chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (side effects) and SUSPECTED COVID-19 (wondering if it could be Covid) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects) and SUSPECTED COVID-19 (wondering if it could be Covid). At the time of the report, VACCINATION COMPLICATION (side effects) and SUSPECTED COVID-19 (wondering if it could be Covid) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter. Sender's Comments: This case concerns a patient (demographics not provided) with no relevant medical history, who experienced the unexpected Non-serious AESI event of suspected COVID-19 and vaccination complication (side effects). The events occurred at unspecified interval after the booster dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable as events occurred after a booster dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.
Patient got super sweaty and heart racing and after we got a cold towel and water on his forehead, he threw up in the trash can. Paramedics came and took his vital and he was fine after.
She got her vaccine, her arm was swollen, couldn't move it.  Woke up the next morning with cold chills, achy body, fever to 101, headache.  She had all the symptoms other than the diarrhea with it. She took some Ibuprofen and then she put a cold washrag on her head.  It went away again and then went to town and came back and felt sick again, and came back and checked her temperature and her fever was still running high at 101 again.  This went on throughout that day and finally broke and went away.  By the following evening all of the symptoms went away.  The arm continued to be swollen and sore, so sore that she could not touch it to take off the band-aide so left it on until the 3rd day.  After the 3rd day she was feeling better.  She is now back to her previous health .   She has an APT with her PCP this Friday, first appointment, and she will mention that she had side effects to the vaccine.
nerve damage on one; Loosing balance/ not walking normal/ wobbling from side to side was trying to be sturdy but could not walk/ would not stand up; numbness; tingling of the feet/ sensation on the feet/ sensation on right leg from foot to ankle and it went to the left leg it got worse got to the calf (expanding and contracting) upto the thighs; This serious case was reported by a consumer via call center representative and described the occurrence of peripheral nerve injury in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (on an unknown date received 1st dose  No issues with Dose 1).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced peripheral nerve injury (Verbatim: nerve damage on one) (serious criteria GSK medically significant), balance difficulty (Verbatim: Loosing balance/ not walking normal/ wobbling from side to side was trying to be sturdy but could not walk/ would not stand up), numbness in feet (Verbatim: numbness) and tingling of extremity (Verbatim: tingling of the feet/ sensation on the feet/ sensation on right leg from foot to ankle and it went to the left leg it got worse got to the calf (expanding and contracting) upto the thighs). The outcome of the peripheral nerve injury, balance difficulty and numbness in feet were unknown and the outcome of the tingling of extremity was not resolved.   It was unknown if the reporter considered the peripheral nerve injury, balance difficulty, numbness in feet and tingling of extremity to be related to Shingrix.     It was unknown if the company considered the peripheral nerve injury, balance difficulty, numbness in feet and tingling of extremity to be related to Shingrix.   Additional Information: GSK receipt date: 14-NOV-2023 The patient reported that he received 2nd dose of Shingrix in the month of September or October and 20 minutes to half an hour of the shot at the grocery store he felt a sensation on the feet, loosing balance, numbness, as if its going to sleep, was not walking normal.  On Saturday same symptoms during the day so sat and relaxed.  On Thursday while walking he had sensation on right leg from foot to ankle and it went to the left leg it got worse got to the calf (expanding and contracting) upto the thighs.  Try to put foot down would not stand up with use of cane was woobling from side to side was trying to be sturdy but could not walk.  Next day called physician send to therapist got MRI found nerve damage on one other 2 are ok.  No probelm with upper body only lower body.  As if now (at the time of reporting) still had tingling of the feet and getting acclimated to it.  The patient had no issues with Dose 1. The reporter consented to follow up.
CDC failed to notify organizations that they are officially unauthorizing bivalent until the approval announcement on the 12th. Bivalent were given on the 12th bc of the lack of such communication.
3/9, admitted day after covid vaccine with new onset afib. Presented to ED with atrial arrhythmia and it was determined that it was not atrial fibrillation.  Initially the patient was managed on the line of atrial fibrillation and heart rate was controlled and he converted to sinus rhythm. He was started on anticoagulation but later on anticoagulant was discontinued by cardiology because it was not typical atrial fibrillation. Echo was done. Because of low ejection fraction and global hypokinesia, Patient underwent cardiac catheterization. Advised him to follow-up with doctor.
Vaccine was administered after being stored on the refrigerator for more than 30 days; expired dose administered; ear infection today; This spontaneous case was reported by an other health care professional and describes the occurrence of EAR INFECTION (ear infection today), EXPIRED PRODUCT ADMINISTERED (expired dose administered) and PRODUCT STORAGE ERROR (Vaccine was administered after being stored on the refrigerator for more than 30 days) in a 1-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 vaccination. Patient do not have any allergies(medications, food and other products), patient had no Medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination, Patient never had COVID positive test or diagnosis and no other vaccines given within one month prior to Moderna COVID-19 vaccine. On 25-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In July 2022, the patient experienced EAR INFECTION (ear infection today). On 25-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was administered after being stored on the refrigerator for more than 30 days). The patient was treated with AMOXICILLIN for Ear infection, at a dose of 1 dosage form. At the time of the report, EAR INFECTION (ear infection today), EXPIRED PRODUCT ADMINISTERED (expired dose administered) and PRODUCT STORAGE ERROR (Vaccine was administered after being stored on the refrigerator for more than 30 days) 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. It was reported as one dose of the vaccine was administered after being stored on the refrigerator for more than 30 days. Patient did not experience any symptoms but today patient experienced ear infection and prescribed amoxicillin, after the administration of the vaccine. It was also reported that AE cause patient to seek ( medical care office visit, Urgent care, ER, hospitalized) and patient did not experienced a similar event in the past. No concomitant information were reported by the reporter.
Starting the day after, patient describes the start of symptoms as radiating shoulder pain ranging from neck to wrist. She described herself as feeling very weak, having 0 appetite, and experiencing fatigue, She then describes herself as having slept mostly for the next 2 days. Ultimately, she described the overall experience as feeling "drugged".
patient experienced transient tingling of lips shortly after vaccine administration (within 15 minutes but could not specify exact time after). Symptoms resolved on its own within 10 minutes of reporting to us (pharmacists). Declined oral diphenhydramine at time of reporting to us but said she would let us know if she had any changes. No further adverse events or symptoms returning >2 hours after initial report.
Significant flu like symptoms: fever, chills, body aches, head ache for 36 hours and four inch diameter circle around the injection site, raised, red, and hot with shoulder (injection site) very sore to touch.
Information has been received from a health professional concerning a 9 yr old male who on 27Apr98 was vaccinated with a 0.5ml dose of varicella virus vaccine live (lot 7160E). Two days ago, on 10May05, the pt experienced breakthrough chickenpox with about 50 lesions. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information from a health professional indicated that on 10May05 the pt experienced mild upper respiratory infection symptoms and multiple scattered lesions in different stages of eruption over his entire body. It was reported that the pt recovered. Additional information is not expected.
PT said he awoke on Monday and his left side of face was twitching under eye .  It proceeded to continue all day   I told him to report to CDC -vsafe and I would report to VAERS.  HE should see a doctor, but he does not have a family physician. I told him to see a walk in clinic to establish baseline
STEMI heart attack; This is a spontaneous report received from contactable reporter (Consumer or other non HCP).  A 68-year-old male patient received BNT162b2 (BNT162B2), on 30Jun2022 at 14:00 as dose 4 (booster), single (Lot number: FM0173) at the age of 68 years, in left arm for covid-19 immunisation; atorvastatin calcium (LIPITOR), (Batch/Lot number: unknown) at low dose. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (1st vaccine 27Dec2020 Lot - unknown. Injected in left arm.), administration date: 27Dec2020, when the patient was 66-year-old, for Covid-19 immunization, reaction(s): "Covid-19"; BNT162b2 (2nd vaccine given on 20Jan2021, Lot EL9262, or EL9161 Expiration is unknown. Injected Left arm. ), administration date: 20Jan2021, when the patient was 66-year-old, for Covid-19 immunization, reaction(s): "Covid-19"; BNT162b2 (3rd dose , 1st booster, given on 09Oct2021 Lot FF8839 expiration of 31Dec2021, injected in left arm.), administration date: 09Oct2021, when the patient was 67-year-old, for Covid-19 immunization, reaction(s): "Covid-19". The following information was reported: ACUTE MYOCARDIAL INFARCTION (hospitalization) with onset 16Jul2022, outcome "recovered with sequelae", described as "STEMI heart attack". The patient was hospitalized for acute myocardial infarction (start date: 16Jul2022). The event "stemi heart attack" required emergency room visit. The patient underwent the following laboratory tests and procedures: Lab Test: (Apr2022) Normal. The action taken for atorvastatin calcium was unknown.  Additional information: On 16Jul2022, he had a STEMI heart attack. He survived that.  He had a complete blockage of LAD and has no prior history of heart disease. He survived because his collateral arteries were so good. He had no sign of heart disease. Is not hypertensive, and is on a low dose of Lipitor. Outcome: Recovered with lasting effects and it is somewhat unknown. An item of both. He was working for his former employer and this occurred on an airplane and he is pulmonary critical care. It depends on his heart remodels and his Ejection fraction and he is compromised.  Procedure was that he had a stent placed in his LAD and it was on 16Jul2022.  Reason why reporting is they had friend who was a gastroenterologist who had a cardiac event after receiving the COVID vaccine. She does not know if he reported. Neither one of them had any heart issues. He said that should not have happened to me.  She did not wish to complete report for him.
Child received vaccines at HD. According to mother received DPT, IPV & Prevnar. Onset vomiting that evening. Contacted me, pediatrician, by phone next day at 11:30am. Placed on clear liquids and improved. Contacted office after hour at 12:30 pm on Sunday, 08/04/02, stating child vomiting intermittently was lethargic and looking yellow. Child seen in ER. He was seen by pediatric Gastroenterologist on 08/07/02 with a diagnosis of transient hepatitis of unknown etiology. Liver enzymes will repeated next week and ultrasound of liver as well
Extreme fatigue and weakness Sinus pain Back pain Abdominal discomfort  Spent 26 hours in bed
dilution was with 2 ml for whole vial, dose injected was 0.27 ml
Severe swelling spreading from deltoid to elbow.  no fever.  normal range of motion.  Reaction site resolved after 24 hours.  Parents and I have pictures
sharp pain; Developed swelling on both arms on elbow joints and on knee joints.; Developed swelling on both arms on elbow joints and on knee joints.; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: SMPHO ER2613) via an unspecified route of administration in the right arm on 25Mar2021 at 10:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and asthma. The patient had a history of allergy to penicillin and sulfa drugs. The patient received other medications (unspecified) within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: SMPHO EN6202) via an unspecified route of administration in the left arm on 02Mar2021 at 11:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 at 11:30, the patient had experienced swelling of both arms, elbow joints, knee joints and at 16:30 (after 06 hours of vaccination), she had experienced sharp pain which ran through the right side of the body. The patient did not receive any treatment for the adverse events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events developed swelling on both arms on elbow joints and on knee joints and sharp pain was unknown at the time of report.  No follow-up attempts are needed. No further information is expected.
This case was reported by a nurse practitioner and describes the occurrence of vertigo in a 56 year old male who received Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. The pt's medical history included rheumatoid arthritis, atherosclerosis, and hypertension. Surgical history included coronary artery bypass grafting. Concurrent medications were not reported. The pt received injections of LYMErix on 4/9/99, 5/13/99, 6/17/99 and 6/12/00. This represents a schedule of 0, 1, 2 and 14 months rather than the recommended schedule of 0, 1, and 12 months. On 6/13/02, approximately two years after the fourth dose of LYMErix, the pt began to experience vertigo which was considered disabling by the reporter. The event was unresolved. The nurse practitioner considered the vertigo to be possibly related to vaccination with LYMErix. She also reported that there was "no identifiable cause yet." Information from Annual Follow-up report states reporters no longer available and contact number/addres. No further information.
Pt stated that she received the vaccine on 02/03/2021 and started having a fever, headache, chest pain and heaviness in her left arm on 02/06/2021. She stated that she felt better by 02/09/2021. Pt was seen in the office on 02/09/2021 and she was feeling much better. Patient also stated three to four days after vaccine her left arm turn red and was hot to the touch that lasted about 4 days.
Hives, itching, starting night of vaccine and persisting to time of presentation. No systemic symptoms otherwise.
p/vax devel swollen rt arm & had trouble moving the arm; w/pressure arm would give out; lightheaded; felt as if taken muscle relaxant; legs & arms weak; 3/25 devel head congestion; sore throat;3/26-2''x2'' red rash at inj site;condition ong
Numbness and swelling to right side of face. Patient cannot smile on the right side. No pain. This started a little over 1 month after third dose (booster) of Moderna Covid vaccine.
Administered vaccine 10-31-11, sx developed on 11/4/11 burning pain at inj site, intermittent pain per patient. Felt "like a branding sensation going into the muscle". Tx - recommended APAP - call MD especially if sx linger or increase. Complaint made 11/8/11. Localized only sx in left arm.
After about 15H after the vaccine I strayed to feel very tired and started having severe body aches, chills, sweating  and my teeth were hurting.  By 2pm I had 102.5F /103F which lasted all day. At 1am I was in unbearable body ache  and 103F  that I took Tylenol  and finally got some relief.  The following morning I felt better still with 100F and body aches but better.
administration of Arexvy to a patient a portion of the vaccine sprayed out so, an incomplete dose was given; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 64-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 7K545, expiry date 22-OCT-2024) for prophylaxis.   On 16-SEP-2023, the patient received Arexvy. On 16-SEP-2023, an unknown time after receiving Arexvy, the patient experienced incomplete dose administered (Verbatim: administration of Arexvy to a patient a portion of the vaccine sprayed out so, an incomplete dose was given).  The outcome of the incomplete dose administered was unknown.   Additional Information: GSK receipt date: 19-Sept-2023 The pharmacist asked for recommendations on this situation. The reporter consented to follow-up. During the process of administration of Arexvy to a patient a portion of the vaccine sprayed out so, an incomplete dose was given, which led to incomplete dose administered.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-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-Nov-2020 and the estimated date of delivery was 08-Aug-2021. On 03-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twelfth week of the pregnancy.  On 03-Feb-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided .
Pt appeared OK day of shot on 9/23/03. Arm was red when went to school. Teacher informed mother at 11:15 AM that pt was "pale and had thrown up". Pt's arm left was swollen "baseball size" and bright red. Mother denies fever, rash, respiratory difficulties.
p/vax pt joints hurt upon waking in the morning; pt stated pain was not unbearable;
2 days after vaccination at DPH on 7/11/06 Child developed redness 3 inches from shoulder down and around 2 inches across the width of the arm. Saw Dr. who thinks that could be due to contaminated needle or the vaccine. Dr. prescribed Augmentin 400mg BID for 5 days.
3rd dose; some arm pain that occurred at injection site.; slightly light headed right after the vaccine in the first 20 minutes; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 45 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 30Nov2021 14:00 (Batch/Lot number: unknown) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: Mar2021, when the patient was 44 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: Mar2021, when the patient was 44 years old, for COVID-19 immunization. The following information was reported IMMUNISATION (non-serious) with onset 30Nov2021 14:00, outcome unknown; VACCINATION SITE PAIN (non-serious) with onset 30Nov2021, outcome recovering; DIZZINESS (non-serious) with onset 30Nov2021, outcome recovered (30Nov2021). Therapeutic measures were not taken as a result of vaccination site pain, dizziness.  The reporter stated that the person had some arm pain that occurred at injection site. Sounds mild-moderate. persisted mild the morning after. Also felt slightly lightheaded right after the vaccine in the first 20 minutes, and that dissipated. The patient had no known allergies and other medical history. The patient had no COVID prior vaccination and not tested for COVID post vaccination. No other vaccine in four weeks and no other medications in two weeks prior to dose 3 (booster).  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Symptoms started the night that I took the vaccination. I got it around 4:00 pm. About a few hours later I was experiencing sweating and high heart rate. I was dizzy and had a fever.
Patient was reported to us by Public Health to be 4 years of age on 05/02/2022. Her DOB on Vaccine Card this day was. Patient had immunization at our facility on 03/28/2022, where forms were completed by mother and DOB was listed, making the patient 5 years of age already. Since no form of ID could be produced we had no choice but to accept the age. It is not clear if the age is 4 or 5, but the forms that were filled out and scanned into our charts were within the age limits for vaccination. We wanted to report this event as it was not clear and we have not been able to reach the patient at the provided numbers.
4 hours after receiving PENTACEL in (L) thigh, area became red, swollen, warm, hard intradermal mass, severe irritability.