chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe joint pain/left knee, then left shoulder,then left hip, now it is my right shoulder; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single, then on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced "severe joint pain/left knee, then left shoulder,then left hip, now it is my right shoulder" on an unspecified date. Ever since receiving both Pfizer doses, patient has been dealing with severe joint pain. That pain has randomly moved from one major joint to the other (left knee,then left shoulder,then left hip, now it is his right shoulder). He had never dealt with anything like that before. He would like to know if anyone else was complaining of that type of side effect. He had gone for blood work and everything comes up normal. The patient underwent lab tests and procedures which included blood work: everything comes up normal on unspecified date. The outcome of the event was not recovered.    Information on the lot/batch number has been requested.
On 11-1-07 pt. received flu vaccine and noted pain, redness, nodule, warm to touch 5 X 4 cm area to left arm.  On 11-2-07 reassessed area and noted 4 X 2 cm area remains painful, nodule and warm to touch.
SORE ARM; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age and sex. 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, start therapy date were not reported 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 an unspecified date, the patient experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm. This report was non-serious.
fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   The reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as per the vaccine indication. The age at vaccination was not reported. The patient asked what to take for fever caused by Shingrix.
Recommended by my private physician to get the SHINGRIX vaccine through pharmacy. Went to pharmacy and they administered first dose on 4/2/2018. On 4/3/18, I was terribly sick with diarrhea, nausea, body chills, fever, headache, arm swollen from vaccine and in pain, couldn't eat or drink for 12 hours. On 4/4/18, all symptoms are gone except for pain to vaccinated arm and swelling is coming down slowly, but remains itchy and irritated with less pain.
This case was reported by a consumer and described the occurrence of shingles in a 14-month-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 1 January 2011 the subject received 1st dose of INFANRIX (unknown, right thigh). On 01 January 2011 the parent brought in the subject, a 14 month old breastfed, natural birth son to the emergency room (ER) after a fall. The ER staff recommended a tetanus shot and once it was discovered the subject had had no vaccinations to date, consent was obtained and a primary INFANRIX vaccine was injected into this right thigh leg. On 20 January 2011, 19 days after vaccination with INFANRIX, the subject experienced shingles, impetigo and rash. On 20 January 2011, the mother noticed a rash on the subject's right upper face which she believed to be Impetigo. Since that time the rash had worsened spreading to his forehead, upper and lower eyelids, upper cheek and ending behind his ear. The subject has been seen by his primary care physician, dermatologist and ophthalmologist and his shingles treated with two antibiotics and two topical medications without benefit. The mother now regrets allowing the subject to be vaccinated in the ER at all. It was indicated that the subject's birth weight was 22 pounds however there was a possibility she was mistakenly reported the subject's weight at the time of the vaccination. The subject was treated with antibiotics and unspecified medications. At the time of reporting the shingles, impetigo and rash were worse.
Pt. states that after receiving the 2nd dose of Phizer 03/30/2021, started experiencing symptoms 05/21/2021 of passing out resulting in four fractures in the *Right arm, possible Concussion, broken Jaw, 34 stitches throughout the face, and brain fog. Emergency Room visit 05/21/2021, admitted to Hospital for 7 days then transported to a Rehabilitation center 05/28/2021-06/20/2021. Discharged and continues to experience symptoms of Brain Fog, weakness, and Incontinence.
Child was awake during night of shots and had temperature (according to mother, but did not take temperature to see how high and may also be teething). Mom gave child Tylenol during the night. Now has a red raised rash on all of body except legs. Exposed to 5th disease, 2 weeks ago. Told mom to call doctor now. No respiratory problems. On 6/6/01, mom called next day and said she called the doctor and he said to give baby Benadryl and mom did this and rash cleared up a lot by the next day. No temperature and was to take baby to doctor if it didn't clear up.
03/13/2021 tired, arm swollen, red circle on arm, hot to touch 03/04 hives on the neck and went away within a few hours  Recommendation  cold compress to the area, you could call your PCP for any other recommendations but it sounds like your symptoms are subsiding from what you are stating
This spontaneous report as received from a pharmacist refers to a 19 year old male patient who on 14-AUG-2013, was vaccinated with GARDASIL lot # H015555 dose 1, 0.5ml, intramuscular. Pharmacist reported that patient experienced sudden dizziness and almost fainted. According to the pharmacist the patient "had to be held up by his grandmother" immediately after receiving the GARDASIL injection. The patient was given some food and something to drink and observed for an additional half hour at which point patient was considered well enough to leave the unspecified physician's office. No further information available. Therapy was not discontinued. The outcome of sudden dizziness was reported as recovered/resolved on 14-AUG-2013. The relatedness between adverse event and GARDASIL was unknown.  Additional information has been requested.
Began with very itchy arm, then swelling ,  redness and again very itchy whole upper arm.  Lasted 4 days.
Severe diarrhea about 72 hours after first dose, persisting for about 5-6 days. Also experienced some aches and temperature of about 102 degrees F about 72 hours after first dose, but this only lasted about 1 day.
On 20 Aug 2021, she received her first Pfizer COVID-19 vaccine (Lot FC3181) in the R arm in the morning. On the evening of 22 Aug 2021, she noted itching, red, raised rash on her abdomen, back, arms, legs and face. She took Benadryl without relief and on 24 Aug 2021, went to her PCM who prescribed Prednisone 20mg daily for a 10 day course and Diphenhydramine 25mg every 4-6 hours daily. The lesions gradually resolved after 7 days and she stopped all meds at that time. She reports no other upper/lower respiratory symptoms. She was not taking medications at the time of onset.
Misadministration of H1N1. The child received 2 0.5 ml's over a 4 week time span.
tingling in face; swollen right side of face; A spontaneous report was received from a consumer concerning a 70 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tingling in face/paraesthesia, swollen right side of face/swelling face.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 26 Feb 2021, approximately one hour after the vaccination, patient experienced the event(s) tingling in face/paraesthesia, swollen right side of face/swelling face.  Treatment information was provided as Benadryl and generic zyrtec.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), tingling in face/paraesthesia, swollen right side of face/swelling face was unknown.
3/28 Pt developed whole body rash. 3/29 MD visit Patient has diffused itchy rashes that started last night. No wheezing, shortness of breath, or fever.  Pt speaks full sentences over the phone and provides clear history. No acute distress. No face swollen. No wheezing. ASSESSMENT AND PLAN:  Acute urticaria Consulted allergy specialist, recommendation as follow: Zyrtec 40 mg qd, 20 mg if 20-50 rashes Allegra 180 mg x4  Hydroxyzine 50 mg qhs 2 wks up to 4-6 wks Sedation, avoid driving 4/7 repeat visit w/ MD Per pt "My hives and itching cleared up completely by Friday. The antihistamine was drying me out so much I stopped taking it on Sunday. Yesterday and today I have a really bad headache with a lot of pain in my face. Today is worse. I have pain behind my eyes and my jaw. Motrin or pseudophed don't provide any relief. I tried steam and a nasal rinse. There is a lot of light sensitivity. I don't know if this a migraine or sinus. " Patient had migraine on Sat, imitrex worked for one day but not anymore.  The HA started at the time tapered zyrtec from 40 mg to 30 mg then stopped w/in a few days. Not worse HA ever, no fever, no extremity weakness or numbness. Pt speaks full sentences over the phone and provides clear history. ASSESSMENT AND PLAN: Likely allergy and migraine Will continue current migraine management and restart zyrtec, 20 mg once a day for a wk then 10 mg once a day for 2 weeks.
6-month-old patient received BNT162b2 (BNT162B2); 6-month-old patient received BNT162b2 (BNT162B2); A 6-month-old developed eye-rolling seizures two days after the second dose of the Pfizer vaccine, leading to hospitalization; A 6-month-old developed eye-rolling seizures two days after the second dose of the Pfizer vaccine, leading to hospitalization; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 6-month-old patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN, Lot number: Unknown), for COVID-19 immunization. The following information was reported: SEIZURE (hospitalization, medically significant), EYE MOVEMENT DISORDER (hospitalization), all with latency 2 days after the suspect product(s) administration, outcome "recovered" and all described as "A 6-month-old developed eye-rolling seizures two days after the second dose of the Pfizer vaccine, leading to hospitalization"; OFF LABEL USE (hospitalization, medically significant), PRODUCT USE ISSUE (hospitalization, medically significant), outcome "unknown" and all described as "6-month-old patient received BNT162b2 (BNT162B2)".  Clinical course: It was reported that a 6-month-old developed eye rolling seizures two days after the second dose of the Pfizer vaccine, leading to hospitalization. All symptoms resolved "17 days after onset," and the participant was withdrawn from the study by parental request."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a patient who on 10-AUG-2007 was inadvertently administered ZOSTAVAX instead of VARIVAX. There was no product confusion. The patient was not experiencing any known symptoms. Additional information has been requested.
This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. The patients medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 15-NOV-2017, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (route, dose, frequency and anatomical location were unknown) with lot # N011867 and expiration date 8-NOV-2017 for prophylaxis. No adverse effects reported.; Sender's Comments:  US-009507513-1711USA009458:
(R) shoulder pain & (R) arm pain x13 days, including axillary & neck/chest pain. Unable to sleep well at night because of pain. Pain continues today 3/10/11.
chills after her first vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills after her first vaccine.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concomitant products included ACETAMINOPHEN for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced CHILLS (chills after her first vaccine.). At the time of the report, CHILLS (chills after her first vaccine.) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The medical history was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-068335 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jan-2022: Follow up  contains no new information.
This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (right hand swell), PARAESTHESIA (right hand became very sensitive to touch), GOUT (could be gout), ARTHRITIS (could be arthritis) and PAIN (pain) in a 67-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: FLU [INFLUENZA VACCINE] (many years ago that the patient took the flu vaccine). Past adverse reactions to the above products included No adverse event with FLU [INFLUENZA VACCINE]. Concomitant products included VITAMINS NOS for an unknown indication.    On 25-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced PERIPHERAL SWELLING (right hand swell), PARAESTHESIA (right hand became very sensitive to touch), GOUT (could be gout), ARTHRITIS (could be arthritis), PAIN (pain), INFLAMMATION (inflammation), PAIN IN EXTREMITY (pain on the right thumb and it went up to where the injection site was on the right arm/thumb sore that if they touch anything it painful) and PERIPHERAL SWELLING (right thumb pretty large). The patient was treated with INDOMETHACIN [INDOMETACIN] for Pain and Inflammation, at a dose of UNK, tid. At the time of the report, PERIPHERAL SWELLING (right hand swell), PARAESTHESIA (right hand became very sensitive to touch), GOUT (could be gout), ARTHRITIS (could be arthritis), PAIN (pain), INFLAMMATION (inflammation), PAIN IN EXTREMITY (pain on the right thumb and it went up to where the injection site was on the right arm/thumb sore that if they touch anything it painful) and PERIPHERAL SWELLING (right thumb pretty large) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: not broken.
Case number PHEH2014US010361, is an initial spontaneous report received from a pharmacist on 19 May 2014. This report refers to a 22 year old male patient. He received Men CWY liquid conjugate component of MENVEO (batch number: X13011) without being reconstituted with Men A lyophilized component on 16 May 2014. No adverse event was reported.
I had no reaction to initial Moderna vaccine on 1/15/2021.  After the booster received 2/10/2021 the vaccine site became red, swollen and sore after midnight.  By morning I also had a lot of joint pain, especially in knees and legs.
This case was reported by a nurse via other manufacturer and described the occurrence of flu symptoms in a patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced flu symptoms. On an unknown date, the outcome of the flu symptoms was unknown. It was unknown if the reporter considered the flu symptoms to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not applicable for this report. The reporter saw unspecified flu symptoms in the first 24 hours in about I5 percent of the patients who received SHINGRIX. The lot number and expiration date was unspecified. This information had not been reported to the FDA. No further details were provided.
INFANT REPORTED TO START CRYING, W/UNUSUAL CRY, APPROX. 4 HRS P/ IMMUN, DEVELOPED FEVER, VOMITED ANY FORMULA GIVEN THROUGHOUT NIGHT & CONT NEXT DAY ALTHOUGH CRYING DEC. GIVEN APAP Q 4-6, TEPID BATH & COMFORT. T @ 1500 27FEB91 = 100.2ax.
received a dose of expired Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Herpes zoster (Shingrix) (batch number unknown, expiry date 26th November 2021) for prophylaxis.   On 7th December 2021, the patient received Shingrix. On 7th December 2021, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were reported as follows: Age at vaccination was not reported. The patient received an expired dose of Shingrix on 7th December 2021, which led to expired vaccine used. The health care professional was not in the pharmacy to provide patient's information, lot number or further details. The patient consented to follow up. This was 1 of the 3 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR252431:same reporter US-GLAXOSMITHKLINE-US2021252024:same reporter
Approximately 30 seconds following administration of meningococcal vaccine patient complained of itching at injection site. Hives noted surrounding site along with faint erythema, area outlined. Pruritis resolved after 1 min. but hives persisted localized to the outlined area. Denied any difficulty breathing, chest tightness, SOB, throat tightness, difficulty swallowing, tongue swelling, headache, stomach ache, or nausea. Exam at onset of hives and through 45 min. of monitoring following revealed a calm, alert male in NAD with lungs CTA, no diaphoresis, no facial or tongue swelling and no additional area of hives aside from immediately surrounding the site of injection on the upper left arm. VSS. One time dose of diphenhydramine given and instructed to continue Q6h with follow up tomorrow. Instructed to seek immediate care for any of the denied symptoms above or for any other concerns. On 4/12/2018, patient came back into the clinic for a recheck. Hives had nearly resolved.
drug allergy; This case was reported by a nurse via other manufacturer and described the occurrence of drug allergy in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   The patient's past medical history included hypertension, osteoporosis, hypercholesterolemia and breast cancer. Previously administered products included Ibrance (for breast cancer). Concurrent medical conditions included allergic reaction to analgesics and penicillin allergy. Concomitant products included losartan potassium, metoprolol tartrate and chlortalidone (Chlorthalidone).   On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced drug allergy. The patient was treated with meclozine (Meclizine), ondansetron, levofloxacin and fluticasone propionate. On an unknown date, the outcome of the drug allergy was unknown.   It was unknown if the reporter considered the drug allergy to be related to Flu vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Fluarix and had drug allergy. The patient received Ibrance and feel tried. The patient allergy to opioids.
After receiving the vaccine I felt sick. I had a low grade fever for a couple of days. I had a slight headache and felt crappy. I felt bad for 2 or 3 days. I took Tylenol to relive symptoms.  On Christmas I hung out with my family. Then I found out that my niece had tested positive for covid. 3 days after that I started feeling sick. I tested negative for covid, but I had tested positive for the flu. In January I got covid, and the symptoms were mild. My girlfriend hasn't gotten covid even though we were around each other. My niece and my daughter were also around each other but my daughter didn't catch covid either.
Within 10 minutes of receiving the vaccine patient began to look sleepy and  started to gasp for breath. She called for help  and slouched over in a chair and was moved to lay on the floor. Her feet were elevated and 911 was called.  Epinephrine was given, patient responded by being able to gasp for breath and her face returned to a more natural state. Within 5 min she began to struggle to breath and epi was given again.  Some improvement  did occur. EMS arrived and she was taken to the hospital.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Tachycardia-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium, Additional Details: bp was 104/60, pt reported bp to normally be slightly high. started within 5 min of administration, ~5:20pm
Initial misuse report received from the health care professional on 29 August 2014. A patient (gender and age not reported) had received 0.25 ml dose of FLUZONE instead of 0.5 ml dose on an unspecified date, which led to vaccine under dose. No adverse event was reported. List of documents held by sender: None.
Patient under age 2 was given LAIV intranasally- 1/14/10 TC to mother -No problems reported - TC to CDC - No need to repeat dose.
Extreme hypertension  Needed to add more hypertensive meds to bring down BP BP finally back to baseline on 11/17/23
Localized pain & swelling at injection site x 4 weeks (10/25 reported).
Patient received her first dose of the pfizer vaccine to her left deltoid muscle on 5/24/21.  Patient states her arm was sore for the following 3 days.  Then last night patient states she had increased pain to her left arm and when she awoke this AM she has redness, warmth, swelling and pain to the site. Patient currently has cellulitis and will be treated with 10 days of antibiotics.
Developed severe gastroenteritis on June 16. Was in contact with 10 month old granddaughter who developed symptoms 4 days earlier at day care center. Later notified there was a Covid + baby at this day care center at this time. My symptoms included nausea, severe diarrhea, dehydration and syncope. Symptoms resolved after 48 hours but hit head with syncope. Went to urgent care 6/18 and CT head negative for bleed (Xarelto). Covid test and labs done all negative.