chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had headache and fever, into the second day post vaccine.; Some arm soreness, dissipated after less than 48 hours; Headache a few hours after receiving first dose; Headache a few hours after receiving first dose, alongwith lethargy.; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 15Apr2021 at 15:00 (at the age of 17-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included amfetamine (ADZENYS XR ODT), biotin (MANUFACTURER UNKNOWN) and citalopram (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) and sulfamethoxazole; trimethoprim (BACTRIM DS)  for unknown indications on an unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 18:30, the patient experienced some arm soreness, dissipated after less than 48 hours. The patient had headache a few hours after receiving the first dose, along with lethargy. The patient felt fine until around 4 p.m. The day after into the second day post vaccine on 16Apr2021, the patient had headache and fever. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event arm soreness, headache a few hours after receiving the first dose, along with lethargy and fever was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Severe muscle and bone aches. Felt like the Flu in lower back area. Treated with Naproxin.
COULD NOT MOVE LEGS, ARMS AND UPPER BODY; LOSS OF APPETITE; CHILLS; This spontaneous report received from a consumer concerned a 66 year old male. The patient's height, and weight were not reported. The patient's past medical history included aneurysm in 2012 (rupture killed the nerve with one leg), the aneurysm changed the way he was walking and problems walking and concurrent conditions included ex-alcohol user (Stopped drinking 2 years ago), non-smoker, rheumatoid arthritis, and blood thinner. The patient had no known allergies. The patient had no history of drug abuse or illicit drug use. The patient was previously treated with prednisone. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, 1 total, administered on 03-MAR-2021 in left deltoid for prophylactic vaccination. Concomitant medications included infliximab for rheumatoid arthritis. The last dose of infliximab was in FEB-2021. The patient did not discuss getting the vaccine with rheumatoid arthritis doctor.  On 05-MAY-2021, the patient had more limited movement until could not move legs and was not walking good. It went up from legs to arms, upper body (coded as could not move legs, arms and upper body). The patient went to emergency room at hospital and stayed in hospital for 1 week. The patient went to rehabilitation one week after for physical therapy. The patient was about ninety percentage back to where he was before the vaccine. The patient also experienced chills and loss of appetite. The symptoms lasted 3 weeks and went away.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of appetite, and chills, and was recovering from could not move legs, arms and upper body. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210730947-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Could not move legs, arms and upper body. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE.
Patient's mother c/o "prolonged reaction" to Varicella #2 after 6 days. Reaction appear with erythema on area of Approx 10x12 mm, no induration or increased temp on area, no pain.
Vaccine inadvertently administered. Patient did not show any distress after 1st dose. After speaking with CDC COVID-19 vaccine hotline representative advised us to give 2nd dose vaccine off label.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 19-NOV-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K011562, expiry date: 08-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: EN6198), in left arm, on 30Mar2021 as dose 2, single (Lot number: ER8734), in left arm, on 12Oct2021 as dose 3 (booster), single (Lot number: FP2589), in left arm and on 01Aug2022 as dose 4 (booster), single (Lot number: FP7138) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing); "Elevated cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient received Paxlovid from 27Ma2023 to 31Mar2023 for treatment of COVID-19.
With first short, (R) leg swelled and turned red same day, lasted about 2 days; with third short, red, softball-sized area within 24 hrs; resolved after 48 hrs without concern.
Within 12 hours of vaccination Patient presented with severe head ache, Fever-100.2 .    Nausea, muscle aches, vomiting, chills. Within 24 hours of vaccination Patient was suffering head ache, disorientation, Fever 102.2.  Muscle aches and weakness,   Chills, fatigue.   Day 3 post vaccine patient began to normalize. Day 4 post vaccine patient began regular activities with only lingering loss of appetite, fatigue and head ache.
Dizziness- 10 minutes after Covid 19 vaccin. Low BP, and SOB,- Vasovagal after vaccination . BP 95/76- IV saline bolus in ED - discharged .
Information has been received from a nurse concerning a 57 year old female hospital employee who on 10/12/01 was vaccinated with varicella virus vaccine live. On 10/27/01, the pt developed a continuous fever that ran between 100.3F and 100.5F. On 10/29/01, the pt broke out with 3 chickenpox vesicles which were described as red spots that elevated to a vesicular, itchy rash that erupted and crusted. On 11/13/01, following treatment with ibuprofen (Advil), the pt's fever spiked to 102F. The pt was subsequently, hospitalized for the events and was treated with ibuprofen (Advil), acyclovir and hydroxyzine hydrochloride (Atarax). It was reported that the pt was found to have a non-skin abscess which was being surgically addressed. It was also reported that the pt had total of approx. 12 vesicles which at the time of this report, were resolving. At the time of this report, the pt was still experiencing a low-grade fever. Additional information has been requested. The follow up states that on 11/10/01, the pt ws still febrile, therefore blood work and a chest x-ray were taken. The pt was found to have an elevated white blood cell count and an abnormal ESr however all other diagnostic studies were noted to be normal. The chest x-ray was also reported as normal. On 11/13/01, following treatment with Advil, the pt's fever spiked to 102 deg F. The pt was subsequently hospitalized on 11/14/01 for the events and was treated with Advil, acylcovir, and have a large abdominal abscess which was surgically drained. The pt was hospitalzied for 8+ days and by 12/16/01 had recovered from all of the events. The pt's internist felt that the abdominal abscess was probably not related to varicella virus vaccine live. The reporter felt that the events were important for an other medical event (OMIC). No further info is expected.
Bivalent dose was administered as the 1st dose in primary series; No Adverse Reaction; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Bivalent dose was administered as the 1st dose in primary series) and NO ADVERSE EVENT (No Adverse Reaction) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Bivalent dose was administered as the 1st dose in primary series) and NO ADVERSE EVENT (No Adverse Reaction). At the time of the report, WRONG PRODUCT ADMINISTERED (Bivalent dose was administered as the 1st dose in primary series) and NO ADVERSE EVENT (No Adverse Reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Reaction) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Bivalent dose was administered as the 1st dose in primary series).    Concomitant medications were not reported.  The Moderna Covid-19 Bivalent dose was administered as the 1st dose in the primary series. Treatment medications were not reported.
Major outbreak of chicken pox rash covering entire body following vaccination. Fever around 101. Extreme irritation, loss of appetite, sleeplessness. Oatmeal baths, calamine lotion to treat.
Rash left upper extremity. Tylenol administered by mom. Progressing to 2/16.
1/13/2021 left arm injection site is raised, red and warm to touch about the size of a quarter coin. Still raised today, 1/14/2021.
Atrophy in the left thigh overlying the injection site.  Mother states she noticed this when patient was 10 months old.  Clinically I appreciated the changes when he came in for a flu vaccine in October 2019.   Initially I did not believe the changes were related to vaccines.  In November, when I saw patient for his 12-month Well Check, I began considering the possibility of atrophy of the subcutaneous fatty tissue.  I referred him to pediatric dermatology for further evaluation.   Diagnosis from Dr. (pediatric dermatologist) is not certain, possibilities include lipoatrophy secondary to immunization.  Presumably since mother reports noticing these changes by 10 months old, the most recent injection on the affected thigh would be the Pediarix dose given on May 8, 2019.  Dr. states she has seen this adverse reaction from steroid injections, but never seen it secondary to immunizations.   Other possible causes of the skin changes on the left thigh include morphea and anetoderma (per Dr.'s note).  Unknown if this will cause permanent damage or disability yet.
Membranous nephropathy; This literature marketed report has been received from the authors of a published literature article, titled as stated below, concerning a 56-year-old male patient who was referred or a second opinion regarding MN.The patients medical history included colonoscopy and PSA with result of normal levels. Concurrent conditions and concomitant therapies were not reported.   On unknown date (reported as one month prior), the patient was vaccinated with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (strength, dose, rout of administration, anatomical location, lot number, and expiration date were not reported).  On unknown date, the patient presented with joint pain and bilateral extremity paresthesias. He soon developed marked edema and hypertension, with over 20 lbs weight gain, associated with weakness and unsteady gait. He had taken NSAIDs for pain but no other medications. He was found to have 17 grams of proteinuria/24 hs and was diagnosed with nephrotic syndrome. His renal function was normal. Serological workup including C3/ C4, ANA, RF, ANCA, anti-GBM antibodies, hepatitis panel, SPEP, UPEP was negative. Renal biopsy showed membranous nephropathy (glomerulonephritis membranous). PLA2R was positive (1:40). Concomitantly, he was diagnosed with inflammatory demyelinating polyradiculopathy and was started on prednisone 60 milligram (mg) daily. Over the next several months he showed neurological improvement, and the steroid dose was titrated down. Proteinuria also improved (greater than 1g /24 hrs) and the nephrotic syndrome resolved. Repeat PLA2R levels have been negative.  The causal relationship between the suspect vaccine and the event was related.  Upon internal review, the event glomerulonephritis membranous was determined to be medically significant.  Literature Report.
About 1 month after vaccination of dose 4, I started having sinus drainage, upper airway congestion, and cough. I did a home Covid test on 5-22 which was negative. I noticed on 5-23, I started becoming more congested. On 5-24, I took another home Covid test and it was faintly positive so I went by the Pharmacy and done a drive thru test and it was positive. They recommended I call my doctor and so I called the doctor and left a message. On 5-25, the doctors office called in Paxlovid. I started taking it last night as well as Mucinex. I am feeling slightly better. I am reporting my breakthrough case of Covid.
pt turned bluish gray, unresponsive, had sz activity, trouble breathing, screamed in unusual tone-T101;
Saturday afternoon (2 days after dose) I broke out in extremely bad hives all over my back, face and head. I called ER to see what I should do because this has never happened before. I've never had any allergic reaction to anything and I was concerned since I just received my 2nd dose. ER recommended I come in, since nothing in my normal life changed to cause this also because my lips were getting swollen and throat was scratchy. Once I was checked out in ER they gave me an IV with another antihistamine to get in my system faster. I was releases later that night with a script for prednisone (2 pills for 3 days). Everything was fine Sunday however, i woke up Monday with the rash and hives coming back. I then made another appointment with a Dr, who prescribed more prednisone. Hives have since been gone and not returned.
Patient stated that a couple of days post flu shot his upper arm and shoulder began to ache and over the next several days he has noticed a generlized shoulder weakness. He stated he did not have redness or soreness at the injection site.
patient got immediately dizzy, nauseated got cold sweat. Lasted approx. 15 min hat patient put head between knees cold compress to back of neck. when she felt better gave H20 + crackers
p/vax pt dx w/Bell's Palsy; unable to close lt eye completely or wrinkle forehead on lt side;lt side mouth droop;unable to retain air on lt side;tx tapered dose prednisone & acyclovir;ENT states function at 50-60%;Annual follow-up provides no additional data.
Information has been received from a consumer concerning a male who " a couple of months ago" was vaccinated with a dose of Zostavax (Oka/Merck).  On 13-AUG-2007 the patient's spouse was diagnosed with shingles.  Unspecified medical attention was sought.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
right arm swelling /erythema/induration reaction. Prescribed Keflex/ Benadryl/ Motrin and cold compresses PRN for Mild cellulitis.
severe local rxn-erythema, swelling w/febrile response <24hr p/vax & for 72hr rxn lt arm;
Fever & chills starting at 9/10 pm on the day of the vaccine. Body aches, headache & joint pain by midnight . Fainted around 5:30 the following morning within 24 hours of the vaccine.
Unexplained hematuria 4 weeks after 2nd vaccine; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 24Mar2021 at 12:00 as a single dose for COVID-19 immunisation. Medical history included skin cancer and penicillin allergy. Concomitant medications included vitamin d nos (VITAMIN D). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Apr2021 at 07:00, 4 weeks after second vaccine the patient experienced unexplained hematuria. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event unexplained hematuria 4 weeks after second vaccine was unknown at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in a 30-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-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. On 11-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.).    Concomitant medications details were not reported by the reporter.  It was reported that 51 doses received to several patient from Lot AS7140C. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment details were not reported by the reporter.
This case was reported by an other health professional via call center representative and described the occurrence of shoulder pain in a 18-year-old male patient who received BEXSERO (batch number ABX6C1AA, expiry date 31st August 2019) for prophylaxis. On 13th March 2019, the patient received the 1st dose of BEXSERO. In March 2019, less than a week after receiving BEXSERO, the patient experienced shoulder pain, injection site pain, joint range of motion decreased and radiating pain. On an unknown date, the outcome of the shoulder pain, injection site pain, joint range of motion decreased and radiating pain were recovering/resolving. It was unknown if the reporter considered the shoulder pain, injection site pain, joint range of motion decreased and radiating pain to be related to BEXSERO. Additional details were provided as follows: The medical assistant reported that the patient experienced shoulder and injection site pain, limited range of motion, and pain radiating into the neck after receiving 1st dose of BEXSERO. The reporter stated that the patient was seen in the office on 19th March 2019 for events. This case has been linked with case US2019GSK054990, reported by the same reporter.
Chills, fever (102.4 F), vomiting, body sweats, stomach ache/nausea, sore muscles
Red, swollen eyes, with hot red blotchy patches around mouth and chin. Repeated flares approx. 3-5 days after use of prescribed ointment
After 1 month of 1st shot, patient is have an radiated pain on the left arm when she got the shot. It's on and off but it never goes away. She has seen her primary doctor but they said nothing they can do...
mom states lt leg started turning red p/bandaid off;lt thigh has 9cm x 9cm red warm area w/white area in the center of site of bandaid;
Left arm at injection site erythema, swelling same hardness. Client states reaction started 9/12/06. She also states HA and temperature.
Mom returned to office approx. 10 min after vaccines given due to childs arm having a welt and being red and swollen. A circle was drawn around red area and BENADRYL was given in office.
Swollen red warm arm, Headaches, Myalgia, Arthralgia. Nausea and then a rash of blisters on the left buttock very painful upper arm then radiated to the shoulder and neck associated with general weakness.
Sometime in October, my doctor sent me to get a CAT scan done, the CAT scan came back with an enlarged right lymph node. A few days later I got a biopsy for the right lymph node and came positive for cancer. They sent me to get a sonogram and an advanced mammogram of my R breast and I did that and they saw a small mass on my right breast. Biopsy on that mass and positive for stage 2 breast cancer. They sent me to get an MRI of my left breast, then the next day I got an MRI of brain, then needed to go a PET scan for the rest of my body to see if cancer was anywhere else. Since then I have started chemotherapy and I?m on 4 chemo drugs and go to chemo every 3 weeks. They give me anti-nausea medication and anti-vomiting medication  because the chemotherapy makes me very sick and I?m sick for 2 weeks after chemo. By the 3rd week, I feel better but I have to get chemo again. In May 2022, I will be getting a double mastectomy with both lymph nodes removed, left and right. Then will be doing chemo again. We will check towards the end of the year to see if there?s any more cancer, if not, I will not need radiation. If there is still cancer, they will finish it off with radiation treatment. When I start chemo again after the procedure, I will going down to 2 drugs instead of the original 4.
Breakthrough case of COVID-19 after fully vaccinated with 1 dose of viral vector vaccine and 1 booster dose of mRNA vaccine.
102F temp for 2 days 9/6-9/8 in AM small red bumps on 9/8 on belly/back now on rest of body
slurred speech, progressive malaise & weakness x 1wk, numbness & pain rt leg, T102;tx neurological exam, IV fluids, hemodialysis x 1;Annual follow-up dated 12/6/00 provided no additional data. 60 day follow-up dated 2/15/01 provided no additional data.
Left deltoid injection site reaction. 3cm tender nodule subdermal improved on follow up. By 10/20/06 nodule decreased 15mm.