chrisvoncsefalvay/vaers-outcomes huggingface dataset:
on going lightheadedness; on going headache; on going fatigue; ongoing slight nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (on going lightheadedness), HEADACHE (on going headache), FATIGUE (on going fatigue) and NAUSEA (ongoing slight nausea) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 018L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced DIZZINESS (on going lightheadedness), HEADACHE (on going headache), FATIGUE (on going fatigue) and NAUSEA (ongoing slight nausea). At the time of the report, DIZZINESS (on going lightheadedness), HEADACHE (on going headache), FATIGUE (on going fatigue) and NAUSEA (ongoing slight nausea) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable.  Concomitant product use was not provided by the reporter. Treatment information was not provided.
pt. has had 4 days of nausea with vomiting, fatigue, change in stool consistency.
Hot injection site; Itching at the injection site; Swelling at the injection site; Redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Hot injection site), INJECTION SITE PRURITUS (Itching at the injection site), INJECTION SITE SWELLING (Swelling at the injection site) and INJECTION SITE ERYTHEMA (Redness at the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 015M20A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced INJECTION SITE WARMTH (Hot injection site), INJECTION SITE PRURITUS (Itching at the injection site), INJECTION SITE SWELLING (Swelling at the injection site) and INJECTION SITE ERYTHEMA (Redness at the injection site). At the time of the report, INJECTION SITE WARMTH (Hot injection site), INJECTION SITE PRURITUS (Itching at the injection site), INJECTION SITE SWELLING (Swelling at the injection site) and INJECTION SITE ERYTHEMA (Redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
Left arm he will not use at all. Pt can move arm but is limited to how far he will move it. Both vertically and horizontally.
Initial report received from a healthcare professional on 18 April 2013. A 32-year-old female patient had received an intramuscular first dose of ADACEL vaccine (batch number: C4366AA, expiry date: 06/27/2015, site of administration was not reported) on 18 April 2013. The patient was pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. The patient's risk factors included obesity. The patient's last menstrual period date was 30 August 2012 and expected date of delivery was 06 June 2013. As of 19 April 2013, the patient didn't present any adverse event. Follow up information received from a healthcare professional on 19 August 2013. Father's age was unknown. The patient had received vaccine in the left deltoid. The patient had no risk factors (e.g.: alcohol, tobacco or recreational drugs), relevant ongoing illness, family history of congenital abnormality and concomitant medications. Father had no relevant ongoing illness. The mother had not received any drug during pregnancy or prior to fertilization that could remain present at the time of fertilization. The patient's prenatal tests were normal. The patient's body weight during pregnancy was 188 pounds and height 5'4'', while body weight at delivery was 239 pounds. The patient had not previous pregnancy. The pregnancy outcome details were as follows: on 11 June 2013, the patient gave birth to a male single baby weighing 3.37 (kg) without congenital abnormality and mode of delivery was C-section. The APGAR score at 1 min was 9 and at 5 min were 9. It was reported that there was no complication of labor/or delivery. The patient had not received any treatment for infertility. At the time of the report, the patient had not experienced any adverse events. List of documents held by the reported: None.
Woke up and face numb and worsened throughout day and by next day went to ER   on 2-9-2021and was diagnosed with Bell's Palsy.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Tinnitus-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient stated she felt ringing in the ear and darkening of vision within 5 minutes of vaccine administration. Patient felt better after drinking orange juice, and water. Patient was observed for total 30 minutes.
Severe ?COVID arm?, 2-3? red ring around injection site. Hot to the touch, firm bump, itchy
06/25- very bad bloody nose 06/26 armpit pain 06/27 extreme pain in both armpits, in neck and groin 06/28 very swollen glands in armpits, neck and groin  very painful joints - shoulders, elbows, wrists, knees and feet swollen, painful hands and finger joints 06/29 confusion, foggy thoughts 06/29 & 06/30 extreme incontrollable shaking, fever and chills 07/07 red rash spots on Right lower side of neck, upper right upper shoulder and chest 08/06/19- I still have sore shoulder and swollen sore fingers and hands
iT seemed on Tuesday the following week I had hive throughout my entire body. I went to the Doctor on 2/18/2021 and recieved a Steroid Shot, Steroid Pills, and also presciption benadryl.
itchy arm per patient, no visible redness or swelling, was given a 25mg diphenhydramine tablet for allergic reaction
Rash appeared in groin area; spread over 36 hours down right thigh to knee; itching; pain; round blistery rash.
Day 1: in bed all day, total effort to get up to use restroom, loss of appetite, total fatigue-slept most of day, shot site was red, warm and raised (site was size of 2 50 cent pieces). Day 2 same as Day 1. Day 3 both hips hurt and walked with effort but bent over. Did get dressed for part of day but stayed home. Day 4 not as much fatigue as I sat up some, hips still hurt and walked bent over, redness remains at injection site with swelling down some. If I walked any distance I had to sit down and catch my breath due to fatigue. Also these continued symptoms brought on frustration. Day 5 morning nap, walked with a cane due to hips hurting, redness at injection site remains, still tired and not doing much except sitting.
L leg limp, unable to walk on it, redness, water filled blister at sight, (L thigh) (varicella lesion)? Treatment-Dr visit-CBC, ESR drawn, Motrin for pain, re check leg next day 2/16/06
Client reports pain in left arm, starting at neck and extending to elbow.  Reports difficulty raising left arm.  Saw physician and has been taking anti-inflammatories and apply cold to site, had MRI done.
Per Patient, he developed facial droop approximately 12-13 days after receiving his first Pfizer COVID-19 vaccine.  He called his PCP at the VA, who advised him to present to the ER. Patient states that the ER ruled out stroke and diagnosed Bell's Palsy.  He was prescribed prednisone 20 mg TID x7 days and valcyclovir 1g q8 hours x7 days--he will take his last dose today. Patient stated he has been diagnosed with Bell's Palsy at least twice in the past, and sustained "some" nerve damage from a previous episode.
History of prior COVID19 infection in March 2021, mild symptoms. Vaccine #1 on 5/14/21, Vaccine #2 on 6/11/21. Acute onset chest pain/pressure on 6/13/21 in the early morning. Chest pain slowly improved throughout the day. Treated with NSAIDs and colchicine due to concern for myopericarditis.
Nausea, headache, light headedness...treated the symptoms. They appeared within 24 hours of the #1 vaccine. Declined, but reappeared with more discomfort 10-14 days after the #1 vaccine.   NOTE:  I was tested for antibodies in June 2020 and was positive for antibodies. Never was sick at all, but had traveled over a month internationally mid Feb - mid March 2020. Went on to donate convalescent plasma four times. My nurse practitioner & friends in the medical field shared info that suggest that my body was fighting vaccine #1 as is often the case for vaccine #2.
Systemic: Other- TONGUE, LIPS AND NECK NUMB AND TINGLING-Mild
Given 3 immunizations. Left arm with 2, developed redness and swelling on large area of vaccinated arm. MD was consulted. Prescribed antibiotics to take and home care treatment. Return if s/sx don't improve.
A very hard spot where the vaccination was given; Starting to itch a little bit; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a very hard spot where the vaccination was given and starting to itch a little bit.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, prior to the onset of the event a very hard spot where the vaccination was given the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) for prophylaxis of COVID-19 infection.  On an unknown date, the patient developed a very hard spot where the vaccination was given which was 4 inches long and 2 inches across. It was started to itch a little bit but it was a big lump in the muscle.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the events were unknown.; Reporter's Comments: This case concerns a female of unknown age who experienced nonserious unexpected events of Vaccination site mass and pruritus.  The events occurred with unknown latency after the first dose of mRNA-1273. Treatment not reported. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
2 cm red indurated area on right thigh (MMR site) within 5-10 min. 2 hours later began vomiting for 3 times & had confluent macular rash on lower extremities.
Papulovesicular lesions scattered on trunk, post scalp upper thighs, shoulders, very itchy. sitting on chair rubbing back on it to scratch.
I started to notice that I was having irritation around my eyes and they were crusty. They were itchy at times. I got a third dose of Moderna in March and that is when everything started to get worse with my eyes. I had to see an optometrist who prescribed medication, that was sulfa based, and it made things worse. She provided me with a different medication after that which has helped. I also noticed a rash up and down my arms.
severe pain and swelling in left lower leg. Diagnosed with 2  DVTs 3 days later in emergency room.
05/17/2022 - Slight runny nose /scratchy throat; performed an in home test which was positive                       Called Dr. who prescribed PAXLOVID. 05/19/2022 - Whent to Curative for another test which was positive                       Started PAXLOVID 5 day regime 05/23/2022 - Ended PAXLOVID 5 day regime       Have felt really great since Friday 05/19/2022. Took home test at 7:00 AM 05/24/2022 a very, very faint line was barely visible under the T.
Urticarial rash on face and neck after taking 2 of 4 caps. Rash developed on day 6 pt missed 3rd dose.
Reddened hot area approx 2" x 2" warm around injection site. Zyrtec x 5 days and ice to site.
Patient initially only received 0.5mL of pediatric Hep-B (Energix) vaccine, instead of 1mL dose of adult preparation Hep B vaccine.  Patient was later given additional 0.5mL of pediatric Hep-B vaccine to meet correct adult dose. Patient did not have any adverse events surrounding vaccinations.
The pt died approximately 36 hours after receiving the immunizations. Cause of death is unknown. Autopsy states the cause of death as pneumonia.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 11-FEB-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml, (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion was 24 hours with the lowest recorded temperature of -1 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
eight days after vaccine had a large 2" red, raised hot area at injection site.   Called  where I received vaccine and was advised to go to  ER.  They put me on  prednisone 50 mg  and Benadryl.    Has faded but still there.   Advised to still have second vaccine on Feb 8 but to take Benadryl  first.
Night vaccines were delivered. Patient complained of light headed and "weird". Woke next am with same feeling. Progressed to weakness in legs, stiffness in thighs, sore neck and sensation of touch had changed. Patient stated felt like entire body was "asleep". Patient seen in PCP office 1/6/10, had difficulty staying awake during exam. Increased lethargy and weakness while in office. Sent to ER. Patient was evaluated by neurology in ER with normal V/A, toxin screen, EKG, normal neurological exam. Patient given 1L IV fluid, improved and was discharged.
pt devel significant pain & erythema w/swelling @ inj site;devel syncope & brought to ER;orthostatic in ER-adm for observation given fluids, DPH, solumedrol;no wheezing, angioedema, etc;
The pt experienced swollen eyes, rash with welts from waist up. The feet were swollen redness to the left leg. ER administered Benadryl and Motrin.
Information has been received from a registered nurse concerning a 6 year old healthy female child who on 11/17/1998 was vaccinated with varicella virus vaccine live. On 01/04/2002 the child presented to her physician with a mild varicella rash. No treatment was ordered and the child received comfort measures only. At the time of this report, the outcome of the event was unknown. No further info is expected. The nurse also reported that a 5 year old male and a 7 yea old male developed varicella followng vaccination with varicela virus vaccine live (WAES0201USA02889 and 0201USA02891).
Pfizer Dose 1 3/24/21 (ER8732) Pfizer Dose 2 4/14/21 (EW0161) COVID Positive 1/24/22  1/20/22: 66-year-old male with recurrent GI bleeding from cecal AV malformation status post cauterization and Endoclip most recently January 5, 2022, heart failure with preserved ejection fraction, paroxysmal atrial fibrillation not on anticoagulation, coronary artery disease status post PTCA and stents most recently September 2021 LAD stent, DVT/PE status post IVC filter and COPD sent from nursing home for low hemoglobin.  Patient reports he was sent from the nursing home because his blood count was low, he is not sure how low.  Patient denies any coffee-ground emesis, hematemesis, melena or hematochezia.  In fact his last bowel movement was 1 week ago, has mild lower abdominal pain, no nausea or vomiting.  Denies any fever chills or rigors.  Patient had mild chest discomfort which is not shortness of breath is about the same no other complaints. In the emergency room patient was hypotensive with normal heart rate.  Initial hemoglobin was 7.9 recheck was 6.4 , sodium 132, potassium 2.8 normal WBC count.  Stool guaiac is negative and  BUN 13.  Abdominal CT showed large stool burden with  proctitis/stercoral colitis.  CT chest is negative for pulmonary embolism  or other acute abnormalities.  Patient is receiving 2 units of PRBC, received bolus of fluids and  Zosyn in the emergency room.  1/25/22: 66-year-old male with recurrent GI bleeding from cecal AV malformation status post cauterization and Endoclip most recently January 5, 2022, heart failure with preserved ejection fraction, paroxysmal atrial fibrillation not on anticoagulation, coronary artery disease status post PTCA and stents most recently September 2021 LAD stent, DVT/PE status post IVC filter and COPD sent from nursing home for low hemoglobin.   In the emergency room patient was hypotensive with normal heart rate.  Initial hemoglobin was 7.9 recheck was 6.4 , sodium 132, potassium 2.8 normal WBC count.  Stool guaiac is negative and  BUN 13. Abdominal CT showed large stool burden with proctitis/stercoral colitis.  CT chest is negative for pulmonary embolism  or other acute abnormalities.  Patient is received 2 units of PRBC on admission , received bolus of fluids and  Zosyn in the emergency room.   his hemoglobin has been stable with minimal fluctuation in the last 3 days.  Patient has multiple large bowel movements with improvement in his abdominal pain and tenderness  He  was treated with IV Zosyn that we  changed to oral Flagyl and levofloxacin today. The pt needs regular lactulose to move his bowels  and relieve chronic constipation  The patient will be discharged back to skilled nursing facility on oral antibiotics supplementation  He needs to follow with his PCP in 3-5 days of hospital discharge
It started at 9 pm with a  high pitch ringing in my ears that lasted for around 1 minute. Next, I got a fever of 104. My body temperature was changing: 104, 99, 98, 104, 103, etc.  Despite the fever, I felt a burst of energy followed by a heart rate of 180 beats per minute, palpitations. For the next few weeks, I was waking up with "fog" in my right eye.  Since I had the second dose of Moderna the ringing in my ears has not gone away, also I was diagnosed with SVT (I have never had any issues with my heart, no tachycardia tendency based on my few years of medical history).
Increasing redness, heat and swelling, similar to cellulitis in appearance, occurred 7 days post vaccination. In a span of 48 hrs, redness and swelling had increased past two circles drawn to mark spread. (pictures available upon request)
This spontaneous report was received from a pharmacist refers to a female patient of unknown age. The patient current conditions included high blood pressure and depression. On 03-JUN-2013 the patient was vaccinated with ZOSTAVAX (dose and frequency was not reported) lot # J000430 (Expiry: 10-APR-2014), subcutaneous. Concomitant therapies included SERTRALINE HYDROCHLORIDE, WARFARIN SODIUM and METOPROLOL. ON an unknown date, the patient experienced shingles on the neck. The patient sought medical attention and went to the physician office. On 11-FEB-2014, the patient was prescribed with hydrocodone/acetaminophen and VALTREX. It was reported that the patient has not yet started with these medications. The outcome of the event shingles on the neck was reported as not recovered. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to a multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies, drug reactions, allergies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II lot # M007279 with expiration date on 09-FEB-2019 and M011667 with expiration date on 08-MAR-2018 (dose and route of administration were not reported), reconstituted with properly stored sterile diluent (manufacturer unknown). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 9 degrees Celsius and 25 degrees Celsius for 19 minutes. A digital data logger was involved. There were no previous temperature excursions reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA009357.
The patient developed fatigue, malaise, skin allodynia, fever (103.5F) and took acetaminophen and ibuprofen. The fever resolved but he was diaphoretic. He also had a headache, vomiting, then lost consciousness overnight and had a tonic-clonic seizure lasting 10 minutes. He was brought to the emergency department and had 2 more seizures there which was controlled with lorazepam. He was admitted to the hospital and started on broad spectrum antibiotics (acyclovir, ceftriaxone, and vancomycin). On 4/11/21, the patient was extubated and improved symptomatically, and antibiotics were narrowed to doxycycline. He was then discharged on doxycycline and levetiracetam.
Pt states soreness on date of vaccination on 12/17/2018. Pt had a physical fitness test on 12/17/2018 in the afternoon time. Pt went to Urgent Care for body pain. Pt prescribed Meloxicam as well muscle relaxer which pt took later that evening. 12/18/2018 pt noticed when she came home from work the right arm was still sore and had developed redness at injection site. Pt also noticed fever of 101.8 and called the nurse advice line for guidance. Nurse advice line said that the symptoms were normal after a vaccine and advised to take TYLENOL for fever. Pt states symptoms stayed the same throughout 12/19-12/20/2018, pt walked into be seen by PCM. PCM stated cellulitis and pt placed on antibiotics.
Initial information received on 26-Jul-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case is linked with 2018SA207851, 2018SA208860, and 2018SA208862 (same reporter). This case involves an infant patient (unknown gender, age reported as 12-9 days months old ) who was vaccinated with a 0.5 ml fourth single expired dose of vaccine ACT-HIB lot UI719AAA, (expiry date: 18-Oct-17), in the left thigh on 09-Jan-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE for Immunisation; PREVNAR 13; and MMR VACCINE. It was a case of actual medication error due to expired vaccine used and inappropriate schedule of vaccine administered. It was unknown whether patient experienced any adverse event to product. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the 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. Documents held by sender: None.