chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This medically confirmed literature report (initial receipt 15-May-2014) concerns a 33-year-old female patient. The patient had a medical history of rheumatoid arthritis. On an unspecified date, the patient received influenza vaccine injection (manufacturer and batch number not provided) and PS 23 injection (manufacturer and batch number not provided) for immunosuppressive therapy in rheumatoid arthritis. Both vaccines were received in the same arm. On an unspecified date, within 1 day of vaccination, the patient developed fever greater than 101.5 degree Fahrenheit. The patient had maximum temperature of 101.8 degree Fahrenheit. She developed rigors, erythema, edema and warmth of the pneumococcal and influenza injection site. The patient had local swelling, severe redness and swelling and large local inflammatory reaction. The local reaction expanded well beyond the immediate injection area by day 3-4 post vaccination. The patient sought care within 2-3 days of vaccination. The patient was admitted to the hospital for observation with or without treatment for presumed cellulitis. The patient received full course of antibiotics to cover for common skin flora as well as methicillin-resistant Staphylococcus aureus. She had received several different antibiotics due to worsening of skin erythema despite aggressive intravenous antibiotic therapy. She had a significant leucocytosis with white blood cell count at 19.2 K/ul with the predominance of neutrophils. She also had elevated erythrocyte sedimentation rate (ESR) at 71 mm/hr and elevated C-reactive protein (CRP) at 14 mg/dl. Within 5-7 days, the patient improved in the skin findings and there was resolution of the systemic symptoms. The outcome was reported as recovering. Reporter's comments: The reporter stated that the local reaction experienced by the patients who received both influenza vaccine and PS23 in the same arm was due to PS23 vaccine rather than the influenza vaccine. The patient experienced fever and systemic symptoms with local erythema within 24 hours of PS23 administration and this timing is not consistent with a secondary infection of the injection site. In addition, the patients who were treated with antibiotics did not improve as would be expected if these local reaction represented cellulitis infection.
This spontaneous report was received from a medical assistant concerning a female patient of approximately 10 years old.     The patient did not have concurrent conditions, medical history or concomitant medication. The patient had a drug reaction or allergy to amoxicillin. In 2016 (on an unspecified time last year), the patient was vaccinated with the first dose of GARDASIL 9 as prophylaxis (dose, route of administration, lot number and expiration date were not reported). Shortly after vaccination, the patient developed tenderness, hardness, redness and itching at the injection site; the reporter also noticed the injection site. The patient's parents contacted the site where the vaccine was administered and they were advised (by an unspecified staff) to apply ice on the location. When the patient went to the office, to inform the response to the first dose, an unspecified provider called the symptoms as an allergic reaction. The patient received treatment for the events. The second dose of GARDASIL 9 was not administered. At the time of the report, the patient was "doing good". No further information was provided. The outcome of vaccination site pain, hypersensitivity, vaccination site pruritus, vaccination site erythema and vaccination site induration was not reported, neither was the causal relationship between the event and vaccine. Additional information has been requested.
got first COVID vaccine shot mon 4/26/21.  two days after shot Wednesday, 4/28/21, she could not  be woken, she was unconscious , like comatosed,  we couldnt wake her to eat or drink.  Awoke for a few minutes on Thursday, 1/29/21 for very short spurts.. contacted dr by phone.  she said keep watching her and try to get her to eat and drink-  vitals still fine.  but  Friday, 1/30/21 BP down to 80/40.  Gave her a T of salt and 32 ounces of water.  slowly got BP back up by Saturday 5/1/21.  today is Sunday, and her BP is back up, but respirations remain down to 54, normally 74.  She's eating and drinking.  We think we've saved her and we keep praying.  dr said second shot not advisable.
On the next morning around 4am I started with chills, felt very fatigue, muscle aches, nausea & I slept constantly. It was for the first 48hrs. I also had low grade fevers of 101, brain fogginess & fatigue that lasted 2 to 3 weeks. I seen my provider as well and they did lab work.
Metallic taste in mouth minutes after booster and all of day 1 after booster Fever/chills day 1 and 2 after booster shot Headache day 1, 2 and 3 after booster Body aches day 1 and 2 after booster Pain and stiffness of neck and back of head day 1 after booster Naseau day 1 and 2 after booster Fatigue and boughts sleeping  day 1,2,and3 after booster Swollen lymph node left side of neck by clavicle appearing day after vaccine
Headache, Sedation, Myalgia, Fever,  NauseaVomiting, Tachycardia,  Pain @ injection site, Swollen lymph nodes
EYES WERE HURTING; CONGESTION; EXTREMELY BAD MEMORY FOG; BODY PAIN; BACK OF MY NECK WAS HURTING; CHILLS; FEVER; FELT VERY TIRED; HEADACHE/HEAD CONTINUES HURTING/OCCIPITAL AREA HURTING; FELT THE HEAD WAS HEAVY; BLURRY VISION; This spontaneous report received from a patient concerned a female 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 06-AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 06-AUG-2021, the patient experienced felt the head was heavy. On 06-AUG-2021, the patient experienced blurry vision. On 06-AUG-2021, the patient experienced chills. On 06-AUG-2021, the patient experienced fever. On 06-AUG-2021, the patient experienced felt very tired. On 06-AUG-2021, the patient experienced headache/head continues hurting/occipital area hurting. On 07-AUG-2021, the patient experienced eyes were hurting. On 07-AUG-2021, the patient experienced congestion. On 07-AUG-2021, the patient experienced extremely bad memory fog. On 07-AUG-2021, the patient experienced body pain. On 07-AUG-2021, the patient experienced back of my neck was hurting. Laboratory data (dates unspecified) included COVID-19 virus test (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from felt the head was heavy, blurry vision, chills, fever, felt very tired, headache/head continues hurting/occipital area hurting, eyes were hurting, congestion, body pain, and back of my neck was hurting, and had not recovered from extremely bad memory fog. This report was non-serious.
Patient requested to lie down due to history of fainting and history of anaphylaxis. Patient laid down and shot was given.. Reports feeling dizzy. Waited with patient for 30 minutes. Patient left feeling fine after 30 minutes.
CLIENT RECEIVED MODERNA DOSE AT 17YO. MODERNA IS APPROVED FOR AGES 18YO AND UP.
Anaphylaxis Warm feeling from head down to both legs (waves), slightly itchy throat/sore throat, slight chest discomfort. Narrative:  Vitals: 1535 BP 118/83, P: 67 Vitals: 1540 BP: 140/92, P: 71, T: 97.7 Vitals: 1545 BP: 129/86, P: 71 Vitals:  1548 BP: 128/82, P: 68, O2: 100% RA
Pt had seizure-like activity with rhythmical movement of her head on the evening after her immunization.
Patient is a 91-year-old male who has not seen a primary care physician in over 40 years.  He presents to the emergency room ambulatory in the company of his neighbor complaining of a worsening cough and some shortness of breath over the last 10 days.  Denies fever or chills.  Denies any associated chest pain.  He does admit to swelling of his lower extremities however states that has been there for years.  He has been fully vaccinated for COVID.  Patient states his shortness of breath is worse when he is coughing or exerting himself.  He does sleep decent at nighttime. Associated Symptoms: cough, edema, fatigue, joint pain, orthopnea, sensory changes, shortness of breath, weakness
Symptoms directly following vaccination:  severe dizziness, near loss of consciousness, internal trembling for 90 mins (I stayed at the facility for 2 hours until symptoms calmed down).  Left side face tingling about 4 hours after shot, headache for 3 days, fogginess and unable to concentrate for 3 days.   About two-three days after vaccination, i began to experience chest pains; particularly in the left side of my chest, which started as a stabbing pain and is now a dull aching constant pain which radiates up my left back and neck.  My other vitals (blood pressure, heart rate and breathing) have been normal.  I did see my primary care doctor for an ECK 5 days after vaccination, and she referred me to a cardiologist for further testing.  I saw a cardiologist 9 days after vaccination, and I'm waiting on results from the echocardiogram the doctor ordered to check for possible pericarditis.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications or treatment details were reported.   This case was linked to MOD-2021-395985 (Patient Link).
ALLERGY ATTACK; HEAVY NOSE BLEED/NASAL BLOOD CLOTS IN BOTH NOSTRILS; PUFFY,PURPLE COLORED BAGS UNDER BOTH EYES; ITCHY BAGS UNDER BOTH EYES; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (HEAVY NOSE BLEED/NASAL BLOOD CLOTS IN BOTH NOSTRILS), PERIORBITAL SWELLING (PUFFY,PURPLE COLORED BAGS UNDER BOTH EYES), EYE PRURITUS (ITCHY BAGS UNDER BOTH EYES) and ALLERGY TO VACCINE (ALLERGY ATTACK) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 013M20a) for COVID-19 vaccination.     Concurrent medical conditions included Hay fever.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced PERIORBITAL SWELLING (PUFFY,PURPLE COLORED BAGS UNDER BOTH EYES) and EYE PRURITUS (ITCHY BAGS UNDER BOTH EYES). On 12-May-2021 at 4:00 AM, the patient experienced EPISTAXIS (HEAVY NOSE BLEED/NASAL BLOOD CLOTS IN BOTH NOSTRILS). On an unknown date, the patient experienced ALLERGY TO VACCINE (ALLERGY ATTACK). At the time of the report, EPISTAXIS (HEAVY NOSE BLEED/NASAL BLOOD CLOTS IN BOTH NOSTRILS), PERIORBITAL SWELLING (PUFFY,PURPLE COLORED BAGS UNDER BOTH EYES), EYE PRURITUS (ITCHY BAGS UNDER BOTH EYES) and ALLERGY TO VACCINE (ALLERGY ATTACK) outcome was unknown.            Concomitant product use was not provided by the reporter.  Patient experience a heavy nosebleed and he followed the medically recommended method of pinching his nostrils and sitting with his head tilted forward.  Patient has never experienced nosebleeds prior or hand any bad allergy reactions for at least 20 years. No treatment information was provided.   This case was linked to MOD-2021-030752 (Patient Link).
15 yo M, previously healthy, with 2 d of chest pain s/p COVID mRNA vaccine booster (3rd dose) on 1/8, with tachycardia, normotension, elevated CRP, significantly elevated troponin, and abnormal EKG, all most consistent with myocarditis, timing suggestive of COVID vaccine-associated myocarditis -- however, given other etiologies of myocarditis should also be considered, e.g. viral. Overall pattern of presentation less suggestive of MIS-C or systemic autoimmune disease.
Fever, vomiting within 6 hours of injection/ingestion. Received Acetaminophen for fever.
Patient received her Hep A and PCV 20 vaccine on 09/11/23. On 09/13/23, patient called the clinic and reported that she has large raised welts, hives, and pink bumps all over her body, neck, facial area, and was feeling itchy. The patient also felt dizzy and weak. Patient also awoke to a mild sensation of heaviness in her chest area. Patient was advised to go to the Emergency Department for further medical evaluation and plan was discussed with the doctor.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. It was reported "a patient received first and second dose of GARDASIL (lot # was not reported) 4 years ago in 2008, the patient is in the office today on 16-JUL-2012 for the third dose". No adverse effect reported. Additional information has been requested.
Patient was complaining of general itching in extremities.  Vitals were taken and there were no signs of severe allergic reaction.  No trouble breathing or aggravation or itchiness in throat.  Patient was advise to remain under observation for an additional 15 minutes.  Itchiness declines and patient left the facility.
This spontaneous report as received from a physician via company representative via on-line document (social media) (source unspecified) refers to an 11 or 12 year old female patient. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date the patient was vaccinated with GARDASIL (strength, dose, dose number, dose schedule, route, anatomical location, lot number and expiration date were unspecified). No concomitant therapies were reported. On 27-AUG-2014 the 11 or 12 year old female died after receiving GARDASIL. At the time of this report it was not known if an autopsy were performed. The outcome of the event was reported as fatal. The relatedness between the event and GARDASIL was not reported. Additional information has been requested.
Typicial symptoms started about 12 hours after the injection.  Very bad body aches, severe headache, eye ball pain (weird), chills.  About 2 days after the vaccination, all of my previous respiratory symptoms that I have had well managed and under control have returned.  I am wheezing, congested, ringing in my ears, coughing, chills, and anytime I eat, all the symptoms are exacerbated, which means I am having some sort of histamine or cytokine response/reaction.  I can't eat normally, otherwise I feel really sick again: body aches, wheezing increases, feel like a fever is coming (it doesn't), very exhausted.  These are all symptoms I dealt with about 3-4 years ago, though all of this was under control with my current med/supplement regimen.  Have to say I am very very upset about all of this.  I have no idea when or if these will subside but they don't seem to be going away.
On 01/05/2023, I had a sore throat. The next day, I tested myself for COVID-19 and it was positive. I felt like I had a bad cold for the next few days. I was run down and tired, but my symptoms weren't bad overall. I stayed hydrated and rested and took a few days off of work. I never had a fever and had mild symptoms. I had a bit of a runny nose, and the biggest thing was that I was really tired. I also never lost my sense of taste or smell. At that time, I did not have a cough. A few weeks went by, and I started to have a cough and shortness of breath. When I was younger, I had allergy induced asthma, and I felt like I was wheezing. I had an inhaler from an episode that I had after receiving an earlier COVID-19 vaccine. I ultimately ended up getting a maintenance inhaler and an emergency inhaler that I was on for weeks. I really struggled with my breathing for around a month and a half. I'm still using the inhaler, but it's not as pronounced as it was, and I can run a bit now. Before, I was having trouble breathing even when I was walking.
Rash starting on right axilla and spreading to chest, abdomen, back and a few on lower right upper extremities. It was maculo-papular, bright red and erythemic lesions.
Patient called in on 3/21/12 to report having redness and swelling at site of pneumonia vaccine administered 3/20/12. Patient was advised to come in but later canceled visit and went to local ED for these symptoms. Patient states site is swollen and warm. Patient was diagnosed with cellulitis infection at local ED and was given IV antibiotics, Cephalexin 500 mg QID X 10 days, BENADRYL 25-50 mg q 6 hr and taking ibuprofen for pain. Symptoms: Erythema multiform and erythema, edema, pain at injection site.
This spontaneous report was received from a nurse concerning to a 6 months old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 11-JUN-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # K023534, expiration date: 22-MAY-2016) (strength and dose were unspecified), the route was defaulted to oral. No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Dose #1: Sore arm at site of injection for 2 days  Dose #2:   Night 1 - Intense whole body ache, low fever, unsteady on feet through the night accompanied by brain fog.  Day 2 - Fatigued, sluggish. Day 3 - Return to normal energy. Day 8 - Rash on belly (small rough bumps similar to when I eat gluten), spreading to back.  Day 9 - Red splotches developed on R breast (1, then 2, then 3); hard nodules formed after a few hours. Another red splotch developed close to armpit, perhaps lymph node? in the evening.  Soreness with this splotch.  Day 10 - L sore wrist that intensified with finger/hand movement. Pain spread to elbow. Swelling followed at wrist and hand. Ibuprofen and ice eventually reduced. Took over 24 hours to resolve. Day 11 - Red splotches appeared on L breast. Day 15 - Dr. visit. No diagnosis. Unknown if related to vaccination. Perhaps all separate signs & symptoms? Staph? Day 17 - Brain fog returned throughout the day; overall low energy. Day 18 - One new red splotch on R breast.
Minimal pain around injection site within 15 minutes of receiving injection. Minimal pain until around 3 am, woke up with severe muscle pain that continued to worsen into the next day- 4/14/2021. I could barely move my arm, the pain had me in tears a few times. Accompanied by inflammation surrounding injection site. Used a cold pack on the area within the first 24 hours, it did not help nor did ibuprofen, naproxen sodium, or acetaminophen. Used a heating pad on low on the area to help with muscle stiffness, it helped minimally. Today, 4/15, the pain and inflammation is improved greatly but hives developed along with a very mild temperature. Symptoms improving overall
I felt a pain in my right arm. That was anticipated. But at around one in the morning,  I felt a sharp pain in my upper right abdominal. Over the course of the next several days, that pain increased and persists until today, albeit faint now.  I had Epstein Barr last year that impacted my liver so I knew where the pain was coming from as I underwent a multitude of testing on my liver. My AST and AKT levels finally normalized in August, 2021 and my hepatologist declared me healthy again.
This spontaneous report as received from a registered nurse refers to a 5 years old patient of unknown gender. On 19-SEP-2014, the patient was vaccinated with a dose of PROQUAD (Merck) lot # K008579, expiration date 13-DEC-2015, (dose, dose number, route and frequency were not reported) that was exposed to 19.5 F for 9 hours (supported). No adverse effects were reported. No product quality complaint (PQC) involved. This is one of the several reports from the same source. Additional information has been requested.
anaphylactic rxn, facial swelling, periorbital swelling, wheezing;
Ringing in both ears, starting at 3am on March 22. 2022. Left ear was extreme. Abated around 8 am. in both ears. Muscular discomfort at neck still applicable and up left side of head. Taking no medication for it. Will see if any more side effects tonight during or after sleep. If so I will make an appointment to see my Doctor.
45 minutes after the injection  symptoms started as tingling of lips, then tingling of tongue, then my throat felt dry, hard to swallow. I drank fluids thinking that might help.  The symptoms got stronger in a few hours when my heart beat was irregular and only 51-57bpm. I laid down and took my blood pressure which was normal and heart beat became normal. Later I could tell my lips and tongue were swollen. I live alone and had no way to get to the hospital so  late at night . I called my primary doctor to see if I could be a walk-in and the nurse said to go to the ER immediately.  my neighbor brought me. There I was given steroids and Benadryl and monitored for a couple of hours. I am on prednisone for 5 days total and was told to take two Benadryl if symptoms return. I will take it now, because my throat still feels funny.
Sore throat; aches/pains; Fatigue; Congestion; This non-serious case was reported by a consumer and described the occurrence of sore throat in a 72-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 24-SEP-2023, the patient received Shingles vaccine. On 26-SEP-2023, 2 days after receiving Shingles vaccine, the patient experienced sore throat (Verbatim: Sore throat), pain (Verbatim: aches/pains), fatigue (Verbatim: Fatigue) and respiratory tract congestion (Verbatim: Congestion).  The outcome of the sore throat, pain, fatigue and respiratory tract congestion were not resolved.   It was unknown if the reporter considered the sore throat, pain, fatigue and respiratory tract congestion to be related to Shingles vaccine.     It was unknown if the company considered the sore throat, pain, fatigue and respiratory tract congestion to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-SEP-2023 The patient self-reported this case. The patient had sore throat, aches, pains, fatigue and congestion. The symptoms were not treated.
pt recvd vax 11OCT95 in lt deltoid started seein rx 13OCT95 states posterior & anterior upper lt arm is red & hot to touch;site of inject swollen to size of orange;no rash or difficulty breathing;PHN instructed pt to TC personal physician
seizure disorder (rolls eyes, arms stiffen, purses lips); onset 27APR93 Phenobarbitol
EMS notified 7:02 (Numbness in tongue) reported to staff by Pt. VS taken BP 104/80 P- 86 O2 98. 07:04 Pt now complains of numbness in upper extremities. BP 125/82 P-88 O2 96. 07:10 Pt states feels like goin to pass out. When asked further questions pt unable to form words with tongue. Starts crying. BP 132/88 P. 91 O2 @ 95% EMS on scene. At hospital gave BENADRYL and steroids.
Began experiencing double vision 48 hrs after receiving the Fluzone Quadrivalent flu shot.  Condition worsened over the following 48 hrs.  Had body aches, chills, some diarrhea, nausea, slight headache, fatigue and insomnia.  These effects continued but decreased over the following days.