chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Atrial fibrillation; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation) in a 34-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation) had resolved.            Concomitant product use was not provided by the reporter. The patient experienced an episode of atrial fibrillation which was diagnosed in a hospital emergency room. The episode occurred about 5.5 months after second dose of Spikevax. He was observed there without drug treatment. The atrial fibrillation resolved in the emergency room on the same day. The precise duration of atrial fibrillation was not reported. The atrial fibrillation had not recurred.  Company comment: This spontaneous case concerns a 34-year-old male patient, with no medical history reported, who experienced the serious (medically significant) unexpected AESI of Atrial fibrillation, which occurred 5.5 months after the second dose of mRNA-1273. It was reported that the patient was observed without drug treatment and resolved in the emergency room on the same day. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 34-year-old male patient, with no medical history reported, who experienced the serious (medically significant) unexpected AESI of Atrial fibrillation, which occurred 5.5 months after the second dose of mRNA-1273. It was reported that the patient was observed without drug treatment and resolved in the emergency room on the same day. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
p/vax pt devel dark urine & general sx (NOS);pt referred to MD who dx hepatitis A in icteric phase of mild intensity w/o complications;reporter considers event to be disabling/incapacitating & r/t vax;pt not recovered;
Information has been received from a Registered Nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD lot # M035143 and expiration date of 30-JAN-2018 (route of administration, dose and anatomical location were unknown) for prophylaxis; reconstitued with sterile diluent (lot # and expiration date were not provided). The vaccine was exposed to a temperature excursion of  6°F to 14°F with a time frame of 45 minutes, while the sterile water diluent did not undergo a temperature excursion. There was no previous temperature excursion. A "data logger" was involved.  No adverse effects were reported. There was not product quality complaint involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA007143:
Patient received her second covid 19 vaccine on the 18th of February - about four hours after she developed some soreness, fatigue and had a hard time moving her arm. Continued for a couple of days. Sunday 2/21 patient woke up without taste and her tongue was numb. That evening she began having some neck pain, below her ear, she massaged and didn't help all that well. At around 3 am that night, the pain was entirely on the right side of her neck and face, she took ibuprofen which mildly helped at night it was the entire neck. Monday 2/22 patient massaged area and it helped a little. She continued to have pain Tuesday 2/23 - Around 9am that morning patient noticed right sided facial drooping and her tongue was not working properly. She also noticed that her eye would not respond like her left eye. It was sluggish. When she went to brush her teeth, she noticed that the water would not stay in her mouth and it came out. At around 7pm that evening she went to the emergency room
Muscle pain in arm going down to elbow. As days go on it gets worse. No pain reliever is helping. No redness or rash. Just extreme pain in muscle. It's very hard to sleep on this arm. I also had a tetanus shot in the right arm at the same time. It's not hurting nearly as bad. I called County Health Dept. they haven't had any reactions like this, also called nurse hotline. This was the Quadrivalent shot. It didn't hurt when she gave it to me. What can I do?
fainted/blacked out; fainted/blacked out; skin felt like had spider and ants crawling all on skin; goosebumps; farted; fell backwards and hit the elbow, and thumb and back of head on the floor; fell backwards and hit the elbow, and thumb and back of head on the floor; fell backwards and hit the elbow, and thumb and back of head on the floor; fell backwards and hit the elbow, and thumb and back of head on the floor; could not walk; dizzy; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Apr2021 (Lot Number: ER8737, unknown expiration) as a single dose for COVID-19 immunisation.  Medical history included COVID-19 disease from 06Jan2021 to an unknown date. The patient's concomitant medications were not reported.  The patient woke up in the middle of the night on 03Apr2021 at 02:00 AM, and the patient's skin felt like had spider and ants crawling all on skin and got goosebumps and had to get up to go to the restroom. The patient went to the restroom and urinated, and when he/she was ready to get up from the toilet he/she farted, the patient fainted/blacked out and fell backwards and hit the elbow, and thumb and back of head on the floor. The patient woke up, when that happened, it was a very hard crash. After that, the patient was unable, could not walk because when he/she tried, he/she got dizzy and had to crawl back to bed, with hands and knees back to bed. The patient asked if he/she should get the second shot. Outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 06-OCT-2014 the patient was vaccinated with an expired dose of ZOSTAVAX, 0.65 ml, once in the right deltoid region (lot # and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Lt upper arm had erythema, edema, hives on body, employee not feeling well. To clinic. Augmentin and Prednisone Rxs.
Pt got shot at 9:50am and came back to the pharmacy at 10:10 stating that her arm felt heavy and tingly. We told her to wait 30 minutes and let us watch her. She did not want to wait so at 10:30 she was ready to leave. Her arm did not get worse but still "felt heavy" when she left. she had no other symptoms. We made her sign a form saying she wanted to leave before the recommended time and I referred her to an MD
Pt turn pale then diaphoretic after the fourth vaccine administration.  Juice was offered, VS taken WNL. Pt vomitted, then wheeled pt to exam table pt layed down for 15 min color came back. Pt left with parents fully ambulatory stable condition.
12/23/2020 developed left ear pain and next day experienced drooping of  left side of face, difficulty blinking left eye Bells Palsy
This case was reported by a physician and described the occurrence of arms redness in a 51-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included codeine and novacaine allergy. On 4 November 2008, the subject received a dose of FLUARIX (unknown, right arm). At an unspecified time after vaccination with FLUARIX, the subject experienced arms redness, swelling arm and arm stiffness. Physician reported a 51-year old male subject received FLUARIX on 04 November 2008 and then experienced swelling, redness, and stiffness in his right arm. He was advised to take ADVIL and use ice packs. At the time of reporting the events were unresolved. The physician considered the events were probably related to vaccination with FLUARIX. Follow-up information received on 05 December 2008 indicated that the events began one day following administration of FLUARIX on 05 November 2008. It was reported that the events were improved and considered by the reporter to be possibly related to FLUARIX. A history of Novacaine allergy was indicated.
pt recv vax in 1973 in Canada;pt exp hearing loss in 1yr;No further details were provided;
About 60 hrs after receiving the Yellow Fever vaccine, I developed chills, uncontrolable shivering, headache, and minor transient back muscle, shoulder and elbow joint pains. I put on warmer clothing took 650mg of acetaminophen. After about 3-4 hrs, the symptoms resolved. Oral temperature ranged from 99.3 to 99.7 F. The acetaminophen was continued every 4 hours for 12 hrs. and temperature returned to normal. A feeling of fatigue continued for about 24 hrs.
For 3-4 days post vax, the pt experienced a large amount of blood from urinary tract. Saw urologist and nothing was found.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Fever-Mild, Additional Details: patient went to work out 1 hour  before appt
dizziness; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included zostavax vaccination. Concurrent medical conditions included fibromyalgia.   On 1st March 2019, the patient received the 1st dose of Shingrix (intramuscular). On 1st March 2019, immediately after receiving Shingrix, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was recovered/resolved.   It was unknown if the reporter considered the dizziness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced dizziness right after the dose. Did not consent to follow-up.
Fever Chills Headaches Body aches joint pain Bone pain Nausea vomiting arm pain extreme fatigue  All lasted until Monday 2/1/2021 morning, although some brain fog and fatigue remain
Patient telephoned to report that the evening following her Tdap injection given on 3/23/18, the site was "painful and hot" over an area about the size of a half dollar. Over the next couple days the area covered entire upper deltoid area from the injection site to just above the elbow. She then followed up with her primary care provider on 3/26/18 and was told she had cellulitis and was given an antibiotic and told to take Benadryl. She reports she was told to call back for a possible steroid if symptoms not subsiding. She says the area still remains red and "itchy" and she has called her provider back today.
Flu vaccine administered around 4:15pm. Around 4:25pm, pt. reported hand tingling and racing heart. BP144/100 Pulse 92. Lungs clear. Pt. reported feeling worse. States breathing became more difficult, and throat felt like it was closing. Per protocol,.5cc adrenaline administered s.q. Oxygen 2 liters administered at 4:35pm. Pulse 100 Pt. still reported throat tightness and was transported to emergency room
First adverse condition symptom began approximately 5 hours after injection with initially mild injection site pain.  Then, the pain radiated to entire upper arm between elbow and shoulder on the right arm by the 6pm.  By 8pm, it was difficult to move or bend arm.  Could not sleep on that arm due to pain.  Next day, pain in arm persisted at full arm between elbow and shoulder, but slightly less.  Arm pain finally went away on its own on Monday March 22nd.  On that same day, feelings of a mild headache began along with congestion and feeling like I'm about to get a cold or similar illness.  By March 24th, fatique, same feeling of illness is to such a point, I am going in for COVID testing at a drive thru facility and I cannot get my physical therapy done because of sudden nasal congestion, fatique and feeling like I'm going to get a sore throat, but do not actually get one.
12/28/2021 Covid symptoms started with cough, congestion, headache, chills, and achiness. I still have a cough, but the fever was gone after 2 days. I also have tiredness still. The other symptoms lasted 2 days. The achiness and chills lasted 2 days, and the cough and congestion is still lingering but it's mild. I tested positive for Covid on 12/29/21.
Information has been received from a health professional concerning a 15 year old female who "about 6 years ago" in approximately 2000 was vaccinated with a 0.5 mL SC dose of Varivax. Subsequently "about six years ago" in approximately 2000 the patient experienced breakthrough chickenpox. Unspecified medical attention was sought. No laboratory diagnostic tests were performed. Subsequently, the patient recovered. There was no product quality complaint involved. It was reported that the patient's brothers (WAES#'s 0607USA04565 and 0607USA04566) developed similar adverse experience after vaccination with Varivax. Additional information has been requested.
Covid arm:  8 days after vaccine, woke up with itchy, red, firm area on arm about 3? in diameter
Patient given monovalent covid vaccine booster after CDC had approved Covid bivalent vaccine booster on Sept 1, 2022.
mom reported on 30SEP92 when brought pt in that had swelling @ the rt thigh site for 5 days w/o fever;  white head devel @ the site; upon exam the rt thigh was indurated about 3x3 cm, w/small opening in center;
Passed out when vaccines given, woke up when picked up, took awhile to completely come to.
Feeling lousy, similar to the flu, headache, blister (2.5" x 1.5")
12/19-12/24 had my last regular period. 12/26/2021 the 5 members in the family contracted COVID-19 that week. Then I had my menstrual cycle 12/31, it went on for 5 days. Then got my period 1/10- 1/14 again. And then again 1/31- 02/05. And then again 02/16-02/21. I saw the provider on 2/28/2022-I gave her the whole run down of the periods because that has never happened to me before. I told her I had COVID-19. She did a regular pelvic exam, pap smear, HPV and all were normal. She ordered an ultrasound of my uterus and all that was normal. She also ordered blood work. She was trying to rule out what was causing the bleeding. Now it its April 20th and I have not had a period. The doctor does not know if maybe the COVID-19 triggered the onset of the pre-menopause or if it was going to naturally happen. Nobody knows, just the timing was very odd.
Left thigh with 23 cm X 14 cm area of redness, warth induration, 3 large bullae and numerous surrounding vesicles.
PT. was given their second dose of Moderna at 1038,  PT. show no signs of reaction.
Moderna COVID-19 Vaccine EUA  Patient presented with swollen eye lids, painful eyes, itchy eyes morning after vaccine administration.  2 days later patient complained of redness(blood shot) eyes.  3 days after vaccine administration patient called pharmacy complaining of blurred vision.  Patient was instructed to seek medical care.  Patient was seen by ophthalmologist who prescribed prednisolone and cyclopentolate eye drops and will continue to follow until improved.
Swelling of right deltoid 4" x 2" red patch warm to touch. Nausea.
Soreness in the arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: A patient experienced soreness in the arm. Consented to follow up. This case has been linked with US2020060863 and US2020060864, reported by same reporter.
I got a severe headache/migraine soon after the shot and it lasted for about 72 hours. It did seem worse than usual and lasted longer than is typical, but it might have been a coincidence since I do get frequent headaches or might have something to do with the vaccine.
pt recvd vax & w/in 8-10 hrs post vax exp gen urticaria, vomiting, stomach cramps & diarrhea;seen in ER & adm to hosp @ 01:00 on 1APR95; no resp or BP problems were reported;discharged 2APR95 & fully recovered
Flu like symptoms, fever, body ache, lasting for 4 days now and still ongoing.
No adverse reactions were seen at the time of administration, but the patient received the Pfizer Covid vaccine instead of  a flu shot and had previously been fully vaccinated with the Moderna Covid vaccines back on 03/27/2021.
Information has been received from a registered nurse concerning a patient with egg allergy and a history of chickenpox who on an unspecified date was vaccinated with VARIVAX (Oka/Merck) instead of ZOSTAVAX (Oka/Merck) by mistake. The nurse reported this was a product confusion "because the products sound the same". No adverse reactions reported. Additional information has been requested.
pt recv vax 130PM & inj site became red, swollen, & sore @ 7PM & had fever 101;pt took APAP for pain & fever w/minimal relief;pt also exp nausea & reported to ER for eval;given phenergan & demerol for plain;
adult patient received a Havrix expired vaccine; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 43-year-old female patient who received HAV (Havrix) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   On 11th November 2022, the patient received Havrix. On 11th November 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 11-NOV-2022 Reporters comment:  The patient received a Havrix expired vaccine.  The reporter consent to follow-up by email. Additional Supportive information: The patient received a Havrix expired vaccine which led to expired vaccine used.
Hospitalized (gave birth);  COVID positive (4.14.22);  Fully vaccinated PLUS booster (received booster while pregnant).   BRIEF OVERVIEW: Admission Date: 4/15/2022 Discharge Date: 4/17/2022 Active Hospital Problems   Diagnosis Date Noted POA ? Cesarean delivery indicated due to breech presentation   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: History of cesarean section Cesarean delivery indicated due to breech presentation Status post repeat low transverse cesarean section HOSPITAL COURSE: Patient underwent an uncomplicated cesarean delivery and was discharged home in stable condition. LABOR AND DELIVERY SUMMARY:   Delivery Details DELIVERY TYPE: C-Section    ESTIMATED DUE DATE: Estimated Date of Delivery: 4/20/22 GESTATIONAL AGE AT DELIVERY: 39w2d  G2P2002 Patient is a 39 y.o. G2P1001 female at 39w2d with Estimated Date of Delivery: 4/20/22 who presents today for PROM, had SROM at 2345.  Has a hx of 1 prior CS in 2018.  Plans for repeat CS due to breech presentation.  Pt endorses good fetal movement. Denies any vaginal bleeding or loss of fluid FINDINGS: NEWBORN STATUS: Living  NEWBORN SEX:  boy 7:10 AM   WEIGHT: 3.215 kg  APGAR:  1 minutes 5 minutes 10 minutes  8  9    Liveborn infant, of singleton pregnancy, born in hospital by cesarean delivery 39 week AGA male infant. Mom presented to L&D with SROM, delivered by repeat C/S due to breech presentation. Maternal h/o anxiety, ADHD, and COVID-19 in the 3rd trimester (+3/22).  Patient did get hospitalized again 4.22.22 - 4.23.22 (24 hours) for Preeclampsia in postpartum period.  HISTORY OF PRESENT ILLNESS: Patient is a 39 y.o. female who is PPD #7 from a repeat cesarean section that presents for evaluation of elevated blood pressures and headache. She reports that she developed a persistent headache after she was discharged from the hospital. She has a history of blood pressure issues following the birth of last child, but denies any blood pressure issues this pregnancy. Due to her persistent headache and her history, she began checking her blood pressures at home and was noted to have BP's of 140's/80's. Due to her symptoms and blood pressures, she contacted her OB who recommended that she present to the emergency room for further evaluation. She reports that other than her headache, she has been doing well since delivery. She denies any visual changes, chest pain, or RUQ pain. Her lochia has been appropriate and she is currently breast feeding.
Severe chills approximately six hours after vaccination (~10 PM). Hypersensitivity in the fingers and toes at the same time that lasted approximately two hours. After waking up, had significant fatigue that lasted roughly until 7PM. Slight headache persisted throughout, and continued for a total of twenty-eight (28) hours. All symptoms gone roughly two full days after symptoms began.
Tingling sensation in the right leg; Pain in the right leg; Soreness; Joint pain; Pressure in head; Pain all over body; Drowsy; Pressure in head; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Drowsy), the first episode of HEAD DISCOMFORT (Pressure in head), the second episode of HEAD DISCOMFORT (Pressure in head), PAIN (Pain all over body) and PARAESTHESIA (Tingling sensation in the right leg) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20N) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Herniated disc and GERD since an unknown date. Concurrent medical conditions included Cholesterol and Sjogren's syndrome. Concomitant products included SIMVASTATIN for Cholesterol, PANTOPRAZOLE for GERD, CEVIMELINE for Sjogren's syndrome.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced SOMNOLENCE (Drowsy) and the first episode of HEAD DISCOMFORT (Pressure in head). On 02-Mar-2021, the patient experienced the second episode of HEAD DISCOMFORT (Pressure in head), PAIN (Pain all over body), MYALGIA (Soreness) and ARTHRALGIA (Joint pain). On 07-Mar-2021, the patient experienced PARAESTHESIA (Tingling sensation in the right leg) and PAIN IN EXTREMITY (Pain in the right leg). On 18-Feb-2021, SOMNOLENCE (Drowsy) had resolved. At the time of the report, last episode of HEAD DISCOMFORT (Pressure in head), PAIN (Pain all over body), PARAESTHESIA (Tingling sensation in the right leg), PAIN IN EXTREMITY (Pain in the right leg), MYALGIA (Soreness) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information were not provided   This case was linked to MOD-2021-183795 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Reporter contact information was updated, relevant medical history was updated, vaccine facility details were added, concomitant medications were added, new events were added.
Dorsum of both hands reddened and itchy on 1/15/2021. OTC Cortisone and Benadryl Cream