chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In November 2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product was reported. No treatment information was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's causality for the event with Humira was no reasonable possibility. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns a 59-years-old male patient, with concurrent medical condition of Rheumatoid arthritis treated with ADALIMUMAB (HUMIRA), who experienced the unexpected non serious AESI of COVID-19, that occurred in context to a dose with mRNA-1273 vaccine. SARS-CoV-2 test was Positive as on unspecified date. No further information on risk factors, co morbidities and treatment was available in the report. The event outcome was resolved. Non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis could be the risk factor for the event. Ongoing COVID-19 pandemic could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness was assessed as per medical judgement and available information.; Sender's Comments: This spontaneous case concerns a 59-years-old male patient, with concurrent medical condition of Rheumatoid arthritis treated with ADALIMUMAB (HUMIRA), who experienced the unexpected non serious AESI of COVID-19, that occurred in context to a dose with mRNA-1273 vaccine. SARS-CoV-2 test was Positive as on unspecified date. No further information on risk factors, co morbidities and treatment was available in the report. The event outcome was resolved. Non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis could be the risk factor for the event. Ongoing COVID-19 pandemic could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness was assessed as per medical judgement and available information.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapies were not reported. On 02-FEB-2023, the patient was vaccinated with PROQUAD subcutaneous injection (0.5 ml, lot #W019626, expiration date: 19-DEC-2023, therapy type: rHA) administered for prophylaxis (strength and route of administration were not provided) after a temperature excursion (product storage error). The vaccine was exposed to minus 11.9 degrees Celsius for an unknown time frame. There was also previous excursion. No additional adverse event was reported (no adverse event).
Patient passed out immediately after shot given, patient came to within 10 to 15 seconds, pale in color and incoherent at first. Cold compress applied to neck and forehead.  patient passed out second time after 1 to 2 minutes and EMS contacted. Patient came to within 10 to 15 seconds and still very incoherent. patient was laid down flat on back with cold compress. EMS arrived ,  pulse no other vitals taken EMS determined patient was ok to leave after approximately 30 minutes. Patient refused any further treatment.
Around three on the following day I began to feel a tingling sensation in my legs and was extremely cold. A coworker recommended I got my temperature checked and it was 100.4. At it height my fever was 101.6.
Mother states received MMR/DPT on 9/16 at Health Dept. Rash noted 9/22. Temp 101.8 9/26.
Received the Moderna booster on 11/29/2021 after previously receiving the Johnson & Johnson 1 shot Covid19 vaccine 4/11/2021 (had no adverse symptoms to J&J 1 shot). After the Moderna booster 11/29, I had a headache, fatigue and arm soreness at the injection site but no other symptoms. By 12/1/2021, I noticed a rash developing on my left side of my body, the side I also had received the Moderna booster. The rash was on my left side torso and some of my back on the left side. I am 30 years old and otherwise healthy so I was not sure if it was just an allergy to the booster. Over the next few days, the rash got progressively worse, blistering and causing pain. I was diagnosed on 12/5/2021 with shingles. I was prescribed an antiviral pill to help recovery over the next week. I was advised to avoid others and my workplace for 1 week.
Since my second shot on February 19, I have started sleeping more and more.  I am sleeping from 14 to 18 hours a day and could sleep more if I didn't force myself to get up.  No other symptoms just extreme fatigue
Lump in left leg with bruising. 10 mm by 10 mm bruise.
Almost immediately after the vaccine on  1/23/2021, the patient started having what she described as little "flutters" on her L side (patient states she usually she gets them in her chest) this time on the  left side, almost like a "strike" = per patient like a painful electric shock down her side. Worsened and on 1/9/2022 taken to the ED. Exam there showed tenderness at mid sternum. XR was normal and an EKG was normal. In the ED, the patient reported the episodes stopped. Thought likely some component of costochondritis. Told to f/u with cardiology.   Seen by Cardiology;  on exam had reproduced left lower sternal border pain with palpation, no murmurs. EKG normal.  CXR was clear. Tested for COVID twice and negative, also flu negative.  Then after about a week she felt better and was cleared for physical activity. However, on 1/29/2022  during the second half of a field hockey game she began to "not play right", walking rather than running, experiencing vague dizziness and chest discomfort, and feeling as though her heart was beating kind of funny.  Over the next 20 minutes, these symptoms progressed. When she was taken out of the game to rest, she walked over to the shade because she was feeling weak and "really hot".  She was "not walking right", fell to the ground, but did not experience actual LOC, bodily injury, tongue biting or urinary incontinence.  She was picked up and placed on the nearby training table, where she remained awake but showed some delay in responding to questions.  Her mother noticed that she had perioral pallor at that time.  She was ultimately put in to an ambulance, and taken to the ED, where extensive testing was performed: negative thyroid function screen, D-dimer, sed rate, CRP, BNP, procalcitonin, CBC, BMP, total CK, and viral tests (Covid, flu, RSV). In addition, she had a negative chest x-ray and normal echocardiogram.  Initial serum troponin I was 0.09 ng/mL (upper limit of normal in that facility was 0.05 ng/mL) - trending showed drop in troponin to 0.03 and then <0.03 by the next morning.  She was observed in the ICU, and had a benign exam and ECG tracings.  It was recommended that she follow-up with cardiology after discharge. Afterwards she still continues to have symptoms of "fluttering" in her chest (longstanding), but to date no other symptoms.  A followup troponin and CRP on 2/14/2022 were normal.  Cardiology thoughts: Numerous published reports re: mild transient serum troponin elevation in exercising individuals, seems to reflect normal physiological response rather than pathological process. Considering evaluation for rare congenital coronary artery anomalies with chest CT angio.
Started 1/4/22 with itching hive-like rash on neck that progressed to bilateral arms and hands. 1/6/22 Rash progressed to legs with new onset joint pain in ankles, knees, wrists, and fingers bilaterally. 1/6/22 Temp max of 99.6.
Patient came to the pharmacy around 4 pm on 4/25. His left upper arm was red, swollen, and hot to the touch above the elbow. He stated that this started in the evening of 4/23 after his vaccination. I suggested he go to urgent care. He came back around 5:30 with scripts for an antibiotic and steroid. He was diagnosed with cellulitis and told to go to the ER if no improvement.
This spontaneous case was reported by a patient and describes the occurrence of PAIN (Pain), INSOMNIA (cannot sleep because it's itching), HYPERHIDROSIS (sometimes break out in a sweat for no reason, like it's raining), ILLNESS (I'm angry of being sick for 2 years) and BACTERIAL INFECTION (I had bacterial infection and HPV) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Pain), INSOMNIA (cannot sleep because it's itching), HYPERHIDROSIS (sometimes break out in a sweat for no reason, like it's raining), ILLNESS (I'm angry of being sick for 2 years), BACTERIAL INFECTION (I had bacterial infection and HPV), PAPILLOMA VIRAL INFECTION (I had bacterial infection and HPV), RASH (she has a rash on her chest, lower back, feet, and back of her legs, experiences pain with the rash) and RASH PRURITIC (she has a rash on her chest, lower back, feet, and back of her legs that continually itches, itching comes and goes). At the time of the report, PAIN (Pain), INSOMNIA (cannot sleep because it's itching), HYPERHIDROSIS (sometimes break out in a sweat for no reason, like it's raining), ILLNESS (I'm angry of being sick for 2 years), RASH (she has a rash on her chest, lower back, feet, and back of her legs, experiences pain with the rash) and RASH PRURITIC (she has a rash on her chest, lower back, feet, and back of her legs that continually itches, itching comes and goes) outcome was unknown and BACTERIAL INFECTION (I had bacterial infection and HPV) and PAPILLOMA VIRAL INFECTION (I had bacterial infection and HPV) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Bacterial test: positive (Positive) Positive and negative (Negative) negative. On an unknown date, Human papilloma virus test: positive (Positive) Positive and negative (Negative) negative. No concomitant medication was reported. This day the patient has a rash on her chest, lower back, feet, and back of her legs that continually itches. The patient also experiences pain with the rash. The patient cannot sleep properly because the patient was always itchy. The itching comes and goes. The patient sometimes breaks out in a sweat for no reason, like it's raining. The patient knows this was all due to the Moderna vaccine she received. The patient was extremely angry of being sick for 2 years now. The patient was in perfect health before got the Moderna vaccine. The patient had been to 3 different doctors for symptoms and no one had been able to help. The patient had been asked by HCP to see an allergist but the patient refuses to see an allergist because the patient knows this was due to the Moderna vaccine. No treatment medication was reported. Reporter did not allow further contact
Presented to Medical Clinic on 3/17/08 with c/o knot to lower right shin times one week. MD evaluated. 4-5cm lump on medial aspect of right tibia. MD believes associated with smallpox vaccination.
Severe head pain at base of skull with vomiting. Then severe back pain which led to transverse myelitis. Flown to hospital on 11/23. Diagnosed with Neuro Myelitis Optica.
Presyncopal episode with nausea, flushing, lightheadedness, need to defecate
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX subcutaneous (lot, dose, strength, site of administration not reported). On an unknown date the patient experienced knot, forming at the injection site immediately after receiving ZOSTAVAX. The knot was described further as a harder nodule, than normal, which lasted a day or two, and resolved in two or three days (date of recovery not reported). The relatedness between knot and ZOSTAVAX was not reported. This is one of several reports from the same source. Additional information has been requested.
Patient presented to pharmacy approx 72 hours after vaccine was given. Her injection site and surrounding arm was red & swollen and pt said it was itching (redness extended around site in a circle about 5 in in diameter). Pt was referred to PCP who diagnosed a skin infection and treated her with a 10 day course of doxycycline.
Initial information received on 08-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 71 years old male patient who was administered a 0.5 ml 2/3rd dose from the physician and needle was too tight and came off during injection of FLUZONE HD, while he received vaccine FLUZONE HIGH DOSE (Batch number: UJ029AA, expiration date: 02-May-2019, site of administration was right deltoid and route was unknown) on an unknown date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to underdose (physician administered 2/3rd of FLUZONE HD) and needle issue (needle was too tight and came off during injection of FLUZONE HD). It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
6mo old child came to health department for immunizations. Was inadvertently given FLUARIX 0.5ml (3yr and up) instead of Hep B, 0.5 ml. Packaging colors are similar. Child had left the office - event was discovered while entering data in electronic record. Incident was reported to the state immunization program. Mother was notified and advised to observe child closely, give TYLENOL q4hrs for 24-48 hours, contact pediatrician/take child to the emergency room for any other adverse events. Since it is late in the flu season, my action was to move flu vaccine stock to the back of the refrigerator to prevent further incidents.
Patient came seeking 3rd dose of Hepatitis B to complete the series 3/3.  I gave patient 1 pediatric Hepatitis Engerix-B Lot 333m4 IM in error to LD at 2:30PM . I called Immunization Consultant who directed me to administer 1 additional pediatric  Hepatitis Engerix-B 333m4 dose to complete citing 2 pediatric doses would total 1 adult dose equivalant vaccine dose.  I administered 1 additional  Hepatitis Engerix-B Lot 333m4 to RD at 2:45PM to complete this dose. Patient tolerated both vaccines well without any symptoms or reactions.
Shot received 4/29/05 AM, AM on 4/30/05 Sore RD arm at injection site and right under arm, lymph node enlarged size of egg. Pain a 9 on 1-10 scale. Cold compresses 4/30 on both sites and took Darvocet 100 Sat 4/30 PM to sleep. 5/1/05 used warm compresses to both sites. Today 5/2 site slightly tender and normal size at lymph site.
Radiating heat all over body.  Sweats with 99.8 fever.  horrible pain in all joints especially back.  extreme thirst.  brown urine.  head ache. All began around 2am on Saturday and the most severe lasted until approximately 7am.  From 7am to 8pm was able to start advil and tylenol rotation which helped stop the joint pain and the radiating heat.  the sweats continued along with the thirst.
This spontaneous report as received from Medical Assistant refers to a 2 day old female patient. On 11-JAN-2013 the patient was vaccinated with RECOMBIVAX HB dose 1. The reporter noticed the Hepatitis B vaccine (recombinant) (manufacturer unknown) syringe was leaking of the patient as the first dose was administered. On 19-MAR-2013 the patient received second dose of RECOMBIVAX HB at the physician's office with no issues reported. The reporter stated she noticed the RECOMBIVAX HB lot # reported as J007329 exp date: 27-MAR-2013 syringe was leaking into the thigh of the patient as she was administering the third dose of patient on 30-OCT-2013. A PQC was filed. No additional dose was administered. The reporter stated the physician, planned to do titer testing when the patient would be two-years-old. No AE symptoms were reported. The patient did not seek medical attention. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Leg pain), VISION BLURRED (Blurred vision in my left eye lasted 15 minutes), NECK PAIN (Neck pain), ARTHRALGIA (Shoulder pain) and MYALGIA (muscles in the back of my thighs and neck started to ache) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 012L20A) for COVID-19 vaccination. Concurrent medical conditions included Atrial fibrillation since 2014 and Thyroid disorder since 1997. Concomitant products included DRONEDARONE HYDROCHLORIDE (MULTAQ) from an unknown date to 06-Jun-2021 and WARFARIN from an unknown date to 06-Jun-2021 for Atrial fibrillation, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, RIVAROXABAN (XARELTO) for an unknown indication. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Leg pain), VISION BLURRED (Blurred vision in my left eye lasted 15 minutes), NECK PAIN (Neck pain), ARTHRALGIA (Shoulder pain) and MYALGIA (muscles in the back of my thighs and neck  started to ache). The patient was treated with PREDNISONE at a dose of 40 mg once a day; GABAPENTIN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Leg pain), VISION BLURRED (Blurred vision in my left eye lasted 15 minutes), NECK PAIN (Neck pain), ARTHRALGIA (Shoulder pain) and MYALGIA (muscles in the back of my thighs and neck started to ache) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Blurred vision worse everyday. Prednisone stopped the pain but came back at once. The patient did not have anything like those before. Most recent FOLLOW-UP information incorporated above includes: On 01-Aug-2021: Follow-up information included no new information. On 04-Aug-2021: As reported events term and details of concomitant medications and treatment medication were updated. Current condition, vaccine facility information, additional concomitant medication, second dose information and lab tests were added. Event description was updated.
left thumb and finger tips went numb and palm became tingly.  lasted 2 hours.  a few hours later I noticed purple spots on my middle fingertip.  the purple spots looked like broken blood vessels or pin pricks.  gone by the next morning.  Chills and diarrhea that evening for 1-2 hours.    6 days later a warm, red itchy hive like area showed up near the injection site.
Approximately 5 minutes after receiving the HPV vaccination, patient passed out and experienced involuntary jerking of arms and hands for about 20 - 30 seconds.  After regaining consciousness she felt sleepy and "mentally foggy" for about 30 minutes.
Pt experienced dizziness, feeling light-headed, and numbness, and tingling in L arm, face, and BIL LE within 15 minutes of vaccine administration. Pt BP and HR were elevated for approximately 30 minutes after administration as well.
On Thursday,  January 14th at approximately 7PM at night, noticed left arm was red, swollen, and hot to touch at the injection site. Called doctor January 15, and was seen in doctors office at 11AM.   Doctor stated that it was cellulitis and prescribed Cephalexin 500 mg/ 3 times per day until finished.  Still taking the antibiotic.  Spoke to another woman at employment who had the vaccine the same day , 15 minutes before me.
This is in follow-up to report(s) previously submitted on 7/8/2008; 10/8/2008. Initial and follow up information has been received from a registered nurse through the Merck Pregnancy Registry concerning a 16 year old female with atypical squamous cells of undetermined significance (ASCUS) and human papillomavirus (HPV) positive seen on atypical pap smear with high risk human papillomavirus prior to vaccination on 28-FEB-2008, who on 28-APR-2008 was vaccinated intramuscularly in the left deltoid with GARDASIL vaccine (lot # 660387/1967U). There was no concomitant medication. The nurse reported that the patient is now pregnant and no problems were reported. The reporter also noted that the patient had an ultrasound and a blood pregnancy test (results not reported). The patient's last menstrual period was 07-APR-2008 with an estimated delivery date of 12-JAN-2009. The patient sought medical attention for pregnancy follow up. On 30-MAY-2008, the patient underwent an ultrasound to verify delivery date. Results showed an estimated delivery date of 21-JAN-2009 which differed by 9 days from the LMP which was 07-APR-2008. The nurse reported that on 10-JUN-2008 the patient was treated with MACROBID 100mg BID x 7 days for urinary tract infection. No other information was reported. Follow up information received from a registered nurse who reported that complications during pregnancy included pylonephritis. Medications during pregnancy included MACROBID 100 mg twice a day started on 10-JUN-2008 for seven days also started on 10-NOV-2008 (dose and duration not provided), MACRODANTIN 50 mg daily started on 21-NOV-2008, and TERBUTALIN every four hours started on 07-NOV-2008 for preterm labor. The baby was born 22-DEC-2008, 36 weeks from LMP, female 5 pounds 14 ounces, 18 inches tall. Infant was born normal with no congenital anomalies. Complications include a preterm labor and preterm delivery at 35 6/7 weeks. Additional information considered important in relation to the outcome of this pregnancy include, inadequate weight gain of the patient, smoking and teen pregnancy. Baby was considered small for gestational age. No further information is available.
I got the covid-19 vaccine on January 4th, 2021 at 8:00a.m. after 5 or 10 min later my right side of my lips up and down started getting numb for around 5 min. The same day around 1:30pm. all my mouth and tongue started getting numb again, my throat dried to the point that made me vomit. This time numbness was for around 50min. to an hour.
Moderna Monovalent was given on September 1, 2022 before the nurse was notified of the change in booster doses. There were 10 patients seen that day and no adverse reactions have been reported.
Vaccine expired 2 weeks ago (5/25/21) and was given today (6/7/21)
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: RED, INFLAMMED, WARM TO TOUCH, 4 INCH DIAMMETER RASH EXTENDING OVER BICEPS AREA OF LEFT ARM