chrisvoncsefalvay/vaers-outcomes huggingface dataset:
48 patients received an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided Treatment medications were not provided.
Patient was seen at  on 03/08/2021 and vaccinated underage. Parent with patient and aware of situation. Parents understands the situation and is willing to wait for the second dose. No adverse reaction noted after administration per patient and parent. Patient asked to return for second dose upon turning 18 years old and/or approval of trial studies on pediatric patients by the CDC or FDA. Second dose was not administered.
Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 37-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concomitant products included OMEGA-3 FATTY ACIDS and pre natal vitamins for an unknown indication.    On 28-Jan-2021 at 9:05 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 28-Sep-2020 and the estimated date of delivery was 05-Jul-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  seventeenth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
This case was reported by a pharmacist and described a dose of an injection site reaction in a pt who received Infanrix. On an unspecified date in 2003, the pt received a dose of Infanrix. On an unspecified date in 2003, at an unspecified period of time following the administration of Infanrix, the pt experienced a "bump" at the injection site. The bump at the injection site hardened "over the pasy year". The pt was seen at a physician's office. The injection site reaction was ongoing at the time of initial reporting. The reporting pharmacist, considered the events to be unrelated to vaccination with Infanrix.
Patient is reporting joint pain and lack of mobility of their left arm. Joint pain is in the shoulder. It set in the day after the shot, and today and four days later and it has still not resolved.
Narrative: Breakthrough Covid-19: history of CAD and prior MI which was medically managed as well as HIV infection who presents to the ED with cough, shortness of breath, and chest pain.
08/29/21 The patient presents with 73 year old female with a medical Hx of pulmonary embolism, sleep apnea, Pulmonary fibrosis (on 6L of O2 at home) presents COVID positive onset of today to the ED. Per EMS patient was placed on 6.5L of O2 via nasal cannula prior to arrival. Patient reports of generalized weakness and fatigue. Patient has received both of her covid vaccinations. Denies any chest pain, shortness of breath, diarrhea, urinary complications, vomiting, fevers or chills..  The onset was just prior to arrival.  The course/duration of symptoms is constant.  The character of symptoms is generalized, lack of stamina and lack of strength.   Risk factors consist of obesity and age,
Pt brought to med obs #1 via stretcher after experiencing tunnel vision/blurred vision, warmth, weakness, dizziness, and full syncopal episode with LOC. Placed on floor with BLE prior to stretcher arrival. Brought to med obs #1 with staff. Alert to voice, appears lethargic, but able to answer questions appropriately. Pt reporting she "feels exhausted." Denies history of syncope/LOC. Continuous VS monitoring in place. No s/s of distress noted. Improvement of symptoms noted, alert to voice, eyes opening spontaneously. Pt instructed to call daughter for ride home. Given water, declined snack. Orthostatic VS obtained. VSS. Symptoms completely resolved. Daughter arrived to collect pt. Pt and daughter escorted to exit by staff via wheelchair. VS are as follows: 1155: BP 151/97, HR 90, RR 20, O2 sat 98% on RA 1200: BP 137/88, HR 79, RR 20, O2 sat 96% on RA 1205: BP 137/88, HR 78, RR 20, O2 sat 97% on RA 1210: BP 130/82, HR 80, RR 18, O2 sat 99% on RA 1215 (lying): BP 142/90, HR 74, RR 18, O2 sat 98% on RA 1225 (sitting): BP 149/94, HR 73, RR 18, O2 sat 98% on RA 1226 (standing): BP 141/89, HR 72, RR 17, O2 sat 99% on RA 1234: BP 148/88, HR 74, RR 18, O2 sat 98% on RA
DAWNED WITHOUT TASTE; DAWNED WITHOUT SMELL; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced dawned without taste, and dawned without smell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dawned without taste and dawned without smell was not reported. This report was non-serious.
ear infections; ear infections; there was a less than 0.3 mcg/ml antibody level for serotypes 1, 2,3,5, 14, and 19F; upper respiratory infections; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  A 4-year-old patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3, single (Batch/Lot number: unknown) and as dose 4, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), EAR INFECTION (medically significant), outcome "unknown" and all described as "ear infections"; ANTIBODY TEST ABNORMAL (medically significant), outcome "unknown", described as "there was a less than 0.3 mcg/ml antibody level for serotypes 1, 2,3,5, 14, and 19F"; UPPER RESPIRATORY TRACT INFECTION (non-serious), outcome "unknown", described as "upper respiratory infections". The patient underwent the following laboratory tests and procedures: Antibody test abnormal: less than 0.3mcg/ml, notes: there was a less than 0.3mcg/ml antibody level for serotypes 1, 2, 3, 5, 14, and 19F.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine towards the onset of ear infection/antibody levels low in this patient cannot be completely excluded.  Further information like confirmative pathological/serotype results and vaccination schedule are needed for full medical assessment.
Patient received first dose of Pfizer vaccine on 8/5/21 and second dose of Pfizer vaccine today 8/26/21. It is later discovered in database on 8/26/21 that patient received a dose of J&J vaccine months ago on  3/12/21.
A non-serious spontaneous report of fever, loss of appetite and fatigue has been received from a consumer concerning a four-year-old female, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Neither relevant past medical history nor concomitant medications had been reported for this patient. The patient received FLUMIST on 29-Sep-2011. The patient's mother stated that her daughter did receive FLUMIST and was not sure if her daughter received the FLUMIST from one syringe or if a second syringe was used to administer the dose in the other nostril. She stated her view of the nurse was blocked because she was facing the nurse's back and could not see her hands. After receiving FLUMIST, the patient developed a loss of appetite on 30-Sep-2011. On 06-Oct-2011, the patient developed fatigue and fever of 99.6 F. The mother gave ibuprofen on 06-Oct-2011. The event of loss of appetite resolved on 01-Oct-2011 and the events fever and fatigue resolved on 07-Oct-2011.
RIGHT AFTER THE VACCINATION, PATIENT STARTED FEELING WEAK, LOSING VISION, LOSING HEARING, WAS SWEATING AND HAD NAUSEA. PATIENT WAS ALERT AND SITTING UPRIGHT. AFTER 3 MINUTES, THE VISION AND HEARING CAME BACK AND STARTED FEELING BETTER. PULSE WAS 80 AND 5 MINUTES LATER BLOOD PRESSURE WAS 110/70. NO FURTHER TREATMENT WAS NEEDED. PATIENT FEELING FINE.
ringing, or buzzing in both ears, never quits, had perfect hearing before the moderna booster shot
Patient was given 8/10/11 PCV 13 (R) deltoid. Complaints increased swollen, redness on 8/12/11. Reaction is erythematous/tenderness with diameter 6cm x 8cm. No weakness/numbness (R) shoulder full range of movement (ROM).
on 1/12 started body aches and chills, took Tylenol and felt better, Wednesday felt short beat and irregular and heart beat not regular. checked pulse and it was irregular, that night 9-9:30  I went to ER close to house and pulse and heart rate abnormal after 2 hours went home and advised to contact cardiologist, he said to come in Thursday and the irregular beats were off and on atrial flutter, on Friday I came home and went back to hospital and got the shot cardio version or ablation to revert the rhythm and because the rhythm was back and forth I was observed until released on 1/19/21. Surgery was in 2017 and never had problems and they stated heart was compromised and maybe this is your reaction to the vaccine.
Administration of incorrect dose. Patient was given 0.3 ml instead of 0.1 ml.
RUNNY NOSE; CHILLS; MILD FEVER; TIRED; NAUSEA; This spontaneous report received from a patient concerned a 73 year old female. The patient's weight was 160 pounds, and height was 164.6 centimeters. The patient's concurrent conditions included shellfish allergy, mold allergy, iodine allergy, alcohol user, nonsmoker, vestibulitis and blood pressure, and other pre-existing medical conditions included no drug abuse. The patient was previously treated with for prophylactic vaccination.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and batch number: 1805025 expiry: 25/05/2021) dose was not reported, administered on 10-MAR-2021 15:30 for prophylactic vaccination. Concomitant medications included olmesartan medoxomil for blood pressure, estradiol for vestibulitis, gabapentin for vestibulitis, ergocalciferol, and magnesium. On 11-MAR-2021, the subject experienced runny nose. On 11-MAR-2021, the subject experienced chills. On 11-MAR-2021, the subject experienced mild fever. On 11-MAR-2021, the subject experienced tired. On 11-MAR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 102 degree F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from runny nose, chills, mild fever, tired, and nausea on 12-MAR-2021. This report was non-serious.
MMR II Live vaccine given to traveling nurse who was told to get boosted because of a low titer. Giving the vaccine was uneventful. I talked to patient for a few minutes after the vaccine to make sure everything was ok. I told her to stay about 15minutes to make sure there were no issues. She walked to back of store with husband I believe. A few minutes later someone came to pharmacy looking for a wheelchair, saying that someone fell and people were helping her up. Then I found out it was the person I gave the vaccine to. She seemed a little disoriented. She said she hadn't gotten much sleep and was falling asleep in chair as I was giving vaccine. The husband said he wanted an incident report  written because she hurt her knee. I called for a manager who came to do the report. He said her story kept changing. (dip in floor /dizzy/stumbled over feet)
Approximately 2 1/2 hours after getting the vaccine my entire body starting itching (mild) and my cheeks were bright red and hot.  This lasted approximately 8-10 hours after onset and then cleared up.
Lightheadedness Difficulty breathing Excessive coughing Phlegm Tired Runny nose
pt recvd vax & devel fever of 103-105 10 days p/vax; No further details were provided; MD reported 15 similar pts;
I had my 2nd vaccine January 8th, 2021 and was in bed due to being exhausted and not feeling well Saturday Jan 9th, Sunday January 10th and Monday January 11th. .  I was scheduled to work the 11th and let my supervisor know Sunday night that I was still exhausted and not able to work  January 21, 2021 Began having occasional episodes of shortness of breath, I was not sick, sometimes I wasn?t doing anything, one time I was in the shower that was the 1st time which was 1/21/2021 I had to sit down and then had to stop shower for a few minutes. This has happened several times and continues currently. It?s not everyday but seems to happen in clusters. Several days at a time then  I still feel short of breath but at least don?t  ha be to sit down or stop shower.   February 2nd- I was at working in the ER, not doing anything but walking from office to Pt room and while I was working became SOB, and spoke with a provider and they wanted me to be checked in.  I was admitted to the ER.  I had to leave my shift due to this.  The provider was concerned about possible PE and did chest X-ray and MRI on my brain. Both were fine.  2/18/2021   I saw Dr.  due to continued symptoms and in his notes he states that it is unclear relationship to Covid Vaccine.  Since then, I have had an array of symptoms- Pain, weakness, numbness tingling, increased heart rate, shortness of breath. Unfortunately this has been ongoing since January 21, 2021   2/19/2021,   2/20/2021    2/21/2021 I had a large dose of steroids   On 2/22/2021 I worked, but was tired and just didn?t feel well.  I went home after my shift and was so tired and weak, I didn?t finish dinner but just went to bed.  (7:45 or 8) and slept deeply until 8 the next morning.  I got up and was completely wiped out, I was having difficulty walking, and felt very weak and just felt very off.  I attempted to come to work, hoping that my condition would improve.  I was wiped out and short of breath just getting from my car across from the street to the ED.  I spoke to my supervisor and she told me to go home.  I went home and slept/ rested the next 2 days.  I saw Dr.  again and he was concerned and offered to do  paperwork and told me that it would take time and I would need rest.  I was having significant difficulty walking and it was more of a shuffle than walk.
Patient called pharmacist attention at 6:55pm. Patient's eyes glossy and rolled into back of head, patient then fainted.  When patient awoke she started having difficulty breathing, started coughing and seemed panic.  She had a rapid acting albuterol inhaler with her - she took 2 puffs immediately, breathing did not improve.  Pharmacist grabbed emergency kit and administered epinephrine (right IM leg) and benadryl (right IM arm).  Patient refused EMS or AMR service many times. Follow up phone call on 7/9/2021 - patient has recovered and no other side effects at this time.
Several red plaque on the diffuse both arms, both legs, abdomen, and back. Inflammed mucosa and nares.
experience mild itchiness on my back; This is a spontaneous report from a contactable consumer (patient). A 18-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiry date were not reported) via an unspecified route of administration, administered in left arm on 31Mar2021 14:15 (at the age of 18-year-old) as dose 1, single for COVID-19 immunization (Health Clinic). The patient had no medical history. The patient concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient reported had not diagnosed with COVID-19 prior to the vaccination. On an unspecified date, the patient had experience mild itchiness on my back. On 26Apr2021, the patient underwent nasal swab SARS-CoV-2 test which was negative. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of event which included hydroxyzine 10mg three times a day. The outcome of the event was not recovered.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a 23 year old female with a history of type 1 diabetes mellitus and no allergies, who on 22-SEP-2010 was vaccinated with a first dose of RECOMBIVAX HB. After the vaccination the patient's blood sugar went up and lasted for 4-5 days. On 25-OCT-2010 the patient was vaccinated with a second dose of RECOMBIVAX HB and her glucose level went up again. Concomitant therapy included HUMALOG, LANTUS, LEVOXYL, SEASONIQUE and vitamins (unspecified). No laboratories studies performed. The patient did not seek medical attention. At the time of this report the patient had not recovered from elevated glucose level. Additional information has been requested.
Number one i got norovirus symptoms. Then i got a cold and fought it until we got on the cruise. I tested negative 4 times. I was at the doctor twice between the 2nd and the 5th. On the 9th I had a negative antigen test to get me on the cruise. On the 19th I started coughing a lot and didn't think about it because I had so many problems with colds until my husband got really tired with a sore throat while on the cruise. When we got back we both tested positive. Neither one of us was really sick. I still have a little bit of coughing.
Sept. 5, 2012 received FLUZONE vaccine. Sept. 9, 2012 awoke with pain in (L) after, crying in sleep 9/9 - present day arm black and blue down past elbow and up to shoulder, and is "achey" with muscle aches & "knot" where injection was given.
PT REPORTED TO WINDOW ON 10/11, HAVING SHOTS ON 10/7.  PT REPORTS DECREASED SORENESS, BUT INCREASED REDNESS, WARMTH, AND SWELLING LOCALIZED TO INJECTION SITE. NO FEVER, NO RADIATION OF PAIN.  ADVISED PT TO ALERT PCP FOR FURTHER ACTION.
This spontaneous report as received from a certified medical assistant reported that on an unknown date an unspecified number of patients were vaccinated with ROTATEQ (strength, dose and lot # not reported), orally. The doses of ROTATEQ were exposed to a supported temperature excursion in "March or April 2014". No adverse effects had been reported. Additional information has been requested.
This spontaneous report was received from a pharmacist reported an unspecified number of patients received ZOSTAVAX (lot# unspecified), route unspecified "in the back of the arm". No adverse symptoms reported. Additional information has been requested.
This spontaneous report has been received from a registered medical assistant concerning a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 11-FEB-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 0.5 ml, intramuscular, lot # K007826 and expiration date 03-FEB-2016. Concomitant or co-suspect therapies were not provided. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Arm pain at injection site started 24hours later lasted 72 hours, Drowsiness started with in hours of injection lasted 48 hours,Sweating,Vomiting ,Dizziness,chills and Rapid heart beat started 48 hours later,sweating  and vomiting lasted and hour.Rapid heart beat lasted about 15 min. Took anti nausea medicine for the vomiting and Tylenol & Motrin for arm pain.
Clubbing of fingers and toes, tackycrdia, labored breathing, 122/90, Resp. 24, HR 100. Pt. observed with clubbing of fingers, anxiety, panic attack,  Emergency Personnel was notified and patient was transferred to Hospital for further evalution.
Narrative:  COVID infection following COVID vaccine series 03/05, Janssen, dose #1 08/03 COVID swab, result: detected 08/03 pt cc: chills, cough, diarrhea; exposure: unknown 08/10 PT cc: headache, sinus congestion,sinus pressure, rhinorrhea, myalgias 08/10 z-pack ordered
Janssen COVID-19 Vaccine EUA Severe chills and high fever Face/cheek swelled up one hour later
Information has been received from a physician concerning a 6 year old female who on 20-NOV-2007 was vaccinated subcutaneously in the left arm with zoster vaccine live (Oka/Merck) ( lot# 658605/1089U) instead of varicella virus vaccine live (Oka/Merck). The office indicated they have a refrigerator for the pediatric vaccines and a refrigerator for the adult vaccines. On 20-NOV-2007 someone in the office moved the pediatric vaccines to the adult refrigerator. The medical assistant (MA) did not realize this and did not look clearly at the vial to see it was zoster vaccine live (OKA/Merck) and not varicella virus vaccine live (Oka/Merck). The MA states this was clearly a staff error only. Additional information has been requested.
I took first shot and broke out worst then when I had them. Don't care about getting it again.; This case was reported by a consumer and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional information was provided as follows: The age at vaccination was not reported but was captured as adult as per vaccine indication. The patient broke out worst then when had Shingles. The patient did not care about getting the vaccine again. The patient stated it as a bad experience.
Arm just hurts; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 20th August 2022, the patient received the 2nd dose of Shingles vaccine. In August 2022, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK receipt date: 21-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the 2nd dose one day before the reporting date and his/her arm just hurts this time. Additional supportive information: The follow-up could not be possible as no contact details were available.
pt recv vax 26APR96 7 2MAY96 pt devel gen rash & a fever blister on lip;