chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; 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) and NO ADVERSE EVENT (No adverse event) in a 57-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    NDC ID reported as 80777027398. Patient's age reported as 57 year 11 months. Concomitant medication was not provided. The lot  O70H21A had been received by patients between 08-Apr-2022 and 15-Dec-2022. A second past Lot 065F21A had also been administered after expiration to patients. Treatment information was not reported. Order date and Completion date reported as 05-May-2022.
Severe cramping in abdomen. Now seems to be localizing around lower rt quadrant. no fever. but thinking no longer celiac inflammation but appendix?  Calling gastro if doesnt resolve in a day. pain range 8 on scale of one to ten. Haven't been eating much. Light headed if I bend at waist.
COVID Arm - Left arm has just developed a large, swollen, red ring has around the injection site less than 2 days later. Arm is sore and a little itchy. I elected to have both Flu Shot and Bivalent administered in same arm. I did this for booster in 2021 and had no issues, but am now experiencing this side effect for the first time after the Bivalent booster.  Monitoring condition and have not sought treatment at this time.
ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 8/8/2021 EMPHYSEMA
Subsequent to receiving one dose of varicella virus vaccine live the pt developed a rash that started on chin and spread to the entire body, a mild headache, tiredness and a loss of appetite. The rash blistered and resolved four days post onset. This was considered to be a case of mild breakthrough chickenpox.
Got his 1  st dose of the Moderna COVID-19 Vaccine, 5 months ago; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Got his 1  st dose of the Moderna COVID-19 Vaccine, 5 months ago) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Got his 1  st dose of the Moderna COVID-19 Vaccine, 5 months ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Got his 1  st dose of the Moderna COVID-19 Vaccine, 5 months ago) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. No Treatment information was reported.   Reporter did not allow further contact
Patient complained of an "egg size" "jelly filed" protrusion in armpit of the arm immunized.
severe headache with intermittent migraines, blurry vision, joint pain, jaw pain,
Fever (100.6), Chills, Sever headache, body aches, fatigue, tachycardia. All except tachycardia ended by afternoon of 2/5.  Tachycardia ongoing. Heart rate raises to ~108 with a mere walk down the hallway of my house.
Presented to ED today onset of chest pain today. He received his Pfizer booster vaccination does 2 days ago on 1/5/22 (primary series completed 6/4/21). Then yesterday postvaccine only had some mild fatigue and dizziness. Then chest pain occurred this am upon waking up. The chest pain was retrosternal and worse with taking a deep breath and lasted one hour.  Admitted to hospital for myopericarditis
The vial expiration date was 13-Oct-2021 and date of vial placed in refrigerator before administration was on 27-Nov-2021; Dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) and PRODUCT STORAGE ERROR (The vial expiration date was 13-Oct-2021 and date of vial placed in refrigerator before administration was on 27-Nov-2021) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial expiration date was 13-Oct-2021 and date of vial placed in refrigerator before administration was on 27-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) and PRODUCT STORAGE ERROR (The vial expiration date was 13-Oct-2021 and date of vial placed in refrigerator before administration was on 27-Nov-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that there was a confusion between the expiration date printed in the carton and the expiration date when the quick response code was scanned. Date vaccine was placed in refrigerator is 27-Nov-2021. Vaccine did not undergo any temperature excursion and patient had not experienced any adverse event. No treatment medications were reported.   This case was linked to MOD-2022-491837 (Patient Link).
Day one I started to get a bump at injection site.  Day 5 bump seemed nearly gone. Day 7 bump was back and itchy. Day 9, today, bump is bigger and itchy and red in two places.
Post vax, the pt developed a mild case of varicella. No treatment given except for comfort measures.
Beginning around bed time or a little earlier that night of the vaccine, I could tell something was off. Began feeling weak, heart rate was up above normal, head aches began. I had trouble sleeping and had a bad headache all night. Body aches also, occurring most strongly at site of injection but radiated throughout my body. That night, my average resting heart rate was 77, and my minimal RHR was 73. My normal average is around 59 and minimum is around 55. (This is tracked via an activity tracker.) The next day I felt terrible, really awful, for pretty much the whole day. The best way to describe it was like having a really bad hang over. Headache, no energy, motivation, just felt like I wanted to lie down and rest. The following day (today) I am feeling much better and almost back to normal. It was bad enough that I will think twice (or three times) before getting a flu shot again... I have gotten an annual flu shot regularly the last few years and never had a reaction like this.
Swelling and redness at injection site followed by tingling/numbness in same extremity- lasted for roughly 15 mins. Dizziness/lightheaded and high heart rate (135) lasted initially for 1 hr, subsided some with increased fluid intake, but persisted over the course of 4 days.
hands swollen,finger tips swollen; hands numb,finger tips numb; rash all over his body including his head; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (hands swollen,finger tips swollen), HYPOAESTHESIA (hands numb,finger tips numb) and RASH (rash all over his body including his head) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CELECOXIB (CELEBREX) and GABAPENTIN for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (hands swollen,finger tips swollen), HYPOAESTHESIA (hands numb,finger tips numb) and RASH (rash all over his body including his head). At the time of the report, PERIPHERAL SWELLING (hands swollen,finger tips swollen), HYPOAESTHESIA (hands numb,finger tips numb) and RASH (rash all over his body including his head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2022-485647, MOD-2022-485571 (Patient Link).
Patient's father said that her arm was sore after the vaccine, which has now resolved.  No other adverse events.
Child developed difficulty using left thumb after vaccine recieved. symptoms similiar to that of trigger finger. uncle and cousin also had similar reaction after recieving their vaccine which self resolved in approx 6 weeks
DULL HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced dull headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from dull headache. This report was non-serious.
A report has been received from a consumer concerning a 14 years old female patient. No concomitant medication or medical history was reported. The patient received nasal FLUMIST QUADRIVALENT on 14-Oct-2013 and one week later started to experienced flu like symptoms, cough and throat hurt. She also had a mild headache, but reported that she received a mild concussion over the weekend while playing soccer. The reporter who was the mother of the patient reported that the patient developed flu-like symptoms after receiving FLUMIST QUADRIVALENT. Over the weekend prior to seeing her doctor, the patient experienced a mild concussion. On 21-Oct-2013 (Monday) she went to see her physician for the concussion at which time she was ok. While she was at the doctor's office, she was given FLUMIST QUADRIVALENT. Later that day, the patient began to have symptoms but she did not have fever. The patient did not see her doctor for the symptoms. The mother said she was well now. The patient was treated with ibuprofen/ TYLENOL and DAYQUIL. The outcome of the events of patient experienced flu like symptoms after one week of receiving FLUMIST QUADRIVALENT, cough, throat hurts, concussion and headache were unknown. The events of patient experienced flu like symptoms after one week of receiving FLUMIST QUADRIVALENT, cough, throat hurts and headache considered to be non-serious by the reporter and the event of concussion have been identified by the company physician from the source documents and added as non-serious adverse event. Summary of follow up information received by MedImmune 30-Oct-2013 from consumer: Form completed date updated. Dosing regimen updated.
Pt. c/o chest tightness, shortness of breath and generalized muscle aches.
fever; chills; body aches; mild headache; This is a spontaneous report from a non-contactable consumer. A adult female patient received the second dose of bnt162b2 (lot number: EL3249), via an unspecified route of administration on 19Jan2021 at single dose for covid-19 immunization. Medical history included autoimmune conditions. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (lot number: EJ1685), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunization. Patient indicated that after 12h post 2nd shot, began experiencing fever, chills, and body aches. Symptoms continued for 12 hours and subsided to a mild headache. The events were occurred on 20Jan2021. The outcome of the events fever, chills, and body aches were recovering, the event headache was unknown.  No follow-up attempts are possible. No further information is expected.
PT STATES LARGE SORE AREA AT INJECTION SITE APPROXIMATELY 2 INCHES BY 1 INCH, RED AND SWOLLEN THAT BURNS.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 13-AUG-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (strength, dose and frequency were not reported) lot # L007224, expiration date 03-MAR-2017. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
I woke up the next morning with a severe migraine (worse than normal ones) and swollen lymph nodes on the left side of my neck. I decided to take my migraine which did not alleviate my symptoms. I ended up sleeping off and on all day, and after a few days my symptoms had resolved.
Severe swelling (site greater than silver dollar, visibly raised from skin), redness, hard knot at vaccination site.
Site: Swelling at Injection Site-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Visual Changes/Disturbances-Medium
shingles; This is a spontaneous report from a Pfizer-sponsored program. A contactable pharmacist reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as 1st dose single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient took the first dose of the vaccine and 6 days later developed shingles. Patients doctor wants to put the patient on Acyclovir and the pharmacist was calling to make sure medication will not affect the efficacy of the vaccine. The outcome of the event was unknown.  Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information is expected.
Following a trip, I started feeling a head cold of sorts coming, lost my voice, had a terrible sore throat, and a productive cough that got worse over the course of a week and a half. I went in to the doctor after my left ear became plugged up, unable to pop, and I could not hear out of it at all, and my other symptoms had not improved at this time.  I was diagnosed with a sinus and  middle ear infection at the time, and was prescribed a course of antibiotics.  My sinus infection improved over the antibiotic course, but I could not pop my ear or hear out of it for another week after the course of antibiotics.  My ear still routinely gets a bit more plugged up and it takes a lot more to pop than it used to. I used the vSafe check-in during my vaccination experience, and at my  last followup check-in reported this. I was then called by a representative and asked to call back to report or fill out this self reporter.
BLURRED VISION, COULD NOT SEE BOARD AT SCHOOL AND NURSE AT THE SCHOOL WAS CONCERNED.  NO PREVIOUS ISSUES WITH ANY VISION PROBLEMS.
Pulmonary embolism; pain on his side; pain in his chest area; This case was reported by a consumer via call center representative and described the occurrence of pulmonary embolism in a 55-year-old male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th September 2021, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 16th September 2021, 1 days after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced pulmonary embolism (serious criteria GSK medically significant), pain and chest pain. On an unknown date, the outcome of the pulmonary embolism was recovered/resolved and the outcome of the pain and chest pain were unknown.   It was unknown if the reporter considered the pulmonary embolism, pain and chest pain to be related to Engerix B and Engerix B Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: This case was reported by the patient himself. The patient received his second dose of the Engerix-B vaccine in his right arm.  On 16th September 2021 he woke up with pain on his side and in his chest area.  He went to the emergency room on the following Tuesday. They performed a chest x-ray and a CT (computerized tomogram) scan to find he had multiple pulmonary embolisms (AE).  The patient was requesting information regarding GlaxoSmithKline to do additional testing on him to determine causation of the pulmonary embolisms. The reporter provided permission to contact healthcare professional. The reporter consent to follow up. No additional details were provided by the reporter.
This case was reported by a consumer and described the occurrence of genital herpes in a male patient who received Influenza vaccine for prophylaxis. The patient's past medical history included genital herpes and chickenpox. Concurrent medical conditions included blood pressure high and benign prostatic hyperplasia. On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced genital herpes and condition aggravated. On an unknown date, the outcome of the genital herpes and condition aggravated were unknown. It was unknown if the reporter considered the genital herpes and condition aggravated to be related to Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient's herpes genitalis flared up after receiving anti-flu vaccine. This case has been linked with US2018GSK119866, reported for the same patient for SHINGRIX vaccine.
On 1/4/21 mild pain during injection and no further pain that day, days two and three more soreness in arm where shot was administered.  No other symptoms until 1/12/2021, at about 18:00, area of injection was itchy, later that night around 22:30 I noticed arm was very itchy, with redness compared to the size of a large egg  with bumps or hives. 1/13/021 arm is still itchy with redness, no hives.
Information has been received from a registered nurse concerning an 8-year-old female with no pertinent medical history and no drug reaction or allergies who on 25-MAR-1999 was vaccinated subcutaneously with a dose of Varivax. Concomitant therapy included polyethylene glycol 3350 (MIRALAX) (Lot #629541/1894H). There was no illness at the time of vaccination. On 12-DEC-2006 the patient experienced 10 lesions that were flat and maculopapular; one of two lesions were slightly vesicular. No fever was noted. The patient was examined again on 17-Dec-2006 and was observed to have approximately 25 lesions, some of which were vesicular. Unspecified medical attention was sought. The patient was treated with diphenhydramine (BENADRYL) and Aveeno Bath. The patient's lesions persisted. There were no lab studies performed. There was no other information to report. Follow-up information was received in which a nurse noted that the 10 lesions were located behind the ears, stomach, chin, and arm. The lesions were described as flat, red, macules with a "pimple-like center;" one or two appeared to be slightly vesicular. There was no illness at the time of vaccination. On 17-DEC-2006, the patient recovered. No additional information is expected.
sore throat; sniffles; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 31 year-old male patient received bnt162b2 (BNT162B2) (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: OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; RHINORRHOEA (non-serious), outcome "unknown", described as "sniffles".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Maternal  exposure during pregnancy; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal  exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Family history included Cancer and Heart disease, unspecified. Concurrent medical conditions included Hypertension and Polycystic ovarian syndrome. Concomitant products included AMLODIPINE, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and LEVOFLOXACIN (LEVOFROXIN) for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 08-Dec-2020 and the estimated date of delivery was 23-Sep-2021. On 09-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal  exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  ninth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Outcome Pending. For foetus 1, The outcome was reported as Unknown. On 09-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal  exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2021, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The date of positive pregnancy test 18-Jan-2021 and ultrasound scan was done on 02-Feb-2021. The patient has an established prenatal care. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Feb-2021: Internal review on 21-Jul-2021 resulted in update of pregnancy details.
1. Eyes felt swollen, ached sensitivity to light 2. Chills 3. Body aches  4. Fever 100.6 5. General malaise 6. Tiredness 7. Injection site red, hot and swollen to tennis ball size
10 minutes after the administration of the vaccine, the patient complained that she felt very hot.  She was visibly flushed and diaphoretic.  She developed nausea.  At 1532, BP 142/94, P88 and O2 sat 100%.  She was given cold water to drink and monitored. At 1540 BP 144/93.  Applied cool compresses to forehead and neck.  Patient continued to drink cold water.  Continued to monitor patient. No further nausea.  At 1555 BP 135/87.  Stated that she felt much better but still felt a little off.  No longer flushed or hot, no longer diaphoretic.  At 1604, stated feeling even better.  BP 119/87.   Walked around a bit with patient and she stated she felt ok.  No further symptoms.  At no time did she have any rash or respiratory issues.