Yes" when the ChatBot asked if they had received the Moderna COVID-19 Vaccine and experienced a side effect.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Consumer answered "Yes" when the ChatBot asked if they had received the Moderna COVID-19 Vaccine and experienced a side effect). At the time of the report, VACCINATION COMPLICATION (Consumer answered "Yes" when the ChatBot asked if they had received the Moderna COVID-19 Vaccine and experienced a side effect.) outcome was unknown.            Description of Event or Problem: AE submitted via Chatbot: "What are common side effects the after you get the" "Second shot. day after"
Immediately became light headed but remained oriented.  Vitals stable after resting for 20 minutes. Was diagnoses 4/2014 with mycoplasma pneumonia. Presented 5/8/14 in office for extreme fatigue.  Patient was found to have pancytopenia and ITP.  Mom believes the fatigue, pancytopenia, and ITP are result of Gardasil.
This spontaneous report was received from a nurse referring to 2 patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapy were unknown. On unknown dates the patients were vaccinated with doses of PNEMOVAX23 (lot#, route and dose not reported). The nurse indicated that each dose of PNEUMOVAX23 administered was different lot number. On unspecified dates after the administration, both patients developed pain, warmth and redness that traveled to the inner arm, lasting for an unspecified duration of time. The nurse did not indicate the present status of either patient. Additional information has been requested.
Woke up on 1/9 with major headache.  During the day this progressed to nausea, body aches, chills and fever 100.4.
Patient was given flu shot. Doctor would not give patient any information. Doctor says flu shot did not cause his issues, it was a good shot. Patient began with pain behind knees again 7 days after flu shot. Same occurrence that had happened to him from the flu shot in 2018.  Patient went back to Dr. to tell her the same events were occurring as what happened to him last year and she said it had nothing to do with the shot.  She asked him if he was still taking the prednisone and he said, no that she had weaned him off.  She said to patient you are still to be taking the prednisone and prescribed it again for him.
Swollen Lymph Nodes - under arms, both sides; Swollen Lymph Nodes - under arms, both sides, tender sides of breasts.; CBC blood test showed doubled levels of absolute eosinophils; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Jul2021 16:30 (Lot number: EW0170) at the age of 46 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Heart murmors" (unspecified if ongoing); "known allergies; Tetracyclins" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 18Jul2021 08:15, outcome "not recovered", described as "Swollen Lymph Nodes - under arms, both sides"; BREAST TENDERNESS (non-serious) with onset 18Jul2021 08:15, outcome "not recovered", described as "Swollen Lymph Nodes - under arms, both sides, tender sides of breasts."; EOSINOPHIL COUNT INCREASED (non-serious) with onset 18Jul2021 08:15, outcome "not recovered", described as "CBC blood test showed doubled levels of absolute eosinophils". The events "swollen lymph nodes - under arms, both sides", "swollen lymph nodes - under arms, both sides, tender sides of breasts." and "cbc blood test showed doubled levels of absolute eosinophils" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lymphadenopathy, breast tenderness, eosinophil count increased.  Additional information: Swollen Lymph Nodes - under arms, both sides, tender sides of breasts. CBC blood test showed doubled levels of absolute eosinophils. Scheduled to follow up next week with new blood testing, recommended to get hematology consult, Ae treatment: Prescription strength anti-inflammatory drugs, if covid prior vaccination: No, if covid tested post vaccination: No, Known allergies: Tetracycline. Other medical history: Heart murmors  Follow-up attempts are completed. No further information is expected.
Case number PHEH2012US023115 is an initial spontaneous report received from a nurse on 15 Nov 2012. This report refers to a 28-years-old female patient. It was reported that she received only the MenCYQ-135 liquid conjugate of MENVEO (batch number: X11082) intramuscularly and did not receive Men A lyophilized conjugate on 07 Nov 2012. No adverse reactions were reported.
Vaccine was expired on 07-Apr-2022 and administered on 08-Apr-2022 / expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-Apr-2022 and administered on 08-Apr-2022 / expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration) in a 68-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-Apr-2022 and administered on 08-Apr-2022 / expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-Apr-2022 and administered on 08-Apr-2022 / expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 173 doses. The vial did not undergo any temperature excursions.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received contains non significant information.
DIFFICULTY BREATHING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 11-APR-2021, the subject experienced difficulty breathing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of difficulty breathing was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
The pt started with a rash on 5/6/00, got worse, was seen in office on 5/8/00 with diagnosis of varicella.
flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included flu shot (getting (yearly) flu).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient reported the case for herself. The patient experienced flu-like symptoms for a couple days. The side effects were expected and left after a day or so. The reporter did not specify if side effects occurred after dose 1 or dose 2 or both. The reporter did not consent to follow-up. For 2nd dose, refer case US2021AMR193160, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021192911:same reporter US-GLAXOSMITHKLINE-US2021AMR193164:same reporter