chrisvoncsefalvay/vaers-outcomes huggingface dataset:
11/19/19: Fever (100.4 PO) and rash onset in the afternoon following flu vaccine administration earlier that morning.  Per parent fever (to touch) x 2 days.  Slightly pruritic non-urticarial rash progress to trunk (chest/abdomen, back) and arms the morning following vaccination.  It then progressed to b/l lower extremities  and the trunk cleared by 11/22/19.  Face, genital region spared.  Pt evaluated on 11/22/19 - afebrile, felt well except for concern about the appearance of rash.  Dx: Erythema Multiforme rash b/l lower extremities, buttocks, R palm and b/l upper extremities.   Loratadine with positive effect.  Pt re-evaluated 11/25/19 - rash nearly resolved, pt feeling well.
One week after vaccine I had a red raised rash that was hot to the touch. It was like that all night on Saturday night. I put ice on it.The next day it was less red and by Sunday night was gone.
I signed up for the database and just noticed that I gave an incorrect answer to the Health Check-In. The answer should have been that I was unable to perform normal daily activities. I'm entering this here because I could find no other way to correct my response.
Information has been received from a registered nurse (R.N.) referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were vaccinated with MMR II (rHA) (K002036, expiration date 10-FEB-2016; lot# K005431, expiration date 15-APR-2016; lot# K009957, expiration date 17-JUL-2016; dose and route were not reported) that had been improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient came to pharmacy and said she has muscle pain from flu shot. She has been experiencing discomfort since after the shot. We asked that patient contact her provider and she said she will call tomorrow.
has bradycardia; sprained his ankle; his heart rate was 45/had a slow heart rate/he has never had a slow heart rate like that; This is a spontaneous report from a contactable consumer or other non-healthcare professional (parent). A 14-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date in Aug2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced has bradycardia. On an 12Sep2021, the patient sprained his ankle and his heart rate was 45/had a slow heart rate/he has never had a slow heart rate like that. The reporter stated, the 14 years old son received the Pfizer vaccine the first dose about three weeks ago and he received the first dose in a Vaccine three weeks ago, he was healthy with no medical history and today he sprained his ankle, so we had to take him to the ER and they took his vital signs and his heart rate was 45 and he is never had a heart condition or abnormal heart rate. So he was due to get the second dose of the vaccine. The reporter enquired if that was the side effect bradycardia or heart arrhythmia. The reporter asked if this was a side effects heard before. The reporter stated, the reporter don't know if it was a side effect of the Pfizer vaccine but he has never had a slow heart rate like that. So the reporter was supposed to take him for the second dose actually today and was not doing that. The reporter asked for opinion and recommendation as what should be the next step. The report was not related to a study or programme. On 12Sep2021, the patient underwent lab tests and procedures which included heart rate: 45 and vital signs: unknown result. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Mild fever, back and rib pain, no cough, no smoking. Left deltoid vaccination site= 5mm pustule with erythematous ring < 2cm in diameter. Dx= mild rxn to Smallpox vaccination. Temp 100.0
This case was reported by a pharmacist via call center representative and described the occurrence of guillain barre syndrome in a 61-year-old male patient who received SHINGRIX (batch number 79N59, expiry date 30th January 2020) for prophylaxis. Concurrent medical conditions included diabetes. On 21st May 2018, the patient received the 1st dose of SHINGRIX .5 ml. In May 2018, 7 days after receiving SHINGRIX, the patient experienced Guillain Barre Syndrome (serious criteria hospitalization and GSK medically significant), tingling of extremity, numbness in feet and chest pain. On an unknown date, the outcome of the Guillain Barre Syndrome, tingling of extremity, numbness in feet and chest pain were unknown. It was unknown if the reporter considered the Guillain Barre Syndrome, tingling of extremity, numbness in feet and chest pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a registered pharmacist. The patient received SHINGRIX vaccine on the right arm. The patient experienced tingling of feet and numbness, then developed chest pain and was seen by cardiologist. The patient was referred to neurologist who performed spinal tap and was diagnosed with Guillain-Barre Syndrome. The patient was hospitalized for a period of time for treatment as well. The reporter was unsure of exact dates or length of hospitalization. The contact details of the physician was provided.
COVID-19; COVID-19; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported by the consumer that his father was already administered his first dose of Pfizer COVID-19 Vaccine because he was of advanced age. His father then tested positive for COVID-19. His father was scheduled to receive second dose of Pfizer COVID-19 Vaccine tomorrow morning at 10:00. He called to ask if his father could still get the second dose of Pfizer COVID-19 Vaccine with ongoing COVID-19 or if they should delay second dose. Caller reported that he himself also tested positive for COVID-19 but had not been administered any doses of Pfizer COVID-19 Vaccine. Outcome of the events was not recovered.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
One week after injection, site started to itch. Then spread to surrounding area.  rash appeared.  Tried OTC hydrocortisone which did not help.  one week later used Triaconolone which helped after 2 applications, but reappeared again a few days later.
Faint urticaria 2 days after vaccine. Benadryl cream and PO Benadryl if rash continues after cream application.
headache (constant, more intense in AM/PM), 2 capsules in morning and at night, dampened but didn't completely remove nausea (constant, worsened with food) night sweats (only for first four nights post vaccine) fatigue (constant since vaccine)
A 5 yr old female pt had received a SC, left thigh, fourth dose injection of Ipol, lot number 40638; an IM, left thigh, fifth dose injection of Infanrix, lot AC14B018AA; and a SC, right thigh injection of MMR vaccine, lot number 0377R; on 05May06. The next day, the pt developed a large local reaction of redness and swelling measuring six inches in diameter over the IPOL and Infanrix vaccination sites on the left thigh. Two days later, the pt was evaluated and prescribed ice to the site and Benadryl for any itching. No diagnostic or lab tests were performed. At the time of this report, the pt's recovery status was unk. Follow up information received on 07Jun06 from a healthcare professional. The event did not require Benadryl administration. The reporter confirms the low number as Y0638. It was unk whether the redness and swelling crossed over any joints. Per the reporter, the duration of the event was three to four days.
Mom reports redness and swelling in right leg. Mom took child to Dr on 10/31/2008. Started oral antibiotics. Took child to ER on 10/31/2008 and spent 8 hours in ER. 2 doses of IV CLINDAMYCIN. CLINDAMYCIN given. Patient then took 14 days oral CLINDAMYCIN. Mom said child had 6x5 red area on right thigh. Diagnosis of cellulitis per ER doctor per mom.
Immediately after administration, the patient slid off the chair and bumped her head on the trash can. She came to, but did not remember what happened. She was pale in color and started to perspire. We gave her water and was asked to lay on the floor. No medication was given and patient concentrated on breathing until she was able to get up. She layed on the floor for approximately 5 minutes until she was feeling better.  We continued to monitor her until 4PM
This spontaneous report as received from a nurse practitioner refers to a 25 year old female patient. The patient was not pregnant. In 2008 the patient was vaccinated with the first dose of GARDASIL (Lot# and dose not reported) intramuscularly. The second dose of GARDASIL (Lot# and dose not reported) was received intramuscularly in 2010. On 29-MAY-2013 the patient was vaccinated with the third dose of GARDASIL (Lot # and dose not reported) intramuscularly. Concomitant medications included tretinoin cream and erythromycin cream for acne, and "Plan B emergency contraceptive" (14-MAY-2013). On 29-MAY-2013, the day of vaccination, the patient experienced dizziness and nausea. And she felt fine on 2nd day post-vaccination. On 3rd day post-vaccination, on 31-MAY-2013, the patient experienced fever, chills and muscle aches to the point where she could not get out of bed. And she felt fine on 4th day post-vaccination. On 5th day post-vaccination, on 02-JUN-2013, the patient experienced fever, chills and muscle aches to the point where she could not get out of bed. And she felt fine on 6th day post-vaccination. The nurse instructed the patient via phone to take TYLENOL if fever and/or muscle aches re-occur. It was not known if the patient sought medical treatment elsewhere. Outcome and drug causality was not reported. Additional information has been requested.
Patient states that she was give the Fluzone HD on 9/10/19  then on 9/13/19 she experienced  hives and lost her voice. On 9/21/19 she experienced swelling in her face. During this time period she was administered Synvisc injections on 9/11/19 and 9/18/19 . Patient is not getting worse with her symptoms but was counseled and advised to speak to her physician if symptoms worsen or persist.
Patient reported issue with SHINGRIX. Patient had fever, pain in inside of her mouth, stomach hurt, lump feeling in the arm, headache and shaky.
Patient c/o throat feeling tight and difficulty with swallowing. Stated symptoms the same as with shellfish allergy. Face and neck area were flushed. Benadryl 50mg IM given in right arm. Pulse at 80 BPM throughout the event, alert and oriented, normal breathing. Benadryl took effect within 5 minutes with person stating she could feel her throat loosening up, and tongue feeling smaller.   Requested no epinephrine unless really needed. Does carry and EpiPen with her. Observed for one hour after event pulse 78  BPM at discharged. Advised to take Benadryl every 4 hours as needed and to come to ED with any return of worsening symptoms. Escorted to car where family member will drive her home.
Hot, vision decreases  Vital Signs: BP 108/58 HR 68 Resp 18 O2Sat 98 Skin Signs: Diaphoretic  Circulation: Cap refill <2sec  Initial Treatment: Supportive and observation 1:02 PM Vital Signs: BP 128/68 HR 70 Resp 16 O2Sat 99 Skin Signs: Warm and dry  Circulation: Cap refill <2sec  Respiratory: Breath sound clear bilaterally  1:17 PM  Vital Signs: BP 132/72 HR 74 Resp 16 O2Sat 99 Follow up Treatment: Hydration and supportive  Notes:  Complete recovery reported by patient. Discharged to self. Continued to inform medical personal of this episode.
8 days after injection the upper left arm. Started getting sore and as the day moved on the pain has increased. Around 1800 checking the area not blotchy raised areas as an allergic reaction (hives).   Iced the area and took a 25mg generic benadril tablet.
Information has been received from a physician concerning a 17 year old male who on 19-MAY-1993 was vaccinated with a first dose of MMR II (route, site, dose and lot number not reported). On 25-JUN-1997, the patient was vaccinated with a second dose of MMR II (route, site, dose and lot number not reported). On 10-NOV-2009, the patient experienced mumps (thought the date diagnosed was reported as 16-NOV-2009). On 16-NOV-2009 the patient had the following exams done: IgM (<1:10) negative, IgG (>1.10) 5.28, serum amylase 5.28. The patient was afebrile and had parotitis. At the time of the report the outcome for mumps was not reported. Follow up information has been received from the physician who reported that the 16 year old patient at symptoms onset date experienced mumps on 14-JAN-2010 (previously reported as 30-NOV-2009). The date diagnosed was reported as 15-JAN-2010 (previously reported as 16-NOV-2009). The patient had right parotitis. On 15-JAN-2010, the blood work test showed IgM <1:10, IgG 7.23 and serum amylase 69. At the time of the report the patient's outcome was unknown. This is one of several reports from the same source. No further information is available.
Patient presented to emergency department on 8/20/2021 with fatigue. She had tested positive for COVID-19 on 8/19/2021. She was admitted and started on dexamethasone. She was discharged on 9/1/2021 to a skilled nursing facility.
patient felt dizzy and unresponsive approximately 1 minutes. no breathing  issue and had normal pulse and BP. no treatment was provided. patient felt fine and completely recovered after 10 minutes.
Dosage Error, Booster Dose: Pfizer-BionTech 5-11 formulation (orange cap) administered to a person 18 years or older.  Patient notified and was informed that repeat dose was available.
Pt recvd vax & 3 wks later pt devel elevated SGOT, elevated LDH, low hemoglovin & hematocrit, dec red blood count & h/a;
This spontaneous case was initially received on 19-Oct-2015. The case report was received from a Health Professional and concerns a patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 16-Oct-2015  16-Oct-2015, Batch no: U55106, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 16-Oct-2015, after starting/treatment with AFLURIA the patient experienced Fever, Chills, Headache, Vomiting. No antipyretic treatment administered. For relevant test results see appropriate report section.
Part of the dose is lost; Needle was not screwed tightly; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Part of the dose is lost) and DEVICE CONNECTION ISSUE (Needle was not screwed tightly) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced UNDERDOSE (Part of the dose is lost) and DEVICE CONNECTION ISSUE (Needle was not screwed tightly). On 02-Apr-2021, UNDERDOSE (Part of the dose is lost) and DEVICE CONNECTION ISSUE (Needle was not screwed tightly) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was provided Treatment information was not provided
Client admitted to  St Luke's for chest pain, SOB, and aortic stenosis requiring oxygen.
Joint pain in knuckles on fingers, knees, ankles, and wrists; slight headache; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK4176), via an unspecified route of administration in the left arm, on 22Jan2021 at 13:45 (at the age of 37-years-old) at a single dose for COVID-19 immunisation. Medical history included asthma, high cholesterol, and allergies to mushrooms. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no concomitant medications taken within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced slight headache on 22Jan2021 at 21:00 and joint pain in knuckles on fingers, knees, ankles, and wrists on 29Jan2021. The events were reported as non-serious. The clinical course was reported as follows: The patient started to feel a slight headache a few hours after vaccination, which had gotten worse and at the time of reporting, it was week 3. The patient also experienced joint pain in knuckles on fingers, knees, ankles, and wrists. The joint pain started a week after vaccine administration. The patient never felt joint pain before until now. The patient did not receive any treatment for the events. The clinical outcome of slight headache and joint pain in knuckles on fingers, knees, ankles, and wrists was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
golf sized hard bump at the injection site; hot to touch at the injection site; which is sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (golf sized hard bump at the injection site), VACCINATION SITE HYPERSENSITIVITY (hot to touch at the injection site) and VACCINATION SITE PAIN (which is sore at the injection site) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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-Mar-2021, the patient experienced VACCINATION SITE MASS (golf sized hard bump at the injection site), VACCINATION SITE HYPERSENSITIVITY (hot to touch at the injection site) and VACCINATION SITE PAIN (which is sore at the injection site). At the time of the report, VACCINATION SITE MASS (golf sized hard bump at the injection site), VACCINATION SITE HYPERSENSITIVITY (hot to touch at the injection site) and VACCINATION SITE PAIN (which is sore at the injection site) outcome was unknown.            No concomitant medication were provided  Treatment medication was not provided.  Action taken with mRNA-1273 Moderna vaccine was Not applicable
Sinuses are irritated, runny nose, ear aches, vomiting, coughing, sore throat. Started the next morning after receiving vaccination. Took Tylenol Cold and Sinus day and nighttime, Dayquil and Niquil, sweet oil for earaches.
After Proquad given leg became swollen and red, given Benadryl 25 mg  every 4 hours and use ice
12/10/22  I woke up and felt totally fine. That afternoon I was visiting my friend and I started feeling sniffly and my throat was sore.   That evening, I tested positive with a home COVID test.  I had a runny nose and was feeling congested, but I did okay.  I called my doctor?s office on 12/10/22 and I was prescribed Paxlovid. I began taking the Paxlovid on 12/11/22 around 8:30am.  I had mucous in my chest and still a scratchy throat. On the night of 12/12/22, I woke up because I was having trouble breathing and would have to sit up to breathe.  This happened several times during the night going into 12/13/22.  After I finished the Paxlovid, I continued to feel congested and sniffly. I occasionally would have a cough, it felt like a mild cold. Then I felt better.  I thought I had fully recovered, then yesterday I went out for the first time and I felt sniffly and I came home. I tested for COVID with a home test and it was negative.
Within a few hours below the injection sight, not at the site, a 3"x3" area of skin turned very red and was very hot to touch and tender. The muscle was sore, as was expected following the injection. The 3x3 area was inflamed and stayed red, hot to touch and at times was bumpy under the skin as the area moved down towards the elbow over a 4 day period. Every few hours you could see the red patch had moved downwards on the arm. The whole arm wasn't increasing with the size of the patch, the patch area was moving without expanding.
Sore arm at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old male patient received bnt162b2 (BNT162B2), (Age at Vaccination  : 32 years) administered in arm left, administration date 23Mar2021 10:30 (Lot number: ER8730) at the age of 32 years 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: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "Sore arm at injection site".  Additional information : No Covid prior to vaccination. No covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Swelling in feet; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling in feet) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Cholesterol. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (COMBIVENT) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling in feet). At the time of the report, PERIPHERAL SWELLING (Swelling in feet) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Right Bells palsy. treated with acyclovir, prednisone, lortab and lacrilube, by ER physician. Seen by me on 11/19/2009, she was getting better, but still having discomfort to right eye and showing asymmetry to face. I added Super B complex vitamins and Refresh ointment to  apply at bedtime. 12/1/2009 Ed records for 11/16/2009, patient with c/o's rt facial droop, slurred speech, unable to close rt eye and headache. Dc Dx Bell's Palsy, Tx prednisone, Acyclovir, Lortab, Lacrilube eye gtts 12/1/2009 PCP records for 11/19/2009, patient doing better but still with some rt eye pain, rx'd vit b complex and eye ointment.
Swollen mouth: tongue, lips, inside lips (not gums, throat or other);  injection given 6/3/2022; onset of swollen mouth 6/11/2022; duration approx. 10 days.  I am unsure if there is a relationship between the 2nd booster shot and swollen mouth. No changes in home or diet can account for this swelling of the mouth. Am unsure whether I burned my mouth initially or whether my mouth was beginning to become sensitive and swollen. Mouth burns heal much more quickly in my experience and do not involve the external  lips. Doctor advised rinsing with salt and seeing if the inflammation would resolve with time and an NSAID