chrisvoncsefalvay/vaers-outcomes huggingface dataset:
periods laster longer than ususal; Got another periods after 13 days; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (periods laster longer than ususal) and POLYMENORRHOEA (Got another periods after 13 days) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (periods laster longer than ususal) and POLYMENORRHOEA (Got another periods after 13 days). At the time of the report, HEAVY MENSTRUAL BLEEDING (periods laster longer than ususal) and POLYMENORRHOEA (Got another periods after 13 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment information provided.   This case was linked to MOD-2021-103999 (Patient Link).
Patient experienced dizziness. She sat down for around 30 minutes. During this time, she stated the dizziness went away. Her daughter arrived to pick her up. She went home with her daughter.
Within 1 hour of receiving vaccine had pounding headache, vomiting and body aches lasting 24 hrs. Had the exact same reaction after receiving a flu shot on 1-14-15 (FLULAVAL - ID Biomedical)
blood clots and she will be going to the Emergency Room to have the knot evaluated.; Agent states that caller reports injection arm pain that began a few days after the second shot; caller also recently noticed the development of a knot near her wrist in the same arm.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date 27Dec2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1.), administration date: 06Dec2021, for COVID-19 immunization. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "blood clots and she will be going to the Emergency Room to have the knot evaluated."; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Agent states that caller reports injection arm pain that began a few days after the second shot"; NODULE (non-serious), outcome "unknown", described as "caller also recently noticed the development of a knot near her wrist in the same arm.".Clinical course was reported as, reporter stated she Patient had received her first Pfizer Covid Vaccine on 06Dec2021 and her second dose on 27Dec2021. Patient had reported injection arm pain that began a few days after the second shot and continued. Also recently noticed the development of a knot near her wrist in the same arm. patient later stated she had a history of blood clots and she will be going to the Emergency Room to have the knot evaluated. PQC was not present. AE Present was reported as yes. Case was reported as Non-Serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Extreme facial swelling, closing of throat, loss of vision in right eye, uveitis, extreme fatigue, headache
TOES ARE TINGLING; POOR CIRCULATION; NUMBNESS; JOINT PAIN; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 21-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced toes are tingling, poor circulation, numbness, and joint pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the toes are tingling, poor circulation, numbness and joint pain was not reported. This report was non-serious.
Nausea, vomiting, dizziness, diarrhea, extreme body aches
ABDOMINAL PAIN; This spontaneous case was received from a physician on 16-May-2019. It describes 15-year-old consumer who had abdominal pain, after the administration of oral Vivotif for an unknown indication.  Case report: The consumer had severe abdominal pain after the administration of the first dose of Vivotif and it got worse after the second dose. The consumer took PeptoBismol for the event.  Action taken with Vivotif was unknown.  The consumer had not recovered from the event.  Company's Comment: In this case, it was reported that the consumer had abdominal pain after the administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, abdominal pain is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer had abdominal pain after the administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, abdominal pain is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.
An extremely heavy menstrual cycle when it was the heaviest I've ever experienced since having a menstrual cycle or even before I had my fibroid surgery
red bumps that itched and felt like they were burning; red bumps that itched and felt like they were burning; red bumps that itched and felt like they were burning; hives; allergic reaction spread throughout the torso, neck, behind the ears and down the arms; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red bumps that itched and felt like they were burning), PRURITUS (red bumps that itched and felt like they were burning), BURNING SENSATION (red bumps that itched and felt like they were burning), URTICARIA (hives) and HYPERSENSITIVITY (allergic reaction spread throughout the torso, neck, behind the ears and down the arms) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     Concurrent medical conditions included Nail infection and Sleep problem. Concomitant products included HYDROCHLOROTHIAZIDE for Blood pressure management, TERBINAFINE for Nail infection, GABAPENTIN for Sleep problem, ETANERCEPT (ENBREL) for an unknown indication.   On 29-Sep-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 30-Sep-2021, the patient experienced RASH ERYTHEMATOUS (red bumps that itched and felt like they were burning), PRURITUS (red bumps that itched and felt like they were burning), BURNING SENSATION (red bumps that itched and felt like they were burning), URTICARIA (hives) and HYPERSENSITIVITY (allergic reaction spread throughout the torso, neck, behind the ears and down the arms). The patient was treated with PREDNISONE for Hives, at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (red bumps that itched and felt like they were burning), PRURITUS (red bumps that itched and felt like they were burning), BURNING SENSATION (red bumps that itched and felt like they were burning), URTICARIA (hives) and HYPERSENSITIVITY (allergic reaction spread throughout the torso, neck, behind the ears and down the arms) had not resolved.            Patient started getting red bumps that itched and felt like they were burning. This allergic reaction spread throughout the torso, neck, behind the ears and down the arms. Those symptoms are ongoing.
I am unable to have complete range of motion in my left arm. Any extension results in pain that radiates to the wrist and fingers. It beings between the bicep and tricep area. I cannot lie on my right side and I have to sleep with a pillow propped under my left arm.
pt recv vax; high fever till 24may95;v & d till 28may95; bright red rash; clearing 27may
Lymphadenopathy in left axilla starting approximately 6 hours after vaccine and lasting for about 3 days. Self-limiting, Tylenol used for symptom control/pain
Information has been received from a 69 year old female with pertinent medical history which includes "thyroid surgery about 6 weeks ago (on 17-SEP-2007) and no drug reactions/allergies, who on 23-OCT-2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck). Concomitant therapy included "cholesterol medication". On 25-OCT-2007, the patient experienced an itchy rash on her right upper thigh. On 26-OCT-2007, the patient noticed a bright red, warm and itchy rash which was located on the underside of her arms and torso from her breasts down to buttocks. On 26-OCT-2007, the patient spoke with her pharmacist who instructed to use a cortisone based ointment. The patient had no relief from any of the symptoms. The patient had an appointment with her physician on 29-OCT-2007, for unspecified medical attention. No further information was available. The outcome was reported as not recovered. There was no product quality complaint. Additional information has been requested. Follow-up received 04/16/2008 indicated that this facility "did not administer vaccine to patient".
Mother reports pt started running fever and after he awoke from a nap he had lost milestones. He could not talk any longer. He ran fever of 100-102.5 for 3 days. She took him to doctor for follow up. Doctor referred him to neurologist.
Initial information received on 24-Jan-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case was linked to 2019SA024754 (same reporter). This case involves a 15 months old patient (one of the twins) who received an expired fourth single dose of 0.5 ml of vaccine DAPTACEL (lot C5102AA and expiry date 04-Dec-2018) via unknown route in the right thigh on 22-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE. It was a case of actual medication error due to expired vaccine used. It was not reported if the patient had any adverse event. 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. Follow-up information received on 20-Feb-2019 regarding an unsolicited valid non-serious case received from a Nurse. No new information was received. List of documents held by sender: none.
Information has been received from a physician concerning a 15 years old female who was vaccinated subcutaneously with two doses of VARIVAX (Merck). Subsequently the patient experienced chickenpox. There were more than 50 lesions and scattered all over her body. The physician did mention that this incident occurred after an exposure to a girl who had shingles and the two girls shared a sweater. Additional information has been requested.
At first sore arm. I received the booster shot at 6 p.m. By midnight my upper arm was swollen and I had severe pain, like an ankle sprain. It kept me up most of the night. My arm was swollen, red, and painful to the touch thru Saturday. I had to call out of work on Friday because I did not have full use of my arm nor drive effectively.  By Sunday I could raise it, but not before. On Saturday it looked like I had like half of a lemon on my upper arm. It was very odd. I had 2 doses of Phizer by April 5th 2021.
Cellulitis on upper left arm, redness, pain, began 12/15, began antibiotics 12/16.
Patient began presenting swollen lymph nodes all over her body in July less than a month after testing. She would seek care but was told she had an infection and anxiety, He function slowly began to decline until she lost the ability to walk. She was diagnosed with GBS and Myasthnia Gravis. Patient is normally in perfect health her entire life until after she recieved the vaccine
Muscle pain, severe pain at injection site, flu like symptom, fatigue, headache. muscle weakness,   difficulty concentrating, body as a whole pain , I only mention these because the pharmacist said they had no record of any negative side-affects from the Pfizer booster shot.  this is almost as bad as shot two/three, which put me down for three days with severe flu/covid -like symptoms.  no improvement yet but having minor shortness of breath.   I am able to work but want it on record for the sake of others receiving the booster.
felt pressure in chest; he turned pale; started sweating; terrible flu like symptoms; blacked out twice; very tired, and went back to bed; came out with a terrible headache; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (blacked out twice) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Medical history not provided.).    On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced HEADACHE (came out with a terrible headache). On 18-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (blacked out twice) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (terrible flu like symptoms) and FATIGUE (very tired, and went back to bed). On 24-Mar-2021, the patient experienced CHEST DISCOMFORT (felt pressure in chest), PALLOR (he turned pale ) and HYPERHIDROSIS (started sweating). On 17-Mar-2021, HEADACHE (came out with a terrible headache) had resolved. On 18-Mar-2021, LOSS OF CONSCIOUSNESS (blacked out twice) and FATIGUE (very tired, and went back to bed) had resolved. On 19-Mar-2021, INFLUENZA LIKE ILLNESS (terrible flu like symptoms) had resolved. At the time of the report, CHEST DISCOMFORT (felt pressure in chest), PALLOR (he turned pale ) and HYPERHIDROSIS (started sweating) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Blood test: negative (Negative) blood work came back negative. On 19-Mar-2021, Electrocardiogram: negative (Negative) ECG came back negative. On 19-Mar-2021, X-ray: negative (Negative) X-ray came back negative. On 24-Mar-2021, Blood pressure measurement: negative (Negative) Blood pressure results negative. On 24-Mar-2021, Blood test: negative (Negative) blood work came back negative. On 24-Mar-2021, Magnetic resonance imaging: negative (Negative) MRI of head came back negative.         Concomitant product use was not provided.  The patient saw their cardiologist on 26-Mar-2021 who could not determine what was causing patient's symptoms.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Migraine, muscle spasms in neck and upper back. Swelling at injection site, no appetite, weak, exhausted, fever and chills --  unable to go to work since 10/17/2011.
I had been traveling and because I was sneezing and had a sore throat, I tested and, it was positive. I had no fever. It was mainly sneezing and coughing and a sore throat. And I put it into my my-charts system, and my doctor recommended that I visited a doctor that was in chain. I had chills and sneezing, and I thought I had hay fever. I was out of town and drove back to my house and I was positive again. I then I went to a local urgent care, and they tasted me again. Urgent care recommended me to another hospital to get me the mono antibodies done.
Sore arm, fever, chills, headache and dizziness. All symptoms resolved within 36 hours except headache and dizziness. Dizziness is the biggest complaint 4 days post vaccine.
Slight tenderness in the left arm. Chills in the morning with slight headache and muscle aches not associated with the arm discomfort. Generally feel lethargic.  It is 9:00 A.M. so I have not recovered yet (see item 20).
Patient received vaccine at (13:22) directly afterwards, patient states "I feel hot, my eyes are turning black, I cannot see." "I am sweating bad." Patient was noted to be pale and offered wheel chair. Patient was taken to private room and assisted to lie down at (13:30). Patient continued to be oriented  (BP - 118/40) HR-76 / O2 -97. Patient complains of dizziness and black spots in vision. Continued to monitor. Cool rag applied to forehead (1:34 PM - BP -123/69 HR - 75  / O2-98) (1:36) (13:37) Patient assisted to sitting position. BP -114/59 Voiced feeling better. (13:40 PM) BP - 120 /75 / (13:40 - stood patient up and assisted to chair. Patient was normal and fine while sitting in chair. (13:50) Patient was clammy, stated she felt as though she would pass out. BP - 119/27 / HR - 89 O2 98 / assisted to lie down, continued to complain of dizziness. Clammy, (13:59) EMS called / BP -115/92 - HR -76. Ambulance arrived at (14:05). Before transfer of care BP - 125/71 - HR 107 / O2- 98
Therapy non-responder. This case was reported by a nurse and described a 36-year-old female patient who did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series. The reporter is the patient. On an unspecified date, the patient received the sixth dose of Engerix-B. On an unspecified date following the sixth dose of Engerix-B., a hepatitis B surface antibody titer indicated that the patient "did not have a positive titer." The nurse considered the event to not be related to vaccination with Engerix-B.
Confusion, Palpitations, HYPERtension, Syncope,  Flushing/, not thinking clearly , chills/clammy  Narrative:  Immediately post vaccine, had facial flushing/redness, dizzy and c/o brain fog. Recovered after lying down/resting. Returned to work, 2 hours post vaccine again felt like not thinking clearly, chills/clammy, palpitations and felt like she was going to pass out. 911 activated/paramedics transported to ER
headache, muscle ache, fever, chills, fever, lymphadenopathy, injection site pain, tiredness
No treatment needed. Symptoms could be related, but may be from another cause. Slight to moderate nausea later in evening after vaccination and during the next day. Some slight joint discomfort, general malaise, and feverish feeling though no fever registered when temperature taken.  Ingested extra fluids to help hydrate. Symptoms cleared by  the morning of  3/9/21 (a bit over 24 hours after onset)
CHIEF COMPLAINT The patient is a 80 y.o. male who presents with shortness of breath and chest wall pain in the setting of a mechanical fall and also with COVID-19 infection.    HISTORY OF PRESENT ILLNESS The patient has a significant past medical history of COPD (maintained on p.r.n. albuterol nebulizers with no baseline supplemental oxygen) along with chronic heart failure (EF 34% in 2019 maintained on spironolactone, Lasix, and losartan) in the setting of ischemic heart disease (12 stents), atrial fibrillation on chronic amiodarone and aspirin (previously declined anticoagulation) with pacer/defibrillator (since 2009), chronic lymphocytic leukemia with baseline anemia requiring intermittent red blood cell infusions and chronic thrombocytopenia, chronic stage IIIB kidney disease, nicotine dependence, hypothyroidism, GERD, chronic back pain, and mild cognitive impairment. Patient is confused and not able to convey an accurate history.  I spoke to a family member by phone to confirm the details of the history.  She reports she was up all night with him because he was so short of breath.  At one point he went to the bathroom when she dozed off and fell as he was walking to the bathroom onto his right side hitting the rocking chair.  He had told me he fell getting out of the car. She said he was in the car yesterday when they went for the antibody infusion but did not fall, and that she no longer lets him drive due to his confusion.  She describes his mental status as currently at baseline.  She says he has been SOB and has had a non-productive cough but doesn't know if he has had any fevers.  He has had the right-sided chest pain since the fall but not previous. He was first COVID-19 PCR + on 10/21/21 and received outpatient monoclonal antibody (Casirivimab-Imdevimab) infusion on 10/22/21.  He did receive Pfizer dose 1 and 2 in Feb/March but has not received a booster. CT scan in the emergency department showed right posterior 11th and 12th rib fractures, mildly displaced, small hydropneumothorax, and COVID-19 related pneumonia findings including new patchy ground-glass opacities throughout both lungs superimposed on emphysematous changes.
The vaccine was given on 8/14/23 but the expiration date was marked 8/11/23.  Patient had no symptoms after receiving the immunization.
pt recv vax; aching muscles on limbs & aching joints on 27jun;woke up w/ severe itching on feet & hands; no rash; dizziness & some tingling in hands;
After shot had to wait 1 hour to leave, after I got in the car to leave I experienced cramps in both feet , after getting out and walking the cramps went away. Then after being home for about 2 1/2 hours which would put us at about 2:15 pm I had been watching tv for about an hour maybe a little longer and I again experienced cramps in both lower legs, again after walking they went away. I was drinking water and I drank 2 Gatorade?s during this time.  The next morning when I woke up it felt like there was something settling in both lower legs, kind of like moving in your skin. But after that no more issues.
This spontaneous report as received from a 70 year old female consumer refers to herself with unspecified blood pressure problem. The patient's medical history included two prior cases of shingles. On 09-MAY-2012 the patient was vaccinated with a dose of ZOSTAVAX (route and lot # not reported). Concomitant therapies included SPIRIVA and unspecified blood pressure medication. In July 2012, two months after receiving the ZOSTAVAX vaccine, she developed a third case of shingles on her "tailbone" area. Approximate time was two months later, after receiving the vaccine. She reports that the lesions are "bigger" than before. The outcome of shingles is unknown. The patient did not seek medical attention. No treatment was given for shingles. Additional information has been requested.