chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Burning feeling on skin, upper back area; This non-serious case was reported by a consumer and described the occurrence of burning sensation skin in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.  Concurrent medical conditions included blood pressure high and cholesterol. Concomitant products included amlodipine and rosuvastatin.  On 02-MAY-2023, the patient received Shingrix. On 03-MAY-2023, 1 days after receiving Shingrix, the patient experienced burning sensation skin (Verbatim: Burning feeling on skin, upper back area). The outcome of the burning sensation skin was not resolved.  It was unknown if the reporter considered the burning sensation skin to be related to Shingrix.  It was unknown if the company considered the burning sensation skin to be related to Shingrix.  Additional Information: GSK Receipt Date: 05-MAY-2023 This report was submitted by public reporting reference via the online direct entry reporting system.  The reporter had self-reported for himself and had burning feeling on skin on upper back area day after getting the vaccine but no sign of any rash. The Skin appeared to be normal. The symptoms was not treated. The reporter had consented to follow up.
Protocol to dilute Pfizer 5-11yrs old wasn't followed.  vial wasn't not diluted.  no s/s noted after 15 minutes of observation period was over.
5 mins after inject, dizziness 0954:  Severe left ear pain, that minimized and I developed bilateral cheek/mouth numbness 1004: Numbness developed in my mouth, tongue and throat 1030: Sitting up right and with feeling of left sided drift 1230: Numbness going down my chin and throat  1530:  Drinking water, coughing up water, severe throat pain, numbness all over face, RUE, and going down chest. Took a dose of PO Zyrtec OTC 1600: Spouse and son noticed right sided face mouth drooping, right side of lip not moving. RLE felt like weight on my leg 1715: Went to ER, rec'd 1L of NS, IV Benadryl, IV Solu-Medrol, IV Pepcid 2300: Noticed my face was symmetrical and RLE heaviness gone 5/14:  Continued with numbness around mouth. No RUE, Throat or RLE pain  05/15: 1050: Feeling better, mild HA. on PO Prednisone taper
This morning pt noticed red, raised area on back of left arm (injection site of Varicella vaccine) - not painful. Pt was examined at nurse visit and advised to ice area & apply either BENADRYL cream, Hydrocortisone cream, or take BENADRYL PO (per Dr) and call us if it worsens/becomes painful.
This spontaneous report as received from a registered pharmacist refers to an unknown number of patients who were vaccinated with doses of GARDASIL (Lot # not reported) on an unspecified date, that were exposed to 29 F for 15 minutes. No adverse effect was reported. Additional information has been requested.
w/in 24hr of vax pt exp flu-like sx characterized by fatigue, dizziness, h/a, fever & nausea;pt also exp inj site swelling;2 days p/vax pt devel urticaria from shoulder to elbow;
patient stated diagnosed with cellulitis in right arm since vaccination with fever and rash, patient currently on antibiotics
At around 4:00 p.m. the same day of receiving the vaccine I started feeling slightly dizzy which progressed. Went to bed early evening to lie down, assuming possible side effect from vaccine.  Also felt very slight feeling of nausea. I got up a couple of times to go to bathroom and still felt slightly dizzy as I walked into bathroom each time. Overnight, but before morning found myself sweating a lot as if I might have a fever. It was not hot in the loft where I was sleeping; however. I changed into a tiny slip. By the next morning I felt better but was still slightly dizzy when I sat up in bed. I started to feel less dizzy as the morning progressed and got up to eat mid morning. Between 1:30 and 2:30 p.m. Saturday (the following day) I felt fine and went outside. I called my insurance company's 24-hour nurse on Saturday but have not yet contacted doctor. During time I felt dizzy  as a precaution I would not have gotten into my car to drive anywhere and did not feel bad enough to call taxi to go anywhere either.
Patients states her shoulder is hurting evening when she laying down.  shoulder injury related to vaccine administration (SIRVA).
Information has been received from a physician, via a company representative, regarding a female patient (age not specified), who on an unknown date was vaccinated IM with a dose of Gardasil (Lot # not provided).  Concomitant therapy included DTaP (manufacturer unspecified).  Following the vaccination with Gardasil the patient fainted.  At the time of this report, the outcome of the event was unknown.  No further information is available.
foot swollen; foot painful; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (foot swollen) and PAIN IN EXTREMITY (foot painful) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced PERIPHERAL SWELLING (foot swollen) and PAIN IN EXTREMITY (foot painful). At the time of the report, PERIPHERAL SWELLING (foot swollen) and PAIN IN EXTREMITY (foot painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and treatment information were reported.   This case was linked to MOD-2021-194324 (Patient Link).
Patient reports "cold Sweats" headache and body aches.Symptoms began 06/21/07. Patient leaving on boat, states does not have time to come in for check.
ADMISSION: 12282021 - 70-year-old male presents to the emergency room with acute onset of shortness of breath and chest discomfort this evening.  Patient states that he was getting ready for bed when he had a sudden onset of shortness of breath and epigastric discomfort and burning sensation.  Patient has had some nausea.  Patient has a history of coronary artery disease and has had a coronary artery bypass graft approximately 5 years ago at a local Hospital.  Patient is from  another area.  He is in the area currently visiting his children.  Patient has not had a cough or fever.  He has been fully vaccinated for COVID plus a booster. He has not had any known exposure.  His COVID swab is positive in the emergency room tonight.  Prior to his sudden onset of symptoms this evening he reports that he was feeling good and was not having any symptoms.  Patient reports that he has a past history of coronary artery disease, hypertension, diabetes mellitus, hyperlipidemia.  He is a nonsmoker.  No alcohol use.  His current home medications are unknown.  At the time that I have been notified to admit the patient his serial troponins are pending.  A CBC is pending.  The patient has a minimally elevated proBNP.  Chest x-ray does show bilateral infiltrates which could be consistent with pulmonary edema or COVID.  Patient denies having a history of congestive heart failure.  He has been given Lasix in the emergency room and has had a brisk diuresis.  He reports that overall he has been feeling better after his diuresis.  I have been asked to admit the patient for COVID pneumonia with hypoxia.  The patient was hypoxic on presentation and initially required 6 liters/minute of oxygen by nasal cannula.  He currently has been weaned down to 3 liters/minute.    PATIENT IS STILL INPATIENT AT THIS TIME.
BODY ACHES; CONGESTION; COVID-19; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 vaccination. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. 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 01-DEC-2021, the patient experienced covid-19. On an unspecified date, the patient experienced body aches, and congestion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient had not recovered from covid-19, and congestion, and the outcome of body aches was not reported. This report was non-serious.
Bruise (1 inch long by 1.5 inches wide) on top of right deltoid right after vaccination. A few hours later, rash and redness right underneath the injection site, which got progressively bigger and redder the days after (currently on day 4 after vaccination and it currently measures 3.5 inches long and 4.5 inches wide). Very painful, itchy, and warm to the touch. Other adverse reactions include headaches, nausea, low grade fever (under 100) and extreme fatigue for three days after vaccination. (provider who administer the vaccine) was contacted on 09/12/2022 (video visit request)
Legs were trembling and she couldn't hardly walk; Legs were trembling and she couldn't hardly walk; She was feeling pretty bad; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administration date 06May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TREMOR (non-serious), GAIT DISTURBANCE (non-serious) all with onset May2021, outcome "unknown" and all described as "Legs were trembling and she couldn't hardly walk"; FEELING ABNORMAL (non-serious) with onset May2021, outcome "unknown", described as "She was feeling pretty bad".  Additional information: Patient explained that her legs were trembling and she couldn't hardly walk. Soon as she got inside she sat in a chair in the living room and stayed there from 330 until 1am the next morning. She was feeling pretty bad.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt had a Pfizer COVID-19 vaccination about 3 weeks prior.  She received the injection at the right upper arm.  Soon-after the vaccination, she developed a ?warm, flushing feeling? at the right upper arm, right upper shoulder and then the right lateral neck.  This resolved after about 2 minutes.  She had a second Pfizer COVID-19 vaccination today.  She received the vaccination in the right arm.  Soon-after she developed a ?warm, flushing feeling? at the right upper arm, right upper shoulder and right lateral neck.  This resolved after about 2 minutes.   After the 30 minutes observation period, she felt well and she left the building.  Minutes later, she noted right-sided dysphagia.  A few minutes later, she developed left-side dysphagia.  She was able to swallow liquids and solids.  She returned to the vaccination site. Subjective:  On arrival, she was well-appearing and was ambulatory.  She was speaking normally.  She drank apple juice. Denied fever, chills, flushing now, otalgia, nasal congestion, rhinorrhea, sore throat, neck pain, vocal changes, chest pain, cough, wheezing, dyspnea, abdominal pain, nausea, vomiting, diarrhea, UIC after LMP, joint pain, myalgias, rash, headaches, dizziness, weakness, parathesias.  PMH:  Illnesses:  Possible allergy to tree nuts, including almonds and cashews.  Surgeries:  None.  Medications:  None.  No known drug allergies.   LMP:  04/03/2021  No tobacco, ETOH or other recreational substance use. Vital signs at 1:23 PM: BP:  130/90, P: 80, RR:  14, O2 sat was 100 % on room air.  Gen:  No apparent distress. Drank a can of apple juice without difficulty.  HEENT:  AT.  PERRL bilaterally.  EOMI bilaterally.  Nasal mucosa was pink.  No oral lesions.  Posterior oropharynx was pink, moist, symmetric and without lesions.  Neck:  Supple.  No masses.  Trachea is at midline.  No LAD.  CV:  RRR.  No m/g/r.  Pul:  CTA bilaterally.  Abdomen:  +BS?s.  Soft.  NT.  ND.  Ext:  No clubbing, cyanosis or edema.  Strong pulses.  Cap. Refill < 2 seconds throughout.  No TTP.  Neuro:  Grossly non-focal.  Vital signs at 1:47 PM. BP:  140/98  P:  63  RR:  14  O2 sat was 100 % on room air. She noted that she was feeling ?better? and that she still had bilateral dysphagia.  Assessment:  dysphagia due to allergic reaction, other.  Plan:  Discussed the s/s of anaphylaxis.  Discussed treatment options.  Recommended that she be transported to the nearest hospital.  She noted that she has insurance and that, as she was feeling better, she would have her husband drive her to the hospital, directly, now.  Recommended that the pull-over and call emergency assistance prn.   They verbalized understanding of, and agreement with, the plan.
Severe muscle, joint and nerve pain in legs. Couldn't walk or sleep. Symptoms still exist, though not as severe. This has lasted for three and a half weeks past the booster. This was a Pfizer booster. I previously had gotten the Moderna in the spring. I weigh 127 lbs, and I feel like I may have been given too much of a dose.  My physical therapist (not my primary doctor) told me that several of her patients experienced similar reactions.
had a seizure 3 hours following administration of bivalent booster dose, unknown as to how long out, slow recovery reporting brain fog
Doses administered after more than 1 temperature excursion; Doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021 at 1:39 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 02-Feb-2021 at 1:39 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter.  The patient age was reported as 72.04.  No concomitant medication was provided.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.    No treatment medication was provided
Patient experiencing extreme shoulder and back pain shortly after vaccine was administered. She is following up with her PCP.
legs have swelled up; burning sensations in legs and feet; tingling sensations in legs and feet; knees were hurting, joint pain in knees; Muscle pain in her legs; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (legs have swelled up), BURNING SENSATION (burning sensations in legs and feet), PARAESTHESIA (tingling sensations in legs and feet), ARTHRALGIA (knees were hurting, joint pain in knees) and MYALGIA (Muscle pain in her legs) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 immunization.     Concurrent medical conditions included Arthritis (At baseline). Concomitant products included FISH OIL, MULTIVITAMIN [VITAMINS NOS] and VITAMIN D3 for an unknown indication.    On 02-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 PERIPHERAL SWELLING (legs have swelled up), BURNING SENSATION (burning sensations in legs and feet), PARAESTHESIA (tingling sensations in legs and feet), ARTHRALGIA (knees were hurting, joint pain in knees) and MYALGIA (Muscle pain in her legs). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Adverse event, at a dose of UNK dosage form and IBUPROFEN for Adverse event, at a dose of UNK dosage form. At the time of the report, PERIPHERAL SWELLING (legs have swelled up), BURNING SENSATION (burning sensations in legs and feet), PARAESTHESIA (tingling sensations in legs and feet), ARTHRALGIA (knees were hurting, joint pain in knees) and MYALGIA (Muscle pain in her legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Reported dark colored emesis x2 episodes Tachycardia Tachypnea, SPO2 <89% on room air- Started on Oxygen   Recently was being treated for constipation with episodes of emesis prior to vaccination
The evening after receiving vaccine, patient reported significant body aches, chills, headache, nausea, diarrhea, and low grade fever (up to 101, but controlled below 99 with Tylenol). Continued throughout the next day, and into the 3rd day. Patient was then evaluated, and ruled out for COVID infection.
was diagnosed with Mononucleosis; This is a spontaneous report from Pfizer-sponsored program. A contactable consumer (patients mother) Parent reported for a patient (reporters son).   An unspecified age male received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported, Expiry date was not reported) via an unspecified route of administration on an unspecified date in Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received 1st dose of the Pfizer Covid-19 vaccine 3 weeks ago and was diagnosed with Mononucleosis on 19Apr2021 and is currently taking steroids. His second dose was scheduled on 26Apr2021. The reporter wanted to ask if it was okay for her son to take the 2nd dose while under steroid medication. Treatment received for the event of steroids. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Similar to after the first dose, I was tired, achy, my head hurt, and my should felt bruised. All of that I was expecting. But the morning after this shot I woke up with the worst sore throat I've ever had in my life. It was extremely painful and difficult to swallow. All I could get down were liquids. I also had a countless number of tonsil stones that were visible at the back of my throat. I thought I must have caught step or gotten Covid because I hadn't heard of anyone else getting these symptoms after their shot.  Symptoms didn't subside until seven days post-shot (I got the shot on Tuesday morning and barely felt well enough to go to work the following Monday morning).
fever (?);skin pale-bright red blotches over body;given DPH at ER;
swelling at the site of injection; redness at the site of injection; hardness at the site of injection; fever; soreness at the site of injection; A spontaneous report was received from a healthcare professional concerning a 64-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events soreness, swelling, redness, hardness, fever at the site of injection.  The patient's medical history include past medical history of 3 cancers and lung issues, rheumatoid arthritis, and skin disorder due to her cancers and surgeries. No relevant concomitant medications were reported.  On 4 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 015M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 4 Feb 2021, the patient experienced the event soreness . On 11 Feb 2021, the patient experienced the events swelling, redness, hardness, fever at the site of injection. Treatment details included Ice, Tylenol, and Aleve.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events soreness, swelling, redness, hardness, fever at the site of injection was unknown.
eyes rolled back, gen tonic-clonic like movements described by mom lasted less than 15-20seconds w/perioral cyanosis;
VACCINE WAS ADMINISTERED TOO LOW ON THE ARM AND CAUSE PAIN, REDNESS, AND SWELLING.
I had pain on the left side under my ribs and then I developed a painful rash.  I saw my doctor and he said it was the shingles.  So apparently I got the shingles from the shingles vaccine.
Received the first, second and third dose of the Pfizer Comirnaty vaccine; Received the first, second and third dose of the Pfizer Comirnaty vaccine; Pressure on her head; Headache; This is a spontaneous report from a contactable consumer (patient) reported for herself that. A 66-years-old female patient received BNT162B2 (, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 3 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 3, SINGLE for covid-19 immunizations. The patient medical history and concomitant medications were not reported.  The patient experienced pressure on her head from horrific headache that lasted 9 days, received the first, second and third dose of the pfizer comirnaty vaccine.  Caller wanted to know if this is a common side effect of the third dose. Caller stated that she feels better now and that her HCP has recommended treatment for her headache. The event outcome was unknown for off label use and extra dose administered and recovered for headache and Pressure on her head.  Response: Spoke from attached document PI Table 4: Study 2  Frequency and Percentages of Participants with Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After Each Dose  Participants 56 Years of Age and Older.  From an independent report in 99 individuals who had undergone various solid organ transplant procedures (heart, kidney, liver, lung, pancreas) the adverse event profile was like that after the second dose."  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
I woke up in the middle of the night after getting the vaccine, I had a severe head ache, chills, nausea, fever, sweating, vomiting, couldn't move. A day later shingles started forming on the bridge of my nose. I spoke to the pharmacist and I let him know what's going on and he really didn't know what to tell me. About a week later the shingles started to go away and a red dry patch formed. I spoke with my dermatologist and I have an appointment scheduled with him in a few weeks.